Accelerating the Development of New Drugs and Diagnostics Maximizing the Impact of the Cures Acceleration Network: Workshop Summary (2012) / Chapter Skim
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1 Introduction
1 Introduction
Pages 1-14
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This ever-widening gap between scientific discoveries and the translation of those discoveries into life-changing medications is a major source of frustration for patients, biomedical researchers, businesses, and policy makers. One response to this gap has been a renewed emphasis on collaborative approaches within federal agencies, academia, and industry directed at the advancement of the drug development enterprise.
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Chapter 2 examines different approaches to accelerating translational science, in part through case studies of successful drug development projects. Chapters 3 and 4 examine two unusual features of CAN: the authority to require that some of its grants be matched by funds from other sources, and the authority to use a more flexible form of contracting known as "other transaction authority" (OTA)
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· Identify barriers and potential solutions to facilitate coordination of activities under CAN with the FDA regulatory review process and timelines. Director, Centers for Public Health Research and Evaluation, Battelle Memorial Institute; Lili Portilla, Director, Office of Strategic Alliances, NCATS; Barbara McGarey, Deputy Associate General Counsel for Public Health, Office of the General Counsel, NIH; and Kathy Hudson, Acting Deputy Director, NCATS, and Deputy Director for Science, Outreach, and Policy, NIH Office of the Director.
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Meetings with patient advocates and venture capitalists led to the idea for a Cures Acceleration Network -- a name originally suggested by the autism community, according to Parikh.3 The network was intended to have the following characteristics: authority to give large awards, a program allowing for matching grants to take advantage of the passion and expertise of patient groups, and administration outside NIH. Additional goals were to broaden the range of eligible grantees and reviewers, with the latter including venture capitalists and patients.
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The appropriated budget for CAN in FY 2012 was only $10 million. The Structure of NCATS and CAN At this level of funding, CAN is the smallest of the four major programs and initiatives within NCATS -- Clinical and Translational Science Activities, Rare Diseases Research and Therapeutics, Re-engineering Translational Sciences, and CAN.
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For example, it views the drug development process not as a linear path from laboratory to clinic, but as an iterative process in which feedback loops connect basic research, translational research, clinical research, population research, and public health. a This box is based on the presentation by Tom Insel, Acting Director, NCATS.
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. The statute defines both medical products and high need cures very broadly, with a significant amount of discretion to work strategically in the translational science arena.
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Insel noted that advisory boards at NIH have different characteristics at the different institutions and centers. At NCATS, the responsibilities of the CAN Board are to advise and provide recommendations to the Director of NCATS regarding the policies, programs, and procedures for carrying out the duties of the Director and to identify significant barriers to the successful translation of basic science into clinical application, including issues under the purview of other agencies and departments.
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Although NIH has historically had the authority to use OTA, only a single NIH staffperson was trained to work with it, and the authority was little used. Under OTA, certain government regulations and policies do not necessarily apply, including the Federal Acquisition Regulation (FAR)
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· What tools, methods, and approaches can accelerate translational science? · What is the best use of the matching and flexible research authori ties established in legislation?
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Approaches to Accelerating Translational Science7 CAN does not yet have the funding to support major projects, but it can be a crucial catalyst for innovation within NCATS. To do so, Bill Chin, Executive Dean for Research, Harvard Medical School, noted that it needs to foster a bidirectional flow of information between basic scientific research and the process of translating scientific results into products.
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Nancy Sung, Senior Program Officer, Burroughs Wellcome Fund, noted that it is important to get partners engaged with each other early in the process. Through early involvement, partners can shape the project from the start.
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OTA essentially allows a government agency to start with a blank piece of paper in writing a contract with a nongovernmental organization. According to Daniel Wattendorf, Program Manager, Defense Sciences Office, DARPA, success requires that the people who are relevant to the discussion be represented and that they are able to convey to each other what they want to achieve.
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Officials from FDA have expressed their eagerness to work with CAN because of CAN's potential to help them solve problems they face. This cooperation could be a model for interagency collaboration, and this collaboration could form the basis for much broader changes in the drug development ecosystem.
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