Public Workshop: Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval - Biographies
- Irving L. Weissman, M.D., is the Director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine and Director of the Stanford Ludwig Center for Cancer Stem Cell Research. Dr. Weissman was a member of the founding Scientific Advisory Boards of Amgen (1981-1989), DNAX (1981-1992), and T-Cell Sciences (1988-1992). He co-founded, was a Director, and chaired the Scientific Advisory Board at SyStemix 1988-1996, StemCells in 1996-present, and Cellerant in 2001-9.
His research encompasses the biology and evolution of stem cells and progenitor cells, mainly blood-forming and brain-forming. He is also engaged in isolating and characterizing the rare cancer and leukemia stem cells as the only dangerous cells in these malignancies, especially with human cancers. He discovered that all cancer stem cells express CD47, the ‘don’t eat me’ signal, to overcome prophagocytic signals that arise during cancer development, and has shown that blocking antibodies to CD47 have therapeutic potential for all tested human cancers. Finally, he has a long-term research interest in the phylogeny and developmental biology of the cells that make up the blood-forming and immune systems. His laboratory was first to identify and isolate the blood-forming stem cell from mice, and has purified each progenitor in the stages of development between the stem cells and mature progeny (granulocytes, macro-phages, etc.). At SyStemix he co-discovered the human hematopoietic stem cell and at StemCells, he co-discovered a human central nervous system stem cell. In addition, the Weissman laboratory has pioneered the study of the genes and proteins involved in cell adhesion events required for lymphocyte homing to lymphoid organs in vivo, either as a normal function or as events involved in malignant leukemic metastases.
Professor Weissman is a member of the National Academy of Sciences, the Institute of Medicine at the National Academy, and the American Association of Arts and Sciences. He has received many awards, including the Kaiser Award for Excellence in Preclinical Teaching, the Pasarow Award in Cancer Research, the California Scientist of the Year, the De Villiers International Achievement Award of the Leukemia Society of America, the Robert Koch Award, the Rosenstiel Award, The Max Delbruck Medal, and the Jessie Stevenson Kovalenko Award of the National Academy of Sciences. He is also the recipient of the 2004 New York Academy of Medicine Award for distinguished contributions to biomedical research, and has several honorary doctorates.
- Steven R. Bauer, Ph.D., is the Chief of the Cellular and Tissue Therapy Branch (CTTB), Division of Cellular and Gene Therapies (DCGT) in the Office of Cellular, Tissue, and Gene Therapies (OCTGT) at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA). As the Chief of CTTB, Dr. Bauer supervises CBER scientific staff engaged in review of cell-based biological therapies, policy development in emerging areas of cellular therapies, and research relevant to their use in clinical trials. His current research focuses on mesenchymal stem cell biology and stromal cell-hematopoietic cell interactions that influence development of lymphocytes. Dr. Bauer received his Ph.D. in Biochemistry from the University of Maryland in 1986. From 1986 through 1991, Dr. Bauer was a scientific member of the Basel Institute for Immunology in Basel, Switzerland. In 1991, Dr. Bauer joined CBER’s Division of Cellular and Gene Therapies.
- Jacques Galipeau, M.D., FRCP(C), is a Professor of Hematology and Medical Oncology at the University of Wisconsin in Madison. He obtained his Medical Degree from the University of Montreal in 1988 and completed specialty training in internal medicine at the McGill-affiliated Jewish General Hospital. He went on to the Tufts-affiliated New England Medical Center in Boston for three years of subspecialty training in Hematology and Oncology followed by a two-year scientific fellowship in gene Therapy at St-Jude Children’s research hospital in Memphis Tennessee. In his 12 year career at McGill University starting in 1997, he initiated and developed a research program in mesenchymal stromal cells (MSCs), cell and immunotherapy of catastrophic illnesses including cancer and immune disease. He relocated to Emory University in October 2009 where he established the Emory Personalized Immunotherapy Center [EPIC] whose mission was to develop evidence-based and innovative personalized cell therapies for immune and malignant disorders. He is an internationally recognized expert in translational development of MSC cell therapies and the sponsor of a series of FDA INDs examining the use of autologous marrow-derived mesenchymal stromal cells for immune disorders. As of September 1st, 2016, Dr. Galipeau is the inaugural director of the University of Wisconsin advanced cell therapy program and assistant dean for therapeutics discovery and development.
