Task Force on Clinical Translation of Stem Cells

Members

Chair:
Olle Lindvall, University of Lund, Sweden
Dr. Olle Lindvall is Professor of Clinical Neurology and Chairman of the Division of Neurology at the University Hospital, Lund, Sweden. He has served as Chairman of the Swedish Movement Disorder Society 1995-1998, Vice-Dean of the Medical Faculty at the University of Lund 1997-1999, elected member of the Board of the Swedish Research Council (medical division) 2001-2006, clinical coordinator in EU-sponsored integrated project EuroStemCell 2003-2007, and Chairman of the Steering Committee for Nordic Centers of Excellence in Molecular Medicine 2003-2007. He has received numerous Prizes and Awards. Dr. Lindvall is since 2004 member of the Board of the International Society for Stem Cell Research, and since 2005 member of the Board of Reviewing Editors for SCIENCE and member of the Scientific Advisory Board of the Michael J. Fox Foundation for Parkinson's Research.

Since 1983 Dr. Lindvall has headed the clinical neurotransplantation program in  Lund. This program has pioneered cell replacement strategies and been the first to show proof-of-principle, i.e., that transplanted neurons can survive, grow, restore transmitter release, become functionally integrated, and give rise to clinically measurable improvements in the diseased, 50-60 year old human brain. Current research interests in Dr. Lindvall's laboratory are the development of stem cell-based approaches for cell replacement in Parkinson's disease and stroke, and of gene therapeutic strategies for neuroprotection and neuroregeneration in Parkinson's disease. Much focus is on the role and possible therapeutic relevance of neurogenesis from the adult brain's own neural stem cells in stroke and epilepsy.

Co-Chair:
Insoo Hyun, Case Western Reserve University, Ohio, USA
 Insoo Hyun received his Ph.D. in Philosophy from Brown University and his B.A. and M.A. in Philosophy from Stanford.  His scholarly interests include stem cell research ethics and policy, medical decision-making and informed consent, and the allocation of scarce health resources.  In 2005, he was awarded a Fulbright Research Award by the U.S. Department of State to study the ethical, legal, and cultural dynamics of human research cloning in South Korea.  In 2006 he chaired the Subcommittee on Human Biological Materials Procurement for the International Embryonic Stem Cell Guidelines Task Force, a multinational, multidisciplinary working group for the ISSCR (International Society for Stem Cell Research).  Currently, Dr. Hyun is Chair of the ISSCR's Ethics and Public Policy Committee.  Dr. Hyun's scholarly bioethics articles have appeared in Science, Nature, Cell Stem Cell, The Hastings Center Report, The Cambridge Quarterly of Healthcare Ethics, andThe Kennedy Institute of Ethics Journal, among others.   

Subcommittee 1, Quality Control and Manufacturing, Chair:
Mahendra Rao, Invitrogen, Washington, DC, USA
 Rao completed his medical training from Grant Medical College -India and subsequently obtained a Ph.D from California Institute of Technology- USA. He trained with Paul Patterson, David Anderson and Story Landis and his early work focused on the developing nervous system. Dr. Rao joined the faculty in the Department of Neurobiology and Anatomy where he lead a group that studied neuron-glial lineage diversification in the central nervous system. Soon after obtaining tenure Dr. Rao was recruited to the Laboratory of Neuroscience at the  National Institute of Aging to lead the NIA's efforts on embryonic and neural stem cells. Dr. Rao currently leads the stem cell effort at Invitrogen as the Vice President-Research Stem Cells and Regenerative Medicine.

Dr. Rao holds faculty appointments at the National Center of Biological Sciences (India), the Buck Institute (CA), and JHU school of Medicine (MD). He has served as a consultant to several biotechnology companies, investment firms, governments and various regulatory and advisory agencies. Dr. Rao serves on the editorial Board of several journals including Stem Cells and Stem Cells and Development and the SAB of several granting agencies and University grants.

Dr. Rao's research focus continues to be identifying stem cell populations that could be used for discovery, screening and therapeutic purposes and developing the appropriate tools and reagents to enable a transition from the research domain to the clinic.

Subcommittee 2, Preclinical Testing, Chair:
Giulio Cossu, Stem Cell Research Institute, Italy
Giulio's research has focused on the development of pre-clinical models of cell therapy for muscular dystrophy. His lab has characterized a population of mesoderm progenitors from the blood vessels of fetal and adult mammalian tissues, named mesoangioblasts. These cells have been delivered systemically to dystrophic mice and dogs and caused amelioration of muscle structure and function. Based on these results we are now planning a phase I/II clinical trial in pediatric patients affected by Duchenne muscular dystrophy.

Giulio Cossu is a member of the Directory Board of the Italian Radical Party and of the Luca Coscioni Association for freedom of research.

