Dissecting the Direction of CDER and CBER with Paul Kim

Dissecting the Direction of CDER and CBER with Paul Kim – FDA Watch

Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies and former head of FDA and federal government strategies practices at a leading law firm for 20 years. Together, they discuss major legal issues and concerns with what the agency is aiming to accomplish; priorities for CDER Director Dr. George Tidmarsh and CBER Director Dr. Vinay Prasad; the direction of CDER and CBER on orphan drugs, rare diseases, and vaccines; reviews under the Commissioner's National Priority Voucher Program; and much more. This episode and all bonus episodes do not include the usual Headlines and Resources Links segments. To subscribe or find out more information about our podcast, visit FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net. Music by Dvir Silver from Pixabay.

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Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies and former head of FDA and federal government strategies practices at a leading law firm for 20 years. Together, they discuss major legal issues and concerns with what the agency is aiming to accomplish; priorities for CDER Director Dr. George Tidmarsh and CBER Director Dr. Vinay Prasad; the direction of CDER and CBER on orphan drugs, rare diseases, and vaccines; reviews under the Commissioner’s National Priority Voucher Program; and much more.

This episode and all bonus episodes do not include the usual Headlines and Resources Links segments.

About Our Guest

Paul Kim

Paul T. Kim, JD, MPP, is principal of Kendall Square Policy Strategies LLC, providing advice on FDA, life science, and public health policy to Fortune 500 companies, national patient advocates, life science trade associations, and emerging companies in the US, Europe and Korea.

Paul was head of the FDA and federal government strategies practices at a leading law firm for 20 years, following his work as counsel to the late Senator Edward Kennedy, Congressman Henry Waxman, and the late Senator David Pryor. Paul also worked for the FDA, the American Foundation for AIDS Research, and a global biopharmaceutical.