AABB24: Cellular Starting Material Forum 2024

This year’s forum on Cellular Starting Material (CSM) continued the important exchange of expert perspectives from CSM collectors and the developers who modify the CSM to create advanced therapies for a growing spectrum of patients. The forum was conversational—among the panelists themselves and with audience members.

Donor Education, Consent and Sustainability
Forum moderators Linda Barnes, DrPH, MHA, RAC, CABP(H), from Linda S. Barnes Consulting; and Jeff Wren, MBA, CABP, vice president of biotherapies at AABB, opened the forum by posing several questions to the panelists about their interests in donor sustainability, the needed updates in the informed consent process and scalability concerns.

As the conversations broadened to include the attendees, the discussions touched on the following:

• The need for donors to understand long-term uses of their donations.
• The need to convey that although manufacturers of cell and gene therapy (CGT) products generate millions of dollars in revenue, the costs are also substantial.
• How sustainability of the donor base for cord blood and adult donors impacts the CGT products of the future.
• Concern about the scalability of supply chains that need to grow with development needs.
• Collaborative strategies between therapy developers and CSM suppliers to ensure sustainable sourcing.
  

Overcoming Barriers and Ensuring Sustainability
As the conversations continued, the topics varied and included the following points:

• Difficulties in identifying the “optimal donor” and “super donors.”
• The benefit of including ethicists and lawyers in creating informed consent processes.
• Overcoming the reluctance of investors who do not believe in the potential benefit of CGT products.
• Importance of updating and harmonizing donor consent for commercialization purposes.
• The need for a database or registry of CSM donors, particularly for those who donate repeatedly over time.
• Difficulties in determining which donor characteristics lead to the optimal CSM.
• Overcoming the barriers of donor variability and costs involved in collection and processing.
• Recognition that when science out-paces processes, it may appear that “wrong” decisions have been made. The reality is that the decisions were made with the most advanced science at the time.
  

Conclusion
In a brief conclusion, moderators Barnes and Wren summarized the importance of a collaborative approach to the shared challenges, a theme in comments from panelists and attendees alike. Also touched on was the role AABB could play in addressing the challenges noted during the forum discussions.

Thank You
AABB thanks the panelists, who made the forum possible:

• Priya Baraniak, PhD, chief business officer, OrganaBio LLC
  
• Colleen Delaney, MD, founder and chief scientific officer, Deverra Therapeutics
• Diana Hernandez, PhD, chief, immunotherapy research group, Anthony Nolan Research Institute
• Heather Muñoz, MN, RN, CPN, CPHON, QIA, Sana Biotechnology
• Rob Tressler, PhD, chief scientific officer, Excellos