This MPWRM Resource Center is governed by an Operating Committee composed of the distinguished members of academia and industry who have extensive experience in translating TE/RM research and who bring expertise in interdisciplinary program administration. The Operating Committee’s role is to provide leadership and advice to the PIs concerning the progress and direction of the Resource Center and is responsible for: (1) setting policies and prioritizing selection of technologies recommended by clinical and industrial boards; (2) matching clinical needs with areas of technological expertise; (3) creating missions for each team within the Resource Center, including success criteria for advancing through the stages of the translational pipeline; (4) monitoring progress toward fulfilling the objectives of the Resource Center; and (5) advising on preparing a strategy for the sustainability of the Resource Center.
Ms. Ambruster is CEO of The Avenues Company. She has previously been a Research Scientist and Business Leader at W. L. Gore and Associates, where she worked in medical product and business development and was responsible for launching a global business dedicated to oral regeneration beginning with FDA clearance of Gore’s first guided tissue regeneration product. She was ultimately responsible for all business functions (R&D, clinical, regulatory, manufacturing, quality, sales, marketing). In 2000, she founded The Avenues, which provides in-depth clinical and market assessments as well as product and business development support for innovations in the oral and tissue engineering/regenerative fields.
Connie Chang brings a 25-year career in life science and business to the Operating Committee having worked in large and small pharma, early-stage biomedical technology commercialization and management consulting. She is currently Chief Operating Officer of ONL Therapeutics, a venture-backed clinical stage biopharma company developing a novel peptide technology to address diseases of the retina. Previously, she was Vice President of Corporate Affairs at Millendo Therapeutics responsible for building critical infrastructure as the company became publicly traded, including investor and public relations and integrating global company operations. She served as the inaugural managing director of Fast Forward Medical Innovation (FFMI), the commercialization and entrepreneurship arm of the University of Michigan Medical School, supporting early-stage technology development. At Sepracor, Ms. Chang was Senior Director and brand team leader for the sedative hypnotic and respiratory franchises, developing integrated marketing and launch plans. Earlier in her career, Connie worked at Pfizer on commercial teams in allergy/respiratory, cardiovascular and CNS.
Connie received her Bachelor of Arts degree in psychobiology from Harvard University, graduating magna cum laude and Phi Beta Kappa, and an MBA from Harvard Business School.
Kay Fuller, RAC
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 40 years’ experience developing, validating and commercializing complex medical device, biologic and combination drug/device products, as a board certified regulatory affairs professional.
Ms. Fuller has led successful global clinical studies and regulatory marketing authorization submissions for more than 40 Class II & Class III medical devices and combination products, via the FDA IDE, IND, 510(k), PMA and EU CE mark processes, which have enabled over $5B in global medical product sales.
In addition to her regulatory, clinical research and product development experience, Ms. Fuller previously served as an inaugural member of the UM-BME Coulter Translational Partnership Program Technical Oversight Committee and as the initial Core Leader of the National Standards and Compliance Advisory Core for the NIH National Cancer Institute’s Network for Translational Research (NTR): Optical Imaging in Multimodal Platforms program.
A seasoned regulatory executive, strategist, speaker, and author, Ms. Fuller has guided many organizations toward gaining FDA enforcement action resolutions, including those associated with warning letters and product recalls. She also consulted for two of the largest FDA federal court ordered consent decrees (Pharmaceutical and Biologics Manufacturers) as a nationally recognized third-party cGxP regulatory and quality systems management expert.
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. She is the primary inventor on three patents and received her undergraduate degree in Veterinary Technology from Texas State Technical College.
William Giannobile, DDS, DMSc
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.
Last year, 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.
Kenneth Hargreaves, DDS, PhD
Ken Hargreaves is professor and Chair of the Department of Endodontics at UT Health San Antonio, and is jointly appointed as a professor in the Departments of Pharmacology, Physiology and Surgery in the School of Medicine. Ken currently he serves as PI or co-PI on >$30m in NIH/DoD research grants and previously has received an NIH MERIT Award, the ADA Gold Medal Award for Research, the AAE President’s Award, the AAE Louis I. Grossman Award for Research and the UTHSCSA Presidential Distinguished Senior Research Scholar Award. Ken has published >250 papers, two textbooks, is Editor of the Journal of Endodontics and has five patents issued/pending. Among these papers are the description and validation of the “Hargreaves method”, which is broadly recognized as a standard method for evaluating new analgesic drugs and is in the top 5% of all papers cited in the field of pain research.
Darnell Kaigler, DDS, PhD
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.
David Kohn, PhD
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). 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) and American Association for the Advancement of Science (AAAS). He is also a recipient of a Distinguished Scientist award from the International Association for Dental Research (IADR).
Paul Kostenuik, PhD
Dr. Kostenuik is the former Scientific Director for Metabolic Disorders Research at Amgen and currently an Adjunct Professor at Michigan. Dr. Kostenuik spent 16 years as an industry-based drug developer, with significant expertise in many scientific, regulatory, legal and clinical pathways and challenges involved in bringing products to a commercial stage. Dr. Kostenuik led several research projects from discovery into clinical development and has followed projects through the entire development cycle, regulatory approval, and commercialization (eg. Prolia®, Xgeva®).
David Mooney, PhD
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.
Katherine Moynihan, PhD
Katherine Moynihan, PhD, is the Principal Consultant at Blue Ridge Bio Consulting, and previously served as the Vice President of Business Development and Marketing at Genezen, a boutique CDMO in the cell and gene therapy space focused on lentiviral and retroviral vector process development, GMP manufacturing, and analytical testing. Previously, Moynihan served as Associate Vice President of Indiana University (IU) Ventures focused on sourcing and due diligence on life science investment opportunities and retains a role as an IUV EIR and board participation in an IU Ventures portfolio company. Prior to her position in venture capital, she managed the protection and commercialization of technologies emanating from academic researchers as Acting Director of the Innovation and Commercialization Office at Indiana University and before joining IU, at University of Michigan’s Office of Technology Transfer. Moynihan holds a B.S. in chemistry from The College of William and Mary, a Ph.D. in cell and developmental biology from Vanderbilt University, and an MBA from the IU Kelley School of Business.
Vicki Rosen, PhD
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.
Charles Sfeir, DDS, PhD
Dr. Sfeir is the Associate Dean for Research and the Director of the Center for Craniofacial
Regeneration at the University of Pittsburgh. He is also Associate Professor in the Departments of Oral Biology and Periodontics. Dr. Sfeir holds a DDS and a Ph.D. in molecular biology. His research is multidisciplinary and translational in nature, focusing on designing therapies for craniofacial and dental diseases. As a clinician scientist with 3 technologies from his laboratory well underway in the translational pathway, Dr. Sfeir’s expertise in device development as well as in clinical dentistry and craniofacial tissue engineering are invaluable to this resource center.
Antonio (Tony) Torres
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.
William Wagner, PhD
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.