“Every day I look around the University and the Medical Center and am ‘wowed’ by the number of clinical trials, the types of new products that are being tested by our investigators here and the ingenuity of the research which is conducted by our faculty and staff. This level of creativity along the continuum of translational research is constantly adding to the repertoire of life-saving drugs and medical devices that are available for use in patient care.” Dr. Joan Adamo
A key objective of the University of Rochester Clinical and Translational Science Institute (CTSI) is to support creative research and training methods to drive innovation across the entire medical product development pathway. Along with this creativity comes the need to ensure medical products are safe and effective. The FDA is the federal agency tasked with regulating drugs, biologics and devices and they must constantly update and enhance the processes to regulate these products. There is also the need to keep up with new technologies and scientific developments. The rapid advances in stem cell research, nanotechnology-based therapies and diagnostics, 3-D printing of tissues and organs, direct-to-consumer genetic tests, the marketing of products such as electronic cigarettes, and other developments present both opportunities and challenges for the FDA.
The academic research community has an opportunity to speed the development and approval of beneficial medical products by collaborating with the FDA, industry and other academic partners in the field of Regulatory Science. Regulatory Science is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. As the technology improves and the cures become more complex, the agency which regulates them needs solid, evidence-based research to improve the way products are reviewed and approved. Additionally, the FDA and other regulatory agencies can enhance the way they interact with the public, academic institutions and industry to achieve their main mission of protecting public health.
This fall we will highlight and bring to the University of Rochester campus a panoply of Regulatory Science leaders who are currently working to address these issues. The Fall CTSI Seminar Series “Advancing Regulatory Science and Translational Science: Research, Training and Partnerships” held on Tuesdays at 12noon in Helen Wood Hall will highlight Regulatory Science research and detail Regulatory Science training programs that are being developed both locally and in conjunction with our CTSA partners. We will also hear from experts in industry and at the FDA about what they see as the Regulatory Science priority areas and how our research and training efforts can have the greatest impact.
The organizers of the CTSI Seminar Series, Dr. Joan Adamo and Dr. Scott Steele, will provide a kick-off presentation on Regulatory Science on Tuesday, 8 September 2015. Click here to access the full schedule.
Meliora! The motto of the University of Rochester does not ring clearer than it does when we look to improve public health by making the process of developing and regulating safe and efficacious products ever better.