Speaker Biographies

Optimizing Cell Culture Technology

Jan Bechmann, PhD, Associate Director, Late-Stage Upstream Process Development, Boehringer Ingelheim Pharma GmbH & Co. KG
Jan Bechmann has 10 years’ experience in the bioprocess industry. After his studies of Biotechnology, he focused on the application of advanced analytics for upstream bioprocess design. He worked as Postdoc and Senior Scientist driving technology development in cell culture with major focus on cell culture media and product quality modulation. Currently he is working as Associate Director in the Process Sciences department at Boehringer Ingelheim, where he is responsible for late stage process development.

Michael Butler, PhD, CSO, Cell Technology, National Institute for Bioprocessing Research and Training (NIBRT)
Michael Butler is the Chief Scientific Officer at the National Institute of Bioprocessing Research & Training (NIBRT), Ireland, Adjunct Full Professor in University College Dublin as well as Distinguished Professor Emeritus of the University of Manitoba, Canada. He holds degrees in Chemistry and Biochemistry from the Universities of Birmingham, London (UK) and Waterloo (Canada). He was the scientific director of MabNet, a Canadian network for Mab production and founder of Biogro Technologies Inc., a spin-off company dedicated to serum-free media development. His research work focuses on the development of bioprocesses using mammalian cells for the production of recombinant proteins, monoclonal antibodies and viral vaccines.

Véronique Chotteau, PhD, Researcher Principal Investigator, Cell Technology, Industrial Biotechnology, KTH Royal Institute of Technology
Dr. Chotteau has 30 years of experience in mammalian cell culture including ≥ 10 years in biopharmaceutical industry (at Pharmacia Upjohn/Biovitrum, Stockholm, nowadays Swedish Orphan Biovitrum). She is the Director of AdBIOPRO, Centre for Advanced Bioproduction by Continuous Processing, and Coordinator of the EU IMI2 project iConsensus, developing new solutions for real-time monitoring of the culture. In 2008, she was offered to lead the animal cell cultivation activities at KTH. Her group is focusing on cell-based processes for biologics production, high cell density perfusion of CHO and HEK293 cells and mathematical modelling. It was the first to publish cell densities higher than 200 million cells/mL in CHO cell perfusion process.

Mark Dürkop, PhD, Project Leader, Biotechnology, University of Natural Resources and Life Sciences, Vienna (BOKU)
With more than nine years of experience, Mark is a passionate scientist in the field of biopharmaceutical process development. He worked together with Novartis and Boehringer-Ingelheim targeting their needs in process development and understanding. Together with his team, he is developing a QbD software for both up and downstream processes. This software utilizes process data and first principle models (hybrid models) to quickly predict critical quality attributes (CQAs) from critical process parameters (CPPs). Hereby, bioprocess development and characterization will be accelerated significantly while simultaneously a better process understanding is gathered. From this research project, the company “Novasign” will be founded within 2019 offering this unique software solution.

Taylor Forte, Engineer I, Cell Culture Development, Biogen
Taylor Forte is an Engineer I in the Cell Culture Development department at Biogen with over 2 years of experience in upstream development. Taylor received a Bachelor’s degree in Biology and Mathematics from Emory University in 2017.

Brian Keppler  Director, Discovery and Translational Sciences  Metabolon, Inc.
Dr. Keppler received his Ph.D. in Pharmaceutical Sciences from the University of North Carolina at Chapel Hill where he focused on identifying novel ways to inhibit telomerase as an anticancer approach.  He completed his postdoctoral training at the NIEHS in molecular carcinogenesis.  Dr. Keppler joined Metabolon in 2011. 

António Lima Grilo, MSc, Early Stage Researcher, Chemical Engineering, Imperial College London
Antonio Grilo is a final year PhD Candidate in the Department of Chemical Engineering at Imperial College London under the supervision of Prof A. Mantalaris. His PhD work has focused on the development of mathematical models integrating growth, death and metabolism data and their use to predict CHO and NS0 cell cultures. These include multivariate bioprocess data analysis, first-principles predictive mathematical models and their integration. He has obtained BSc and MSc degrees in Biochemical Engineering from Instituto Superior Técnico, University of Lisbon, Portugal. His MSc dissertation was on alternative harvesting techniques for high-density CHO cell cultures in collaboration with Amgen. He authored 5 peer-reviewed publications and has presented his work is international conferences in Europe and the USA.

Rudiyanto Gunawan, PhD, Associate Professor, Chemical and Biological Engineering, University at Buffalo – SUNY
Rudiyanto Gunawan is an Associate Professor in the Department of Chemical and Biological Engineering at the University at Buffalo – SUNY. His research group is engaged in a broad range of activities in the areas of computational systems biology, biopharmaceutical engineering and bioinformatics. The group’s research mission has been to create enabling and innovative tools for the extraction of mechanistic and actionable insights from biological data, based on rigorous mathematical underpinnings, systems modeling and analysis, and advanced machine learning and optimization algorithms. These tools have been motivated by and applied to a range of problems with biopharmaceutical, pharmaceutical, and biomedical significance, through collaborations with research groups worldwide. Dr. Gunawan is a co-author on >70 peer-reviewed publications, and has given >35 invited lectures at academic research institutions and regional and international conferences. Dr. Gunawan is a co-recipient of Best Paper awards from the Journal of Process Control and Computers and Chemical Engineering journal.

Uwe Jandt, PhD, Senior Research Associate, Institute of Bioprocess and Biosystems Engineering, Hamburg University of Technology (TUHH)
With his background as a trained electrical engineer and years of experience in computer assisted medical imaging obtained at Philips Research Labs, Uwe is now senior group leader at the Hamburg University of Technology. His work focuses on novel computational approaches for bioprocesses and biosystems, such as cell culture technology, process control, as well as enzyme engineering and automation of simulation-experimental feedback loops.

Kelvin Lee, PhD, Professor, NIIMBL, University of Delaware
Kelvin H. Lee is Gore Professor of Chemical and Biomolecular Engineering at the University of Delaware and is Director of NIIMBL: the National Institute for Innovation in Manufacturing Biopharmaceuticals, one of 14 Manufacturing USA Institutes. He received a BSE in Chemical Engineering from Princeton and PhD in Chemical Engineering from Caltech. He spent several years in the Biotechnology Institute at the ETH in Zurich, Switzerland and also completed a postdoc in Caltech's Biology Division.

Alan G. Ryder, PhD, Professor, Nanoscale Biophotonics Laboratory, Chemistry, National University of Ireland Galway
Prof. Alan G. Ryder is based in the School of Chemistry at the National University of Ireland, Galway (NUIG).  He has a B.Sc. and Ph.D. in chemistry from NUIG.  After a stint as a postdoctoral researcher in UCC, he rejoined NUIG in 1997 to work on developing quantitative Raman spectroscopy-based methods for measuring illicit narcotics.  In 2003, he formed the Nanoscale Biophotonics Laboratory (NBL) which is focused on the use of photonics and chemometrics technologies for life and physical science applications.  In 2006 obtained tenure in the School of Chemistry at NUIG where he lectures mainly in spectroscopy and has two core research areas: Analytical Sciences and Photonics which cover a wide range of applications.  In the Analytical Sciences domain, his main research area is the development of rapid, quantitative analytical methods for the analysis of complex materials with particular focus on biopharmaceutical manufacturing and cell culture media analysis.  Key methods employed include Raman and Fluorescence spectroscopies and chemometrics.  He has collaborated with a wide range of industry partners including Bristol-Myers Squibb and Janssen-Biologics.  He has authored in excess of 95 publications, generated 3 patents, graduated 17 PhD students.

Gerald Striedner, PhD, Associate Professor, Biotechnology, University of Natural Resources and Life Sciences, Vienna (BOKU)
Gerald is an Associate Professor at the Department of Biotechnology (BOKU), head of the working group microbial fermentation, and principal investigator in the Austrian Center of Industrial Biotechnology (ACIB). The working group has established an integrated systems approach for bioprocess development and is focused on the implementation of PAT and QbD concepts in bioprocessing and rational host cell design. CHO, E. coli, insect cells and vero cell lines are used as expression systems for production of a representative set of biopharmaceuticals (mABs, Fabs, scFvs, VLPs, viruses, DNA).

Krithiknath Tirupapuliyur, Scientist, Biologics Process Development and Commercialization, Merck and Company
Graduated Carnegie Mellon University with Masters in Chemical Engineering. Has been working in biologics process development and commercialization for three yrs at Merck.

Hima Bindu Yalamanchili, PhD, Postdoctoral Fellow, Pharmaceutical Operations and Technology, Biogen
Hima Yalamanchili is a postdoctoral scientist at Biogen working on cell line development. Hima’s prior work focused on developing novel approaches for cancer characterization using machine learning. From a technical perspective, most of her experience is in bioinformatics and molecular biology. Hima’s educational background includes a MS in Cellular and Structural Biology and a PhD in Biomedical Sciences and Bioinformatics.

Jamey Young, PhD, Associate Professor, Chemical and Biomolecular Engineering, Vanderbilt University
Dr. Jamey D. Young is an Associate Professor of Chemical and Biomolecular Engineering at Vanderbilt University. The overall goal of his lab is to develop novel engineering approaches to measure, understand, and control cellular metabolism. Dr. Young has authored ~60 articles and book chapters describing the application of mathematical modeling and 13C flux analysis to a variety of research topics, including microbial physiology, liver and islet cell physiology, cancer cell metabolism, photosynthetic metabolism, and cell culture engineering. He developed the first publicly available software package (INCA) capable of both isotopic steady-state and nonsteady-state 13C flux analysis. INCA has been licensed over 100 times annually for academic use and by 10 different companies. His lab has successfully applied INCA to achieve several breakthroughs, including the first comprehensive 13C flux studies of photosynthetic cyanobacteria and plant leaves. He was awarded the NSF CAREER Award in 2010, the DOE Early Career Award in 2012, an NIH R01 award in 2015, and he was named a Vanderbilt Chancellor’s Faculty Fellow in 2017. Dr. Young is also a co-founder of Metalytics, LLC, which is a provider of metabolic flux analysis software and services to the biotechnology industry.

Xiaotian Zhong, PhD, Senior Principal Scientist & Lab Head, BioMedicine Design, Pfizer Research Labs
Dr. Xiaotian Zhong is currently Senior Principal Scientist and Lab Head at BioMedicine Design of Pfizer Worldwide R&D.  Prior to joining Pfizer in October 2009, he was Principal Research Scientist and Lab Head at Wyeth Research from June 2002 to September 2009. With 17 years pharmaceutical industry experience in Drug Discovery and Development, Dr. Zhong has a strong scientific and technical background in mammalian cell biology, therapeutic protein production & engineering, and antibody-drug conjugation. His current and past therapeutic research focuses include Oncology, Autoimmune diseases, and Cardio-Renal diseases. Dr. Zhong received a Ph.D. degree in Molecular Genetics from Georgia State University (Atlanta, GA), an MPH degree in Management from Harvard University, and a post-doctoral fellowship in Molecular Cell Biology at Harvard University. Dr. Zhong is an author or co-author of 33 peer-reviewed publications, and an inventor of 4 issued patents and 10 patent applications.

Anupam Singhal, PhD  Sr. Manager, Technology Development  Berkeley Lights
Anupam Singhal earned his PhD from the University of British Columbia and has over 15 years of experience in nanotechnology and microfluidics. His work has been cited over 600 times and resulted in patents that have been licensed and commercialized for molecular disease diagnosis, antibody therapeutics discovery, and development of cell-lines for bioproduction. At Berkeley Lights, Anupam leads the design and development of next-generation platforms for the discovery and development of biologics.

Kevin Tan, PhD  Senior Scientist  FUJIFILM Irvine Scientific Inc.
Kevin Tan is a senior scientist at FUJIFILM Irvine Scientific and works on developing and optimizing cell culture media for various industrial cell culture applications. He received his Ph.D. from the University of Washington and his B.S. from the University of California, Los Angeles.

Continuous Processing in Biopharm Manufacturing

Udayanath Aich, PhD, Assoc Director, Bristol-Myers Squibb
Currently Dr. Udayanath Aich is an Associate Director at Bristol Myers Squibb with extensive experience and management skills in analytical chemistry, and CMC analytical strategies for early, late and commercial biologics products. Dr. Aich completed his Ph.D. from Indian Institute of Technology Madras in the area of Chemical Biology. After completion Ph.D., he has joined in Biomedical Engineering Dept of Johns Hopkins for his postdoctoral study in the field of cell engineering, glycoengineering and structure-activity relationship. Subsequently, he has decided to move to Massachusetts Institute of Technology to gain extensive skills in the area of Biopharmaceutical characterization and drug development. Dr. Aich joined at Thermo Fisher Scientific in the chromatographic and mass spectrometric division to broaden his extensive analytical skills. Then Dr. Aich worked as Investigator at GlaxoSmithKline in the area of protein and glycans characterization, process analytics, CMC analytical strategies as ATL and structure-function study. Finally, before joining at Bristol Myers Squibb, Uday was working at Sanofi related to high throughput technologies, process analytical technologies (PAT), Analytical method harmonization, multi-attribute method Dev, analytical method dev, robustness, qualification and transfer for early and late stage product including 2nd generation commercial product as part of life-cycle analytics.

Srinivas Chollangi, PhD, Downstream Manager, MS&T, Bristol-Myers Squibb
Dr. Srinivas Chollangi is currently the Downstream Manager in Manufacturing Sciences & Technology group within Bristol-Myers Squibb (BMS) located in Devens, MA. Prior to this, he served in Process Development department for Six years in various roles with increasing responsibilities. Over the course of his tenure within Industry and Academia, Srinivas has authored 16 peer-reviewed publications, 2 Book Chapters and gave more than 35 conference presentations. Srinivas holds a PhD in Bioengineering and a Master’s in Chemical Engineering

Robert Dream, PE, CPIP, Managing Director, HDR Company, LLC.
Robert Dream is an industry leader with 30+ years of experience, including 20 years of executive leadership in the pharmaceutical and biotechnology industries. He has led projects, improved processes, helped move drug substance and drug products from R&D, clinical, regulatory licensing approvals through operational excellence strategies and leading edge technologies. He is business minded person and has an innovative knowledge and knowhow of manufacturing, logistics, supply chain, risk mitigation and management. He is experienced in therapeutic biotechnology and biological drug substance and drug products manufacturing, with extensive hands-on, senior leadership and executive experience at world-leading organizations. He wrote numerous articles for many journals and publications and lead and presented at many institutions, organizations, and conferences. He is a registered professional engineer and an active member of the ISPE and PDA. He is a member of the editorial advisory Board; Pharmaceutical Processing, Pharmaceutical Manufacturing, Pharmaceutical Technology, Pharmaceutical Engineering, and the INTERPHEX Advisory Council. He is a member and Process Chair of the PDA “Aging Facilities Modernization” Team. He is the Chair of the ISPE GUIDE: “Biopharmaceutical Process Development and Manufacturing”; published 2013, ISPE “Sustainability Handbook”; Published 2015 and numerous other relevant publication to list few.

Jared Franklin, MSc, Sr. Research Engineer, Continuous Manufacturing Skill Center, Sanofi
Jared Franklin is an upstream engineer in the Continuous Manufacturing Skill Center at Sanofi in Framingham, MA. After attaining his master’s degree from WPI in 2015, he worked on perfusion processes in Sanofi’s Bioprocess Development group. Since joining the Continuous Manufacturing Skill Center, Jared has been focused on developing an intensified perfusion platform, particularly through automation.

Ping Y. Huang, PhD, Director, Bioprocess Development, OED CMC Biologics, Abbvie
Ping is Head of Drug Substance biologic processes for Oncology Early Development in Abbvie. He obtained Ph.D in Biochemical Engineering from University of Maryland Baltimore County in 1992. After post Doc in NC State, he joined Protein Design Lab which was later acquired by Abbvie. In the last 23 years, he led teams of scientists and engineers in bioprocess dev, tech transfer and scale-up. He worked on projects in least 30 INDs, two of them successfully progressed to BLA and FDA approvals in 2015 and 2016.

Alfred Luitjens, PhD, Director Cell Technology, Batavia Biosciences
He has a profound background in development and production of vaccines, with more than 30 years of experience. He worked for research & development at Solvay, DSM Biologics and Crucell. He had a management position at the Animal Science Group and was senior manager process architecture at GSK.
At Batavia Biosciences Alfred is responsible for all upstream development vaccine projects.

Duarte Martins, PhD Student, Lab of Protein Technology and Downstream Processing, Univ of Natural Resources and Life Sciences Vienna, Austria
Duarte L. Martins is a PhD student in Prof. Jungbauer’s research group at the University of Natural Resources and Life Sciences (BOKU) in Vienna (Austria). His current research interests include continuous processing and virus clearance. From 2014 until 2016 he worked at Novasep CMO (Belgium), as Process Development Engineer, where he worked on purification processes for vaccines and gene therapy vectors. In 2013 he completed his master project at the Animal Cell Technology Unit, iBET/ITQB (Portugal).

Dan Milano, PhD, Senior Development Engineer, Conjugation Process Development, ImmunoGen, Inc.
Daniel is a Senior Development Engineer in the Conjugation Development Group at ImmunoGen. He serves as the technical lead for all late-stage conjugation development activities. His primary focus has been the process characterization and validation activities surrounding ImmunoGen’s lead product candidate mirvetuximab soravtansine and pipeline candidate IMGN632. Prior to joining ImmunoGen, Daniel received his PhD in chemical engineering from Northeastern University.

Jeffrey Roberts, PhD, Senior Research Scientist. Small Molecule Design and Development, Eli Lilly and Company
Jeffrey Roberts earned his Ph.D. in 2005 from Dalhousie University in Halifax, Canada.  He then received a Natural Sciences and Engineering Research Council (NSERC) Canada fellowship, and completed a post-doctoral appointment at Queen’s University in Kingston, Canada.  Dr Roberts joined Eli Lilly in 2008, where he has led the development of analytical control strategies for numerous late-phase portfolio assets.  He is currently a Senior Research Scientist in Small Molecule Design and Development, where he is responsible for implementation of process analytical technologies on continuous processes.

Shannon Ryan, PhD, Associate Director, Downstream Process Integration, BioContinuum™ Platform,  MilliporeSigma
In his role, Shannon focuses on connected and continuous mAb processing.  He has held multiple positions at MilliporeSigma including Segment Marketing and Senior Scientist roles in Clarification R&D and the Process Development Scientist Group.  Before joining MilliporeSigma, Shannon was with a start-up firm that focuses on development of novel antibacterial compounds based on chitosan.  He holds a Ph.D. in Organic Chemistry from Colorado State University, and a BA in Biology and Chemistry from Central College.

Ricardo Silva, PhD, Scientist, Animal Cell Technology Unit, iBET

Ricardo Silva received his Ph.D. degree in Chemical and Biochemical Engineering from the New University of Lisbon in 2013. His studies focused on the development and optimization of countercurrent adsorption processes for purification of biopharmaceutical products. Since 2014 he is a researcher at Animal Cell Technology Unit in iBET, pursuing the development of continuous purification processes and identification of new purification strategies for vaccines, gene therapy vectors and cell-based products.

Christoph Slouka, PhD, PostDoc, Institute of Chemical, Environmental and Bioscience Engineering, TU Wien
Christoph Slouka studied technical chemistry in his bachelor at TU Wien. He continued two master studies in material science and biotechnology. The topic of first Ph. D thesis was the defect chemical investigation of piezoelectric materials in the group of Prof. Fleig at TU Wien. Afterwards, he joined the group in biochemical engineering of Prof. Herwig, where he performed his second Ph.D working on modulations of IB properties in E. coli processes. After his thesis, he got a PostDoc position working mainly on establishment of continuous processing in E. coli.

Jonathan Souquet, PhD, Head, GD&L Technology & Innovation, Merck Serono
No bio available

Louis Taylor, BSc, Downstream Scientist, Biologics, Center for Process Innovation
Louise Taylor is a Downstream Scientist at CPI Biologics. She has 5 years of experience in Biologics process development alongside facility design & commissioning, having joined CPI in 2014 to help establish the new National Biologics Manufacturing Centre. Her current focus is on the development of recovery and purification processes, including continuous processing, for a wide range of biopharmaceuticals including recombinant proteins, MAbs, AAV, pDNA and nanoparticle therapies.

Agata Villiger-Oberbek, PhD, USP Head, Upstream Process Development, Codiak Bio
No bio available

Chiming Yu, PhD, Assoc Director, Downstream Process Development, Boston Institute of Biotechnology
Experienced strategic and scientific leader with thirteen years’ experience in process development, cGMP manufacturing, and with Lean Six Sigma Black Belt certification. Demonstrated record in process development for both microbial and mammalian cell derived therapeutic proteins. Previously, Chi-Ming worked in Abbvie Inc, Therapeutic Proteins International, Boehringer Ingelheim, and Xencor Inc.

Host Cell Proteins

Eric Bishop, Vice President of Research and Development, Research and Development, Cygnus Technologies
Eric has worked within the Biotechnology industry for 21 years. Eric was hired at Cygnus Technologies in, 2010 as the Vice President of Research and Development. His current responsibilities at the company include: business development, technical support, new product development,  custom services, along with being the Head of Research and Development Laboratory. 

Heather Boux, PhD, Principal Scientist, Attribute Sciences, Process Development, Amgen
https://www.linkedin.com/in/heather-boux-86606392/

Erika Friedl, PhD, Quality Expert, Hematology and Transfusion Medicine, Paul-Ehrlich-Institute
Erika Friedl is working as quality expert (pharmaceutical quality/CMC) at the Paul-Ehrlich-Institute (PEI) in Langen, Germany. She is responsible for the evaluation of blood products, and is involved in GMP inspections. Erika is a member of the Host Cell Protein Working Party at the EDQM

Abraham M. Lenhoff, Allan P. Colburn Professor, Department of Chemical and Biomolecular Engineering, University of Delaware
Abraham Lenhoff is the Allan P. Colburn Professor of the Department of Chemical and Biomolecular Engineering at the University of Delaware, where he has been on the faculty since 1984 and was Chair from 2012-7.  He earned a Bachelor's degree from the University of Cape Town and Master's and Ph.D. degrees from the University of Wisconsin, all in chemical engineering. His research is primarily on application of principles of thermodynamics, transport phenomena, biophysics and colloid science to protein separations and phase behavior, especially chromatography and crystallization.

