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Stem Cell Summit

2017-11-182018-01-122017-12-12
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The 2018 speakers list is currently being formed.

Please come back and visit this page for updates.

BELOW IS THE SPEAKERS LIST FROM 2017.

PLENARY KEYNOTE SPEAKERS
Lee Rubin

Lee Rubin
Professor and Director of Translational Medicine
Harvard University and the Harvard Stem Cell Institute
Lee Rubin
Professor and Director of Translational Medicine
Harvard University and the Harvard Stem Cell Institute
 
About Speaker:

Dr. Rubin has a broad experience in both academia and industry, particularly in the realms of cell-based assays and drug discovery. Prior to coming to Harvard, he was Chief Scientific Officer of Curis, Inc., a Cambridge-based biotechnology company, where his group identified the first small molecule regulators of the hedgehog signaling pathway. One of these antagonists was developed by Genentech and is now (as Erivedge) approved as the first oral treatment for metastatic basal cell carcinoma.

At Harvard, much of his work is focused on finding key molecular mediators of different neurodegenerative diseases and on searching for effective preclinical therapeutic candidates. His research takes advantage of his group’s ability to produce large numbers of patient-derived induced pluripotent stem cell lines and of effective means of deriving differentiated neurons from them. They have set up an array of techniques that allow them to identify early cellular and physiological changes in neurons as they become diseased. For example, they have identified new targets for the treatment of the motor neuron disorders Spinal Muscular Atrophy and Amyotrophic Lateral Sclerosis. They are also studying Psychiatric disorders, Parkinson’s disease and Alzheimer’s disease. Recently, his group discovered that a circulating protein, GDF11, has the ability to reverse some of the changes in the CNS associated with aging. They are actively exploring the therapeutic implications of these observations as well.   Dr. Rubin received his PhD in neuroscience from the Rockefeller University and had postdoctoral training, also in Neuroscience, at Harvard Medical School and Stanford University School of Medicine.

 

Donna Skerrett

Donna Skerrett
Chief Medical Officer
Mesoblast
Donna Skerrett
Chief Medical Officer
Mesoblast
 
About Speaker:

Dr. Skerrett has practiced Transfusion Medicine and Cellular Therapy at New York institutions for close to two decades. In 2004, a research collaboration led to her involvement in regenerative medicine and her subsequent role as a founding contributor to Mesoblast. In her current role as Chief Medical Officer, she provides strategic insight and direction to the development of cell-based therapies for tissue repair and the modulation of pathological immune responses. Dr. Skerrett provided the medical and regulatory oversight that led to the first clinical studies of allogeneic mesenchymal precursor cells for tissue repair indications. Under her medical direction, clinical development has advanced to several global phase 3 programs and noted partnering and licensing deals.  She advocates rigorous science underpinned by a genuine commitment to alleviate the suffering associated with many serious medical conditions to guide the development of these potentially transformative therapies. Dr. Skerrett understands the value of medical and business communications with investors, diligence partners and stakeholders at large. In addition to her role with Mesoblast, Dr. Skerrett is an Executive Board member with the Alliance of Regenerative Medicine and until recently (June 2016) chaired the NYS Department of Health Council of Blood and Transfusion Services. Dr. Skerrett, a graduate of Temple University School of Medicine, is a member of the Board of Visitors for that institution, and is on the   Board of Directors of Fox Chase Cancer Center.  Dr. Skerrett is a founding board member of Mount Vernon Star Scholars- a community organization that mentors high school students.

Michael D. West

Michael D. West
Chief Executive Officer
BioTime, Inc.
Michael D. West
Chief Executive Officer
BioTime, Inc.
 
About Speaker:

Michael West joined BioTime (BTX) as CEO in 2007 and become co-CEO in October 2015. He has served on the company’s board of directors since 2002, and also serves on the board of BioTime affiliate Asterias Biotherapeutics (AST). He was previously CEO and CSO of Advanced Cell Technology, which, as Ocata Therapeutics, was acquired by Astellas Pharma of Japan in early 2016. 

In 1990 Dr. West founded Geron (GERN), which may have been the first regenerative medicine company. He secured funding for Geron from venture capital firms Kleiner Perkins Caufield & Byers, Venrock and others, and for the company’s Scientific & Clinical Advisory Board he recruited Nobel Laureates Drs. Carol Greider and James Watson, as well as Leonard Hayflick and others. While at Geron Dr. West also organized and managed the research between Geron and its academic collaborators Drs. James Thomson and John Gearhart that led to the first isolation of human embryonic stem cells.

Dr. West received a B.S. from Rensselaer Polytechnic Institute in 1976, an M.S. in Biology from Andrews University in 1982, and a Ph.D. from Baylor College of Medicine in 1989, with a concentration on the biology of cellular aging.

PLENARY SPEAKERS
Scott R. Burger

Scott R. Burger
Principal
Advanced Cell & Gene Therapy
Scott R. Burger
Principal
Advanced Cell & Gene Therapy
 
About Speaker:

Scott R. Burger, MD, is the Principal of Advanced Cell and Gene Therapy, a consulting firm specializing in cell and gene therapy product development, manufacturing, and regulatory affairs. Dr. Burger has over 25 years of experience developing cell and gene therapy products and has consulted for over 100 industry and academic clients in North America, Europe, Asia, and Australia. He has directed or consulted on process development, manufacturing, and regulatory aspects of a wide range of cell therapy and gene therapy products, including CAR T-cells, gene-edited cells, dendritic cell vaccines, natural killer (NK) cells, and other immunotherapies, hematopoietic stem cells (HSCs) from bone marrow, blood, umbilical cord blood, and regenerative medicine products such as mesenchymal stem cells (MSCs), chondrocytes, pancreatic islet cells, and other somatic cell therapies. Prior to founding Advanced Cell & Gene Therapy in 2002, Dr. Burger was Vice-President for R&D at Merix Bioscience, and director of the University of Minnesota Cell Therapy Clinical Laboratory. His regulatory background includes numerous IND and IDE submissions and productive interactions with FDA-CBER Office of Tissues and Advanced Therapies (OTAT, formerly the Office of Cellular, Tissue and Gene Therapies, OCTGT). Dr. Burger is a member of several scientific advisory boards, and has served on the USP Cell, Gene and Tissue Therapies Expert Committee, the ISCT advisory board and ISCT committees on gene therapy, regulatory affairs, commercialization, and product/process development. A graduate of the University of Pennsylvania School of Medicine, Dr. Burger completed training in clinical pathology and transfusion medicine at Washington University in St. Louis, and is author of over 200 scientific publications and presentations, and recipient of numerous honors and awards.

