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Forum on Drug Discovery, Development, and Translation 2015 Annual Report (2016) / Chapter Skim
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Forum Themes and Priorities
Pages 16-21

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From page 16...
... The Forum offers a venue to discuss effective collaboration in the drug discovery and develop ment enterprise and also hosts discussions that could help chart a course through the turbulent forces of disruptive innovation in the drug discovery and development "ecosystem." January 15 December 19 Workshop Summary Report February 13–14 Action Collaborative Meeting #1: Release: Developing and Workshop: International Regulatory Developing a National Accreditation Strengthening the Global Supply Harmonization Amid Globalization System to Improve Clinical Trial Chain for Second-Line Drugs for February 12 of Biomedical Research and Medical Performance Multidrug-Resistant Tuberculosis Forum Meeting #24 Product Development 2013 January 16–18 June 3 China Workshop: The Global Crisis of Drug- Forum Meeting #25 Resistant Tuberculosis and Leadership of the BRICS Countries
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From page 17...
... Recent rapid Academia in innovative drug development • advances • Federal research & • Biomedical research foundations Partners science present opportunity for revolutionary developments of new scientificadvocacy • Disease techniques, Priorities Science Across the Lifecycle regulatory agencies • Large pharmaceutical organizations therapeutic products, and applications. The Forum provides a venue to• Patients, ongoing & Clinical Trials & Product Development companies focus consumers, attention • Small biotechnology & research participants and visibility to these important drug development needs and facilitates exploration of new Infrastructure & Workforce emerging companies approaches across the drug development lifecycle.
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From page 18...
... Collaborative, cross-sector approaches can help articulate and address these key challenges and foster systemic responses. The Forum has convened a multiyear initiative to examine the state of clinical trials in the United States, identify areas of strength and weak ness in our current clinical trial enterprise, and consider transformative strategies for enhancing the ways in which clinical trials are organized and conducted.
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From page 19...
... Strategies • Facilitating attention, visibility, and continuous discussion • Workshop summaries • Defining the scope of the field Products • Workshops in brief • Educating and elevating understanding of issues • Discussion papers & • Clarifying and expanding areas of agreement commentaries • Exploring new approaches to gridlocked areas • Fostering collaboration * Spinoff consensus studies • Setting the stage for policy action October 20 Workshop: Priorities to Advance the Field of Regulatory Science 2016 October 21 Forum Meeting #32
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From page 20...
... On March 26 and 27, 2015, the Forum on Medical and Public Health Preparedness for Catastrophic Events, in collaboration with the Forum on Drug Discovery, Development, and Translation, convened a workshop in Washington, DC, to discuss how to achieve rapid and nimble MCM capability for new and emerging threats. Public- and private-sector stakeholders examined recent efforts to prepare for and respond to outbreaks of Ebola Virus Disease, pandemic influenza, and coronaviruses from policy, budget, and operational standpoints.
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From page 21...
... Uncertainty is amplified when drugs receive accelerated approval based on preliminary evidence or surrogate outcomes. Communicating uncertainty about new drugs is an important challenge facing FDA but opportunities exist to create realistic expectations and highlight the inherent uncertainty associated with accelerated approval.
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Key Terms

  • drug development
  • forum meeting
  • clinical trials
  • clinical trial
  • development lifecycle

  • improve clinical
  • development enterprise
  • action collaborative
  • national accreditation
  • unmet medical

  • translational science
  • collaborative meeting
  • sclerosis drug
  • clinical product
  • forum provides

  • disease threats
  • accelerated approval
  • address unmet
  • trial performance
  • emerging infectious

  • rapid medical
  • emerging threats
  • infectious disease
  • regulatory science
  • pharmaceutical products

  • catastrophic events
  • unique platform
  • communicating uncertainty
  • health preparedness
  • countermeasure response


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