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 obstacles; 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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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