Plenary Keynote Sessions
MONDAY, AUGUST 16
4:20 pm Plenary Keynote Introduction
James Warren, PhD, Vice President, Pharmaceutical Development, Ultragenyx Pharmaceutical
4:30 mRNA Vaccines: A Paradigm Shift in Pandemic Preparedness
Sudha Chivukula, PhD, Head, mRNA Technology, Sanofi Pasteur Biologics Co.
The rapid development for clinical proof-of-concept and bioprocess scale-up
leading to commercial manufacturing and approval under emergency use authorization of COVID mRNA vaccines highlights the potential for an mRNA platform to address future pandemics as well as other unmet public health needs. The framework for optimizing
novel mRNA vaccines and formulations, which could include adaptation to monovalent and multivalent vaccines, delivery and balanced immune responses to address emerging viral pathogens such as SARS-COV-2 and pandemic Influenza, will be discussed.
5:00 Lessons Learned from the Pandemic
Darrin Cowley, PhD, Vice President & Head, Developmental Quality Biologics, Quality Lead COVID Vaccine, AstraZeneca
During the pandemic, there had to be focus in several areas. Primarily, the safety of the workforce and allowing
front line operators to function unhindered. Management needed to change its ways of working, prioritize and create the environment for optimal working. Decision-making and digital tools were implemented and an altered culture was created. Ways of
dealing with virtual inspections were also developed.
5:30 Bioprocessing Summit Connects
WEDNESDAY, AUGUST 18
3:50 pm Plenary Keynote Introduction
Dominic Clarke, PhD, ISCT Process & Product Committee Co-Chair & Chief Technology Officer, Cell and Gene Therapy, Discovery Life Sciences
4:00 Manufacturing Next-Generation Therapies
Martha Rook, PhD, Chief Technical Operations Officer, Sigilon Therapeutics, Inc.
Cell and gene therapies have shown dramatic clinical progress in recent years. Driven by this clinical success and the needs of commercialization, manufacturing
strategies are progressing. Nevertheless, a standard manufacturing template for these therapies has not evolved and with novel modalities continuing to emerge we may be in a post-template manufacturing landscape. CMC strategies must be developed to
avoid manufacturing becoming a roadblock to therapeutic success.
4:30 Sustainability and the Future of Bioprocessing
Kristi Budzinski, PhD, Principal Product Stewardship & Green BioPharma Manager, Genentech, Inc.
The future of bioprocessing demands flexible, scalable solutions that can accommodate the rapidly evolving landscape of biopharmaceutical
products while also minimizing impact on the environment. This talk will highlight some of the major opportunities for reducing the environmental impact of bioprocessing through the application of metrics such as process mass intensity and lifecycle
assessment methodology. Results will be presented from both a Genentech perspective and industry-wide perspective.
5:00 Bioprocessing Summit Connects
James Warren, PhD, Vice President, Pharmaceutical Development, Ultragenyx Pharmaceutical
Dr. Warren has more than 25 years of experience in the pharmaceutical and biotechnology industry, with a focus in bioprocess development and manufacturing of viral vectors, viral vaccines, and biologics. At Ultragenyx, he leads a team of 50 scientists and engineers, responsible for all early and late stage Process and Analytical Development of viral vector products as well as Pilot Scale Manufacturing in the Woburn, MA Pilot Plant. Before coming to Ultragenyx Jim held senior CMC leadership positions at Homology Medicines, bluebird bio, and Shire. Earlier in his career, Jim spent 16 years at Merck & Co., Inc., where he led process development, technology transfer, and manufacturing sciences teams responsible for development of several clinical vector and vaccine candidates and the licensure of multiple commercial vaccines (RotaTeq®, Varivax®, ProQuad®, and Zostavax®). Dr. Warren holds BS/MS degrees in Biotechnology from William Paterson University and a PhD in Molecular and Cellular Biology from Lehigh University.
Sudha Chivukula, PhD, Head, mRNA Technology, Sanofi Pasteur Biologics Co.
