- November 18, 2019
8:00 AM - 5:00 PM ET
Sponsored by the Office of Clinical Pharmacology
OTS, CDER, U.S. Food and Drug Administration (FDA)
Co-Chairs: Yuching Yang, PhD, FDA, CDER, OCP
Xinyuan Zhang, PhD, FDA, CDER, OCP
Lauren Milligan, PhD, FDA, CDER, OCP
Under the FDA Reauthorization Act of 2017, FDA agreed, in accordance with section I of the PDUFA VI Performance Goals, Ensuring the Effectiveness of the Human Drug Review, part J, Enhancing Regulatory Decision Tools to Support Drug Development and Review, to convene a series of workshops to identify best practices for model informed drug development (MIDD).
The Food and Drug Administration (FDA) will convene a workshop on model informed drug development approaches using physiologically based pharmacokinetic analyses as part of this workshop series.
Date: November 18, 2019
Time: 8:00 a.m. to 5:00 p.m.
Location: FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503 - Great Room B & C
Silver Spring, MD 20993
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.
FDA notes that PBPK modeling and simulation approaches are extensively 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.
- 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”)
- Share experiences and cases applying PBPK modeling and simulation that highlight the opportunities and limitations of this approach
- Obtain input from the stakeholders on when, where, how, and with what limitations PBPK modeling and simulation may be applied in regulatory decision-making
- Discuss the knowledge gaps and research needs to advance PBPK modeling sciences in drug development and regulatory evaluation
Who should attend:
This workshop will be open to the public. The primary audience will include pharmaceutical scientists working with small molecule development from academia, industry, and government regulatory agencies, both domestic and international.
Links and Registration Information:
Additional information on this workshop can be found at https://go.usa.gov/xmJXF. The Federal Register Notice for this event can be viewed at https://go.usa.gov/xmuvU . You can register online by November 8th, 2019 at https://www.eventbrite.com/e/pbpk-modeling-to-support-clinical-pharmacology-regulatory-decision-making-tickets-59005519096.
The FDA will provide a free-of-charge, live webcast of this workshop.
The URL for Adobe Connect is: https://collaboration.fda.gov/nov182019
In the event that the main webcast URL reaches capacity, please try the second webcast URL: https://collaboration.fda.gov/nov182019overflow
- Final Agenda
- Speaker Bios
- Mager, Donald E. PBPK State of the Science (PDF - 94MB)
- Hall, Stephen D., PhD. The State of the Science Industry Perspective(PDF - 1.56MB)
- Wang, Yaning, PhD. PBPK Current Status and Challenges(PDF - KB)
- Snoeys, Jan. Application of PBPK modeling to support labelling initiatives: Janssen case study, (PDF - 1,822KB)
- Isoherranen, Nina, Ph D. Lessions Learned from Model Development that Seemed to Go Wrong. (PDF - 1589KB)
- Zhang, Xinyuan (Susie), Ph.D. Physiologically Based Pharmacokinetic Modeling & Simulation in OCP Submissions: Case Studies (PDF - 289KB)
- Fraczkiewicz, Grace. PBPK Modeling - Knowledge Gaps and Challenges. (PDF - 838KB)
- Gardner, Iain, PhD. Future development of PBPK science – opportunities and barriers. (PDF - 966KB)
- Gastonguay, Marc R.PhD. Bridging Knowledge Gaps in PBPK through Open Science. (PDF - 198KB)
- Heimbach, Tycho, PBPK Model Applications: Supplementing Clinical Trials with limited Patient PK Data (PDF - 822KB)
Lauren Milligan, PhD
Regulatory Project Manager
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
Food and Drug Administration
|PBPK_WorkshopAgenda||pdf (97.56 KB)|
|Speaker Bios PBPK workshop||pdf (188.04 KB)|
|Session1_DonMager||pdf (1.94 MB)|
|Session1SteveHall||pdf (1.56 MB)|
|Session1_YaningWang||pdf (1.32 MB)|
|Session2_ColleenKuemmel||pdf (889.60 KB)|
|Session3_JanSnoeys||pdf (1.78 MB)|
|Session3_Ninal_PBPK||pdf (1.55 MB)|
|Session3_XinyuanZhang_PBPK||pdf (288.68 KB)|
|Session4_GraceF||pdf (837.36 KB)|
|Session4_IainGardner||pdf (965.73 KB)|
|Session4_MarcG||pdf (197.41 KB)|
|Session4_TychoHeimbach||pdf (821.89 KB)|
|Transcript_FDA_PBPK_workshop||pdf (595.10 KB)|