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Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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Appendix B

Speaker Biographical Sketches

Steven R. Bauer, Ph.D., is the chief of the Cellular and Tissue Therapy Branch (CTTB), Division of Cellular and Gene Therapies in the Office of Tissues and Advanced Therapies at the Center for Biologics Evaluation and Research (CBER) in the U.S. Food and Drug Administration. 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 the 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.

Robert Deans, Ph.D., is the chief technology officer at BlueRock Therapeutics, a biotechnology company creating innovative cell therapeutics by harnessing gene editing tools and pluripotent stem cell biology. Prior to joining BlueRock, he was the chief scientific officer at Rubius Therapeutics, a red cell therapeutics platform company. Dr. Deans was previously the executive vice president at Athersys, Inc., an adult stem cell therapeutics company now in late-stage clinical development, and prior to that the vice president of research at Osiris, Inc., developing the Prochymal MSC-based product line. Dr. Deans was also experienced in hematopoietic stem cell isolation and gene therapy while director of the Immunotherapy Division of Baxter

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

Healthcare. Dr. Deans has also contributed to numerous regulatory and industry commercialization workshops and societies.

Adrian Gee, Ph.D., received his bachelor’s degree from the University of Birmingham, England, and his Ph.D. from the University of Edinburgh, Scotland. He did his postdoctoral training at the National Institutes of Health and the University of Toronto before taking a faculty position at the University of Florida. There he performed some of the first applications of immunomagnetic tumor purging in the United States, and his laboratory became a central cell processing facility for this procedure. He joined Baxter Healthcare in 1987, where he worked on the development of the MaxSep and Isolex magnetic cell separators. He co-founded the International Society for Hematotherapy and Graft Engineering (now ISCT) and the Journal of Hematotherapy (now Cytotherapy) in 1992. From 1992 to 1997 he helped establish the stem cell transplantation program at the University of South Carolina. He then directed the Cell Processing Laboratory at The University of Texas MD Anderson Cancer Center until 1999, when he joined the Center for Cell and Gene Therapy at Baylor College of Medicine in Houston. He was involved in the development of standards for the collection processing and transplantation of hematopoietic stem cells for the Foundation for the Accreditation of Cell Therapy (FACT), the AABB, and the National Marrow Donor Program. He has written more than 180 scientific articles and has authored and edited a number of books on graft engineering and stem cell processing. He currently is a member of the Health Resources and Services Administration committee on Blood Stem Cell Transplants, the FACT committee on Regenerative Medicine, and the Program Review Group for the California Institute of Regenerative Medicine. He received the FACT Career Achievement Prize in 2017.

Dean Kamen is an inventor, an entrepreneur, and a tireless advocate for science and technology. His roles as inventor and advocate are intertwined—his own passion for technology and its practical uses has driven his personal determination to spread the word about technology’s virtues and by so doing to change the culture of the United States.

As an inventor, he holds more than 440 U.S. and foreign patents, many of them for innovative medical devices that have expanded the frontiers of health care worldwide. While still a college undergraduate, he invented the first wearable infusion pump, which rapidly gained acceptance from such diverse medical specialties as oncology, neonatology, and endocrinology. In 1976 he founded his first medical device company, AutoSyringe, Inc., to manufacture and market the pumps. Then, working with leading diabetes researchers, Mr. Kamen pioneered the design and adoption of the first portable insulin pump. It was quickly demonstrated that using a pump could

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

much more effectively control patients’ blood glucose levels. At age 30 he sold AutoSyringe to Baxter Healthcare Corporation.

Following the sale of AutoSyringe, Inc., he founded DEKA Research & Development Corporation to develop internally generated inventions as well as to provide research and development for major corporate clients. Mr. Kamen led DEKA’s development of the HomeChoice™ peritoneal dialysis system for Baxter International Inc. The HomeChoice™ system allows patients to be dialyzed in the privacy and comfort of their home and quickly became the worldwide market leader. Mr. Kamen also led the development of technology to improve slide preparation for the CYTYC (now Hologic Inc.) ThinPrep® Pap Test. Kamen-led DEKA teams have also developed critical components of the UVARTM XTSTM System, an extra-corporeal photophereisis device marketed by Therakos, a unit of Johnson & Johnson, for treatment of T cell lymphoma. An advanced prosthetic arm in development for DARPA should advance the quality of life for returning injured soldiers. Other notable developments include the Hydroflex™ surgical irrigation pump for C.R. Bard; the Crown™ stent, an improvement to the original Palmaz-Schatz stent, for Johnson & Johnson; the iBOT™ mobility device; and the Segway® Human Transporter.

