• Research

    Advancing promising therapies through regulatory programs

Learn about the latest regulatory programs designed to accelerate promising new therapies toward clinical care at the Mayo Clinic Symposium on Regenerative Medicine & Surgery 2023. The event featuring nationally and internationally known speakers will be held April 3–5 at the Westin Kierland Resort and Spa in Scottsdale, Arizona.

Peter Marks, M.D., Ph.D., director of the Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA), will lead an online fireside chat about the FDA's commitment to approving safe and effective products that address unmet patient needs.

Peter Marks, M.D., Ph.D.

"The FDA is committed to advancing the development of innovative regenerative medicine products, including cell, tissue and gene therapies. It is doing so by working to advance manufacturing and characterization of these products, clinical trial design and use of expedited regulatory programs," says Dr. Marks.

Among the obstacles to moving advanced therapies, Dr. Marks says, are bottlenecks in manufacturing, including developing scalable biomanufacturing processes and new tools for product characterization.

Product characterization is the data that defines the characteristics and structure, and proves safety, effectiveness, purity, quality and strength of a biotherapeutic. Dr. Marks also points to a need for well-controlled clinical trials for some regenerative medicine products, particularly those addressing more common conditions.

The FDA supports the Regenerative Medicine Advanced Therapies (RMAT) program, which lays the foundation for accelerating approval of promising new biotherapeutics.

"Cell and gene therapies may offer a transformative approach to a number of diseases, able to address unmet medical needs that would be difficult or impossible to address by conventional small molecule or protein therapies," says Dr. Marks. "It is our hope that increasing application of the expedited programs like RMAT, as well as improved communication between the agency and sponsors, will help bring the benefit of new discoveries to patients sooner."

In addition to Dr. Marks’ presentation, the symposium will offer the latest in tissue engineering, 3D printing and bioprinting, cell-free therapies and bioengineered organs. Conference attendees may earn 9.25 continuing medical education credits.

Richard Hayden, M.D.

"The Mayo Clinic Symposium on Regenerative Medicine & Surgery 2023 is a great opportunity for current and future providers to learn about regulatory issues that may shape the practice in the years to come," says Richard Hayden, M.D., course director. "The symposium will also cover many forward-looking topics that will help clinicians deliver the latest regenerative therapies."

Keynote speakers at the symposium include:

  • Shinya Yamanaka, M.D., Ph.D., the Nobel laureate who discovered how to reprogram human cells and who also is director of the Center for iPS Cell Research and Application, Kyoto University.
  • Bruce Levine, Ph.D., immediate past president of the International Society for Cell & Gene Therapy. Dr. Levine also is founding director of the Clinical Cell and Vaccine Production Facility in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania.
  • Raghu Kalluri, M.D., Ph.D.,professor and chairman of the Department of Cancer Biology and the director of the Metastasis Research Center at MD Anderson Cancer Center.
  • Harald Ott, M.D., associate professor of surgery at Harvard Medical School and a thoracic surgeon at Massachusetts General Hospital.

Attendees will have access to keynote presentations, breakout sessions, networking and poster presentations. The symposium is open to specialists and nonspecialists who are interested in regenerative medicine therapies and techniques.

Register now for the Mayo Clinic Symposium on Regenerative Medicine & Surgery 2023.


Attendance at any Mayo Clinic course does not indicate or guarantee competence or proficiency in the skills, knowledge or performance of any care or procedure that may be discussed or taught in this course.