Operating Committee

Ms. Fuller is president of MDRS, LLC, a regulatory consulting firm that specializes in providing strategic FDA and global regulatory, product development and clinical research expertise to biotechnology companies throughout the translational “bench-to-bedside” product life cycle. She has more than 45 years’ experience developing, validating and commercializing complex medical device, biologic and combination drug/device products, as a board certified regulatory affairs professional. She has led successful global clinical studies and regulatory marketing authorization submissions via the FDA IDE, IND, 510(k), PMA and EU CE mark processes. Ms. Fuller has held R&D, regulatory and clinical affairs management positions with global medical device companies, including W.L. Gore & Associates, P-S Medical (acquired by Medtronic), Bard, Terumo Corporation, Tangent Medical and Rindex Medical.

Dr. William Giannobile, dean of Harvard School of Dental Medicine (HSDM), is a leader in the field of periodontology and an internationally recognized scholar in oral regenerative medicine, tissue engineering, and precision medicine.  His research focuses on oral and periodontal regenerative medicine, tissue engineering and precision medicine. He has maintained a continuously NIH-funded research program over the past 25 years and has produced over 300 manuscripts, textbook chapters, and patents focused on periodontology, regenerative medicine and oral health research. He is the editor or co-editor of nine books focused on clinical, translational research, periodontology and regenerative medicine. Dr. Giannobile recently completed a ten-year term as the editor-in-chief for the Journal of Dental Research, the official journal of the International Association for Dental Research. He is also a consultant to the U.S. Food and Drug Administration for Dental Devices, and serves as an associate editor for the upcoming report on the Surgeon General’s Report on Oral Health – 2020.

Dr. Giannobile received the American Dental Association’s Norton Ross Award for Excellence in Clinical Research. He is also a recipient of the Distinguished Scientist Award from the Academy of Periodontology, and a fellow of the American Association for the Advancement of Science, the American Association for Dental Research and the International and American Colleges of Dentists. He is a past president of the American Academy of Periodontology Foundation, and currently serves as the president of the Osteology Foundation, an organization devoted to oral tissue regeneration by the promotion of science and clinical practice. In addition to his research efforts, he is involved in clinical and didactic teaching in periodontology and will practice clinically in periodontics and implant dentistry at the Harvard Dental Center.

Dr. Darnell Kaigler is the Associate Professor of Dentistry in the Department of Periodontics & Oral Medicine at the University of Michigan.   Dr. Kaigler was the first person to complete a dual DDS/PhD degree (Oral Health Sciences) at the University of Michigan. Dr. Kaigler went on to receive additional clinical training at the U of M earning certificates in operative dentistry and periodontics. He also received advanced post-doctoral research training at the U of M earning an MS in Clinical Research Design and Statistical Analysis. Dr. Kaigler is currently a tenured Associate Professor in the Department of Periodontics and Oral Medicine (School of Dentistry) and Biomedical Engineering (College of Engineering). He has an active research program where he is the director of a research laboratory and lead investigator of clinical trials. A central focus of his research group is the development and implementation of stem cell-based therapies for the regeneration of oral tissues. Outside of his research and teaching responsibilities at the U of M, Dr. Kaigler participates in patient care in a multi-specialty group practice in downtown Detroit. Dr. Kaigler is a Diplomate of the American Board of Periodontology and involved in a number of professional organizations, including currently serving as the President of the Midwest Society of Periodontology.

Dr. Kohn is the Natalie C. Roberts Endowed Professor at the University of Michigan in the Departments of Biologic and Materials Sciences (Dentistry) and Biomedical Engineering (Engineering), and Director of the Translational Resource Center. He received his BS in biomedical engineering from Tulane University and his Ph.D. in bioengineering from the University of Pennsylvania. Dr. Kohn’s laboratory focuses on biomineralization, which is investigated by establishing structure-function relations in mineralized tissues and utilizing this information to develop biomimetic strategies to engineer tissue. Over the past 30 years, Dr. Kohn’s research has spanned numerous areas, including biomineralization, biomimetic materials, discovery of novel dual-function peptides, and functional adaptation of tissues in response to exercise, diet and genetic influences. Dr. Kohn is also the PI and Director of Michigan’s NIH-supported Training Program in Tissue Engineering and Regeneration and Director of a university-wide regenerative medicine program funded by the President’s Biosciences Initiative.  Dr. Kohn is past President of the Society for Biomaterials and serves on the advisory boards of several universities and has consulted for many medical device companies. Dr. Kohn is a Fellow of Biomaterials Science and Engineering of the International Union of Societies for Biomaterials Science, and a Fellow of the American Institute of Medical and Biological Engineering (AIMBE), American Association for the Advancement of Science (AAAS), and Biomedical Engineering Society. He is also a recipient of a Distinguished Scientist award from the International Association for Dental Research (IADR), and Clemson Award from the Society for Biomaterials.

