Former FDA Regulatory Section Chief Joins ReMDO

Newswise — WINSTON-SALEM, NC, DECEMBER 2, 2022 – A former FDA official with  31 years of regulatory experience, clinical trials oversight and research experience in cell-based biological therapies is joining the Regenerative Medicine Hub (RegenMed Hub) endeavor. Steven R. Bauer, PhD, will be an available resource to the ever-growing biotechnology innovation ecosystem underway in the Innovation Quarter.

The RegenMed Development Organization (ReMDO), one of the driving forces behind the RegenMed Hub with its RegeneratOR programs, and its collaborative research partner, the Wake Forest Institute for Regenerative Medicine (WFIRM), made the announcement today.

“Dr. Bauer was a witness to the birth of the FDA’s regulatory response for regenerative medicine science when it first emerged,” said WFIRM Director Anthony Atala, MD. “Having him join our endeavors means great things for everyone working in the regenerative medicine space.”

Bauer was a researcher and reviewer at FDA in 1991 and was involved in oversight of regenerative medicine product development since the creation of the Division of Cellular and Gene Therapies in 1992. He retired from the FDA as the Chief of the Cellular and Tissue Therapy Branch (CTTB), Division of Cellular and Gene Therapies (DCGT) in the Office of Tissues and Advanced Therapies (OTAT) at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA).

As the Chief of CTTB, Bauer supervised CBER scientific staff engaged in review of cell-based biological therapies, policy development in emerging areas of cellular therapies, and research relevant to their use in clinical trials.

The addition of Bauer comes at a particularly exciting time for ReMDO and WFIRM. Earlier this year, ReMDO launched the RegeneratOR, a three-part engine of the RegenMed Hub ecosystem to support biotechnology innovation and business. The RegeneratOR focuses on bringing together resources and talent in support of startups and growth and established companies, through its Test Bed and Innovation Accelerator.

With his regulatory affairs experience and background, Bauer will provide support to ReMDO and the companies engaged in the Test Bed and Innovation Accelerator as they pursue FDA approvals for new technologies and therapies.

“I don’t typically use superlatives, but in this case, I want to express how exciting this hire is overall for ReMDO, WFIRM, and the RegenMed Hub,” said Gary Green, EdD, Chief Operating Officer of ReMDO. “This is quite a coup.”

Bauer said the offer to roll up his sleeves on behalf of ReMDO and the RegeneratOR  was too good to pass up. “I wasn’t ready to step fully away from the field. I feel fortunate to be able to come work among WFIRM’s high level scientists and their teams,” he said. “Together, we are going to make great things happen for the field of regenerative medicine.”

In his new role, Bauer will also oversee regulatory aspects for WFIRM’s Translational Core which is made up of research project teams that are working to advance new regenerative medicine therapies and technologies into clinical use. WFIRM researchers have successfully engineered replacement tissues and organs in all four categories – flat structures, tubular tissues, hollow organs and solid organs – and 15 different applications of cell/tissue therapy technologies, such as skin, urethras, cartilage, bladders, muscle, kidney, and vaginal organs, have been successfully used in human patients in clinical trials.

Bauer received his Ph.D. in Biochemistry from the University of Maryland in 1986. From 1986 through 1991, Bauer was a scientific member of the Basel Institute for Immunology in Basel, Switzerland. In 1991, Bauer joined CBER’s Division of Cellular and Gene Therapies. He joined CBER FDA as a senior staff fellow in 1991. He became Chief of the Cellular and Tissue Therapies Branch in 2005. His research interests include development of strategies to improve characterization of stem-cell based therapies and to enhance our understanding of how manufacturing of regenerative medicine products influences the biological properties of these complex and heterogeneous products.

About the Wake Forest Institute for Regenerative Medicine: The Wake Forest Institute for Regenerative Medicine is recognized as an international leader in translating scientific discovery into clinical therapies, with many world firsts, including the development and implantation of the first engineered organ in a patient. Over 400 people at the institute, the largest in the world, work on more than 40 different tissues and organs. A number of the basic principles of tissue engineering and regenerative medicine were first developed at the institute. WFIRM researchers have successfully engineered replacement tissues and organs in all four categories – flat structures, tubular tissues, hollow organs and solid organs – and 15 different applications of cell/tissue therapy technologies, such as skin, urethras, cartilage, bladders, muscle, kidney, and vaginal organs, have been successfully used in human patients. The institute, which is part of Wake Forest School of Medicine, is located in the Innovation Quarter in downtown Winston-Salem, NC, and is driven by the urgent needs of patients. The institute is making a global difference in regenerative medicine through collaborations with over 400 entities and institutions worldwide, through its government, academic and industry partnerships, its start-up entities, and through major initiatives in breakthrough technologies, such as tissue engineering, cell therapies, diagnostics, drug discovery, biomanufacturing, nanotechnology, gene editing and 3D printing.