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OCR for page 65
Appendix A
Workshop Agenda
ASSESSING AND ACCELERATING THE DEvELOPMENT OF
bIOMARkERS FOR DRuG SAFETy
NAS keck Center, Room 100
500 Fifth Street NW, Washington DC
October 24, 2008
Objectives: The primary goals of this workshop are
• to assess the current state of the art for screening technologies to
find off-target effects early in drug development—what have we
been able to accomplish, and what remains to be done;
• to develop a prioritized questions list to address remaining obsta-
cles; and
• to discuss how to accelerate the efforts through public and private
means.
8:00–8:15 WELCOME AND INTRODuCTION OF WORkSHOP
ObJECTIvES
RobeRt Califf (Forum Member)
Duke University Medical Center
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DEVELOPMENT OF BIOMARKERS FOR DRUG SAFETY
8:15–10:15 MORNING SESSION—
ASSESSING THE CuRRENT STATE OF bIOMARkERS
TO PREDICT DRuG-INDuCED TOXICITy.
• What is the current state of the art for screening technologies
to find off-target effects early in development—what have we
been able to accomplish, and what remains to be done?
• What are the obstacles impeding progress?
• How can these efforts be accelerated through public and
private means?
Moderator: Mikhail Gishizky (Forum Member)
Entelos
Overview
8:15–8:30
alastaiR Wood
Symphony Capital, LLC
Cardiac Toxicity
8:30–8:45
NoRMaN stoCkbRidGe
U.S. Food and Drug Administration
daNiel blooMfield
Merck Research Laboratories
Hepatotoxicity
8:45–9:00
Paul WatkiNs
university of North Carolina at Chapel Hill
Nephrotoxicity
9:00–9:15
fRaNk sistaRe
Merck Research Laboratories
Panel Discussion
9:15–10:10
10:10–10:15 Charge to the breakout Groups
RobeRt Califf (Forum Member)
Duke University Medical Center
10:15–10:30 bREAk
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APPENDIX A
10:30–12:30 bREAkOuT SESSION 1—
PREDICTIvE bIOMARkERS FOR NEPHROTOXICITy
Room 206
Moderators: fRaNk sistaRe
Merck Research Laboratories
PRasad devaRajaN
C
incinnati Children’s Hospital Medical Center, University
of Cincinnati
Panelists: josePh boNveNtRe
Harvard Medical School, Brigham and Women’s Hospital
fRaNk dieteRle
d
Novartis Pharma
RobeRt staR
N
ational Institute of Diabetes and Digestive and Kidney
Diseases
MelaNie blaNk
U.S. Food and Drug Administration
david WaRNoCk
University of Alabama at Birmingham
10:30–12:30 bREAkOuT SESSION 2—
PREDICTIvE bIOMARkERS FOR HEPATOTOXICITy
Room 201
Moderators: Paul WatkiNs
university of North Carolina at Chapel Hill
ChRistiNe huNt
GlaxoSmithKline
Panelists: johN blooM
Eli Lilly and Company
MaRk aviGaN
U.S. Food and Drug Administration
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DEVELOPMENT OF BIOMARKERS FOR DRUG SAFETY
leoNaRd seeff
National Institute of Diabetes and Digestive and Kidney
Diseases
jaMes fRestoN
University of Connecticut Health Center
10:30–12:30 bREAkOuT SESSION 3—
PREDICTIvE bIOMARkERS FOR CARDIAC TOXICITy
Room 109
Moderator: jay MasoN
University of Utah
Panelists: daNiel blooMfield
Merck Research Laboratories
NoRMaN stoCkbRidGe
U.S. Food and Drug Administration
Paul eiseNbeRG
Amgen
MiChael doMaNski
National Heart, Lung, and Blood Institute
12:30–1:45 LuNCH
Room 100
1:45–3:15 bREAkOuT SESSION REPORTS
Moderator: RobeRt Califf (Forum Member)
Duke University Medical Center
Nephrotoxicity breakout Report
1:45–2:00
PRasad devaRajaN
C
incinnati Children’s Hospital Medical Center, University
of Cincinnati
Hepatotoxicity breakout Report
2:00–2:15
johN blooM
Eli Lilly and Company
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APPENDIX A
Cardiac Toxicity breakout Report
2:15–2:30
alastaiR Wood
Symphony Capital, LLC
Panel Discussion
2:30–3:15
3:15–3:30 bREAk
3:30–5:30 AFTERNOON SESSION—
COPING WITH THE INCREASED COMPLEXITy
OF vALIDATING AND QuALIFyING
MuLTIMARkER PANELS.
Until recently biomarkers have been developed one at a time, and at times
the scientific community has debated their utility. The advent of large-scale
genomic, proteomic, metabolomic, and advanced imaging technologies is
changing the environment in which biomarkers are identified and assessed.
During this session speakers will: explore the potential of applying cutting-
edge scientific technologies to enhance prediction and detection of drug-
induced toxicity; discuss integration of systems biology and computational
biology into toxicity assessment in early drug development; and consider
the regulatory and scientific challenges involved in the validation and quali-
fication of multimarker panels.
Moderator: RobeRt Califf (Forum Member)
Duke University Medical Center
Regulatory Considerations for validation and Qualification
3:30–3:45
of Multimarker Panels
jaNet WoodCoCk (Forum Member)
U.S. Food and Drug Administration
Systems biology of biomarkers
3:45–4:00
Ravi iyeNGaR
Mount Sinai School of Medicine
A Future Direction of Drug Safety Assessment—
4:00–4:15
North Carolina biomarker Factory Project
RobeRt Califf (Forum Member)
Duke University Medical Center
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0 DEVELOPMENT OF BIOMARKERS FOR DRUG SAFETY
biomarkers for Psychiatric Drug Toxicity:
4:15–4:30
Opportunities and Challenges
thoMas iNsel
National Institute of Mental Health
Panel Discussion—Integration of New Science into Drug
4:30–5:30
Safety Prediction and Assessment
• How can we develop more efficient approaches to
biomarker evaluation and qualification in animals and
humans?
• What potential policies could be enacted to help guide
this effort?
• How could these efforts be advanced through public or
private means?
5:30 ADJOuRN
