Appendix B
Speaker Biographical Sketches
Guillermo Ameer, D.Sc., is the Daniel Hale Williams Professor of Biomedical Engineering and Surgery in the Biomedical Engineering Department at the McCormick School of Engineering and the Department of Surgery at the Feinberg School of Medicine, Northwestern University. He is the founding director of the Center for Advanced Regenerative Engineering. Dr. Ameer received his bachelor’s degree in chemical engineering from The University of Texas at Austin and his doctoral degree in chemical and biomedical engineering from the Massachusetts Institute of Technology. His research interests include biomaterials, tissue engineering, regenerative engineering, on-demand patient-specific medical devices, controlled drug delivery, and bio/nanotechnology for improved therapeutics and diagnostics. Dr. Ameer’s laboratory pioneered the development and medical applications of citrate-based biomaterials. These materials have been adopted for various bioengineering applications by hundreds of researchers around the world. He has co-authored more than 250 peer-reviewed journal publications and conference abstracts, several book chapters, and more than 48 patents issued and pending in 9 countries. Several of his patents have been licensed to companies to develop medical products. Dr. Ameer is a fellow of the American Institute of Medical and Biological Engineering, a fellow of the Biomedical Engineering Society, and a fellow of the American Institute of Chemical Engineers. Dr. Ameer is an associate editor of the Regenerative Engineering and Translational Medicine journa; a member of the boards of directors of the Biomedical Engineering Society (BMES), the Regenerative Engineering Society, and the American Institute of Medical and Biological Engineering; a co-chair of the BMES diversity committee; and a member
of the scientific advisory board of Acuitive Technologies, Inc., a company that is bringing one of his technologies to the musculoskeletal surgery market. Dr. Ameer is also a co-founder of several medical device companies.
Stephen Badylak, D.V.M., Ph.D., M.D., is a professor in the departments of surgery and bioengineering and the deputy director of the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. Dr. Badylak has practiced both veterinary and human medicine, and is now fully engaged in research.
Dr. Badylak holds more than 60 U.S. patents and 300 patents worldwide, has authored more than 360 scientific publications and 50 book chapters, and recently edited a textbook entitled Host Response to Biomaterials. He has served as the chair of several study sections at the National Institutes of Health (NIH), and is currently a member of the College of Scientific Reviewers for NIH. Dr. Badylak has either chaired or been a member of the scientific advisory board to several major medical device companies. More than 8 million patients have been treated with bioscaffolds developed in Dr. Badylak’s laboratory.
Dr. Badylak is a fellow of the American Institute for Medical and Biological Engineering, a member of the Society for Biomaterials, a charter member of the Tissue Engineering Society International, a past president of the Tissue Engineering Regenerative Medicine International Society (TERMIS), and a founding international fellow of TERMIS.
Carl Burke, Ph.D., is currently involved in progressing novel platforms and technologies as part of BioTherapeutics Development at Janssen Research & Development and is involved in cell and gene therapy development. He previously led process and analytical development at Janssen Vaccines and earlier led drug product development for biologics and parenterals after joining Janssen. Dr. Burke previously worked in drug product development at Merck and developed live viral, bacterial, DNA, and polysaccharidebased vaccines as well as protein and RNA therapeutics. He has contributed to the licensure of many products and has been involved in all phases of development efforts as well as transfer and support of manufacturing processes.