John Campbell

John Campbell
Associate Director, Research, Development & Innovation
SNBTS, National Science Laboratory
John Campbell
Associate Director, Research, Development & Innovation
SNBTS, National Science Laboratory
 
About Speaker:

Professor John Campbell is Associate Director of Research and Development at the Scottish National Blood Transfusion Service (SNBTS) in Edinburgh. He completed his PhD in Pathology at Edinburgh in 1995 on the immunopathogenesis of lymproliferative disease, and has worked in the cellular therapy field for over 20 years in academic and industry positions. He is currently the national head of research for SNBTS and holds academic appointments at the Universities of Glasgow and Edinburgh. SNBTS has a substantial cellular therapy research programme, with over 40 full time scientists working on basic cellular function; translation of laboratory protocols to full GMP processes; and production of cellular therapeutics for treatment of patients. SNBTS has a dedicated, fully MHRA licensed, GMP cellular therapy production centre at the Scottish Centre for Regenerative Medicine. This GMP manufacturing and development capacity will be substantially increased when SNBTS moves to the Jack Copland Centre, Edinburgh, in early 2017. Cellular therapeutics in development and early phase clinical trials include, mesenchymal stromal cells, corneal limbal stem cells, macrophages for tissue repair and virus -specific T Lymphocytes.

Melody Eble

Melody Eble
Director, Global Regulatory Affairs-Advanced Therapies
Janssen Research & Development, LLC
Melody Eble
Director, Global Regulatory Affairs-Advanced Therapies
Janssen Research & Development, LLC
 
About Speaker:

Melody has over 20 years of regulatory experience and has worked on products at various stages of development, from early through to filing, approval and commercialization. Currently, Melody provides global strategic regulatory oversight for Janssen’s lead cell therapy program and is responsible for coordinating Janssen’s advanced therapy regulatory policy efforts. In her prior role, as a Director in Global Regulatory Policy and Intelligence, Melody was responsible for leading and delivering regulatory policy and intelligence analyses to enhance global regulatory strategy for Janssen products across all therapeutic areas. Melody completed her B.S. and Doctor of Pharmacy degrees at University of Buffalo in New York and completed an ASHP Accredited Post-Doctoral Residency in Oncology Pharmacy in San Antonio, Texas.

Douglas Losordo

Douglas Losordo
Chief Medical Officer, Senior Vice President of Clinical, Medical & Regulatory Affairs
Caladrius Biosciences
Douglas Losordo
Chief Medical Officer, Senior Vice President of Clinical, Medical & Regulatory Affairs
Caladrius Biosciences
 
About Speaker:

Dr. Losordo is the Chief Medical Officer and Senior Vice President of Clinical, Medical and Regulatory Affairs of Caladrius Biosciences, Inc, Clinical Professor of Medicine at  the New York University Langone Medical Center  and Adjunct Professor of Medicine at the Northwestern University Feinberg School of Medicine in Chicago, Illinois.

Dr. Losordo’s career has been dedicated to patient care and to the development of novel therapeutics aimed at the reversal or repair of chronic conditions such as heart failure, critical limb ischemia, cancer and diabetes.

A native of Brooklyn, NY, he received his medical degree from the University of Vermont. Dr. Losordo completed an internship, residency and fellowship at St. Elizabeth’s Medical, Boston, Massachusetts, where he subsequently joined the faculty, working with the late Jeff Isner to develop a program in gene therapy and cell-based tissue repair. Dr. Losordo’s group has executed the full “translational medicine” paradigm: identifying potential therapeutic approaches in the laboratory, investigating these strategies in pre-clinical/IND-enabling models and designing and executing first-in-human and proof-of-concept clinical trials as the study sponsor/IND-holder. His work has included developing VEGF gene therapy for myocardial ischemia and diabetic neuropathy, CD34+ cell therapy for refractory angina, critical limb ischemia, severe claudication and coronary microvascular dysfunction and regulatory T cell therapy for autoimmune disease. Two of these candidates advanced to phase 3. At Caladrius Dr. Losordo has initiated a phase 2 study of autologous regulatory T cell therapy for new onset type 1 diabetes in children and recently received Japanese PMDA agreement on a study of CD34 cell therapy for critical limb ischemia targeting conditional approval under the new Japanese regulatory rules governing regenerative therapies. In addition to his own work Dr. Losordo has also mentored numerous scientists and physician-scientists from around the world who now have their own independent programs in translational research.

Felicia Pagliuca

Felicia Pagliuca
Vice President, Cell Biology R&D
Semma Therapeutics
Felicia Pagliuca
Vice President, Cell Biology R&D
Semma Therapeutics
 
About Speaker:

Dr. Pagliuca currently serves as Vice President of Cell Biology Research and Development and is scientific co-founder of Semma Therapeutics. She leads cell-based research and development and plays a key role in supporting Semma's preclinical, regulatory, and manufacturing strategies for its cell therapy products. Felicia also works closely with Semma’s senior leadership on corporate development activities, including key collaborations and partnerships. Previously, Felicia was a postdoctoral fellow in Professor Doug Melton’s laboratory at the Harvard Stem Cell Institute. Felicia was part of the team in the Melton lab that discovered how to generate stem cell derived beta cells and published a seminal paper in Cell in 2014. She is an expert in stem cell biology and diabetes and one of the inventors of Semma Therapeutics’ key technologies. Felicia received a B.S. from Duke University and a Ph.D. from Cambridge University where she was a Marshall Scholar. She is currently on leave from Harvard Business School where she was a Kaplan Fellow.