Subcommittee 3, Clinical Trials, Chair:
Ira Fox, Nebraska Medical Center, Nebraska, USA
Ira Fox, M.D is the Charles W. McLaughlin Professor of Surgery and former Senior Associate Dean for Research and MD-PhD Program Director at the University of Nebraska Medical Center. His major research interests involve the study of experimental therapies for liver disease, including liver assist devices, liver cell transplantation, and liver stem cells. His laboratory examines the efficacy of transplanting primary and conditionally immortalized hepatocytes in rodents, and studies the immunologic barriers to cross-species transplantation in rodents and primates. His laboratory also studies differentiation of mouse and human embryonic stem cells into liver cells. He has initiated clinical trials involving extracorporeal liver perfusion to treat patients with acute liver failure, and has demonstrated successful correction of liver-based metabolic deficiencies in newborns and young children by transplantation of isolated liver cells.

Subcommittee 4, Social Justice, Chair:
Laurie Zoloth, Northwestern University, Illinois, USA
Laurie Zoloth is Director of the Center for Bioethics, Science and Society and Professor of Medical Ethics and Humanities at Northwestern University, Feinberg School of Medicine, and Professor of Religion and a member of the Jewish Studies faculty at Northwestern University, Weinberg College of Arts and Science.  In 2005, after two terms of service on NASA's National Advisory Council, she received the NASA Public Service Medal.  In 2001, she was President of the American Society for Bioethics and Humanities. Professor Zoloth is the chair of the HHMI Bioethics Committee and is a founding board member of the International Society for Stem Cell Research, and of the Society for Neuroethics, on NASA's first Planetary Protection Advisory Committee, and on the boards of several national organizations. In 2007 she was nominated to the Institute of Medicine. She is the author of The Ethics of Encounter: A Jewish Perspective on Health Care Justice, and is co-editor of two books on religion, science, and ethics.  In 2000, she was co-PI for an NIH ELSI grant on identity, ethnicity, and citizenship after the Human Genome Project. She has published extensively in the areas of ethics, family, feminist theory, religion and science, Jewish Studies, and social policy.  Her current research projects include work on the emerging issues in medical and research genetics and on the ethical issues in stem cell research, and her research interest in distributive justice in health care continues. 

Members:
Lars Ahrlund-Richter, Karolinska Institute, Sweden
 Lars Ährlund-Richter, Ph.D. is Professor of Molecular Embryology at the Dept. of Woman and Child Health, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden. L.Ä.R. received a MSci in Biology at Stockholm University (1975) and a PhD at the Karolinska Institute (1983). Following a period as post doctoral fellow at the National Institute of Medical Research, London, UK, he became associate Professor in Tumor Immunology (1990), Reader of Molecular Embryology (2000) and Professor of Molecular Embryology (2001), at the Karolinska Institute.

L.Ä.R. was founder and head of the Karolinska Institute core facility “Mammalian Embryo and Genome research", and in this role 1996-2006 a member of the Board of Directors of the European mouse mutant archive (EMMA), Monterotondo, Italy; member of the Committee on ES cells in the Federation of International Mouse Resources (FIMRE) (2005-2006) and member of Ethical Committee on animal experimentation, District Court of Huddinge, Sweden (2002-2006). He was scientific consultant at the laboratory of the IVF unit, Sophia Hemmet Hospital, Stockholm (1993-1994); of the IVF unit Huddinge University Hospital, Stockholm (1994-1998); and coordinator of the Karolinska Institute Network on “Derivation, characterization and banking of human embryonic stem cells" 2003-2005. This network has derived and characterized a series of hESC lines. Since 2005 L.Ä.R. is a member of the ISSCR Stem Cell Standards Committee and was 2006 a member of the ISSCR task force; “Guidelines for the conduct of human embryonic stem cell research". Recent research include xeno-transplantation of hESC with normal and abnormal karyotypes, with emphasis on stem cell derived microenvironments and possible applications in tumour research.

Elena Cattaneo, University of Milan, Italy Elena Cattaneo is full professor of Pharmacology at the University of Milano. She is the director of the "Laboratory of stem cell biology and pharmacology of neurodegenerative diseases" at the Department of Pharmacological Sciences (www.cattaneolab.it) and co-founder and first  appointed Director of UniStem, the Centre for Stem Cell Research of the University of Milano (www.unistem.it).  The main research themes of her lab are neural stem cell biology and the molecular pathophysiology of Huntington's Disease.

Marina Cavazzana-Calvo, INSERM, France  Marina Cavazzana-Calvo obtained a MD at the University of Padua School of Medicine (Italy) in 1983 and a PhD in Blood Cell Biology at Paris VII University (France) in 1993. In 2000 she became Professor of Hematology at Paris V University, and Head of the Departement of Biotherapy at Necker Children's Hospital, Paris, France, in 2003. Her major research interests involve the setting up of new therapeutic approaches for inherited diseases of the hematopoietic system.