Karen Christman, Ph.D., is a professor in the Department of Bioengineering and the associate dean for students in the Jacobs School of Engineering at the University of California, San Diego. She received her B.S. in biomedical engineering from Northwestern University in 2000 and her Ph.D. from the University of California, San Francisco, and, Berkeley, Joint Bioengineering Graduate Group in 2003, where she examined in situ approaches to myocardial tissue engineering. She was also a National Institutes of Health
(NIH) postdoctoral fellow at the University of California, Los Angeles, in the fields of polymer chemistry and nanotechnology. Dr. Christman joined the Department of Bioengineering in 2007 and is a member of the Institute of Engineering in Medicine at the University of California, San Diego. Her lab, which is housed in the Sanford Consortium for Regenerative Medicine, focuses on developing novel biomaterials for tissue engineering and regenerative medicine applications and has a strong translational focus, with the main goal of developing minimally invasive therapies for cardiovascular disease. Dr. Christman is a fellow of the American Heart Association and the American Institute for Medical and Biological Engineering, and has received several awards, including the NIH Director’s New Innovator and Transformative Research Awards, the Wallace H. Coulter Foundation Early Career Translational Research Award, the American Heart Association Western States Innovative Sciences Award, and the Tissue Engineering and Regenerative Medicine Society’s Young Investigator and Senior Scientist Awards. Dr. Christman is also co-founder of Ventrix, Inc., which has completed a phase I clinical trial and is currently planning a phase II trial with the cardiac extracellular matrix hydrogel technology developed in her lab at the University of California, San Diego.
Jennifer Elisseeff, Ph.D., is a professor in and the director of the Translational Tissue Engineering Center at the Johns Hopkins Department of Biomedical Engineering and the Wilmer Eye Institute with appointments in chemical and biological engineering, materials science, and orthopedic surgery. She was elected a fellow of the American Institute of Medical and Biological Engineering, a member of the National Academy of Inventors, and a Young Global Leader by the World Economic Forum.
Dr. Elisseeff received a bachelor’s degree in chemistry from Carnegie Mellon University and a Ph.D. in medical engineering from the Harvard University–Massachusetts Institute of Technology (MIT) Division of Health Sciences and Technology. Later she was a fellow at the National Institute of General Medical Sciences Pharmacology Research Associate Program, where she worked in the National Institute of Dental and Craniofacial Research. She has published more than 200 papers, book chapters, and patent applications and has received a number of awards, including the Carnegie Young Alumni Award. In 2002 she was named by MIT Technology Review as a top innovator under 35.
Dr. Elisseeff’s research focus is the development of biomaterials for regenerative medicine applications in orthopedics, plastic and reconstructive surgery, and ophthalmology. She is also now investigating the role of biomaterials-directed regenerative immunology and the role of the adaptive immune system in tissue repair. She is committed to the translation of regenerative biomaterials and has founded companies (Cartilix and
Aegeria) and has participated in a number of industry advisory boards (Kythera Biopharmaceuticals, Bausch and Lomb, Histogenics and Cellular Bioengineering).
Andrew Fesnak, M.D., is an assistant professor of clinical pathology in the Perelman School of Medicine at the University of Pennsylvania (Penn). He currently serves as the director of manufacturing in the Clinical Cell and Vaccine Production Facility (CVPF) at Penn. In that role he is responsible for overseeing the translation of pre-clinical work into clinical-scale cell manufacturing protocols. The CVPF has supported dozens of investigational new drugs, treated hundreds of patients, and manufactured thousands of clinical cell therapy products.
Dr. Fesnak is also a board-certified clinical pathologist and transfusion medicine physician who shares medical oversight of the blood bank, stem cell lab, and apheresis clinic. The Transfusion Medicine and Therapeutic Pathology division in the Department of Pathology and Laboratory Medicine at Penn is an active clinical service responsible for performing 10,000 procedures per year. Dr. Fesnak’s area of research interest is the intersection of transfusion medicine and cell therapy, particularly optimization of apheresis collection for downstream manufacturing.
Erik Finger, M.D., Ph.D., is a transplant surgeon and research scientist at the University of Minnesota with two main areas of study: immune tolerance and organ and tissue cryopreservation. In the first area he focuses on the translational application of regulatory T cells and other immunomodulatory cell therapies to allow transplantation without immunosuppression. In the second area he studies novel approaches for the cryopreservation of organs, tissues, and other biological materials. This approach has a broad range of potential applications—organ transplantation, regenerative medicine, cellular therapy, maintenance of biodiversity, aquaculture, and preservation of tissues for research application. As part of a multidisciplinary research effort, which includes transplant surgery, mechanical engineering, chemical engineering, chemistry, radiology, and other specialties, Dr. Finger and his colleagues have developed an approach for the indefinite storage of biologic substances in a stable vitrified (glass-like) state. Critical to this success has been the development of advanced technologies that allow the recovery of vitrified tissues from cryogenic temperatures with extremely rapid and homogeneous heating in an approach called nanowarming.
