The Yale School of Public Health (YSPH) is partnering with Tevogen Bio, a clinical stage biotechnology company, on a major expansion of the school's regulatory sciences program.
Financial support from Tevogen Bio will help subsidize the creation of a robust suite of academic course offerings in regulatory sciences and regulatory affairs at YSPH. The school is also seeking to broaden its research and health policy portfolios to reflect this rapidly expanding and important field.
"Stakeholders are searching for talented and emerging leaders in regulatory science, but current educational programs are scarce," said Sten H. Vermund, dean of the Yale School of Public Health. "With Tevogen Bio's support, we have an opportunity to reimagine our program and to grow it into one that matriculates students who ultimately become national and international leaders in the field."
Regulatory science focuses on the development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of products produced by various industries. Those products include medications, biologics like vaccines, medical devices, food, the environment, and worker safety. Regulatory affairs, in contrast, focuses on the administrative, policy, and legal aspects of product regulation. The regulatory sciences program will build upon the success of the current regulatory affairs track in the Yale School of Public Health's Master of Public Health (M.P.H.) degree program, founded and led by Professor Robert Makuch in the Department of Biostatistics.
Tevogen Bio CEO Dr. Ryan Saadi, M.D., M.P.H., hopes that others will join in supporting this initiative of the Yale School of Public Health to become a global leader in regulatory sciences.
"Continued advancement in cell and gene therapy, the new frontier of medical innovation, will in part depend on vibrant leadership in the regulatory sciences field," said Saadi, who obtained his M.P.H. degree in infectious diseases from Yale University in 1995. "Tevogen Bio applauds the YSPH leadership for its efforts to cultivate talent in this important field and is honored to contribute to this initiative."
Tevogen Bio is preparing to initiate clinical trials for TVGN-489, its investigational COVID-19 therapy, which in preclinical study has demonstrated strong antiviral activity against SARS-CoV-2, the coronavirus that causes COVID-19. The company's Investigational New Drug Application (IND) for TVGN-489 recently received clearance to proceed from the U.S. Food and Drug Administration. The proprietary immunotherapy technology employs highly purified allogeneic cytotoxic T lymphocytes (CTLs) that are capable of recognizing specific targets encoded by SARS-CoV-2 and eliminating virus infected cells. The New Jersey-based biotech company is also exploring use of its proprietary technology to treat other viral infections, such as Hepatitis B, HPV, HIV, and CTL-based therapeutics for solid and hematologic malignancies.
The Yale School of Public Health has provided graduate-level training in regulatory affairs for more than 10 years as part of its existing curricula for a master's degree in public health under Professor Makuch's leadership. The multidisciplinary academic track prepares students with essential knowledge and training in such areas as food and drug law, ethics, biostatistics, epidemiology, clinical trials, and risk analysis. YSPH is seeking to broaden the program to include more offerings in health policy, global regulations, business, pricing and project management to reflect the growing international scope of field.
"Regulatory sciences and regulatory affairs are a major, and sometime underappreciated, concern for health systems," said Professor Jason Hockenberry , Ph.D., chair of the YSPH Department of Health Policy and Management. "The pandemic-related discussions of these processes that continue today highlight the need for robust training programs that prepare tomorrow's leaders in this field. This gift will help us expand and strengthen our program in this area."