Her group studies the means to improve the clinical results of hematopoietic stem cell transplantation cross HLA-barriers in humans, and the differentiation of mouse and human stem cells towards lymphocyte lineages. She has initiated several clinical trials based on the use of ex vivo gene modified cells to treat patients with inherited disorders, the preliminary clinical results of which are encouraging. This work was rewarded by the American Society of Hematology (Award on Clinical Research in Gene Therapy in 1999) and by the French Academy of Sciences (Special Medical Award in 2000 and Jean-Pierre Lecocq Award on Gene Therapy in 2004). She is a member of the Transatlantic Gene Therapy Consortium since 2005, of the American Society of Gene Therapy Hematopoietic Committee and Ethics Committee since 2006, and an invited member of the Blood Editoral Board since 2008.

George Q. Daley, Children's Hospital Boston, Massachusetts, USA
George Q. Daley, M.D., Ph.D. is Associate Professor of Hematology/Oncology at Children's Hospital Boston and Biological Chemistry and Molecular Pharmacology at Harvard Medical School, and an investigator of the Howard Hughes Medical Institute. He is Associate Director of the Stem Cell Program at Children's Hospital, a member of the Executive Committee of the Harvard Stem Cell Institute, and currently President of the International Society for Stem Cell Research. Dr. Daley received his bachelor's degree magna cum laude from Harvard University, a Ph.D. in biology from MIT, and his M.D. summa cum laude from Harvard Medical School. He is a fellow of the American Association for the Advancement of Science, a member of the American Society for Clinical Investigation, and has received the NIH Director's Pioneer Award, the Judson Daland Prize from the American Philosophical Society, and research awards from Harvard Medical School, the National Institutes of Health, the New England Cancer Society, the Burroughs-Wellcome Fund, the Edward Mallinckrodt, Jr. Foundation, and the Leukemia and Lymphoma Society of America.

Michele de Luca, University of Modena, Italy
Michele De Luca, MD is Full Professor of Biochemistry, Director, Centre for Regenerative Medicine and Interdepartmental Center for Stem Cells and Regenerative Medicine, University of Modena and Reggio Emilia, and Scientific Director of Holostem Terapie Avanzate S.r.l. Michele played a pivotal role in epithelial stem cell-mediated cell therapy and gene therapy. Beside his pioneering work on the use of human epidermal stem cell cultures in life-saving treatment of massive full-thickness burns and in repigmentation of stable vitiligo and piebaldism, he, and his prinicpal collaborator Graziella Pellegrini, were first in establishing human urethral epithelia stem cell cultures aimed at urethra regeneration in posterior hypospadias and human limbal stem cell culture aimed at corneal regeneration in patients with chemical burn-dependent corneal destruction. This latter treatment leads to recovery of vision in patients with poor alternative therapy. Michele is currently coordinating the first (successful) ex-vivo epithelial stem cell-mediated gene therapy clinical trial for the gene therapy of genetic skin diseases as Junctional Epidermolysis Bullosa.

Claude Gerstle, MDUSA
Dr. Gerstle had been dedicated to patient care for over 30 years before he became quadriplegic in a bicycle accident in August, 2003. Transformed from a knowledgeable physician to a questioning patient, he wondered if promising new stem cell research could cure his damaged spinal cord. He just finished the documentary, “Travels with My Dad" in search of that answer. In his role as the chief interviewer of the film, he tracked down the thinkers, the politicians, the crusaders and the naysayers in an effort to understand the potential of this exciting area of biomedical research and why a political quagmire in the United States is stalling its progress.

Prior to his accident, he founded a full service ophthalmologic clinical practice in New Jersey from 1975-2003 that focused on the diagnosis, management and surgical/medical treatment of ocular diseases. He is a graduate of the Massachusetts Institute of Technology and New York University Medical School. For the last four years he has been a trustee of MIT's Corporation.

He works on his physical rehabilitation for three hours daily and is becoming a better bridge player.

Bob Goldstein, JDRF, New York, USA
 Robert A. Goldstein, M.D., Ph.D. is the Chief Scientific Officer for JDRF where he is responsible for guiding national and international research programs of the foundation. He received his undergraduate degree from Brandeis University, his medical degree from Jefferson Medical College, his Ph.D. (in Microbiology/Immunology) from George Washington University and his MBA from the Stern School of Business, New York University. He is a Fellow of the American College of Physicians, the American College of Chest Physicians and the American Academy of Allergy, Asthma and Immunology.  Before joining JDRF in 1997, he was Director of the Division of Allergy, Immunology and Transplantation at the National Institute of Allergy and Infectious Diseases of the US National Institutes of Health (Dr. Anthony Fauci, Director). 

