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.

Over the next few years, federal agencies, foundations, municipalities and industry will invest hundreds of millions of dollars to support research, education, training and outreach related to the regulatory sciences. In response to these challenges from the various regulatory agencies and their affiliated industries, the goals of the institute are to:

• Increase the quality and quantity of interdisciplinary research in the many disciplines that form the basis of the regulatory sciences, and to procure external support for that research;
• Synergize the existing strengths at UGA to be able to respond comprehensively as an institution to significant research and development opportunities;
• Proactively develop interdisciplinary publications and modular research proposals focused on the regulatory sciences prior to announcements of significant funding opportunities;
• Enhance the visibility of UGA by establishing a national presence in the regulatory sciences;
• Attract high quality students and faculty and provide them with effective mentoring in the regulatory sciences;
• Increase financial support and educational opportunities for students pursuing training in the regulatory sciences;
• Strengthen our existing relationships with major regulatory agencies to advance the regulatory sciences through research, training and outreach activities.

Advances in science create new challenges and opportunities in the regulatory sciences. The institute will allow UGA to purposefully address how new discoveries both here at UGA and elsewhere will change the pathways to both the approval and continual delivery of health care. Faculty members initiating the institute represent many academic units (Appendix 2) and bring a tremendous depth and breadth of expertise. During the development of this proposal, we have identified several intersecting research themes and topics that synergize existing strengths and align with forthcoming opportunities for significant research support including:

Biopharmaceutics

• Development of new therapeutics from proteins, oligonucleotides, cells and tissues.
• New methods of producing biopharmaceutical therapies
• New methods for assessing the quality of biopharmaceutical therapies
• Assess the ability of current regulatory systems to accommodate new and emerging technologies and approaches
• Identify best practices for the integration of new and emerging biopharmaceuticals into current health care systems

Biocompatible Materials

• Development of new materials for use in drug delivery systems and medical devices
• Methods to assess biocompatibility
• Methods to manufacture biocompatible materials
• Methods to assess the quality of biocompatible materials Combination Products
• Development of products that involve more than one major classification of medical products (drugs, medical devices, biologics, animal health products).
• Assess the ability to accommodate combinations of traditional and emerging technologies within the current regulatory systems.
• Identify of best practices within current regulatory systems to accommodate new and emerging technologies that involve complex approval pathways.

Risk Assessment

• Risk modeling for manufacturing and distribution systems
• Risk assessment of batch and continuous manufacturing processes
• Development of new methods to assess product risk

Quality Systems

• Develop new methods to assess the quality of biomedical products
• Assess the effectiveness of quality systems to protect patients
• Develop new methods for the rapid identification of microbial contamination in biomedical products and facilities
• Identify best practices for the implementation of quality systems and for the assessment of the integrity and quality of data

Security of Biomedical Products

• Develop systems that can be used to ensure the integrity of biomedical products
• Develop systems that can be used to effectively track biomedical products and their constituent parts from their origin to their point of use
• Assess the effectiveness of current practices to ensure the security and supply of medical products

We envision subsets of these topics being organized into focus areas within the institute as a result of conferences, workshops, writing retreats and other activities.