Flagg Flanagan has more than 30 years of experience in the medical device field as an entrepreneur, executive, and advisor. He currently serves as the chief executive officer and the chairman of the board for DiscGenics, a clinical-stage regenerative medicine company focused on developing regen-
erative therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. Early on in his career, Mr. Flanagan founded Flanagan Instruments and built it into a leading neurosurgical device distribution business specializing in microscopes, spine products, and biologics. He sold the company to Itochu International in 2005. Mr. Flanagan is currently on the boards of TrueVision Systems and the global advocacy organization Alliance for Regenerative Medicine, serves as a consultant to Leica MicroSystems, and recently sat on the board of Image Stream Medical until its 2017 acquisition by Olympus. He completed the Owner/President Management Program at Harvard Business School.
Allison Hubel, Ph.D., is a professor of mechanical engineering and the director of the Biopreservation Core Resource (BioCoR, www.biocor.umn.edu), a national resource in biopreservation. Dr. Hubel has studied both basic science and translational issues behind preservation of molecules, cells, and tissues. Her research focuses on the development of fit-for-purpose protocols for preservation, the development of technology to improve the preservation and processing of cells, and understanding the molecular mechanisms of damage during preservation. She has developed and offered professional short courses on the preservation of cell therapies and biospecimens. She has several patents in the area of preservation, some of which are being commercialized. She is a co-principal investigator for the National Institutes of Health–funded REACH program, which helps faculty commercialize their research at the University of New Mexico. She is a fellow of the American Society of Mechanical Engineers and the American Institute for Medical and Biological Engineering and is a National Blood Foundation Scholar. She has been honored recently with the Outstanding Achievement in Biobanking Award from the International Society for Biological and Environmental Repositories. She has published numerous articles related to preservation and is a former deputy editor of Biopreservation and Biobanking.
Peter Marks, M.D., Ph.D., received his graduate degree in cell and molecular biology and his medical degree at New York University and completed an internal medicine residency and hematology/medical oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the U.S. Food and Drug Administration in 2012 as deputy center director for the Center for Biologics Evaluation and Research and became the center director in January 2016.
George Muschler, M.D., is a professor of orthopaedics and a clinician–scientist at the Cleveland Clinic. His clinical and research practice integrates complex adult reconstructive surgery, the treatment of fracture non-union,
and cartilage repair in osteoarthritis. He also serves as the director of the Cleveland Clinic Joint Preservation Center, which seeks to advance biological therapies that preserve or restore joint function without surgery.
Dr. Muschler leads the Regenerative Medicine Laboratory at Cleveland Clinic, focusing on adult stem and progenitor cell biology and applications in quantitative clinical diagnostics, aging, gender variation, and tissue engineering. Dr. Muschler’s laboratory has been funded by the National Institutes of Health and the Department of Defense for more than 20 years.
As an institutional leader and mentor, Dr. Muschler served as the vice chair of the Cleveland Clinic Department of Bioengineering (2004–2013); the director of the Orthopaedic Research Center (2005–2013, embracing clinical and basic musculoskeletal research across 13 departments); and the vice chair of the Orthopaedic and Rheumatologic Institute (2007–2013, joining the departments of orthopaedics and rheumatology). Dr. Muschler has led the development of several multi-institutional collaborative translational networks, founding and leading the Ohio-based Clinical Tissue Engineering Center (2005–2012) and serving as the founding co-director of the Armed Forces Institute of Regenerative Medicine (2008–2011), a national network funded by the Department of Defense and dedicated to the accelerated development of improved therapies to serve wounded warriors. In addition to 27 years of orthopaedic surgery residents and fellows, Dr. Muschler has mentored more than 29 research postdocs and graduate students. He was the founding chairman of the Cleveland Clinic Bone, Cartilage, and Health Care Quality Innovation Summits (2004–2011). Dr. Muschler has also served in many committees within the American Academy of Orthopedic Surgeons (AAOS) and the Orthopaedic Research Society, most recently as the vice chair of the AAOS Performance Measures Committee. Dr. Muschler earned his undergraduate degree in chemistry at the University of Illinois in Champaign-Urbana and his M.D. at the Northwestern University School of Medicine in Chicago, Illinois. He completed his residency in orthopedic surgery at the University of Texas Southwestern in Dallas, Texas, and a musculoskeletal oncology fellowship at the Hospital for Special Surgery (1986–1988).
