Life after ISCT: Reflections on the industry by Akron’s Claudia Zylberberg

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Last month, Akron attended the 20th annual ISCT Meeting in Paris. This year’s was the largest ISCT meeting yet, with hundreds of delegates participating in dozens of sessions across multiple subject areas.

Akron participated via multiple channels: our booth and scientific poster were a constant source of traffic and scientific exchange, while Akron’s Claudia Zylberberg participated in a number of scientific platforms.

One of these was a panel on Quality and Operations titled “Ancillary Materials for Cellular Therapies”. Apart from Akron, other panelists included scientists from MD Anderson, USP and Stem Cell Technologies. Of the panel, Dr. Zylberberg said:

“This was a very enlightening session. Lynn Csontos and Jennifer Solomon, highlighted the importance of language, labeling and quality harmonization between continents. The session, led by ISCT-FACT, brought to light the need for a workshop to discuss this subject in more depth. The session, in proposed partnership with USP, would answer such critical questions as when cGMP ancillary materials are needed and what the real meaning of cGMP within this context is, with the aim of bringing clarity to an otherwise murky subject. “

Another of Dr. Zylberberg’s highlights included a session on reimbursement strategies and cost of goods.

“Michael May from CIRM spoke about the importance of including reimbursement strategies early in the cell therapy development process. Understanding the reimbursement process is of utmost importance. In Canada, in a fixed budget system, reimbursement is “complicated”. There is a need to recognize both the opportunity to recoup the investment as well as the value proposition when other therapies for the same indication exist on the market. They have a very systematic approach for evaluating reimbursement options for early-stage cell therapies in line with patients’ needs. During that same session, Margaret Parton (from the UK’s NHS) highlighted that negotiations are typically based on cost instead of value. The message was clear: when implementing strategies for reimbursement for cell therapies, evidence and data for their value and effectiveness needs to be gathered from the very start.

During William Milligan’s session on COGs, Bob Preti (PCT) discussed the key impact of the COG on the overall process – it was clear to me the need to understand and streamline the process as a whole is critical. Evelyn Stalmeijer pointed out the need of cost modeling, by considering and adding up components within facility design, process, capacity and supply chain areas. Indeed, failures in cell therapies occur mostly because of the high COG’s and uncontrolled process variability.

Akron is now gearing up for the upcoming ISSCR meeting which will take place in Vancouver June 18-21. More details to follow.

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