Master of Science, Regulatory Science - so what does that mean?

Based on the US Food and Drug Administration (FDA) definition, "regulatory science" refers to the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA- regulated products, such as small molecule drugs, biologics, and medical devices. The FDA co- initiative with the National Institutes of Health (NIH) to advance regulatory science was launched February 2010 with the intent to accelerate the process from innovative discovery to marketed new products. The strategic plan for this initiative and its nine priority areas can be found here, including: enhancing national and global drug and food safety and biosecurity, stimulating innovation in clinical evaluations and personalized medicine, improving product manufacturing and quality, enhancing FDA's innovation evaluation, harnessing "Big Data", and to strengthen the available tools for consumers, prescribers, and patients. Regulatory science is cited as the "foundation of decision-making at FDA", reinforcing its mission to promote and protect public health. And while directly related to the FDA mission, regulatory science also relates to protecting public health and the environment (EPA) as well as public health at work (OSHA). Having worked as Quality Manager for the American Industrial Hygiene Association (AIHA)'s Laboratory Accreditation Programs and Proficiency Analytical Testing Programs, continuing my personal ideals to protect public health by seeking a Master of Science in Regulatory Science was the obvious next step.

Regulatory science both differs from and contains elements of regulatory affairs and regulatory/pharmaceutical law, as stakeholders include regulators; sponsors, manufacturers, contractors, and their employees; the research community; and of course, patients, payers, and consumers . In addition to statute and regulation implementation, compliance, and enforcement, the latter term "science" indicates additional focus on the chemistry, biochemistry, toxicology, physiology, and statistics that drive the full product lifecycle from molecule discovery to continuing post-market studies. The FDA-academia collaboration Center(s) for Excellence in Regulatory Science and Innovation (CERSI) at the University of Maryland - Baltimore (UMB) and College Park campuses, Georgetown University, UCSF - Stanford, and Johns Hopkins University enhance research and promote innovation to aid public health. The UMB School of Pharmacy's Regulatory Science M.S. program is led by Dr. James Polli, the Shangraw/Noxell Endowed Chair in Pharmaceutical Sciences.

I look forward to the public health contribution opportunities from combining my B.S. in biochemistry and molecular biology and previous experience in bio-pharma industry and Quality with this comprehensive bridge of both science and regulation provided by the M.S. program in Regulatory Science. This past April 2015, the FDA's Office of Regulatory Science and Innovation (ORSI) held a one-day Science Symposium on this initiative and this was released this month, December 2015, regarding the NIH Tobacco Regulatory Science Program (TRSP) to regulate the manufacture, marketing, and distribution of tobacco products for public health. Nature published an article on opportunities in Regulatory Science... those opportunities appear to be continuing to grow. What an exciting time to be involved in promoting and enhancing our health and welfare - locally, nationally, and globally!