Agenda September 23, 2026: Main Conference Day One - ET (Eastern Time, GMT-05:00)
- Uwe Buecheler - Ad Board Chair, Passion Bio
- Rick Morris - Distinguished Fellow, Technology Strategy and Innovation, CTO, Cytiva
- Joerg Ahlgrimm - CEO, SK Pharmteco
- Jacqualyn Schulman, Ph.D. - Principal Scientist, Cell Line Development & ‘Omics Biologics Development, Bristol-Myers Squibb
- Yang Mei - Senior Scientist, Johnson and Johnson
- Dylan Frabutt - Research Scientist, Elanco
- Yang Wu - Principal Scientist, Sanofi
- Alexander Wu - Associate Scientist, Amgen
- Rajlaxmi Deshpande - Associate Scientist II, BioProcess Development, Alexion Pharmaceuticals
- Garima Thakur - Staff Engineer, Regeneron Pharmaceuticals
- Kevin Brower - Global Head of Purification Development, Sanofi
- Lei Wang - Principal Scientist, Gilead Sciences
- Yi Li - Principal AI Engineer, AbbVie
- Preeya Boppana - Director Manufacturing Science & Technology, AstraZeneca
- Yuxiang (Henry) Zhao - Senior Scientist, Bristol-Myers Squibb
- Kevin Zen, PhD - Senior Director of CMC Technical Operations, Opthea
- Kumar Dhanasekharan, PhD - President and CEO, Gokyo Biosciences Inc.
- Alois Jungbauer - Professor, Dept. of Biotechnology, BOKU University (BOKU)
This interactive workshop will run from 9am – 12:45pm.
Through a series of presentations, case studies, interactive discussion and exercises this workshop will delve deeply into the underlying science of developing potency assays.
Some of the topics to be discussed include:
- Overview of what potency is, and what it is not
- Considerations when qualifying and validating bioassays
- From initial ideas, through characterisation to the final potency method
- Clinical correlation
- Regulator objections and why
- Examples of potency assays for approved products
- Examples of a cell and gene therapy potency assays for various product types
- Christopher Bravery - Consulting Regulatory Scientist, Advbiols
This interactive workshop will run from 9am – 12:45pm.
Through a series of presentations, case studies and interactive discussions and exercises this course will focus on CDMO oversight- selection, negotiation, tech transfer and life cycle management specifically for cell and gene therapy products.
Some of the topics to be discussed include:
- CDMO Selection: Models and Process
- Contract and Quality Agreement Negotiation
- Tech Transfer: Best practices and risk management for external tech transfers
- Knowledge Management and Digital Transformation in Tech Transfer
- Quality Assurance and Quality Control
- Life Cycle & Relationship Management
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
- Tania Chakraborty Kelly - Senior Scientist, Merck
- Tomohiro Makino - Senior Director, Head of Cell Line Development at Bioprocess Technology Research Laboratory II, Daiichi Sankyo
- Hesam Mahjoubi - Senior Principal Scientist, Amgen
- Wade Nudson - Strategic Implementation Manager, MilliporeSigma
- Aditya Walvekar - Scientist, Genentech
- Alaina Anand - Scientist, Upstream Process Development, Bioprocess R & D, Pfizer
- Sarah Scully - Scientist, Purification Process Development, Pfizer
- Christina Passno - Senior Staff Engineer, Regeneron Pharmaceuticals, Inc.
- Ran Chen - Associate Director of Process Development Downstream, Henlius Bioscience
- Bingyu Kuang - Senior Scientist II, Abbvie
- Martin Kockx - Principal Manufacturing Systems Engineer, Vertex Pharmaceuticals
- Till Briskot - Senior Scientist, Boehringer Ingelheim
- Alpana Naresh, Ph.D. - Chief Manufacturing Officer, Hinge Bio, Inc.
