CELL THERAPY MANUFACTURING XCHANGE
2024
San Diego, February 29

Welcome to hubXchange’s Cell Therapy Manufacturing Xchange San Diego 2024, bringing together executives from pharma and biotech to address and find solutions to the key issues faced in cell and gene therapeutics.

Discussion topics will cover Measuring Product Potency, Autologous C&G, Allogeneic Cell Therapies, and iPSCs Technology.

Take advantage of this unique highly interactive meeting format designed for maximum engagement, collaboration and networking with your peers.

Venue: Handlery Hotel San Diego, 950 Hotel Circle North, San Diego CA 92108

SNAPSHOTS OF DISCUSSION TOPICS

  • Employing Cytotoxicity and Proliferation Assays to Address the Inconsistencies in Potency Measurements of cytotoxicity
  • Employing Droplet Digital PCR for precise vector genome titration in AAV-based gene therapies
  • Navigating the Investment Timing and Challenges in Adopting New Analytical Technologies seamlessly for Cell Therapy drug products
  • Why focusing on a quality end product from the beginning makes sense | Managing your journey to commercialization with quality raw materials.
  • Improving efficiency and reducing inter-batch variation with automated Cell Expansion Systems.
  • Enabling long-term storage and transportation using Cryopreservation Techniques.
  • Using closed system automation to improve consistency and repeatability in allogeneic T cell manufacturing processes.
  • Implementing in-process assays to monitor and steer successful manufacturing outcomes.

Full Xchange Agenda

Click on each track for detailed agenda

Measuring Product Potency

Time
Titles and Bullets
Facilitator
08:00 – 08:30
Registration 
08:30 – 09:00

Opening Address & Keynote Presentation

09:05 – 10:05
Employing principles of Analytical Quality by Design (AQbD) to address the inconsistencies in potency measurement
  • What analytical target profile (ATP) should be defined for the potency assay?
  • What are the critical analytical attributes and how to control critical method variables for potency assays?
  • How do we employ the principles of Design of Experiment (DoE) to optimize the parameters contributing to inconsistencies of potency assays?
  • What strategies we should employ to establish the assay and product acceptance criteria for potency assay?

Dedicated scientist with over 20 years of experience in research and drug development. Strong analytical background with accomplished leadership in drug development, characterization of response mechanism to novel therapeutics and analytical development for quality control of cell therapy manufacturing. Extensive experience with current immunology, molecular biology, biochemistry and bioinformatics approaches. Passionate about advanced therapeutic development to bring the cures to the patients in need.

Jie Wei
10:10 – 10:40
1-2-1 Meetings/Networking Break
10:40 – 11:10
1-2-1 Meetings / Networking Break
11:10 – 11:20
Morning Refreshments
11:20 – 12:20

Autologous C&G track: How starting with an autologous cell therapy product can lead to successful allogeneic product development 

  • Other than cost/patient and using donor (non-patient derived material) do allogeneic products have any benefits?
  • With the additional complexity of gene editing, HLA mismatches etc, does allogeneic offer any off-setting potential therapeutic benefit?
  • For any cell therapeutic does allo or auto provide the best chance for a clinical proof-of-concept success?

Brian Newsom joined Theragent as the VP of Business Development in October of 2023. Prior to Theragent, Brian spent six years at KBI Biopharma and almost a decade at Thermo Fisher Scientific (and legacy companies) in business development. Brian’s technical background includes posts as Head of R&D at Opexa Therapeutics and five years at Baylor College of Medicine, Center for Cell and Gene Therapy. Brian began his career in cell therapy at Aastrom Biosciences, one of the industries pioneering companies, in 1992. Brian received his degree in Microbiology from Texas Tech University and an MBA from Texas A&M University.

Brian Newsom
12:20 – 13:20

Networking Lunch

13:20 – 13:50

Spotlight Presentation

What do I need to run a successful Cell and Gene therapy clinical trial? Roadmap to de-risking today’s Cell and Gene based trials.

This presentation explores the essential components for a successful cell and gene
therapy clinical trial. Addressing the complexities of today’s trials, it provides a roadmap to de-risk the process. Emphasizing key requirements, we will delve into the necessary infrastructure, regulatory considerations, study design insights, logistical support needed, and strategic planning crucial for trial success. The presentation aims to guide stakeholders in pharma and biotech through the intricate journey of cell and gene therapy trials, fostering a comprehensive understanding of the challenges and mitigating risks for advancing these transformative treatments.

As part of Biorasi leadership, Dr. El-Hokayem holds a unique expertise in C&G therapy development spanning from basic science to successful clinical trial execution. He currently sits on the scientific advisory board of the FAST foundation. Dr El-Hokayem has numerous published contributions on early models of iPSC derivation from PBMCs.

.Jimmy El Hokayem
13:55 – 14:25
1-2-1 Meetings / Networking Break
14:25 – 14:55

1-2-1 Meetings / Networking Break

15:35 – 16:35

Cell Therapy Release and Characterization Assays

  • How important are in-process analytics? 
  • What are some universal release assays for cell and gene therapy drug products? How would you manage comparability across varied labs for cell therapy drug products? 
  • How do you reduce the number of samples required for cell therapy release assays, when we have low yield of drug product itself?

I have been in the cell and gene therapy space for over 15 years, starting off my career in academia working in James Wilson’s lab at the University of Pennsylvania. Since then, I have worked in both process and analytical development roles and companies such as BioMarin, Pfizer and Sangamo Therapeutics. I current lead analytics of a cell therapy drug product at Bayer.

Jigesha_Dholakia
16:35 – 17:35

Evening Drinks Reception

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