- Michael A. Matthay, M.D., is a Professor of Medicine and Anesthesia at the University of California at San Francisco and a Senior Associate at the Cardiovascular Research Institute. He is Associate Director of Critical Care Medicine. He received his AB from Harvard University and his MD from the University of Pennsylvania School of Medicine. He received an American Thoracic Society award for Scientific Achievement in 2002 and the UCSF Award for Outstanding Clinical Research in 2006, as well as the Lifetime Achievement Award in Mentoring at UCSF in 2013. He is a member of the American Association of Physicians.
Dr. Matthay’s basic research has focused on mechanisms of salt, water, and protein transport across the pulmonary alveolar epithelium that account for the resolution of pulmonary edema. He has also studied the pathogenesis and resolution of pulmonary edema and acute lung injury and the clinical counterpart, the acute respiratory distress syndrome (ARDS). His more recent research since 2005 has also focused on the biology and potential clinical use of allogeneic bone marrow derived mesenchymal stromal (stem) cells for ARDS in critically ill patients.
- Gregory Russotti, Ph.D., is currently Vice President of Technical Operations at Celgene Cellular Therapeutics in Warren, NJ, responsible for process development, analytical method development, clinical manufacturing, and quality control and quality operations.
Prior to joining Celgene in 2006, Greg spent nearly 15 years at Merck Research Laboratories developing products that included live virus vaccines, monoclonal antibodies, recombinant vaccines, and microbially-produced natural products. He worked on development, scale-up, and tech transfer of cell culture, microbial fermentation, and downstream isolation processes to clinical and commercial manufacturing facilities. Greg received his B.S. and M.S. degrees in Chemical Engineering from Rensselaer Polytechnic Institute and his Ph.D. in Chemical and Biochemical Engineering from Rutgers University.
- Dennis Clegg, Ph.D., earned his BS degree in biochemistry at UC Davis and his PhD in biochemistry at UC Berkeley, where he used emerging methods in recombinant DNA to study the sensory transduction systems of bacteria. As a Jane Coffin Childs Postdoctoral Scholar at UCSF, he studied neural development and regeneration. He has continued this avenue of research since joining the UCSB faculty, with studies of extracellular matrix and integrin function in the developing eye. His current emphasis is in stem cell research, with a focus on developing therapies for ocular disease. Dr. Clegg is the recipient of the UCSB Distinguished Teaching Award in the Physical Sciences, the UCSB Community Affairs Board Award, the National Eye Institute Audacious Goals award, and served as Chair of the Department of Molecular, Cellular and Developmental Biology from 2004-2009. He has been a Frontiers of Vision Research Lecturer at the National Eye Institute, a Keynote Lecturer at the Stem Cells World Congress, and a TEDx speaker. He is founder and Co-Director of the UCSB Center for Stem Cell Biology and Engineering, and has served on advisory boards for the California Institute for Regenerative Medicine and the National Institutes of Health Center for Regenerative Medicine. He is a Co-Principal Investigator of The California Project to Cure Blindness, a multi-disciplinary effort to develop a stem cell therapy for Age-Related Macular Degeneration.
- Christopher Breuer, M.D., is a Professor of Surgery at The Ohio State University. He serves as the Director of the Tissue Engineering Program and as Director of Surgical Research at Nationwide Children’s Hospital. Dr. Breuer is a Board certified Pediatric surgeon. He is a staff surgeon and member of the Division of Pediatric Surgery at Nationwide Children’s Hospital. Dr. Breuer runs a NIH funded laboratory that focuses on cardiovascular tissue engineering. His work is both basic and applied in nature. His basic science research is centered on investigating the cellular and molecular mechanisms underlying neotissue formation in cardiovascular tissue engineered constructs. His applied studies explore the use of tissue engineering technology for the development of improved vascular grafts and replacement heart valves for use in children. Dr. Breuer is the investigator-sponsor on a clinical trial evaluating the use of tissue engineered vascular grafts in congenital heart surgery. This study is evaluating the safety and growth potential of tissue engineered vascular graft in congenital heart surgery.
