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Forum on Drug Discovery, Development, and Translation 2015 Annual Report (2016) / Chapter Skim
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Reflecting Back: Forum Activities in 2015
Pages 4-11

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From page 4...
... In addition, the Forum convened public workshops and collaborative activities, described below. Workshops: Financial Incentives to Support Unmet Medical Needs for Nervous System Disorders -- Workshop (January 2015)
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From page 5...
... Enabling Rapid Response and Sustained Capability with Medical Countermeasures to Mitigate Risk of Emerging Infectious Diseases -- Workshop (March 2015) Global attention to recent large-scale outbreaks and their public health and medi cal consequences has made clear that the current medical countermeasure (MCM)
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From page 6...
... The workshop featured invited presentations and discussions that explored current regulatory science priorities and strategies in federal, academic, and private-sector settings; considered the current state of regulatory science as a discipline; explored the core components of a robust discipline of innovative regulatory science; con sidered gaps and key opportunities to address needs to support the discipline of innovative regulatory science; and examined needs and barriers to collaboration among, across, and within the public and private sectors. June 13 Workshop: Addressing March 28–29 the Barriers to Pediatric October 24–25 Forum Meeting #4 Drug Development Forum Meeting #6 2006 May 30–31 June 27–28 Workshop: Understanding the Forum Meeting #5 Benefits and Risks of Pharmaceuticals
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From page 7...
... It could also facilitate ongoing discussion Priorities to Advance the Field of Regulatory Science panelists (left to right) Stephen Ostroff, Alastair Wood, Martin Philbert, John Wagner, Brian Strom, and Darrell Abernethy.
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From page 8...
... to help frame, map, and synergize activities across the biomedical innovation ecosystem. Defining key terms, such as translational science and regulatory science, and locating complex activities within the biomedical innovation ecosystem landscape might help to articulate problem areas and provide opportunities to learn from local environments where the system is efficient and well-integrated with other areas.
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From page 9...
... The pharmaceutical industry offers many opportunities for disruption in each of these areas. The Forum convened an action collaborative that set out to identify and highlight potentially breakthrough ideas and visionary approaches to the "drug development and translational science enterprise of the future." The effort addressed new technologies (e.g., biosensors, apps and telemetry, synthetic biology, or new delivery technologies)
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From page 10...
... This action collaborative is an ad hoc convening activity under the auspices of the Forum, which provides a venue for joint and col laborative activities among participants to advance development of standards or a system to improve clinical trial performance through accreditation of clinical trial sites. Participants, who are drawn from multiple sectors and disciplines, are preparing a Perspectives paper that will summarize their perspectives on a process for standards development and on the establishment of a mechanism to facilitate coordination of an experimental approach to align existing standards and improve clinical trial site March 13 April 27 Discussion Series: FDA Community Update Workshop: Streamlining on Personalized Medicine and the Genetic Clinical Trial and Material Basis of Adverse Events Transfer Negotiations 2009 February 23 April 27–28 July 10 Capitol Hill Briefing: Growing Forum Meeting #12 Symposium: Drug Regulation with Threat of Drug-Resistant Tuberculosis FDA Commissioner Peggy Hamburg (Forum Meeting #13)
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From page 11...
... September 2 February 22–24 Discussion Series: FDA Workshop: The Public Health Emergency Community Update on October 15–16 Medical Countermeasures Enterprise (in collaboPost-Market Drug Safety Forum Meeting #14 ration with the Medical Preparedness Forum) 2010 October 7–8 February 26 Workshop: Transforming Clinical Workshop: Building a National Framework Research in the United States for the Establishment of Regulatory Science for Drug Development
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Key Terms

  • regulatory science
  • clinical trial
  • forum activities
  • biomedical innovation
  • innovation ecosystem

  • action collaborative
  • collaborative participants
  • sharing clinical
  • translational science
  • trial site

  • fda commissioner
  • forum convened
  • improve clinical
  • innovative regulatory
  • clinical trials

  • drug safety
  • drug development
  • drug discovery
  • trial data
  • science panelists

  • public workshop
  • disruptive innovation
  • medical countermeasures
  • site standards
  • health emergency

  • perspectives paper
  • stephen ostroff
  • countermeasures enterprise
  • technical infrastructure
  • business models


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