[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]
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