The Challenges of the Journey from Clinical to Commercial Cell Therapies (PDA/FDA Joint Regulatory Conference 2023)

Humberto Vega, PhD, Executive Director, Bristol Myers Squibb, discusses the journey from clinical to commercial cell therapies as a part of his session, "Successfully Navigating Global Cell Therapy Requirements."

Vega: The case of cell therapies is one word data is now being generated. And the different companies are learning about processes and products, as they are in development. It is not a new journey, it began back in the 70s and even earlier, but the learning about sales and the immune system really grew during the last 20 years with the advantage of technologies and that is one challenge that is being overcome. Now, the regulatory space and the compliance space is something that is now being developed, is growing, and each country has various specific requirements, looking not only on having a product that is safe, but also protecting the patient from the use of the cells and how those products are now develop use, and in the future, they will become the mainstream. So, the challenge is making sure that all the regulatory aspects are properly addressed during clinical stage and development all the way into the routine commercial promotion.

Vega: One key element is understanding what is expected from the regulatory space, having a close communication with the agency, having clear, a change of information with those regulatory bodies to ensure their expectations, their regulatory space, is very clear to the company and the group developing and transitioning into a commercial space in particular products. So, there are no surprises at the time, the product is fine, and all the information required by the regulatory group is provided and explain and justify, and then once approved, how to maintain the quality and the regulatory posture as a production is now in a commercial stage.