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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5 Situating CAN Within the Drug Development Ecosystem
5 Situating CAN Within the Drug Development Ecosystem
Pages 51-64
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From page 51... ...
· Possible tasks include helping to develop a regulatory science toolbox and working with industry to facilitate regulatory science to support the regulatory approval process. · CAN could contribute to the development of a drug development ecosystem "master plan" that would establish the vision for the system, science, and tools that are needed.
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From page 52... ...
Myrl Weinberg, President, National Health Council, moderated the second panel, which considered the role of CAN in advancing cross-sector and other collaborative translational science activities. This chapter provides an integrated summary of the presentations and panel discussions, organizing the remarks by sector to offer a multifaceted perspective on CAN's role in the drug development ecosystem and future.
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From page 53... ...
Basic science will continue to be important to develop cures for diseases, said Goodman, but so will such steps as building precompetitive cross-cutting consortia, developing better evaluative tools and measures, and supporting relevant data-gathering and data-sharing initiatives. CAN could stimulate such opportunities through project design and evaluation criteria in areas such as toxicology or Alzheimer's disease.
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From page 54... ...
Goodman noted the importance of FDA's commitment to working with CAN and its partners in the broader ecosystem. Specific Proposals Goodman suggested several specific potential projects for CAN related to regulatory science: · Develop new approaches to clinical studies.
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From page 55... ...
To predict, measure, and improve efficacy, major advances are needed, including new endpoints, new trial designs, better biomarkers to divide diseases into subsets according to prognostic or response predictors, patient-reported outcomes that have credibility, and natural history studies to understand disease course, particularly for rare diseases. These are "great concepts," said Buckman-Garner, but no one organization has the job of developing these ideas.
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From page 56... ...
Creating an integrated workforce for translational science requires professionals skilled in clinical investigation, drug devel opment, regulatory science, medical informatics and computer sci ence, statistics, and other fields. Today, unmet needs exist in many of these areas, said Buckman-Garner.
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From page 57... ...
THE OFFICE OF SCIENCE AND TECHNOLOGY POLICY1 Thomas Kalil, Deputy Director for Policy, Office of Science and Technology Policy, Executive Office of the President, said that, according to an analysis by Warburg Pincus, venture capital returns on investments in the life sciences are only around 1 percent. He commented that "limited 1 This section is based on the presentation by Thomas Kalil, Deputy Director for Policy, Office of Science and Technology Policy, Executive Office of the President.
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From page 58... ...
THE PHARMACEUTICAL INDUSTRY Garry Neil, Corporate Vice President, Science and Technology, Johnson & Johnson, addressed trouble in the pharmaceutical industry. With the cost of getting a single new drug to market approaching $4 billion by some estimates, industry is highly motivated to do what it can to boost productivity in the drug development ecosystem.
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From page 59... ...
In many areas, industry can collaborate on precompetitive research because there is no competitive advantage in owning this knowledge. A Master Plan for Cures Acceleration Freda Lewis-Hall, Chief Medical Officer, Pfizer Inc., also commented on CAN's role from an industry perspective.
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From page 60... ...
· CAN's limited funds preclude its being able to tackle all of the problems confronting the drug development ecosystem. How ever, CAN has the opportunity to catalyze work through provi sion of seed funding and following on by, for example, helping to create a foundation or other group that would be resourced to extend the work.
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From page 61... ...
For example, training programs can help patient representatives be more effective and also have the effect of bringing in new people rather than using the same people repeatedly. CAN could do things that others are not doing by working with existing foundations, partnerships, companies, agencies, and other parts of the drug development ecosystem.
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From page 62... ...
As an example of a recent success, David Wholley, Manager, The Biomarkers Consortium, FNIH, mentioned the establishment of new endpoints for clinical trials of community-acquired bacterial pneumonia and acute skin infections so that FDA can continue to approve new anti-infectives in these diseases. Wholley suggested that The Biomarkers Consortium could be a model for NCATS and for CAN because of its diverse representation from all sectors of the drug development ecosystem.
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From page 63... ...
For example, the National Breast Cancer Coalition trains not just advocates slated to serve on panels, but also scientists to understand why the advocates are there, so that information flows in both directions. Also, scientists teach some of the classes to advocates, partly to convey an understanding of scientific terminology and also to discuss and model effective behaviors in advisory roles.
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From page 64... ...
Neil said he could think of at least half a dozen cases of high need populations with no treatment alternatives where the problems are potentially tractable based on current scientific understanding. These cases may not be commercially attractive projects, but they offer excellent case studies of whether the drug development ecosystem could work in a different way to come up with an effective, safe, small-molecule treatment for a high need population.
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