CBSET Board of Directors
Chairman: Elazer Edelman, MD, PhD - Director, Harvard-MIT Biomedical Engineering Center
Dr. Edelman is the Edward J. Poitras Professor in Medical Engineering and Science at MIT, Professor of Medicine at Harvard Medical School, and Senior Attending Physician in the coronary care unit at the Brigham and Women’s Hospital in Boston. He directs the Harvard-MIT Biomedical Engineering Center (BMEC), dedicated to applying the rigors of the physical sciences to elucidate fundamental biologic processes and mechanisms of disease. BMEC programs span a wide range of disciplines, with its resources made available to investigators from MIT and Harvard. Dr. Edelman has authored or co-authored 312 original scientific publications.
Peter M. Markham, MS - CBSET CEO and Co-Founder
CBSET's President and CEO since 2006, Peter has more than 30 years of management and regulatory experience in GLP contract research. Prior to CBSET, he was general manager of the Worcester/Southbridge division of Charles River Laboratories, a diverse division of more than 440 employees. Previously, he served as a senior executive at Genzyme Transgenics, Primedica, BioDevelopment Laboratories, and Arthur D. Little. He has broad scientific expertise in both drug and device development. Peter is known for his expertise in GLP regulatory compliance, setting and implementing corporate regulatory strategy and policies, and providing leadership and regulatory strategies for novel technologies. He has authored or co-authored numerous original scientific publications.
Adam Groothuis, PhD - CBSET Co-Founder; Vice President of Medical Affairs, Mitralign
Dr. Adam Groothuis, PhD, is the Vice President of Therapy Development at Cardiovalve and a co-founder of CBSET. He is considered an expert in pre-clinical science and has advised many medical device companies. Prior to Cardiovalve, he was Vice President of Medical Affairs at Mitralign, and before that, COO at CBSET, where he was responsible for research in cardiovascular devices and daily operational oversight. Previously, he was Associate Director of the Experimental Cardiovascular Interventional Laboratories at Brigham and Women’s Hospital. He has authored or co-authored 13 original scientific publications and is frequently invited as faculty to national and international congresses.
Campbell Rogers, MD - Chief Medical Officer of HeartFlow, Inc.
Dr. Rogers currently serves as the Chief Medical Officer of HeartFlow, Inc., a private cardiovascular diagnostics company based in California. Prior to joining HeartFlow, he was the Chief Scientific Officer and Global Head of Research and Development at Cordis Corporation, Johnson & Johnson, where he was responsible for leading investments and research in cardiovascular devices. Prior to Cordis, he was Associate Professor of Medicine at Harvard Medical School and the Harvard-M.I.T. Division of Health Sciences and Technology, and Director of the Cardiac Catheterization and Experimental Cardiovascular Interventional Laboratories at Brigham and Women’s Hospital. He served as Principal Investigator for numerous interventional cardiology device, diagnostic, and pharmacology trials, is the author of numerous journal articles, chapters, and books in the area of coronary artery and other cardiovascular diseases, and was the recipient of research grant awards from the NIH and AHA.
CBSET Management Team
Peter M. Markham, MS - President and CEO
Peter is a well known and accomplished executive with 25 years of management and regulatory experience in the field of GLP contract research. Prior to joining CBSET, Mr. Markham served as General Manager of the Worcester/Southbridge division of Charles River Laboratories where he had P&L responsibility for a multi-disciplinary pre-clinical business unit which serviced the Toxicology, Pharmacology, Surgery, Metabolism, Pharmacokinetics, and Bioanalytical Chemistry markets. Prior to CRL, Mr. Markham served as a senior executive at various scientific research companies including: Genzyme Transgenics, Primedica Corporation, BioDevelopment Laboratories, and Arthur D. Little, Inc. where he played key roles in corporate acquisitions, and created several novel business units through strategic implementation of newly marketed technologies. Mr. Markham has broad scientific expertise in both drug and device development with specific expertise in metabolism, pharmacokinetics, bioanalytical chemistry, and the application of these scientific disciplines to the development of combination products. He is known for his expertise in GLP regulatory compliance, setting and implementing corporate regulatory strategy and policies, and providing leadership and regulatory strategies for novel technologies.