Michele Myers, Ph.D., is the senior director of cell process development for cell and gene therapies within GlaxoSmithKline’s (GSK’s) Platform and Technology Sciences Department. She played an important role as part of the team responsible for gaining approval of Strimvelis, an ex vivo gene therapy product for the treatment of adenosine deaminase severe combined immunodeficiency. Before joining the platform and technology sciences team, Dr. Myers worked in GSK’s global manufacturing and supply organization, where she supported commercial biopharmaceutical production, the development of production control strategies, and process validation.
Dr. Myers was previously an associate director at Johnson & Johnson, where she worked in support of REMICADE production, managed a group responsible for process development for a cell therapy product, and prepared regulatory filings in support of cell therapy programs. Dr. Myers is a certified Six Sigma Black Belt and holds a B.A. in biology from Temple University and a Ph.D. in biochemistry from The Pennsylvania State University.
Ivonne Hernandez Schulman, M.D., is a professor of clinical medicine in the Division of Nephrology and Hypertension and the fellowship program director at the Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami Miller School of Medicine. Dr. Schulman received her medical degree from the University of Miami. She completed her internship, residency, and nephrology clinical and research fellowships at University of Miami/Jackson Memorial Hospital and Veterans Affairs Medical Center and joined the University of Miami School of Medicine faculty in 2004. In addition to working as a clinical nephrologist and hypertension specialist, Dr. Schulman is a research scientist with expertise in cardiovascular and renal molecular biology, stem cell culture techniques, and the design and implementation of stem cell preclinical studies and clinical trials for the treatment of cardiovascular disease, chronic kidney disease, and frailty. Her laboratory at ISCI focuses on identifying the mechanisms underlying the cardiovascular regenerative capacity of stem cells. In a recent publication her laboratory demonstrated the critical role of oxygen concentration on the proliferation, senescence, and migration of cardiac stem cells, which has important implications for the production and development of stem cell therapies. Ongoing studies are examining the role of sex-related differences on adult stem cell function in an effort to bridge the gender gap in cardiovascular research and health disparities. Dr. Schulman has also developed a large animal model of chronic kidney disease–induced heart failure with preserved ejection fraction to study the safety, efficacy, and mechanisms of action of stem cells in kidney and cardiac functional recovery and structural repair. Using this model, her team is testing several strategies for cell-based therapeutics, investigating the mechanisms of action, and developing preclinical data to initiate clinical trials in patients. In addition, Dr. Schulman is a co-investigator in the National Institutes of Health–sponsored Cardiovascular Cell Therapy Research Network (CCTRN), which is conducting various clinical trials of stem cell therapy for heart and vascular diseases, and she has recently initiated a National Institutes of Health–sponsored clinical trial to study the effects of mesenchymal stem cell therapy on endothelial function in patients with type 2 diabetes. As the fellowship program director for ISCI, she oversees the recruitment as well as supervision and mentoring of the translational research investigators in the clinical research skills development program of the CCTRN.
David Stroncek, M.D., is the chief of the cell processing section in the Department of Transfusion Medicine at the National Institutes of Health (NIH) Clinical Center. The facility he oversees develops and manufactures a wide range of cell and gene therapies for NIH intramural program phase I and II clinical trials. The staff in the cell processing section developed and is validating a good manufacturing process method to produce autologous induced pluripotent stem cells (iPSCs) from blood and to differentiate the iPSCs into retinal pigment epithelial cells. The cell processing section is currently manufacturing chimeric antigen receptor T cells, lymphocyte engineered to express cancer associated antigen specific T cell receptors, dendritic cells, natural killer cells, and genetically modified hematopoietic stems cells. In addition, the facility processes hematopoietic stem cell grafts for transplantation.