Mr. Kamen has received many awards for his efforts. Notably, he was awarded the National Medal of Technology in 2000. Presented by President Clinton, this award was in recognition for inventions that have advanced medical care worldwide and for innovative and imaginative leadership in awakening America to the excitement of science and technology. Kamen was also awarded the Lemelson–Massachusetts Institute of Technology Prize in 2002, and was inducted into the National Inventors Hall of Fame in May 2005. He is a fellow of the American Institute for Medical & Biological Engineering and has been a member of the National Academy of Engineering since 1997. In 2010 Mr. Kamen hosted the Planet Green television series Dean of Invention. In addition to DEKA, one of Mr. Kamen’s proudest accomplishments is founding FIRST® (For Inspiration and Recognition of Science and Technology), an organization dedicated to motivating the next generation to understand, use and enjoy science and technology. Founded in 1989, this year FIRST® will serve more than 1 million young people ages 6 to 18 in more than 86 countries around the globe. Last year, high-school-aged participants were eligible to apply for more than $50 million in scholarships from more than 200 leading colleges, universities, and corporations.

Linda Kelley, Ph.D., is the Cell Therapy Facility director and a senior member at Moffitt Cancer Center as well as a professor at the University of South Florida. Dr. Kelley has provided leadership for cellular therapy facilities for more than 20 years at three institutions: University of Utah,

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

Dana Farber Cancer Institute, and Moffitt Cancer Center. She received graduate and postdoctoral training in immunology and hematology from Vanderbilt University in Nashville, Tennessee. Her scientific career evolved from a fundamental interest in immunological mechanisms of T lymphocyte function, the growth mechanisms of hematopoietic stem and progenitor cells, and the molecular changes associated with malignant transformation. Knowledge of the hematopoietic system led to an interest in stem cell biology and therapies. As the director of the Cell Therapy Facility at the University of Utah from 1994 to 2011, she was responsible for developing and expanding a Cell Therapy and Regenerative Medicine Laboratory. During her tenure she was responsible for pre-clinical and clinical cell therapy product development to support investigational new drug (IND) applications for the production of allogeneic mesenchymal stromal cells (MSCs), autologous bone marrow-derived mononuclear cells, and allogeneic fetal-derived oligodendrocytes. As director of the Cell Manipulation Core Facility at the Dana Farber Cancer Institute at Harvard from 2011 to 2012, she oversaw management of 20 FDA-approved INDs for the manufacture of gene-modified CD34+ cells, tumor cell vaccines, dendritic cells, MSCs, and others. As director of the Cell Therapy Facility at Moffitt Cancer Center, she oversees 22 active INDs for a variety of products largely to support immunotherapy for adult and pediatric patients. She currently serves as the principal investigator for production assistance for cellular therapies–cell processing facilities to perform pre-clinical cell therapy product development in collaboration with the National Heart, Lung, and Blood Institute and other Production Assistance for Cellular Therapies Centers and as core laboratory technical director for the Moffitt Cancer Center Support Grant. Dr. Kelley excels at bridging the gap between laboratory-based discoveries and new therapies for patients.

Bruce Levine, Ph.D., the Barbara and Edward Netter Professor in Cancer Gene Therapy, is the founding director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. He received a B.A. in biology from the University of Pennsylvania and a Ph.D. in immunology and infectious diseases from the Johns Hopkins University. The CVPF develops and tests novel cell and gene therapies in clinical trials in patients with hematologic malignancies, solid tumors, HIV infection, and genetic disease. First-in-human trials include the first use of a lentiviral vector, the first infusions of gene edited cells, and the first use of lentivirally modified cells to treat cancer. Dr. Levine has overseen the production, testing, and release of 2,700 cellular products administered to more than 1,000 patients in clinical trials since 1996. Through these technologies, personalized and enhanced immunity

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

has been engineered. T lymphocytes from HIV+ subjects have been rendered resistant to HIV infection and reinfused. T lymphocytes from cancer patients have been redirected with chimeric antigen receptors to hunt and destroy their malignancies, an investigational therapy that received the first Breakthrough Designation from the U.S. Food and Drug Administration for an academic institution and is currently in commercial development. Dr. Levine is co-inventor on 23 issued U.S. patents and co-author of 130 publications with a Google Scholar citation h-index of 66. He has been interviewed by The New York Times, The Wall Street Journal, National Geographic, Forbes, BBC, and other international media outlets.

Robert McBurney, Ph.D., is the chief executive officer of the Accelerated Cure Project for Multiple Sclerosis and a co-principal investigator for the iConquerMS™ Patient-Powered Research Network. In a career spanning more than 35 years, Dr. McBurney has conducted basic and clinical research and managed research groups for drug discovery, personalized medicine, and clinical decision support systems at medical schools, research institutes, biopharmaceutical companies, and nonprofit organizations in Australia, the United Kingdom, and the United States.