Dr. Sudha Chivukula is a PhD in Biochemistry and a management graduate, with several years of vaccine R&D experience, in-depth scientific expertise and
business acumen. Sudha has held scientific and managerial positions in translational research and taking vaccine candidates from conceptual phase through pharmaceutical and clinical development phases. She is involved in developing strategy, design
and process development for new vaccines with an objective to meet the medical need and regulatory requirements for vaccines. Sudha is currently leading the RNA Vaccine Technology at Sanofi Pasteur with a mission to build and integrate strategy to
develop a robust mRNA vaccine platform.
Darrin Cowley, PhD, Vice President & Head, Developmental Quality Biologics, Quality Lead COVID Vaccine, AstraZeneca
Darrin Cowley, PhD, is currently Head of Developmental Quality, Biologics & COVID Vaccine at AstraZeneca.
He was previously Executive Director Product Quality at Amgen, Inc. He trained in Molecular and Cell Biology and has a PhD in Biochemistry and NIH Post-doctoral work in cell signaling and sorting. Darrin has extensive experience in the development,
filing and commercialization of a wide range of synthetic and biological molecules including biosimilars and COVID vaccine. Darrin has experience with the development and approval of several types of combination products such as auto-injectors and
on body injectors. Most recently, Darrin has served as quality lead supporting the global development and approval of AstraZeneca’s COVID vaccine.
Dominic Clarke, PhD, ISCT Process & Product Committee Co-Chair & Chief Technology Officer, Cell and Gene Therapy, Discovery Life Sciences
Dr. Clarke has over 15 years of experience developing enabling solutions to support cell and gene therapies. He was the Global Head of Cell Therapy at HemaCare, a leading provider of source material for clinical development and commercial manufacturing of cell-based therapies. His previous roles include Global Product Manager for Charter Medical's cell therapy and bioprocessing single-use systems portfolio and Director of Research and Development for BioLife Solutions. Dominic currently serves as the Co-chair for the International Society for Cell and Gene Therapies' Process and Product Development Committee with efforts directed towards translating research and process development from bench to clinic.
Martha Rook, PhD, Chief Technical Operations Officer, Sigilon Therapeutics, Inc.
Martha Rook, PhD, is the Chief Technical Operations Officer for Sigilon Therapeutics. She has more than 20 years of experience in analytics and bioprocessing including more than 10 years in the development of cell and gene therapy manufacturing processes. Prior to joining Sigilon, Dr. Rook was VP and Head of the Gene Editing & Novel Modalities Business of MilliporeSigma. There she led a team developing and providing tools and services for cell and gene therapies from discovery to GMP manufacturing. Dr. Rook received her PhD in biochemistry from MIT and holds a BS in chemistry from Texas A&M University. She pursued post-doctoral studies in neuroscience as a Lefler Fellow at Harvard Medical School’s Center for Neurologic Diseases.
Kristi Budzinski, PhD, Principal Product Stewardship & Green BioPharma Manager, Genentech, Inc.
Kristi Budzinski joined Genentech’s Environment Health and Safety department in 2011 to help create and launch the Green BioPharma
program with the mission of integrating and adapting Green Chemistry principles in Research and Development. She has created Green Lab assessment tools for researchers to identify opportunities to reduce their environmental impact, developed supplier
collaborations for take-back and recycling initiatives and advanced environmental metrics for drug development and manufacturing. She is a founding member of the biopharma focus group, a part of the American Chemical Society Green Chemistry Institute
Pharmaceutical Roundtable. Through this industry consortium, she participated in the development of Process Mass Intensity and Cleaning Mass Intensity metrics for biologics which measures the environmental impact of biologics production. She also
serves as a Board member for BioLink Equipment Depot, a bay area non-profit empowering educators and researchers through donated scientific equipment and supplies. Kristi received her undergraduate degrees in Biochemistry and Mathematics from the
University of Southern Mississippi and her PhD in chemistry from the University of Washington.