- Jonathan Kimmelman, Ph.D., is Associate Professor at McGill University in Biomedical Ethics Unit with a cross appointment in Experimental Medicine. His research centers on ethical, policy, and scientific dimensions of drug and diagnostics development, and he directs the Studies of Translation, Ethics and Medicine (STREAM). In addition to his book, Gene Transfer and the Ethics of First-in-Human Experiments (Cambridge Press, 2010), major publications have appeared in Science, PLoS Medicine, BMJ, and Hastings Center Report. Kimmelman received the Maud Menten New Investigator Prize (2006), a CIHR New Investigator Award (2008), and a Bessel-Humboldt Award (2014). He has served on various advisory bodies within the National Heart Lung and Blood Institute, the U.S. Institute of Medicine, and the Canadian Institutes for Health Research, and makes frequent appearances in the news media. He chaired the International Society of Stem Cell Research Guidelines for Stem Cell Research and Clinical Translation task force.
- Massimo Dominici, M.D., is a 44 year-old clinical scientist developing cell and gene therapy approaches for cancer patients. He received his MD degree at the University of Pavia (Italy) then internship, residency and post-doctoral training between the Institute of Haematology, Vienna University (Austria), the Division of Immuno-haematology, Ferrara University (Italy) and St Jude Children's Hospital, Memphis (USA). Later, he served as a hospital physician, associate professor of Medical Oncology, and head of the Laboratory of Cellular Therapies at the University of Modena (Italy). Dr. Dominici has published, or has in press, more than 100 papers on stem cells, tissue regeneration, experimental oncology, and hematology, with over 11200 citations and serves as co-editor, editorial board member, and referee of more than 50 scientific journals. He is the scientific founder of the University start-up Rigener and founder and scientific coordinator of the Mirandola Science & Technology Park. He has been co-founder of the Forum of Italian Researcher on MSC (FIRST), board member of JACIE, WBMT, and advisor for the Italian Minister of Health. Dr. Dominici has been a member of ISCT, ASH, ESCGT, IFATS, IPLASS and served as President of ISCT from 2014-2016. He is currently Chair of the ISCT advisory board and Chair of the ISCT presidential task-force on unproven cellular therapy.
- J. Peter Rubin, M.D., is Chair of the Department of Plastic Surgery, the UPMC Endowed Professor of Plastic Surgery, and Professor of Bioengineering at the University of Pittsburgh. He earned his undergraduate degree in biology from Grinnell College and his M.D. degree from Tufts University School of Medicine. He completed a residency training program in general surgery at Boston University/Boston City Hospital. He took time away from the clinic to pursue a two-year fellowship in surgical basic science at Massachusetts General Hospital/Harvard Medical School. During this research fellowship, he studied tissue engineering and transplantation immunology. After graduating from general surgery residency, he completed a three-year residency in plastic surgery at Harvard Medical School. He then joined the plastic surgery faculty at the University of Pittsburgh. He is a core faculty member in the McGowan Institute of Regenerative Medicine (MIRM).
Dr. Rubin is well recognized for his surgical skills and innovative solutions to complex reconstructive problems. In addition to his active clinical program, Dr. Rubin directs a basic science research program in the biology of adipose derived stem cells and serves as co-director of the Adipose Stem Cell Center at the University of Pittsburgh. He is the principal investigator in an NIH funded line of research aimed at developing cell based methods for clinical soft tissue reconstruction after cancer therapy. He directs a related line of research aimed at soft tissue reconstruction for injured military personnel as an investigator for the Department of Defense Armed Forces Institute for Regenerative Medicine (AFIRM). To facilitate the rapid translation of new technology, he founded the Center for Innovation in Restorative Medicine (CIRM) at the University of Pittsburgh. This “clinical accelerator” has a staff of experts in regulatory affairs, clinical trials implementation, and preclinical testing and has successfully taken new therapies through the IND and IDE process. He has moved his work from the laboratory to the clinic, and he is conducting clinical trials funded by the Department of Defense that are assessing new minimally invasive therapies to improve the lives of our wounded warriors.