He has authored more than 50 scientific publications and is a reviewer for scientific journals including the American Journal of Respiratory and Critical Care MedicineAnnals of Internal MedicineJournal of the American Medicine Association, and the New England Journal of Medicine. He has served and continues to serve on many advisory committees, including the UK National Institute for Health Research Advisory Board, the US Food and Drug Administration Science Board, and the Agenxia Italiana del Farmaco. He has participated in National Academy of Sciences workshops on Embryonic Stem Cell Research, and on California Institute of Regenerative Medicine advisory committees. He has represented JDRF at the International Stem Cell Forum since its inception in 2003.

Göran Hermerén, Lund University, Sweden
Göran Hermerén, Professor of Medical ethics,  Lund University, Sweden since 1991, professor of philosophy, Lund University 1975. Previously visitng fellow at Princeton University, University of Michigan and Trinity College, Dublin, published books and papers on aesthetical and ethical problems raised by research in medicine. Partner in several EU-funded projects on stem cell research. Chairman of the advisory board of the German reference centre for ethics in the life sciences DRZE (Bonn). President of the European Group on Ethics in Science and New Technologies (Brussels).

Göran Hermerén, Professor of Medical ethics,  Lund University, Sweden since 1991, professor of philosophy, Lund University since 1975. Previously visitng fellow at Princeton University, University of Michigan and Trinity College, Dublin. Has published books and papers on aesthetical and ethical problems in international periodicals.  Partner in several EU-funded projects on stem cell research. Partner in several research projects funded by the EU. Member of the National Council on Medical Ethics in Sweden since its start. Chairman of the ethics committee of the Swedish Research Council (Stockholm), chairman of the advisory board of the German reference centre for ethics in the life sciences DRZE (Bonn) and President of the European Group on Ethics in Science and New Technologies (Brussels).

Katherine High, University of Pennsylvania, Pennsylvania, USA
 Katherine High graduated from Harvard with a degree in Chemistry before carrying out her M.D. studies at the University of North Carolina (UNC) School of Medicine. She then trained as a Fellow in the Hematology Section at Yale University School of Medicine for four years, before returning to UNC as a faculty member in the Department of Medicine and the Curriculum in Genetics. Later, she moved to Philadelphia to her present concurrent positions as William H. Bennett Professor of Pediatrics at the University of Pennsylvania School of Medicine, Investigator, Howard Hughes Medical Institute, and Director, Center for Cellular and Molecular Therapeutics at The Children's Hospital of Philadelphia.

Dr. High's research interests have focused on the molecular genetic basis of blood coagulation. The work involves structure-function studies and gene expression analysis of factors involved in the coagulation process.  More recently, her work has focused on development of novel therapeutics for hemophilia, which includes completion of clinical trials of an AAV-mediated, liver-directed approach.

Dr. High has published over 100 scientific articles, including one of the first reports of gene transfer in patients with hemophilia B.  She is an active member and Councillor of the American Society of Hematology, serves on the National Heart, Lung, and Blood Institute Advisory Council, and Past President of the American Society of Gene Therapy.  Dr. High is an associate editor of the Journal of Clinical Investigation, and also serves on the editorial boards of BloodHuman Gene Therapy and Molecular Therapy.

Hyun Ok Kim, Yonsei University, Korea
Hyun Ok Kim, M.D., Ph.D. is a professor in the Department of Laboratory Medicine at Yonsei University College of Medicine, Seoul, Korea.  She is presently the medical director in Transfusion Medicine and the director of the Severance Hospital Cell Therapy Center.

Dr. Kim received her M.D. degree at Yonsei University in 1982.  She then completed her intership and residency in the Department of Clinical Pathology at Severance Hospital, affiliated with Yonsei University Medical Center in 1982-1985, and received her Ph.D. from Yonsei University in 1990.  Furthermore, she trained as a post-doctoral research fellow at Johns Hopkins Medical Institute in Baltimore, USA.  Subsequently, she became professor in the Department of Laboratory Medicine at Yonsei University College of Medicine in 2004. 

Dr. Kim serves as a member in multiple associations, including the Korean Society of Blood Transfusion, the Korean Society of Laboratory Medicine, the Korean Society of Hematology, American Association of Blood Transfusion (AABB), Internal Society of Celllular Therapy (ISCT), International Society of Blood Transfusion (ISBT).  She has also been the academic consultant of Korean Red Cross Blood Research Center from 1989, served as a council member of Nation Blood Safety and Control Advisory Committee since 2004, and participated in the Cell Therapy Advisory Committee in association with the Korean FDA since 2005.  She also acted as the vice director of Blood Safety Improvement TFT, Korea, and was elected to be the Chairman of the Board in the Korean Society of Blood Transfusion in 2005-2008. 

