Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development Workshop Summary (2012) / Chapter Skim
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3 Defining a Discipline of Regulatory Science and Core Competencies for Its Workforce
3 Defining a Discipline of Regulatory Science and Core Competencies for Its Workforce
Pages 19-30
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From page 19... ...
The discussions in the next session of the workshop recognized and were built from the premise that developing a discipline of regulatory science calls for defining what is meant by regulatory science and then building a workforce equipped with a set of core competencies to fit that definition. In a dialogue, Barry Coller, The Rockefeller University, and Rob Califf, Professor of Medicine, Vice Chancellor for Clinical and Translational Research, Duke University Medical Center, described regulatory science 19
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• Regulatory science is the application of the scientific method to improve the development, review, and oversight of new drugs, biologics, and devices that require regulatory approval prior to dissemination. Translational science traditionally has been broken down into four phases: • T1: Discovery to candidate health application • T2: Health application to evidencebased practice guidelines • T3: Practice guidelines to health practice • T4: Practice to population health impact The taxonomy of regulatory science can be aligned with the transla tional science taxonomy through four analogous phases, as follows: • RS1: Preclinical evaluation of safety and efficacy • RS2: Clinical trial design and analysis • RS3: Postmarketing review of safety and optimal utilization • RS4: Health policies, including social aspects of regulatory science From this taxonomy, it is possible to develop a list of the multidisciplinary research expertise needed in regulatory science.
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From page 21... ...
For example, the FDA goals to modernize toxicology to enhance product safety, support new approaches to improve product manufacturing and quality, and ensure FDA readiness to evaluate innovative emerging technologies all fit within "RS1," the first phase of the regulatory science taxonomy. Others, such as implementation of a new prevention-focused food safety system to protect public health and facilitate development of MCMs to protect against threats to U.S.
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From page 22... ...
, NIH. As defined by Lane, regulatory science is "the intellectual and practical activity encompassing the systematic study of the structure and behavior of the regulatory world through observation and experiment to determine the impact of the rules, principles, and laws governing FDAregulated research." This definition gets to the notion that regulatory science should address the value that regulations provide.
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From page 23... ...
Mary Dwight, Vice President for Government Affairs, Cystic Fibrosis Foundation, amplified this comment by noting that political drivers are overwhelming regulatory concerns today. Patient education must be part of the solution to this problem so that patients can speak out about their needs for more effective, efficient therapeutic development models based on good regulatory science.
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From page 24... ...
. CORE COMPETENCIES OF REGULATORY SCIENCE As part of a panel discussion of the core competencies that a regulatory science workforce should have, Steven Galson, Vice President for Global Regulatory Affairs, Amgen Inc., listed certain core competencies that would be helpful in addressing the types of research questions relevant to the impact of regulation on clinical research.
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. Regulatory science sits at the core of what the CTP is now charged to do to protect the nation's health, but until now the country has never attempted to create science-based regulations for tobacco products.
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requires public health experts, medical professionals, lawyers, educators, communications specialists, and behavioral scientists, all of whom understand and appreciate the role of regulatory science as it applies to tobacco product regulation, said Deyton. Centers for Disease Control and Prevention (CDC)
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27 DEFINING A DISCIPLINE OF REGULATORY SCIENCE BOX 3-3a Disciplinary Components of Regulatory Science • Basic investigation • Bioengineering • Bioethics • Bioinformatics • Biology • Bionutrition • Biostatistics • Chemistry • Clinical investigation and clinical trial design • Clinical pharmacology • Clinical research operations • Communication • Decision theory • Drug/device discovery and development • Drug disposition and metabolism • Economics • Epidemiology • Genetics • Government/policy • Information technology • IRB experience • Law • Medical informatics • Medicine • Metrics • Microbiology • Monitoring and quality assurance • Nutrition • Pharmacology (whole animal) • Pharmacy • Protection of human subjects • Public health • Regulatory knowledge • Research pharmacy • Risk assessment and communication • Surveying/methods • Systems analysis • Systems biology • Technology transfer • Toxicology • Veterinary a This box provides an integrated list of disciplinary components of regulatory science offered throughout the workshop by speakers and audience members.
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From page 28... ...
Other definitions offered related, complementary perspectives on the definition and components of regulatory science. Alastair Wood, Partner and Managing Director, Symphony Capital LLC, remarked that, although science includes them both, innovation and discovery are different things.
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From page 29... ...
, distinguished regulatory science from regulatory research. Regulatory science, he said, is the entire body of knowledge practiced by FDA and by those regulated by FDA, including law, economics, and an overriding ethic of protecting the public health.
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