Yan-Hui Liu, PhD, Principal Scientist, Sterile Product and Analytical Development, Biologics Development, Merck & Co., Inc.
https://www.linkedin.com/in/yan-hui-liu-7348ab26/

Diane McCarthy, PhD, Senior Manager, Science and Standards Biologics Pipeline Development, USP
Dr. McCarthy is Senior Manager, Science and Standards Biologics Pipeline Development within USP’s Global Biologics Department. Diane works with stakeholders to identify areas where standards are needed and define and develop new standards. Prior to joining USP, Dr. McCarthy was Senior Scientific Director at Caprion Biosciences, where she focused on the use of mass spectrometry for characterization of biologics and host cell proteins. Her previous roles also included Director of Scientific Affairs at Ezose Sciences, where she focused on identification and quantitation of glycans by mass spectrometry and Global Manager, Biomarker Research Center, at Bio-Rad Laboratories, where she directed translational and biomarker research contracts and collaborations with industry, key consortia, academic, and government groups.

Emily Menesale, PhD, Senior Associate Scientist, Analytical Development, Biogen
Emily Menesale is a senior associate scientist in the bioassay and gene therapy analytical development group at Biogen where she has worked for the past 11 years. Emily’s work focuses on bioassay development, specifically HCP assay development and characterization methods. She received a Master of Science in Pharmaceutical Sciences from Northeastern University and a Bachelor of Science in Psychology and Neuroscience from UMass Amherst.

Ejvind Mortz, PhD, Chief Operating Officer, Alphalyse
Ejvind Mortz has a PhD in protein mass spectrometry, and he has been working the last 20 years developing analytical characterization methods for biopharmaceutical proteins. He is co-founder and Chief Operating Officer of Alphalyse providing protein analysis services.

Nisha Palackal, PhD, Director, Protein Biochemistry, Regeneron Pharmaceutical, Inc.
https://www.linkedin.com/in/nisha-palackal-a418ba/

Gwenaël Pottiez, PhD, Principal Scientist, Proteomics, CAPRION BIOSCIENCES
Gwenael Pottiez Ph.D., is Principal Scientist at Caprion. His research concentrated on biomarker identification using proteomic approaches. He focused essentially on neuroscience, identifying and quantifying biomarkers for neurodegenerative diseases as well as identifying biomarkers associated to the differentiation the blood-brain barrier. In 2018, Gwenael joined Caprion to manage research studies for clients, such as biomarker discovery, HCP discovery, neo-epitope discovery as well as research and development studies.

Veronika Reisinger, PhD, Lab Head Physico-Chemical Characterization, Technical Research & Development, Novartis-Global Drug Development
Veronika Reisinger works currently in the physico-chemical characterization group at Novartis Global Drug Development in Austria as laboratory head. Before joining Sandoz in 2011 as scientist in the characterization group, Veronika worked as a postdoctoral fellow in a protein biochemistry laboratory at the University of Stavanger, Norway. Her current work focuses on the mass spectrometric characterization of biopharmaceuticals and associated impurities.

Jeff Schneiderheinze, PhD, Director, Bioanalytical Method Development, Regeneron
Obtained a Ph.D. in Analytical Chemistry in 2000 from Missouri Science and Technology university.  Worked for a brief period at Quintiles CRO doing small molecule method development and validation.  Accepted a position with Pfizer in 2002 performing analytical method development and validation of biotherapeutics.  Held several positions at Pfizer in analytical method development before joining Regeneron in 2013 continuing work in analytical method development and validation of biotherapeutics.  Currently the Director of Bioanalytical method development in the Regeneron Analytical Sciences department.

Don Walker, PhD, Pharma Technical Development, Genentech
Don obtained his Bachelor of Science degree in Chemistry from the University of Georgia.   Since then, he has worked in research and development both in the public sector (NIH) and the biopharmaceutical industry for over 30 years, with over 25 years of experience in mass spectrometry.  He has been at Genentech in South San Francisco, CA for the last 6 years developing Host Cell Protein LC-MS/MS detection and quantification methods for their biopharmaceuticals.

Fengqiang Wang, PhD, Associate Principal Scientist, Merck
Fengqiang received his Ph.D. in Cancer Pharmacology in 2002 from Peking Union Medical College & Chinese Academy of Medical Sciences. He then completed a post-doctoral training at Northwestern University on Cancer Biology from 2002 to 2004. Subsequently, he started his academic career at New York University School of Medicine and became Assistant Professor in 2007.  In 2011, Fengqiang joined Merck Research Laboratories as a Senior Scientist and then Associate Principal Scientist in the Bioprocess Development Department. At Merck, a major part of his focus is on host cell protein assay development and HCP characterization by immunoassay, 2D-DIGE, 2D-LC-MS, and 2D-Western blot. He is also specialized in assay development for monitoring other process residuals such as Trypsin, CBP B, protease inhibitors, β-glucan etc. He has authored more than 40 peer-reviewed scientific publications and presented at many national and international meetings.

Ying Zhang, PhD, Principal Scientist, Analytical Research & Development, Pfizer
Dr. Ying Zhang is currently a Principal Scientist in the mass spectrometry and biophysical characterization group (MSBC) within Analytical Research and Development (ARD) organization at Pfizer. At present, Ying is responsible for development of mass spectrometry based method and characterization of protein therapeutics within Pfizer's biotherapeutics portfolio. Ying is also the SME of HCP analysis by mass spectrometry within Pfizer. Ying received her BS degree in Chemistry from Nanjing University in China. She then decided to pursue her PhD degree in mass spectrometry at Washington University in St. Louis under the supervision of Prof. Michael Gross. She obtained her degree in 2014 and joined Pfizer Chesterfield site shortly thereafter.

Rapid Methods to Assess Quality & Stability of Biologics

Arun Alphonse Ignatius, PhD, Principal Scientist, Pharmaceutical Research and Development, Biotherapeutics, Pfizer, Inc.

Arun Alphonse Ignatius is a Principal Scientist and Group Leader in the Pharmaceutical R&D group at Pfizer. He manages a group of scientists and as a matrix team(s) lead he is responsible for CMC aspects of drug product development for early and late-stage programs. He is currently involved in advancing the GTx portfolio and building platform formulation and process development capabilities. He is the unit point of contact in Pfizer Worldwide R&D postdoctoral program committee and a current postdoctoral mentor. His research focuses on the applications of NMR in the higher-order structural characterization of antibodies and fusion proteins. He has over 30 peer-reviewed publications in the area of protein formulation, biophysical characterization and structural biology. 

Cesar Calero-Rubio, PhD, Scientist, Biologics Drug Product Development, Sanofi
Cesar Calero-Rubio, Ph.D., is currently a member of the Biologics Drug Product (DP) Development group at Sanofi. He has more than 5 years of experience studying and developing formulations for biologic modalities (e.g., poly-peptides, enzymes, monoclonal antibodies, bi-specifics, tri-specifics and gene therapy programs). He currently leads and enables DP development workflows of early and late-stage gene therapy and other biologic modalities. He received his Ph.D. in Chemical Engineering from the University of Delaware working with Prof. Christopher J. Roberts and is an active contributor to the scientific literature involving protein physical stability and DP long-term storage.

Mark Dürkop, PhD, Project Leader, Biotechnology, University of Natural Resources and Life Sciences, Vienna (BOKU)
With more than nine years of experience, Mark is a passionate scientist in the field of biopharmaceutical process development. He worked together with Novartis and Boehringer-Ingelheim targeting their needs in process development and understanding. Together with his team, he is developing a QbD software for both up and downstream processes. This software utilizes process data and first principle models (hybrid models) to quickly predict critical quality attributes (CQAs) from critical process parameters (CPPs). Hereby, bioprocess development and characterization will be accelerated significantly while simultaneously a better process understanding is gathered. From this research project, the company “Novasign” will be founded within 2019 offering this unique software solution.

Austin Gallegos, BS, R&D Associate, Dosage Form Design and Development, AstraZeneca
Austin Gallegos received a Bachelor of Science degree in Molecular Biology from Towson University in 2015, where he characterized previously un-identified short open reading frames and associated small proteins in E. coli. Upon completion of his degree, Austin participated in a postbaccalaureate research fellowship at the National Institutes of Health. His studies involved work with transmembrane proteins including functional dissection of the mitochondrial iron transporter, Mitoferrin-1. He joined MedImmune/AstraZeneca at the end of 2016 and is currently a Research and Development Associate with the Dosage Form Design and Development group. Austin’s work is currently focused on drug product development and the impact of oxidative degradation and environmental factors such as light exposure.

Constanze Helbig, PhD, Postdoctoral Scientist, Coriolis Pharma Research GmbH
since 2017           Postdoctoral Scientist at Coriolis Pharma
2012 – 2017        Research Associate and PhD student at Ludwig-Maximilians-Universität (Munich)
2011                       Degree in Biophysics, Technical University of Munich

Kara Huang, PhD, Senior Scientist, Drug Product Development, AbbVie
Kara is a senior scientist at AbbVie in the Drug Product Development group. As the pre-formulation representative on project teams, she acts as a bridge between discovery and development providing the discovery team with developability assessments for new biologics. Previously she was a scientist in the Biomolecular Characterization division at NIST. She received her Ph.D. in Biological Engineering at MIT and a B.S. in Chemical Engineering at Caltech.

Elisabeth Kast, PhD, Senior Scientist, Protein Analytics, AbbVie
Elisabeth has been a senior scientist in Protein Analytics at AbbVie since 2016.  She has supported the method development of challenging fusion proteins as well as platform method development for mAbs, with a passion for glycan analysis.  Prior to joining AbbVie, she worked at a small, niche CRO focusing on glycoanalytics for 9 years.  She obtained her PhD from UMass Lowell.

Haripada Maity, PhD, Director, Biologics Formulation Development, Jazz Pharmaceuticals
https://www.linkedin.com/in/haripada-maity-3b41769/

Subhashchandra Naik, PhD, Senior Scientist, Reform Biologics
Subhashchandra Naik is a protein biochemist interested in the stability and folding kinetics of proteins.  He has a Masters in pharmaceutical sciences and a Ph.D. in biochemistry and molecular biology from the University of Kansas. He was a postdoctoral researcher at the University of Kansas and the University of Delaware and is currently a senior scientist at Reform Biologics. He has worked extensively on characterizing and stabilizing pre-aggregates in therapeutic protein solutions and has a patented platform technology to identify and quantify unfolded protein states that cannot be easily detected using existing analytical techniques.  He also has several publications and awards and has presented at numerous conferences.

Belinda Pastrana, CEO, Protein Dynamic Solutions
Following her training at Rutgers and Mayo, Dr. Pastrana has dedicated thirty years to developing and patenting cutting-edge solutions for protein and biologic characterization. She is a tenured faculty member at the University of Puerto Rico, and has trained a generation of students for subsequent employment in the biopharmaceutical industry.

Dean Ripple, PhD, Leader, Bioprocess Measurements Group, NIST
Dean received a PhD from Cornell University in 1991. After a successful career at NIST developing methods and standards in thermometry, in 2010 he became Leader of the Bioprocess Measurements Group, which conducts research supporting biomanufacturing and health care. His own research focuses on new standards and methods for characterizing protein particulates. Dean has presented workshops on measurement issues to many industrial groups, ranging from petroleum producers to vaccination program coordinators. He is an active member of the NCSLI Healthcare Metrology subcommittee, the ASTM committee on the Manufacture of Pharmaceutical Products, and expert panels of the US Pharmacopeia. In recognition of his contributions, he has received awards from the Department of Commerce, ASME, and two ASTM committees.

Satish K. Singh, PhD, Head, Sterile Product Technology, Moderna Therapeutics
https://www.linkedin.com/in/satish-singh-4024a8/

Mark Skasko, Ph.D, Science & Standards Liaison, Global Biologics, US Pharmacopeia
Mark Skasko joined Global Biologics at USP with 8 years of CMC/Product Quality experience from the FDA working within CDER and CVM on biotherapeutics and other complex pharmaceutical dosage forms. Prior to his tenure with the FDA, Mark studied retroviruses for 9 years focusing on understanding pathogen-host cell interactions.   

Tingwan Sun, PhD, Senior Scientist, Protein Analytics, Adimab LLC
Dr. Tingwan Sun got his Ph.D. from UT Southwestern Medical Center in 2008. He joined the Protein Analytics group at Adimab in 2012 as a Scientist. Currently he is working on antibody characterization and developability related assays.

Michael Swanson, Senior Scientist, Merck
 https://www.linkedin.com/in/swansonscientist/

Laura Tanenbaum, PhD, Scientist, BioTherapeutics Drug Product Development, Janssen R&D
Laura Tanenbaum is a Scientist in BioTherapeutics Drug Product Development at Janssen R&D as part of the formulation development group. She received a BS in Chemical and Biomolecular Engineering from Rice University and a PhD in Medical Engineering from Massachusetts Institute of Technology.

Cell Therapy CMC & Analytics

Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals, Ltd.
Christopher founded Consulting on Advanced Biologicals Ltd at the end of 2009 in order to focus his activities within the Regenerative Medicine sector.  CAB Ltd provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine.  Christopher has a PhD in xenotranplantation immunology and spent 8 years in biotech (Imutran Ltd, A Novartis Pharma AG Co. and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time Christopher was involved with National implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.  

Anna Brown, Associate Director, Process & Analytical Development, Unum Therapeutics
Anna Brown is an Associate Director at Unum Therapeutics, where Anna leads the assay development team developing assays to release and characterize cell therapies including support of in-process development testing. Anna has worked for 17 years in the pharmaceutical industry developing, qualifying and validating biological assays to characterize and release live vaccine, recombinant protein and monoclonal antibody products. After a successful career in assay development Anna, is now advancing cell therapy analytics at Unum Therapeutics with the aim of expanding product and process understanding and establishing robust GMP-ready release tests.

Dominic Clarke, PhD, ISCT Process & Product Committee Member and Global Head, Cell Therapy, HemaCare
Dr. Dominic Clarke joins the company in Los Angeles after previous positions held at Charter Medical and BioLife Solutions. At Charter Medical, Dr. Clarke successfully launched their first FDA 510(K) approved product for cell & gene therapy manufacturing use and was instrumental in positioning the company as a leading supplier to the industry. While at BioLife, Dr. Clarke led the research and development to support the critical role of biopreservation in maintaining viable, functional cell-based materials.  With a Ph.D. in Cell and Molecular Biology from Binghamton University in New York and a postdoctoral fellowship in cell and developmental biology from SUNY Upstate Medical University, Dr. Clarke will offer scientific insight, product development strategy, and advanced support to HemaCare’s growing customer base.

Anthony Davies, PhD, Founder and CEO, Dark Horse Consulting
Anthony founded Dark Horse Consulting in 2014, bringing his 20+ years of leadership experience in product, process and manufacturing development to cell and gene therapy companies in need. His extensive network within the biotechnology industry allowed him the privilege of hand-picking the exceptional team of consultants working at Dark Horse, chosen for their top-notch performance, broad abilities, and unique expertise. Anthony’s responsibilities as Chief Executive Officer include defining the strategic growth and focus of the practice, team building, liaising with key clients and developing business for the company. He is a highly sought-after keynote speaker and chair of national and international conferences and seminars, noted for his provocative, thoughtful and sometimes contrarian presentations.

Amanda Fitzgerald, PhD, Senior Scientific Consultant, Biologics, Genedata
Amanda Fitzgerald leads a team of scientific consultants at Genedata, who provide solutions for organizations with large molecule and data management needs. She received her doctorate in Biochemistry and Molecular Pharmacology from the University of Massachusetts Medical School and has pharmaceutical industry experience in biotherapeutic discovery and production groups, including scientific support for strategic alliances and development of a high-throughput protein production platform at Pfizer.

Mo Heidaran, PhD, Vice President, Technical, PAREXEL Consulting, Former FDA Reviewer
Dr. Heidaran joined PAREXEL International as Vice President of Technical in December of 2018. Mo has worked previously as a Branch Chief (Acting) in Division of Cellular and Gene Therapy (DCGT) in the Office of Tissues and Advanced Therapies (OTAT) and as a CBER wide subject matter expert providing advice to ADRM in the Office of CBER Director on special subject matters related to CMC policies and regulatory review management processes. He also has close to 8 years prior experience as a Biologist and as a Master Reviewer in OTAT, and as a facility reviewer and inspector in the Division of Manufacturing and Product Quality (DMPQ).  During his tenure at OTAT, in addition to his review responsibilities, he has served as a DCGT representative to several FDA and CBER wide working groups and outside organizations such as USP.  He has also been involved in various standard development activities, cell based product manufacturing initiatives and various compliance actions.

Ruud Hulspas, PhD, Independent Consultant, Cellular Technologies Bioconsulting, LLC
Dr. Ruud Hulspas is the Founder of Cellular Technologies Bioconsulting, a company dedicated to increasing reproducibility and quality of (pre-)clinical research, with a focus on the development of manufacturing processes for cellular therapy. Dr. Hulspas brings 25 years of experience in cytometry and the development of novel technologies to international efforts to incorporate reliable cytometry-based quality control systems into manufacturing platforms for cell-based products in cellular therapy.

Paul Kopesky, PhD, Director, Manufacturing and Supply Chain, Magenta Therapeutics
Paul Kopesky is the Director of Manufacturing and Supply Chain for Magenta Therapeutics’ cell therapy program. He has more than 15 years of experience in advanced therapy research, process development, and GMP manufacturing. He holds a BS and MS in chemical engineering and a PhD. in biological engineering from MIT.

Angela Keightley, PhD, Director, Assay Development, Bluerock Therapeutics
Dr. Angela Keightley is the Director of Assay Development at BlueRock Therapeutics, an engineered cell therapy company with a focus on developing regenerative medicines for intractable diseases.  At BlueRock Therapeutics, Dr. Keightley is responsible for establishing and qualifying critical characterization and quality control assays for cell therapy products and manufacturing processes.  She has over 15 years of experience in assay development and validation in the contract research industry to support the preclinical and clinical development and manufacturing support of novel biological drug products, including cellular and gene therapies, across diverse therapeutic programs.  Dr. Keightley received her B.Sc. in Biology from Trent University and her Ph.D. in Pathology from Queen’s University.

Katja Kleinsteuber, PhD, Scientist II, Cellular Analytics, Bluebird Bio
Immunologist with focus on infectious diseases, rare diseases and cancer. I received my PhD in 2012 from the University of Hamburg (Germany) and trained as a postdoctoral fellow at the Ragon Institute of MGH, MIT and Harvard in Cambridge, MA. I have studied T cells in the context of tuberculosis, HIV and melanoma by applying single cell technologies such as flow cytometry and mass cytometry (CyTOF). I am interested in characterizing cellular drug products to better understand their mechanism of action and to identify biomarkers of response. I strive to better serve our patients by understanding the “full picture” of cellular drug products.

Athanasios (Sakis) Mantalaris, PhD, Professor, W.H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology & Emory University
Athanasios (Sakis) Mantalaris is currently Professor in the W.H. Coulter Department of Biomedical Engineering at Georgia Institute of Technology & Emory University. Prior, he was Professor of BioSystems Engineering in the Department of Chemical Engineering at Imperial College London. He received his PhD (2000) in Chemical Engineering from the University of Rochester. His expertise is in modelling of biological systems and bioprocesses with a focus on mammalian cell culture systems, stem cell bioprocessing, and tissue engineering. He has published over 170 original manuscripts, co-edited one book, and holds several patents with several more pending. He has received several awards including the Junior Moulton Award for best paper by the Institute of Chemical Engineers (IChemE) in 2004. In 2012, he was elected Fellow of the American Institute for Medical & Biological Engineering and in 2013 he was awarded a European Research Council (ERC) Advanced Award. In 2015, he was awarded the Donald Medal by the Institution of Chemical Engineers (IChemE) for his contributions to biochemical engineering.

Krishnendu Roy, PhD, The Robert A. Milton Chair and Professor, Biomedical Engineering; Director, Marcus Center for Cell Therapy Characterization Manufacturing (MC3M), Georgia Tech
The overall goal of the Laboratory of Cell and Macromolecular Engineering is to achieve a basic understanding of how the immune system responds to genetic manipulations and how cellular fate is decided based on microenvironmental cues. Not only is this going to help us find novel treatments for diseases but will also help us understand the fundamentals of genetic manipulations, cell differentiation and cell-cell interactions i.e. the complex interplay between cells and their environment.

Sumona Sarkar, PhD, Biomedical Engineer, Biosystems and Biomaterials Division, Biomaterials Group, NIST
Dr. Sumona Sarkar is a biomedical engineer in the Biosystems and Biomaterials Division at the National Institute of Standards and Technology. Dr. Sarkar conducts research in the area of measurement assurance to address analytical challenges in cell therapy and regenerative medicine.  She is currently serving as an US expert in the Analytical Methods working group of ISO/TC 276: Biotechnology and has been contributing to the development of standards for cell counting and cell characterization.

Ilya Shestopalov, PhD, Senior Scientist, Cellular Process Characterization and Analytics, Bluebird Bio
Ilya Shestopalov, PhD currently leads the cell analytics group within cellular process development at bluebird bio.  His research focuses on development of cell-based assays for hematopoietic stem/progenitor and CAR-T products.  Prior to bluebird bio, Dr. Shestopalov was a postdoctoral fellow in stem cell biology at Boston Children’s Hospital and Harvard University working with zebrafish hematopoietic stem cells.  Dr. Shestopalov received his PhD in 2010 from the Chemical Biology program at Stanford University and a B.Sci in Biological Chemistry from University of Chicago in 2004. 

Junxia Wang, PhD, Director, Analytical Development, Mustang Bio, Inc.
Junxia Wang, is a Director of Analytical Development at Mustang Bio, a Fortress biotech for the development of CAR T cell therapy for oncology and stem cell therapy for rare diseases. She is responsible for strategic planning and execution of analytical activities for all clinical programs. She and her team are responsible for technology transfer and the development of lot release and characterization assays for clinical manufacturing of CAR T cell and stem cell products. She designs… assays for biomarker discovery.. in the Prior to Mustang Bio, she is an Associate Director of Immunosafety and Bioanalytical Development at Editas Medicine, responsible for the development and implementation of strategies for safety evaluation CRISPR/Cas9 programs across portfolio with a focus on immunogenicity. Prior to Editas, Junxia worked at Novartis, where she was a Fellow in Cell and Gene Therapy, Oncology Business Unit, a project leader in Technical Research and Development spearheaded exploratory analytical activities for biomarker discovery and led functional assay design and development to support process development, manufacturing and clinical development of CAR T-Cell immunotherapy.

