Joyce Frey-Vasconcells, Ph.D., Regulatory Expert, Frey-Vasconcells Consulting
Dr. Frey-Vasconcells is considered one of the foremost regulatory experts regarding cell therapies, combination products, gene therapies, tumor vaccines and tissues and brings extensive regulatory expertise and experience for this unique group of products. Prior to starting Frey-Vasconcells Consulting, Frey-Vasconcells served six years as a regulatory consultant for Pharmanet, working with industry whose mission is to foster product development in the areas of cell therapy, tissues, gene therapy and tissue engineered products. Prior to joining Pharmanet, she served more than 12 years at the FDA. There, Frey-Vasconcells was the Deputy Director, Office of Cellular, Tissue, and Gene Therapies (OCTGT) with the Center for Biologics Evaluation and Research (CBER). She was instrumental in developing many of CBER’s science and public health policies regarding the regulation of cells, tissues, gene therapies, tumor vaccines and combination products (tissue engineered products). In 2001, Dr. Frey-Vasconcells was named the Regulatory Expert for Cell Therapies at FDA. She also served on various committees related to combination products, tissue reference group, and HHS committee on tissue engineering, to name a few. Since starting Frey-Vasconcells Consulting, she has continued working with industry on an individual basis and with organizations whose mission is to foster product development in the areas of cell therapy, tissues, gene therapy and tissue engineered products.
Tatsuo Heki, Senior Expert, Fujifilm Healthcare Business Development Office
In addition to his role at Fujifilm Healthcare, Heki is currently the Chair of the Japanese ISO/TC276 (Biotechnology) mirror committee. He is also leading the ISO/TC276/TG4 (Bioprocessing) at the international level, which will work on regenerative medicine standards. He represents the Standards Working Group at FIRM (Forum for Innovative Regenerative Medicine), which is the primary industry association promoting regenerative medicine in Japan. He has been working on standards since the Advanced Photographic System, which is the last photographic film system in its history.
Silviu Itescu, M.B.B.S., CEO & Managing Director, Mesoblast
Prior to founding Mesoblast in 2004, Professor Itescu established an outstanding international reputation as a physician scientist in the fields of stem cell biology, autoimmune diseases, organ transplantation and heart failure. He is an active faculty member of Melbourne and Monash Universities in Australia and was previously a faculty member of Columbia University in New York. Under his leadership, Mesoblast received the 2011 Deals of Distinction™ Award from The Licensing Executives Society (United States and Canada) for its alliance with Cephalon, Inc., later acquired by Teva Pharmaceutical Industries Ltd, and the 2013 Scrip Award for Financing Deal of the Year. In 2011, Itescu was named BioSpectrum Asia Person of the Year. In 2013 he received the inaugural Key Innovator Award from the Vatican’s Pontifical Council for Culture for his leadership and ingenuity in translational science and clinical medicine in relation to adult stem cell therapy. Itescu has consulted for various international pharmaceutical companies, has been an adviser to biotechnology and health care investor groups and has served on the Board of Directors of a number of publicly-listed life sciences companies.
Perry Karsen, CEO, Celgene Cellular Therapeutics; EVP & COO, Celgene Corporation
Mr. Karsen was appointed CEO of Celgene Cellular Therapeutics (CCT), the company’s placental stem cell research and development division, in May, 2013. Previously, Karsen was Senior VP and Head of Worldwide Business Development at Celgene and was also responsible for emerging businesses as President, Asia/Pacific Region. From 2009-2010, Karsen served as President and CEO at Pearl Therapeutics, a privately-held biotechnology company that was subsequently acquired by Astra-Zeneca. Karsen also held executive roles at Human Genome Sciences, Bristol-Myers Squibb, Genentech and Abbott Laboratories. In addition, Karsen was a General Partner at Pequot Ventures. Karsen is a member of the Board of Directors of the Biotechnology Industry Organization (BIO), BayBio and The Life Sciences Foundation. He is also a member of the Board of Directors of Agios Pharmaceuticals and Alliqua, Inc.. Karsen has a Masters of Management degree from Northwestern University’s Kellogg Graduate School of Management, a Masters in Teaching of Biology from Duke University, and a B.S. in Biological Sciences from the University of Illinois, Urbana.
