Forum on Drug Discovery, Development, and Translation 2016 Annual Report (2017) / Chapter Skim
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Reflecting Back: Forum Activities in 2016
Reflecting Back: Forum Activities in 2016
Pages 4-11
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Forum director Anne Claiborne and Forum co-chairs Russ Altman and Steven Galson brainstorm during the October 18 Forum meeting. June 29–30 Forum Meeting #2 FORUM ACTIVITIES TIMELINE 2000–2004 2005 Clinical Research Roundtable, March 23–24 predecessor to the Forum Forum Meeting #1
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With the large volumes of genetic and phenotypic data that are planned to be col lected, these efforts could provide a valuable trove of information for identifying and validating potential targets, elucidating underlying disease and mechanistic biology, and developing biomarker assays and targeted therapies. Questions remain about how large cohort studies could be designed, the types of data that should be collected, and which business models could engage stakeholders most effectively.
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The traditional process for evaluating new therapeutics does not produce the evidence that patients, clinicians, and payers need for real-world decisions. The volume and complexity of information about individual patients are greatly increasing with the use of electronic health records and personal devices.
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In collaboration with the National Cancer Policy Forum, the Forum convened a workshop in December 2016 to examine the challenges of the traditional cancer drug development process and explore opportunities to promote seamless cancer drug development. The workshop facilitated discussion about strategies to improve the collection of information across the lifecycle of cancer therapies; streamline and adapt drug development based on compelling evidence; and consider ethical and regulatory implications for a seamless cancer drug develop ment paradigm.
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Collaborative participants will author a peer-reviewed journal article and accompa nying NAM Discussion Paper to inform and help guide future dialogue and progress. Disruptive Innovation and the Transformation of the Drug Development and Translational Science Enterprise -- Action Collaborative Many argue that the current paradigm for drug discovery and development requires disruptive innovation to break out of a crisis in research and development (R&D)
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April 27 September 2 Workshop: Streamlining Discussion Series: FDA Clinical Trial and Material Community Update on October 15–16 Transfer Negotiations Post-Market Drug Safety Forum Meeting #14 April 27–28 July 10 October 7–8 Forum Meeting #12 Symposium: Drug Regulation with Workshop: Transforming Clinical FDA Commissioner Peggy Hamburg Research in the United States (Forum Meeting #13)
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This Collaborative is an ad hoc convening activity under the auspices of the Forum, which provides a venue for joint and collaborative activities among participants to advance the development of standards or a system to improve clinical trial performance through the accreditation of clinical trial sites. Participants, who are drawn from multiple sectors and disciplines, are preparing an NAM Discussion Paper that will summarize their perspectives on a process for standards development and on the establishment of a mechanism to facilitate the coordination of an experimen tal approach to align existing standards and improve clinical trial site standards based on continuous data collection.
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The work ing group convened on February 3, 2016, at the National Academies and then released its suggested way forward at a meeting at the Wellcome Trust in London in March 2016. Also launched in 2016 under the auspices of the Collaborative is a workstream addressing Data Sharing Principles for Nonprofit Clinical Trial Funders, which is convening nonprofit funders of research, focusing on disease advocacy and patient-focused organizations, to develop standards and policies for foster ing, promoting, or requiring data sharing by grantees.
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