
[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Page 20233]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08614]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Joint Workshop on Drug Transporters in Absorption, Distribution, 
Metabolism, and Excretion: From the Bench to the Bedside

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Drug Transporters in Absorption, Distribution, 
Metabolism, and Excretion (ADME): From the Bench to the Bedside.'' The 
public workshop is an American Association of Pharmaceutical 
Scientists/International Transporter Consortium (AAPS/ITC) Joint 
Workshop, cosponsored with AAPS, the American Society for Clinical 
Pharmacology and Therapeutics, and the European Federation for 
Pharmaceutical Sciences. The goals of this public workshop are to 
provide an opportunity for scientists in academia, industry, and 
regulatory agencies to exchange ideas about the cutting edge science in 
transporters, and to facilitate and enhance translational applications 
of new development in transporter research in drug development and 
regulatory review of new therapeutics.
    Date and Time: The public workshop will be held on April 20, 2015, 
from 8:15 a.m. to 7 p.m.; April 21, 2015, from 8 a.m. to 6:30 p.m.; and 
April 22, 2015, from 8 a.m. to 3:45 p.m.
    Location: The public workshop will be held at the Renaissance 
Baltimore Harborplace Hotel, 202 East Pratt St., Baltimore, MD 21202. 
The hotel's phone number is 410-547-1200.
    Contacts: FDA: Lei Zhang, Food and Drug Administration, Center for 
Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Rm. 
3196, Silver Spring, MD 20993, 301-796-1635, email: 
leik.zhang@fda.hhs.gov. AAPS: For questions related to this event, 
please contact AAPS at registration@aaps.org.
    Registration: Workshop information and the registration link are 
posted at the AAPS meetings and professional development conference 
site. To register for the workshop, please visit http://www.aaps.org/Meetings_and_Professional_Development/Conference_Mini_Sites/AAPS_WS_Transporters15/Register/. The cost of registration is as 
follows:

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AAPS Member................................................       $1,815
Nonmember..................................................        2,190
Government.................................................          675
Academic...................................................          880
Student....................................................          110
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    The registration fee will be waived for 50 FDA employees. If you 
need special accommodations because of a disability, please contact 
AAPS at registration@aaps.org. Onsite registration on the day of the 
workshop will be available.
    Additional Information About the Workshop: The workshop agenda and 
additional background materials will be accessible at http://www.fda.gov/Drugs/NewsEvents/ucm439157.htm to all registrants.

SUPPLEMENTARY INFORMATION:

I. Background

    Transporters serve an important role in the ADME of drugs, and in 
turn could affect their safety or efficacy. The AAPS/ITC joint 
transporter workshop in 2015 aims to continue on the success of 
preceding AAPS workshops on Drug Transporters meetings (2003, 2005, 
2007, 2009, 2011, 2013) and ITC transporter workshops (2008 and 2012) 
to provide an opportunity for scientists in academia, industry, and 
regulatory agencies to exchange ideas about the cutting-edge science. 
Key areas of focus will include the following:
     Transporter tools of the future (e.g., organs-on-a-chip, 
humanized mouse models, and transporter imaging);
     Interplay of drug metabolism and transporters;
     ``State of the art'' sessions on:
    [cir] Emerging transporters,
    [cir] Endogenous biomarkers to assess transporter-mediated drug 
efficacy and toxicity or to predict drug-drug interactions, and
    [cir] Quantitative transporter proteomics in translational drug 
metabolism and pharmacokinetics;
     ``Hot Topics'' in the translation of transporter data to 
the clinic;
     Prospective transporter substrate modeling; and
     Review of comments related to transporters following 
recent guidances issued from the regulatory agencies, including FDA, 
European Medicines Agency, and Pharmaceuticals and Medical Devices 
Agency (Japan).

II. Goals and Objectives

     To provide a forum for open interchange, dissemination, 
and discussion of cutting edge science in transporters among scientists 
from academia, industry, and regulatory agencies.
     To develop a mutual understanding on what needs to be done 
in transporter research and how to translate knowledge obtained from 
the bench to bedside.
     To facilitate and enhance translational applications of 
new development in transporter research in drug development and 
regulatory review of new therapeutics.

    Dated: April 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08614 Filed 4-14-15; 8:45 am]
 BILLING CODE 4164-01-P


