Advancing the Discipline of Regulatory Science for Medical Product Development An Update on Progress and a Forward-Looking Agenda: Workshop Summary (2016) / Chapter Skim
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4 Regulatory Science Infrastructure and Workforce
4 Regulatory Science Infrastructure and Workforce
Pages 31-38
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From page 31... ...
• A streamlined FDA hiring process, funding for regulatory sci ence efforts, incentivizing and rewarding regulatory scientific accomplishments on their own terms rather than through tradi ional academic rewards, and generally making regulatory t science more respectable will help attract scientific leaders to the field. (Abernethy, Honig, Landray, Ostroff, Philbert, Potter, Weichold, Wood)
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From page 32... ...
This chapter summarizes discussions held at the workshop to characterize the components of a well-working and robust regulatory science infrastructure, with an emphasis on training of regulatory scientists. CHARACTERIZING THE DISCIPLINE OF REGULATORY SCIENCE Regulatory Science as an "Enlightened Discipline" Garret FitzGerald, professor of medicine and pharmacology, University of Pennsylvania, noted that the environment in which regulatory science is situated is undergoing a multidimensional shift influenced by many outside factors, including technology, trade, politics, intellectual property, global influence, a desire for transparency, and patient empowerment.
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From page 33... ...
• Medical Product Regulation and Pharmacology • Clinical Pharmacology • Toxicology • Epidemiology • Clinical Trial Design • Combination Therapies • Influence of Diet • Intellectual Property • Communications • Data Science and Informatics • Clinical Validity of Biomarkers SOURCES: FitzGerald and Honig presentations, October 21, 2015. Navigating the Interface Between Science and Society Regulatory scientists participate in a social discourse that extends far outside of the laboratory and clinic, and correspondingly, regulatory decisions do not influence just the scientific community, but also the public at large, noted Martin Philbert, professor and dean, University of Michigan School of Public Health.
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He highlighted the importance of significant and complementary training in academia, industry, and regulation. Steele noted that one potential way to expand opportunities for regulatory science training is by maximizing the shared missions of the CERSIs and CTSAs to improve medical product development by tapping into the CTSA consortia.
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From page 35... ...
Fields described Pfizer programs, which include internships, temporary assignments, mentoring, and industry-FDA collaborations. Eileen Cannon, president, PhRMA Foundation, noted that the PhRMA Foundation is in the process of developing regulatory science rotations between industry and academia, as well as a mechanism that will facilitate FDA access to senior academic scientists to discuss current and specific needs.
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From page 36... ...
Weichold noted that there is currently scarce funding to develop or implement successful regulatory science research efforts, especially in academic settings. He and other individual workshop participants noted that increasing and targeting funding for regula tory science research could encourage innovation in the field and the development of career regulatory scientists.
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From page 37... ...
. Darrell Abernethy, associate director for drug safety, office of Clinical Pharmacology, FDA, suggested that the lengthy time involved with applying for and receiving an FDA position might be a burden for applicants.
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