Jason Kolbert, M.B.A., Head of Healthcare Research, Senior Managing Director & Biotechnology Analyst, Maxim Group
Mr. Kolbert has worked extensively in the healthcare sector as product manager for a leading pharmaceutical company, a fund manager and as an equity analyst. Prior to joining Maxim Group, he spent seven years at Susquehanna International Group where he managed a healthcare fund and later founded SIG’s sell-side biotechnology team. Previously, Kolbert served as the healthcare strategist for Salomon Smith Barney. He is frequently quoted in Barron’s and is regularly featured on CNBC. Prior to beginning his Wall Street career, Kolbert served as a product manager for Schering-Plough in Osaka, Japan. He received a B.S. in Chemistry from SUNY New Paltz, and an M.B.A. from the University of New Haven.
Bruce Levine, Ph.D., Barbara & Edward Netter Associate Professor in Cancer Gene Therapy, Department of Pathology & Laboratory Medicine, University of Pennsylvania (Penn)
Dr. Levine is the Director of the Clinical Cell and Vaccine Production Facility (CVPF) at the Abramson Cancer Center and Perelman School of Medicine, in addition to his responsibilities in the Department of Pathology and Laboratory Medicine. He is also an alumnus of Penn and received his Ph.D. in Immunology and Infectious Diseases from the Johns Hopkins University in 1992. While a post-doctoral fellow at the Naval Medical Research Institute in Bethesda, he developed a system for large-scale efficient culture of T lymphocytes that has proved to be the foundation for over 35 early-phase clinical trials of adoptive immunotherapy. At the CVPF, Levine oversees 40 clinical laboratory scientists and regulatory professionals, as well as the development, manufacturing and testing of novel cell and gene therapies in clinical trials at Penn and collaborating institutions in hematologic malignancies, solid tumors, HIV infection and genetic disease. The CVPF, which currently supports 21 FDA IND’s and holds three Biologics Master Files, has been accredited by the Foundation for the Accreditation of Cellular Therapy. Levine and the CVPF produced cells for the first infusions of purified activated CD4+ T cells as adoptive immunotherapy, directed the first lentiviral transduced cell infusions, and the first infusions of zinc-finger nuclease-modified CD4 T cells. Based on the platform of gene modified T cells Levine and colleagues developed, Penn and Novartis entered into an exclusive global collaboration to research, develop and commercialize targeted chimeric antigen receptor (CAR) immunotherapies for the treatment of cancers. Levine has overseen the production, testing and release of 2000 cellular products administered to over 650 patients in clinical trials since 1996.
Geoff MacKay, President & CEO, Organogenesis Inc.
Mr. MacKay has served in his current leadership role since December 2003. MacKay provides Organogenesis with significant global, commercial experience spanning the pharmaceutical and biotechnology sectors. MacKay has held numerous leadership positions within Novartis AG in roles such as Vice-President and Business Unit Head, Transplantation and Immunology at Novartis Canada, Vice-President of Tissue-Engineering in Novartis USA, Head of Global Sales Immunology and Transplantation based in Basel, Switzerland, and prior to that as Sales and Marketing Manager of Novartis Biotech Europe. MacKay has been specifically involved in the emerging field of regenerative medicine for the last decade. He currently serves as Chairman of the Board of Directors for the Massachusetts Biotechnology Council (MassBio), and as Chair of the Alliance for Regenerative Medicine (ARM).
