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| Sanguine
has brought together a professional team of scientists, physicians and developers with the
required expertise to bring PHER-O2 through development and the FDA approval process. The
company management and advisory board consist of the following members: Dr. Thomas C. Drees, MBA, PH.D. Dr. Drees’ role in the Company is to drive the business technical and regulatory development of PHER-O2. He also holds four patents on fluorocarbon synthetic red blood cells.
The
Following are Members of our FDA Medical Program Team
A.M. James Shapiro, M.D., Ph.D., FRCS(Eng), FRCSC,
D.S.c (Hon) Born in Leeds, England, Dr. Shapiro obtained his Medical Degree at the University of Newcastle-upon-Tyne and trained in Surgery at the University of Bristol. He went to Canada in 1993 to train in liver transplantation and hepatobiliary surgery, and continued his research studies in experimental islet transplantation that he began in Newcastle as a medical student. His Ph.D. studies in Edmonton initially involved the screening of new drug combinations for possible testing in islet transplantation. He then further trained in liver surgery in Vancouver, in living donor liver transplant surgery in Japan, and in whole pancreas transplant surgery at the University of Maryland. In 1998, he was recruited back to the University of Alberta as a talented multiorgan transplant surgeon. With his strong background in clinical immunosuppression and experimental islet transplantation research, Dr. Shapiro was asked to lead the Clinical Islet Transplant Program team in Edmonton and, together with Drs. Lakey, Ryan, Rajotte, Kneteman and Korbutt, Dr. Shapiro developed and tested a new protocol that used a steroid-free antirejection regimen, coupled with sufficient numbers of transplanted islets. This research has since become known as the “Edmonton Protocol”, and has galvanized research activity in clinical islet transplantation worldwide. Dr. Shapiro also initiated the whole pancreas transplant program at the University of Alberta in 1999, and in the same year performed the first emergency living-related donor liver transplant in Canada in a child with fulminant liver failure. Dr. Shapiro is the principal investigator of the high-profile, international, multicenter trial of islet transplantation to test the Edmonton Protocol at 9 international sites, sponsored by the Immune Tolerance Network. He is also the principal investigator and director of the Juvenile Diabetes Research Foundation (JDRF) Clinical Center for Islet Transplantation, created in 2001, at the University of Alberta. In 2002, Dr. Shapiro was awarded the Canadian Institutes of Health Research/Wyeth Clinical Research Chair in Transplantation at the University of Alberta for his accomplishments in islet transplantation research. He has developed a strong collaborative link with Dr. Chris Larsen of Emory University, and is the principal investigator of an upcoming joint Edmonton-Emory clinical trial of LEA29Y in islet recipients supported by the National Institutes of Health. Dr. Shapiro maintains an active immunology/transplant research laboratory focused on the aspects of tolerance induction relating to islet transplantation with emphasis on costimulatory blockade and chimerism, with translational potential to clinical islet recipients. In early 2004, Dr. Shapiro was awarded an Alberta Heritage Foundation for Medical Research Scholarship to support his ongoing tolerance research. As the director of the clinical islet transplant program, Shapiro led the clinical team, and together with Dr. Lakey and others, developed and tested a new protocol that used a steroid-free antirejection regimen, together with sufficient numbers of transplanted islets. Using this protocol, clinical success was improved from 8% to 100% insulin independence at one year. http://www.isletmedical.com/pdf/NEJM_Shapiro_Edmonton_Protocol.pdf
John Dillberger,
