CBER Director Marks Traverses the Complex COVID-19 Vaccine/Therapy Regulatory Landscape at FDLI’s Annual Conference

At the 2020 annual conference of the Washington, D.C.-based Food and Drug Law Institute (FDLI), held virtually on October 6-8, Center for Biologics Evaluation and Research (CBER) Director Peter Marks provided valuable insights on the difficult terrain that the regulators at CBER have to navigate to reach their goal of making effective vaccines and therapeutics for COVID-19 available as efficiently as possible.

Marks explained all that has to be gotten right in the science, manufacturing, delivery, and industry/regulator interactions to achieve this goal, the challenging problems that need to be carefully addressed, and the harsh consequences of any significant missteps along the way.

He began his FDLI conference presentation on the top issues CBER is facing and its priorities and goals for the coming year by reviewing the center’s regulatory responsibilities and applied regulatory research program and the developments that have been taking place in the cell and gene therapy (CGT) arena. [Editor’s Note: For an in-depth review of the CGT quality regulatory issues and developments – including a wealth of insights from Marks and other CBER managers – see IPQ’s July/August Monthly Update.]

Marks then provided an update on CBER’s engagement with COVID-19 convalescent plasma and vaccine development, respectively.

Following the prepared remarks, Celldex Therapeutics Law and Compliance VP Freddy Jimenez, who serves as Secretary and General Counsel for the FDLI Board of Directors, interviewed the CBER director about some of the most pressing regulatory concerns the center is facing in its efforts to respond to the pandemic and bring the needed vaccines and therapies forward through the review process.

A half-hour “post-session roundtable” followed, which offered attendees the opportunity to query Marks further on these concerns.

Emerging from the discussions was a clearer picture of the pieces of the regulatory puzzle and the complexities of trying to fit them together in the context of the urgency and dimension of the needs and stakes involved.

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