She is currently studying various areas in transfusion medicine and cellular therapy.  Her interests include the establishment of guidelines for clinical application involving human participation in transfusion and cellular therapy, which are collaborative projects with the KFDA.  She is also actively studying human cord blood stem cells and their differentiation into red blood cells, hepatocytes, dendritic cells, etc.  Her projects include establishment of methods designed to amplify these cells for clinical application. 

HP Lee, National University of Singapore, Singapore
Dr LEE Hin-Peng is Professor and former Head (1987-2001) in the Department of Community, Occupational and Family Medicine, National University of Singapore.  He was also Vice-Dean of the Medical Faculty (1985-1997) and Chairman of the Specialist Training Committee in Public Health (1987-2004). His main teaching and research interests are in non-communicable disease epidemiology, especially cancer epidemiology and prevention. He is co-Principal Investigator of the NUS-UM Chinese Health Study (The Singapore Cohort Study) and Chairman of the Singapore Cancer Registry.  He graduated from the University of Singapore's Medical School in 1971, obtained the M.Sc. (Public Health) and also the Fellowship of the UK Faculty of Public Health (FFPH) of the Royal Colleges of Physicians.  He has also done postgraduate work in the UK and USA.  In addition, he was on the Singapore Medical Council (1989-2004) and continues on the Board of St Luke's Hospital, where he is Chairman of St Luke's Eldercare. He was also Master of King Edward VII Hall at National University of Singapore (1996-2005). In 2003, he was appointed Chairman of the NUS Institutional Review Board (IRB), and in 2005 was also Chairman of the Working Group for the Health Services Research Unit of the School of Medicine. Recently, he was appointed Deputy Chair of the Singapore Bioethics Advisory Committee. He received the Public Service Star from the Government in 2005.

Ephrat Levy-Lahad, Israel
Ephrat Levy-Lahad, MD is director of the Medical Genetics Unit at Shaare Zedek Hospital in Jerusalem, Israel and associate professor of Internal Medicine and Medical Genetics at the Hebrew University-Hadassah Medical School. She received her MD degree from Hebrew University-Hadassah Medical School (1989; Jerusalem, Israel) trained in Internal Medicine at Shaare Zedek Medical Center and in Medical Genetics at the University of Washington in Seattle. She is board certified in Internal Medicine (Israel) and in Clinical and Clinical Molecular Genetics (USA and Israel).

Dr. Levy-Lahad's clinical laboratory includes a large preimplantation diagnosis service, and cancer genetics diagnostics. Her research laboratory focuses on genetic epidemiology of breast cancer, in particular BRCA1 and BRCA2, and genetic and environmental modifiers of penetrance of these genes.

Dr. Levy-Lahad is a current member of Israel's National Bioethics Committee, Israel's National IRB Committee for Genetics and Reproductive studies, and of UNESCO's IBC (International Bioethics Committee).

Lingsong Li, Peking University, China
 Lingsong Li, born in 1962, graduated from Bethune University of Medical Science with his M.D.  He received his Ph.D. major in Molecular and Cellular Biology from the University of Washington.  He worked as a senior research fellow at Stanford University before joining Peking University.  He is now the Yazhi-river Professor and Director of Peking University Stem Cell Research Center.  He also served as the Chairman of the Department of Cell Biology, Peking University Health Science Center.  In addition, he is the principle investigator and the chief scientist for the national “973" and “863"stem cell project.

His research is addressing the molecular mechanism in regulation of ES cell self-renewal by a global comparison of ES cells versus PGC cells.  He also interested in the PAX6-SOX2 interaction in regulation of neural stem cell biology.

Bernard Lo, UCSF, California, US
Dr. Bernard Lo is Professor of Medicine and Director of the Program in Medical Ethics at UCSF.  He is National Program Director for the Greenwall Faculty Scholars Program in Bioethics, a career development award for junior faculty members.  He is co-chair of the Standards Working Group of the California Institute of Regenerative Medicine, which will recommend regulations for stem cell research funded by the state of California under Proposition 71.  He is also a member of the California Human Stem Cell Research Advisory Committee, which will recommend guidelines for stem cell research carried out in California funded from other sources.  He chairs the UCSF committee on Gamete, Embryo, and Stem Cell Research, which oversees all such research.  He previously served on the 1994 NIH Advisory Board on Research on Human Embryos and on the California Advisory Commission on Human Cloning (1998-2002).