William K. Sietsema

William K Sietsema
Executive Director, Global Regulatory Affairs
Caladrius Biosciences
William K Sietsema
Executive Director, Global Regulatory Affairs
Caladrius Biosciences
 
About Speaker:

Dr. Sietsema is Executive Director, Global Regulatory Affairs at Caladrius Biosciences, a company that focuses on innovative cell therapies for difficult-to-treat diseases. Prior to Caladrius, he was Global Regulatory Lead at Amgen where he provided strategic guidance to a portfolio of early stage projects in oncology and inflammation. He was also Vice President, Global Regulatory Consulting and Submissions at Kendle International/INC Research and Adjunct Professor of Pharmaceutical Sciences at the University of Cincinnati, College of Pharmacy, where he taught evening classes in drug development. He has 32 years of experience in the pharmaceutical industry. During his sixteen years with Kendle/INC, he brought leadership to several initiatives in the fields of inflammation, skeletal disease, analgesia, gastrointestinal disease, ophthalmology, and women's health. He played a pivotal role in the rapid development of Pharmacia's Celebrex, which transited from beginning of Phase 2 to NDA approval in less than three years. He received his BA, magna cum laude, in Chemistry from the University of Colorado, Boulder in 1977 and his PhD in biochemistry from the University of Wisconsin, Madison in 1982. He is the author of 24 journal articles, 4 book chapters, 42 presentations and posters and is an inventor on 6 patents. He has published six books on regulatory topics ranging from strategic planning to practical aspects of preparing CTAs and MAAs. He is a member of the American Chemical Society, the Regulatory Affairs Professional Society, and the Association for Regenerative Medicine. He was recognized by R&D Directions as one of the top 20 clinical research scientists in 2007

Devyn Smith

Devyn Smith
Chief Operating Officer
Sigilon
Devyn Smith
Chief Operating Officer
Sigilon
 
About Speaker:

Devyn recently joined Sigilon, a biotechnology company, as its Chief Operating Officer tasked with building out strategy and operational elements of the company as it builds a portfolio of potential new medicines.  Prior to Sigilon, Devyn was part of Pfizer's Medicinal Sciences Division of R&D as Head of Business Operations & Strategy focused on both day to day business operations of the division, as well insuring implementable strategies are developed.  Medicinal Sciences encompasses the groups focused on discovery, formulation, and early manufacturing of the large molecule, small molecule, cell and gene therapy programs in Pfizer R&D.  Prior to this Devyn was Head of Strategy for the Pharmatherapeutics Division of Pfizer R&D focused on developing and implementing core strategies in Winning by Design in Small Molecules as well as optimizing the ROI on novel technology inventions.  Before this role, Devyn was part of Pfizer's Neusentis Research Unit in the UK as Chief Operating Officer responsible for strategy, operations and implementing key strategies.  In addition, he supported the Pharmatherapeutics Global Clinical Research Organization as the Chief Operating Officer.  He joined Pfizer's Strategic Management Group in August 2009.

Prior to joining Pfizer, Devyn was a principal for The Frankel Group (a boutique management consulting firm in New York City and Cambridge).  In his consulting experience, Devyn led a wide range of projects, across multiple therapeutic areas and a host of technology platforms, including basic R&D tools, regenerative medicine, gene therapy, and macromolecules/biologic products. Client relationships have ranged from large pharma to small biotech companies. Regenerative Medicine has been an area of strong focus with over 30 engagements, several published papers, and numerous invited conference presentations. Prior to joining The Frankel Group, Devyn worked as a management consultant at Adventis Corporation focused on clients in information intensive companies. 

Devyn received his Ph.D. in Genetics from Harvard Medical School where his research culminated in 12 publications in leading journals such as Cell, Nature, and Development.  He also holds an MS in Biology from Idaho State University and a BS in Zoology from Brigham Young University.

Evan Y. Snyder

Evan Y. Snyder
Professor and Director, Program in Stem Cell & Regenerative Biology
Sanford-Burnham Medical Research Institute
Evan Y. Snyder
Professor and Director, Program in Stem Cell & Regenerative Biology
Sanford-Burnham Medical Research Institute
 
About Speaker:

Evan Y. Snyder, who is regarded as one of the “fathers of the stem cell field”, earned his M.D. and Ph.D. (in neuroscience) from the University of Pennsylvania and received training in Philosophy, Pscyhology, and Linguistics at Oxford University. He began his career as a physician-scientist at Harvard Medical School and Boston Children’s Hospital where, in addition to running a lab, remained clinically active in pediatric neurology and newborn intensive care medicine. After 23 years at Harvard, he was recruited to the Sanford-Burnham-Prebys Medical Discovery Institute and UCSD as Professor and founding director of the Center for Stem Cells and Regenerative Medicine and the Stem Cell Research Center and Core Facility. His ab studies the basic and translational biology of stem cells (particularly neural) with the goal of understanding normal and aberrant development, tissue homeostasis and plasticity, inter-cellular communication, oncogenesis, and recovery of function as well as using stem cells to model disease for pathway mapping and drug discovery.

