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Suggested Citation:"Forum Themes and Priorities." Institute of Medicine. 2015. Forum on Drug Discovery, Development, and Translation: 2014 Annual Report. Washington, DC: The National Academies Press. doi: 10.17226/26115.
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Suggested Citation:"Forum Themes and Priorities." Institute of Medicine. 2015. Forum on Drug Discovery, Development, and Translation: 2014 Annual Report. Washington, DC: The National Academies Press. doi: 10.17226/26115.
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Suggested Citation:"Forum Themes and Priorities." Institute of Medicine. 2015. Forum on Drug Discovery, Development, and Translation: 2014 Annual Report. Washington, DC: The National Academies Press. doi: 10.17226/26115.
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Suggested Citation:"Forum Themes and Priorities." Institute of Medicine. 2015. Forum on Drug Discovery, Development, and Translation: 2014 Annual Report. Washington, DC: The National Academies Press. doi: 10.17226/26115.
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Suggested Citation:"Forum Themes and Priorities." Institute of Medicine. 2015. Forum on Drug Discovery, Development, and Translation: 2014 Annual Report. Washington, DC: The National Academies Press. doi: 10.17226/26115.
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Suggested Citation:"Forum Themes and Priorities." Institute of Medicine. 2015. Forum on Drug Discovery, Development, and Translation: 2014 Annual Report. Washington, DC: The National Academies Press. doi: 10.17226/26115.
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Page 17

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Forum Themes and Priorities The Forum addresses key problems in the discovery, development, and translation of drugs, covering the full translational continuum from basic discovery to the approval and adop- tion of new therapies into clinical practice. As an overarching and cross-cutting theme, the Forum fosters innovative efforts to identify and highlight potentially breakthrough ideas and visionary approaches to the “drug development and translational science enterprise of the future.” The Forum has also identified four core components of translational science across this continuum that serve as thematic pillars to frame the Forum’s focus areas and activities: (1) Innovation and the Drug Development Enterprise; (2) Science Across the Drug Development Lifecycle (Basic, Translational, and Regulatory Sciences); (3) Clinical Trials and Clinical Product Development; and (4) Infrastructure and Workforce for Drug Discovery, Development, and Translation Innovation and the Drug Development Enterprise Despite exciting scientific advances, the pathway from basic science to new therapeutics faces challenges on many fronts. New paradigms for discovering and developing drugs are being sought to bridge the ever-widening gap between scientific discoveries and transla- tion of those discoveries into life-changing medications. There is also increasing recog- nition of the need for new models and methods for drug development and translational science, and “precompetitive collaborations” and other partnerships, including public–pri- vate partnerships, are proliferating. The Forum offers a venue to discuss effective collabo- ration in the drug discovery and development 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.” February 26 March 3–4 Workshop: Building a National South Africa Workshop: The Framework for the Establishment Emerging Threat of Multidrug- of Regulatory Science for Resistant Tuberculosis April 29–30 Drug Development Forum Meeting #15 2010 February 22-24 May 26–27 Workshop: The Public Health Emergency Medical Countermeasures Russia Workshop: The New Profile Enterprise (in collaboration with the Medical Preparedness Forum) of Drug-Resistant Tuberculosis