He also serves on the Data and Safety Monitoring Committees for diabetes prevention trials at NIDDK and a HIV vaccine trial at NIAID.  He is a member of the Ethics Working Group of the NIH-sponsored HIV Prevention Trials Network, which carries out clinical trials in developing countries.  He is co-Director of the Policy and Ethics Core of the Center for AIDS Prevention Studies at UCSF, which provides technical advice and consultation to researchers carrying out clinical research, including research in resource-poor nations.  He is a member of the steering committee of the UCSF K-12 Roadmap program that provides training in interdisciplinary clinical research. 
           
He is a member of the Institute of Medicine (IOM) and serves on the IOM Council.  He chairs an NAS/IOM committee on conflicts of interest in medical research, medical education, clinical care, and practice guideline development.  He served on the National Bioethics Advisory Committee (1996-2001) and served the Recombinant DNA Advisory Committee at NIH.  He developed a course on Responsible Conduct of Research at UCSF that 120 postdoctoral fellows and junior faculty take each year.  He also carries out research on ethical issues in human participants research and other topics in bioethics. 

Dan Marshak, PerkinElmer, Massachusetts, USA
Daniel R. Marshak, Ph.D. is Vice President and Chief Scientific Officer for PerkinElmer, Inc. (NYSE:PKI). Dr. Marshak is responsible for setting the strategic direction of PerkinElmer's research and development functions, and helping drive its growth strategies in the emerging areas of personalized medicine and predictive diagnostics. Most recently, Dr. Marshak was Vice President & Chief Technology Officer, Biotechnology, for Cambrex Corporation (NYSE:CBM), setting strategy in biosciences and participating in corporate and commercial activities. Dr. Marshak joined Cambrex in 2000, and through 2001 led R&D worldwide for the Bioscience sector. Concurrently, Dr. Marshak also holds an appointment as Adjunct Associate Professor at The Johns Hopkins University School of Medicine, Baltimore, Maryland.

Previously (1994-2000), Dr. Marshak was Senior Vice President and Chief Scientific Officer for Osiris Therapeutics, Inc., a U.S. biotechnology company developing adult stem cell products for the regeneration of diseased or damaged tissues. He was previously (1986-1995) Senior Staff Investigator at the Cold Spring Harbor Laboratory, Long Island, New York, where he and the members of his laboratory conducted research in signal transduction, cellular growth control, and differentiation. Dr. Marshak was concurrently (1987-1994) Assistant Professor, School of Medicine, State University of New York at Stony Brook, where he taught graduate biochemistry.

Dr. Marshak received his B.A. from Harvard University, Cambridge, Massachusetts, in Biochemistry & Molecular Biology, and his Ph.D. from The Rockefeller University, New York City, in Biochemistry & Cell Biology. He did postdoctoral research in Pharmacology at Vanderbilt University School of Medicine, Nashville, Tennessee, and at the National Institutes of Health, Bethesda, Maryland. Dr. Marshak has received several awards for scientific and academic achievements. He is also an inventor on six issued U.S. patents.

Dr. Marshak has extensive research experience in the growth control of human cells. Dr. Marshak is author of more than 100 scientific publications, including one textbook, and he has been editor of five monographs. The most recent monograph, Stem Cell Biology, was published in 2001 by The Cold Spring Harbor Laboratory Press.

Angela McNab, Department of Health, United Kingdom
 Angela has been seconded to the Department of Health for six months to work as Director of Public Health and Performance for the Chief Medical Officer.
           
Angela McNab started her career in the NHS as a clinician before moving into general health management. She is a qualified Speech and Language Therapist. She held a variety of senior positions in Community and Mental Health Trusts

In 1999 Angela joined the Department of Health to lead on the development of the National Sexual Health and HIV Strategy. This gave her experience of working in a very high profile and sensitive field.

She returned to the NHS as Chief Executive of a newly formed North East London Primary Care Trust leading that organisation to achieve the highest performance rating across London at the end of its first year.

In 2002 Angela moved into her current role as Chief Executive of the Human Fertilisation and Embryology Authority and in 2005 became the first Chair of the European Assisted Conception Consortium.

Megan Munsie, Australian Stem Cell Centre, Australia
Dr Megan Munsie has recently joined the Australian Stem Cell Centre as the Director of Government Affairs and Policy.  The Australian Stem Cell Centre is Australia's Biotechnology Centre of Excellence. The Centre's principal objective is to integrate a national multi-institutional research and discovery program to develop treatments for serious disease through the application of stem cells and related technologies.  Megan's role within the Centre is to advise on scientific strategy, provide oversight of ethics procedures and policy, facilitate new collaborative ventures and liaise with researchers within and external to the organisation.

Previously, Megan was the Australian Scientific Development Manager of the UK listed biotechnology company, Stem Cell Sciences, where she was responsible for the coordination and integration of the Australian group's research activities within the SCS network and with local and international collaborators.

