WINSTON-SALEM – A former official of the U.S. Food and Drug Administration will join the Regenerative Medicine Hub, RegenMed Hub, based in Winston-Salem’s Innovation Quarter.

Dr. Steven R. Bauer served in the FDA for 31 years and developed expertise in cell-based biological therapies, according to a statement issued by the RegenMed Hub on Friday.

Dr. Steven R. Bauer. Image provided by RegenMed Hub.

The hub is a part of the RegenMed Development Organization (ReMDO) which is also partnered with the Wake Forest Institute for Regenerative Medicine (WFIRM).

“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, in the statement. “Having him join our endeavors means great things for everyone working in the regenerative medicine space.”

According to the statement, Dr. Bauer was involved in oversight of regenerative medicine product development since the creation of the Division of Cellular and Gene Therapies at the FDA in 1992.

“The addition of Bauer comes at a particularly exciting time for ReMDO and WFIRM,” according to the statement.

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That’s because the organizations launched RegeneratOR earlier this year.  The project is described in a statement as “a three-part engine of the RegenMed Hub ecosystem to support biotechnology innovation and business” and is meant to be a driving force to bring together talented workers and resources to support startup and growing companies through an accelerator-style program.

Now having joined the organization, Bauer will provide support to ReMDO and the companies engaged in the Test Bed and Innovation Accelerator, the statement noted.

“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 in a statement. “This is quite a coup.”

The statement also notes that 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.

To date, WFIRM researchers have successfully engineered replacement tissues and organs in all four categories – flat structures, tubular tissues, hollow organs and solid organs.  That includes 15 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.

W-S organization working on regenerative therapies for 40 organs, tissues