Management
Mireli W. Fino, MBA
In her role as the executive vice chancellor of MassBiologics of UMass Chan, Mireli W. Fino, MBA, will drive MassBiologics mission through the research and development of internal programs with UMass Chan faculty and students while leading the manufacturing facilities in Mattapan and Fall River, and fostering the organization’s industry relationships.
Prior to joining MassBiologics in July of 2021, Fino spent nearly 30 years in the pharmaceutical industry as an accomplished biotech executive with particular expertise in bioprocess development, manufacturing sciences and technology and commercial operations. Most recently, she was with Protein Sciences, in Meriden, Conn., as senior vice president for manufacturing operations since 2012. There, she was instrumental in the approval and launch of the first recombinant influenza vaccine in the U.S. After Sanofi’s 2017 acquisition of Protein Sciences, Fino became the site head of industrial operations, Meriden Conn., and Pearl River New York, where she led the expansion of commercial operations to multiple sites, contract manufacturing organizations and international registrations.
Fino previously worked for 16 years at Wyeth Pharmaceuticals now Pfizer, Inc., in a variety of senior roles, leading large-scale process development and clinical production of viral and bacterial vaccines; ultimately, she was director of manufacturing sciences and technology for bacterial conjugated vaccines, with focus on innovation and new technology implementation.
Fino earned an undergraduate degree in biochemical engineering at The Autonomous University of Aguascalientes in Mexico and an MBA at MIT.
Mark S. Klempner, MD
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 UMass Chan 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.
Adriana Vives Rodriguez
Adriana Vives has over 25 years’ experience in the pharmaceutical industry. Her most recent roles were as the Industrial Affairs Site Head and Quality Head for SANOFI Pasteur in Argentina, followed by SANOFI Pasteur Limited in Canada leading a vaccine´s Bulk Manufacturing organization . In these positions, she led industrial operations ensuring sustainability of supply and services, and securing operations by reinforcing safety, quality, business integrity, revenue and profitability.
While at Sanofi, Adriana was responsible for the delivery of high quality vaccine bulk components for Hepatitis B and Pertussis, used for multiple polyvalent vaccines, successfully meeting regulatory requirements in the US(FDA), Europe(EMA), and rest of the words, supporting distribution through PAHO, WHO and commercial channels. In her capacity as Site Head, Adriana led major projects to increase production capacity, ramp up, process escalation and process yield improvement.
Prior to Sanofi, Adriana work at GSK, where she was part of the 4-year Quality System remediation following the acquisition of a solid dose and clean liquids pharmaceutical manufacturing facility. In addition of participating on the full systems remediation, Adriana led the remediation of the Quality Control laboratories and systems.
Adriana holds a Biochemistry degree from Universidad de Buenos Aires, Facultad de Farmacia y Bioquimica
John Sullivan-Bólyai, MD, MPH
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.
David McNally, PhD
David McNally, PhD is the Head of Viral Vector Technology at MassBiologics. Dr. McNally is responsible for overseeing both cGMP manufacture of viral vector bulk drug substance as well as process and analytical development activities related to viral vectors.
Dr. McNally joined MassBiologics in 2019 to lead process development and technical transfer of viral vector manufacturing processes from the process development group to cGMP manufacturing and has held positions of increasing responsibility since then. Prior to his arrival at MassBiologics, Dr. McNally held positions at MilliporeSigma, St. Jude Children’s Research Hospital and Protein Sciences Corporation in both cGMP manufacturing and process development capacities. During this time he developed, transferred and executed manufacturing processes for both commercial and clinical products targeting a range of indication including oncology, hemophilia and infectious diseases.
Dr. McNally holds a PhD in Chemical Engineering from the University of Cambridge and a BSc in Biomedical Science from the University of Sheffield. Dr. McNally is an Assistant Professor at the University of Massachusetts Chan Medical School and a Research Professor at the University of Massachusetts Lowell in the department of Chemical Engineering. He is the Principal Investigator on a multiple research projects that tackle various aspects of viral vector manufacture, from process intensification to the development of new analytical methods.
Eric Peterson
Eric Peterson joined MassBiologics in 2018 as the Deputy Director of Manufacturing and Facilities. He leads a team of experienced technical professionals and managers responsible for facility upkeep, production of MassBiologics licensed and IND products as well as technical transfer from process development to manufacturing.
Eric came to MassBiologics with over 30 years of experience in the pharmaceutical industry, ranging from large companies to start-ups; most recently as the Operations Director of a sterile fill finish facility. He has had key roles in the production of late-phase and commercial biologics, as well as the licensing of two drugs. He has worked on new plant startups and large renovation projects, including cleanroom HVAC and building management system installations. His experience spans the production of animal vaccines, human diagnostics, and therapeutics for clinical and commercial applications. In his various capacities Mr. Peterson has also had responsibility for supply chain, production planning, and engineering.
Diana Morales
Diana Morales brings over 22 years of experience of Business Development in the biotech and bio pharmaceutical industry with a long track success record. Diana joined MassBiologics in July of 2023 as the Vice President of Business Development and Operations. Diana will work to bring new business and strengthen existing customer relationships at MassBiologics while improving internal tools and processes.
In her latest role at Invetech, Diana led the Cell Therapy Global product teams and assisted with company go-to-market strategy in the Cell Therapy and Viral Vector space. Diana managed global bioprocess mab business across the Northeast and oversees in Europe for GE Healthcare Lifesciences and Cytiva, and also was part of multiple acquisitions while at Thermo Fisher Scientific such as LifeTech, Brammer Bio, Henogen, etc.
Diana holds a dual bachelor’s degree in business administration and business management from Ashford University and University of Phoenix, with multiple leadership awards throughout her career.