Yang (Ted) D. Teng

Yang (Ted) D Teng
Director, Laboratory of SCI, Stem Cell & Neurofacilitation Research PM&R and Neurosurgery
Harvard University and Spaulding Rehabilitation Hospital
Yang (Ted) D Teng
Director, Laboratory of SCI, Stem Cell & Neurofacilitation Research PM&R and Neurosurgery
Harvard University and Spaulding Rehabilitation Hospital
 
About Speaker:

After receiving his Medical Degree and Master of Science in Neuropharmacology, Dr. Teng earned his Ph.D. degree in Cell Biology/Neuroscience at Georgetown University, Washington DC, USA.  For his postdoctoral training, he focused on respiratory neurobiology, and stem cell biology and neurodegeneration at Georgetown University and Harvard Medical School, respectively.  He is presently Director, Laboratory of Spinal Cord Injury, Stem Cell & Neurofacilitation Research, Departments of Physical Medicine & Rehabilitation and Neurosurgery (for which he holds professorships), Harvard Medical School/Spaulding Rehabilitation Hospital/Brigham & Women’s Hospital, and Director, Division of Spinal Cord Injury Research, VA Boston Healthcare System.  Dr. Teng studies Functional Multipotency of Stem Cells and Recovery Neurobiology of the Spinal Cord through multimodal cross-examination approaches that integrate stem cell biology, neural and glial biology, chemical or genetic engineering, molecular pharmacology, and spinal cord oncology.  Work of his team has received the prestigious 2011 Apple Award of the American Spinal Injury Association (ASIA), the ERF New Investigator Award from the Foundation of Physical Medicine & Rehabilitation (2004), and the Mayfield Awards and Larson Research Award from the Congress of Neurological Surgeons and American Association of Neurological surgeons (CNS/AANS) Joint Section on Disorders of the Spine and Peripheral Nerves (2012, 2015 and 2016).  Dr. Teng has been serving as a reviewer for more than 50 academic and clinical journals, and working as a study section member for federal and private funding agencies as well as for European Union academic organizations. He is elected the Secretary (2014-2016) and President (2013-2014) of the American Society for Neural Therapy and Repair (www.asntr.org).

Mark Zimmerman

Mark Zimmerman
Vice President, Strategy and Business Development
ViaCyte
Mark Zimmerman
Vice President, Strategy and Business Development
ViaCyte
 
About Speaker:

Mark Zimmerman received his bachelors in Biology from Syracuse University and his masters and doctorate in Biomedical Engineering from Rutgers University. Mark joined UMD-New Jersey Medical School as an Assistant Professor in 1986 and left in 1996 as an Associate Professor of Surgery with tenure. His research interests spanned musculoskeletal tissue engineering, sports medicine, trauma, and spine biomechanics and biomaterials.

Mark joined Johnson and Johnson in 1997 as a principal scientist/group leader and transitioned into regenerative medicine projects related to orthopaedic surgery, wound healing, vascular biology, and diabetes. Mark was appointed executive director of a Lifescan incubator, BetaLogics, in July 2002. BetaLogics transitioned to a Johnson and Johnson Internal Venture in 2004. The mission of BetaLogics was to discover and develop a cellular product to treat diabetes. Mark was appointed Venture Leader/Vice President of BetaLogics, a business unit of Janssen R&D LLC in 2009. Janssen completed a business transaction with ViaCyte in 2015 and merged the assets of BetaLogics into ViaCyte. Mark is currently seconded to ViaCyte and serves as the Vice President of Strategy and Business Development.

Stem Cell Research & Regenerative Medicine 2017
DISTINGUISHED SPEAKERS
Chad Cowan

Chad Cowan
Scientific Founder and Research Head
CRISPR Therapeutics
Chad Cowan
Scientific Founder and Research Head
CRISPR Therapeutics
 
About Speaker:

Dr. Chad Cowan is an Associate Professor at Harvard University in the Department of Stem Cell and Regenerative Biology, and at Massachusetts General Hospital, with appointments in the Center for Regenerative Medicine, the Cardiovascular Research Center and the Center for Human Genetics Research. He is an associate member of the Broad Institute and a principal faculty member of the Harvard Stem Cell Institute, where he directs the Diabetes Disease Program and the iPS Cell Core Facility.

Chad has led or been a member of several large efforts to use stem cells to better understand disease, including the National Heart, Lung, and Blood Institute’s Next Gen iPS Cell Project and the Progenitor Cell Biology Consortium. More recently, Chad has focused on using gene editing tools as therapeutics.

Chad received his B.A. and B.S., with honors, from the University of Kansas. He received his Ph.D. from the University of Texas Southwestern at Dallas, garnering the Nominata award for most outstanding thesis. He subsequently completed a Damon Runyon fellowship with Professor Douglas Melton at Harvard University. He was named a Stowers Medical Investigator in 2006 and has been a faculty member at Harvard University since 2008.

John E. Davies

John E Davies
Professor, Institute of Biomaterials and Biomedical Engineering (IBBME); President & Chief Executive Officer
University of Toronto; Tissue Regeneration Therapeutics Inc.
John E Davies
Professor, Institute of Biomaterials and Biomedical Engineering (IBBME); President & Chief Executive Officer
University of Toronto; Tissue Regeneration Therapeutics Inc.
 
About Speaker:

Davies is a Full Professor at the Institute of Biomaterials and Biomedical Engineering (IBBME) of the University of Toronto, with cross-appointments to the Faculty of Applied Science and Engineering, the Faculty of Dentistry and the Faculty of Medicine (Dept of Surgery). He is also the founding President, and CEO, of Tissue Regeneration Therapeutics Inc (TRT), a Toronto-based mesenchymal stromal cell company. TRT extracts this population of cells from the perivascular tissue of the human umbilical cord to provide 2 platforms: native and engineered cells. These cells are now in pre-clinical trials for multiple therapeutic targets including pediatric GvHD, lung and pancreatic islet transplantation, bone tissue engineering and wound healing.

Davies trained as an anatomist and oral surgeon in the UK. He was awarded a DSc by the University of London, England, for his sustained research contributions over a period of 20 years to the field of Biomaterials. He has edited 2 books, published over 200 hundred scientific papers and book chapters and filed >70 patents.

