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 RC 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 RC, including success criteria for advancing through the stages of the translational pipeline; (4) monitoring progress toward fulfilling the objectives of the RC; and (5) advising on preparing a strategy for the sustainability of the RC.
Steven Goldstein, PhD
Dr. Goldstein is an Active Professor Emeritus of Orthopaedic Surgery, Biomedical Engineering and Mechanical Engineering at the University of Michigan, and a member of the National Academy of Engineering.
Dr. Goldstein has published more than 215 peer reviewed papers, and received numerous accolades for his research. He has also held significant leadership and academic administrative positions including Associate Chair for Research in Orthopaedics for more than 25 years and former Research Dean of the Medical School at the University of Michigan.
In addition to his scholarly achievements, Dr. Goldstein is also an active entrepreneur. He holds more than 25 patents and has worked as senior scientific advisor, scientific advisory board member, or on the board of directors for more than 15 large companies and 10 small or start-up companies. He has also founded 2 start-up companies, and his substantial translational work has resulted in the development and clinical use of several medical devices ranging from fracture fixation instrumentation to artificial joint components, as well as a gene-based therapeutic strategy for wound repair and several other tissue engineering strategies.
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.
Albert Donnenberg, PhD
Dr. Donnenberg is Professor of Medicine and Director of Laboratory research in the Bone Marrow Transplant program at the University of Pittsburgh. He has directed the UPMC Hematopoietic Stem Cell Laboratory and the University of Pittsburgh Cancer Institute’s Flow Cytometry Facility since 1998. His current research interests are in cellular therapy and cell graft engineering, the role of stem cells in neoplasia, and immunotherapy for metastatic cancer. He is an internationally recognized expert in therapeutic cell processing and flow cytometry. Dr. Donnenberg has co-edited two editions of the CRC Handbook of Human Immunology and has authored more than 200 scholarly publications.
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 V. Giannobile, DDS, DMSc
Dr. William Giannobile is the Najjar Endowed Professor & Chair of the Department of Periodontics and Oral Medicine at the University of Michigan School of Dentistry. He is also a Professor of Biomedical Engineering at the College of Engineering. He received his DDS and MS in Oral Biology from the University of Missouri. He later received his Certificate in Periodontology and Doctor of Medical Sciences in Oral Biology from Harvard University. He completed postdoctoral training in Molecular Biology at the Dana-Farber Cancer Institute and Harvard Medical School. Dr. Giannobile previously served as a faculty member at Harvard and the Forsyth Institute. He has served as a Visiting Professor at the University of Genoa Medical School Biotechnology Institute and in the Department of Periodontology at the Eastman Dental Institute, University College London.
Dr. Giannobile’s continuously funded research program over the past 20 years has focused on Oral and Periodontal Regenerative Medicine, Tissue Engineering and Personalized Medicine. Dr. Giannobile currently serves as the Editor-in-Chief for the Journal of Dental Research, the official journal of the International Association for Dental Research. He is a past-president of the American Academy of Periodontology Foundation. Dr. Giannobile is a consultant to the U.S. Food and Drug Administration for Dental Devices. Dr. Giannobile has received numerous awards including the Jan Lindhe International Periodontal Award, the Distinguished Scientist Award and William J. Gies Award from the American Academy of Periodontology for his research contributions. He is a diplomate of the American Board of Periodontology and practices Periodontology and Implant Dentistry in Ann Arbor, Michigan.
David H. Kohn, PhD
Dr. Kohn is a 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 is President of the Society for Biomaterials. Dr. Kohn 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®).
Laurie K. McCauley, DDS, MS, PhD
Dr. Laurie McCauley is is the William K. and Mary Anne Najjar Professor and Dean of the School of Dentistry, and Professor in the Department of Pathology at the Medical School at the University of Michigan. Dr. McCauley earned her B.S., D.D.S., M.S. and Ph.D. (Veterinary Pathobiology) all from The Ohio State University. She has had several visiting scientist/professor appointments including the Institut de Genetique et de Biologie Moleculaire et Cellulaire, the École Normale Supérieure de Lyon, and the Center for Experimental Therapeutics and Reperfusion Injury, Brigham and Women’s Hospital, Harvard Medical School.
