Mark S. Klempner, MD, is the Executive Vice Chancellor for MassBiologics of the University of Massachusetts Medical School, where he is professor of medicine. Dr. Klempner joined UMMS in July 1, 2012, from the Boston University School of Medicine, where he served as Associate Provost for Discretion, Conrad Wesselhoeft Professor of Medicine and the founding director of the National Emerging Infectious Diseases Laboratories (NEIDL).
Dr. Klempner is an internationally known figure at the intersection of basic infectious disease research and the development of therapeutics and vaccines to combat infections. Dr. Klempner discovered that inflammatory cells secrete & respond to proinflammatory cytokines (IL-1 and TNF) releasing reactive oxygen species & lysosomal contents. These observations have formed the basis for effective anti-cytokine treatments for inflammatory diseases such as rheumatoid arthritis. He engineered the first “reporter pathogens” demonstrating that intracellular changes were crucial to the pathogenesis of staphylococcal and plague infections & discovered the essential role of host plasminogen for transmission of the Lyme disease spirochete. Each of these discoveries have been coupled to translational clinical research including demonstration that lysosomotropic antibiotics eradicate intracellular staphylococci and reduce carriage of staph as well as the recurrence of staphylococcal skin and soft tissue infections. His clinical research on Lyme disease includes the pivotal treatment studies for post treatment chronic Lyme disease and trials of the Lyme vaccine. His research experience formed the basis for successful design and scientific program development for the NIH funded high containment NEIDL.
Dr. Klempner’s research interests include the molecular pathogenesis of Lyme disease, prevention and treatment of Lyme disease, strategies to interrupt transmission of vector transmitted infectious diseases, immune based prevention and treatment of hemorrhagic fever virus infectious diseases, bacterial antibiotic resistance and the role of bacterial subpopulations in hetero-resistance and the development of human monoclonal antibodies for the prevention and treatment of human diseases.
A graduate of the Cornell University Medical College, Dr. Klempner trained at the Massachusetts General Hospital and the Laboratory of Clinical Investigation at the National Institute of Allergy and Infectious Diseases and the National Naval Medical Center. He has held national leadership positions including the American Board of Internal Medicine Chair of the Infectious Diseases Board and member of the Board of Directors, President of the Association of Subspecialty Professors member of the Accreditation Council for Graduate Medical Education, the MA Governor’s Life Sciences Advisory Board, the Board of Scientific Counselors for the NIH Clinical Center. For over a decade he served as Associate Editor of the New England Journal of Medicine, selecting and refining the infectious diseases content of this leading clinical research journal.
Rebecca Cannon, PhD
Rebecca Dahn Cannon, PhD, is the Associate Deputy Director for Quality at MassBiologics of the University of Massachusetts Medical School. As the leader of the Quality Assurance, Quality Control, and Validation departments, she is responsible for ensuring that all MassBiologics and contract manufacturing activities meet Federal and EU regulations and guidances. In addition, Dr. Cannon’s groups apply phase-appropriate cGMPs for Phase I, Phase II, and Phase III studies in a manner that protects patient safety, scientific integrity, and consistency of clinical trial materials. Joining MassBiologics in 2002 as a staff Scientist, Dr. Cannon later served as Senior Manager in the Quality Control Department and as Senior Director, Quality Assurance before assuming her current position.
Dr. Cannon received her PhD in Physical Chemistry and Masters in Analytical Chemistry from Northwestern University. She completed a Post-Doctoral fellowship in Toxicology and Therapeutic Drug Monitoring at the Medical College of Wisconsin and Office of the Milwaukee County Medical Examiner. Prior to joining MassBiologics, Dr. Cannon was the Chief Toxicologist and Acting Director of Toxicology at the Center for Forensic Sciences, Syracuse, NY.
Frank Fazio, MBA
Frank Fazio, MBA is the Deputy Director for Manufacturing at MassBiologics of the University of Massachusetts Medical School and has over 25 years of experience in the manufacture of medical devices, diagnostics and biologics; he holds a patent for a system for removing fluid from blood. He joined MassBiologics in 2010 to manage vaccine manufacturing, monoclonal antibody manufacturing, aseptic filling, supply chain, facilities and engineering. He has significant experience in a broad range of manufacturing technologies, including precision grinding, electro polishing, aseptic fill, and biologics manufacturing. He also has extensive experience in the management and maintenance of licensed manufacturing facilities. He has been part of the senior leadership for two successful medical device startup companies, including Renal Plant Corporation, which he founded in 2000.