Robert Deans

Robert Deans
Chief Technology Officer
BlueRock Therapeutics
Robert Deans
Chief Technology Officer
BlueRock Therapeutics
 
About Speaker:
Wolfgang Hofgartner

Wolfgang Hofgartner
Vice President, Research
Celgene Cellular Therapeutics
Wolfgang Hofgartner
Vice President, Research
Celgene Cellular Therapeutics
 
About Speaker:

Dr. Hofgartner is Vice President of Research & Development at Celgene Cellular Therapeutics, which is a clinical stage company with multiple phase 1/2 programs. The company is focused on developing and advancing a number of distinct cellular immuno-oncology programs for therapeutic areas with high unmet medical need. Prior to joining Celgene Cellular Therapeutics in 2004, Dr. Hofgartner was Medical Director at Becton Dickinson, a global medical technology company. By background he is a board certified Clinical Pathologist, trained at the University of Washington in Seattle, with subsequent fellowship training in Molecular Pathology at the University of Pittsburgh.

 

Hardy T S Kagimoto

Hardy T S Kagimoto
President and Chief Executive Officer
Healios K.K (RIKEN Venture)
Hardy T S Kagimoto
President and Chief Executive Officer
Healios K.K (RIKEN Venture)
 
About Speaker:

Hardy TS Kagimoto, MD is a serial entrepreneur and obsessed with the concept of curing as many patients as possible through technology. At the first biotech, Aqumen, he launched BBG which gained de-facto-standard status in ophthalmology community, globally. And then he founded Healios with the vision to create a world leading regenerative cell therapy company.   He brought Healios public in 2015 and currently running P2/3 trials for acute brain stroke in Japan with somatic stem cell’s immune moderation effect to reduce secondary damage of acute brain stroke. Healios also holds various iPS pipelines which is under clinical research to gain proof of concept with human. He is happily living in Tokyo, Japan, with his British wife, 3 children, 2 turtles, 1 tank of tropical fish and various plants.

Erin Kimbrel

Erin Kimbrel
Senior Director of Development
Astellas Institute for Regenerative Medicine
Erin Kimbrel
Senior Director of Development
Astellas Institute for Regenerative Medicine
 
About Speaker:

Erin Kimbrel is the Senior Director of Development at Astellas Institute for Regenerative Medicine (AIRM), an indirect, wholly-owned subsidiary of Astellas Pharma located in Marlborough, Massachusetts, USA. Dr. Kimbrel has nearly 15 years of experience in the stem cell field, including several years in industry where she has been engaged in research and development of various hESC and iPSC-derived cell-based therapies. She was previously the Director of MSC research at Advanced Cell Technology and Director of Translational Research/Sr. Director of Development at Ocata Therapeutics before the company was acquired by Astellas. She is a co-author on over 20 publications and an inventor on numerous patents. Dr. Kimbrel is a former Fulbright scholar and member of Phi Beta Kappa, receiving her B.A. Magna Cum Laude from Holy Cross College in Worcester, Massachusetts and her Ph.D. in Pharmacology and Cancer Biology from Duke University in Durham, North Carolina. She completed post-doctoral training in Boston, Massachusetts at the Dana-Farber Cancer Institute and Harvard Medical School with a focus on hematopoietic stem cell fate decisions. Her current role at AIRM involves the strategic planning of pipeline programs as well as managing scientists involved in regenerative medicine research and early product development.

Jane Lebkowski

Jane Lebkowski
President, Research & Development
Asterias Biotherapeutics
Jane Lebkowski
President, Research & Development
Asterias Biotherapeutics
 
About Speaker:

Jane Lebkowski has been actively involved in the development of cell and gene therapies since 1986 and is currently President of R&D and Chief Scientific Officer at Asterias Biotherapeutics Inc, where she is responsible for all R&D 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.  During Dr. Lebkowski’s tenure at RPR, she coordinated preclinical investigations of gene therapy approaches for treatment of cancer, cardiovascular disease and nervous system disorders, and directed vector formulations and delivery development.  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 on the board of Directors of the American Society for Gene and Cell Therapy and as the co-chair of the Industrial Committee of the International Society for Stem Cell Research. Dr Lebkowski serves on several scientific advisory boards and other professional committees.

Chris Loose

Chris Loose
Co-founder & Chief Scientific Officer
Frequency Therapeutics
Chris Loose
Co-founder & Chief Scientific Officer
Frequency Therapeutics
 
About Speaker:

Chris is the Chief Scientific Officer and Co-founder of Frequency Therapeutics. He is an entrepreneurial scientist who has overseen the translation of new medical technologies from concept to approved products. Previously, Chris co-founded Semprus BioSciences and served as Chief Technology Officer through the company’s acquisition by Teleflex in 2012. He led the technology team in developing medical products with surface modifications designed to reduce infection and clotting, leading to FDA/CE Mark clearance. In 2011, he was awarded the inaugural Peter Strauss Entrepreneurial Award from the Hertz Foundation. Chris has also been named to the Technology Review TR35, the 35 innovators under 35 most likely to impact technology, and was named to the Boston Business Journal’s 40 Under 40. He is currently an Associate Adjunct Professor of Urology in the Yale School of Medicine. Chris holds a Ph.D. in Chemical Engineering from MIT, where he studied under Robert Langer, Sc.D., and a BSE from Princeton University.

Margo Roberts

Margo Roberts
Sr VP, Discovery Research
Kite Pharma
Margo Roberts
Sr VP, Discovery Research
Kite Pharma
 
About Speaker:

Dr. Roberts has more than two decades of biomedical research, drug discovery and development experience. From 1999 to 2013, Dr. Roberts held an Associate Professor position at the University of Virginia where she pursued interdisciplinary research in the area of immunity and inflammation. From 1990 to 1998, she served as Principal Scientist and Director of Immune and Cell Therapy at Cell Genesys, Inc. Dr. Roberts is the inventor on the first set of CAR patents, including second-generation CAR constructs that incorporate the domains of costimulatory receptors, such as CD28, aimed at improving CAR T cell survival and function. She is the author of more than 25 scientific publications and inventor on 13 issued US patents and three published US patent applications related to CAR technology and tumor vaccine therapies. Dr. Roberts was a postdoctoral fellow at Yale and at the LGME of the CNRS in France. She received her BSc with honors and her PhD from the University of Leeds in England.