Dr. McBurney is currently a member of the American Academy of Neurology, the Society for Neuroscience, the PhRMA Foundation Informatics Advisory Committee, and the International Society for Pharmacoeconomics and Outcomes Research. He is also a trustee emeritus of the F.W. Olin College of Engineering. Dr. McBurney received B.Sc. and Ph.D. degrees from the University of New South Wales, Australia.

Laura Niklason, M.D., Ph.D., is the Nicholas M. Greene Professor at Yale University in anesthesia and biomedical engineering, where she has been on faculty since 2006. Dr. Niklason’s research focuses primarily on regenerative strategies for cardiovascular and lung tissues. Her engineered blood vessels are currently in clinical trials and are the first life-sustaining engineered tissue to be studied in any Phase III trial. Dr. Niklason’s lab was also one of the first to describe the engineering of whole lung tissue that could exchange gas in vivo, and this work was cited in 2010 as one of the top 50 most important inventions of the year by Time magazine. She was inducted into the National Academy of Inventors in 2014 and was elected to the National Academy of Medicine in 2015.

Dr. Niklason received her Ph.D. in biophysics from the University of Chicago and her M.D. from the University of Michigan. She completed her residency training in anesthesia and intensive care unit medicine at the Massachusetts General Hospital in Boston and completed postdoctoral scientific training at the Massachusetts Institute of Technology.

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

Anne Plant, Ph.D., received her Ph.D. from Baylor College of Medicine in Houston, Texas, in Biochemistry. She is the chief of the Biosystems and Biomaterials Division at the National Institute of Standards and Technology (NIST). She served for 1 year in the White House Office of Science and Technology Policy and is currently the NIST representative to the National Science and Technology Council (NSTC) Life Science Sub-Committee. She serves on the National Institute of Biomedical Imaging and Bioengineering’s National Advisory Council for Biomedical Imaging and Bioengineering, co-chairs ASTM International Committee F04.46 on Standards for Cell Signaling, and is on the editorial advisory board of the journal Biointerphases. She is a fellow of the American Institute for Medical and Biological Engineering. Her research has recently been focused on the robust quantification of cell response through quantitative cell imaging and theoretical approaches for the prediction of complex biological response.

Robert Preti, Ph.D., is the co-founder of PCT and the visionary behind its successful growth and development strategy over much of the last two decades. Upon PCT’s acquisition by Hitachi Chemical Co. America, Ltd. (Hitachi Chemical’s consolidated subsidiary) in May 2017, Dr. Preti’s role expanded to chief executive officer and president of PCT, responsible for development, management, and oversight of the global business operations of Hitachi Chemical’s regenerative medicine business unit. Dr. Preti is currently the chairman of the Alliance for Regenerative Medicine (ARM). He holds a B.S. in biology from Fordham University and an M.S. and doctorate, both in biology, from New York University.

Dr. Preti built PCT to meet a recognized need for high-quality manufacturing and development services in an emerging industry. As the cell therapy field has grown, so too has PCT. The company has now served more than 100 clients and performed more than 20,000 cell therapy procedures. His leadership has been instrumental in creating PCT’s client-focused model which helps bridge the gap between discovery and patient care through the efficient transfer of cell-based therapies from laboratory into clinical practice. His vision for PCT includes expansion of its manufacturing capacity in the United States, Asia, and Europe as well as the development of new technological and engineering innovations that will help streamline and automate many cell processing techniques, leading to faster scale-up, appropriate cost of goods, and robust quality for the industry.

Rodney Rietze, Ph.D., began his graduate training in regenerative medicine in the laboratory of Samuel Weiss (director, Hotchkiss Brain Institute), who is credited with the discovery of adult neural stem cells (NSCs). After completing a master’s degree on the role these cells played in adult hippocampal neurogenesis, he moved to the laboratory of Perry Bartlett (Walter and Eliza

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

Hall Institute of Medical Research, Melbourne) and focused his studies on the successful purification of an adult mammalian NSCs. His doctoral work enabled the direct interrogation of this elusive population and opened the door to uncovering the biology that underpins this highly regenerative population of cells. As a founding faculty member of the Queensland Brain Institute (Brisbane, Australia) and principal investigator of the Neural Stem Cell and Aging Laboratory, Dr. Rietze continued to investigate the biology of adult NSCs, cumulating with the discovery of the essential role that growth hormone receptor signaling plays in stimulating endogenous precursors and reversing age-related cognitive decline.