Dr. McCauley is a diplomate of the American Board of Periodontology, a fellow in the American Association for the Advancement of Science, a former council member of the American Society for Bone and Mineral Research (ASBMR), former Associate Editor of the Journal of Bone and Mineral Research (JBMR), a Fellow in the American College of Dentists and the International College of Dentists, and also served on the National Institutes of Health, National Advisory Dental & Craniofacial Research Council. For more than twenty years, Dr. McCauley has led an active research program in hormonal controls of bone remodeling, parathyroid hormone anabolic actions in bone, and prostate cancer skeletal metastasis. Among her many recognitions are the inaugural Paula Stern Achievement award from the ASBMR, a distinguished scientist award from the International Association for Dental Research, The Ohio State College of Dentistry Distinguished Alumnus award, and membership in the National Academy of Medicine.
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.
J. Peter Rubin, MD
Dr. Peter Rubin is Chair of the Department of Plastic Surgery, UPMC Endowed Professor of Plastic Surgery, and Professor of Bioengineering at the University of Pittsburgh. He is an internationally recognized expert in the science of adipose stem cells and fat grafting. He serves as co-director of the Adipose Stem Cell Center and is founder and director of the Center for Innovation in Restorative Medicine in the Department of Surgery at the University of Pittsburgh.
Dr. Rubin is principal investigator in an NIH-funded line of research aimed at developing cell based methods for clinical soft tissue reconstruction after cancer therapy, and directs a related line of research aimed at soft tissue reconstruction for injured soldiers as an investigator for the Department of Defense Armed Forces Institute for Regenerative Medicine. His scientific leadership positions include past president of the International Society of Adipose Therapeutics and Science (IFATS), Board Chair of IFATS, and past Chairman of the Plastic Surgery Research Council.
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.
Donald P. Taylor, PhD, MBA
Dr. Taylor has more than 20 years of life sciences commercial development experience. His current responsibilities include driving leadership and excellence across the six University of Pittsburgh health sciences schools (Medicine, Nursing, Pharmacy, Dental Medicine, Public Health, and Health & Rehabilitation) to accelerate commercial translation of Pitt’s discoveries and inventions, grow corporate sponsored research, secure commercial translation grants, and help train the next generation of world-class commercial translation students, staff, and faculty.
Dr. Taylor previously served as CEO of Health Stratica LLC and as an executive-in-residence at the Pittsburgh Life Sciences Greenhouse, where he focused on healthcare information technology and biotechnology mentorship to startup companies. He was vice president of corporate development for Cellumen Inc., a bio-tools/informatics company, and for its predecessor company, Cernostics Inc., a cancer molecular diagnostics company. Prior to these positions, Dr. Taylor was the global pharmaceutical and biotechnology market segment manager for Thermo Fisher Scientific Inc., where he led product marketing campaigns involving a sales team of more than 500 people and $400 million in revenue. He was the senior director of business development for Vivisimo, Inc., (acquired by IBM in 2012) providing artificial intelligence software to the pharmaceutical and biotech industries. Prior to Vivisimo, Dr. Taylor was the vice president of business development for Strategic Healthcare Programs, LLC (SHP),
Dr. Taylor’s research investigates mechanisms of breast cancer metastatic latency through computational models and human, 3D-perfused micro-scale tissue bioreactors. He explores different approaches for diagnostic and therapeutic treatment of quiescent lesions, and his research has helped suggest that targeting therapeutics to adjacent noncarcinoma cells is a viable strategy to treat metastatic disease. He has been published in leading journals such as Cancer Research, Stem Cell Research and Therapy, and Topics of Health Information Technology.
William R. 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.
INTERDISCIPLINARY TRANSLATIONAL PROJECTS PROGRAM