Pre-Conference Workshop Day

Tuesday | November 28, 2023

9:00 am Registration & Morning Coffee

9:30am – 12:00pm
Workshop A

9:30 am Exploring Regulatory Considerations for Genetic Engineering of Immune Cells & Donor-Derived Material


Due to the ability to treat multiple patients from one donor source, allogeneic cell therapies hold the blockbuster potential to usher in a new “future” of cell therapy, with the capacity to provide “off-the-shelf” treatments to improve the accessibility, cost of goods, and turnaround times for cell therapies. However, taking cells from donors and the inconsistency of starting material quality presents regulatory challenges, questions and hurdles to be overcome.

Join this workshop to:

  • Gain an understanding of the global views of regulatory bodies with regards to donors selection, testing, recruitment and ethics
  • Explore the top regulatory considerations (FDA vs EMA vs Japanese agencies) and reaffirming up-to-date guidelines
  • Obtain insight into how to build effective communication with these agencies and strategic alignment on the required demonstration of donor contribution to safety/efficacy of the final cell product

12:00 pm Break

12:01 pm 1:30pm – 3:30pm
Workshop B

1:30 pm Overcoming Challenges in Donor Management to Ensure a Reliable and Sustainable Pool for Manufacturing

  • Jennifer Collins Vice President - Procurement, Poseida Therapeutics
  • Kevin Liao Associate Director, Supply Chain, Caribou Biosciences


As more allogeneic pipelines progress through clinical development, with larger patient cohorts being tested for safety/efficacy, there is an increased demand for donor material to meet the requirement of increased dosing of the allogeneic products. It is business critical to address how to scale these therapies from clinical trial to being market ready to meet the vast and global patient demand. To achieve the high volumes of allogeneic cells needed for a commercialised product it will require a consistent and reliable donor source – meaning drug developers will need to outline an early strategy for not only donor selection criteria, but how to retain a steady donor pool also.

Join the workshop to:

  • Explore new techniques and strategies for ensuring a constant supply of donors with the required characteristics
  • Discuss the number of donors needed to be screened annually to keep the donor pool at the necessary volumes needed for manufacturing

3:30 pm End of Pre-Conference Workshop Day