Agenda September 23, 2026: Main Conference Day One - ET (Eastern Time, GMT-05:00)
- Yang Mei - Senior Scientist, Johnson and Johnson
- Dylan Frabutt - Research Scientist, Elanco
- Gavin Barnard - Chief Scientific Officer, ATUM
- Yang Wu - Principal Scientist, Sanofi
- Alexander Wu - Associate Scientist, Amgen
- Rajlaxmi Deshpande - Associate Scientist II, BioProcess Development, Alexion Pharmaceuticals
- Samuel Dorey - Principal Scientist, Materials and Irradiations, Sartorius
- Garima Thakur - Staff Engineer, Regeneron Pharmaceuticals
- Kevin Brower - Global Head of Purification Development, Sanofi
- Lei Wang - Principal Scientist, Gilead Sciences
- Chineye Emeche - Technical Applications Manager, Avantor
- Preeya Boppana - Director Manufacturing Science & Technology, AstraZeneca
- Yuxiang (Henry) Zhao - Senior Scientist, Bristol-Myers Squibb
- Sean Muthian, Ph.D., MBA - Chief Scientific Officer, Cytiva
- 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)
- Scott Wilson - Director of Raw Material & Manufacturing Innovation R&D, MilliporeSigma
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
- Yifeng Xu - Principal Scientist, Pfizer
- 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 Kuan - 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
- Wei Lu - Senior Staff Engineer, Takeda Pharmaceuticals
- Christopher Bravery - Consulting Regulatory Scientist, Advbiols
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
- Sushma Nayak Teichert - Senior Global Product Manager, Cytiva
- Charles Meadows - Senior Solutions Marketing Expert, Sartorius
- Jinghan Li - Applications Scientist, Croda Inc.
- Taeheui Lee - Vice President, Head of Ab Cell Culture PD, Samsung Biologics
- Alicia Barker - Cell Line Development- Scientist I, Just-Evotec
- Benjamin Duckless - Field Application Scientist, Nova Biomedical
- Rachael Cohen - Director of Automation & Assays, Prime Medicine
- Jonathan Jones - Manager, Microbial-Upstream, CPI
- Thomas Jostock, PhD - Associate Director, Novartis
- Rajesh Beri Ph.D. - Chief Development Officer, Wheeler Bio
- Yang Wu - Principal Scientist, Sanofi
- Jesse Fisher - Senior Associate Scientist, Gilead
- Duncan Omune - Senior Director of MSAT, Lonza
- Sanjay Kumar - Senior Subject Matter Expert, Lonza Bioscience, USA
- 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
- Daniel Yur - Senior Scientist, Merck
- Deekshith Vemireddy - Senior Manager, Downstream Process Development, Alvotech
- Alex Vaca - Senior Engineer II, Biogen
- Christian Airiau, Ph.D - Global Head, Data Sciences, Sanofi
- Joseph Hunziker - Process Characterization and Technology Scientist, Regeneron
- David Hansen - Principal Engineer, MilliporeSigma
- Amber Petersen - R&D Manager, MilliporeSigma
- Arvind Srivastava, Ph.D. - Senior Vice President, ThirdArcBio
- Christopher Marlein - Senior Principal Scientist, Process Development, FUJIFILM Biotechnologies
- Todd McDevitt - Vice President, Cell Therapy, Genentech
- Kevin Cognetti - Head of Corporate Strategy, Kite Pharma
- Angela Moore - VP, US GM, CAR-T Immunology and Oncology, Novartis
- 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
- 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
Gain an insight into some of the most cutting- edge technology and services hitting today’s Cell & Gene Therapies market through a series of 10-minute product demos live at the exhibit booths.
If you are interested in presenting your technology or service as part of the live lab tour please contact Roshni Shah – Roshni.shah@informa.com for more information.
- Aashish Tuladhar - Spectrometer Products Supervisor, HORIBA Instruments Incorporated
- Tricia Bitetto - Program Manager, Venture Café Cambridge, CIC