Khalid Shah

Khalid Shah
Director Center for Stem Cell Therapeutics and Imaging
Harvard Medical School
Khalid Shah
Director Center for Stem Cell Therapeutics and Imaging
Harvard Medical School
 
About Speaker:

Dr. Shah is an Associate Professor at Harvard Medical School. He is also the Director of Center for Stem Cell Therapeutics and Imaging and Vice Chair of Research at Brigham and Women’s Hospital and a Principal Faculty at Harvard Stem Cell Institute in Boston. His laboratory focuses on developing therapeutic stem cells for receptor targeted therapies for cancer and testing their efficacy in clinically relevant mouse tumor models. In recent years, Dr. Shah and his team have pioneered major developments in the stem cell therapy field, successfully developing experimental models to understand basic cancer biology and therapeutic stem cells for cancer, particularly brain tumors. These studies have been published in a number of very high impact journals like Nature Neuroscience, PNAS, Nature Reviews Cancer, JNCI, Stem Cells and Lancet Oncology, validating the use of therapeutic stem cells alone and in combination with clinically approved drugs for cancer therapy.

Recently, Dr. Shah's work has caught the attention in the public domain and as such it has been highlighted in the media world-wide including features on BBC and CNN. Dr. Shah holds current positions on numerous councils, advisory and editorial boards in the fields of stem cell therapy and oncology. The technologies from Dr. Shah’s laboratory have led to the foundation of a biotech company, AMASA Technologies Inc. whose main objective is the clinical translation of therapeutic stem cells in cancer patients.

John Sinden

John Sinden
Chief Scientific Officer
ReNeuron
John Sinden
Chief Scientific Officer
ReNeuron
 
About Speaker:

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.

Anthony Ting

Anthony Ting
Vice President
Athersys
Anthony Ting
Vice President
Athersys
 
About Speaker:

Dr. Ting is the Vice President of Regenerative Medicine and Head of Cardiopulmonary Programs. With more than thirty years of experience in cell and stem cell biology, Dr. Ting has developed expertise in translational clinical studies with adult stem cell therapies and has been responsible for all stages of the development of MultiStem® from the bench to the bedside. Dr. Ting manages all programs in the cardiovascular and pulmonary areas at the Company, as well as the evaluation of potential new uses for the cell therapy product. Dr. Ting serves on several regenerative medicine society committees including the International Society for Cell Therapy, the Alliance for Regenerative Medicine and the American Society for Gene and Cell Therapy. From 1995 to 2001, Dr. Ting was a Principal Investigator and Head of the Screening for Novel Inhibitors group at the Institute of Molecular and Cell Biology (IMCB) at the National University of Singapore. Prior to joining IMCB, he was a post-doctoral fellow in the department of Molecular and Cellular Physiology at Stanford University. Dr. Ting received his Ph.D. in Cell Biology from Johns Hopkins University and his B.A. in Biology from Amherst College.

Stem Cell Product Development & Commercialization 2017
DISTINGUISHED SPEAKERS
Matthew Durdy

Matthew Durdy
Chief Business Officer
Cell Therapy Catapult
Matthew Durdy
Chief Business Officer
Cell Therapy Catapult
 
About Speaker:

Part of the team that created the Catapult, he is also an Executive Director. He is responsible for finding, funding and transacting the business of the Catapult and has been a champion of the early integration of healthcare economics and reimbursement expertise into decision- making and clinical product design.  He began his career in international investment banking and has successfully managed a number of SMEs in the biotechnology sector.   His first degree was from Oxford University in Biology and he has an MBA (High Honors) from Chicago Booth. He is a non-executive director of two immune-oncology companies and periodically assists the UK Government and international organisations in the development of initiatives in healthcare innovation.

Spencer Hoover

Spencer Hoover
Development Manager
CCRM
Spencer Hoover
Development Manager
CCRM
 
About Speaker:

Spencer Hoover is a development manager at CCRM, a Canadian, not-for-profit organization supporting the development of foundational technologies for commercializing cell and gene therapies.

His current focus is on business development and technical projects directed towards PSC and viral vector manufacture for immunotherapy.

Prior to joining CCRM, Dr. Hoover spent five years developing FDA-cleared multiplex molecular diagnostics for Luminex Corporation in the US and Canada. 

He completed a B.S. in chemistry at the University of Louisville and a Ph.D. in microbiology (focus on virology) at the University of Wisconsin – Madison.  He was then a postdoctoral fellow in the chemical engineering department at UW-Madison (focus on metabolic engineering). 

Hans Keirstead

Hans Keirstead
Chief Executive Officer
AIVITA BIOMEDICAL
Hans Keirstead
Chief Executive Officer
AIVITA BIOMEDICAL
 
About Speaker:

Dr. Keirstead is an internationally known stem cell expert and has led therapy development for late stage cancers, immune disorders, motor neuron diseases, spinal cord injury and retinal diseases. He is the CEO of AIVITA Biomedical, an Irvine, CA-based company focused on the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. As Full Professor of Anatomy and Neurobiology at the University of California at Irvine he founded and directed the Sue and Bill Gross Stem Cell Research Center. He has been a long-time advisor to several governments on biomedical policy, and was a founding advisor of the California Stem Cell Initiative that resulted in a $3 billion stem cell fund (CIRM).

Robert Konopacz

Robert Konopacz
Vice President of Manufacturing
Rubius Therapeutics
Robert Konopacz
Vice President of Manufacturing
Rubius Therapeutics
 
About Speaker:

Robert Konopacz, is responsible for manufacturing and bioprocess development at Rubius Therapeutics, based on his background in Gene Therapy and Biological Manufacturing.

