Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development Workshop Summary (2012) / Chapter Skim
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7 Collaborative Models and New Paradigms for Supporting Regulatory Science Research and Practice
7 Collaborative Models and New Paradigms for Supporting Regulatory Science Research and Practice
Pages 57-64
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From page 57... ...
Given budgetary constraints that are unlikely to ease in the near future, efforts to develop the discipline of regulatory science and a regulatory science workforce may increasingly seek to rely on indirect support more than direct funding. To explore this issue, the workshop discussed funding opportunities and collaborative models that would need to be available to strengthen and support regulatory science research and prac tice in therapeutics development.
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From page 58... ...
, described a new initiative designed to transform the drug development ecosystem. William Greenlee, President and Chief Executive Officer, the Hamner Institutes for Health Sciences at Research Triangle Park, summarized the Hamner Institutes' approach to collaborative efforts among government, industry, and academia.
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Presentation at IOM workshop on Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development. ule, NEWDIGS researchers build test beds that are designed to combine stakeholders, real-world demonstration projects, and academic research in a way that enables rapid-cycle learning.
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From page 60... ...
Developing a Collaborative Workforce Hirsch described a regulatory science workforce as a virtually collaborative workforce of individuals from different disciplines and market sectors. She offered the following observations for supporting such a workforce: • Establish a "safe haven" environment through specific ground rules for workshops as a critical element for enabling learning and innovative thinking.
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REGULATORY SCIENCE: SOLVING FOR A LARGER CONTEXT3 Regulatory science must be addressed within a broader context to address important public health needs and accelerate drug development. This broader context starts with the drug development environment; the pharmaceutical industry is experiencing transformational trends, including very difficult scientific challenges and rapidly increasing expenses and price pressures, while the public sector and academia are developing new skills 2 This section is based on the presentation by William Greenlee, President and Chief Execu tive Officer, the Hamner Institutes for Health Sciences at Research Triangle Park.
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Funding such an initiative will require a concerted effort from all stakeholders. Reiss suggested that initial funding should come from the proposed NCATS, with universities following by providing matching infrastructure funds, adding that NIH should ensure that there is a balanced portfolio of funding initiatives between discovery and development projects.
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From page 63... ...
• Without a separate discipline of regulatory science, it will be diffi cult to train a workforce with the necessary mindset to understand the needs of regulatory versus discovery science. 4Participants in the summary panel were Barry Coller, Vice President for Medical Affairs, Physician-in-Chief, and David Rockefeller Professor, The Rockefeller University; Elaine Gallin, Principal, QE Philanthropic Advisors; Steven Galson, Vice President for Global Regulatory Affairs, Amgen Inc.; William Greenlee, President and Chief Executive Officer, the Hamner Institutes for Health Sciences at Research Triangle Park; Gigi Hirsch, Executive Director, Center for Biomedical Innovation, MIT; Carl Peck, Professor of Pharmacology and Medicine, UCSF; Theodore Reiss, Research Professor of Medicine, Vanderbilt University School of Medicine; and Alastair Wood, Partner and Managing Director, Symphony Capital LLC.
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From page 64... ...
Link this effort to RFAs that would support pursuit of these big questions. • Opportunities to increase interest in the discipline among students and investigators include reinvigorating and expanding research fellowships in clinical pharmacology and embedding regulatory science research fellowships in translational medicine and thera peutics through such programs as the CTSA institutions and the proposed NCATS.
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