Regenerative Medicine: Transitioning Therapeutics from Cells to the Clinic

Organizers

Jane S. Lebkowski, PhD

Asterias Biotherapeutics

Jane Lebkowski has been actively involved in the development of cell and gene therapies since 1986 and is currently Chief Scientific Officer and President of R&D at Asterias Biotherapeutics Inc, where she is responsible for all preclinical product development of Asterias’ products. From 1998 to 2012, Dr. Lebkowski was Senior Vice President of Regenerative Medicine and Chief Scientific Officer at Geron Corporation. Dr. Lebkowski led Geron’s human embryonic stem cell program, being responsible for all research, preclinical development, product development, manufacturing, and clinical development activities. Prior to Geron, Dr. Lebkowski was Vice President of Research and Development at Applied Immune Sciences.  Following the acquisition of Applied Immune Sciences by Rhone Poulenc Rorer (RPR, currently Sanofi), Dr. Lebkowski remained at RPR as Vice President of Discovery Research. Dr. Lebkowski received her Ph.D. in Biochemistry from Princeton University in 1982, and completed a postdoctoral fellowship at the Department of Genetics, Stanford University in 1986. Dr. Lebkowski has published over 70 peer reviewed papers and has 13 issued U.S. patents. Dr. Lebkowski has served as the co-chair of the Industrial Committee of the International Society for Stem Cell Research and serves on several scientific advisory boards and other professional committees.

George Zavoico, PhD

JonesTrading Institutional Services LLC

George Zavoico is a Senior Equity Analyst, Healthcare, at JonesTrading Institutional Services, a leading equity trading firm with a focus on block trading and a growing capital markets business.  He has over 11 years of experience as a life sciences analyst writing research on publicly traded equities. His principal focus is on biotechnology, biopharmaceutical, specialty pharmaceutical, and molecular diagnostics companies. He received The Financial Times/Starmine Award two years in a row for being among the top-ranked earnings estimators in the biotechnology sector. In 2009, Zavoico was hired as the first equity analyst at MLV & Co., a New York-based boutique investment bank and institutional broker-dealer at the time, where he helped establish its Healthcare research team. He returned to MLV in mid-2014 after serving for a brief period as a Senior Equity Analyst at H.C. Wainwright & Co. in early 2014, and then joined JonesTrading in early 2015. Previously, Zavoico was an equity research analyst in the healthcare sector at Westport Capital Markets and Cantor Fitzgerald. Prior to working as an analyst, Zavoico established his own consulting company serving the biotech and pharmaceutical industries, providing competitive intelligence and marketing research, due diligence services and guidance in regulatory affairs. Zavoico began his career as a senior research scientist at Bristol-Myers Squibb Co., moving on to management positions at Alexion Pharmaceuticals Inc. and T Cell Sciences Inc. (now Celldex Therapeutics Inc.). Zavoico has a bachelor's degree in biology from St. Lawrence University and a PhD in physiology from the University of Virginia. He held post-doctoral fellowships at the University of Connecticut School of Medicine and Harvard Medical School/Brigham & Women's Hospital. He has published more than 30 papers in peer-reviewed journals and has coauthored four book chapters.

Sonya Dougal, PhD

The New York Academy of Sciences

Caitlin McOmish, PhD

The New York Academy of Sciences

Speakers

John F. DiPersio, MD, PhD

Washington University School of Medicine

Dr. John F. DiPersio, Deputy Director, Alvin J. Siteman Cancer Center and Chief of the Division of Oncology at Washington University School of Medicine in St. Louis and the Virginia E. and Samuel J. Golman Professor of Medicine. Dr. DiPersio’s research focuses on fundamental and translational aspects of leukemia and stem cell biology. These studies include identification of genetic abnormalities in human leukemias, understanding processes involving stem cell and leukemia cell trafficking, and clinical and translational programs in both leukemia/myelodysplastic syndrome and stem cell transplantation. Dr. DiPersio is Chair of ASH Scientific Committee on Hematopoiesis, a member of the Board of Scientific Counselors (Clinical Science and Epidemiology) of the National Cancer Institute, and the 2013 recipient of the Daniel P. Schuster Distinguished Translational Investigator Award from Washington University, the 19th Annual AACR Joseph H. Burchenal Memorial Award for Outstanding Achievement in Clinical Cancer Research in 2014 and the 2014 recipient of the American Society of Hematology Mentor Award for Clinical Investigations..  He has authored or co-authored more than 300 publications and over 60 invited reviews and book chapters. Dr. DiPersio received his M.D. and Ph.D. from the University of Rochester and his B.A. in Biology from Williams College.  He completed an internship and residency at Parkland Memorial Hospital and The University of Texas Southwestern Medical Center in Dallas. After serving as chief resident at Parkland Memorial Hospital, Dr. DiPersio completed a fellowship in the Division of Hematology/Oncology at the University of California, Los Angeles (UCLA).

