Joint Workshop on Drug Transporters in Absorption, Distribution, Metabolism, and Excretion: From the Bench to the Bedside, 20233 [2015-08614]
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Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices
Dated: March 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
www.aaps.org/Meetings_and_
Professional_Development/Conference_
Mini_Sites/AAPS_WS_Transporters15/
Register/. The cost of registration is as
follows:
[FR Doc. 2015–08618 Filed 4–14–15; 8:45 am]
BILLING CODE 4164–01–P
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.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice of public workshop.
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 https://
VerDate Sep<11>2014
17:29 Apr 14, 2015
Jkt 235001
20233
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
AAPS Member ..........................
$1,815 research and how to translate
Nonmember ..............................
2,190 knowledge obtained from the bench to
Government ..............................
675 bedside.
Academic ..................................
880
• To facilitate and enhance
Student .....................................
110 translational applications of new
development in transporter research in
The registration fee will be waived for drug development and regulatory
50 FDA employees. If you need special
review of new therapeutics.
accommodations because of a disability,
Dated: April 8, 2015.
please contact AAPS at registration@
Leslie Kux,
aaps.org. Onsite registration on the day
Associate Commissioner for Policy.
of the workshop will be available.
Additional Information About the
[FR Doc. 2015–08614 Filed 4–14–15; 8:45 am]
Workshop: The workshop agenda and
BILLING CODE 4164–01–P
additional background materials will be
accessible at https://www.fda.gov/Drugs/
DEPARTMENT OF HEALTH AND
NewsEvents/ucm439157.htm to all
HUMAN SERVICES
registrants.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
I. Background
[Docket No. FDA–2015–N–0001]
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:
Æ Emerging transporters,
Æ Endogenous biomarkers to assess
transporter-mediated drug efficacy and
toxicity or to predict drug-drug
interactions, and
Æ 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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Request for Nomination for Industry
Representatives and Participation
From Industry Organizations on Public
Advisory Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of
nonvoting industry representatives to
serve on its public advisory committees
for the Center for Drug Evaluation and
Research (CDER) notify FDA in writing.
FDA is also requesting nominations for
nonvoting industry representatives to
serve on CDER’s public advisory
committees. A nominee may either be
self-nominated or nominated by an
organization to serve as a nonvoting
industry representative. Nominations
will be accepted for current vacancies
effective with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by May 15, 2015, (see sections I
and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by May 15, 2015.
ADDRESSES: All statements of interest
from interested industry organizations
interested in participating in the
selection process of nonvoting industry
representative nominations should be
SUMMARY:
E:\FR\FM\15APN1.SGM
15APN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.aaps.org/Meetings_and_Professional_Development/Conference_Mini_Sites/AAPS_WS_Transporters15/Register/. The cost of registration is as
follows:
------------------------------------------------------------------------
------------------------------------------------------------------------
AAPS Member................................................ $1,815
Nonmember.................................................. 2,190
Government................................................. 675
Academic................................................... 880
Student.................................................... 110
------------------------------------------------------------------------
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 https://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