Megan is fascinated by all aspects of stem cell biology with a particular interest in derivation and differentiation of embryonic stem cells. Megan is a member of the successful Stem Cell Sciences team that derived the MEL series of human embryonic stem cell lines in a NHMRC licensed project with Melbourne IVF and the Australian Stem Cell Centre. She has also been involved in an innovative strategy to derive purified populations of mouse neuronal cells for use in drug screening and development.

In 2000, Megan published the first proof-of-principle for ‘therapeutic cloning'. In this ground breaking paper she demonstrated that it was possible, through the technique of somatic cell nuclear transfer (SCNT), to reprogram the nucleus from an adult mouse cell back to an ‘embryonic' state. By generating an embryonic stem cell line from the resulting nuclear transfer ‘embryo', she provided the first evidence that the generation of individual-specific stem cell lines was feasible.

Megan has been actively involved in petitioning for reform to the current Commonwealth legislation that would allow Australian scientists the opportunity to use SCNT to generate disease-specific cells for disease modelling and drug discovery.

Megan is skilled in all aspects of assisted reproductive technology with over twelve years experience as an embryologist in several IVF practices in Australia. Megan completed her undergraduate degree at the Queensland University of Technology and has received a Masters of Reproductive Sciences and Doctorate of Philosophy from Monash University.

Hiro Nakauchi, University of Tokyo, Japan
Hiro Nakauchi obtained a M.D. from Yokohama City University School of Medicine and a Ph.D. in immunology from University of Tokyo Graduate School of Medicine.  He isolated CD8 genes during his post-doc period at the Laboratory of Prof. Leonard Herzenberg at Stanford University. After coming back to Japan, he started working on hematopoietic stem cells in his laboratory in RIKEN. In 1994, he became Professor of Immunology in the University of Tsukuba where he determined the phenotype of mouse hematopoietic stem cells and established an in vivo clonal analysis system.  Since April 2002, he has been a Professor of Stem Cell Therapy in the Institute of Medical Science at the University of Tokyo.  Goals of his work are to clarify the mechanism of stem cell self-renewal and to contribute to the cell/gene therapy and regenerative medicine. 

Carlos Simon, Valencia Stem Cell Bank, Spain
 Obtained his MD degree with award of excellence from Valencia University in 1985 and is Board Certified Obstetrics and Gynecologist after completing his residency in Obstetrics & Gynecology in the University Clinical Hospital of Valencia from 1986 to 1991 and Doctor after passed his Doctoral Thesis in Valencia University. Founded by a grant from the Spanish Government, Dr. Simon completed a postdoctoral research fellowship on Reproductive Immunology in the Department of Ob/Gyn at Stanford University, California USA, from 1991 to 1994.
Since 1994 he has been Associate Professor in the Department of Pediatrics, Obstetrics and Gynecology, at Valencia University Spain, and Scientific Director of the Instituto Valenciano de Infertilidad Foundation (FIVI). In 2004, He has been appointed as Head of the Valencia Stem Cell Bank and Coordinator of Regenerative Medicine Príncipe Felipe Research Centre, a private non-profit organism devoted to stem cell derivation and research. In 2007 he obtains the first place in the national examination to become Full Professor at the University of Valencia. Research in his laboratory focuses on human embryonic implantation, uterine receptivity, human embryonic and adult stem cells leading to the publication of over 232 per review papers and 12 books. Since 2001, his background on Reproductive Medicine led him to the research on human embryonic stem cells in Spain. His group derived the first two clinical grade embryonic stem cell lines in Spain, named Valencia 1 and 2 (VAL1 and VAL2) and recently, his lab derived and published Val-3, -4, -5. Awarded by the Spanish Fertility Society in 1991, 2001 and 2003; Society for Gynaecological Investigation (SGI) (President Poster Award), in 1993 (President's Presenter Awards) 2002, and the Society of Reproductive Endocrinologist of the American Society for Reproductive Medicine (ASRM) in 1993, 1995, 1997, 1999, 2001 and 2005. Member of the Editorial Board of several international publications including Human Reproduction and Reproductive Biomedicine on line. Dr. Simon has served as member in the research committees of international societies including SGI, ASRM, ESHRE and IFFS and the World Health Organization as member of the HRP Scientific and Ethical Review Group since 1998.

Alok Srivastava, Christian Medical College, India
 Alok heads the Department of Haematology at CMC, Vellore which provides the largest comprehensive haematology service in India that also includes the largest stem cell transplantation program in the country. He is also responsible for establishing the Center for Stem Cell Research in this institution. This is a joint venture of the Department of Biotechnology, Government of India with CMC, Vellore, first of its kind in the country, and is aimed at developing translational research with stem cells. As co-chair of the national task force for stem cell research in India, he is also involved with planning and supporting this field in the country. He is  involved with both basic research and clinical trials with stem cells. His other research interest is in haemostasis, where he chairs the FVIII / IX subcommittee of the Scientific and Standardization committee of the International Society on Thrombosis and Haemostasis.