Substance—What We Aim For Forum Themes and Priorities Innovation & the Enterprise Translating Discoveries Thematic Priorities Science Across the Lifecycle into Medicines SUBSTANCE—What We Aim For The Forum fosters dialogue and Clinical Trials & Product Development collaboration to illuminate and act on potentially breakthrough ideas and visionary approaches to the biomedical innovation Infrastructure & Workforce system of the future. es tiv es y p ec ng nc ers lle are tP ally ha sp n b lC Tra n tie Glo ica Pa g th ing ing gin gE at t ga in cilit ora En res s Fa orp d Inc Ad Guiding Principles Science Across the Drug Development Lifecycle Key gaps remain in our knowledge about science, technology, and methods needed to sup- port drug discovery and development. Recent rapid advances in innovative research devel- • Biomedical drug Innovation & the Enterprise • Academia • Federal research & foundations opment science present opportunity for revolutionary developments of new scientific Partners Priorities Science Across the Lifecycle regulatory agencies • Disease advocacy • Large pharmaceutical organizations techniques, therapeutic products, and applications. The Forum provides a venue to focus Clinical Trials & Product Development companies • Patients, consumers, & • Small biotechnology & research participants ongoing attention and visibility to these important drugcompanies emerging development needs and facilitates Infrastructure & Workforce exploration of new approaches across the drug development lifecycle. The Forum has held workshops that have contributed to the defining and establishment of regulatory science and have helped inform aspects ofDiscovery, IOM Forum on Drug drug regulatory evaluation. PROCESS—How We Do It Development, and Translation Activities • Workshops Board on Health Sciences Policy • Working groups • Action collaboratives The Forum provides a unique platform for dialogue and collaboration among August 5–6 thought leaders and stakeholders from diverse sectors. The Forum convenes April 18–19 Discussion Series: several times each year to identify key problems and strategies; hosts public workshops and produces reports; and fosters collaborations among its India Workshop: Facing the Conflict of Interest members and constituencies. Reality of Multidrug-Resistant (Forum Meeting #16) March 28 Tuberculosis Forum Meeting #18 Strategies • Facilitating attention, visibility, and continuous discussion • Workshop summaries • Defining the scope of the field 2011 Products • Workshops in brief • Educating and elevating understanding of issues • Discussion papers & October 29 • Clarifying and expanding areas of agreement March 29–30 commentaries • Exploring new approaches to gridlocked areas Discussion Series: Administrative and Regulatory Workshop: Advancing Regulatory Science for Medical Countermeasure • Fostering collaboration *Spinoff consensus studies Inefficiencies in Clinical Trialsstage for policy action • Setting the (Forum Meeting #17) Development (in collaboration with the Medical Preparedness Forum)

Clinical Trials and Clinical Product Development Clinical research is the critical link between bench and bedside in developing new therapeu- tics. Significant infrastructural, cultural, and regulatory impediments challenge efforts to inte- grate clinical trials into the health care delivery system. 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 weakness in our current clinical trial enterprise, and consider transformative strategies for enhancing the ways in which clinical trials are organized and con- ducted. In addition to sponsoring multiple symposia and workshops, under this initiative, the July 12 South Africa Workshop Summary November 7–8 Report Release: The Emerging Threat of Workshop: Envisioning a Transformed Multidrug-Resistant Tuberculosis: Global Clinical Trials Enterprise in the United June 28–29 October 4–5 States: Establishing an Agenda for 2020 and Local Challenges and Solutions Forum Meeting #19 Forum Meeting #20 2012 June 27–28 September 20–21 Workshop: Public Engagement and Clinical Workshop: Strengthening a Workforce for Innovative Trials: New Models and Disruptive Technologies Regulatory Science in Therapeutics Development

Forum Themes and Priorities Forum is fostering innovative, collabora- tive efforts to facilitate needed change in areas such as improvement of clinical trial site performance. Infrastructure and Workforce for Drug Discovery, Development, and Translation Considerable opportunities remain for enhancement and improvement of the infrastructure that supports the drug development enterprise. That infrastruc- ture, which includes the organizational structure, framework, systems, and resources that facilitate the conduct of biomedical science for drug development, faces significant challenges. The science of drug discovery and development, and its translation into clinical practice, is cross-cutting and multidisciplinary. Career paths can be opaque or lack incentives such as recognition, career advancement, or financial security. The Forum has considered workforce needs as foundational to the advancement of drug discovery, development, and translation. It has convened workshops examining these issues, includ- ing consideration of strategies for developing a discipline of innovative regulatory science through the development of a robust workforce. October 4–5 June 4–5 Workshop: Sharing Clinical Workshop: Maximizing the Goals of Research Data (in collaboration the Cures Acceleration Network to with the Neuroscience Forum, March 13–14 Accelerate the Development of New June 5 National Cancer Policy Forum, Forum Meeting #21 Drugs and Diagnostics Forum Meeting #22 and Genomics Roundtable) November 15 July 31–August 1 Russia Workshop Summary Report Release: The New Profile Workshop: Developing and Strengthening the Global Supply Chain of Drug-Resistant Tuberculosis: A Global and Local Perspective for Second-Line Drugs for Multidrug-Resistant Tuberculosis

