The Ides of March – FDA’s Pharmaceutical and Clinical Pharmacology Advisory Committee Meeting

While ominously scheduled for March 15, no such drama (like the assassination of Julius Caesar, the origins of ‘beware the Ides of March’) occurred during the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee (AdCom) meeting. It was quite productive, acknowledging the tremendous impact of modeling and simulation in drug development and regulatory review moving the technology further into the mainstream.

Organized by Dr. Issam Zineh, Director of FDA’s Office of Clinical Pharmacology, the invitation stated:

The use of model-informed drug development (MIDD) for new and generic drugs has significantly increased over the past several years. In the regulatory context, MIDD approaches hold particular promise in key opportunity areas including, but not limited to, physiologically-based pharmacokinetic (PBPK) modeling and simulation and risk prediction/assessment.

A Packed Agenda – Favorable to the Advancement of MIDD

The committee, comprised of regulatory, industry and academic key opinion leaders, began the day discussing strategies, approaches and challenges in MIDD, followed by a focus on two areas. This blog post will discuss the first area.

    Session 1: Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulation discussed approaches to and considerations for applying PBPK modeling and simulation throughout a drug’s lifecycle;
    Session 2: The Comprehensive In Vitro Proarrhythmia Assay (CiPA) discussed mechanistic model-informed safety evaluation focusing on drug’s arrhythmia potential.

The FDA has identified MIDD as an important pathway for lowering drug attrition and ameliorating regulatory uncertainty. It drives four of the agency’s eight science priority areas and has been incorporated in both PDUFA and GDUFA. The introduction of both special topics—PBPK and CiPA-were focused on improving predictability around safety-related drug attrition. MIDD challenges addressed during the meeting included modeling best practices; identification and transparent communication of knowledge gaps; data/knowledge warehouses; varying degrees of comfort by end-users; and clarity of regulatory expectations.

See more at: https://www.certara.com/2017/03/31/the-ides-of-march-fdas-pharmaceutical-and-clinical-pharmacology-advisory-committee-meeting

Related article at: Pharmacology Help Online