Jeremy Sugarman, Johns Hopkins University, Maryland, US
 Jeremy Sugarman, MD, MPH, MA is the Harvey M. Meyerhoff Professor of Bioethics and Medicine, Professor of Medicine, Professor of Health Policy and Management, and Deputy Director for Medicine of the Berman Institute of Bioethics at the Johns Hopkins University. Dr. Sugarman conducts both theoretical and empirical research in medical ethics. His work concentrates on informed consent, research ethics, and the ethical issues associated with emerging technologies. He is the author of over 150 publications in peer-reviewed journals.  In addition, he has edited or co-edited four books (Beyond Consent: Seeking Justice in Research; Ethics of Research with Human Subjects: Selected Policies and Resources; Ethics in Primary Care; and Methods in Medical Ethics).  Dr. Sugarman is a contributing editor for IRB, and is on the editorial boards of Accountability in Research, the American Journal of Bioethics, Clinical Trials, and Theoretical Medicine and Bioethics. Dr. Sugarman serves on the Scientific and Research Advisory Board for the Canadian Blood Service and the Maryland Stem Cell Research Commission.  He is currently Chair for the Ethics Working Group of the HIV Prevention Trials Network, the Ethics Officer for the Resuscitation Outcomes Consortium, and Co-Chair of the Johns Hopkins' Embryonic Stem Cell Research Oversight Committee.  Dr Sugarman is a member of the American Society of Clinical Investigation and a Fellow of the American Association for the Advancement of Science, the American College of Physicians, and the Hastings Center.

Patrick Taylor, Children's Hospital Boston, Massachusetts, USA
 Patrick L. Taylor is Deputy General Counsel and Chief Counsel, Research Affairs, at Children's Hospital Boston, in a position focused mostly on legal and policy issues in biomedical research, biotechnology
(including intellectual property, start-ups and licensing), research ethics, privacy, human subject protection and compliance.   He has had a diverse career in representing and counseling not-for-profit, for-profit, and government clients involved in health, biotechnology, medical research, and human services.   He received his BA from the University of Wisconsin-Madison  (Phi Beta Kappa, highest honors), and received his JD with honors from Columbia University Law School.  He also holds a faculty position as a Lecturer at Harvard Medical School.  His research and writing focus on issues in research ethics, academic-industry collaborations, conflicts of interest, stem cell research, privacy, and the electronic medical record network.  His writings have appeared in Science, Nature Biotechnology, Cell Stem Cell, Academic Medicine, Drug Development, and Science and Engineering Ethics, as well as numerous legal journals.

Anna Veiga, Barcelona Stem Cell Bank, Spain
Born in Barcelona in 1956. Graduated in Biology (1974-1979). Ph.D. in Biology (Cum Laude). Universidad Autonoma de Barcelona 1991.  IVF laboratory Director (1982-2004), Scientific Director of Servei de Medicina de la Reproducción, Dpto Obstetricia y Ginecología, Institut Universitari Dexeus (2005).  Director of the Barcelona Stem Cell Bank . Centre for Regenerative Medicine in Barcelona. (May 2005) Coordinator of the Msc Master course on Reproductive Biology and ART, Universitat Autónoma de Barcelona since 1998.  Associate professor of Departament de Ciències Experimentals i de la Vida, Universitat Pompeu Fabra since 2002.  Founder and President of the Spanish Embryologist Society (ASEBIR) (1993 –2003).  Member of the Alpha Scientists in Reproductive Medicine Executive committee (1998-2002).  Member of the Executive committee of the European Society for Human Reproduction and Embryology (ESHRE) (2001- 2005). Chairman of the Special Interest Group in Stem Cells.  Scientific Coordinator of European Human Embryonic Stem Cell Registry(EU hESCreg)(2006- ).  Actively involved in Assisted Reproductive Technologies (ART) since the early times of In Vitro Fertilization, she has published many articles in national and international journals and book chapters related to the field. She has participated in national and international meetings as well as in the diffusion of ART in Spain. Actively involved in Bioethics, she is the director of the "Bioethics in Biomedical Research" Group, Comite Consultiu de Bioetica de Catalunya. Her main areas of interest are Clinical Embryology, Reproductive Genetics, Embryonic Stem Cell research and Bioethics. Scientific Director of the Reproductive Medicine Service. Institut Universitari Dexeus. Barcelona Director of Barcelona Stem Cell Bank. Centre for Regenerative Medicine CMR[B]. Parc de Recerca Biomedica de Barcelona.