Daniel Wilkinson, PhD, Scientist, Computational Biology, Bluerock Therapeutics
Dan Wilkinson holds a PhD in Materials Science and Engineering from the University of California, Los Angeles. He joined BlueRock Therapeutics in early 2018 as the lead computational biologist. His work focuses on applying a range of analytical techniques to discover and monitor phenotypic markers during stem cell differentiation for R&D process optimization and manufacturing control. He believes that through large dataset acquisition, curation and machine learning treatments it is possible to identify and act upon key mRNA molecular profiles, single cell morphologies and chemometric states that under proper statistical control will result in manufacturing reproducibility and success. In his free time, Dan enjoys reading science fiction and dreams of one day traveling to and vacationing on Mars.

Qiong (Chelsea) Xue, PhD, Associate Director, Head Analytical Development, Cell Therapies, Pharmaceutical Sciences, Takeda Pharmaceuticals
Chelsea is currently Head of Analytical Development for Cell Therapies in Takeda. She is building the analytical capabilities and developing an integrated analytical package to enable product quality control, drive product understanding and next-generation design. In her previous role at Novartis, Chelsea contributed significantly on product analytics and CQA discovery for CTL019 which was later approved for ALL as Kymriah. She later led a group focused on clinical biomarker development. Chelsea received her PhD from Texas A&M Health Science Center and competed postdoc training in Yale University.

1B: Bioproduction: Scale, Bioreactors & Disposables

Woo Suk Ahn, PhD, Scientist Upstream, Process Science, Global Manufacturing Science and Technology (MSAT), Sanofi US
I am a cell metabolism scientist. I am interested in how cellular metabolism impacts cellular physiology and its applications at upstream process for biologics production.

Dr. Wasfi AlAzzam, Chief Scientific Officer, TechnoPharmaSphere (TPS)
In this role, he provides scientific, research, development and technology development consultations for pharmaceutical and biotechnology products in the early and late stages. He helps technology/method developers develop and promote their technologies. Additionally, he helps intellectual property law firms evaluate data and identify infringement, acts as an expert witness, and drafts patents. He helps review, draft, and address questions on regulatory submissions. Before this, Dr. AlAzzam was a Fellow in CMC analytical development at GlaxoSmithKline, and formulation and delivery lead at Bayer Healthcare. 

Jonathan Bones, PhD, Principal Investigator, Characterization and Comparability Laboratory, National Institute for Bioprocessing Research and Training (NIBRT)
Jonathan received his PhD in Analytical Chemistry from Dublin City University in 2007. Jonathan then moved to NIBRT - The National Institute for Bioprocessing Research and Training, working under the mentorship of Prof. Pauline M. Rudd within her GlycoScience Laboratory. In 2010, Jonathan was appointed the John Hatsopoulos Research Scholar within the Barnett Institute of Chemical and Biological Analysis at Northeastern University, Boston, working under the mentorship of Prof. Barry L. Karger. Jonathan returned to NIBRT in 2012 and is the Principal Investigator of the NIBRT Characterization and Comparability Laboratory and an Associate Professor in the School of Chemical and Bioprocess Engineering at University College Dublin.

Jeremy Discenza, MSc, Scientist I, Bristol-Myers Squibb Co.
• Designed, executed, and optimized lab-scale bioreactor models in support of mAb commercial bioprocesses.
• Experience in designing and conducting Upstream bioprocess studies including characterization, qualification, and DOE screening studies. Experience in CFD modeling for use in SDM development.
• Experienced in process modeling with the end goal of process robustness and improvement, ensuring product quality targets and supporting yeild optimization.
• Provided recommendations and implemented continuous improvement to optimize workflow in lab-scale bioreactor processes.
• Experience in set-up, maintenance, and troubleshooting lab-scale bioreactors, metabolite analyzers and cell counters.

Jean-François Hamel, PhD, Research Engineer, Chemical Engineering, Massachusetts Institute of Technology (MIT)
Jean-François Hamel is French-born Biochemical Engineer sharing his passion for biological systems teaching students and training professionals.  As an educator and consultant, he has a wide international network and is based in the Boston area. He has integrated creative and engaging approaches to enhance learning outcomes in courses and to prepare students for cutting-edge research in academic or industry environments.  In his work, Dr. Hamel focuses on upstream and downstream processes in microbial and cell culture processes, and uses integrated advanced analytical technologies. He has helped to bring novel technologies into the student curriculum, including beta-testing the first rock-bed single-use bioreactor perfusion system, the earliest portable microbial flow cytometer, in-situ glucose and O2, CO2, pH optical sensors, advanced analyzers, expanded-bed chromatography, and computer simulation tools. 

Menzo Havenga, PhD, CEO, Batavia Biosciences
Dr. Havenga is CEO at Batavia Biosciences. With almost 20 years of industry experience, he was Managing Director business unit Biosciences at TNO, Vice President R&D at Crucell (now J&J) and held senior positions at IntroGene. He holds a PhD degree from the University of Leiden, the Netherlands.

Anil Kumar, PhD, Principal Process Engineer, Global MSAT, Sanofi Genzyme
Dr. Kumar is an Experienced Principal Process Engineer with a demonstrated history of working in the biotechnology industry. He possesses Strong professional skills in Biotechnology, Biopharmaceuticals, Purification, Product Development, and the U.S. FDA. Prior to working at Sanofi Genzyme, Dr. Kumar spent 9 years at Pall Life Sciences.  He received his MS and PhD from the City College of New York in Chemical Engineering.

Will Johnson, PhD, Principal Engineer, Digital Integration & Predictive Technologies (DIPT), Process Development, Amgen, Inc.
Will Johnson is a member of Amgen’s Advanced Modeling and Simulation group, a multidisciplinary team of scientists and engineers engaged in transforming Amgen’s product & process development lifecycle using computational models based in fundamental understanding, enabling world-class process development and manufacturing. An alumnus of UCLA and UC Berkeley, he’s spent the last decade optimizing process and device design in the biotechnology and active implantable medical device industries.

Michael Mollet, PhD, Principal Scientist, AstraZeneca
I am a cell culture scientist focused on late stage process development, production bioreactor scale-down modeling and process characterization in particular. I have designed and executed scale-down modeling studies on four different monoclonal antibodies (mAb) and am currently leading a group of scientists performing process characterization studies on another mAb. I have also led a cell culture scale-up lab group, overseeing the operation of 20L to 500L stainless steel and single use bioreactors.

Gregg Nyberg, PhD, Associate Vice President and Head, Biologics Process Development and Clinical Manufacturing, Merck & Co., Inc.
o Lead organization responsible for clinical supply and commercialization of biologics. 
o Management of scientists and engineers supporting cell line development, upstream and downstream process development, technology development and clinical manufacturing.  Gregg received his Doctor of Philosophy (Ph.D.) in Chemical Engineering from the Massachusetts Institute of Technology (MIT).

Alan G. Ryder, PhD, Professor, Nanoscale Biophotonics Laboratory, Chemistry, National University of Ireland-Galway
Prof. Alan G. Ryder is based in the School of Chemistry at the National University of Ireland, Galway (NUIG).  He has a B.Sc. and Ph.D. in chemistry from NUIG.  After a stint as a postdoctoral researcher in UCC, he rejoined NUIG in 1997 to work on developing quantitative Raman spectroscopy-based methods for measuring illicit narcotics.  In 2003, he formed the Nanoscale Biophotonics Laboratory (NBL) which applies photonics and chemometrics technologies to applications in the life and physical sciences.  In 2006 obtained tenure in the School of Chemistry at NUIG as senior lecturer and was promoted professor there in 2016.  He has two core research areas: Analytical Sciences and Photonics which cover a wide range of applications.  In the Analytical Sciences domain, his main research area is developing of rapid, quantitative analytical methods for the analysis of complex materials with particular focus on biopharmaceutical manufacturing and cell culture media analysis.  He has collaborated with a wide range of industry partners including Bristol-Myers Squibb and Janssen-Biologics.  He has authored more than 95 publications, generated 3 patents, graduated 17 PhD students.

Stefan Schmidt, PhD, MBA, COO and Head, Operations, BioAtrium AG
Dr. Stefan R. Schmidt MBA, currently serves as Head of Operations/COO at BioAtrium AG, a joint venture of Lonza and Sanofi in Visp, Switzerland. Previously he held the position as CSO and other senior executive roles at Rentschler Biopharma with overall responsibilities for development and production for more than 5 years. Before that, he was CSO at ERA Biotech in Barcelona, directing the company’s R&D efforts. Prior to that, he worked for 7 years at AstraZeneca in Sweden where he led the unit of Protein Sciences as Associate Director. He started his leadership career at Biotech companies in Munich where he built up protein biochemistry teams for Connex and GPC-Biotech.

T. Craig Seamans, PhD, Senior Principal Scientist, Biologics Process R&D, Merck & Co., Inc.
Ph.D. in Biochemical Engineering with over 20 years of experience in the Biotechnology Industry; supporting increasing responsibilities across the areas of upstream process development, scale up, technology transfer, and plant operations.

Rustin M. Shenkman, PhD, Senior Upstream Development Engineer, Process Development Biologics, Shire US, Inc., a Takeda Company
Rustin Shenkman is a bioprocess engineer with experience leading early- and late-stage upstream process development, characterization, and technology transfer. He specializes in continuous bioreactor perfusion and harvest clarification.

Johannes Wirth, MSc, Scientist, Bio Process Science, Rentschler Biopharma SE
After completing his studies in Pharmaceutical Biotechnology at the University of Ulm (MSc), Johannes Wirth joined Rentschler in 2017 as a scientist in the department of Bio Process Science. The department is engaged in all aspects of modern bioprocess development with a focus on implementing new technologies and approaches to improve upstream bioprocesses.

Michelet Dorceus, Bioprocess Senior Field Applications Specialist, Eppendorf
Michelet Dorceus is our Bioprocess Senior Field Applications Specialist at Eppendorf Americas.  Michelet earned his bachelor degree in biology and chemistry from Salem State University.  He has worked in process development and manufacturing in the biotechnology/biopharmaceutical industry for over 15 years.

Jamie McCarry, Process Development Engineer II, Bioprocess Engineering, APC Ltd.
Jamie has a Chemical Engineering Master’s from University College Dublin and specializes in bio-process scale-up at APC Ltd. He is an expert user of engineering modelling and analysis tools to develop right first-time scaling parameters and significantly reduce validation batches needed to develop and qualify a robust bio-process control strategy 

Advances in Purification & Recovery

Engin Ayturk, PhD, Director, CMC Process Engineering & Conjugation, Mersana Therapeutics
Engin Ayturk, is a Director at Mersana Therapeutics, leading the CMC Process Engineering and BioConjugation departments and responsible for the development, scale-up and cGMP manufacturing, late-stage characterization and validation of novel antibody drug conjugate (ADC) technology platforms. Previously as a Senior Manager at Biogen, Dr. Ayturk led the Cambridge Process Biochemistry (PBC) small and pilot scale purification and bioseparation development teams and was responsible for the development of purification processes for clinical and commercial biologics programs. During his tenure at Pall Life Sciences, as a Sr. R&D Manager, Dr. Ayturk led the BioPharm Applications R&D Integrated Continuous BioProcessing team and the Filtration Groups for the development and commercialization of next generation novel bioprocess platforms and technologies. In addition to his primary focus on product, process and technology development, characterization, scale-up and tech transfer and cGMP manufacturing, Dr. Ayturk brings a strong emphasis on process modeling, bioprocess economics and the development of process control strategies for various technologies and is well recognized for cross-functional team leadership, internal/external collaborations and partnerships, and CDMO/CMO management as has numerous business certifications on project and people management, agile product development and innovation coaching modules. Dr. Ayturk holds M.Sc. and Ph.D. degrees both in Chemical Engineering and previously worked as a Research Assistant Professor at Worcester Polytechnic Institute (WPI).

Haiying Bao, Scientist II, Biologics Process Development Downstream, Bristol-Myers Squibb

I have worked as a member of the biologics process development downstream team at BMS since August 2015. My primary role has been to conduct research and development, leading to efficient, scalable recovery and purification processes for early phase portfolios. For the past 14 years and counting, I have worked in a pharmaceutical industry environment. Before joining BMS, I worked in process development at Merck where I was responsible for developing and optimizing purification processes for therapeutic proteins. Prior to that, I’ve held roles at Gilead Sciences, Inc. (formerly Pharmasset) working in multiple scientific disciplines. I have also earned my Masters in Biochemistry from Kansas State University.

Ronald Bates, PhD, Director, MS&T, Bristol-Myers Squibb
I lead the Manufacturing Science and Technology (MST) group at Bristol-Myers Squibb (BMS) in Syracuse, NY and am responsible for monitoring, validating, transferring, and improving late-stage and commercial manufacturing processes. Prior to BMS, I led the process development and MST group at Allergan focusing on developing, optimizing, characterizing, transferring, and support manufacturing of wild-type and recombinant prokaryotic-based systems to manufacturing. At Allergan, we developed high throughput methods and implemented disposable processing. Prior to Allergan, I worked at BMS-Syracuse developing and transferring downstream processes to manufacturing for late-stage Fc-fusion and monoclonal antibodies. Before BMS, I worked at Pfizer purifying small molecule moieties using chiral, normal phase, and reversed phase chromatography in traditional, flash, and multi-column continuous systems.  I received my Ph.D. from the University of Maryland, Baltimore County in Biochemical Engineering under Doug Frey studying mathematical modeling of ion exchange chromatography and my B.S. in Chemical Engineering from Rensselaer Polytechnic Institute.

Sonja Berensmeier, PhD, Professor, Bioseparation Engineering, TU Munich
Sonja Berensmeier leads the Bioseparation Engineering Group at the Technical University of Munich since 2009, after several years as a group leader at the Karlsruhe Institute of Technology in the area of biofunctional surfaces. She meets the challenge for applied integration of molecular biology, biotechnology, particle technology, and process engineering. The focus of the current research is process intensification by adsorptive and extractive separation methods. In the field of adsorbents she is specialized in magnetic and conductive particles.

Wilfred Chen, PhD, Gore Professor, Chemical Engineering, University of Delaware
Professor Wilfred Chen joined the University of Delaware in January 1, 2011 as the Gore Professor of Chemical Engineering. He obtained his B.S. degree from UCLA in 1988 and his Ph.D. from Caltech in 1993, both in Chemical Engineering. After one-year postdoc in Switzerland, he joined UC Riverside in 1994. He was Professor of Chemical and Environmental Engineering and the holder of Presidential Chair until he joined Delaware in 2011. His research interests are in Synthetic Biology and Protein Engineering. Prof. Chen has published more than 250 journal papers and delivered over 90 invited lectures. He serves on the editorial board for many scientific publications including Applied and Environmental Microbiology and Biotechnology and Bioengineering. He is also the editor/associate editor for Biochemical Engineering Journal, Biotechnology Journal, and AICHE Journal. He is a fellow of the American Association for the Advancement of Science (AAAS) and the American Institute for Medical and Biological Engineering (AIMBE).
Prof. Chen has also received numerous awards, including NSF Career Award, AIChE Food, Pharmaceutical, and Bioengineering Division 15c Plenary Lecture, Biotechnology Progress Award for Excellence in Biological Engineering Publication, Daniel I.C. Wang Award for Excellence in Biochemical Engineering from AICHE/SBE, Marvin J. Johnson Award in Microbial & Biochemical Technology from ACS, and the AICHE Food, Pharmaceutical & Bioengineering Division Award.

Robert Gronke, PhD, Senior Principal Scientist, ASO Process Development & Manufacturing, Biogen
Robert Gronke is a Senior Principal Scientists in the ASO Process Development and Manufacturing Dept at Biogen. For the past 29 years, he’s been involved in the purification development, CMC team leadership, regulatory liaison and new technology assessment for recombinant biopharmaceuticals including Biogen’s commercial and clinical antisense oligonucleotide and biologic products. Rob currently manages a group of 4 associate scientists.
Prior to joining Biogen, Rob was a post-doc at Merck, West Point PA. He received his PhD degree in Biochemistry from the University of Kansas, Lawrence Kansas in 1987 and a BS degree in Biochemistry from Northern Illinois University, DeKalb, IL in 1982.

Juan Hernandez Bort, PhD, Head, Gene Therapy Technologies, Takeda
Dr Juan A. Hernandez Bort works currently at Takeda (Austria) as Head of Gene Therapy Technologies and he collected, in the past 20 years, extended experience in the upstream and downstream process development of plasma-derived products, recombinants and lately gene therapy products. He hold a Master Degree and PhD in Biotechnology from the University of Natural Resources and Life Sciences in Vienna (BOKU), Austria. His current work is focused on Adeno-Associated Virus production for Gene Therapy.

Hemant Kumar, PhD, CPM, Senior Vice President & Head, Technical Development & Manufacturing Operations, AnaptysBio, Inc.

Dr. Hemant Kumar is a SVP / Head of  Technical Development and Manufacturing Operations at AnaptysBio responsible for management of  MST process development, analytical and formulations development, CMC program management,  and clinical /commercial manufacturing (DS & DP) functions including CMO partnership strategy to support a growing portfolio of early to late stage clinical assets (MAbs, Bi-specific MAb, and Tri-specific MAb). He has over 20+ year of experience in biologics and vaccine development and GMP manufacturing including CMC strategy design and implementation for accelerated  commercial process development of drug targets with FDA Breakthrough Therapy designation for orphan and rare diseases. Prior to AnaptysBio, Hemant was Associate Vice President at Merck Biologics & Vaccines Sub-Division at Merck Research Labs which followed his tenures at Sanofi Genzyme, Lonza Biologics, Sanofi Pasteur, Ortho Biotech /J&J, and Wyeth. Over the course of his career, he has contributed to the successful development and commercialization of many high value innovative biotherapeutic drugs and vaccines. Hemant holds Ph.D. in Biochemistry, and postdoctoral fellowship at Yale University School of Medicine.

Jungbauer, PhD, Professor, Biotechnology, University of Natural Resources and Life Sciences, Vienna and Austrian Centre of Industrial Biotechnology
Professor Alois Jungbauer received his PhD in Food Technology and Biotechnology from the University of Natural Resources and Life Sciences Vienna, Austria 1986. He serves since then as a professor at the Department of Biotechnology. He teaches Protein Technology and Downstream Processing and Bioprocess Engineering. He also acts as area head and Deputy Director of Research in the Austrian Centre of Industrial Biotechnology. He is currently working in the field of bioengineering of proteins, plasmids and viruses with special focus on expression, downstream processing and characterization of large biomolecules.  For more than 10 years he is working on continuous manufacturing of biopharmaceuticals.
As a proliferate researcher he has more than 340 publications on recombinant protein production and bioseparation, 17 patents and 12 book contributions and recently a monograph entitled “Protein Chromatography, Process Development and Scale Up”. He is executive editor and co-founder of Biotechnology Journal, and member of editorial boards from numerous journals in the area of biochemical engineering.  He acts also as the vice president of research of the European Society of Biochemical Engineering Science.

Hemant Kumar, PhD, Senior Vice President, Head, Process Development and Manufacturing, AnaptysBio, Inc.
No bio available
 
Karol Lacki, PhD, Vice President, Technology Development, Avitide, Inc.
VP of Technology Development at Avitide, Inc. Over 20 years’ experience in downstream processing of biologics. Previous positions: 18 years as a scientist and R&D Customer Collaboration Leader at GE Healthcare; Director of Mathematical Modeling Department at Novo Nordisk; Head of Technology Development at Puridify. Over 60 scientific papers, and presentations. Co-editor of Biopharmaceutical Processing (Elsevier 2018). Subject matter expert on development, characterization and optimization of bioprocesses. 

Wan-Ching Lai, PhD, Principal Scientist, Abbott Diagnostics Division, Abbott Laboratories
Wan-Ching has more than 15 years of experience in protein purification. In current position, she introduces new technologies and applies cost saving approaches for manufacturing Biologics. Between 2004 and 2008, she worked for Tanox, Inc. where she developed chromatography procedures of four antibodies for phase I/II of clinical production, and she conducted virus clearance studies within cGLP compliance for Investigatory New Drug filing. After graduation from UIUC, she was a postdoctoral fellow at National Institute of Health at Bethesda, Maryland where she studied signal transduction pathway of human primary monocyte.

Abraham M. Lenhoff, PhD, Allan P. Colburn Professor, Chemical and Biomolecular Engineering, University of Delaware
Abraham Lenhoff is the Allan P. Colburn Professor of the Department of Chemical and Biomolecular Engineering at the University of Delaware, where he has been on the faculty since 1984 and was Chair from 2012-7.  He earned a Bachelor's degree from the University of Cape Town and Master's and Ph.D. degrees from the University of Wisconsin, all in chemical engineering. His research is primarily on application of principles of thermodynamics, transport phenomena, biophysics and colloid science to protein separations and phase behavior, especially chromatography and crystallization.

Karolina Les, PhD, Scientist II, Biopharmaceutical Development, AstraZeneca
Karolina Alicja Les is a Scientist in Purification Process Sciences group in BioPharmaceuticals Development, R&D BioPharmaceuticals Unit at AstraZeneca. Her primary focus area is design and optimisation of purification processes and their transfer into manufacturing facilities to support early clinical trials. Karolina is also working at the research/development interface providing CMC input to early stage projects. Prior to this, she had worked on half-life modulations of biopharmaceuticals and characterisation of antibody-drug conjugates (ADCs) at Abzena Company. Karolina obtained her PhD from School of Pharmacy of University College London.

Ursula Simon, MSc, PhD Researcher, Institute of Bioengineering, University of Edinburgh
Ursula Simon is a final year PhD researcher at the Institute for Bioengineering at The University of Edinburgh, UK. Her research interests lie in 3D printing, material development and protein separations. In her PhD research she is developing photocurable materials for the direct 3D printing of fully functional ion exchange monoliths with highly ordered bed structures (following the principle “3D print your own chromatography column”).

Lu Wang, PhD, Senior Scientist, CMC Process Development, Teva Pharmaceuticals
Lu is the Senior Scientist from the CMC process development group of Teva Pharmaceuticals USA Inc. She joined Teva in 2015. Her major responsibility is overseeing downstream process development for Teva early phase and late phase molecules. Before joined Teva, Lu worked 4 years in Bristol Myers Squibb Co. She held PhD in Biochemical Engineering from McMaster University of Canada. Lu's specialty expertise includes downstream process development, tech transfer and downstream processing.

Daniel Yoo, PhD, Scientist, Biologics, Amgen Inc.
No bio available

Accelerating Analytical Development

Tasneem Bahrainwala, PhD, Group Leader, Analytical Sciences Mass Spectrometry, MacroGenics, Inc.
https://www.linkedin.com/in/tasneem-bahrainwala-1955797/

Peter Bryngelson, PhD, Senior Scientist, Analytical Development, Biogen
Peter received his PhD in Bioinorganic Chemistry from the University of Massachusetts at Amherst. With a background of spectroscopy and molecular biology biotech was a good fit.  His responsibilities at Biogen in Analytical Development have included testing group management, method development, and leading a group focused on laboratory and data automation.

