[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Pages 27136-27137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12256]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2039]


Development of Best Practices in Physiologically Based 
Pharmacokinetic Modeling To Support Clinical Pharmacology Regulatory 
Decision-Making; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) Center for Drug 
Evaluation and Research (CDER), in collaboration with the Center for 
Biologics Evaluation and Research (CBER), is announcing a public 
workshop entitled ``Development of Best Practices in Physiologically 
Based Pharmacokinetic Modeling to Support Clinical Pharmacology 
Regulatory Decision-Making.'' The purpose of this public workshop is to 
discuss best practices and evidentiary criteria in the use of 
physiologically based pharmacokinetic (PBPK) modeling approaches to 
support regulatory decision-making; share experiences and cases where 
applying PBPK modeling and simulation highlight the opportunities and 
limitations of this approach; obtain input from stakeholders on when, 
where, how, and with what limitations PBPK modeling and simulation may 
be applied in regulatory decision-making; and discuss the knowledge 
gaps and research needed to advance PBPK modeling sciences in drug 
development to support regulatory decisions. This public workshop is 
also being conducted to satisfy 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), to hold a series of workshops related to model-informed drug 
development (MIDD).

DATES: The public workshop will be held on November 18, 2019, from 8 
a.m. to 5 p.m., Eastern Time. See the SUPPLEMENTARY INFORMATION section 
for registration date and information.

ADDRESSES: The public workshop will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503, B and C), Silver Spring, MD 20993-0002. Entrance for public 
workshop participants (non-FDA employees) is through Building 1 where 
routine security procedures will be performed. For parking and security 
information, please refer to: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Lauren Milligan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3159, Silver Spring, MD 20993-0002, 240-
402-6421, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Under FDARA, and in accordance with section I, part J of the PDUFA 
VI Performance Goals, FDA agreed to convene a series of workshops to 
identify best practices for MIDD (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf at 27). FDA 
is conducting this workshop as part of the MIDD workshop series.
    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.

II. Objectives

    The objectives of the workshop are to:

    1. Discuss ``best practices'' in integrating in vitro and in 
vivo data to develop PBPK models and developing evidentiary criteria

[[Page 27137]]

for PBPK models to be used for regulatory decision-making.
    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.
    4. Discuss the knowledge gaps and research needs to advance PBPK 
modeling sciences in drug development and regulatory evaluation.

    A detailed agenda will be posted in advance of the workshop at 
https://www.fda.gov/Drugs/NewsEvents/ucm633778.htm.

III. Participating in the Public Workshop

    Registration: 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. Please provide complete 
contact information for each attendee.
    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 a.m.
    If you need special accommodations due to a disability, please 
contact Lauren Milligan (see FOR FURTHER INFORMATION CONTACT) no later 
than November 8, 2019.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast. A live webcast of this workshop will be available at 
https://www.fda.gov/Drugs/NewsEvents/ucm633778.htm on the day of the 
workshop. If you have never attended a Connect Pro event before, test 
your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro 
program, visit https://www.adobe.com/go/connectpro_overview. FDA has 
verified the website addresses in this document, as of the date this 
document publishes in the Federal Register, but websites are subject to 
change over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.fda.gov/Drugs/NewsEvents/ucm633778.htm. It may be viewed at the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852. A link to the transcript 
will be available on the internet at https://www.fda.gov/Drugs/NewsEvents/ucm633778.htm.

    Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12256 Filed 6-10-19; 8:45 am]
 BILLING CODE 4164-01-P