Dr. Stroncek’s research is focused on investigating new measures of cell and gene therapy quality and potency and developing new manufacturing methods to improve the consistency and quality of cellular therapies cells. In the past he has served as the director of the human leukocyte antigen, red blood cell, platelet, and neutrophil immunology reference laboratories. He has also served as the medical director of the Blood Bank at the Department of Transfusion Medicine at the NIH Clinical Center and at the University of Minnesota Hospital and Clinics in Minneapolis, Minnesota.
Dr. Stroncek has a bachelor of science degree in chemical engineering from the University of Minnesota. He completed medical school, an internal medicine internship and residency, and a hematology and oncology fellowship at the University of Minnesota Medical School. He serves on the board of directors of the American Association of Blood Banks and is a past member of the U.S. Food and Drug Administration Blood Product Advisory Committee. He is editor of the cell, tissue, and gene therapy section of the Journal of Translational Medicine. He has more than 340 peer-reviewed articles in the fields of transfusion medicine, blood cell immunology, and cellular therapies.
Clive Svendsen, Ph.D., did his pre-doctoral training at Harvard University and received his Ph.D. from the University of Cambridge in England, where he then established a stem cell research group before moving to the University of Wisconsin in 2000 to became a professor of neurology and anatomy, the director of a National Institutes of Health–funded stem cell training program, and the co-director of the University of Wisconsin Stem Cell and Regenerative Medicine Center. In 2010 he moved to Los Angeles to establish and direct the Cedars–Sinai Regenerative Medicine Institute, which currently has 15 faculty members and approximately 100 staff. One focus of his current research is to derive cells from patients with specific disorders that can then be “reprogrammed” to a primitive state and used
as powerful models of human disease. Dr. Svendsen led the first groups to successfully model both spinal muscular atrophy and, more recently, Huntington’s disease using this technology. The other side of his research involves cutting-edge clinical trials. He was involved with one of the first growth factor treatments for Parkinson’s disease and is currently working closely with neurosurgeons, neurologists, and other scientists to develop novel ways of using stem cells modified to release powerful growth factors to treat patients with neurological diseases, such as amyotrophic lateral sclerosis, Huntington’s disease, Alzheimer’s disease, and Parkinson’s disease.
Joseph Wu, M.D., Ph.D., is the director of the Stanford Cardiovascular Institute and the Simon H. Stertzer Professor of Medicine (Cardiology) and Radiology at the Stanford School of Medicine. Dr. Wu received his M.D. from the Yale University School of Medicine. He trained in internal medicine and cardiology at the University of California, Los Angeles, followed by earning a Ph.D. in the Department of Molecular Pharmacology. His lab works on biological mechanisms of patient-specific and disease-specific induced pluripotent stem cells. The main goals are to (1) understand basic cardiovascular disease mechanisms, (2) accelerate drug discovery and screening, (3) develop a “clinical trial in a dish” concept, and (4) implement precision cardiovascular medicine for prevention and treatment of patients.
Dr. Wu has received numerous awards, including the National Institutes of Health (NIH) Director’s New Innovator Award (2008), NIH Roadmap Transformative Award (2009), American Heart Association (AHA) Innovative Research Award (2009), Presidential Early Career Award for Scientists and Engineers bestowed by President Obama (2010), AHA Established Investigator Award (2012), Burroughs Wellcome Foundation Innovation in Regulatory Science Award (2015), and AHA Merit Award (2017). Dr. Wu currently serves on the scientific advisory board for the Keystone Symposia (2014–2020); the Cellular, Tissue, and Gene Therapies Advisory Committee of the U.S. Food and Drug Administration (2017–2020); and the AHA national board of directors (2017–2019). He is the chair of the AHA Basic Cardiovascular Science Council (2018–2020) and of the AHA National Research Committee (2017–2019).
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