Alejandro Carpy, PhD, Senior Scientist, Large Molecule Research, Roche Diagnostics GmbH, Germany
Dr. Alejandro Carpy is a Senior Scientist and Group Leader at Large Molecule Research in pharma Research and Early Development (pRED) at the Roche Innovation Center Munich. Among his responsibilities are the molecular assessment, analytical method development and method handover to the technical development function and the in-depth biophysical characterization of therapeutic antibodies and next generation biologics. He is involved in defining the analytical characterization strategy for several next generation biologics projects. He holds a PhD in Biochemistry from the University of Tübingen (Germany). Before joining Roche, he started his career at Novartis and worked at diverse sites gaining cross-functional experience in Quality, Production and Development.

Win-Den Cheung, PhD, Associate Director, Analytical Development, Regenxbio
Win Cheung is Associate Director of the Cell-Based Potency group in the Analytical Development department at REGENXBIO. Prior to joining REGENXBIO, Win was a Senior Manager in Analytical Development at Novavax. Win received his bachelor’s degree in Biochemistry from Worcester Polytechnic Institute and his PhD in Biological Chemistry from The Johns Hopkins University School of Medicine.

Sachin Dubey, PhD, Head, Formulation, Analytical and Drug Product Development, Glenmark Pharmaceuticals SA, Switzerland
Sachin Dubey is presently working with Glenmark Pharmaceuticals, Switzerland, where he is heading formulation, analytical and drug product development unit. His current responsibilities includes designing and executing product development and characterization strategies for both early and late stage products for Glenmark Biologics. Sachin earned his PhD from the University of Geneva, Switzerland and has previously worked with Novozymes Biopharma, Denmark. He has ~ 12 year of experience in biopharmaceutical formulation and analysis. His principal research interests are protein formulation, stabilization, combinational product development, analytical characterization, DOE and QbD. He also has a keen interest in practicing lean principles. He has received multiple research awards and has several publications and presentations to his credit.

Jianwen Feng, PhD, Director, QC-IND of MassBiologics, Umass Medical School

Dr. Jianwen Feng is a director at MassBiologics of Umass Medical school, managing assay development and validation of mAb, gene therapy and vaccine products. Jianwen has over 13 years of experience in QC, development and discovery of antibody, gene therapy and vaccine. He completed his Ph.D. in Biochemistry/Enzymology from Boston College, and then joined Prof. Wucherpfennig’s lab as a PostD in Department of Cancer Immunology and Virology, Dana-Faber Cancer Institute, Harvard Medical School.  

Since 2006, Jianwen has worked in manufacture (MassBiologics), CMO (Lonza), large pharma (Shire) and biotech startup (Jounce Therapeutics) companies with increasing roles and responsibilities. His main interest focuses on protein characterization, antibody developability/manufacturability assessment and analytical development/formulation of mAb and gene therapy products.  He has developed and established various platforms in protein characterization, antibody developability/manufacturability assessment and formulation to accelerated drug development.

John Gebler, PhD, Director, Waters Corporation
https://www.linkedin.com/in/jgebler/

Dan (Cassie) Liu, Statistician, Bristol-Myers Squibb
Cassie Liu is a statistician in Biologics Development Department at Bristol-Myers Squibb. She joined BMS in 2016. Over the years, she provides statistical support in a great number of CMC projects, including stability analysis, bioassay analysis, design of experiment, analytical method performance monitoring, etc. She holds a master’s degree in statistics from University of Connecticut and a bachelor degree in statistics from Nankai University in China. Prior to joining BMS, she was a statistician in a research lab at Yale University.

Mark McCoy, PhD, Principal Scientist, Merck
Mark McCoy is currently a Principal Scientist in the Discovery Chemistry group at Merck. His recent interests are in biophysical and structural studies of therapeutic proteins and peptides. His early work in this area provided the first understanding of Keytruda’s mechanism of action, using NMR spectroscopy. Prior to joining Merck Mark worked at the Wistar Institute, UPenn and at Sterling-Winthrop. He has a Ph.D. from Princeton University and carried out postdoctoral research at ETH-Zürich and at Bristol-Myers Squibb.

Muthuraman (Muthu) Meiyappan, Head of Analytical Research, Discovery Therapeutics, Takeda Pharmaceutical Company Ltd.
Muthu Meiyappan has over 20 years of experience in Protein Biochemistry and Structural Biology. He got his Ph.D degree from Indian Institute of Science in India and post-doctoral training at Cornell and Harvard Universities in USA. He joined Shire, now part of Takeda, in 2009, worked on molecular biology, protein engineering, purification and characterization of various biomolecular research and development candidates. Muthu, a two times CEO award winner at Shire, is currently heading Analytical Research group in Discovery Therapeutics department. His group is involved in molecular selection and characterization of biotherapeutic research and development candidates as well as characterization of protein targets for small molecule drug discovery.

Prasad Oruganti, PhD, Scientific Leader, Biopharm Product Sciences, Biopharm R&D, GlaxoSmithKline
Prasad Oruganti received his Ph.D.in Biomedical Engineering from Case Western Reserve University. His interests are in automating R&D workflows. At GSK he is involved in developing and embedding automated workflows for biopharmaceutical formulation and drug product development.

Elena Smith, PhD, Deputy Director, Quality Control, Sanofi Pasteur
Elena Smith, PhD is a Head of Quality Control of Protein Sciences, A Sanofi Company (Sanofi Pasteur site). Dr Smith joined Protein Sciences Corporation (acquired by Sanofi in 2017) in 2013 and led Quality Control for the commercialization of the new product Flublok® (world first recombinant Influenza vaccine) with several seasons of product scale up on the market. Dr Smith was a QC lead for process validation of new APIs manufacturing sites, new fill/finish facilities for the Flublok. Dr Smith is a company representative at the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) as Science/Policy/Regulatory expert for Influenza Vaccine. Prior joining Protein Sciences Dr Smith was a coordinator (contractor) for BARDA/US DHHS funded projects in the Division of Biological Standards and Quality Control/OCBQ/CBER/FDA aimed to improve timeline for the influenza vaccine. At this function Dr Smith led the work “HA trimer in SRID assay” which provided impetus to the development of alternative potency methods for the influenza vaccine worldwide. Dr Smith obtained her PhD in Molecular Biology in 2004 from State Research Center of Virology and Biotechnology “Vector”, Russia on HIV antiviral and completed her postdoctoral training on HIV antiviral/Host infection mechanisms at US National Institutes of Health. Dr Smith has 5 patents, 12 scientific full-length publications, 2 reviews, 1 book chapter in research field. Dr Smith focus her Industrial Operations interests on Standards, Pharmacopeias, QC assays implementation (development, validation, troubleshooting and comparability), assay transfer and Microbiological Control of Manufacturing sites.

Yunan Wang, PhD, Scientist, Amgen
Yunan Wang is a Scientist at the Pharmacokinetics and Drug Metabolism Department of Amgen. Yunan’s work at Amgen includes developing capillary electrophoresis-mass spectrometry methods to identify the protein therapeutic biotransformation catabolites and to quantify biomarkers. She also works on protein therapeutic characterization with other CE techniques, such as CE-SDS, CE-LIF, etc. Yunan received her Ph.D. degree in Chemistry from the University of Kansas.

Kristeena Wright, PhD, Application Scientist, Advanced Instruments
Kristeena Wright, PhD is an Application Scientist at Advanced Instruments working to identify and share the value of osmolality testing within the biotech industry. She spent two years as a Process Development Engineer at Taelcris Biotherapeutics and 8 years in molecular biology research between graduate school and her Postdoctoral Fellowship at Harvard University by way of Boston Children’s Hospital.

Li Zang, PhD, Director, Protein Analytics, AbbVie
Li Zang, Ph.D. in Analytical Chemistry, had over 13-year experience in biopharmaceutical development of more than 30 various protein modalities in Biogen and later in AbbVie. She is currently leading the Protein Analytics department in AbbVie Bioresearch Center, and her group is responsible for analytical method development, QC method transfer, In-depth protein characterization and analytical testing. She has authored or co-authored 26 scientific publications in her career so far.

Le Zhang, PhD, Senior Scientist, Amgen
Le Zhang is a Senior Scientist in Attribute Sciences in the Process Development Organization at Amgen. Le has extensive experience in analytical method development, qualification and transfer to quality control labs. She has been leading analytical teams to support process and product development for several clinical programs and authored CMC sections for the regulatory filings. Le has comprehensive knowledge in the characterization of therapeutic proteins, including glycoproteins, antibodies and Fc fusion proteins and her recent work has resulted in 8 papers in peer-reviewed journals. Le received her Ph.D. in Analytical Chemistry from University of Washington in Seattle.

Optimizing Biologics Formulation and Stability

Daniel G. Anderson, PhD, Associate Professor, Chemical Engineering and Institute for Medical Engineering and Science, Harvard-MIT Division of Health Sciences & Technology, Massachusetts Institute of Technology
Professor Daniel G. Anderson is a leading researcher in the field of nanotherapeutics and biomaterials. He is appointed in the Department of Chemical Engineering, the Institute for Medical Engineering and Science, the Koch Institute for Integrative Cancer Research, and the Harvard-MIT Division of Health Science and Technology at MIT. The research done in Prof. Anderson’s laboratory is focused on developing new materials for medicine. He has pioneered the development of smart biomaterials, and his work has led to advances in a range of areas, including medical devices, cell therapy, drug delivery, gene therapy and material science. Prof. Anderson received a B.A. in mathematics and biology from the University of California at Santa Cruz and a Ph.D. in molecular genetics from the University of California at Davis. His work has resulted in the publication of over 400 papers, patents and patent applications. These advances have led products that have been commercialized or are in clinical development, as well as to the foundation of companies in the pharmaceutical, biotechnology, and consumer products space including CRISPR Tx (Nasdaq:CRSP), Living Proof, Sigilon, Verseau Tx, and Olivo Labs.

Lisa A. Kueltzo, PhD, Director, Formulation and Stabilization Sciences, Vaccine Production Program, Vaccine Research Center, National Institute of Health

https://www.linkedin.com/in/lisa-kueltzo-2377483/

Deborah Bitterfield, PhD, CEO and Founder, Lindy Biosciences, Inc.
Dr. Deborah Bitterfield is CEO and Founder of Lindy Biosciences. Her experience reflects a broad range of disciplines, including R&D and corporate collaborations. Prior to launching Lindy Biosciences, she joined innovation lab Southeast TechInventures, where she led scientific operations and project management. She holds a PhD in Materials Science from Duke University. Her research has focused on the physical chemistry of two-phase microsystems, including protein dehydration and polymer microsphere formulation.

Danny K. Chou, PharmD, PhD, President, Biopharmaceutical Characterization and Formulation Development, Compassion BioSolution, LLC
Dr. Danny K. Chou is a biopharmaceutical industry veteran with expertise in biopharmaceutical characterization, formulation development, and emerging technologies for protein aggregate/subvisible particle analysis. Currently, Dr. Chou is the Founder and President of Compassion BioSolution, a biopharmaceutical consultancy and analytical testing service provider that serves clients throughout the world. Prior to starting Compassion BioSolution, Dr. Chou was a lead formulation scientist at Gilead Sciences, where he successfully converted IV formulations of monoclonal antibodies to high concentration formulations that are more stable and can be easily administered by subcutaneous injection. In the past 15 years, Danny has developed stable pharmaceutical dosage form for proteins, monoclonal antibodies, peptides, and oligonucleotides for clients ranging from small start-up biopharmaceutical companies to Fortune 500 pharmaceutical companies. Danny received his PhD from the University of Colorado Center for Pharmaceutical Biotechnology under the tutelage of Professor John Carpenter and his PharmD from the University of Florida.

Sachin Dubey, PhD, Deputy Director, Formulation, Analytical and Drug Product Development, Glenmark Pharmaceuticals
Sachin Dubey is presently working with Glenmark Pharmaceuticals, Switzerland, where he is heading formulation, analytical and drug product development unit. His current responsibilities include designing and executing product development and characterization strategies for both early and late-stage products for Glenmark Biologics. Sachin earned his PhD from the University of Geneva, Switzerland and has previously worked with Novozymes Biopharma, Denmark. He has ~ 12 years of experience in biopharmaceutical formulation and analysis. His principal research interests are protein formulation, stabilization, combinational product development, analytical characterization, DOE and QbD. He also has a keen interest in practicing lean principles. He has received multiple research awards and has several publications and presentations to his credit.

Britta Furtmann, PhD, Section Head – Formulation and Process Development, Biologics Drug Product, Sanofi
Upon finalizing her studies at the University of Bonn, Britta joined Bayer Health Care to perform her practical training as pharmacist working in the field of formulation development. During her PhD studies at Miltenyi Biotec and Yale University, Britta was working on the development of novel peptide and protein delivery systems including in vitro and in vivo testing in the field of immuno-oncology. Upon receiving her PhD from the University of Heidelberg, Britta joined Sanofi in Frankfurt. In her current role as section head of formulation and process development, she is heading a group focusing on drug product development for biological molecules including early and late-stage programs.

Marina Kirkitadze, PhD, MBA, Head, Analytical Process Support & PAT Platform, Analytical Sciences, Sanofi Pasteur, Canada
Marina Kirkitadze, Ph.D, MBA has 17 year experience in Sanofi Pasteur, the vaccine division of Sanofi group. She is Head of Analytical Process Support and PAT Platform, Analytical Sciences Toronto.  Marina's main focus is characterization of vaccine components, specifically, protein conformation and stability in solution and in adjuvanted form, analysis of raw materials, particle sizing technologies, and recently inline PAT applications. Her contributions went towards CMC section in eBLA application for Adacel, new manufacturing facility submission, Pentacel, and to Module 3 CTD of Hexaxim vaccine submission. Marina has published 35 manuscripts.

Thomas Laue, PhD, Professor Emeritus, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire
Tom Laue is the emeritus Carpenter Professor of Molecular, Cellular and Biomedical Sciences, and emeritus professor of Material Sciences at the University of New Hampshire. He is the founder of the Biomolecular Interaction Technologies Center. He received his bachelor’s degree in Natural Sciences from the Johns Hopkins University in 1971and his PhD in Biophysics and Biochemistry from the University of Connecticut in 1981. His post-doctoral studies were conducted at the University of Oklahoma. Between 1969 and 1975, he worked as a technician in the deep space program of NASA. His work has focused on developments for the analytical ultracentrifuge and analytical electrophoresis. Data from these instruments have contributed to over 3800 publications since 1980.

Brittney J. Mills, PhD, Senior Scientist II, NBE Development, Formulation, AbbVie, Inc.
Brittney Mills received her Ph.D. in Chemistry in 2014 from the University of Kansas.  Her graduate work focused on investigating the effects of a novel metal-binding tripeptide tag on the expression, purification, and stability of protein systems.  She then worked as a Postdoctoral Fellow at the Macromolecule and Vaccine Stabilization Center, also at the University of Kansas.  During this time, she gained experience in antibody characterization and formulation development using traditional biophysical methods, as well as HDX-MS.

In 2015, she joined AbbVie and focused on the development of assays for investigating the amorphous solubility of small molecules and the effect of formulation on intestinal absorption.  She transitioned back to the characterization of biologic modalities in 2016, first focused on Preformulation candidate assessment and is now responsible later stage formulation evaluation, as well.  In her spare time, Brittney enjoys spending time with her husband and two-year old son and training for marathons.

 Mitra Mosharraf, PhD, MSc, EMBA Candidate, Consultant
Mitra Mosharraf has 20 years of experience in the development of biotechnology products. She is an entrepreneur, inventor and author of several papers in peer reviewed journals. As the Chief Scientific Officer and partner at HTD Biosystems (2005-2017), she worked with the development of biopharmaceuticals for more than 100 clients worldwide. Mitra has served in various scientific positions for such companies as Pfizer, Pharmacia and Santen working with development of combination products. She received her Masters of Pharmacy and Ph.D in Pharmaceutical Sciences from Uppsala University in Sweden and is currently earning her Executive MBA from Massachusetts Institute of Technology.

Danika Rodrigues, Associate Scientist, BioTherapeutics Drug Product Development, Janssen Research and Development
Danika Rodrigues is an Associate Scientist in BioTherapeutics Drug Product Development at Janssen R&D as part of the early formulation development group. She received a BSE and MSE in Biomedical Engineering from the University of Michigan - Ann Arbor.

Atul Saluja, PhD, Senior Director, Head Formulation & Process Development, Sanofi

Atul Saluja is Senior Director and Head of Formulation and Process Development (US) within the Global Biologics Drug Product Development and Manufacturing organization at Sanofi. Prior to joining Sanofi, he worked at Bristol-Myers Squibb, Amgen and KBI Biopharma in various capacities within the biologics development network. During his tenure in the industry, Atul has successfully developed clinical and commercial products spanning multiple dosage forms and modalities, transferred products from laboratory to manufacturing sites, enabled execution of validation campaigns, instituted LCM process changes as well as workflow improvements through strategic initiatives covering a broad development space. He has been actively engaged with the scientific community at-large through presentations, symposia, focus group discussions, and publications in peer-reviewed journals. Atul received his Ph.D. in Pharmaceutics from the University of Connecticut in 2006 and has been with the industry since. 

Vishal Toprani, PhD, Development Scientist-I, Pharmaceutical Development, Alexion Pharmaceuticals
Dr. Vishal Toprani is a Scientist in the Pharmaceutical Development department at Alexion Pharmaceuticals, New Haven, CT. Dr. Toprani received his Ph.D. in Pharmaceutical Chemistry from Macromolecule and Vaccine Stabilization Center at University of Kansas in which his doctoral studies was focused on better understanding of vaccine stability as applied to pharmaceutical development of various recombinant protein vaccine candidates. After his Ph.D, he subsequently started as a scientist at Alexion Pharmaceuticals. He is currently focused on stabilizing and formulating high concentration antibody drug products using state-of-the-art biophysical technologies and modern high throughput approaches.

Philip Wuthrich, Senior Scientist, Research, Research & Development, ReForm Biologics
Philip Wuthrich is a Senior Research Scientist at ReForm Biologics in Woburn, MA, holding a Bachelor of Science degree in Chemical Engineering from the University of Massachusetts-Lowell.  He has nine years of experience in technology development, with the last five years at ReForm Biologics.

Kevin Zen, PhD, Executive Director, Analytical Characterization, Formulation Development, and Biologics Manufacturing, AnaptysBio Inc.
Kevin Zen has 25 years of experience in developing biologics drugs for clinical and commercial. He is currently an executive director responsible for analytical characterization, formulation development and drug product manufacturing at AnaptysBio in San Diego, USA. 

Cell Therapy Manufacturing

Ravi Bhatia, PhD, Scientific Director, Janssen
https://www.linkedin.com/in/rbhatia156/

Dominic Clarke, PhD, ISCT Process & Product Committee Member and Global Head, Cell Therapy, HemaCare
Dr. Dominic Clarke joins the company in Los Angeles after previous positions held at Charter Medical and BioLife Solutions. At Charter Medical, Dr. Clarke successfully launched their first FDA 510(K) approved product for cell & gene therapy manufacturing use and was instrumental in positioning the company as a leading supplier to the industry. While at BioLife, Dr. Clarke led the research and development to support the critical role of biopreservation in maintaining viable, functional cell-based materials.  With a Ph.D. in Cell and Molecular Biology from Binghamton University in New York and a postdoctoral fellowship in cell and developmental biology from SUNY Upstate Medical University, Dr. Clarke will offer scientific insight, product development strategy, and advanced support to HemaCare’s growing customer base.

Lan Cao, PhD, Senior Director, Head Product Development and Manufacturing, Cell Therapy, Takeda
https://www.linkedin.com/in/lan-cao-b665a31/

Fabio Fachin, PhD, Head, Cell Engineering and Automation, Takeda
https://www.linkedin.com/in/fabio-fachin-45982a7/

Ohad Karnieli, PhD, MBA, Chair, Process and Product Development Subcommittee, International Society of Cellular Therapies, CEO and Co-Founder, Atvio Biotech Ltd
Ohad Karnieli, Ph.D. (ATvio Biotech) holds a Ph.D. from Tel Aviv University and MBA from Haifa University. He is the founder and CEO of ATvio Biotech, a lead cell & gene therapy CDMO located in Israel. Dr. Karnieli serves as the chair of the Process and Product Development Committee of the International Society for Cellular Therapies (ISCT) and is regarded as a world expert in cell therapy process and product development and is an expert member in the ISO TC276 bioprocessing international committee. Additionally, Dr. Karnieli runs his own consultancy services (Karnieli Ltd) for cell therapy process development, automation, and cGMP manufacturing. Prior to founding Atvio, Dr. Karnieli was the vice president of Technology and Manufacturing at Pluristem Therapeutics.

David Hsu, PhD, Senior Director, Center for Biomedicine and Genetics, City of Hope
Dr. Hsu has over 20 years of experience in biotech/biopharma sector, including Chiron, Merck, and City of Hope, with a focus in the viral vector manufacturing for gene therapy and vaccine development.  He has participated in the product development projects spanning from phase I to phase IV clinical trials and BLA filing. He is one of the pioneers in the gene therapy filed and has made critical contributions to the manufacturing processes for the Retroviral and Lentiviral vectors. Since Dr. Hsu joined City of Hope in 2004, he has directed the process development and production of over 70 lots of clinical grade Lentiviral vector used in early and late phase clinical studies that have facilitated the breakthrough of CAR-T immunotherapy for cancer treatment.

Jean-Pierre Latere, COO, Celyad
Jean-Pierre joined Celyad in January 2016 and is responsible for strengthening the organization and key processes in manufacturing, quality, program management, clinical operations and regulatory affairs. He started his career as a Research Associate at the Michigan State University in the US. Following that assignment, he moved to the Johnson & Johnson group where he held various positions, from Scientist to Senior Scientist. He then joined Cardio3 BioSciences in 2008 as Project Manager Delivery System and left the company in 2012 in the position of Senior Director Business Development. Prior to joining Celyad, Jean-Pierre served as Beauty Care and Healthcare Market Global Leader at Dow Corning. Jean-Pierre holds a PhD in Chemistry from the University of Liège, Belgium.