D.V.M., Ph.D. Dr. Dillberger is a preclinical development consultant specializing in the application of pharmacology, toxicology, and pathology expertise to the safety evaluation of drugs, devices, and biologics. His clients include biopharmaceutical companies in the United States, Korea, Japan, Italy, and New Zealand, as well as nonprofit foundations and investment firms with pharmaceutical company portfolios. Over his 16 years in the pharmaceutical industry, Dr. Dillberger has held positions of increasing responsibility at Marion Merrell Dow, GlaxoWellcome, Triangle Pharmaceuticals, and Charles River Laboratories. He has served as Head of U.S. Pathology, Director of U.S.‑Based Development Projects, Worldwide Specialist in Oncology Drug Projects for GlaxoWellcome, and as Director of Toxicology at Triangle Pharmaceuticals. Dr. Dillberger has prepared safety evaluation packages for numerous clinical trial and marketing applications in the United States and Europe, including the recently approved NDA for the antiretroviral drug Coviracil®. Dr. Dillberger received his D.V.M. degree from Iowa State University in 1979, completed a three‑year residency in Comparative Pathology at the University of Miami School of Medicine and Papanicolaou Cancer Research Institute in 1986, and received a Ph.D. degree in Pathology and Environmental Toxicology from Michigan State University in 1989 for research into the molecular mechanisms of carcinogenesis. He was certified in Veterinary Pathology by the American College of Veterinary Pathologists in 1987 and in Toxicology by the American Board of Toxicology in 1992. In 2001, he became one of a handful of pathologists accepted as a Fellow in the International Academy of Toxicologic Pathology. He is the author of numerous scientific papers and a book chapter entitled “Nonclinical Development of Drugs and Biologics: Pharmacology and Toxicology”. He serves as reviewer for Antimicrobial Agents and Chemotherapy and is presently serving a second term on the editorial board of Veterinary Pathology.
Steven P. Miller, Ph.D., M.B.A. Dr. Miller received his Ph.D. in Human Biological Chemistry and Genetics from the University of Texas Medical Branch in Galveston, TX, and his M.B.A. from Santa Clara University in Santa Clara, CA. He performed postdoctoral fellowships at Scripps Clinic and Research Foundation in La Jolla, CA, and the University of California at Berkeley. He has over two decades of experience in the medical diagnostic, device, and pharmaceutical industries. Before joining BAI in 2005, Dr. Miller was Senior Director of Business Development for Cardinal Health Pharmaceutical Development, responsible for sales in the Western United States. Prior to joining Cardinal Health, he was the chief executive officer of University Clinical Investigators, a clinical research and specialty laboratory company dedicated to diabetes treatment and study. Prior to joining UCII, he was the vice president of Research and Development for LXN Corporation, responsible for the development of a hand-held blood glucose and fructosamine monitor for diabetes. Dr. Miller has variously held senior positions in International Marketing and Sales, Research and Development, and Operations at Quidel Corporation, Biotrack (now Ciba Corning), MAST Immunosystems (now Hitachi Chemical Diagnostics, Inc.), and SmithKline Instruments (now Beckman Coulter Inc.). Dr. Miller is responsible for the introduction of over 30 diagnostic products into the U.S. market and has over 20 scientific publications and 4 issued patents. Additional Medical Advisory Board Members L.
Cass Terry, MD, Ph.D., Pharm.D Dr. Terry has a critical array of contacts in both the medical and academic communities, which will greatly enhance the development of Sanguine’s technology. Sanguine will utilize his strong clinical background in anti-aging research to promote PHER-O2’s development. Dr. Terry has lead an extensive number of studies, funded by over $6.9 million in research grants over the past twenty years. These studies have lead to authorship or co-authorship of well over a hundred publications. Herbert
J. Meiselman, Sc.D. Dr. Meiselman has published
extensively. A few notable articles are: Dr. Meiselman’s background and direction are pivotal in the technical development
of PHER-O2. Craig
Morrison, MD
Robert
Kwun, MD Dr Kwun received his undergraduate degree from Harvard University and his Doctor of Medicine degree from Columbia University in New York, New York. Dr. Kwun’s clinical training includes Columbia University’s Manhattan Eye Ear and Throat Hospital, Los Angeles Children’s - USC Medical Center, the Doheny Eye Institute, and New York’s St. Vincent’s Hospital. Dr. Kwun has received numerous honors and awards in retinal surgery in addition to having authored or co-authored many articles in the area of macular degeneration and other areas ophthalmic surgery. David
Nelson Leonard
Burningham, Esq. [top] |