Jonathan D. Glass, MD

Emory University School of Medicine

Jonathan D. Glass is Professor of Neurology and Pathology, and the Director of the Emory ALS Center in the Department of Neurology at Emory University in Atlanta, Georgia. He is widely known for his research on the pathogenesis and prevention of nerve degeneration in neurological diseases, and for his work in human and experimental neuropathology. His laboratory currently focuses on the causes of neurodegeneration in cellular and animal models of motor neuron disease, including the development of novel therapeutic interventions to prevent the death of neurons, nerve fibers, and the neuromuscular junction. Dr. Glass is the Principle Investigator for the ongoing clinical trial of intraspinal stem cell transplantation for ALS (Neuralstem). Dr. Glass is an active clinician who has been cited each year since 2001 as one of "America's Top Doctors" (Castle Connelly) and since 2005 as one of the very few neurologists in "Atlanta's Top Doctors" (Atlanta Magazine). He is also a teacher and mentor to young physicians and served as the director of Emory's Neurology residency program from 2001-2006. Dr. Glass received his undergraduate degree from Middlebury College (Vermont) and his MD from the University of Vermont.  He trained in Neurology and Neuropathology at Johns Hopkins, where he was a faculty member until moving to Emory in 1996.

Edward O. Lanphier

Sangamo BioSciences, Inc.

Edward Lanphier is the founder of Sangamo BioSciences, and has served as president, chief executive officer and a member of the Board of Directors since the company’s inception in 1995.  Sangamo BioSciences, Inc. is a leader in therapeutic genome editing and gene regulation. Edward has over 35 years of experience in the pharmaceuticals and biotechnology industry including 25 years in gene therapy and modified-cell therapies. He is currently the Chairman of the Alliance for Regenerative Medicine, the principle industry advocacy organization in the gene and modified-cell therapy space.  He is also a member of the Industry Advisory Board for the California Institute for Regenerative Medicine, the Dean’s Advisory Board of the University of Michigan School Of Public Health, a director of The Biotechnology Institute, and the Board of Trustees of The Buck Institute for Research on Aging.

Jane S. Lebkowski, PhD

Asterias Biotherapeutics

Jane Lebkowski has been actively involved in the development of cell and gene therapies since 1986 and is currently Chief Scientific Officer and President of R&D at Asterias Biotherapeutics Inc, where she is responsible for all preclinical product development of Asterias’ products. From 1998 to 2012, Dr. Lebkowski was Senior Vice President of Regenerative Medicine and Chief Scientific Officer at Geron Corporation. Dr. Lebkowski led Geron’s human embryonic stem cell program, being responsible for all research, preclinical development, product development, manufacturing, and clinical development activities. Prior to Geron, Dr. Lebkowski was Vice President of Research and Development at Applied Immune Sciences.  Following the acquisition of Applied Immune Sciences by Rhone Poulenc Rorer (RPR, currently Sanofi), Dr. Lebkowski remained at RPR as Vice President of Discovery Research.  Dr. Lebkowski received her Ph.D. in Biochemistry from Princeton University in 1982, and completed a postdoctoral fellowship at the Department of Genetics, Stanford University in 1986. Dr. Lebkowski has published over 70 peer reviewed papers and has 13 issued U.S. patents. Dr. Lebkowski has served as the co-chair of the Industrial Committee of the International Society for Stem Cell Research and serves on several scientific advisory boards and other professional committees.

