Tuesday 16th September, 2025 - Workshop & Keynotes - ET (Eastern Time, GMT-05:00)
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
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
- Digital Transformation in Tech Transfer
- Quality Assurance and Quality Control
- Life Cycle & Relationship Management
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
- Tracy Payne - SVP Business Development, Principal Consultant Business Strategy & Operations, Windshire Group, LLC. Labshire, LLC
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
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
- Digital Transformation in Tech Transfer
- Quality Assurance and Quality Control
- Life Cycle & Relationship Management
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
- Tracy Payne - SVP Business Development, Principal Consultant Business Strategy & Operations, Windshire Group, LLC. Labshire, LLC
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.
The CGT Supply Chain forum provides a unique, powerful and valuable space for candidly sharing ideas and experiences between supply chain executives of 20-30 CGT therapeutic development companies.
An exclusive invite-only session, the forum will include 2-3 case studies and panel discussions focussed on brainstorming solutions to navigate the complexities of supply chain management for CGTs. Offering comprehensive insights into innovations, tools and trends to enhance efficiency, visibility, and responsiveness across the entire network and ultimately increasing CGT access to patients.
Join us for an engaging Lunch & Learn session where leading technology, product, and service providers showcase the latest advancements in bioprocessing. Enjoy your meal while exploring cutting-edge solutions designed to enhance efficiency, scalability, and innovation in biomanufacturing.
This interactive session offers a unique opportunity to gain insights into breakthrough technologies, ask questions directly to industry experts, and network with peers—all in a relaxed, informal setting.
Whether you're looking to optimize your processes, explore new tools, or simply stay ahead of industry trends, this is a must-attend event a Cell and Gene Therapy International.
Join us for an engaging Lunch & Learn session where leading technology, product, and service providers showcase the latest advancements in bioprocessing. Enjoy your meal while exploring cutting-edge solutions designed to enhance efficiency, scalability, and innovation in biomanufacturing.
This interactive session offers a unique opportunity to gain insights into breakthrough technologies, ask questions directly to industry experts, and network with peers—all in a relaxed, informal setting.
Whether you're looking to optimize your processes, explore new tools, or simply stay ahead of industry trends, this is a must-attend event a Cell and Gene Therapy International.
Join us for an engaging Lunch & Learn session where leading technology, product, and service providers showcase the latest advancements in bioprocessing. Enjoy your meal while exploring cutting-edge solutions designed to enhance efficiency, scalability, and innovation in biomanufacturing.
This interactive session offers a unique opportunity to gain insights into breakthrough technologies, ask questions directly to industry experts, and network with peers—all in a relaxed, informal setting.
Whether you're looking to optimize your processes, explore new tools, or simply stay ahead of industry trends, this is a must-attend event at Cell and Gene Therapy International.
Join us for an engaging Lunch & Learn session where leading technology, product, and service providers showcase the latest advancements in bioprocessing. Enjoy your meal while exploring cutting-edge solutions designed to enhance efficiency, scalability, and innovation in biomanufacturing.
This interactive session offers a unique opportunity to gain insights into breakthrough technologies, ask questions directly to industry experts, and network with peers—all in a relaxed, informal setting.
Whether you're looking to optimize your processes, explore new tools, or simply stay ahead of industry trends, this is a must-attend event at BioProcess International.
Join us for an engaging Lunch & Learn session where leading technology, product, and service providers showcase the latest advancements in bioprocessing. Enjoy your meal while exploring cutting-edge solutions designed to enhance efficiency, scalability, and innovation in biomanufacturing.
This interactive session offers a unique opportunity to gain insights into breakthrough technologies, ask questions directly to industry experts, and network with peers—all in a relaxed, informal setting.
Whether you're looking to optimize your processes, explore new tools, or simply stay ahead of industry trends, this is a must-attend event at BioProcess International.
Join us for an engaging Lunch & Learn session where leading technology, product, and service providers showcase the latest advancements in bioprocessing. Enjoy your meal while exploring cutting-edge solutions designed to enhance efficiency, scalability, and innovation in biomanufacturing.
This interactive session offers a unique opportunity to gain insights into breakthrough technologies, ask questions directly to industry experts, and network with peers—all in a relaxed, informal setting.
Whether you're looking to optimize your processes, explore new tools, or simply stay ahead of industry trends, this is a must-attend event at BioProcess International.
- Wolfram Carius - EVP Pharmaceuticals, Bayer
- Erin Kimbrel - President & Head, Astellas Institute for Regenerative Medicine
- Stephen Kennedy - Head of Technical Operations, CRISPR Therapeutics
- Ruth Salmon - VP, BMS Cell Therapy Research, Bristol Myers Squibb
- Bryan Poltilove - Strategic Advisor and Independent Board Director, Independent
- Daniel Friedman - Principal, BroadOak Capital
- Aaron Fisher - Director, Life Sciences Investments, ARCHIMED
- Case Studies: Success stories of regulatory approvals and commercialization
- Overcoming Hurdles: Key challenges from R&D to approval—and how to tackle them
- Scaling Up: Strategies for manufacturing, validation, and CMC data packages
- Regulatory Insights: Feedback from authorities on characterization, specifications, and approval pathways
- Post-Approval Management: Long-term data tracking, durability studies, and lifecycle strategies
- End-to-End Logistics: Mastering supply chain and global distribution
- Pathways to approval –Case study on the journey from discovery to commercial development and beyond