His many scientific leadership positions include current Co-Chair of the American Society of Plastic Surgeons (ASPS) Task Force on Regenerative Medicine and Regulatory Chair for ASPS, 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. Dr. Rubin is the recipient of a Presidential Early Career Award for Scientists and Engineers (PECASE). The Presidential Award is the highest honor bestowed by the United States government on outstanding scientists and engineers early in their research careers. It is intended to recognize some of the finest scientists who show exceptional potential for leadership at the frontiers of scientific knowledge during the twenty-first century. He has served as editor for four textbooks, published over 130 peer reviewed articles, and presented over 300 invited lectures.
- Ms. Kristy Pottol is the Project Manager and Director of the Tissue Injury and Regenerative Medicine Project Management Office (TIRM PMO) at the US Army Medical Materiel Development Activity on Ft Detrick, MD. Ms. Pottol is a certified Defense Acquisition Professional Program Management Level 3 and Project Management Professional (PMP). She has worked in project management, biotechnology product development, FDA quality systems, business operations, and strategic communications for over 15 years and has an extensive and varied background in product development projects for militarily-relevant medical solutions from vaccines to devices. Ms. Pottol has recently taken on the additional responsibility as Program Manager for the Advanced Tissue Biofabrication Manufacturing Innovation Institute (ATB-MII).
Ms. Pottol spent six years in service, in the US Navy and Army National Guard. She holds a Master’s of Business Administration (MBA) from Regis University, a Masters of Science in Accounting with an emphasis on Information Systems from the University of North Carolina at Wilmington, and a Bachelor’s of Science in Physics with an emphasis in biophysics from East Carolina University.
The TIRM PMO is responsible to develop and deliver innovative products to restore form, function, and appearance for wounded warriors who have suffered catastrophic injuries. The project efforts range across many Defense-related regenerative medicine, prosthetics, and sensory projects spanning skin repair, extremity injury, craniomaxillofacial injury, vascularized composite allotransplantation (hand and face transplants), genitourinary injury, hearing loss, and assistive technologies. The ATB-MII is an $80 million effort by the Department of Defense to advance emerging manufacturing and testing industries that support tissue biofabrication and engineering. This is a national program with broad inter-agency support.
- Martha Lundberg, Ph.D., is a Program Director in the Advanced Technologies and Surgery Branch in the Basic and Early Translational Research Program in the Division of Cardiovascular Sciences at the National Heart, Lung, and Blood Institute (NHLBI). Her current portfolio includes human cell-based systems for cardiovascular regenerative medicine, smart polymer systems and biodegradable matrices, and technologies for tissue engineered blood vessels, heart valves and cardiac patches. Since joining the NHLBI in 2000, Martha has developed and advanced targeted investment in over a dozen research technology programs. She represents the NHLBI and the NIH at Congressional meetings, National scientific conferences, and other Trans-governmental activities, such as the Multi-Agency Tissue Engineering Science Interagency Working Group and the National Academy of Medicine’s Regenerative Medicine Forum. Martha received her Ph.D. in Medical Sciences from the Department of Medical Physiology at Texas A&M University Health Science Center in the College of Medicine. Her studies were one of the first to explore the interplay of extracellular matrix and mechanics on stretch-activated gene expression and vascular cell function. In 1995, Martha accepted the National Academy of Sciences Award from the National Research Council, which provided private research support at the National Institute on Aging (NIA) in Baltimore, MD. Martha’s work at the NIA focused on the regulation of vascular cell function and the delivery of survival signals to heart cells exposed to oxidative stress. She has received many academic and industrial awards for publishing on the mechanisms regulating cell death in the heart and the progression of atherosclerosis. Martha continued this research until joining the NHLBI Division of Cardiovascular Sciences in 2000.