Robert has more than 35 years of experience in Biotechnology Therapeutics which includes work with virus and T cell processing, mammalian, bacterial and yeast expression systems, blood fractionation, and transgenic animals. He most recently served as Head of Advanced Medicines Relationship Management for Novartis AG Global Technical Operations supporting their Cart 19 program.

Prior to Novartis, Robert was Senior Director of Manufacturing at Genetics Institute (Pfizer) responsible for the manufacturing of recombinant Factor VIII, BMP-2, and IL-11.  Robert was an original manufacturing team member at Genentech, developing and launching hGH and tPA.

He has also held positions of increasing responsibility at Chiron, and Baxter Healthcare.

Robert holds has a B.Sc. in Chemical Engineering and a B.Sc. in Microbiology from the Michigan State University.

Brian Miller

Brian Miller
Chief Executive Officer
Sentien Biotech
Brian Miller
Chief Executive Officer
Sentien Biotech
 
About Speaker:

Brian Miller brings over 18 years of experience in the life sciences industry, currently serving as Co-Founder and CEO of Sentien Biotechnologies, a regenerative medicine company developing cell based devices for organ failure. Mr. Miller has previously held the roles of Executive Director and Head, Corporate Development at FORMA Therapeutics, a clinical stage oncology company, and Head of Business Development – Asia Pacific Region for Quosa, Inc., a life science informatics company, where he led the commercial launch of their product line in the Asia Pacific region. He began his biotech career at Eli Lilly and Company, where he led the identification, evaluation, and in-licensing of research informatics technologies in the Global External Research & Development group. Brian received BA degrees in Chemistry and Business from Goshen College, an MS degree in Health Sciences from the Harvard-MIT Division of Health Sciences Technology, and an MBA from the MIT Sloan School of Management.

Kevin Murray

Kevin Murray
Vice President, Global Sales
BioSpherix Medical
Kevin Murray
Vice President, Global Sales
BioSpherix Medical
 
About Speaker:

Sales Manager for BioSpherix, Ltd. BS BioChemistry, MBA Finance & Marketing, 20+ Years experience in the Pharmaceutical/Biotech/Medical Research Industry.

Aliki Nichogiannopoulou

Aliki Nichogiannopoulou
Director, Biotechnology
European Patent Office
Aliki Nichogiannopoulou
Director, Biotechnology
European Patent Office
 
About Speaker:

Aliki Nichogiannopoulou was born in Athens, Greece. She studied biology and philosophy at the Albert-Ludwigs-University in Freiburg, Germany and did her diploma thesis in molecular immunology at the Max-Planck-Institute of Immunology in Freiburg. She completed her Ph.D. thesis on adult, fetal and embryonic stem cells in the Department of Genetics at Harvard Medical School in Boston, and did her post-doctoral research on stem cells at Harvard Medical School at the Massachusetts General Hospital. She became a patent examiner at the European Patent Office in September 1998 and joined the Patent Law department in 2004. She was holding a joint appointment in the two departments until December 2009. She participated in all major stem cell cases at the European Patent Office and represented the President of the European Patent Office in front of the Office's Enlarged Board of Appeal in the Thomson case on human embryonic stem cells. She has represented the Office in patent law, scientific and ethical conferences and workshops and has lectured on the legal and ethical aspects of stem cell and DNA patenting at several occasions. In January 2010 she was appointed director in Biotechnology at the European Patent Office. Since January 2017 she holds a position in the European patent office’s International Cooperation department.

Gary M. Pigeau

Gary Pigeau
Development Manager, Cell Therapy
GE Healthcare & CCRM (BridGE)
Gary Pigeau
Development Manager, Cell Therapy
GE Healthcare & CCRM (BridGE)
 
About Speaker:

Gary Pigeau received his Ph.D. in Biotechnology from Brock University in St. Catharines, Ontario. He completed a postdoctoral fellowship at the University of Alberta with a visiting scientist appointment at the University of Oxford. Gary moved to private industry in 2008, where his research group focused on process development and scale-up of a proprietary bioprocess technology. He then moved to commercial, large-scale biomanufacturing in 2013. Gary joined GE Healthcare and BridGE @ CCRM in 2016 and leads the pluripotent stem cell process development, scale-up and manufacturing efforts.

 
Zorina Pitkin

Zorina Pitkin
Vice President, Quality Systems
Organogenesis
Zorina Pitkin
Vice President, Quality Systems
Organogenesis
 
About Speaker:

Dr. Zorina Pitkin is Senior Vice President of Quality Systems at Organogenesis Inc., a regenerative medicine company focused on development and commercialization of both cellular and acellular therapies in the areas of bio-active wound healing and bio-surgery.

She has over 20 years of extensive experience in the field of biotechnology including the development of Quality System programs for autologous and allogeneic cellular therapies, biologic/device combination products, and for xenotransplantation. Prior to joining Organogenesis in 2008, Zorina held senior management positions at RenaMed Biologics and Circe Biomedical, the two Companies developing bioartificial organs and therapeutic cell systems for treatment of acute renal failure, and acute liver failure and diabetes, respectively; and before then, a variety of positions of increased responsibility at Cellcor, a Company developing autologous cell-based treatment for renal cell carcinoma and Hepatitis B.

Dr. Pitkin has published 16 original papers in professional journals and has presented at numerous national and international conventions. She holds a Ph.D. in Biological Sciences from the Research Institute of Influenza, Russian Academy of Medical Sciences, and is Regulatory Affairs certified.

