Clinical Pharmacology Corner: FDA to Host Physiologically Based Pharmacokinetic Modeling Public Workshop on November 18, 2019

FDA to Host Physiologically Based Pharmacokinetic Modeling Public Workshop on November 18, 2019

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER), will host a public workshop entitled “Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-Making” on November 18, 2019.

Physiologically based pharmacokinetic (PBPK) modeling is a drug development tool that mathematically integrates physiological, physicochemical, and drug-dependent preclinical and clinical information to predict an investigational drug’s absorption, distribution, metabolism, excretion, and pharmacokinetics (PK). Over the past several decades, there has been extensive research using PBPK modeling and simulation to address a wide range of clinical questions, such as exploring the effects of extrinsic factors (e.g., concomitant medications, food intake) and intrinsic factors (e.g., age, organ dysfunction, disease status, genetics) on drug exposures. PBPK modeling and simulation approaches are used in regulatory submissions to predict the potential for drug-drug interactions and to support dosing recommendations for certain drugs when they are co-administered with metabolic enzyme modulators. However, challenges and knowledge gaps prevent PBPK modeling from being routinely used for specific regulatory decisions. Given the current limitations of the approach, it is important that the scientific community explore when, where, and how PBPK modeling and simulation may be applied in regulatory decision-making.

The objectives of this public workshop are to:

1. Discuss “best practices” in integrating in vitro and in vivo data to develop PBPK models and developing evidentiary criteria for PBPK models to be used for regulatory decision-making (see FDA’s recent white paper, “Consideration of a Credibility Assessment Framework in MIDD: Potential Application to PBPK Modeling and Simulation”);
2. Share experiences and cases applying PBPK modeling and simulation that highlight the opportunities and limitations of this approach;
3. Obtain input from the stakeholders on when, where, how, and with what limitations PBPK modeling and simulation may be applied in regulatory decision-making; and
4. Discuss the knowledge gaps and research needs to advance PBPK modeling sciences in drug development and regulatory evaluation.

One of FDA’s performance goals included in the sixth reauthorization of the Prescription Drug User Fee Amendments (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA), is to hold a series of workshops related to model-informed drug development (MIDD). FDA is conducting this workshop as part of the MIDD workshop series.

The date, time, location, and other details of the workshop are as follows:

Date: November 18, 2019

Time: 8:00 a.m. – 5:00 p.m.

Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503, B and C), Silver Spring, MD 20993-0002

Additional information on this workshop can be found at https://go.usa.gov/xVhgf. The Federal Register Notice for this event can be viewed at https://go.usa.gov/xmuvU.

Persons interested in attending this public workshop must register online by November 8, 2019 at https://www.eventbrite.com/e/pbpk-modeling-to-support-clinical-pharmacology-regulatory-decision-making-tickets-59005519096. Registration is free and based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited. FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 8:00 a.m.

The FDA will provide a free-of-charge, live webcast of this workshop, recordings of the webcast, and transcripts when available at https://go.usa.gov/xVhgf.

For further information, contact: Lauren Milligan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Building 51, Rm. 3159, Silver Spring, MD 20993-0002, 240-402-6421, Lauren.Milligan@fda.hhs.gov.