Dr. Mooney is the Pinkas Family Professor of Bioengineering at Harvard University and Core Faculty Member at the Wyss Institute. He is a member of the National Academy of Engineering and the National Academy of Medicine. His inventions have been licensed by twelve companies, leading to commercialized products, and he is active on industrial scientific advisory boards.

His laboratory designs biomaterials to make cell and protein therapies effective and practical approaches to treat disease. He is a member of the National Academy of Engineering, the National Academy of Medicine, and the National Academy of Inventors. He has won numerous awards, including the Clemson Award from the SFB, MERIT award from the NIH, Distinguished Scientist Award from the IADR, Phi Beta Kappa Prize for Excellence in Undergraduate Teaching, and the Everett Mendelsohn Excellence in Mentoring Award from Harvard College.

Vicki Rosen, PhD, is currently Professor and Chair, Department of Developmental Biology at Harvard School of Dental Medicine and a Principal Member of the Harvard Stem Cell Institute. She began her career at Genetics Institute, a biotechnology company, where she was part of the team that isolated the first BMPs genes and successfully launched recombinant human BMP2 as a therapeutic for enhancing bone repair. Dr. Rosen has been honored with numerous awards, including the Kappa Delta Ann Donner Vaughn Award for outstanding orthopedic research, the Marshall Urist Award for excellence in tissue engineering research, the Raine Medical Research Foundation Medal, and the William F. Neuman Award, the most prestigious award given by The American Society for Bone and Mineral Research (ASBMR).  Her laboratory at HSDM studies BMP family molecule signaling in musculoskeletal tissues with the goal of using knowledge gained to enhance tissue repair and regeneration.

Tony has over 30 years of experience and has held numerous senior management positions in the Chemicals, Materials and Construction products sectors as well as startup experience with a number of diverse technical challenges. He founded and currently operates FreeRadicals LLC, a consulting firm and investment holding company exclusively focused on sustainable technologies, efficient construction methods and materials, packaging and renewable energy. Prior to FreeRadicals Tony co-founded Triventas LLC, a small-cap investment firm and was Sr. Consultant at Headwaters, a merchant banking and advisory firm. These opportunities came after accomplished careers in the chemicals industry where he held senior leadership positions for leading firms including Dow Chemical and Nova Chemicals.

At Nova, Tony was President of its construction materials business, SYNTHEON Inc., and ran its Performance Styrenics business with accountability for over $300M in revenue. While at Dow Chemical he held numerous global assignments including; Global Business Director for the Corporate New Ventures Global Growth Center and founder and Director of Dow Fibers Solutions among others. Of late, Tony has focused on the startup of multiple global construction materials businesses through the formation of wholly owned or joint venture companies in India, Chile, Mexico and the United States. This after starting or managing other startup companies in technologies as varied as carbon nanotubes, non-wovens, elastomeric fibers and prefab housing.

For a third time, Tony made a radical change in careers leveraging his corporate and startup experience to become the Lead Entrepreneur in Residence at The University of Pittsburgh. Since his tenure at Pitt Tony and his team have guided the launch of more than 80 startup companies.

He has a Bachelor of Science in Mechanical Engineering from University of Miami, Florida and has completed Executive Programs at MIT for Management of Technology and the Thunderbird International Management Executive Program. Tony is an accomplished lecturer often presenting at leading Universities like Berkeley, Carnegie Mellon, University of Miami and Duquesne. Additionally, he is currently an Adjunct Professor for Intrapreneurship and Hacking for Defense at the University of Pittsburgh’s Swanson School of Engineering and previously Adjunct at Duquesne University teaching Entrepreneurship.

Tony is fluent in Spanish and travels extensively to far reaches of the world. He is relentless in his pursuit of knowledge in science, culture and people so that he can perpetually improve both his artistic and technical skills through the art and science of photography.

Dr. Wagner is the Director of the McGowan Institute for Regenerative Medicine as well as a Professor of Surgery, Bioengineering and Chemical Engineering at the University of Pittsburgh. He also serves as Scientific Director of the NSF Engineering Research Center on “Revolutionizing Metallic Biomaterials” and Chief Science Officer for the Armed Forces Institute of Regenerative Medicine.

Professor Wagner is the Founding Editor and Editor-in-Chief of one of the leading biomaterials journals, Acta Biomaterialia, and is a past-president of the American Society for Artificial Internal Organs (ASAIO). Currently he serves as Chairman for the Tissue Engineering and Regenerative Medicine International Society (TERMIS) Americas region. He is a fellow and former vice president of the American Institute for Medical and Biological Engineering (AIMBE) and has also been elected a fellow of the Biomedical Engineering Society, the International Union of Societies for Biomaterials Science and Engineering, TERMIS, and the American Heart Association

Dr. Wagner’s research focuses on areas tissue engineering with projects that address medical device biocompatibility and design, biomaterial development, tissue engineering, and targeted imaging.