Shashi Murthy, PhD, Professor, Chemical Engineering, Northeastern University
Shashi Murthy, Professor of Chemical Engineering at Northeastern University, is an expert in the areas of cell separation and automated cell culture.  His current work focuses on patient-specific dendritic cell generation and dendritic cell-mediated T cell expansion for therapeutic use. Dr. Murthy’s work has led to the creation of two companies, Quad Technologies (acquired by Bio-Techne in 2018) and Flaskworks. He has authored more than 77 publications and 8 issued or pending patents.

Arvind Natarajan, PhD, Vice President, CMC, Iovance
https://www.linkedin.com/in/natarajanarvind/

Knut Niss, PhD, CTO, Mustang Bio
Dr. Niss has served as Chief Technology Officer since March 2018. Dr. Niss joined Mustang in March 2017 as Vice President of Operations, where he initiated and oversaw the establishment of Mustang’s cell therapy manufacturing facility. Prior to Mustang, Dr. Niss was Cell Therapy Asset Leader at Biogen, where he oversaw CMC-related activities for gene-edited hematopoietic stem cell and lentiviral gene therapy programs for sickle cell disease and hemophilia, respectively. Earlier in his career, Dr. Niss was Senior Technical Project Leader at Novartis’ cell therapy manufacturing facility in Morris Plains, New Jersey, where he directed the transfer and implementation of the CTL019 process from Penn to Novartis. He also served as Senior R&D Program Manager at EMD Millipore, where he established processes for the large-scale expansion of adult and pluripotent stem cells. Dr. Niss began his career in senior research positions in Pfizer’s Regenerative Medicine and Immunology groups. He holds a Ph.D. in molecular biology from Humboldt University of Berlin, and an M.S. in microbiology from the University of Göttingen in Germany. Dr. Niss completed his postdoctoral research at Boston Children’s Hospital and the Dana-Farber Cancer Institute.

David Sourdive, PhD, Executive Vice President, Technical Operations, Cellectis
David Sourdive, Ph.D., is a co-founder of Cellectis and joined the Board of Directors in 2000. Dr. Sourdive holds the position of Executive Vice President, Technical Operations, with the mission to develop the Company’s industrial and technological basis as well as to deploy its operations in the pharmaceutical arena. Dr. Sourdive combines a strong scientific expertise with experience in managing industrial programs bringing innovative technologies to industrial fruition. He served as Executive Vice President, Corporate Development, from 2008 to 2016. In addition to his role at Cellectis, Dr. Sourdive has also served on the board of directors of the Mediterranean Institute for Life Sciences. David Sourdive graduated from École Polytechnique, received his Ph.D. in molecular virology at Institut Pasteur and completed a research fellowship in the Emory University Department of Microbiology and Immunology. His management training is from the HEC (Challenge +) and his decade-long experience in industrial program management was acquired at the French Department of Defense (DGA) prior to Cellectis’ inception.

Devyn Smith, PhD, Chief Strategy Officer, Strategy & Ops, Sigilon
Devyn joined Sigilon, an early stage biotechnology company based in Cambridge, MA in March, 2017 as its Chief Operations Officer and Head of Strategy. Prior to this he was head of Business Operations and Strategy at the Medicinal Sciences Division at Pfizer R&D. He was previously at Pfizer's Neusentis Research Unit in the UK from 2011 as Chief Operating Officer responsible for strategy and operations for the unit. Neusentis was focused on developing assets for pain and sensory disorders as well as developing the Regenerative Medicine portfolio. He joined Pfizer's Strategic Management Group in August 2009 supporting the head of Pharmatherapeutics R&D on developing and implementing business strategies and operational plans as well as the Regenerative Medicine Research Unit in its strategic work.

Juan Vera, PhD, Chief Development Officer, Marker Therapeutics, and Associate Professor, Department of Medicine, Center for Cell and Gene Therapy, Baylor College of Medicine
For the past 12 years, Juan F. Vera has worked extensively on developing novel T cell therapies and optimizing manufacturing processes for clinical applications at the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine. In collaboration with Wilson Wolf Manufacturing, he has been instrumental in the design and testing of the G-Rex® cell culture platform and pioneered its use for the large-scale production of T cells. Dr. Vera has extensive expertise in developing and streamlining therapeutic candidates from the research bench to the cGMP facility while ensuring robust production and scalability. Dr. Vera has previously collaborated with Celgene and Bluebird Bio in developing novel CAR T cell therapies. He has also been the recipient of different prestigious awards including the Idea Development Award from the Department of Defense and Mentored Research Scholar Award from the American Cancer Society.

Wen Bo Wang, PhD, Senior Vice President, Technical Operations, Fate Therapeutics
Dr. Wen Bo Wang is Senior Vice President, Technical Operations at Fate Therapeutics, overseeing the company’s manufacturing strategies for its pipeline of off-the-shelf cell-based cancer immunotherapy candidates and scaling the Company’s induced pluripotent stem cell iPSC platform to support late-stage clinical and commercial operations. She was formerly Senior Vice President Cell Therapy R&D at Fujifilm Cellular Dynamics Inc (FCDI), where she was responsible for developing the cell therapy R&D strategy and the iPSC based pipeline products and led the next generation production technology development efforts. Previously, she was VP Process Sciences, and directed scale up and scale out platform process development for iPSC based iCell products and MyCell products including automation and bioreactor work. Prior to joining FCDI in 2008, Dr. Wang was Group Leader, Process Sciences, at Geron Corporation, Menlo Park, CA working with embryonic stem cell derived cell therapies and dendritic cell cancer vaccine. From 2001 to 2005, Dr Wang held a number of positions at ViaCell, Boston, MA including Associate Scientific Director, ViaCord Human Umbilical Cord Blood Bank (a subdivision of ViaCell). Dr. Wang serves on the board of directors for Standards Coordinating Body and as US expert at the US Technical Advisory Group (US TAG) for ISO TC/276 Biotechnology. Dr. Wang earned a B.S. in Biology from Ocean University of Qingdao, P.R. China and received her Ph.D. in Biology from Newcastle University, United Kingdom. She conducted post-doctoral training in Cryobiology at Biosciences Research Laboratory, USDA/Agricultural Research Service, Fargo, N.D.

Anthony R. Welch, PhD, Program Director/Project Officer, National Cancer Institute, Biological Resources Branch, DTP/DCTD/NCI
Dr. Anthony Welch is a Project Officer at National Cancer Institute (NCI)’s Biological Resources Branch where his project management experience in translational research has enabled moving many different biologics into clinical trials in the last 14 years. He obtained his BS/MS in Molecular Biology from Drexel University and PhD in Pharmacology and Molecular Sciences from The Johns Hopkins University School of Medicine.  After completing post-doctoral research at Roche Bioscience in structure-based drug design and enzyme engineering, Dr. Welch worked at biotech companies Bioqual and Wellstat Biologics.  He has served as adjunct faculty at John Hopkins University and USUHS.  Dr. Welch is co-inventor on five US patents and co-author of numerous scientific papers.   In his current position at NCI, he is responsible for oversight of translational research projects involving Biologics, Cell and Gene Therapies, and Immunotherapeutics.  As an NCI project officer, Dr. Welch oversees a cGMP manufacturing facility for biologics and cell therapies in Frederick, MD.   As NCI Program Director, Dr. Welch is also responsible for oversight of a grant portfolio involving Biologic and Immuno-Oncology approaches to treating cancer.

Chelsea White, PhD, Schneider National Chair, Transportation and Logistics, Professor, H. Milton Stewart School of Industrial and Systems Engineering, Georgia Tech
Chelsea C. White III is the Schneider National Chair in Transportation and Logistics and Professor in the H. Milton Stewart School of Industrial and Systems Engineering at Georgia Tech​.
His most recent research interests include analyzing the role of real-time information and enabling information technology for improved logistics and, more generally, supply chain productivity and risk mitigation, with special focus on the U.S. trucking industry.

Gene Therapy CMC & Analytics

Vanessa Carvalho, Senior Scientist, EM Services, Vironova
Senior scientist at Vironova AB.  From PhD studies at TUDelft Vanessa has experience of protein purification and X-ray crystallography techniques and membrane protein structural characterization using several electron microscopy techniques.  Vanessas profound knowledge in structural biology and electron microscopy bring valuable contributions to the development of image analysis solutions and innovations at Vironova.  

Wei-Chiang Chen, PhD, Senior Scientist, Analytical, Solid Bioscience
https://www.linkedin.com/in/weichiangchen/

Mark Galbraith, PhD, Head, Quality Control and Analytical Sciences, Spark Therapeutics
https://www.linkedin.com/in/mark-galbraith-7370ab7/

Rajiv Gangurde, PhD, Director, CMC Portfolio Management, Voyager Therapeutics
No bio available

Mo Heidaran, PhD, Vice President, Technical, PAREXEL Consulting, PAREXEL International
Dr. Heidaran joined PAREXEL International as Vice President of Technical in December of 2018. Mo has worked previously as a Branch Chief (Acting) in Division of Cellular and Gene Therapy (DCGT) in the Office of Tissues and Advanced Therapies (OTAT) and as a CBER wide subject matter expert providing advice to ADRM in the Office of CBER Director on special subject matters related to CMC policies and regulatory review management processes. He also has close to 8 years prior experience as a Biologist and as a Master Reviewer in OTAT, and as a facility reviewer and inspector in the Division of Manufacturing and Product Quality (DMPQ).  During his tenure at OTAT, in addition to his review responsibilities, he has served as a DCGT representative to several FDA and CBER wide working groups and outside organizations such as USP.  He has also been involved in various standard development activities, cell based product manufacturing initiatives and various compliance actions.

Elizabeth Higgins, PhD, Director, Analytical Sciences, Voyager Therapeutics, Inc.
Elizabeth Higgins is currently the Director of Analytical Sciences at Voyager Therapeutics where she is responsible for analytical testing of Voyager’s gene therapy pipeline. Elizabeth has over 20 years experience in analytical support throughout drug development including with GE Healthcare’s Biomanufacturing Service and Genzyme.

Michael Kelly, PhD, Director, Asset Leadership, Gene Therapy, Biogen
https://www.linkedin.com/in/mike-kelly-231401152/

Christine Le Bec, PhD, Head, CMC Analytical, Technology Development, Genethon
Christine Le Bec joined Genethon in 1997 as a scientist and currently heads the CMC Analytical Department. She is responsible for the analytical activities in the characterization and release testing of gene therapy products at early stage development, stability studies, and interface with CMO for method transfer and validation, analytical/QC testing. She has a strong expertise in the development and qualification of analytical methods based on biochemical, biophysical and cell based assays to assess identity, potency, impurity profile, and safety. Before joining Genethon, she obtained her PhD in Bio-Organic Chemistry from Université Pierre et Marie Curie (Paris VI) in 1993. She worked as a postdoctoral researcher at Thomas Jefferson University (Philadelphia, US) and then at Institut Pasteur (Paris, France) in the field of synthesis, structural analysis and in vitro evaluation of antisense DNA as therapeutic agents for cancer and AIDS.

Anthony Leyme, PhD, Scientist II, Technical Development, Analytical Bioassay Development, Biogen
Dr. Anthony Leyme is currently a Scientist II at Biogen. He has been with the company for 2 years. Anthony is a Scientist in Bioassay Development for Gene Therapy. Anthony holds a Ph.D. in cellular biology from Rennes University, France, where his work focused on the activity of MMPs in liver fibrosis. Dr. Leyme underwent a postdoctoral training in Cellular Biology, Molecular Biology and Biochemistry at Boston University where his work focused on G protein signaling prior joining Biogen.

Xiaohui Lu, PhD, Director, Analytical Development, Ultragenyx Pharmaceutical
No bio available

Damian Marshall, PhD, Director, New Technologies, Cell & Gene Therapy Catapult UK
Damian Marshall is the Director of New Technologies at the Cell and Gene Therapy Catapult and has almost 20 years of industrial experience gained working for SME’s and large companies. He is responsible for providing vision, expertise and leadership to a team of ~70 scientists working with a wide range of cell and gene therapy developers. Together they are addressing some of the fundamental barriers to growth within the industry, developing improved cell and gene therapy manufacturing processes and integrating technologies for advanced product characterisation and process control.

Aisleen McColl-Carboni, PhD, Senior Scientist, Sanofi
Lead a team of scientists: design projects, provide guidance and establish timelines. Development and qualification of analytical methods used in release and characterization testingof monoclonal antibodies and gene therapy candidates in preclinical and early clinical development. SME for cell-based assays, understanding MOAs. GMP release, stability and characterization testing support for early phase clinical developmentprograms. 

Jim Richardson, PhD, Senior Science and Standards Liaison, Global Biologics, United States Pharmacopeia
Dr. Richardson is in the standards pipeline development group within global biologics at USP, leading efforts to develop standards for emerging technologies such as cell and gene therapy.  In previous roles at Advanced BioScience Laboratories and Foundation Fighting Blindness, he led translational science activities for the development of vaccines and biologics to prevent and treat infectious diseases and retinal disease.  Trained as a virologist, Jim has also held positions responsible for performing viral clearance testing at Viromed Biosafety and AAV vector development and characterization at Genovo/Targeted Genetics.

Lawrence Thompson, PhD, Principal Scientist, Analytical Research & Development, BioTherapeutics Pharm Sciences, Pfizer
Lawrence (Larry) C. Thompson, PhD. is a Principal Scientist in Analytical Research and Development within BioTherapeutic Pharmaceutical Sciences at Pfizer.  He has been with Pfizer for 5+ years and is currently analytical lead on viral & plasmid based immunotherapeutics and gene therapies.  He received his PhD in Biochemistry from Vanderbilt University in 2006 for his work with enzymes and their structure/function determination, spent 4 years as a post-doc at the University of Tennessee investigating the binding interactions of serum proteins and then 3 years in small biotech at two different companies as a lead scientist in the development of serum-based cancer diagnostics.  His work has generated a number of peer reviewed publications and presentations at scientific conferences as well as internally within Pfizer.

Sebastiaan Van Zalen, PhD, Quality Manager, Clinical Vector Core, Children’s Hospital of Philadelphia
Dr. van Zalen holds a Ph.D. in Medical Sciences from the University of Groningen, the Netherlands. In 2014, after completing his post-doctoral training in molecular and hematological research at the University of Pennsylvania, Dr. van Zalen joined the Clinical Vector Core (CVC) at Children’s Hospital of Philadelphia, where he is currently leading the Quality Control laboratory which has extensive expertise in testing and certification of clinical grade AAV vectors and development, implementation, and qualification of analytical methods protocols.  

Yu Wang, PhD, Scientist II, Analytical Development, Biogen
Yu Wang is currently Scientist II at Analytical Development, Biogen. He received a B.S. degree in Biological Sciences from Fudan University in China, and Ph.D. in Cell Biology from Mayo Clinic College of Medicine. He joined Biogen after a postdoctoral training at Harvard Medical School. His current work mainly focuses on development of impurity and potency assays to support gene therapy programs, as well as exploration of new technologies to improve assay performance.

Dong Xu, PhD, Senior Scientist, Analytical Development, Biogen, Inc.
Senior Scientist (2017-present) and Scientist II (2013-2017), Analytical Development, Biogen Inc. Scientist in diagnostic industry (2008-2013) Post-doctoral researcher at Brandeis University (2006-2008) and MIT (2003-2006) Ph.D. in Biological Chemistry (2003, University of Michigan, Ann Arbor, MI)

Bo Yan, PhD, Senior Scientist, Analytical Development, Beam Therapeutics
I work in the analytical development team at Beam Therapeutics. Beam Therapeutics is pioneering the use of CRISPR base editing to develop a broad portfolio of advanced genetic medicines. Our groundbreaking base editing technology allows us to make permanent, specific edits to single bases in DNA and RNA, without cutting the strands. Base editor therapeutics represent a new class of “precision genetic medicines,” combining precision targeting of the genome with precision control of editing outcomes.

Digital Biomanufacturing

Christian Airiau, PhD, Head of Data Sciences, Biologics Development, R&D, Sanofi
Christian Airiau is the Head of Data Science in Sanofi, R&D in Biologics Development, based in the Boston Area. He has over 16 years of experience in the Pharmaceutical Industry, working on Data Science, Process Modeling and Process Analytical Technologies (PAT).
His remit is to drive alignment across the global Sanofi network to develop Data Science, Process optimization and process control in Biologics Development. Introducing cutting edge Advanced Analytics concepts and leveraging established methodologies to accelerate Process development and strengthen Control Strategy definition.
Christian is also the Advanced Analytics lead in the CMC Digital Transformation program in Sanofi, across small and large molecules.
Trained as Chemist, he holds a Master and PhD in Data Science / Chemometrics from The University of Bristol in the UK.

Nallakkan Arvindan, PhD, MBA, SVP, Strategic Technology Operations, Five Prime Therapeutics
Nallakkan Arvindan joined Five Prime Therapeutics in 2009 and currently serves as Senior Vice President, Strategic Technology Operations. He is responsible for Systems Engineering (Robotic Automation & Automated Data Integration), Information Technology, Process Development, Manufacturing, and Supply Chain functions. Arvind holds an M.B.A. from the University of California, Berkeley, and a Ph.D. in Chemical Engineering and Nanotechnology from the University of Washington, Seattle.

Richard D. Braatz, PhD, Edwin R. Gilliland Professor of Chemical Engineering, Department of Chemical Engineering, Massachusetts Institute of Technology
Richard D. Braatz is the Edwin R. Gilliland Professor of Chemical Engineering at the Massachusetts Institute of Technology (MIT) where he does research in (bio)pharmaceutical manufacturing. He received a BS from Oregon State University and MS and PhD from the California Institute of Technology, and was a Professor at the University of Illinois at Urbana-Champaign and a Visiting Scholar at Harvard University before moving to MIT. He has consulted or collaborated with more than 20 companies including Amgen, Biogen, and Merck. He is a member of the National Academy of Engineering.

Susan Burke, PhD, Director, Process Dev, Materials Science, Amgen

Susan received a PhD in Chemistry from McGill University, Montreal, Canada. She has since spent several years in various R&D roles within the pharmaceutical and medical device industries overseeing product and process development initiatives. Susan joined Amgen in 2018 and is currently a Director in Process Development leading the Material Sciences organization. This team is responsible for oversight of the technical aspects of the raw materials used in the manufacture of biopharmaceuticals, including data analytics.

Alesssandro Butte, PhD, CEO, DataHow and Lecturer/Sr. Researcher, ETH Zurich

Alessandro Butté received his MSc. at Politecnico di Milano (Italy) and his Ph.D. at ETH Zurich (Switzerland) in Chemical Engineering. After a postdoc at the Georgia Institute of Technology (USA), he join ETH Zurich as senior scientist. In 2008, he joined Lonza as head of downstream technologies in the sectors small molecules and peptides and, later, as project manager. He was also involved in the pilot program to introduce Quality by Design. In 2013, he joined back ETH as lecturer and, in 2017, he founded DataHow AG. He is author of more than 60 papers on international peer reviewed journals and several patents. In 2015 he completed an executive MBA at the University of St. Gallen.

James Daly, Research Associate, Biologics, Celgene
I obtained a BS in Bioengineering from Lehigh University, PA.  I started my career at Celgene in 2016 and have since worked as a Research Associate in the Biologics Upstream Process Development group.  In my current role I work on upstream process development related activities (e.g., process optimization, process characterization, data management) as well act as our group’s principle Genedata Admin for Biologics projects.

Patrick Gammell, PhD, Executive Director, Process Development, Amgen
Patrick Gammell received a Bachelor of Science degree and PhD in Biotechnology from Dublin City University, Ireland. Patrick then spent a number of years as an post-doctoral researcher with a particular focus on the molecular and cellular biology of Chinese Hamster Ovary Cells before moving to the biopharmaceutical manufacturing industry. Patrick joined Amgen in 2013 and is currently an Executive Director within Process Development leading the Material Attributes and Technologies organization, this group is responsible for all aspects of Material Sciences and in particular how to better manage and control material related variation during the manufacture of biopharmaceuticals.   

Francisca Gouveia, PhD, Senior Process Expert, MS&T, Novartis
Francisca Gouveia is currently a Senior Process Expert, MS&T at Novartis BioProduction Operations Huningue, France. She works in end-to-end process analysis and troubleshooting and specializes in multivariate data analysis (MVDA) and process analytical technologies (PAT). Francisca holds a MSc. in Pharmaceutical Engineering (IST, University of Lisbon) and received her doctorate from Copenhagen University working on data-centric lifecycle management initiatives for new and legacy products

Tobias Großkopf, PhD, Scientist, pRED Large Molecule Research, Roche Diagnostics GmbH
Diploma in marine biology. PhD in Kiel (GEOMAR) Marine Biogeochemistry, measuring nitrogen fixation in oxygen minimum zones, modeling global rates of biologic nitrogen fixation. Moved on to sytems biology -> Modeling of microbial communities with focus on anaerobic digestion in Warwick, UK (University of Warwick). With Roche since 2 years as a modeler/ data scientist for cell culture research.

Joshua Hays, B.S.,  Associate Director of Commercial Strategy, BioContinuum™ Platform,  MilliporeSigma
In his current role, Josh establishes industry partnerships and drives the strategy to bring MilliporeSigma’s new digital technologies to market. Before this role, he held numerous positions including Software and Automation R&D, technical sales and technology management. Prior to joining MilliporeSigma, Josh worked for a start-up in API production, process improvement, viral clearance validation and instrument qualification.  Joshua has a B.S. in Biological Sciences from the University of Nebraska at Lincoln.

Scott Kincaid, PhD, Informa Deployment Lead, Pfizer
Scott started his career with Pfizer in 1993 as a R&D Chemist in the Medicinal Chemistry Group in Princeton, NJ and then in Pearl River working in the Medicinal Combinatorial Chemistry .  While in this group Scott was responsible for maintaining lab instrumentation and setting up and documenting libraries of compounds via a database.  In 2001 Scott returned to School to work on his MBA in Information Decision Technology Management at Iona College. After receiving his MBA in 2004, Scott transferred to the Manufacturing Sciences and Technology Group working on creating an integrated project and resource management system.  This led him to work on a database application to capture the process parameters from the master batch records and LIMS system.  This data was used to generate specification and control limits to support the manufacturing process.  In 2010 Scott transferred to site Technical services to support the process monitoring program.  Scott was actively involved on several teams which were constantly looking for way to improve the capture and report of process data.  In 2014 Scott joined a development team to institute a global solution across Pfizer.  Scott positioned himself to become one of the lead deployment specialists to roll  the process out across the company.  He is currently the deployment leader of PGS BT Manufacturing Solution, informa, and is a member of the Process Engineering and Analytics group within Global Technology and Engineering.