Andrew Pecora, M.D., Chief Visionary Officer, NeoStem; Co-Founder & Chief Medical Officer, Progenitor Cell Therapy (PCT)
Dr. Pecora, was appointed to NeoStem’s Board of Directors in December of 2011. Pecora is also Co-Founder and past Chairman and CEO of PCT, which is a subsidiary of NeoStem. Pecora served as NeoStem’s Chief Medical Officer from August of 2011 until his appointment to Chief Visionary Officer in August of 2013. Prior to the acquisition, Pecora had served from 1999 to 2011 as Chairman, CEO and Chief Medical Officer of PCT, and as a member of PCT’s Board of Managers. Pecora is also Chief Scientific Officer of Amorcyte, Inc., a subsidiary of NeoStem acquired in October 2011, and held such position prior to the acquisition.
Marc Penn, M.D., Ph.D., Director of Research, Summa Cardiovascular Institute; Professor of Medicine & Integrative Medical Sciences, Northeast Ohio Medical University
Dr. Penn is a cardiologist and serves as the first Director of the Cardiovascular Disease Fellowship at Summa Cardiovascular Institute, in addition to his other roles. Penn was a staff cardiologist at the Cleveland Clinic from 2000-2011 where he served as the Director of the Coronary Intensive Care Unit, Director of the Experimental Animal Laboratory, Director of the Bakken Heart-Brain Institute and the first Director of the Center for Cardiovascular Cell Therapy. From 2008-10 Penn served as the Senior Medical Director for Emerging Businesses at Cleveland Clinic. He is recognized as one of the top 50 doctors in the history of the Cleveland Clinic (MedCity News, December 2011). Penn completed his undergraduate and postgraduate work at Case Western Reserve University. He completed his Internal Medicine training at University Hospitals of Cleveland and his Cardiovascular Medicine Fellowship at Cleveland Clinic. Penn has an adjunct appointment at Case Western Reserve University in the Department of Biomedical Engineering and the Bioengineering Center at Cleveland State University. He is the founder and CSO/CMO of Juventas Therapeutics and SironRx Therapeutics, privately funded clinical stage regenerative medicine companies founded on intellectual property developed in his laboratory for cardiovascular disease and cosmetic wound healing, respectively. He is co-founder and CMO of Cleveland Heart Labs, a diagnostic company based on biomarkers associated with coronary artery disease, myocardial infarction and other inflammatory diseases that now services over 3000 physicians nationwide. Penn is the PI of the Athersys’ MultiStem in AMI Phase I and II trials, serves on the Scientific Advisory Board (SAB) of NeuroTronik and formerly served on the Aastrom Biosciences SAB. He is a Venture Partner with Oakwood Medical Investors, served on the SAB of Frantz Medical Ventures and as a Clinical Partner with Foundation Medical Partners representing the interests of the Cleveland Clinic.
Thomas Povsic, M.D., Ph.D., Associate Professor of Medicine, Duke University Medical Center
Dr. Povsic received his Ph.D. in Bio-organic Chemistry from the California Institute of Technology and his M.D. at Harvard Medical School. Since 2004 he has been on the faculty at Duke University. His key research interest include the role of cell therapy in vascular disease and the development and translation of novel basic therapeutics to clinical use. Povsic has led a laboratory interested in the assessment of endothelial progenitor cells (EPCs) in a variety of clinical conditions, developing a novel circulating progenitor cell assay and leading core laboratories for the NIH sponsored REVEAL acute MI multicenter study, as well as 10 other clinical programs. Povsic helped lead the MARVEL trial, studying the role of myoblast administration for treatment of congestive heart failure, and is currently the national co-Principal Investigator of the pivotal Phase III RENEW trial, assessing the effectiveness of autologous CD34+ cells for treatment of refractory angina. Povsic has led several other translational projects including RADAR, the first clinical use of a novel aptamer antithrombotic, and leads discovery translational efforts at DCRI to incorporate mechanistic studies into clinical projects.
