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Advancing the Discipline of Regulatory Science for Medical Product Development An Update on Progress and a Forward-Looking Agenda: Workshop Summary (2016) / Chapter Skim
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Appendix B: Workshop Agenda
Pages 49-60

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From page 49...
... defines regulatory science as the science of developing new tools, standards, and approaches to assess the safety, effectiveness, quality, toxicity, public health impact, or performance of FDA-regulated products. Since its inception, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation has focused on the need for strengthening the scientific basis of drug regulation.
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From page 50...
... FDA's Centers of Excellence in Regulatory Science and Innovation enhance training and educational opportunities for regulatory scientists. Private funders have also established programs: For example, in 2011 the Burroughs Wellcome Fund launched Innovations in Regulatory Science Awards (IRSA)
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From page 51...
... • Discuss how new capabilities and access to new information could advance regulatory science for medical product development. • Highlight operational challenges.
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From page 52...
... Food and Drug Administration 10:35 a.m. Identifying and Developing Meaningful Biomarkers Panel Moderator: John Wagner, Senior Vice President,  Head of Clinical and Translational Sciences, Takeda Pharmaceuticals
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From page 53...
... SESSION II, CONTINUED: CONSIDERATION OF REGULATORY SCIENCE APPLICATIONS 12:50 p.m. Clinical Trial Data Integration Panel Moderator: Rob Califf, Deputy Commissioner for  Medical Products and Tobacco, U.S.
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From page 54...
... Platform for Integrating Patient Care and Clinical Research Data Charles Jaffe Chief Executive Officer Health Level Seven International 1:35 p.m. Data Aggregation Across Diseases and Between Stakeholders Enrique Avilés Chief Technology Officer The Critical Path Institute
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From page 55...
... , U.S. Food and Drug Administration 2:15 p.m.
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From page 56...
... Statistical Modeling for Efficient and Adaptive Trial Designs Using Composite Endpoints Brian Alexander Associate Professor of Radiation Oncology Harvard Medical School 4:00 p.m. Model Informed Drug Development and Regulatory Decisions Today and Tomorrow Sandy Allerheiligen Vice President, Modeling and Simulation Merck 4:10 p.m.
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From page 57...
... 8:30 a.m. Welcome and Reflections from Day One Martin Philbert, Workshop Co-Chair Professor and Dean University of Michigan School of Public Health Alastair Wood, Workshop Co-Chair Partner, Symphony Capital Professor of Medicine and Professor of Pharmacology, Weill Cornell School of Medicine SESSION III: ENVISIONING THE FUTURE OF REGULATORY SCIENCE: A FORWARD-LOOKING AGENDA Session Objective: • Discuss opportunities and priorities to advance innovative regula tory science through information.
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From page 58...
... Data Science Workforce Challenges and Solutions: Northrop Grumman Perspectives Sam Shekar Chief Medical Officer Northrop Grumman 9:10 a.m. Developing the Regulatory Scientist for Medical Product Development: Successful Examples from Pfizer Worldwide R&D Owen Fields Vice President, Regulatory Strategy Pfizer Inc.
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From page 59...
... Session II Moderators John Wagner (moderator of Identifying and Developing Meaningful Biomarkers) Senior Vice President, Head of Clinical and Translational Sciences Takeda Pharmaceuticals Brian Strom (moderator of Next-Generation Surveillance)
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From page 60...
... Are the strategic priorities that have been articulated and adopted by the key players aligned with, and positioned to advance, innovative regulatory science? •  hat investments and incentives are needed to get us W there?
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Key Terms

  • medical product
  • innovative regulatory
  • science applications
  • integrating information
  • drug development

  • martin philbert
  • alastair wood
  • panel discussion
  • drug safety
  • science domains

  • drug regulation
  • critical path
  • stephen ostroff
  • cornell school
  • forum held

  • clinical pharmacology
  • clinical trial
  • meaningful biomarkers
  • trial data
  • data integration

  • core components
  • highlight opportunities
  • path institute
  • weill cornell
  • advance regulatory

  • current regulatory
  • advancing regulatory
  • selected regulatory
  • funding regulatory
  • regulatory strategy


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