Jon A. Rowley

Jon A. Rowley
Chief Technology Officer
RoosterBio Inc
Jon A. Rowley
Chief Technology Officer
RoosterBio Inc
 
About Speaker:

Jon A. Rowley, PhD, is the Founder and Chief Technology Officer of RoosterBio Inc and has a personal goal of making significant contributions to the commercial translation of living cellular technologies. Jon holds a PhD from the University of Michigan in Biomedical Engineering and has authored over 30 peer reviewed manuscripts and 15 issued or pending patents related to biomaterials development, tissue engineering, and cellular therapy. He most recently spent 5 years as Director of Innovation and Process Development in Lonza’s Cell Therapy CMO business, and currently resides in Walkersville, MD with his wonderful wife and their 3 young children.

David Russell

David Russell
Chief Scientific Officer
Universal Cells Inc.
David Russell
Chief Scientific Officer
Universal Cells Inc.
 
About Speaker:

Human pluripotent stem cells (PSCs) have the potential to treat diseases affecting almost every organ system. However, the clinical use of PSC-derived products is limited by allogeneic rejection, primarily due to differences in the diverse human leukocyte antigen (HLA) genes, and the use of autologous induced PSCs or the establishment of HLA-typed PSC banks are problematic due to the large number of cGMP-grade cell lines that must be prepared, characterized, and approved by regulatory agencies. Here I will describe an approach for generating universal donor PSCs, which will allow a single PSC-derived cell product to be used in multiple recipients. Gene editing with recombinant adeno-associated virus vectors is used to efficiently alter genes involved in HLA expression, without the use of potentially genotoxic nucleases. Through this process, we eliminate cell surface expression of both HLA class I and class II molecules, which prevents peptide presentation to T cells and recognition by anti-HLA antibodies. Gene editing is also used to reintroduce a non-polymorphic class I molecule and thereby prevent lysis by Natural Killer cells. We show that these HLA-engineered universal donor cells resist allogeneic responses of NK, B and T cells, both in vitro and in vivo in humanized mouse models. Universal donor PSCs can be differentiated into diverse therapeutic cell products that are compatible with all recipients, and they allow the production of off-the-shelf cellular therapy products for many indications.

Gil Sambrano

Gil Sambrano
Vice President of Portfolio Development and Review
California Institute for Regenerative Medicine
Gil Sambrano
Vice President of Portfolio Development and Review
California Institute for Regenerative Medicine
 
About Speaker:

Gil leads the team responsible for selecting the highest quality stem cell-based projects for CIRM funding from Discovery to Clinical programs.  His team builds and cultivates a world class team of expert reviewers and directs a rigorous review process through the governing board-appointed Grants Working Group (GWG).

Gil joined CIRM in 2005 as the first Scientific Officer. During his tenure, Gil has contributed to building the vision of CIRM by leading and advancing the scientific review process, constructing grants administration policies, guiding early development of the Grants Management System, and managing the training grant programs. He has been a key point of contact to help applicants and grantees identify appropriate partnering opportunities and navigate the CIRM solicitation and application process.  He leads the conduct of GWG review meetings and has been the primary liaison with patient advocate and scientific members of the GWG.

Prior to CIRM, he was an assistant professor in the department of Cellular and Molecular Pharmacology at UCSF. In 2001, Gil took on a notable position to coordinate efforts of the Alliance for Cellular Signaling, a multi-institutional and multi-disciplinary consortium of scientists led by the Nobel laureate, Alfred G. Gilman, whose goal is to understand the basic principles that regulate signal transduction in cells.

His scientific education includes a B.S. in biology from the University of Texas at El Paso and a Ph.D. in biomedical sciences from the University of California, San Diego. Gil trained as a postdoctoral fellow at the Cardiovascular Research Institute at the University of California San Francisco.

Beth Shaz

Beth Shaz
Chief Medical and Scientific Officer, Comprehensive Cell Solutions
New York Blood Center
Beth Shaz
Chief Medical and Scientific Officer, Comprehensive Cell Solutions
New York Blood Center
 
About Speaker:

Beth is Chief Medical and Scientific Officer, Senior Vice President at New York Blood Center, and Adjunct Assistant Professor, Department of Pathology and Cell Biology, Columbia University Medical Center. Beth is leading NYBC’s Comprehensive Cell Solutions. CCS is focused on developing, improving, and implementing regenerative medicine, cell therapies, transfusion medicine, and related scientific and medical endeavors. Previously, she was Associate Professor at Emory University School of Medicine and director of the transfusion service at Grady Memorial Hospital. Also, she was associate director of the transfusion service at Beth Israel Deaconess Medical Center, Harvard Medical School. Beth received her Medical Degree with research distinction from University of Michigan and Bachelor of Science in chemical engineering with distinction from Cornell University. She did a general surgery internship at Georgetown University, an anatomic & clinical pathology residency at Beth Israel Deaconess Medical Center, and a transfusion medicine fellowship at Harvard Medical School.

Alain Vertès

Alain Vertès
Managing Director
NxR Biotechnologies GmbH
Alain Vertès
Managing Director
NxR Biotechnologies GmbH
 
About Speaker:

Dr Alain Vertès is a Sloan Fellow from London Business School and a microbiologist by training (University of Illinois at Urbana-Champaign, Institut Pasteur Paris, University of Lille Flandres-Artois). He is a strategy and business development consultant and works to enable funding and partnering in biotechnology. Focusing on technology deployment and innovation commercialization, he has contributed to both white (industrial) and red (pharmaceutical) biotechnology, in different functions including research, manufacturing, contract research, and strategic alliances in pharmaceuticals (Lilly, Pfizer, Roche), biotechnology (Mesoblast), petrochemicals (Mitsubishi Chemical Corporation), public research, and consulting (Australian Strategic Policy Institute, NxR Biotechnologies GmbH). Particularly, he has long been associated with the Research Institute of Innovative Technology for the Earth in Kyoto, Japan, working on developing transformational biorefinery technologies and on deploying green technologies to the marketplace. In the pharmaceutical industry, he champions radical innovation for bringing to patients disease-modifying, paradigm-changing therapeutics such as siRNA, cell- or gene-based pharmaceuticals.