- Jeffrey Kahn, Ph.D., is the Andreas C. Dracopoulos Director of the Johns Hopkins Berman Institute of Bioethics. He is also Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy, and Professor in the Department of Health Policy and Management in the Johns Hopkins University Bloomberg School of Public Health. His research interests include the ethics of research, ethics and public health, and ethics and emerging biomedical technologies; he speaks widely both in the U.S. and abroad, and has published four books and over 125 articles in the bioethics and medical literature. He is an elected Fellow of the Hastings Center, and has chaired or served on committees and panels for the National Institutes of Health, the Centers for Disease Control, and the Institute of Medicine/National Academy of Medicine, where he is currently chair of the Board on Health Sciences Policy. His education includes a BA in microbiology (UCLA, 1983), MPH (Johns Hopkins, 1988), and PhD in philosophy (Georgetown, 1989).
- Brian Mansfield, Ph.D., joined the Foundation Fighting Blindness as the Deputy Chief Research Officer in 2011. He assists the Chief Research Officer in directing the early translational research investment program for the Foundation, ensures implementation of the Foundation’s research strategic plan and manages day-to-day operation of the science department. A key activity is to maintain awareness of current research and development in the inherited orphan retinal degenerative diseases, identify the most promising new developments that might lead to treatments and cures for the inherited orphan retinal degenerative diseases, and then work with academic researchers, small biotech, large pharma, and venture capitalists to facilitate and accelerate translational research towards IND enabling studies. He also established and maintains oversight of an international, patient-driven, on-line registry (My Retina Tracker®) that tracks both the patient’s perspective and clinical perspective of their disease and its progression; to facilitate research, clinical trial enrolment, and increased understanding of the prevalence and genetic heterogeneity of the inherited orphan retinal degenerative diseases. Since 1992, Dr. Mansfield has also been an Adjunct Scientist with the NICHD, NIH, collaborating with Dr. Janice Chou on the molecular genetics of Glycogen Storage Disease Type I (GSD-I), now focused on gene therapy, which has received commercial support for clinical trials. Dr. Mansfield has served on the boards of several medical research foundations and editorial boards. He has over 80 peer reviewed publications.
- Thomas Albini, M.D., received a Bachelor of Arts degree, Magna Cum Laude, from Princeton University and a Doctor of Medicine degree from Johns Hopkins University School of Medicine. He completed an ophthalmology residency at Doheny Eye Institute of the University of Southern California. He then completed a uveitis clinical and research fellowship at Doheny Eye Institute and a vitreoretinal fellowship at Cullen Eye Institute of the Baylor College of Medicine. Dr. Albini currently is an Associate Professor of Clinical Ophthalmology at the Bascom Palmer Eye Institute in Miami, FL. He is a member of numerous professional and honorary societies, including the American Academy of Ophthalmology, the American Society of Retina Specialists, The Retina Society, the Macula Society, the American Uveitis Society and the International Uveitis Study Group. He is currently President of the Vit Buckle Society. He also served as Editor-in-Chief of the American Society of Retina Specialists’ web site for 4 years. Dr. Albini has received numerous awards including an Achievement Award from the American Academy of Ophthalmology and a Senior Achievement Award from the American Society of Retina Specialists. He has authored over 110 peer-reviewed articles on clinical and experimental topics in vitreoretinal disease and uveitis.
- Michael Miller, M.D., Ph.D., is a clinical fellow in neuropathology at Brigham and Women’s Hospital and Harvard Medical School in Boston, Massachusetts. He did his undergraduate studies at Grinnell College in Grinnell, Iowa, then worked on genetic imprinting with Karl Pfeifer at the National Institutes of Health (NICHD) before moving to Hanover, New Hampshire for MD/PhD training. His thesis, with Surachai Supattapone, focused on the mechanisms of formation and propagation of the unusual pathogens, infectious prions. He then moved to Boston for residency in Anatomic Pathology at Brigham and Women’s Hospital, followed by clinical fellowship in Neuropathology, where he is currently the senior fellow.