Plenary Keynote Sessions

Monday, August 24

Solving Today’s Challenges

2:00 Chairperson’s Remarks

John Sterling, MA, Editor in Chief, Genetic Engineering & Biotechnology News (GEN)

2:05 BioTechnology Product Development: Meeting Today’s Challenges While Planning for Tomorrow

Nicholas Warne, PhD, Vice President, Pharmaceutical Research and Development, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc.

Wednesday, August 26

Leading to Tomorrow’s Advances

1:50 Chairperson’s Remarks

Dominic Clarke, PhD, ISCT Process & Product Committee; Co-Chair and Global Head, Cell Therapy, HemaCare Corp.

1:55 Scaling Cell and Gene Therapy: Challenges and Opportunities in Process Development and Manufacturing

Susan Fugett Abu-Absi, PhD, Senior Vice President, Pharmaceutical Development & Technology, bluebird bio, Inc.

2:20 The Future of Gene Therapy Technical Development

James Warren, PhD, Vice President, Pharmaceutical Development; Leader, Biotechnology and Gene Therapy Development, Ultragenyx Pharmaceutical

Conference Keynote Presenters

Stream 1 - Upstream Processing

Alan Dickson, PhD,The University of Manchester

Zorica Dragic, PhD, Novartis Pharma AG

Jochen B. Sieck, PhD, Merck KGaA

Stream 2 - Downstream Processing

Maarten Pennings, MSc, CTO, BiosanaPharma B.V.

David W. Wood, PhD, Professor, Chemical & Biomolecular Engineering, The Ohio State University

Audrey Jia, PhD, Principal Consultant, Regulatory and CMC, DataRevive USA LLC

Stream 3 - Analytical & Quality

Sheetal J. Mehta, Scientist II, Molecular and Analytical Development, Bristol-Myers Squibb Co.

Shelley Elvington, PhD, Director, Analytical Operations, Genentech

Anthony R. Mire-Sluis, PhD, Head, Global Quality, AstraZeneca Biologics

Stream 4 - Formulation & Stability

Michele K. Dougherty, PhD, Vice President, CMC Regulatory, DataRevive, USA LLC

Audrey Jia, PhD, Principal Consultant, Regulatory and CMC, DataRevive USA LLC

Stream 5 - Cell Therapy

Krishnendu Roy, PhD, Robert A. Milton Chair & Director, Center for Cell Manufacturing & Center for Immuno-Engineering, Georgia Institute of Technology

Stream 6 - Gene Therapy

Maria A. Croyle, RPh, PhD, Professor of Pharmaceutics, Department of Molecular Pharmaceutics and Drug Delivery, The University of Texas

Stream 7 - Manufacturing

Maarten Pennings, MSc, CTO, BiosanaPharma B.V.

Christian Airiau, PhD, Global Head, Data Sciences Biologics Development, Sanofi