Wednesday 23rd September - Conference Day One - ET (Eastern Time, GMT-05:00)
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
- Christopher Bravery - Consulting Regulatory Scientist, Advbiols
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
CGT: C-Level Forum - Invite Only
The CGT C-Level Forum provides a unique, powerful and valuable space for candidly sharing ideas and experiences between executives of ~20 CGT therapeutic development companies. The forum is designed to foster new ideas and create new relationships between attendees so that they can leave with tangible outcomes and that will drive their businesses and the sector forward.
An exclusive invite-only session, in a closed room setting, the forum will include 2-3 case studies discussing the right approach to engage and partner with pharma and industry. It will also include general discussion focussed on brainstorming solutions to the most pressing and current challenges of CEO/CSO/CBO/CMOs in the CGT sector.
- Todd McDevitt - Vice President, Cell Therapy, Genentech
- Tyler Koop - Vice President, Global Commercial, Cell Therapy, Bristol Myers Squibb
- Daniel Friedman - Managing Director, BroadOak Capital
- Laura Stoppel - Partner, RA Capital Management
- Christian Uhrich - Executive Investment Director, M Ventures
- Sebastien Latapie - Partner, AVANT BIO
- Tadayuki Tanimura - Executive Vice President / Board Member, Cuorips Inc.
Roundtable 1: AI Revolution in CGT Manufacturing – Beyond the Hype: Where is it Having an Impact?
Roundtable Leader:
Roundtable 2: Navigating IITs in China
Roundtable Leader:
Supply Chain Mastery: Architecting Success from Bench to Market
Roundtable Leader*:
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.