In 2008 Dr. Rietze abandoned academic pursuits to join the newly created Pfizer regenerative medicine unit (Cambridge, UK), where he led research teams in the development of both small molecule and cell-based therapeutics for a variety of neural, autoimmune, and cardiovascular indications. Following the closure of Pfizer’s Sandwich facility, Dr. Rietze was recruited by the technical research and development team at Novartis’s Cell and Gene Therapy Unit (CGTU) in Cambridge, Massachusetts, to lead process automation and deliver innovative and enabling technologies for the manufacture of cell-based therapeutics across the unit’s portfolio. In 2016 Dr. Rietze transitioned from CGTU to the exploratory immuno-oncology group at Novartis Institutes for Biomedical Research, where he continues to develop novel CAR T-based technologies and therapeutics under the direction of Glenn Dranoff.

Isabelle Rivière, Ph.D., received her Ph.D. in cellular and molecular biology from the University of Paris. She initiated her graduate studies at the Institut Curie in Paris and completed her thesis in the laboratory of Richard Mulligan at the Whitehead Institute in Cambridge, Massachusetts. During this time, she developed novel retroviral vectors to investigate the in vivo long-term expression of transgenes in hematopoietic cells using MFG/SFG-based retroviral vectors. These vectors are widely used in clinical studies for the treatment of genetic and acquired disorders. She subsequently worked as a postdoctoral fellow in the laboratory of Dan Littman at New York University. Her studies focused on the regulation of cytokines produce by T helper lymphocytes in vivo.

Dr. Rivière joined the faculty of Memorial Sloan Kettering Cancer Center in 1999. She is currently the director of the Michael G. Harris Cell Therapy and Cell Engineering laboratory where she investigates the genetic modification of hematopoietic cells to increase or retarget the immune response against tumors and to treat genetic disorders. Her laboratory has developed cell manufacturing processes under GMP conditions for several Phase I/II clinical trials in the academic setting. She actively participates in the National Cell Manufacturing Consortium workshop that led to the

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

establishment of the Technology Roadmap to 2025 for Achieving Large Scale, Cost effective, Reproducible Manufacturing of High-Quality Cells. She is a member of the board of directors of the American Society of Gene and Cell Therapy, the Alliance for Regenerative Medicine, and the Center for Commercialization of Cancer Immunotherapy (Canada). She is also an active member of the International Society of Cell Therapy and the International Society of Stem Cell Research.

Katherine A. Tsokas, J.D., is the senior director of Global Regulatory Affairs at Johnson and Johnson. She has 26 years of progressive global regulatory experience in small- and large-sized pharmaceutical companies. She has worked on products at various stages of development, from early through to filing, approval, and commercialization. Currently, her responsibilities include providing strategic regulatory oversight to advanced therapy projects in several therapeutic areas by ensuring that regulatory strategies contribute to and support the development plans for the products and that all opportunities for collaboration internally and externally are used. Furthermore, through the RMAT Network, Ms. Tsokas leads Johnson & Johnson cross-sector efforts to enhance awareness and connectivity for the development of processes that enable assessing, partnering, and developing safe and effective advanced therapies globally. In addition, she represents global regulatory affairs on the Johnson & Johnson First in Human Committee. Ms. Tsokas received her bachelor of science degree in biology from Temple University and a juris doctorate from Widener University Law School and is admitted to the practice of law in Pennsylvania and New Jersey.

Philip Vanek, Ph.D., is the general manager of GE Healthcare’s Cell Therapy Technologies business strategy, a business initiative funded in part by GE Healthymagination, a $6 billion strategy to revolutionize the world’s health by improving the quality, access to, and affordability of care. Prior to joining GE, Dr. Vanek was the head of innovation for Lonza’s pharmaceutical division, leading a group of research scientists, process development engineers, and commercial strategists to drive new technology initiatives focused on cell, protein, and viral therapeutic manufacturing.

Dr. Vanek’s career has included a number of senior innovation, business, and market development roles at Becton Dickinson, Invitrogen, and Life Technologies as well as two start-up biotechnology companies in the Washington, DC, area.

Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 89
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 90
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 91
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 92
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 93
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 94
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 95
Suggested Citation:"Appendix B: Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 96
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On June 26, 2017, the Forum on Regenerative Medicine hosted a public workshop in Washington, DC, titled Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies in order to examine and discuss the challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. The goal of the workshop was to learn from existing examples of the manufacturing of early-generation regenerative medicine products and to address how progress could be made in identifying and measuring critical quality attributes. The workshop also addressed the challenges of designing and adhering to standards as a way of helping those who are working to scale up processes and techniques from a research laboratory to the manufacturing environment. This publication summarizes the presentations and discussions from the workshop.

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