SUBSTANCE— s ve y ecti ge s renc e rsp lly allen s pa n tP ba l Ch n tie lo ica g Tra Pa in gG th tin tin g g ag in gE lita ora En s Fa ci orp d res Inc Ad Guiding Principles Process—How We Do It Innovation & the Enterprise • Academia • Biomedical research • Federal research & foundations Partners Priorities Science Across the Lifecycle regulatory agencies • Disease advocacy • Large pharmaceutical organizations Clinical Trials & Product Development companies • Patients, consumers, & • Small biotechnology & research participants emerging companies Infrastructure & Workforce IOM Forum on Drug Discovery, PROCESS—How We Do It Development, and Translation Activities • Workshops Board on Health Sciences Policy • Working groups • Action collaboratives The Forum provides a unique platform for dialogue and collaboration among thought leaders and stakeholders from diverse sectors. The Forum convenes several times each year to identify key problems and strategies; hosts public workshops and produces reports; and fosters collaborations among its members and constituencies. 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 November 26–27 January 15 Workshop: Large Simple Trials and Workshop Summary Report January 16–18 February 13–14 Knowledge Generation in a Learning Release: Developing and China Workshop: The Global Workshop: International Regulatory Health System (in collaboration with Strengthening the Global Supply Crisis of Drug-Resistant Harmonization Amid Globalization the Roundtable on Value & Science- Chain for Second-Line Drugs for Tuberculosis and Leadership of Biomedical Research & Medical Driven Health Care) Multidrug-Resistant Tuberculosis of the BRICS Countries Product Development 2013 December 19 October 23–24 Action Collaborative Meeting #1: Developing a National February 12 June 3 Forum Meeting #23 Accreditation System to Improve Clinical Trial Performance Forum Meeting #24 Forum Meeting #25

Reports Released in 2014 Forum Themes and Priorities Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products—Workshop Summary Released: September 26, 2014 Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist. As a result, regulatory reviewers are consistently required to draw conclusions about a drug’s safety and efficacy from imperfect data. Efforts are under way within the drug develop- ment community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory deci- sion making. On February 12 and May 12, 2014, the Institute of Medicine’s (IOM’s) Forum on Drug Discovery, Development, and Translation (the Forum) held public workshops at FDA Headquarters in White Oak, MD, to advance the develop- ment of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. This report is a summary of the workshops. Characterizing Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products—Workshop In Brief Released: April 25, 2014 On February 12, 2014, the IOM’s Forum on Drug Discovery, Development, and Translation held a public workshop as the first of a two-part series to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, as well as their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. This brief sum- mary of the workshop provides highlights from the presentations and discussions. March 11 February 12 Action Collaborative Workshop: Characterizing and Meeting #3: Developing August 21 Communicating Uncertainty in the a National Accreditation Action Collaborative Meeting #2: Assessment of Benefits and Risks of System to Improve Clinical Developing a National Accreditation System Pharmaceutical Products (Day 1) Trial Performance to Improve Clinical Trial Performance 2014 October 28–29 March 3–4 Forum Meeting #26 Forum Meeting #27

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In 2014, the National Academies’ Forum on Drug Discovery, Development, and Translation (the Forum) convened a workshop to advance the development of more structured approaches to characterize and communicate uncertainty in the assessment of benefits and risks of pharmaceutical products. The Forum membership continued its focused effort to address challenges in the U.S. clinical trials enterprise, facilitating an action-oriented, collaborative dialogue to advance development of harmonized standards for clinical trial sites.

For more information, please see https://www.nationalacademies.org/our-work/forum-on-drug-discovery-development-and-translation.

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