Antonio Moreira, PhD, Vice Provost, Academic Affairs, University of Maryland, Baltimore County
Dr. Antonio Moreira is Vice Provost for Academic Affairs and Professor of Chemical, Biochemical & Environmental Engineering at UMBC (University of Maryland, Baltimore County).  He was previously Chairman of the Chemical and Biochemical Engineering Department, Associate Dean of Engineering and Associate Provost for Academic Affairs.  Prior to UMBC, Dr. Moreira spent nearly ten years in the private sector, with senior management positions both in the food industry with International Flavors and Fragrances, Inc. and in the pharmaceutical/biotechnology area with Schering-Plough Corporation (now Merck & Co.).  He has significant experience with R&D, scale-up and introduction to commercialization of biotechnology products, such as the blockbuster alpha interferon biomolecule.  Dr. Moreira holds a B.S. degree in Chemical Engineering from the University of Porto, Portugal, and M.S. and Ph.D. degrees in Chemical and Biochemical Engineering from the University of Pennsylvania.

Saly Romero-Torres, PhD, Senior Manager, Advanced Data Analytics, Biogen
Dr. Romero-Torres is a Senior Manager of Advanced Data Analytics at Biogen where she leads a team of mathematicians, statisticians and Advanced Process Control engineers. She has over 15 years of experience in the fielding of Process Analytical Technologies (PAT) and advanced manufacturing of bio-pharmaceuticals with a focus in the use of advanced sensors, advanced process control, data analytics, machine learning and operational excellence tools. She obtained a doctorate in pharmaceutical PAT from Purdue University in 2006 and has worked for companies such as Schering Plough, Wyeth, and Pfizer. In 2014, Dr. Romero-Torres founded Bio-Hyperplane LLC, a data analytics and consultation company. At Bio-Hyperplane LLC, Romero-Torres worked with a broad portfolio of industries including biopharma, automation software (semiconductors), data analytics software and instruments. Her personal mission is advancing pharmaceutical manufacturing processes to enhance plant operations and, more importantly, improving patients’ access to critical therapies.

Cenk Undey, PhD, Head, Digital Integration and Predictive Technologies (DIPT), Process Development, Amgen
Dr. Undey heads up Digital Integration and Predictive Technologies (DIPT) function in Process Development of Operations organization. DIPT is a corporate function with a mission to transform Amgen business from data rich to decision smart. His group’s aim is to improve process and product understanding, process optimization, reduce process development cycle time hence increasing speed to market with reduced development costs using digitizing value chain, and Predictive Technologies like Machine Learning, Smart Sensors and in silico Mechanistic Models. Dr. Undey led the introduction of real-time multivariate statistical process monitoring technology, Watson intelligent search via Natural Language Processing and various Process Analytical Technology (PAT) initiatives resulting in significant business benefits. Dr. Undey and his team’s work were externally recognized receiving CIO100 Award in Life Sciences in 2013 for Amgen implementing advanced data analytical solutions. He has co-authored and co-edited two books, published in scientific journals and books in the areas of process systems engineering, PAT, artificial intelligence, process monitoring, control, supervision, biotechnology and bioengineering. He has received his B.Sc., M.Sc. and Ph.D. degrees all in Chemical Engineering from Istanbul University, Turkey. He also holds an Executive MBA degree from the University of California, Los Angeles, Anderson School of Management. Dr. Undey is based in the headquarters in Thousand Oaks, CA, USA.

Moritz von Stosch, PhD, Senior Manager, Process Systems Biology and Engineering, Centre of Excellence, GSK
Moritz von Stosch works as Senior Manager at Technical R&D of GSK Biologicals, Belgium, leading the Process Systems Biology and Engineering Center of Excellence. He is a process systems engineer by education with a Diplom in Chemical Engineering from the RWTH-Aachen University and PhD in Biochemical Engineering from the University of Porto. Before joining GSK, Moritz worked as a Lecturer at the School of Chemical Engineering and Advanced Materials at Newcastle University, where his research focused on the development of novel hybrid modeling methods and their application to enable more efficient process operation/design.

Jesus Zaragoza, Solutions Architect, Engineering, TetraScience, Inc. 

Completed B.S. Degree in Cell and Developmental Biology at the University of California, Santa Barbara. Completed Masters Degree in Architecture-based Enterprise Systems Engineering at the University of California, San Diego. Worked for 5 years at Navigate BioPharma, a Novartis Company as a Clinical Data Systems Developer and GxP Systems Supervisor. Currently a Solutions Architect at TetraScience.

1C: Optimizing Cell Line Development

Lina Chakrabarti, PhD, Senior Manager, R&D, AstraZeneca
Dr. Lina Chakrabarti is a senior R&D manager at AstraZeneca in Maryland. Dr. Chakrabarti is the key personnel in the Bio Process Development group for planning and execution of projects involving improving the efficiency, predictability and robustness of the cell line development process.

William C.W. Chen, MD, PhD, Research Scientist, Massachusetts Institute of Technology (MIT)
Dr. Chen is a surgeon, engineer, and multidisciplinary scientist with a career vision to improve human health. Dr. Chen is currently a research scientist at Massachusetts Institute of Technology (MIT). He received his M.D. degree and medical training (internship and surgical residency) in Taiwan before pursuing an academic path. Dr. Chen obtained his master’s degree in Biotechnology at the University of Pennsylvania and Ph.D. degree in Bioengineering at the University of Pittsburgh. He finished his first postdoctoral fellowship in Biomaterial and Regenerative Medicine at the University of Pittsburgh. Dr. Chen recently finished his NIH-sponsored joint postdoctoral fellowship at MIT and Massachusetts General Hospital (MGH) under the co-mentorship of Dr. Timothy Lu (MIT) and Dr. Anthony Rosenzweig (MGH). Dr. Chen’s research is focusing on the development of platform technologies for precision biomanufacturing and cardiovascular translational medicine using genetic engineering and synthetic/systems biology approaches. 

Yves Durocher, PhD, Principal Research Officer, Human Health Therapeutics Research Center, National Research Council Canada
Yves obtained his PhD in Biochemistry at the Université de Montréal. He joined the NRC in 1995 to work on the production of membrane receptors and recombinant proteins for various industrial partners involved in drug discovery projects. Yves manages a section of 30 scientists and 4 PhD students involved in protein expression and stable CHO cell line development for internal projects and external clients. His research activities focus on improving large-scale transient gene expression (LSTGE) platforms using HEK293 and CHO cells for r-protein production and on developing and engineering stable CHO pool and clonal cell line platforms for r-protein manufacturing. Yves is also an assistant professor at the Département de Biochimie et médecine moléculaire at the Université de Montréal.

Linda Francullo, Principal Scientist, Drug Substance Development, Pfizer, Inc.I am currently a senior principal scientist, working in cell line development at Pfizer’s Andover campus.
I have been spent 30 plus years in cell line development at the Andover site.  My journey started at Genetics Institute when I was hired as an intern before being converted to a fulltime position after receiving my BA in Biology from Merrimack College.  Genetics Institute was acquired by Wyeth which was ultimately acquired by Pfizer.

Hooman Hefzi, PhD, Postdoctoral Researcher, Pediatrics, UC San Diego (UCSD)
Hooman is a Postdoctoral Researcher in the Systems Biochemistry and Cell Engineering lab of Dr. Nathan Lewis at UC San Diego. His research focuses on integrating multi-omic datasets to understand Chinese hamster ovary (CHO) cell behavior for applications in cell line engineering and optimal bioprocess design. In the course of his studies he has led an effort to construct a consensus genome-scale model of metabolism in CHO cells and identified an engineering strategy to completely eliminate lactate production in this cell line.

Laurie Hullinger, MS, Senior Scientist, Cell Line Development, Merck & Co.
Laurie is a Senior Scientist in the Cell Line Development group at Merck & Co.  Having 18 years of cell line development experience with Merck and Schering-Plough, she has had the opportunity to explore many facets of cell line development in CHO cells.  Laurie received her M.S. in Biotechnology from Kean University in New Jersey.

Thomas Jostock, PhD, Senior Investigator II and Leading Scientist, Novartis Biologics Center, Novartis Pharma AG
Thomas is in charge of the global innovation strategy for cell line development and biologics profiling technologies within the Novartis Biologics Center. Thomas holds a PhD from the University of Mainz and has over 18 years of recombinant protein production and characterization experience in academic, biotech and pharma environments. After working for Dyax Corp on high throughput expression of antibodies, he led a team focusing on novel antibody formats at the University of Braunschweig. Since 2006, Thomas has been working for Novartis in different roles (Laboratory Head, Group Head, Science  and Technology Lead). 

Claus Kristensen, PhD, CEO, GlycoDisplay Aps
I am heading the new biotech start-up company Glycodisplay Aps. We improve biopharmaceuticals by modifying glycans. 
Experiences and competencies include:
- Managing scientists and projects in a complex technology environment 
- Co-founder of GlycoDisplay, the new glycoengineering company
- Inventor of Long-Acting GlycoDesign (LAGD) for improving enzymes for metabolic diseases 
- Managed development of cell lines for 10 biopharm candidates for clinical trials, including two approved coagulation factor products (Factor 8/9)
- Experience with patenting, licensing, bioprocess technology consulting, and business development 

John LaCava, PhD, Research Assistant Professor, Laboratory of Cellular and Structural Biology, The Rockefeller University
Dr. John LaCava is an NIH-funded investigator and research faculty member at The Rockefeller University. He focusses on the development of affinity proteomic methods to capture and characterize endogenous macromolecules – lately pursuing molecular pathophysiology and associated perturbations in protein interaction networks. In summer 2019, Dr. LaCava will start a new laboratory at the European Research Institute for the Biology of Ageing in Groningen, NL.

Elli Makrydaki, MRes, MEng, Graduate Research and Teaching Assistant, Chemical Engineering, Imperial College London
Elli Makrydaki studied Chemical Engineering in the National Technical University of Athens, Greece. In 2014 she received her MRes in Systems and Synthetic Biology at Imperial College London, UK. Shortly after she started her PhD in the Department of Chemical Engineering at Imperial College London and the groups of Dr. Cleo Kontoravdi and Dr. Karen Polizzi. Her research focuses on developing in vitro techniques to control protein glycosylation. By using molecular biology techniques and enzyme immobilisation she is designing a sustainable system, tailored for each application which can improve the production of therapeutic proteins, such as monoclonal antibodies and vaccines.

Lorenz Mayr, PhD, Chief Technology Officer, GE Healthcare Life Sciences
Dr Mayr is Chief Technology Officer at GE Healthcare Life Sciences, where he is responsible for R&D strategy and innovation across all life science business areas. He has extensive global experience in pharmaceutical R&D, including holding positions as Vice President & Global Head at AstraZeneca and Executive Director at Novartis Pharmaceuticals and Bayer Pharmaceuticals. 
Dr Mayr gained his PhD at the University of Bayreuth in Biochemistry and Biophysics, and subsequently completed his PostDoc at the M.I.T/Whitehead Institute. 

Derrick C. Scott, PhD, Assistant Professor, Biological Sciences, and Director, Bioinformatics, Delaware State University
Derrick C. Scott is an Assistant Professor and Director of Bioinformatics in the Biological Sciences department at Delaware State University. Hailing from Varnville, SC, he studied Biology at Virginia State University. He then matriculated at Virginia Tech where he earned a Master’s degree in Molecular Biology. His thesis work entailed the discovery and deactivation of a fungal gene that was necessary for pathogenicity in economically important brassica plants. Afterwards, he earned his Ph.D. in Integrative Biology from the University of South Carolina by discovering a new strain of bacteria and determining the best methodology to sequence and assemble High-GC bacterial genomes. His postdoctoral work included studies on bacterial genomics and the evolutionary history of Caulobacters. He is currently assisting institutions around the globe in their bioinformatics needs while studying bacterial genomics and working with the transcriptomics of Chinese Hamster Ovary cells. He is married to Dr. LaTia Scott and they have three children together, Zoey, Cameron, and Jaxson.

Jennitte Stevens, PhD, Director, Process Development, Drug Substance Technologies, Amgen, Inc.
Jennitte Stevens, Director-Process Development leads the Cell Line Development group in Drug Substance Technology at Thousand Oaks.  Her group is responsible for commercial cell line development and genetic characterization for innovator, biosimilar and T cell therapy programs in Amgen’s pipeline.  She joined Amgen in 2005 in the Protein Sciences Department in Discovery Research, with a focus on protein expression technologies, protein engineering and molecule assessment of biologic therapeutics.  Through roles of increasing responsibility, Jennitte has enabled the seamless transition and advancement of Amgen’s innovative early stage biologic portfolio from Research into Process Development.    She has been instrumental in advancing Amgen’s mammalian expression platforms, biologics informatics tools, and implementation of cutting-edge technologies to improve efficiency and shorten timelines.  Prior to Amgen, Jennitte worked at AmCyte (Santa Monica, CA) focusing on stem cell culture and differentiation to enable pancreatic islet cell therapies.   Jennitte earned her Ph.D. at UCLA in the Molecular Biology Institute (MBI), studying mechanisms of transcriptional activation in mammalian cells.

Aubrey R. Tiernan, PhD, Senior Scientist I and Head, Cell Line Development, Ultragenyx Gene Therapy
Aubrey Tiernan is Head of the Cell Line Development Team in the Gene Therapy Division of Ultragenyx Pharmaceuticals located in Cambridge, MA, USA. She directs efforts by the cell line group to develop robust screening approaches for generating stable producer cell lines to support clinical trials and late-stage readiness efforts.  She received her B.S. from UMass, Amherst and her Ph.D. from Georgia Institute of Technology in Chemical & Biomolecular Engineering. Prior to work at Ultragenyx, her research focused on developing a pancreatic substitute via engineering of non-beta cells for insulin secretion and investigating strategies for enhancing production from intrinsically low-producing cell lines.

Ron Weiss, PhD, Professor, Biological Engineering, Massachusetts Institute of Technology (MIT)
Ron Weiss is Professor in the Department of Biological Engineering and in the Department of Electrical Engineering and Computer Science at the Massachusetts Institute of Technology, and is the Director of the Synthetic Biology Center at MIT.  Professor Weiss is one of the pioneers of synthetic biology.  He has been engaged in synthetic biology research since 1996 when he was a graduate student at MIT and where he helped set up a wet-lab in the Electrical Engineering and Computer Science Department. After completion of his PhD, Weiss joined the faculty at Princeton University, and then returned to MIT in 2009 to take on a faculty position in the Department of Biological Engineering and the Department of Electrical Engineering and Computer Science.  The research pursued by Weiss since those early days has placed him in a position of leadership in the field, as evidenced both by publications from his lab as well as a variety of awards and other forms of recognition.  He pursued several aspects of synthetic biology, including synthesis of gene networks engineered to perform in vivo analog and digital logic computation. The lab focuses both on foundational research, e.g. creating general methods to improve our ability to engineering biological systems, as well as pursuing specific health related applications where synthetic biology provides unique capabilities.

Detection, Characterization and Control of Impurities in Biologics

Michael Anyadiegwu, PhD, Senior Scientist, Downstream Processing, Centre for Process Innovation Ltd., National Biologics Manufacturing Centre
Senior Scientist (Technical Lead Scientist) at the Centre for Process Innovation’s (CPI’s) National Biologics Manufacturing Centre (NBMC) based in Darlington, County Durham, United Kingdom. Michael holds a PhD in Food Biochemistry from the University of Leeds and has extensive experience in the biochemical separation and characterisation of proteins, process development and scale up to produce novel therapeutic products under current Good Manufacturing Practice (cGMP) guidelines.

Roles in Industry have included Technical Project Lead with responsibility for the Technology Transfer, Downstream Process Development and contract manufacturing of Active Pharmaceutical Ingredients (APIs, including domain antibodies) expressed in microbial (E.coli) and yeast (Pichia pastoris) culture at 100L to 3000L scale for toxicology and early phase clinical trials. Michael currently manages an Advanced Manufacturing Supply Chain Initiative (AMSCI) Biostreamline work package centered on the production and purification of 50 monoclonal antibody variants derived for mammalian (CHO) cells at 10L bioreactor scale. Michael is also involved in various collaborative and commercial development projects at the CPI NBMC.

David Cetlin, Founder & CEO, MockV Solutions LLC
David Cetlin is the founder and C.E.O. of MockV Solutions, Inc. A company dedicated towards establishing and commercializing a novel series of BSL-1 compatible viral clearance prediction kits. These kits will be designed to benefit downstream purification process scientists as they develop, characterize, and validate their downstream purification processes. Prior to MockV, David helped develop, characterize, and validate several monoclonal antibody purification processes at Human Genome Sciences/Glaxo Smith Kline and has worked with various separation techniques including all modes of column chromatography, tangential flow filtration, nano-filtration. During his time at HGS/GSK, David routinely designed and executed process related studies including resin lifetime studies, viral clearance studies, design of experiment (DOE) studies, etc. He also participated in the technology transfer of several processes to manufacturing scale cGMP facilities, provided on-site support during cGMP campaigns and conducted investigational studies to support deviations that occurred during such campaigns. He also explored and introduced new technologies and ideas to his purification team including a single pass mode of operating tangential flow filtration, a salt tolerant ion exchange membrane, and a pre-protein A depth filter for improving protein A lifetime.

Robert C Curry, MBA, Director, International Serum Industry Association
Robert (Bob) Curry is the Business Manager for Serum at Corning Life Sciences. Bob has global responsibility for the serum portfolio including wholesale raw serum, OEM serum, and Corning branded retail serum. He has multiple years of experience in the serum industry, having previously worked at GE Life Sciences (HyClone). Bob has also held multiple roles at Corning Life Sciences in product management, strategy and production. Prior to entering the Life Sciences industry Bob was an officer in the United States Navy. He holds a bachelor’s degree in Civil Engineering from Tufts University and a Master of Business Administration from Harvard. Bob has been a member of the ISIA Board of Directors for 2 years. He resides with his wife and two children in the Seacoast region of New Hampshire.

Kashmira Dilrukshan, Associate Research Scientist, Drug Product Science Technology, Bristol-Myers Squibb
I earned a Master of Biotechnology degree from Pennsylvania State University in
December 2015. I received a Bachelor of Arts degree in Biological Sciences and Psychology from Rutgers University in 2013. I joined Bristol-Myers Squibb in 2016 as a biologics formulation scientist. My expertise includes working with formulations of combinations and high concentrations.

Katherine Galindo, Senior Manager Regulatory Affairs, TESARO, Inc.
https://www.linkedin.com/in/katherine-galindo/

Kevin Herbig, BS, Scientist, Biopharmaceutical Technology, GSK

Kevin is a process development scientist at GSK specializing in second generation biopharmaceutical purification processes for monoclonal antibodies as well as the application of statistics on Design of Experiments and process development.  He recently graduated from Ohio State University’s Department of Chemical and Biomolecular Engineering.

Akunna Iheanacho, PhD, Director of Research & Development, Texcell - North America, Inc.
Akunna Iheanacho, PhD is the Director of R&D at Texcell – North America, Inc. where she supports novel assay and process development for viral clearance studies. She serves as a subject matter expert with over 15 years of experience in the purification, recovery, and formulation of proteins, biologics, and gene therapies.

Guifeng Jiang, PhD, Senior Manager, Analytical Science, Boehringer-Ingelheim, USA
Dr. Guifeng Jiang graduated from Fudan University in Shanghai with a BS and MS in chemistry, obtained her Ph.D degree in Analytical Chemistry from University of Alberta, Canada. She did her Postdoc research in Public Health Department, University of Alberta, Canada.
After receiving her education, Dr. Guifeng Jiang worked as scientist/Manager in several companies in California, USA, including Eksigent Technologies, ThermoFisher Scientific, Lancaster Labs and Sutro biopharma. Dr. Guifeng Jiang has been in her current position as Senior Manager at Boehringer-Ingelheim since May 2015. She leads an analytical characterization team and is the head of mass spectrometry lab.

Jen Juneau, Principal Scientist, Pharmaceutical Research and Development, Pfizer, Inc.
Jennifer Juneau joined Pfizer (formerly Wyeth and Genetics Institute) in 1992. She is a Principal Scientist within Biotherapeutics Pharmaceutical Sciences.  Her area of responsibility is in process and product development of liquid/lyophilized biologics with a focus in lyophilization and filtration.  She has developed and transferred drug product manufacturing processes, including lyophilization cycles, for several commercial products and many clinical products.  Jen has also been involved in sterile filtration validation and extractable/leachable efforts within Pfizer.  She received her bachelor’s in chemical engineering from Worcester Polytechnic Institute (WPI).

Douglas E. Kiehl, MSc, Research Advisor, Bioproduct, Research & Development, Eli Lily and Company
Douglas Kiehl is a Research Advisor at Eli Lilly and Company and leads the Characterization Mass Spectrometry, Extractables/Leachables and Elemental Impurities team.  He is responsible for Lilly’s global E&L strategy supporting development and qualification of container/closure and manufacturing systems and drug delivery devices.  His team’s responsibilities include performing structural characterization of process impurities, related substances, degradation products and contaminants across development and commercialization phases for the small and large molecule portfolios.  Mr. Kiehl has over 36 years' experience with application of advanced mass spectrometry in characterization of diverse chemical entities, 24 years of which are in the Pharmaceutical Industry.  He is a member of the USP Packaging and Distribution Expert Committee, the USP Expert Panel on Biocompatibility of Materials Used in Packaging Systems, Medical Devices and Implants, the USP Expert Panel on Elastomeric Closure for Injections, the ELSIE (Extractables/Leachables Safety Information Exchange) Board of Directors, the SPIE Defense and Commercial Sensing Committee and AAPS Impurities Steering Committee.  His research interests include the development of advanced mass spectrometry-based mapping and visualization techniques to enable the rapid and comprehensive characterization of highly complex mixtures of structurally diverse chemical entities.

Wendelin Kranz, MSc, Scientist LC-MS, Coriolis Pharma Research GmbH
2018- today        Scientist at Coriolis Pharma: expert for LC-MS and polysorbate degradation
2015 -2018         Post-doctoral scientist at Coriolis Pharma (Project: polysorbate degradation and characterization)
2012-2015            PhD thesis at Helmholtz Zentrum Munich (manuscript submitted)
2009-2012            Analytical Chemist at Ascendis Pharma

Rong Li, PhD, Associate Director, Sanofi Genzyme
https://www.linkedin.com/in/rong-li-21837926/

Diane McCarthy, PhD, Senior Manager, Science and Standards Biologics Pipeline Development, Global Biologics, US Pharmacopeia
Dr. McCarthy is Senior Manager, Science and Standards Biologics Pipeline Development within USP’s Global Biologics Department. Diane works with stakeholders to identify areas where standards are needed and define and develop new standards. Prior to joining USP, Dr. McCarthy was Senior Scientific Director at Caprion Biosciences, where she focused on the use of mass spectrometry for characterization of biologics and host cell proteins. Her previous roles also included Director of Scientific Affairs at Ezose Sciences, where she focused on identification and quantitation of glycans by mass spectrometry and Global Manager, Biomarker Research Center, at Bio-Rad Laboratories, where she directed translational and biomarker research contracts and collaborations with industry, key consortia, academic, and government groups.

