- Development Services
- cGMP Manufacturing
- Quality Services
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 Research, 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.
John C. Finch, JD, is the Deputy Director for Business Development and Operations at MassBiologics of the University of Massachusetts Medical School. An entrepreneurial administrative leader with 30 years of experience in a variety of disciplines, environments and industries, John Finch joined MassBiologics in 2003, where he took the lead in building its current administrative and operational infrastructure.
Mr. Finch holds a JD degree from Roger Williams University, and is admitted to practice in Massachusetts and Rhode Island. He also holds a Master of Science in Human Resources and Industrial Relations and is certified as a Senior Professional in Human Resources. Mr. Finch has served as a board member at a number of nonprofits, including Lifespan, the VNA of RI and the VNA Foundation.
Deborah C. Molrine, MD, is the Deputy Director for Clinical Affairs at MassBiologics of the University of Massachusetts Medical School and Professor of Pediatrics at the University of Massachusetts Medical School. Dr. Molrine is responsible for the clinical development of investigational new drug products, overseeing study design, implementation and data analysis. She has been the medical director for Phase 1 and Phase 2 clinical studies of human monoclonal antibodies to C. difficile toxins A and B and to hepatitis C virus. Dr. Molrine is also the lead collaborative partner with the Serum Institute of India for a human monoclonal antibody to rabies virus.
Dr. Molrine holds the Master of Public Health degree from the Johns Hopkins University School of Hygiene and Public Health and a medical degree from the University of Pennsylvania School of Medicine. She completed a residency in pediatrics at the Johns Hopkins Hospital and an infectious diseases fellowship at Children’s Hospital in Boston. Before joining MassBiologics in 2000, she was a member of the medical staff in infectious diseases at the Dana-Farber Cancer Institute and Children’s Hospital. She is board certified in pediatric infectious diseases.
The research interests of the Clinical Affairs group are focused on the clinical development of biologics as therapeutics for infectious diseases and unmet global health needs. Staff members have expertise in clinical trial design, protocol writing, case report form development, clinical operations, study site monitoring and preparation of IND submissions.
William D. Thomas, Jr, PhD, is the Deputy Director for Product Discovery at MassBiologics of the University of Massachusetts Medical School and an assistant professor of medicine and pathology at the University of Massachusetts Medical School. Dr. Thomas has more than twenty years of experience in the development and manufacture of vaccines and monoclonal antibodies, holding nine patents for vaccines, adjuvants and monoclonal antibodies. He joined MassBiologics in 2000 to oversee the FDA-licensed manufacturing of adult tetanus and diphtheria vaccine (Td). Under his direction, MassBiologics modernized the tetanus and diphtheria manufacturing process to meet FDA "current good manufacturing process” (cGMP) standards, while scaling up production to meet a national shortage for Td. In 2001, Dr. Thomas established the human monoclonal antibody discovery program at MassBiologics, focusing on human monoclonal antibodies for clinical development. This program has resulted in the identification of multiple monoclonal antibodies for clinical development. His team also developed and implemented manufacturing process and control procedures for monoclonal antibodies against C. difficile and rabies, which are currently in Phase 3 trials.
Dr. Thomas received his PhD in microbiology and immunology from the Medical College of Virginia, where he studied genetic mechanisms of antibiotic resistance in staphylococci. After a postdoctoral fellowship at the University of Wisconsin, Madison, he joined OraVax (now Sanofi) as a research scientist. There he was responsible for vaccine discovery, developing vaccines and adjuvants for use against C. difficile and H. pylori.
Dr. Thomas' research interests are in the development of vaccines and monoclonal antibodies against infectious targets, particularly targeted against anaerobic bacterial toxins. The Process Development group is focused on manufacturing technology for producing clinical grade protein therapeutics from mammalian cells. We are interested in cell culture process development focusing on defined media and bioreactor fed batch bioreactor process for CHO. Our development team utilizes principles of DOE and QbD with high throughput screening to develop production methods for use in our cGMP manufacturing plant.
Mark D. Leney, PhD, is the Deputy Director for Quality and Regulatory Affairs at MassBiologics of the University of Massachusetts Medical School and an assistant professor of medicine at the University of Massachusetts Medical School. An interdisciplinary scientist who brings a wide variety of academic and practical expertise and experience to MassBiologics, Dr. Leney oversees the Quality and Regulatory groups and is responsible for the safety, purity and efficacy of the licensed and investigational products produced at MassBiologics; the integrity of the cGMP manufacturing environments; and procedures, processes, testing, review and release of drug substance and drug products in accordance with the guidance and regulations promulgated by the FDA and other regulatory bodies. Dr. Leney is also responsible for the oversight of the measurement of drug concentration and drug activity in clinical subject serum from investigational studies conducted by MassBiologics, and the management and integrity of clinical study data and investigational samples. Dr. Leney is an active member of the Parenteral Drug Association and has served on task forces drafting PDA technical documents concerning the quality of extemporaneously compounded investigational drugs, phase appropriate application of cGMPs and the quality of pharmaceutical glass containers.
Dr. Leney previously served as an investigator for the US Department of Defense, working as a forensic scientist/anthropologist and recovery team leader for the US Army Central Identification Laboratory; and as a manager and DNA coordinator for the Joint POW/MIA Accounting Command, where he worked on contamination control, optimizing the recovery of DNA from degraded biological evidence and problems of statistical inference in forensic data.
Dr Leney’s research interests include risk management and error reduction, including the utility of statistical analyses of rare events, novel management and control strategies for clean utilities and clean rooms as well as trend and policy analysis of compliance and regulation relating to the production of drugs for human use. The Quality Control group also maintains specific expertise related to the testing of diphtheria and tetanus toxins, including established in vivo test methods. The Quality and Regulatory groups in general have expertise in the control and assurance of chemical raw material quality, clean room and clean utility microbiology, validation of critical processes and equipment and phase appropriate compliance with U.S. regulations concerning the development, production and testing of biologic drugs for human use.
Frank Fazio, MBA is the Associate 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 Associate 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.