He received a bachelor‘s of science degree in biology from Framingham State College in 1988; his MBA from Anna Maria College in 1991; and a Master of Science in Work Environment from the University of Massachusetts Lowell in 1997.
Dr. Sadettin Ozturk, the Deputy Director Process Development, has had a long career in cell culture process development, technology transfer, product licensing, and commercial manufacturing. His early contributions to the field focused on applying chemical engineering principles and process control strategies to the optimization and scale-up of cell culture processes. He was responsible for the development of numerous cell culture based processes and novel technologies that helped not only the companies that he worked for (Verax, Bayer, GlaxoSmithKline, and Johnson & Johnson), but contributed to the rest of the field through his numerous presentations and publications. Sadettin led process development activities and played a key role in the licensing and commercialization of two monoclonal antibodies, Stelera®, and Simponi®. In addition, he transferred and supported the commercial manufacturing of Kogenate® and BeneFix®. Sadettin has published numerous research articles, given presentations, delivered keynote lectures, and edited books. He is a member of several societies including ESACT, American Association for the Advancement of Science, New York Academy of Sciences, American Chemical Society, and American Institute of Chemical Engineering. Sadettin is involved in these scientific organizations and other community activities by serving on their Scientific Advisory Boards and organizing meetings and sessions. He has served Biochemical Technology (BIOT) division of American Chemical Society as the Division Chair, and then as a Councilor. He co-authored a well-respected book in the field entitled Cell Culture Technology for Pharmaceutical and Cellular Therapies. Sadettin also serves on Editorial and Review Boards for several journals and other publications.
Yang Wang, MD, PhD is the Deputy Director of Product Discovery at MassBiologics and an Associate Professor of Medicine at the University of Massachusetts Medical School. As the head of the Product Discovery department, she leads a team of PhD scientists and research associates with the goal of discovery and development of antibody-based biological medicines. Her discovery programs include a broad range of disease targets including infectious disease, cancer and neurodegenerative diseases. She has significant experience and expertise in therapeutic antibody design and function, pre-clinical development as well as supervision of drug discovery programs. She is also the principle investigator for external grant-funded research with a focus on antibody gene-based prophylaxis and therapy.
Dr. Wang received her PhD in Genetics from Tufts University School of Medicine. She also holds an MD degree and a MS degree in Immunology. She joined MassBiologics as an R&D Scientist in 2007, later served as Senior Director in Product Discovery before advancing to the Deputy Director position.
John Z. Sullivan-Bólyai, MD, MPH is the Deputy Director of Clinical and Regulatory Affairs at MassBiologics. Dr. Sullivan-Bólyai leads a team of experienced regulatory affairs and clinical trials scientists and managers responsible for life cycle management of MassBiologics licensed products and for translating and advancing MassBiologics science into clinical development.
Dr. Sullivan-Bólyai came to MassBiologics with over 25 years of experience in the pharmaceutical industry, ranging from large companies to start-ups; Hoffmann-La Roche, Merck, IPSEN, Valeant, Anadys, Idenix; most recently as the Chief Medical Officer of ContraVir Pharmaceuticals. He has had key roles in the filing and international regulatory approval of 15 IND/CTA applications for both small molecules and biologicals, as well as the licensing of five drugs. He has developed therapeutics for multiple indications, including infectious diseases (HIV, HCV, HBV), neuroendocrinology, gastroenterology (HGH, somatostatin) and coagulation (FVIII). His experience spans the evaluation of small molecules and biologicals for clinical and commercial potential; regulatory and commercial strategy; design of IND/CTA enabling preclinical programs; as well as hands-on clinical trials design and implementation from First-in-Human to Phase 4.
Dr. Sullivan-Bólyai received his MD and MPH from the University of Washington in Seattle, where he also completed specialty training in Pediatric Infectious Diseases. He served as an Epidemic Intelligence Officer with the Centers for Disease Control in Atlanta, Georgia. Prior to joining industry, Dr. Sullivan-Bólyai held academic and clinical positions in the departments of pediatrics at the UCLA School of Medicine and the University of Illinois School of Medicine.