- Siddhartha (Sidd) Shrivastava, PhD - SVP, Head of CMC and Global Technical Operations, Cue Biopharma
- Yvette Stallwood - Senior Director, Head of Early Development Services, Lonza
- Dan Stanton - Trade Media Relations Expert, Sartorius
- Wei Lu - Senior Staff Engineer, Takeda Pharmaceuticals
- Christopher Bravery - Consulting Regulatory Scientist, Advbiols
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
- Rui Zheng - Senior Scientist, Bristol-Myers Squibb
- Jacqualyn Schulman, Ph.D. - Principal Scientist, Cell Line Development & ‘Omics Biologics Development, Bristol-Myers Squibb
- Thomas Jostock, PhD - Associate Director, Novartis
- Yang Wu - Principal Scientist, Sanofi
- Jesse Fisher - Senior Associate Scientist, Gilead
- Alex Williams - Scientist, Biologics Development, Bristol-Myers Squibb
- Jacob Crowe, PhD - Associate Director of Technical Services, Hamilton Company
- Bingyu Kuang - Senior Scientist II, Abbvie
- Moritz von Stosch - Co Founding Partner, HINA Bioventures
- Nathan Nicholes - Associate Director Downstream Process Development, Biogen
- Alpana Naresh, Ph.D. - Chief Manufacturing Officer, Hinge Bio, Inc.
- Jin Yu - Senior Scientist, Process Development Downstream, Amgen
- Thomas Johnson, Ph.D. - Lecturer in Downstream Bioprocessing, UCL
- Catherine Spanoudis - Scientist, Downstream Process Development, Forge Biologics
- Arvind Kushwaha - Vice President -Quality, Kemwell Biopharma
- Daniel Yur - Senior Scientist, Merck
- Yi Li - Principal AI Engineer, AbbVie
- Irene Rombel - Co-Founder and CEO, BioCurie
- Christian Airiau, Ph.D - Global Head, Data Sciences, Sanofi
- Kevin Zen, PhD - Senior Director of CMC Technical Operations, Opthea
- Amber Petersen - R&D Manager, MilliporeSigma
- Arvind Srivastava, Ph.D. - Senior Vice President, ThirdArcBio
- Catherine Simpson - Conference Director - Cell and Gene Therapy Portfolio, Informa Connect LifeSciences
- Todd McDevitt - Independent, Independent
- Kevin Cognetti - Head of Corporate Strategy, Kite Pharma
- Erin Kimbrel - Head of Cell & Gene Therapy Research, Astellas Institute for Regenerative Medicine
- Anthony Davies, Ph.D. - Founder & CEO, Dark Horse Consulting Inc.
- Daniel Friedman - Managing Director, BroadOak Capital
- Laura Stoppel - Partner, RA Capital Management
- Christian Uhrich - Executive Investment Director, M Ventures
- Mark Yde - Investor, Ajinomoto Group Ventures
- Khandan Baradaran - Principal, Mill Creek Consulting LLC
- Tadayuki Tanimura - Executive Vice President, Cuorips Inc.
- Willis Thomas - HR Business Partner, PQE
- Lea Wagner - Product Manager, INFORS HT
- Sarah Kenney - Bioanalytical Scientist, MilliporeSigma
- Kevin Brower - Global Head of Purification Development, Sanofi
- Jon Coffman - Executive Director of Bioprocess Technology and Engineering, Astra Zeneca
- Roundtable 1: AI Revolution in CGT Manufacturing – Beyond the Hype: Where is it Having an Impact?
Leader: Thorsten Gorba, Vice President of Process Development at Aspen Neuroscience
- Roundtable 2: Navigating IITs in China
Leader: Scott Jeffers, Chief Technology Officer at GenSight Biologics
- Roundtable 3: Supply Chain Mastery: Architecting Success from Bench to Market
- Thorsten Gorba - VP, Process & Analytical Development, Aspen Neuroscience, Inc.
- Scott Jeffers - Chief Technology Officer, GenSight Biologics
- Tricia Bitetto - Program Manager, Venture Café Cambridge, CIC
- Edward Ahn - Chief Executive Officer, Medipost Inc.
- Francesco Destro - Chief Technology Officer, BioCurie
Head to the Start-Up Zone for Cocktails and Innovation! Uncover the latest developments from industry trailblazers:
BioCurie Inc – 6pm – 6.05pm
Biolinco – 6.05pm – 6.10pm
Bioscibex – 6.10pm – 6.15pm
Green Elephant – 6.15pm – 6.20pm
CATUG Biotechnology – 6.20pm – 6.25pm
CUVIA – 6.25pm – 6.30pm
Genefab - 6.30pm - 6.35pm
Onyx Biotech - 6.35pm - 6.40pm
Eversyn – 6.40pm – 6.45pm
TEK Optima – 6.45pm – 6.50pm
UMTR Co. 6.50pm – 6.55pm
InnoFluidics- 6.55pm – 7pm
