Advancing the Science

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October 20, 2021

Overcoming regulatory challenges to licensing new biotherapeutics

By Susan Buckles

Mayo Clinic's Symposium on Regenerative Medicine and Surgery will explore the challenges and opportunities of bringing next-generation biotherapeutics to patients. Julie Allickson, Ph.D., the Michael S. and Mary Sue Shannon Director of Mayo Clinic's Center for Regenerative Medicine, will deliver a keynote presentation addressing regulatory hurdles standing between the billions of dollars invested in regenerative therapies and the people who desperately need new options for healing.

Julie Allickson, Ph.D.

"Last year, there was an almost a $20 billion investment in regenerative biotherapeutics. There's a significant investment, but not many products being licensed and generating commercialized solutions for patients. What are the challenges, and what are the obstacles," asks Dr. Allickson. "It requires a partnership to move new discoveries to licensure, engaging industry and working with government agencies to facilitate production of biotherapuetics." Dr. Allickson is also the Otto Bremer Trust Director, Biomanufacturing and Product Development, Center for Regenerative Medicine.

Registration is open for the Mayo Clinic Symposium on Regenerative Medicine & Surgery 2021, which will be held Nov. 4–7 at the JW Marriott Desert Ridge Resort and Spa in Phoenix. The symposium will offer in-person and online options. Conference attendees can earn 15.25 continuing medical education credits.

Regenerative medicine is an emerging area of practice that seeks to repair, replace or restore damaged cells, tissues or organs. Mayo Clinic's Center for Regenerative Medicine is at the forefront of this movement that is shifting the focus from fighting disease to rebuilding health.

Promising new regenerative discoveries must first clear regulatory approval from the Food and Drug Administration (FDA) before they are offered as new therapies in the clinic.

"Many factors are involved when it comes to advancing new regenerative medicine products, such as product variability, understanding product potency, scaling-up, and designing the appropriate preclinical studies," says Dr. Allickson.

FDA director to speak at symposium

With challenges come opportunities. Dr. Allickson says the FDA has provided new insights that can help physicians and scientists navigate regulatory pathways toward approval of new biotherapeutics.

After her keynote address, Dr. Allickson will lead a panel discussion, "Advanced Biomanufacturing: Clinical Translation Considerations." Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, will speak in Dr. Allickson's session.

Additional presenters on the panel are:

  • William Faubion Jr., M.D., associate medical director of Mayo Clinic's Center for Regenerative Medicine, who will speak on cellular therapies and the immune system.
  • Juliana Blum, Ph.D., who will share her expertise in biomanufacturing as co-founder of a biotechnology platform company seeking to develop implantable bioengineered human tissue.
  • Todd Rasmussen, M.D., a Mayo Clinic vascular surgeon, who will speak on vascular implants for limb salvage.
  • Atta Behfar, M.D., Ph.D., deputy director of Translation for the Center for Regenerative Medicine and Director of Mayo Clinic's Van Cleve Cardiac Regeneration Program, who will speak on biomanufacturing of extracellular vesicles.

Additional keynote speakers include:

  • Helen Blau, Ph.D.
    Dr. Blau is director of the Baxter Laboratory for Stem Cell Biology and professor, by courtesy, of psychiatry and behavioral sciences, Stanford Medicine. She will speak in a virtual session on reversing muscle aging, stem cell renewal and extending health span.
  • Georg Duda, Ph.D. will present his research in a live session.
    Dr. Duda is director of the Julius Wolff Institute for Biomechanics and Musculoskeletal Regeneration at Charite ― Universitatsmedizin Berlin. He will lead a live session on regenerative medicine and aging. Dr. Duda is an engineer and one of three founding directors of the Berlin-Brandenburg Center for Regenerative Therapies.

The Mayo Clinic Symposium on Regenerative Medicine & Surgery 2021 also will feature the latest innovations in regenerative immunotherapies, oncology, dermatology, surgery, cardiovascular medicine, neurosciences, orthopedic medicine, stem cell research, 3D printing, regenerative medicine education and transplant. In addition, Richard Gray, M.D., CEO of Mayo Clinic in Arizona, will moderate a session with senior policymakers on emerging regenerative medicine initiatives and their economic impact.

Richard Hayden, M.D.

"The Mayo Symposium on Regenerative Medicine & Surgery is a world-class conference that is bringing together physicians, scientists, allied health staff and policymakers from around the globe to share research and best practices in this emerging area of health care," says Richard Hayden, M.D., deputy director of Education for the Center for Regenerative Medicine, and the symposium's course director. "This is a unique opportunity to interact with experts across the spectrum of discovery, translation and application."

View the agenda to learn more about the speakers and breakout sessions at the Mayo Clinic Symposium on Regenerative Medicine & Surgery 2021.

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

Mayo Clinic is closely monitoring COVID-19 prevalence and may adjust live course attendance limits, as advised by the Centers for Disease Control and Prevention, public health authorities and other guidance. Attendees must show proof of a COVID-19 vaccination and a negative COVID-19 test within 72 hours of attending the symposium.

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This article originally appeared on the Mayo Clinic Center for Regenerative Medicine blog.

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Tags: Atta Behfar, biotherapeutics, Center for Regenerative Medicine, Education, Events, Julie Allickson, Mayo Clinic Symposium on Regenerative Medicine & Surgery, republished, Richard Hayden, William Faubion

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