Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development Workshop Summary (2012) / Chapter Skim
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5 Career Paths Within Academia and Industry
5 Career Paths Within Academia and Industry
Pages 43-50
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From page 43... ...
The workshop examined career paths and career development opportunities, both within and outside of academia, that are currently available -- or that would need to be available -- to strengthen and support regulatory science in therapeu tics development. William Chin, Executive Dean for Research, Harvard Medical School; David DeMets, Professor, Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison; and Kathy 43
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From page 44... ...
There are, however, opportunities to associate regulatory science with areas that are getting support, such as translational science and therapeutics, or with rapidly developing fields whose progress eventually will depend on good regulatory science, including personalized medi 1 This section is based on the presentation by William Chin, Executive Dean for Research, Harvard Medical School.
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From page 45... ...
Issues Confronting Academic Regulatory Scientists2 DeMets offered remarks geared toward establishing credibility for expertise in regulatory science in academic institutions. Because regulatory science is inherently multidisciplinary, it is unreasonable for any one person to be well versed in all the involved fields of science.
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From page 46... ...
As with any inherently broad-based field, such as systems pharmacology or pharmacogenomics, the field comprises multiple core competencies, but each regulatory scientist would acquire a deeper understanding in a defined, smaller area, and that discipline would serve as the base for developing an academic career. Giacomini cited an example from her home department, the UCSF Department of Bioengineering and Therapeutic Sciences, a multidisci plinary department that came about through the merger of three depart ments spanning pharmacy, biopharmaceutical sciences, and bioengineering.
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. She stated that the challenges plaguing industry forced introspection, leading to identification of a number of emerging regulatory trends, such as the use of adaptive trial designs and the ability to collaborate more closely with regulatory agencies during the development process.
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Collaboration Trial Designs Adaptive Among Decline in CV Outcomes Studies Regulatory Agencies Productivity; Failures ; REMS Development Adaptive Trial Designs Unsustainable - Personalized Medicine 1983 Paradigm Orphan Drug Indications Rise in CV Outcomes Studies Orphan Outsourcing Emerging Product REMS Development Drug Act (CRO, CMO) Markets Failures; Advanced Therapeutic 1983 2000s 2004–2005 Pipelines Unsustainable Personalized Medicine Paradigm Orphan Drug Indications FIGURE 5-1 Trends in the pharmaceutical industry led to a "perfect storm" lead ing to increased regulatory science demands.
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From page 49... ...
A regulatory scientist's responsibilities would combine strategic and operational excellence in program development planning, strategic regulatory intelligence, regulatory meetings, clinical trial design using advanced methodologies, global regulatory issues, and supervising in a matrix-organization environment. In this regard, Ukwu observed, industry highly values regulatory agency fellowship programs because they turn out regulatory scientists who meet these needs.
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