Robert Preti, Ph.D., President & Chief Scientific Officer, Progenitor Cell Therapy (PCT)
Dr. Preti has overseen the growth of PCT from its inception to its position as a world-leading commercial cell therapy development and manufacturing company. The company has now served over 100 clients and performed more than 30,000 cell therapy procedures. Preti’s leadership has been instrumental in creating PCT’s client-focused model that helps bridge the gap between discovery and patient care through efficient transfer of cell-based therapies from laboratory into clinical practice. Previous positions held include Scientific and Laboratory Director of Hackensack University Medical Center’s stem cell processing and research laboratory, and Scientific Director of the Clinical Services Division at the New York Blood Center. Preti is a founding member the International Society for Cellular Therapies (ISCT) and served on its executive committee and board of directors for 10 years. He recently completed a five year term as a Director for AABB, and is currently an Executive Committee member for the Alliance for Regenerative Medicine (ARM). Preti holds a B.S. degree in Biology from Fordham University, and a Master of Science degree and Doctorate, both in Biology, from New York University.
Eric Roman, M.B.A., General Manager, Research and Applied Markets, GE Healthcare Life Sciences
Mr. Roman was appointed to his current position at GE Healthcare Life Sciences in January 2013. GE Healthcare Life Sciences is a $3.7 billion unit of GE Healthcare, and the Research and Applied Markets business is focused on providing world-class tools and technologies for drug discovery, cell science, cell bioprocessing and adjacent applications such as forensics and diagnostics. Roman began his career with GE in 1989 with GE Transportation Systems, where he held a variety of commercial positions, including a four-year overseas assignment as Regional Sales Manager for Australia and New Zealand. While at GE Transportation, Eric also led the development and launch of GE’s locomotive remote monitoring and diagnostics platform, which was a global first and now is an industry standard. In 2000, Roman joined GE Healthcare as a Business Development Manager with responsibly to help define the company’s molecular imaging strategy. This was followed by a progression of positions including leading GE Life Sciences’ Manufacturing Operations, Genomic Sciences Business Unit, Global Services, Americas Sales & Services, and Global Commercial activities before being named to his current position. Roman earned his bachelor’s degree in Mechanical Engineering from The Ohio State University. He subsequently earned his M.B.A. from Harvard Business School.
Robert Ross, M.D., Vice President, Clinical Development, bluebird bio
In addition to his role at bluebird bio, Dr. Ross is also a lecturer in medicine at the Dana Farber Cancer Institute, where he has instructed since the completion of his fellowship in hematology and oncology in 2005. Prior to bluebird bio, Ross served as Vice President, Clinical Development at Infinity Pharmaceuticals where he was responsible for overseeing all aspects of clinical development including IND filing, monitoring healthy volunteer and oncology Phase I through Phase III clinical trials, running scientific advisory board and data safety monitoring board meetings and representing the company at face-to-face meetings with the FDA and the EMA. Earlier in his career, Ross served as a Contract Medical Director for Genentech where he worked on the development of Avastin in colon cancer. Ross completed his internship and residency in internal medicine at UC San Francisco.
Gregory Russotti, Ph.D., Vice President, Technical Operations, Celgene Cellular Therapeutics
In his current position at Celgene Cellular Therapeutics, Dr. Russotti is responsible for process development, analytical method development, clinical manufacturing, quality control and quality operations. Prior to joining Celgene in 2006, Russotti spent nearly 15 years at Merck Research Laboratories developing products that included live virus vaccines, monoclonal antibodies, recombinant vaccines and microbially-produced natural products. He worked on development, scale-up and tech transfer of cell culture, microbial fermentation and downstream isolation processes to clinical and commercial manufacturing facilities. Russotti received his B.S. and M.S. degrees in Chemical Engineering from Rensselaer Polytechnic Institute and his Ph.D. in Chemical and Biochemical Engineering from Rutgers University.