Racheli Ofir, PhD

Pluristem LTD

Dr. Ofir is the VP of Research and Intellectual Property of Pluristem Ltd. Racheli Ofir holds a PhD from the Technion, Israel Institute of Technology, and a Masters in Law from Haifa University. Dr. Ofir has a broad professional experience in the field of human cell therapy as leading the research team in elucidating the therapeutic effect as well as the Mechanism of Action, Immunogenecity and in-vivo safety of Placenta derived cellular therapy. Dr. Ofir is the co-author of numerous peer reviewed articles and a co-inventor on numerous patents and patent applications in the field of cellular therapy.

Mahendra Rao, MD, PhD

Wake Forest University School of Medicine

Mahendra Rao received his MD from Bombay University in India and his PhD in Developmental Neurobiology from the California Institute of Technology. Mahendra Rao is wisely known for his research involving human embryonic stem cells (hESCs), iPSC, and other somatic stem cells. Dr. Rao and has worked in the stem cell field for more than twenty years with stints in academia, government and regulatory affairs and industry. Dr Rao is currently on the faculty at Wake Forest University and is the Vice president of Research in Regenerative Medicine at Q therapeutics. He currently serves on the Board of CESCA, XCell and Q therapeutics and on the SAB’s and as a consultant of various stem cell companies including the New York Stem Cell foundation. He continues to maintain an active research program in neural development and in evaluating cell based screening and therapy to treat disorders of the nervous system.

Thomas Schulz, PhD

ViaCyte, Inc.

Tom Schulz is the Director of ES Cell Technology & Scale Up of ViaCyte. He completed a PhD in Biochemistry and Molecular Biology from the University of Adelaide. From1997-2003 he held post-doctoral appointments at Tottori University, the NIH and the University of Georgia, prior to joining ViaCyte. Dr Schulz is the author and inventor of multiple articles and patents related to human embryonic stem cells and cellular therapy. He is a member of the International Society for Stem Cell Research.

John D. Sinden, PhD

ReNeuron Limited

John Sinden is Chief Scientific Officer of ReNeuron. From 1998 to 2015 he was a director of the ReNeuron companies. Prior to founding ReNeuron and becoming its first employee, he was Reader in Neurobiology of Behaviour at the Institute of Psychiatry at Kings College London. He graduated in Psychology from the University of Sydney and completed a Ph.D. in Neuroscience from the University of Paris at the College de France. He subsequently held post-doctoral appointments at Oxford University and the Institute of Psychiatry prior to joining the tenured staff of the Institute in 1987. Dr. Sinden is an Honorary Professor in the Faculty of Medical Sciences at University College London and has over 140 scientific publications and book chapters. He holds Fellowships of the Royal Society of Medicine and the Royal Society of Biology and is a member of the International Society for Stem Cell Research and the Expert Working Group on Cell and Gene Therapies for the Bioindustry Organization BioSafe Committee.

Katherine Tsokas, JD

Janssen Research & Development

Kathy Tsokas, JD, is responsible leading the Advanced Therapy Global Regulatory Affairs influencing activities across Janssen Research & Development, and is the Global Regulatory Leader for Janssen’s lead cell therapy project. Kathy has 25 years of global regulatory experience in both small and large sized Pharma companies.  She has worked on products in various therapeutic areas and at all stages of development, from early through to filing, approval and commercialization. Kathy has been with J&J for 8 years.  She has held several roles during this time including Global Regulatory Lead for the Research and Early Development (RED) units.  Currently, her responsibilities include providing strategic regulatory oversight to advanced therapy projects in several therapeutic areas by ensuring regulatory strategies contribute to and support the development plans for the products and that all opportunities for collaboration internally and externally are utilized.  Importantly, Kathy leads efforts internally and externally to enhance awareness and connectivity to influence the development of processes and regulatory pathways that enable the global development and commercialization of safe and effective advanced therapeutics. Kathy participates in discussions with global Health Authorities through internal project work and external collaborations. In addition, she represents Global Regulatory Affairs on the J&J First in Human Committee. Kathy is the Chair for the Alliance for Regenerative Medicine (ARM) Regulatory Committee, and a member of the ARM Government Affairs, and the Science and Technology Committees.  She is a frequent speaker at advanced therapy conferences and is a collaborator on planning programs in advanced therapy. Kathy received her Bachelor of Science Biology from Temple University, Juris Doctorate from Widener University Law School, and is admitted to the practice of law in Pennsylvania and New Jersey.