There is a constant struggle to balance the needs of patients for new and improved lifesaving therapeutics and procedures while ensuring both safety and efficacy. The regulatory sciences encompass the need to continuously encourage innovative biomedical research and development with the realities of our shared responsibility for the safe implementation of these discoveries. However, these continual advances in healthcare face ever increasing challenges that need to be studied and understood in order to bring the highest quality of life to mankind. These include the following areas which have been identified by the U.S. FDA as critical research needs:
• Develop better, faster and less expensive toxicology assessment methods to enhance product safety
• Stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes
• Improve product manufacturing and quality through automation, better analytical methods, quality by design and new approaches to reduce microbial contamination.
• Ensure the readiness of companies and regulatory agencies to accept and evaluate innovative emerging technologies
• Increase the use of “big” data from diverse sources to improve health outcomes
• Strengthen social and behavioral science to help consumers and professionals make informed decisions about regulated products.
• Develop medical countermeasures to protect against pandemics and medical terror threats to global health and security.
• Strengthen the global product safety net to protect against contaminated, adulterated and counterfeit drugs posing threat to the public health.
Advances in technology and our understanding of diseases create new opportunities to positively impact the health and well-being of patients. However, these advances are often accompanied by changes in our understanding that may impact our previous approaches to the treatment of a disease or demonstrate that there are larger unknowns in our knowledge of a specific topic than we previously believed. The regulatory sciences are responsible for the integration of these new innovations in science, technology, engineering, informatics and other related disciplines into guidelines that can be broadly understood and operationalized.
There is an absolute need for this explicit framework to assess medical products. Innovation is stifled when there is a lack of clarity in what is needed in order to develop new products and also to maintain the availability of current products. In our society these products will move throughout the world. Under these circumstances, there becomes an intense need to understand the nuances that different countries expect in order for these products to be utilized within their boundaries. In addition, our global economy creates complex supply and distribution systems that pose significant challenges toward maintaining patient safety.
The University of Georgia established graduate training in regulatory affairs and clinical trials management in 2005. This program had an initial focus toward improving the education of working regulatory professionals in a wide variety of biomedical product areas involving pharmaceuticals, biologics, medical devices and animal health products. This included a strong focus on an understanding of the regulations of the U.S. Food and Drug Administration and also extended to other government agencies such as the U.S. Department of Agriculture and the U.S. Environmental Protection Agency.
The University of Georgia, via the Colleges of Pharmacy, Engineering, Veterinary Medicine and Arts and Sciences, has assembled a faculty with extensive experience in addressing the various parts of this interdisciplinary field. The regulatory sciences provide a common interest and intellectual framework for coordinating these various highly interdisciplinary activities; an institute will provide the procedural structure for implementing these shared interests.