Joshua Schimmer, M.D., M.B.A., Managing Director & Senior Research Analyst, Piper Jaffray
Dr. Schimmer joined Piper Jaffray in 2013 to cover biotechnology companies. Schimmer has been on the Street for more than 10 years. Prior to joining Piper Jaffray, he worked in equity research at Lazard Capital Markets, Leerink Swann and Cowen and Company. In addition, he spent time on the buy side at Davidson Kempner as part of the healthcare investing team. Schimmer holds an M.D. from the University of Toronto, where he specialized in Internal Medicine and sub-specialized in Rheumatology. He also holds an M.B.A. from Harvard Business School.
David Smith, M.B.A., Head of Therapeutic Cell Solutions, Lonza
Mr. Smith joined Cambrex Bioproducts in 2002 as the Business Unit Director of the emerging cell therapy contract manufacturing business. In 2004, he was promoted to Vice President, Business Development, and in December 2005 to Vice President, Cellular Therapeutics. In this role, Smith assumed responsibility for contract manufacturing, process development and clinical/commercial development of Cambrex’s Engineered Skin Substitute (ESS) for catastrophic burns. In 2009, two years following Lonza’s acquisition of Cambrex Bioproducts, Smith became Head of Therapeutic Cell Solutions with additional responsibilities for biotherapeutic media, process development, viral vaccines and gene therapies. In his current role, Smith is responsible for business development for the cell therapy division worldwide. Under Smith’s leadership the cell therapy contract manufacturing business has grown from start-up to market leader. Smith holds a B.S. in Pharmacy from Duquesne University in Pittsburgh, Pennsylvania and a M.B.A. from Wheeling Jesuit University in Wheeling, West Virginia.
Edward Tenthoff, Managing Director & Senior Research Analyst, Piper Jaffray
Mr. Tenthoff is focused on the drug discovery sector of the biotech industry. In April 2013, Tenthoff moderated a cardiovascular medicine panel at the International Adult Stem Cell Conference at the Vatican. He was ranked No. 2 Stock Picker in biotechnology by the 2012 Wall Street Journal “Best on the Street” survey and was ranked No. 1 stock picker for the life science tools and services sector in the 2006 Starmine Analyst Awards. Prior to joining Piper Jaffray in 2003, he covered the genomics sector at Robertson Stephens & Company, and was a medical technology analyst at Lehman Brothers. Tenthoff received a B.S. in International Relations from the University of Pennsylvania.
Andre Terzic, M.D., Ph.D., Michael S. & Mary Sue Shannon Director, Center for Regenerative Medicine; Marriott Endowed Professor in Medicine, Mayo Clinic
In addition to his other roles at Mayo Clinic, Dr. Terzic is Director of the J. Willard Jr. and Donna Marriott Heart Disease Program, Director of the National Institutes of Health Cardiovasology Program and Chair of the President’s Discovery-Translation Scientific Advisory Board. Terzic has pioneered cardioprotective and cardioregenerative modalities at Mayo Clinic. Most recently, he led efforts in the discovery and development of next generation regenerative solutions applied to heart failure. He has authored over 400 publications advancing diagnostic and therapeutic strategies in cardiovascular medicine, with his works cited over 11,000 times. Recognized for contributions to cardiovascular medicine and science, Terzic is the recipient of numerous prestigious national and international awards.
Elizabeth Wolffe, Ph.D., Vice President, Corporate Communications, Sangamo BioSciences
Dr. Wolffe has served in her current role since January 2014. She joined Sangamo in November 2000 as a scientist and moved into corporate communications in 2002. Prior to joining the Company, Wolffe was a staff scientist in the Laboratory of Viral Diseases at the National Institutes of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) where she worked with Dr. Bernard Moss on the structure and assembly of vaccinia virus and on HIV. Prior to that she worked for Glaxo Group Research in the U.K. Wolffe received her Ph.D. in Pharmacology from the Johns Hopkins University School of Medicine, an M.Sc.in Biochemistry from the University of London, U.K. and a B.Sc. in Biological Sciences from the University of Birmingham, U.K.