ASGCT Holds Second Annual FDA Liaison Meeting

ASGCT held the second annual liaison meeting with the FDA’s Center for Biologics Evaluation and Research (CBER) on November 18. This year’s meeting was co-chaired by Adora Ndu, PharmD, J.D., chair of the ASGCT Regulatory Affairs Committee; and Maritza McIntyre, Ph.D., a member of both the ASGCT Board of Directors and the Regulatory Affairs Committee. ASGCT members presented on three topics to staff of the Office of Tissues and Advanced Therapies (OTAT), providing ASGCT recommendations to the Agency on regulatory topics of mutual interest in the field. In addition, OTAT staff provided useful information on common investigational new drug deficiencies and recommendations for improvement. View their presentation slides below.

Dan Levy, MD, PhD, Pfizer
Recommendations on Utilizing Surrogate Endpoints to Accelerate Development

Mike Havert, PhD, bluebird bio
Pre- and Post-Market Manufacturing Changes: Categorization of Major vs. Minor Changes and Requirements for Comparability Assessment for Gene Therapy Products

Anna Kwilas, PhD, Iwen Wu, PhD, and Ilan Irony, MD, FDA CBER OTAT
Common Gene Therapy IND Deficiencies and Recommendations for Improvement

Gabor Veres, PhD, BioMarin Pharmaceuticals
Development and Regulatory Considerations When Leveraging Platform Technology – Same/Similar Vector, Same/Similar Process, and Analytical Process

Read the summary of recommendations that ASGCT presenters provided to FDA.

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