Michael brings a wealth of research and new drug development experience to Theratome Bio. He directed multidisciplinary teams at GeneMedicine and Valentis in Houston, Texas, prior to accepting a role with Centelion (a subsidiary of Sanofi-Aventis) as Vice President of R&D. He there led a team of scientists in discovery, process & clinical development, and regulatory affairs. Most recently, Michael was President and CEO of InGeneron, a medical device firm committed to driving personal regenerative medicine therapies. During his tenure InGeneron attained several regulatory approvals in Europe and initiated clinical trials in the US under FDA approval.
Michael has dedicated his career to developing new therapies, ushering these innovations through regulatory paths, and ultimately seeing new therapies transitioned into the clinic. He has also continued to publish research in peer-reviewed journals and maintain a close relationship with leading researchers and clinicians in academia.
He earned his BS and MS degrees from Texas A&M, his PhD from Penn State, and completed post-doctoral work at the Baylor College of Medicine.
Michael has a passion for the regenerative medicine space. He’s long thought that a cell-free option is where the future of regenerative therapy is headed, and believes that TheratomeTM technology provides the key attributes of product consistency and ease of handling and administration necessary to achieve widespread clinical application. In his own words, “TheratomeTM technology solves the key issues limiting clinical application of stem cell based therapies. I am excited for the opportunity to be part of developing this technology that will provide life changing benefits patients and disrupt the field of regenerative medicine.”
Keith L. March, MD, PhD, FACC, has dedicated his career to bringing new medical approaches to patients. His publications include more than 150 manuscripts. He was the editor of the first book dedicated to cardiovascular gene transfer. Dr. March’s research has resulted in more than 55 worldwide (20+ U.S.) patents, with others pending. He invented the Closer, a widely-utilized patented suture-mediated closure device, used to close the puncture wound in an artery following heart catheterization. This device allows a patient to “walk off the table” after a catheterization without requiring prolonged bedrest. In 1999, Abbott Vascular, an affiliate of Abbott Laboratories, acquired the company that developed this technology, and the Closer approach has been used worldwide to treat more than 8,000,000 patients. He has served as a scientific advisor to numerous pharmaceutical, biotechnology, and medical device companies. Theratome Bio is his most recent venture, based on a patented platform of technology originating in his laboratory that has established the therapeutic factors secreted by stem cells as powerful therapeutics for critical medical needs, including degenerative and ischemic diseases of the nervous system. With FDA input, Theratome Bio is pursuing this off-the-shelf approach to markedly reduce stroke and prolong quality life in ALS (Lou Gehrig’s disease), as two near-term goals.
His laboratory focuses on vascular biology, with a particular emphasis on the function and translational study of stem cells found in the adipose (fat) tissue, which his laboratory identified as cells with critical roles in blood vessel growth and control of inflammation. Dr. March is recognized as a leading expert in the field of adult stem cell research, particularly that involving adipose-derived stem cells. From 2008-2012, he was Chair of the National Institutes of Health Data and Safety Monitoring Board that oversees cell therapy trials in the areas of heart, lung, and blood diseases. In 2012, his center was selected as one of the seven Cardiovascular Cell Therapy Research Network (CCTRN) centers in the USA which would work together to conduct NIH-sponsored cell therapy clinical trials during a 7-year period. He has obtained FDA approval to conduct U.S. trials employing one’s own adipose-derived stem cells: one of these to avoid amputations in legs of patients with severe circulatory disease, and another to avert knee replacements in patients with severe arthritis.
In addition to his research roles, Dr. March has served as the President (2007) of the International Federation of Adipose Therapeutics and Science (IFATS), and as the Chief Medical Advisor for the Cell Therapy Foundation. He continues to serve on the IFATS Board. In these affiliations, he has worked to advance collaboration as well as public awareness about the significance of adult stem cells.
In 2017, Dr. March joined the University of Florida as Director of the University of Florida Center for Regenerative Medicine. This multidisciplinary center is working to bring regenerative therapies to patients with unmet medical needs.
Karen earned a B.A. in Chemistry with a minor in Marketing from the University of Dayton. She completed an Undergraduate Thesis while there, worked for the Office of Admission leading campus tours, and was hired as a new grad to work as a Traveling Student Recruiter.
Karen began her career with the Bristol-Myers Squibb Company shortly thereafter. During her ten years of employment, she served Primary Care and Hospital Sales roles, sold in multiple outpatient and inpatient therapeutic areas, negotiated formulary contracts, earned district, region, and national recognition for sales, and was selected to serve in leadership roles within her district.
Since then, Karen has taken on several non-profit initiatives whereby she has initiated a group, raised funding, and marketed and maintained a leadership role in organizations. She has also used her public speaking abilities to fund-raise. In one such effort, she contributed to the establishment of an in-house Therapeutic Massage Therapy Program to treat Oncology Patients at Oregon Health and Science University (OHSU) Hospital in Portland, Oregon, a cause that was previously only filled by intermittent volunteers.
Karen is happily married, and proud mother to two sons. In addition to multiple volunteer roles at her Parish and children’s schools, Karen reads live broadcasts for IRIS Radio, a free service that provides audio news and literature for the visually impaired. Karen is also the survivor of a stem cell transplant (2009), and an autologous stem cell procedure to her hip to reduce the likelihood for need of replacement. These experiences fuel her unique passion for furthering regenerative medicine innovation.