Wednesday, January 14, 2015

Regulatory Science at Georgetown

Regulatory what?

Earlier this week I participate in a leadership meeting for the Georgetown University Program for Regulatory Science & Medicine (or PRSM) where we discussed the growing potential for ‘regulatory science.’ While regulatory science is not new, the term is not well known so I thought it would be a good topic to share and show another example of the strength of our academic partnership with Georgetown. 

Regulatory science is often confused for regulatory affairs. As you know, regulatory affairs comes into play at specific points in time during research (such as the IRB approval, reporting adverse events or when an IND or NDA are filed with the FDA); regulatory affairs deals with compliance, quality, and ensuring the ethical conduct of research and human subject protection.  As such, it is a vitally important component of any research enterprise.

However, regulatory science is a form of translational science conducted throughout the entire clinical research lifecycle and potentially across multiple studies. It is the science of the regulator process. What is the best way to regulate a study - well, that can be turned into research questions for which a study is designed to answer. Regulatory science looks at innovative approaches or new tools that can be used in the regulatory process of research to improve efficiency, efficacy or quality of the process. For example, does one method of oversight or access to data or consent process produce a better outcome than another?

Another way to distinguish between regulatory affairs and regulatory science is through these questions:
-          Do you want to do research the right way today? If yes, your answer is regulatory affairs.
-          Do you want to do an innovative approach to research to improve the way we do research tomorrow? Then what you need is regulatory science.

The FDA has driven an effort to elevate regulatory science and demonstrate its significance, in part by awarding academic Centers of Excellence – Georgetown PRSM is home to one such Center – and by writing strategic plans or documents that explain the science.

I’m very excited to be part of this team at Georgetown University that aims to catalyze clinical research through regulatory science. It is a very forward-thinking group of individuals who are interested in a wide range of topics relevant to regulatory science, from bioinformatics to patient-reported outcomes research, direct-to-consumer genetic testing, and the transformation of clinical trials.  This group also fits nicely with our other foreward looking clinical research activities such as CTTI (Clinical Trial Transformation Initiative) and UIDP (University Industry Demonstration Project) .

The Georgetown Program for Regulatory Science & Medicine offers research opportunities as well as education and training to FDA, Georgetown, and MedStar employees. As such, it means we at MedStar have a unique opportunity to interact with FDA – and I highly encourage you to take part.

If you would like to learn more about regulatory science or if you would like to participate in seminars, training, or other opportunities, contact Erin Wilhelm (, who directs the program at Georgetown. Erin will be happy to talk with you or connect you to your areas of interest.

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