Edward Mee, DPhil, Senior Scientist, Live Viral Vaccines, Virology, National Institute for Biological
Edward Mee obtained a D.Phil in Clinical Medicine from the University of Oxford in 2005 and began investigating the influence of host genetics on infection with Simian Immunodeficiency Virus. Since 2013 he has worked in the Live Viral Vaccines section of NIBSC, performing control testing of rotavirus and MMR vaccines, adverse event investigations and related research. He is also developing reference materials to support method development for improved adventitious virus screening of vaccine and biotherapeutic products, intermediates and raw materials.

Christopher O’Brien, PhD, Process Engineer III, Process Science, Sanofi
Chris earned his B.S. in Chemical Engineering from Rensselaer Polytechnic Institute and Ph.D. in Chemical Engineering from University of Delaware. His graduate research focused on studying the influence of colloidal protein-protein interactions on protein aggregation. Chris joined the Process Science group at Sanofi in 2017 and has since worked on various projects, including 2nd generation purification process development, drug substance stability, and excipient stability.

Hai Yue, PhD, Senior Scientist, Analytical Development, Juno Therapeutics, A Celgene Company
Dr. Yue currently is a Senior Scientist in Analytical Development at Juno Therapeutics, A Celgene Company. Prior to joining Juno, he worked at Amgen Inc. as a Scientist in Process Development for 4 years. Dr. Yue holds a Ph.D in Biochemistry from Washington University in St. Louis.

Process Characterization & Control

Udayanath Aich, PhD, Associate Director, Bristol-Myers Squibb
Currently Dr. Udayanath Aich is an Associate Director at Bristol Myers Squibb with extensive experience and management skills in analytical chemistry, and CMC analytical strategies for early, late and commercial biologics products. Dr. Aich completed his Ph.D. from Indian Institute of Technology Madras in the area of Chemical Biology. After completion Ph.D., he has joined in Biomedical Engineering Dept of Johns Hopkins for his postdoctoral study in the field of cell engineering, glycoengineering and structure-activity relationship. Subsequently, he has decided to move to Massachusetts Institute of Technology to gain extensive skills in the area of Biopharmaceutical characterization and drug development. Dr. Aich joined at Thermo Fisher Scientific in the chromatographic and mass spectrometric division to broaden his extensive analytical skills. Then Dr. Aich worked as Investigator at GlaxoSmithKline in the area of protein and glycans characterization, process analytics, CMC analytical strategies as ATL and structure-function study. Finally, before joining at Bristol Myers Squibb, Uday was working at Sanofi related to high throughput technologies, process analytical technologies (PAT), Analytical method harmonization, multi-attribute method Dev, analytical method dev, robustness, qualification and transfer for early and late stage product including 2nd generation commercial product as part of life-cycle analytics.

George Bou-Assaf, PhD, Scientist, Protein & Gene Therapy Biophysical Characterization, Biogen
George has a BS in chemistry from the Lebanese University (Beirut, Lebanon) and a PhD in Biochemistry from Florida State University. His graduate studies under Prof. Alan Marshall focused on development and optimization of hydrogen/deuterium exchange mass spectrometry to study the interactions between the subunits of the troponin complex. Shortly after he graduated, he joined the technical development group at Biogen in 2011 where his job responsibilities focus on the biophysical characterization of proteins and gene therapy products.

Richard D. Braatz, PhD, Professor, Chemical Engineering, Massachusetts Institute of Technology
Richard D. Braatz is the Edwin R. Gilliland Professor of Chemical Engineering at the Massachusetts Institute of Technology (MIT) where he does research in (bio)pharmaceutical manufacturing. He received a BS from Oregon State University and MS and PhD from the California Institute of Technology and was a Professor at the University of Illinois at Urbana-Champaign and a Visiting Scholar at Harvard University before moving to MIT. He has consulted or collaborated with more than 20 companies including Amgen, Biogen, and Merck. He is a member of the National Academy of Engineering.

Anna Brousseau, Senior Development Associate, High Throughput Sciences, Analytical & Pharmaceutical Sciences, Immunogen
Anna Brousseau is a Senior Development  Associate and manager of High Throughput Sciences (HTS) in the Analytical and Pharmaceutical Development (APD) at ImmunoGen. Her areas of expertise include developing and performing high throughput analytical assays to support the activities in cell line development and upstream engineering as well as process characterization. She received her B.A. in Biology from Assumption College and M.S. in Medical Laboratory Science from the University of Rhode Island. Prior to ImmunoGen, she worked 6 years in Manufacturing and QA at Siemens Healthcare Diagnostics, 3 years in Analytical Process Development at MassBiologics, and 3 years in High Throughput Sciences at ImmunoGen.

Chris Chumsae, Ph.D., Senior Scientist III, Analytical Characterization Group, Protein Analytics Dept., AbbVie Bioresearch Center

Analytical Scientist and Mass Spectrometrist with over 30 years of experience in the characterization of recombinant biotherapeutics with an expertise in the analysis of proteins and protein variants by LC/MS and LC/MS/MS. Chris has significant contributions towards increasing the understanding of chemical modifications to proteins and the resulting influence on charge. Chris has also used LC-MS as a tool for biophysical characterization of recombinant IgG’s and DVD-Ig molecules in addition to proteomics and metabolomics workflows.  Chris received his Ph.D. in chemistry from Northeastern University. Chris leads a team within the Analytical Characterization Group, Protein Analytics Dept., at AbbVie Bioresearch Center where he has been for the past 18 years.

Wen-Li Chung, Quality Control Scientist, Genentech

Wen-Li Chung is currently a QC Scientist in the Department of Protein Analytical Chemistry at Genentech, a Member of the Roche Group.   She received her B.S. in Zoology from National Taiwan University and a Master Degree in Biochemistry from Auburn University.   Wen-Li worked at Biogen, Curis, Pfizer, Millennium, Altus and Abbott before joining Genentech in 2013.  She currently is the global compendial/general methods technical expert in Roche QC network and also the team lead in South San Francisco. Wen-Li has extensive experience on Formulation, Analytical Method Development and Validation, Protein Characterization, and Quality Control.  She has 5 issued patents and is one of the inventors for liquid formulation Avonex.

Puneet Gupta, Associate Scientist, Bristol-Myers Squibb

Currently I am working as an Associate Scientist at BMS (Bristol Myers’s squib) Devens MA. As part of the Late Phase Separation Method Development Group at BMS our emphasis is  on commercial method development, Robustness and support process characterization. Prior to BMS I worked at Xcellerex/ GE Marlborough MA in similar role. I have also worked at QC lab at Shire Lexington MA. My research work at University of Rhode Island included study of Advanced Glycation end products by the reaction between guanine triphosphate and reducing sugars.

Marina Kirkitadze, PhD, MBA, Head of Analytical Process Support & PAT Platform,
Analytical Sciences, Sanofi Pasteur, Canada
Marina Kirkitadze, Ph.D, MBA has 17 year experience in Sanofi Pasteur, the vaccine division of Sanofi group. She is Head of Analytical Process Support and PAT Platform, Analytical Sciences Toronto.  Marina's main focus is characterization of vaccine components, specifically, protein conformation and stability in solution and in adjuvanted form, analysis of raw materials, particle sizing technologies, and recently inline PAT applications. Her contributions went towards CMC section in eBLA application for Adacel, new manufacturing facility submission, Pentacel, and to Module 3 CTD of Hexaxim vaccine submission. Marina has published 35 manuscripts.

Nandu Madayiputhiya, PhD, Senior Scientist, Celgene
Dr. Nandakumar M.P is currently serving as a Senior Scientist in the Biologic Drug Development and Manufacturing Division at Celgene Corporation in Summit, NJ. Prior to Celgene he was at Acorda Therapeutics, NY working in a Biologic product development group. He has 25 years of multidisciplinary expertise from academia and industry in the realm of upstream/downstream process development, scale up, on-line bioprocessing monitoring, advanced mass spectrometry-based proteomics metabolomics, CQA analysis, and biologics characterization. He authored more than 45 publications.

Naveen Pathak, Director, Process Development, Takeda
Naveen Pathak is Director of Process Development at Takeda. He currently leads a team that owns deployment of QbD and Process Validation. Prior to joining Shire, Naveen has worked at leading biotech and pharmaceutical companies, including Genzyme, Amgen, DSM, and Novartis in Process Development and Manufacturing Science functions.  Naveen is a seasoned biopharmaceutical industry professional with ~ 25 years of experience in process development and technical services spanning non-clinical, clinical, and commercial manufacturing. He has a Masters in Chemical Engineering from University of Oklahoma and Graduate certificate in Quality and Regulatory Affairs from Temple University. Naveen is also actively engaged in teaching QbD related courses at Graduate Schools in US and is an Adjunct Faculty at Keck Graduate Institute in Claremont, CA

Wolfgang Paul, PhD, Principal Scientist and Digitalization Lead, Large Molecule Research, Roche, Germany
After study of biology at RWTH Aachen and PH.D.thesis at the Research Center Jülich, I started in Bioprocess Development of Cell culture, Aventis, Frankfurt-Höchst, promoted to head of cell culture research pilot plant fermentation and purification, Sanofi-aventis, Frankfurt-Höchst. 2007 started as group leader for cell culture fermentation, Pharma Research Roche, Penzberg. 2009 senior Scientist and pilot plant manager for cell culture research fermentation, building up a single use bioreactor based pilot plant and set-up of an innovative data and digitalization management system. Since 2013 technical project leader for several portfolio projects including international project transfers. In 2017 initiation of digitalization and information technology forum. In 2018 as Prinzipal Scientist and Digitalisation Lead driving and coordination digitalization transformation including Data Management, Data Science and Modeling within Large Molecule Research interconnected to local and global partner functions.

Erik Read, PhD, Senior Scientist, Manufacturing Sciences and Technology, AstraZeneca
Erik Read in currently a Manufacturing Sciences & Technology Senior Scientist at the AstraZeneca Frederick Manufacturing Center. Previously he was a CMC reviewer for the FDA Division of Monoclonal Antibodies where he conducted research on cell culture process analytical technologies (PAT). He has a PhD in a Microbiology where he studied protein structure-function.

Patricia Rowicki, Biologics Process Research and Development, Merck Research Laboratories
Ms. Patricia Rowicki is currently a Senior Scientist in the Downstream Process Development and Engineering Group of Biologics Process R&D organization, Merck & Co., Inc located in Kenilworth, New Jersey.  Ms. Rowicki received training in Biochemistry from Richard Stockton University and is currently pursuing a Masters in Regulatory affairs Northeastern University.  Patricia joined Merck in 2007 in the Biologics Development. During this time, she supported early and late-stage processes, process characterization for monoclonal antibodies and biosimilars including the successful commercial process development of Keytruda. Additionally she had a short stay at Eli Lilly & Co., in the M S & T group focusing on manufacturing support of commercial processes.

Sonia Taktak, PhD, Principal Scientist, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.
Sonia joined the Analytical R&D group at Pfizer, Inc. in 2017, as a Principal Scientist. In this role, she is responsible for the development of analytical methods and strategies needed to progress BioTherapeutic products in the pipeline, including method development and qualifications, analytical support for process development, formulation and stability, product characterization and comparability. Prior to Pfizer, Sonia was a Senior Scientist at ImmunoGen, Inc. where she led the CMC development effort of an early phase ADC product. Sonia holds a PhD in Chemistry from Tufts University and was a Harvard Medical School research fellow at the Massachusetts General Hospital.

Axel Wilbertz, PhD, Data Scientist, AbbVie, Germany
Axel Wilbertz received a Master of Science (M.Sc.) from Hochschule Mannheim University of Applied Sciences in Computer Science with a focus on Medical Computer Sciences. Axel joined AbbVie in 2015 as a Data Scientist in the Process Automation & Data Science group in the New Biologics Entities High Throughput & Advanced Formulation Sciences Department . In Mai 2018 Axel started his PhD in collaboration with Medical Faculty Mannheim Heidelberg University with a focus on the prediction of formulation patterns in liquid formulation development.

Wei Xue, PhD, Senior Process Scientist, Regeneron Pharmaceuticals, Inc.
Dr. Xue joined Regeneron since 2016 as a Process Scientist/Sr. Process Scientist. His main responsibilities include supporting upstream manufacturing in process understanding, investigation and raw material identification activities. He received his Ph.D in chemical engineering in the Ohio State University in 2016.

Chunxiang (Kady) Yao, PhD, Scientist, Mass Spectrometry, Analytical & Pharmaceutical Sciences, ImmunoGen, Inc.
Chunxiang (Kady) Yao, is a Mass Spectrometry Scientist with extensive experience in mass spectrometry and analytical science.  She received her B.Sc. from Xiamen University, P. R. China, and a M. Sc. Degree from University of Saskatchewan, Canada. In 2007, she obtained her Ph.D. from Chemistry Department in University of Washington in Seattle. After graduation, she worked as a post-doc for several years in Center for Biomedical Mass Spectrometry at Boston University School of Medicine. Her research had been extended from fundamental dissociation mechanism to proteomics mass spectrometry analysisi in the field of cardiovascular disease and Lyme disease. Ms. Yao has published more than 15 papers as first-author or co-author in high-impact journals.

Before joining Immunogen, Chunxiang worked as a Contract Scientist in Sanofi/Ganzyme in Waltham. She established LC/MRM-MS method for allergen protein quantitation, and protocol design for sample preparation automation. From 2017, Ms. Yao started to work in Immunogen as a Mass Spectrometry Scientist in Analytical and Pharmaceutical Science division.  Her primary role is to perform payload and free drug characterization to support ADC product development activities. She also leads projects for critical reagents characterization, such as chemical reference standards and HCP in antibody production. Besides these, she has great experience in novel methodology investigation and method transfer for antibody and conjugation characterization.

Helen Zhao, PhD, Bristol-Myers Squibb
Helen Zhao is an Associate Scientist II in Process Development Analytics at Bristol-Myers Squibb Company at Devens, MA. She joined BMS in 2017 and specializes in the evaluation, technical transfer and execution of analytical assays for therapeutic biologics.

Gene Therapy Manufacturing

Nathalie Clément, PhD, Associate Director and Associate Professor, Powell Gene Therapy Center, Pediatrics, University of Florida
Dr. Clément gained an extensive knowledge in both the Gene Therapy and Parvovirus fields during her Ph.D work and post-doctoral fellowship, with a special emphasis in the development of AAV-based vectors for Gene Therapy applications. She ran a core facility in the Mount Sinai Hospital where she was in charge of supervising the development of many new AAV-based vectors including their production, purification and quality control assays. She was recently recruited to the PGTC where she continues to dedicate her research to the development of AAV vectors for research and clinical projects.

Michael Collins, Senior Manager, Research and Development, Pall Biotech
Michael Collins has worked for Pall for more than 30 years, with extensive experience in the area of cell harvest/clarification including depth filtration, tangential flow filtration and novel technologies such as Acoustic Wave Separation and PallSep Vibrating Membrane Filtration. Mike manages the Pall Biotech continuous filtration group within R&D.

Terrence Dobrowsky, PhD, Principal Engineer, Gene Therapy, Biogen
https://www.linkedin.com/in/terrence-dobrowsky-b2ab4a1b/

Michael Greene, MD, Executive Director, Technology Transfer Lead, Mustang Bio, Inc.
I have been working in human gene therapy for over two decades. I developed retroviral reagents to study stem cell biology in the late 1990's and more recently performed process development work enabling the first BLA approved CAR-T therapy and the first stable lentiviral producer cell line used in clinical trials. I am a trained hematologist/oncologist with a specialty in stem cell transplant and a love of teaching. I have always believed that gene therapy will broadly change our ability to treat and cure disease and am excited that we are again on the cusp of profound advancements. I am currently working to expand the reach of stem cell gene therapy for devastating pediatric genetic disorders as well as developing improved lentiviral production methods to meet the demand of our growing field.

Josh Grieger, PhD, CTO, Asklepios BioPharmaceutical
Josh Grieger is the Chief Technology Officer with Asklepios Biopharmaceutical, Inc located in Research Triangle Park, North Carolina.  Dr. Grieger was previously a Co-founder and Vice President of Process Development and Manufacturing with Bamboo Therapeutics, Inc. He led and managed the GMP manufacturing and quality release of the rAAV drug product for the GAN Phase I clinical trial and supported the Pre-IND for Duchenne Muscular Dystrophy AAV gene therapy program. Bamboo Therapeutics, Inc was acquired by Pfizer in 2016. As part of Pfizer, Dr. Grieger served as a Senior Director of Gene Therapy focused on the technology transfer of the Pro10 manufacturing process, process development and optimization of scalable rAAV vector manufacturing processes for early and late phase gene therapy clinical trials.

Justin Horvath, PhD, Director, Manufacturing, Regenxbio
Seasoned bioprocess engineer and cross-functional leader with a history of leading technology transfers (clinical and commercial) across multiple organizations and partners. Experience supporting all aspects of drug substance manufacturing from cell culture to formulation across vaccines, biological and gene therapy products. Technical expertise is in purification.

Alois Jungbauer, PhD, Professor, Institute of Biotechnology, University of Natural Resources and Life Sciences (BOKU)
No bio available

Florian Leseigneur, PhD, Viral Vector Development Team, Cell and Gene Therapy Catapult
Florian Leseigneur works as a development scientist within the Industrialisation Team at Cell Gene Therapy Catapult. Within the viral vector team, he contributes to development and the evaluation of downstream processing platform solutions for viral gene therapy products.

Jacek Lubelski, PhD, Vice President, Global Pharmaceutical Development, uniQure
https://www.linkedin.com/in/jaceklubelski/

Luis Maranga, PhD, Chief Technical Operations Officer, Voyager Therapeutics, Inc.
Terrence has led the Upstream Process Development group for Gene Therapy programs at Biogen since 2016.  His group has supported the development of multiple programs, enabled by multiple industry and academic collaborations as well as internal development.  Before joining the Gene Therapy Department, he contributed to program and technical initiatives for Biogen Biologics programs including early phase development, mid-phase optimization and late-phase process characterization.  Terrence earned B.S. in Chemical Engineering from the University of Notre Dame in 2005 and a Ph.D. in Chemical and Biomolecular Engineering from Johns Hopkins University in 2010 where he focused on characterizing lentiviral adhesion kinetics.

Luis Maranga is currently Chief Technical Operations Officer at Voyager Therapeutics, Inc. Dr. Maranga has over 20 years of experience leading the development and manufacturing of biologics, vaccines, and gene therapy products. Dr. Maranga was the technical lead for three BLAs (Optaflu/FluCellVax, Opdivo, and Empliciti), led the development of dozens of investigational products, and was plant manager for small (500‐2,000L) and large‐scale (150,000L) biologics manufacturing facilities.

Jason Morais, DSP Lead, Gene Therapy Development, Sanofi
Jason Morais is a Scientist in the Gene Therapy Development group at Sanofi in Framingham, MA. He leads a team of downstream experts responsible for designing and optimizing purification processes for AAV vectors. Prior to his role in gene therapy, Jason spent 12 years at Genzyme Corporation (and later, Sanofi) developing early phase purification processes for monoclonal antibodies and other Fc constructs. Jason has assumed leadership roles in a number of areas, including process technology transfers and virus validation studies. He brings over 16 years of process development experience to his team. He is a graduate of Northeastern University, having earned a B.S. in biochemistry in 2002.

Alaka Mullick, PhD, Senior Research Officer, National Research Council Canada
Alaka Mullick has been a Research Officer at the National Research Council since 1996. She has developed NRC’s inducible platform for generating stable cell lines, which has been critical in developing packaging and producer cell lines for the production of viral vectors. She works in close interaction with Rénald Gilbert and Sven Ansorge’s teams on the development and scale up of viral vectors. NRC-HHT has developed substantial expertise in stable cell line and process development for viral vectors and Alaka is leading several client and internal project initiatives in this area.

Thomas Page, PhD, Vice President, Engineering and Asset Development, Advanced Therapies, FUJIFILM Diosynth Biotechnologies
Dr. Page has a Ph.D. in Chemical Engineering from Rice University and over 25 years of experience in research and development of pharmaceuticals. He has devised and implemented an Engineering and Production strategy to support regulatory approvals in the U.S., EU, Russia and South Africa. He has been responsible to lead Facility Design, Manufacturing, Engineering, Automation, Process Development, Process Engineering, Metrology, Facilities, Maintenance and Validation groups.

Bryan Piras, PhD, Lead Scientist, Process Development, Therapeutics Production and Quality, St. Jude Children’s Research Hospital
Bryan Piras is a Lead Scientist in the department of Therapeutics Production and Quality in the GMP facility at St. Jude Children’s Research Hospital. While there, he has contributed to the development of AAV and lentiviral vector products, and is currently leading development of a new AAV production platform for the GMP facility. Prior to his position at St. Jude, Bryan earned his PhD in biomedical engineering from the University of Virginia, where he designed AAV vectors for cardiac gene therapy applications. He is originally from Minnesota, where he earned bachelor’s degrees in biomedical engineering and liberal arts from the University of Minnesota and the University of St. Thomas.

John Pieracci, PhD, Director, Purification, Biogen
No bio available

Bharath Raghavan, Senior Engineer, Research and Development,  Pall Biotech
Bharath Raghavan is a Senior Engineer for Pall Biotech based in Westborough, Massachusetts. He joined Pall in 2015, bringing a wealth of experience in the areas of filtration. In his current role, Bharath is involved in new product development and primarily focuses on downstream processing as a part of Biotech Process R&D team.

Matthew Kevin Roach, PhD, Senior Associate Scientist, Gene Therapy Process Development, Pfizer
https://www.linkedin.com/in/matthew-roach-39118ab3/

Peter Slade, PhD, Director, Cell Culture, Voyager Therapeutics
Therapeutic protein, vaccine and gene therapy production. Expertise in early and late stage processdevelopment, drug substance, QbD, DOE, PAT, regulatory filings, analytical chemistry, omics and fluxanalysis

Johannes C.M. van der Loo, PhD, Director, Clinical Vector Core, The Raymond G. Perelman Center for Molecular and Cellular Therapies, Children’s Hospital of Philadelphia
Dr. van der Loo obtained his Ph.D. from the Erasmus University in Groningen, the Netherlands and, after completing his post-doctoral training at Indiana University, obtained a faculty position at the University of Minnesota Stem Cell Institute. He was recruited to Cincinnati Children’s Hospital in 2002 where he built and directed a GMP Manufacturing Facility. In 2015 he joined the Children’s Hospital of Philadelphia as Director of the Clinical Vector Core. His expertise includes process development, scale up, and pre-clinical and clinical cGMP manufacturing of viral vectors, including gamma-retroviral vectors, AAV, foamy virus, and lentivirus.

