Dr Steven Bauer, Former FDA Chief Joins RegenMed Hub

2 minute read

A man standing in a lab

Winston-Salem continues to strengthen its stature as the premiere hub for regenerative medicine around the world as one of the world’s leading experts on regulatory issues relating in the field has joined RemDo as its new Chief Regulatory Science Affairs Program Officer.

Steven R. Bauer, PhD, adds to the ever-growing list of world-renowned resources available to researchers, innovators and regenerative medicine companies available in the RegenMed Hub here in the Innovation Quarter. Bauer is a former FDA official with  31 years of regulatory experience, clinical trials oversight and research experience in cell-based biological therapies. 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 last week.

RegenMed Hub logo

“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).

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 regenerative medicine companies, 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.”