"The future of regenerative medicine is bright," declared Julie Allickson, Ph.D., the Michael S. and Mary Sue Shannon Director of Mayo Clinic's Center for Regenerative Medicine, as she delivered the opening keynote address of the Mayo Clinic Symposium on Regenerative Medicine & Surgery 2021. Dr. Allickson is the Otto Bremer Trust Director, Biomanufacturing and Product Development, Center for Regenerative Medicine
Dr. Allickson highlighted ways regenerative medicine is on the threshold of delivering new therapeutic options to patients. She pointed to the first in-vivo gene editing clinical trial in the U.S. using the CRISPR Cas-9 editing technology and the potential of expanding chimeric antigen receptor-T cell therapy (CAR-T cell therapy) beyond leukemia, lymphoma and multiple myeloma. From advancements in bioengineered organ research to the latest innovations in tissue engineering and 3D printing, regenerative medicine is on the cusp of transforming health care.
Throughout the four-day symposium, experts at Mayo Clinic and around the world shared regenerative medicine applications to aging, musculoskeletal conditions, lung diseases, organ transplantation and cancer.
"The financial investment in new regenerative technology is incredible. Just halfway through 2021, we saw 70% more investment in the first 6 months compared to the $20 billion investment made in 2020," said Dr. Allickson. "Now is the time to fast-track these new promising technologies toward commercialization. The Food and Drug Administration (FDA) is working collaboratively, providing guidance on streamlining approvals of safe and effective therapies that provide new cures for patients."
Dr. Allickson is leading Mayo Clinic's new biomanufacturing strategy that aligns with the institution's "Bold. Forward." strategic plan to bring next generation, first-in-the-world regenerative therapies to the practice.
The focus of Mayo Clinic's biomanufacturing strategy is biologic medicines derived from living cells that can be scaled and delivered to the practice in a cost-effective manner. Research has shown biologics can be targeted to specific areas of healing with potential for fewer side effects than standard pharmaceuticals.
"With opportunities come challenges. One challenge is finding a way to automate biomanufacturing and bring the cost down. Standardization would also reduce the potential of human error," said Dr. Allickson. "Another challenge is the variability of the product and lack of clinical grade supplies and reagents to manufacture. Despite that, regenerative medicine is moving forward with an increasing number of clinical trials maturing from phase 1 to a significant number in phase 2 trials. We are seeing a fair number of late stage phase 3 clinical trials."
Regenerative medicine seeks to shift the focus of health care from fighting disease to rebuilding health by repairing, restoring or replacing diseased cells, tissues or organs. Mayo Clinic's biomanufacturing strategy is directed at commercializing new discoveries that would bring regenerative medicine to more patients. Mayo Clinic's Center for Regenerative Medicine is at the forefront of this movement and as such hosted the symposium to further its strategic objective of training the future regenerative sciences workforce.
"The symposium provided a virtual continuum of biologic sciences to material sciences to engineering, blending biomanufacturing with product development aimed at novel therapeutics that we can deliver to the clinical practice," said Richard Hayden, M.D., deputy director of Education, Center for Regenerative Medicine, and the symposium's course director. "It also took a deep dive into developing the workforce of the future.”
Peter Marks, M.D., Ph.D.,director of the FDA's Center for Biologics Evaluation and Research, pledged support for regenerative medicine in a virtual presentation on the regulation of cellular products and derivatives. Dr. Marks said that the FDA is committed to advancing regenerative technologies for complex medical conditions that provide solutions that have so far eluded medical science.
"The field of regenerative medicine is very exciting," said Dr. Marks. "We want investigators to understand how they could move forward effective, innovative regenerative medicine therapies and associated devices. We've put out various regenerative medicine documents in the past few years to guide them."
Dr. Marks outlined pathways intended to streamline product development and facilitate FDA approval. One is the regenerative medicine advance therapy designation, which streamlines and accelerates approval of gene, cell or tissue therapies. Another is the breakthrough therapy designation, which is a process designed to speed the development and review of drugs that would substantially improve treatment of serious conditions.
Two keynote speakers shared promising research that could one day transform care for degenerative conditions:
Opportunities for commercialization
Richard Gray, M.D., CEO of Mayo Clinic in Arizona, led a panel discussion on emerging regenerative medicine initiatives. The panel discussion included Christina Corieri, senior policy adviser to Arizona Gov. Doug Ducey; Joan Koerber-Walker, president and CEO of the Arizona Bioindustry Association; and Chris Mackay, Phoenix Community and Economic Development director. The discussion centered on how the time is right for growing new biobusinesses capable of quickly bringing to market new, FDA-approved regenerative therapies.
Regenerative medicine education doesn't end with the Mayo Clinic Symposium on Regenerative Medicine & Surgery 2021. Mayo Clinic's Center for Regenerative Medicine has advanced regenerative sciences curricula in all five schools of Mayo Clinic College of Medicine and Science. That coursework provides ongoing learning opportunities for physicians, scientists and allied health professionals.
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