Special Events - ISCT

Alireza Abazari, PhD, Senior Scientist, Process Development, Lyell Immunopharma 

Dr. Abazari is a Senior Scientist at Lyell Immunopharma Process Development department. Currently in his role, Alireza is responsible for setting up the process development lab and processes with focus on formulation and cryopreservation step. Alireza received his PhD in Chemical Engineering from University of Alberta in Canada in 2011, and further postdoctoral training at the Center for Engineering in Medicine at Harvard Medical School and Massachusetts General Hospital. Alireza is an invited member of the Parenteral Drug Association (PDA) taskforce for defining Cryopreservation Standards for Cell and Gene Therapies. He also serves as a member of ISCT Process and Product Development committee as well as a Junior Editor on ISCT Telegraft Editorial Board, and is an invited author, speaker, and lecturer in academic and industry settings in national and international levels.

Dominic Clarke, PhD, Global Head of Cell Therapy, HemaCare, USA
Dominic Clarke, Ph.D., has 15+ years of experience developing enabling solutions for cell therapy and bioprocessing applications. Dr. Clarke is the Global Head of Cell Therapy at HemaCare, the leading provider of donor starting material for development and commercial cell and gene therapies where he is actively engaged with industry experts to ensure the highest quality materials are delivered. Previously, Dominic has held roles as the Global Product Manager for Charter Medical's cell therapy and bioprocessing disposables portfolio focused on creating flexible closed-system solutions for early and late stage production and as the Director of Research and Development at BioLife Solutions, developing novel storage media and methods to support extended stability of cells and tissues. Dr. Clarke has authored or co-authored numerous papers and has been actively involved in the cell and gene therapy industry working closely with groups including the ISCT Process and Product Development committee and the BioProcess Systems Alliance to help define the challenges and develop the tools and products needed for success. He received his Ph.D. in Cell and Molecular Biology from the State University of New York at Binghamton and performed his post-doctoral studies in Cellular and Developmental Biology at Syracuse University Upstate Medical Center.

Shannon Eaker, PhD, Cell Therapy Enterprise Technical Leader, GE Healthcare USA
Shannon received his PhD from the University of Tennessee, Knoxville in Biochemistry, Cellular and Molecular Biology. His expertise is around T-cell, HSC, and ES/iPSC cell biology, and has been with GE Cell Therapy for over 9 years. He is a member of the International Society for Cell Therapy (ISCT) Process and Product Development (PPD) committee, and has authored numerous papers within the field of cell biology and manufacturing. He is currently the Global Technical Leader within GE's Cell and Gene Therapy Enterprise Solutions group. Shannon lives with his wife and 2 kids in Knoxville, TN.

Ohad Karnieli, PhD, MBA, CEO & Co-Founder, Atvio Biotech, Israel
Dr. Karnieli earned his PhD in Biotechnology focusing on Cell & Gene Therapy from the Sacler school of Medicine at Tel Aviv University and an MBA from the Haifa University school of management. Dr. Karnieli served in several executive rolls in the field of cell therapy and medical devices with his last position being the VP of Technology & Manufacturing at Pluristem Therapeutics. A well-known expert in the field of cell therapy process development and serves on several industry committees including chairing of the process & product development committee of the International Society for Cell Therapy and an expert member in the ISO TC276 Bioprocessing committee. Dr. Karnieli is the founder of Karnieli Ltd and ADVA Biotechnology.

Yonatan Lipsitz, PhD, Team Lead, Cell Therapy Process Development, Tech Ops, Sana Biotechnology
Yonatan Lipsitz leads cell therapy process development at Sana Biotechnology, where he advances the cell therapy platform and leads process development of programs from preclinical stages to regulatory filings. Prior to joining Sana, Yonatan worked at Rubius Therapeutics, where he established processes for modification, expansion, and differentiation of blood stem cells into engineered red cell therapeutics. Yonatan provided technical leadership for Rubius’ first clinical candidate, RTX-134, to IND submission, and accelerated development of subsequent programs through strategic investment in core platform technologies. Yonatan studied chemical engineering at McGill University and completed his training in biomedical engineering at the University of Toronto. Under the supervision of Peter Zandstra, Yonatan’s PhD focused on bioprocess development for pluripotent stem cell-derived therapeutics.

David Smith, PhD, Head, Innovation & Engineering, Hitachi Advanced Therapeutics Solutions USA
David Smith leads the Innovation & Engineering Center at Hitachi Chemical Advanced Therapeutics Solutions’ with the drive to develop, evaluate and provide novel technology solutions in order to realize commercial success of cell therapies. Before joining the company in 2015, David completed his PhD at Loughborough University establishing Quality by Design principles within cell therapy manufacturing with an interest in Process Analytical Control. Prior to this, David completed a Masters in Biochemical Engineering based at University of Bath, along with extensive periods at UNSW, Australia and DSM, Netherlands. This interdisciplinary background allows David to enhance the robustness and reproducibility of processes whilst analyzing costs and sustainability to supplement Hitachi Chemical Advanced Therapeutics Solutions’ Development by Design paradigm.

Special Events - WIB

Diane Blumenthal, PhD, Head of Technical Operations, Spark Therapeutics
Diane Blumenthal is Head of Technical Operations at Spark Therapeutics, where her responsibilities include manufacturing, quality control, cGMP and scientific facilities, supply chain and network strategy. She is responsible for leading the CMC (chemistry, manufacturing and controls) efforts that led to the first approval of a gene-therapy product in both the US and EU, which included the US and EU approval of Spark’s manufacturing facility to produce a gene-therapy product. Ms. Blumenthal has more than 30 years of experience in the use of recombinant DNA technology for the expression and manufacture of biotechnology products. Throughout her career, she has played a key role in the development and commercialization of multiple pharmaceutical products, including the cancer drugs, Erbitux (cetuximab) and Cyramza (ramucirumab), and most recently the gene therapy, Luxturna (voretigene neparvovec-rzyl). She has extensive experience in the transfer and scale-up of processes from the laboratory bench to commercial-scale manufacturing with expertise in both microbial and mammalian cell-culture expression systems and the corresponding downstream purification processes. Prior to joining Spark, she served as Vice President of Manufacturing Sciences and Technology for Eli Lilly and Company, following their acquisition of ImClone Systems. Before that she served as a scientific and manufacturing consultant to multiple start-up biotechnology companies and held scientific leadership positions at Zymquest, Inc., Scios, Inc. (formally California Biotechnology), and the Eastman Kodak Company. She received her M.S.E. in chemical engineering from Lehigh University and a B.S.E. in bioengineering from the University of Pennsylvania.

Jessica Bosc, Director, Business Development and Licensing, Selexis SA; President Elect of WIB National
Bio pending

Jennifer S. Chadwick, PhD, Vice President, Biologic Development, BioAnalytix, Inc.; Co-Chair of Mentors, Advisors, Peers and Sponsorship (MAPS) Program, WIB Greater Boston Chapter
Dr. Chadwick is the Director of Biologic Development at BioAnalytix. Prior to joining BioAnalytix, Dr. Chadwick was a tenured Professor and Louise Byrd Graduate Educator in the Department of Pharmaceutical Chemistry at the University of Kansas. She is an expert in the analysis of proteins, and her academic research focused particularly on understanding the molecular mechanisms underlying instability of proteins and their stabilization by exogenous compounds. During her twelve years at KU, Prof. Chadwick also engaged in biologic drug development and collaborated and consulted with numerous pharma/biotech companies to investigate stability problems and related formulations in therapeutic proteins, including monoclonal antibodies and antibody drug conjugates (ADCs). Her academic work spanned a diverse set of research problems, including biomaterials, and has resulted in over 50 peer-reviewed publications, 13 patents and 4 book chapters. Dr. Chadwick is an Associate Director of CASSS and Visiting Scholar in the Department of Chemistry and Chemical Biology at Northeastern University as well as an Editorial Advisory Board member for Journal of Pharmaceutical Sciences and Scientific Reports. She received her PhD from Purdue University, Department of Chemistry for her quantitative analysis of interactions between immunoregulatory cytokines and a diverse set of partner molecules.

Neera Jain, PhD, MBA, Vice President, Chemical and Pharmaceutical Development, Syros Pharmaceuticals
Dr. Jain has almost two decades of progressive research and development experience in the pharmaceutical industry, with vast technical experience in development and manufacturing of drug candidates and is currently Vice President, Chemical and Pharmaceutical Development at Syros Pharmaceuticals. She previously held positions at Synta Pharmaceuticals and Wyeth and has experience through late stage discovery, candidate nomination, toxicology studies, clinical development, and registration studies for small molecules and antibody based conjugates, as well as extensive experience managing CROs and CMOs. Dr. Jain has significant product leadership experience managing portfolio programs in defining strategic goals, identifying risks and mitigation plans, and comprehensive timelines and budget and has built a reputation for being a technical, well-articulated, creative problem-solver, and “go to” person. She earned a PhD in Pharmaceutical Sciences at University of Arizona and MBA in Finance from Iona College.

Keisha Thomas, Assoc Director, Corporate Development, Syros Pharmaceuticals
Bio pending

Bernice Yeung, PhD, Director, Protein Analytical Chemistry, Biogen
Dr. Yeung is an analytical protein chemist with 20+ years of experience in protein characterization, method development, formulation development, and analytical CMC. Currently, she is Director of Protein Analytical Chemistry at Biogen, recently transitioning fromglobal group leader for product characterization at Shire, where she was responsible for biologics product characterization and analytical comparability studies that enable successful regulatory filings and product registrations. Throughout her career, Bernice has been an integral part of process development activities from the analytical perspective, supporting development of upstream and downstream processes, as well as formulation development, for a number of programs spanning from pre-clinical to commercial phase. She has held roles from bench scientist to organizational leader, encompassing hands-on science to CMC and technical strategies, in several major biopharma companies including Amgen, BMS and Shire. Dr. Yeung has authored the CMC sections in regulatory filings for a number of protein therapeutics, and managed external CRO activities. Technical expertise includes structural characterization by mass spectrometry, glycan profiling, HPLC and CE method development, method qualification per ICH guidelines, physicochemical comparability, analytical QbD and BLA-enabling structure-function studies.

Veda K. Walcott, MT, MBA, Vice President, Global Regulatory Affairs and Compliance, Catalent

Ms. Walcott has over 19 years of experience in the Biopharmaceutical industry. Today, she is responsible for corporate quality system policy, compliance and regulatory affairs support for a broad product portfolio across Catalent’s global network of 30+ facilities.  She previously served as Vice President of Quality and Regulatory Affairs for Catalent Indiana, LLC (formerly Cook Pharmica) from 2007 to 2018 and was responsible for oversight of quality assurance, analytical services, validation and regulatory affairs for the state-of-the-art Bloomington, Indiana CDMO facility providing development, mammalian cell culture, formulation, parenteral filling, inspection, and packaging capabilities. She has extensive experience in managing Health Authority inspections, supporting design and qualification of major expansions, and implementing Quality Systems.  She is also passionate about mentorship and is an active member of the Catalent Women’s Network.  Veda holds a bachelor’s degree from Indiana State University in Clinical Laboratory Science, as well as a MBA from Indiana Wesleyan University.

Special Events - NIIMBL

Barry Buckland, PhD, Executive Director, NIIMBL

PhD in Biochemical Engineering at University College London obtained in 1974.  Joined the Merck Research Laboratories (MRL) in 1980 and built a world class Bioprocess R&D group.  Leader of process development of all biologically made product candidates within the MRL pipeline and manufacture of Clinical Supplies during a 20 year time frame. Products developed within this period include MEVACOR^®, ZOCOR ^®, IVOMEC ^®, CANCIDAS^®, RECOMBIVAX HB ^®, VAQTA^®, VARIVAX^®, COMVAX^®., ROTATEQ^® (Rotavirus vaccine),  ZOSTAVAX^® (shingles vaccine) and GARDASIL^® (HPV vaccine). External awards and appointments include being elected to the National Academy of Engineering in 1997 and Fellow of University College London in 1998.  Awards include the Donald Medal, UK Institute of Chemical Engineering in 2002, Prix Galien award:  Member of team to receive Vaccine Award for Gardasil^® in 2007, Merck Board of Directors Award for leading process development for licensure of four (4) new vaccines in 2007. Chaired two International Conferences on Cell Culture (Cell Culture Engineering IV and Cell Culture Engineering V) and co-chaired the first three International Conferences on Metabolic Engineering. Co-chaired the first four International Conferences on Vaccine Technology. Author or co-author of over 70 papers.  Visiting Professor at University College London for past 15 years.  In October 2008, named by AIChE as one of the "One Hundred Chemical Engineers of the Modern Era" (defined as from World War II to Present) as part of the AIChE Centennial Celebration in Philadelphia, USA and also awarded Marvin Johnson Award by ACS (American Chemical Society) for lifetime contribution to Biotechnology.  Awarded PhRMA Discoverer of the Year award in April,2009 for development of the Merck HPV vaccine (along with Eliav Barr and Kathrin Jansen). Starting in May 2009; CEO, BiologicB,LLC. Since this time have provided consultancy worldwide to a number of companies and not-for-profit institutions, in all areas of Biologics including Vaccines, Therapeutic Proteins and Cell Therapy. Chair of Board for a not-for-profit organization, Engineering Conferences International. Continue as Visiting Professor at University College London. Head, Bioprocess Development at Protein Sciences from 2010 to 2014 and the first recombinant Influenza vaccine, Flublok, was licensed in January 2013. Appointed Executive Director of NIIMBL (The National Institute for Innovation in Manufacturing Biopharmaceuticals) in February, 2017. 

Jennifer Stencel Baerenwald, PhD, Scientist I, Biogen

https://www.linkedin.com/in/jennifer-stencel-baerenwald-54abba140/

Ruben Carbonell, PhD, CTO, NIIMBL

Ruben G. Carbonell is the Frank Hawkins Kenan Distinguished Professor of Chemical and Biomolecular Engineering at NC State University, which he joined in 1984 after 10 years at the University of California, Davis. As Executive Director of the Biomanufacturing Training and Education Center (BTEC) since 2008, he led the establishment of its highly regarded academic, professional development, and bioprocess and analytical services programs. Dr. Carbonell is currently on leave from this position, serving as Chief Technology Officer of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Since 1999 he has also served as Director of the Kenan Institute for Engineering, Technology & Science, which supports innovative research, educational, entrepreneurial and public policy programs. 
Dr. Carbonell was elected to the National Academy of Engineering in 2014, in recognition of his work on molecular recognition for biological separations, and on transport processes. He is a Fellow of the National Academy of Inventors, the American Institute of Chemical Engineers, and the Industrial and Engineering Chemistry Division of the American Chemical Society. Dr. Carbonell is a Foreign Member of the Slovenian Academy of Sciences and the Academy of Sciences of the Institute of Bologna. He has won numerous awards, including the Holladay Medal for Excellence at NC State, the highest award given to university faculty, and the O. Max Gardner Award, the highest award given to faculty members in the University of North Carolina System. He has published over 240 technical papers and is an inventor in over 30 patents, several of which have been licensed. 
Prof. Carbonell received his BS degree in Chemical Engineering from Manhattan College in 1969 and his PhD from Princeton University in 1973. He has supervised more than 75 MS and PhD students, and over 35 postdoctoral researchers, many of which hold leading positions in industry and academia.

Bruce Levine, PhD, Barbara and Edward Netter Prof, Cancer Gene Therapy, Center for Cellular Immunotherapy, University of Pennsylvania
Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, is the Founding Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. He received a B.A. (Biology) from Penn and a Ph.D. in Immunology and Infectious Diseases from Johns Hopkins. First-in-human adoptive immunotherapy trials include the first use of a lentiviral vector, the first infusions of gene edited cells, and the first use of lentivirally-modified cells to treat cancer. Dr. Levine has overseen the production, testing and release of 3,000 cellular products administered to >1,200 patients in clinical trials since 1996. He is co-inventor of the first FDA approved gene therapy (Kymriah), chimeric antigen receptor T cells for leukemia and lymphoma, licensed to Novartis. Dr. Levine is co-inventor on 26 issued US patents and co-author of >160 manuscripts and book chapters with a Google Scholar citation h-index of 80. He is a Co-Founder of Tmunity Therapeutics, a spinout of the University of Pennsylvania. Dr. Levine is President Elect of the International Society for Cell and Gene Therapy and serves on the Board of Directors of the Alliance for Regenerative Medicine. He has been interviewed by the NY Times, Wall Street Journal, Washington Post, NPR, Time Magazine, National Geographic, Bloomberg, Forbes, BBC, and other international media outlets.

Jason Martin, Executive Director, Site Head of Warren Manufacturing, Cell Therapy Development and Operations, Celgene

Jason has over 22 years of biopharmaceutical experience at industry leading companies Celgene, Novartis, and Merck & Co. Inc.  He is currently Site Head of Warren Manufacturing where he leads a cross-functional team that manufactures life-saving clinical cell therapies for cancer patients around the world.  Jason joined Celgene in January 2018 as the Global Head of Apheresis Operations and built a global strategic roadmap for onboarding hospitals into the Celgene CAR T manufacturing and commercial network.  Prior to Celgene, he was at Novartis for 6 years in roles as Head of BD and Launch ESO Americas and Director of Americas External Supply Quality Operations.  Highlights include 40 product launches including the first FDA approved biosimilar Zarxio^TM (filgrastim-sndz) and Glatopa®, managing a launch portfolio of over 150 products at all stages of BD, and quality oversight for 54 parenteral products manufactured by a global network of CMOs.  Prior to Novartis, he was at Merck & Co. Inc. for 15 years in roles as Associate Director, Biologic and Sterile Validation, Technical Operations and Manager/Process Engineer, Recombinant Vaccine Technology & Engineering, Technical Operations.  Highlights include oversight of process/cleaning/sterilization validation for 40 parenteral vaccines and pharmaceutical drug products, design and qualification of a commercial scale purification facility for GARDASIL® (HPV vaccine), and technical manufacturing oversight for commercial supply of RECOMBIVAX HB®.  Jason holds a Bachelor of Science and Master of Engineering degree in Chemical Engineering from Lehigh University.

Fernanda Masri, PhD, EVP, Pharmaceutical Development & Operations, Celgene
Fernanda is a Chemical Engineering with a Masters and PhD in Biochemical Engineering from University College London (UK). Early on, her research interest focused on small scale predictive tools for downstream processing (tangential flow filtration) for cell therapies.   Fernanda worked briefly as a post-doc in cryopreservation of human cells for therapies and then moved to Toronto (Canada) in 2015, where she joined the Centre for Commercialization of Regenerative Medicine (CCRM) as a Process Development Engineer. At CCRM, her job focused on advancing cell and gene therapies, ranging from upstream scalable production of human pluripotent stem cells in suspension for cardiac differentiation to downstream processing of lentivirus using stable inducible cell lines. Through CCRM’s partnership with GE Healthcare, Fernanda’s role was to advance the field of cell and gene therapies by providing next generation processes in the laboratory. In her role as Technology Expert for Regenerative Medicine at Sartorius Stedim Biotech, Fernanda acts as a resource for advancing technologies. She aims to accelerate development and manufacture of cell and gene therapies, making them more readily accessible to patients all over the world.

Plenary Keynote

Judy Chou, PhD, Senior Vice President and Global Head, Biotech, Bayer Pharmaceuticals
Dr. Chou is an experienced Senior Vice President of Pharmaceutical / Technical Operations with a demonstrated history of working in the pharmaceutical industry. She is skilled in Biotechnology, Drug Development & Discovery, Manufacturing & Supply Chain, Bioprocess, Analytical & Formulation, and Oncology. Dr. Chou has demonstrated strong leadership skills; and received her doctorate degree from Yale University in Biochemistry and Cell Biology.

Sanchayita Ghose, PhD, Director, Downstream Process Development, Bristol-Myers Squibb Co.
Sanchayita is currently the Director of biologics downstream development at Bristol-Myers Squibb. Prior to that, she was Associate Director in Cell Culture Development at Biogen. She has over 19 years of biologics process development experience in various capacities from Amgen, Biogen and Bristol Myers Squibb. She has > 50 publications/patents and has chaired numerous national & international conferences. Sanchayita holds a PhD in Chemical & Biological Engineering from Prof. Steve Cramer’s lab at Rensselaer, NY.

Yatin Gokarn, PhD, Vice President, Global Head, Biologics Drug Product Development, Sanofi Pharmaceuticals
Yatin joined Sanofi in 2016 and is the Global Head of Biologics Drug Product Development & Manufacturing. Yatin and his teams, based in Framingham, Frankfurt, and Vitry are responsible for the development of clinical, and commercial Drug Products for Sanofi’s Biologics portfolio. Drug Product Development Teams engage early with Biologics Research to enable lead candidate selection, develop drug delivery technical, and then combine formulation & process development, and device integration activities to develop safe, stable, and commercially competitive dosage forms. Yatin also has responsibility for the clinical injectables manufacturing, a network of clinical GMP manufacturing plants.

Prior to joining Sanofi, Yatin led Biologics Drug Product and Device Development at Gilead Sciences, Inc. with prior tenures at Genentech, Amgen, and Pfizer. Yatin has direct experience with successful licensures of multiple biologics and the development of multiple biologics modalities - cytokines, PEG-proteins, Fc-fusion proteins, ADCs, bispecifics, and conventional mAbs in a variety of product formats including liquid and lyo vials, prefilled syringes, cartridges, and pens/auto-injectors.

Yatin is a biophysical chemist (PhD, MS – University of New Hampshire, UNH) and chemical engineering (MS – UNH, BS – Institute of Chemical Technology, Mumbai) by academic training. He serves on the Editorial Advisory Board of the Journal of Pharmaceutical Sciences, and on the Awards Committee of the American Institute of Chemical Engineers.

Anthony Mire-Sluis, PhD, Head, Global Quality, AstraZeneca Pharmaceuticals
Dr Mire-Sluis is currently Head of Global Quality at AstraZeneca. He was previously Vice President, North America, Contract, Singapore and Product Quality at Amgen Inc. Prior to working at Amgen, he was Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego.