case western reserve university

9th Annual Business Education Course: Regenerative medicine




Arnold Caplan, PhD

is Professor of Biology and the Director of the Skeletal Research Center. Dr. Caplan received his PhD from The Johns Hopkins University School of Medicine, Baltimore, Maryland in 1981. He has received the Elizabeth Winston Lanier Award given by the American Academy of Orthopaedic Surgeons as part of their 1990 Kappa Delta Awards Program, the 1999 Marshall R. Urist Award for Excellence in Tissue Regeneration Research given by the Orthopaedic Research Society and the Genzyme Lifetime Achievement Award given by the International Cartilage Repair Society in 2007. He has over 350 published manuscripts and 15 issued patents. He founded Osiris Therapeutics, Inc, Cell Targeting, Inc. and also consulting company, aCa, and has pioneered cell-based therapies in Regenerative Medicine

Stewart Abbot, MSc, PhD

is Senior Director of Stem Cell Research (Celgene Cellular Therapeutics). He holds a B.Sc. in Biological Sciences (Edinburgh), M.Sc. in Biomedical Engineering (Glasgow) and Ph.D. in Pathology (London). His academic career focused on vascular biology, pharmacology and toxicology. He joined Amersham Biosciences (GE Healthcare) in 2000 to develop cell-based assay systems for pharmaceutical screening. Following acquisition of Amersham he transferred to General Electric's Global Research Center (Albany, NY) to manage the Molecular and Cellular Biology research laboratory. In this laboratory Dr. Abbot developed GE's expertise in umbilical cord blood and human stem cell biology. In 2007 he joined Celgene Cellular Therapeutics and now leads the group's efforts to isolate, characterize and develop novel therapeutics based on human placenta derived stem cells. This work is expected to result in clinical trials early in 2009. Throughout his career he has worked across the traditional boundaries of life and physical sciences and has managed a number of successful basic science and cell-based product development programs.

Thomas Flacklam, PhD

has 30 years of experience in the development and manufacture of drugs, biologics, devices and diagnostics for global markets. Additionally, he has extensive experience in development and commercialization of technologies from academic scientists and entrepreneurs. Dr. Facklam has led research and development and product development and manufacturing for a number of pharmaceutical and biotech companies. As Vice President of Drug Development for Serono, he was responsible for the development and manufacture of Saizen«, Gonal-F«, Rebif« . As Vice President, Development and Operations, at Creative BioMolecules, he led the development, manufacture and registration of OP-1« in a joint venture with Stryker. Prior to that role, Dr. Facklam served as Vice President of Technical Operation for Biomira where he was responsible for the development and manufacturing of the cancer vaccine, Theratope« and the development of Stimuvax« acquired by Merck. The global sale of all of these products is in excess of $2 billion annually. In addition to his extensive experience in product development, Dr. Facklam has been responsible for clinical research in Europe, South and Central America and Asia for Johnson & Johnson.
Prior to joining BioMotiv, Dr. Facklam had been a consultant to numerous early-stage biotechnology companies based on technologies emerging from academic medical centers. Dr. Facklam was CEO of the Institute for Food and Agricultural Sciences, Alberta (IFASA), a non-profit institution formed to develop and commercialize technologies from Canadian academic institutions which attracted over $65M investment.
Dr. Facklam has served on the boards of several non-profit companies and biomedical companies. Dr. Facklam received his Ph.D. in Biochemistry from The Ohio State University and his B.S. from Cornell University.

Robert A. Goodwin II

Vice President, Orthofix International NV

Robert J. Hariri, MD, PhD

is Chief Executive Officer of Celgene Cellular Therapeutics, is a scientist, neurosurgeon, inventor, and businessman who has established himself as a recognized leader in the development of new human cellular and tissue therapeutics. As founder of LifebankUSA, Dr. Hariri served as Chairman and Chief Scientific Officer before it was acquired by now parent company Celgene Corporation. He has made his life's work the quest to bring cells into the mainstream therapeutic market place so we can better treat and in some cases eradicate diseases such as leukemia and other cancers, anemias, heart disease, diabetes, paralysis and neurogenerative diseases such as Parkinson's and Alzheimer's. Dr. Hariri has held academic positions at Cornell University Medical College, Cornell University Graduate School of Medical Sciences. He has also played a prominent medical role at Cornell University Medical College, The New York Hospital-Cornell Medical Center and The Jamaica Hospital-Cornell Trauma Center.

Robert J. Harman, DVM, MPVM

is CEO, founder of Vet-Stem. Dr. Harman has more than 15 years of experience as a chief executive and biotechnology entrepreneur in three novel businesses, all financial successes. Dr. Harman is a veterinarian and statistician, and has overseen the completion of more than 1,000 contract research projects in his career for the development of veterinary and human biotechnology products. He has led the following companies: HTI Bio-Services, a contract research company; HTI Bio-Products, a biological reagent and antibody production company; and Animal Health Ventures, a veterinary product licensing company

Al Hawkins, MBA, MSc

has broad expertise in developing new biomedical companies based on technologies licensed identified from universities, hospitals and federal labs. He has spent his career at the intersection of academic institutions and start-up companies in the life sciences as an entrepreneur, fund manager, and university tech transfer officer. Mr. Hawkins was most recently CEO-in-Residence at BioEnterprise, where he launched and helped secure funding for two spin-out companies from academic institutions. Prior to BioEnterprise, Mr. Hawkins was the Director of New Ventures at Boston University, where he managed spin-out companies from the institution's $400 million annual research budget. There, he managed the $40 million BU Venture Fund and also led BU's Launch Award program which made convertible note investments in BU spin-outs. He also managed the BU Photonics Center Incubator and launched the Kindle Mentorship Program which served over 50 seed stage companies.
Formerly, Mr. Hawkins was a Technology Licensing Associate at Yale University and co-founder of Madison, Wisconsin-based Agave Group Venture Consulting, which developed strategy and raised funding for university life science spin-outs and conducted due diligence for early stage investors evaluating these opportunities. He led over 60 seed stage projects as a principal in Agave Group, helping raise over $50M and also co-founded TFX Bioscience, a therapeutics company that was based on technologies licensed from the University of Wisconsin-Madison and the University of Minnesota.
Mr. Hawkins received his BA in Economics from Emory University, an MBA from the University of Wisconsin-Madison and an MS from the Harvard-MIT Biomedical Enterprise Program. He serves as a frequent SBIR grant reviewer for NIH and in 2012, was awarded the Young Entrepreneur Initiative Fellowship from the French government.

Robert D. Hisrich MBA, PhD

is the Garvin Professor of Global Entrepreneurship and Director of the Center for Global Entrepreneurship at Thunderbird School of Global Management. He is also president of H&B Associates, a marketing and management consulting firm he founded. Dr. Hisrich received his MBA and PhD degrees from the University of Cincinnati and honorary doctorate degrees from Chuvash State University (Russia) and the University of Miskolc (Hungary). He has authored or co-authored twenty-one books including: Global Entrepreneurship, Entrepreneurship: Starting, Developing, and Managing a New Enterprise, He has written over 300 articles on entrepreneurship, international business management and venture capital. He has instituted academic and training programs in Hungary, Russia, and China.

Silviu Itescu, MBBS (Hons), FRACP, FACP, FACR

is A medically trained physician scientist, Professor Itescu has established an outstanding international reputation in the fields of stem cell biology, autoimmune diseases, organ transplantation, and heart failure. He has been a faculty member of Columbia University in New York and of the University of Melbourne. His pioneering work in the use of adult stem cells for heart disease has laid the groundwork for a potential paradigm shift in the treatment of cardiovascular disorders. Professor 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 several publicly-listed life sciences companies.

Michael H. May, PhD

is currently the Chief Executive Officer of the Centre for Commercialization of Regenerative Medicine (CCRM), a Canadian, federally incorporated, not-for-profit organization dedicated to supporting the development of foundational technologies that accelerate the commercialization of stem cell- and biomaterials-based technologies. Prior to CCRM, Michael was the President and co-founder of Rimon Therapeutics Ltd., a Toronto-based regenerative medicine company developing novel medical polymers that possess drug-like activity. Dr. May completed his PhD in Chemical Engineering at the University of Toronto in 1998 as an NSERC Scholar and was awarded the Martin Walmsley Fellowship for Technological Entrepreneurship in recognition of company creation from academic discovery.

Randal Mills, PhD

serves as President and Chief Executive Officer of Osiris Therapeutics. Since taking office in July 2004, Dr. Mills' corporate accomplishments include taking the company public in 2006; forging the largest partnership ever for a stem cell company, a $1.5 billion deal with Genzyme Corporation; winning a $224.7 million contract from the U.S. Department of Defense for the development and stockpile of a stem cell countermeasure for radiological warfare; and the commercialization of the world's first stem cell product, Osteocel«, which has now been used in more than 40,000 orthopedic surgical procedures. In 2007, Osiris was named Biotechnology Company of the year for its first-in-class adult derived stem cell therapies.
Prior to joining Osiris, Dr. Mills was an executive officer and founding member of Regeneration Technologies, Inc. (NASDAQ-RTIX) and its predecessor the University of Florida Tissue Bank, Inc. He is the inventor of RTI core technology, BioCleanse«.
Dr. Mills earned a bachelor's degree in microbiology and a Ph.D. in pharmaceutics, both from the University of Florida, and completed an internship in laboratory medicine at Shands Hospital.
He serves on the Board of Directors for Osiris Therapeutics, Tissue Banks International, and Technology Council of Maryland and was appointed by the U.S. Secretary of Health and Human Services as a voting member of the National Institutes of Health, AIDS Research Advisory Council. In 2008, Dr. Mills was named Ernst & Young Entrepreneur of the Year.

Glenn Prestwich, PhD

PresidentialáProfessor of Medicinal Chemistry and Special Presidential Assistant for Faculty Entrepreneurism at the University of Utah. B.Sc. 1970, Chemistry, California Institute of Technology; Ph.D. 1974, Organic Chemistry, Stanford University; NIH postdoctoral fellow 1974-76, Cornell University and International Centre for Insect Physiology and Ecology in Nairobi, Kenya. Co-founder: Echelon Biosciences, Inc.; Sentrx Surgical, Inc.; Carbylan BioSurgery, Inc.; Sentrx Animal Care, Inc.; Glycosan BioSystems; Inc.; GlycoMira, LLC.; Clear Solutions Biomedical LLC. During his 32 years as a faculty member, he has published over 600 technical papers, patents, and book chapters, and has trained over 125 postgraduate scientists. Semi-professional photographer, commercially rated pilot, and first tenor in the Utah Symphony Chorus.

Brock Reeve, MBA

is a graduate of Yale and the Harvard Business School, is Executive Director of the Harvard Stem Cell Institute. In partnership with the Faculty Directors, he has overall responsibility for the operations and strategy of the institute whose mission is to use stem cells, both as tools and as therapies, to understand and treat the root causes of leading degenerative diseases.

Bernard Siegel, JD

is the founder and full-time executive director of the nonprofit Genetics Policy Institute (GPI) based in Wellington, (Palm Beach County) Florida. He is the founder and the co-chair of the World Stem Cell Summit series of global conferences and editor-in-chief of the World Stem Cell Report. A native of Richmond, Virginia, he received his undergraduate and law degrees from the University of Miami. He is a member of the Florida Bar since 1975. In 2003, he traded his 30-year courtroom career to found GPI, which leads the global "Pro-Cures Movement" and Stem Cell Action Coalition. As a recognized policy expert relating to stem cell research, regenerative medicine and cloning, Mr. Siegel works with the world's leading stem cell researchers and advocates. He works with grassroots activists throughout the United States, raising public awareness and educating lawmakers, the media and public on stem cells and regenerative medicine.

David S. Smith, JD

is a corporate lawyer focusing on intellectual property transactions, venture financings and regulatory matters for life sciences companies and investors and is of Counsel with Pepper HamiltonáLLP, resident in its Pittsburgh office. Mr.áSmith's intellectual property-related work includes IP transactions, regulatory issues and licensing. His corporate practice is concentrated in the organization, financing and growth of life sciences companies. He is an authority on the legal issues surrounding the use of human biological materials and the commercial development of tissue, cell and stem cell technologies. Mr.áSmith is a founder and principal of Teregenics, LLC, He is an officer of the Tissue Engineering and Regenerative Medicine International Society and the Pittsburgh Tissue Engineering Initiative, Inc.. He is a past member of the board of directors of the Pennsylvania Biotechnology Association.

Michael D. West, PhD

is the CEO of BioTime, Inc.á and its subsidiaries OncoCyte Corporation, Embryome Sciences, and ES Cell International. The Companies are focused on developing an array of research and therapeutic products using human embryonic stem cell technology. He has focused his academic and business career on the application of developmental biology to the age-related degenerative disease. He was Founder of Geron Corporation, from 1990-98 as Director and VP, he initiated and managed programs in telomerase diagnostics, oligonucleotide-based telomerase inhibition as anti-tumor therapy, and the cloning and use of telomerase in telomerase-mediated therapy wherein telomerase is utilized to immortalize human cells. 1995-98 he organized and managed the research collaboration between Geron and its academic collaborators that led to the first isolation of human embryonic stem and human embryonic germ cells.

Stuart K. Williams, PhD

received his PhD in Cell Biology from the University of Delaware. followed by postdoctoral training in Pathology at the Yale SOM. From 1980-1990 he held a faculty appointment at Jefferson Medical College as Director of Research in the Department of Surgery. In 1990 he joined the faculty at the University of Arizona and established the Section of Surgical Research in the Department of Surgery. In 1997 he founded the University of Arizona Biomedical Engineering Program creating a research and educational link between the Medical School and College of Engineering. In 2007 Dr. Williams was selected as the Scientific Director of the Cardiovascular Innovation Institute, a partnership between Jewish Hospital and the University of Louisville in Louisville Kentucky. His research interests have focused on medical devices, regenerative medicine and infection control. Dr. Williams has authored over 300 scientific publications. His entrepreneurial spirit has resulted in 16 US patents with numerous patents pending. He has founded three biotechnology companies, maintained active managerial positions and is an active consultant.

Robin R. Young, CFA

is founder and president of RRY Publications and Robin Young Consulting Group, a firm specializing in evaluating and promoting orthopaedic technologies and companies. Mr. Young is an internationally recognized expert in his field, with over two decades of experience. Over the course of his career, he has been an active and integral part of the development, analysis and funding of several major orthopaedic technologies including; spine cages, engineered allograft, living cell biomaterials, anti-adhesives, third generation hemostats, calcium-based bone void products, nucleus replacement implants and dynamic stabilization implants. After a successful career as one of the leading medical technology analysts on Wall Street, he was instrumental in forming and managing the HealthpointCapital research and private equity practice. In concert with Healthpoint Capital, Mr. Young wrote three highly acclaimed orthopaedic industry reference books.

© 2004-2016 Case Western Reserve University | Cleveland, Ohio 44106 | +1 (216) 368-2000 | legal notice