Mr. Markham holds a BS and MS in Bioanalytical Chemistry from University of Massachusetts.
Haim Danenberg, MD - Chief Scientific Adviser
Professor Danenberg has served as Head of the Cardiovascular Research Center and Director of Interventional Cardiology at the Heart Institute of Hadassah Hebrew University Medical Center, Jerusalem. In addition, since 2004, he has served as a Visiting Scientist at the Harvard-MIT Center for Biomedical Engineering. Dr. Danenberg is on the editorial board of the Journal of Coronary Artery Disease and has co-authored nearly 100 manuscripts in peer-reviewed journals.
John Keating, DVM, DACVP - Vice President, Pathology
John Keating arrived at CBSET in 2010, following several years in small animal veterinary practice, anatomic pathology training and academia, during which time he collaborated and published extensively with colleagues in clinical veterinary medicine and the basic sciences. He has a broad background in physiology and gross and histologic pathology in a variety of mammalian and non-mammalian, domestic and non-domestic species. Since joining the CBSET histopathology team, he has focused on evaluating tissue responses related to novel biomedical devices and techniques.
Misty J. Williams-Fritze, DVM, MS, DACLAM - Director, Veterinary Services
Misty Williams-Fritze joined CBSET in October 2012.She is responsible for developing and performing surgical models to meet sponsors’ needs and ensuring regulatory compliance with applicable agencies as well as overall management of the animal facilities, and instruction and training of technical staff. Her publishing credits include the Journal of the American Association for Laboratory Animal Sciences (JAALAS) and the Journal of the American Veterinary Medical Association (JAVMA). She holds a DVM and an MS in Laboratory Animal Medicine from Tufts University School of Veterinary Medicine, an MS in Biotechnology from Worcester State University, and is a diplomate of ACLAM (American College of Laboratory Animal Medicine).
Taimi Caron - Director of Regulatory Compliance
Taimi has more than 20 years of planning, managing and directing quality assurance programs, initiatives, policies and standard operating procedures. She has led over a dozen FDA audits and is an expert in all activities involving quality assurance and compliance with the applicable regulatory requirements FDA, USDA, and OUS regulatory bodies. Taimi sets corporate policy for the QAU, serves as a CBSET's primary representative for all Sponsor-related facility and regulatory agency audits, directs process improvement, reviews and interpretations of new and current regulations for regulatory enforcement trends/actions, and directs sponsors on the nuances of interpretation of regulatory policy into operational actions. Her leadership role is critical in validating electronic data systems, drafting policies, procedures, document control standards. Taimi is responsible for hiring, mentoring, evaluating QA staff, as well as leading client, facility, and regulatory visitor tours and responding to internal and external audits (GLP).
Shannon Tierney - Director of Medical Writing and HR
Shannon has over 20 years of experience in managing medical writing and technical writing staff, scientific data analysts, and project coordinators in pre-clinical research. She is an expert in the preparation and content of reports for FDA submission and OUS regulatory bodies. Shannon plays a key role in assuring CBSET deliverables are scientifically accurate and on-time, implementing electronic and manual data systems, policies, procedures, document control, and productivity standards. She oversees quality control review of editorial content in deliverables to ensure adherence to regulatory standards while reducing both turnaround time and reporting costs. Shannon serves a dual role as CBSET's full-time on-site HR representative with the specific goals of providing employees real-time assistance in all HR matters, including employee relations, employee retention, and recruiting.
Michael Naimark, MS - Director of Business Development
Michael Naimark came to the CBSET team from the Neural Stem Cell Institute (NSCI), where he was project manager overseeing the development of a cell-based therapy for macular degeneration under a 4-year award from the New York Stem Cell Foundation. Previously, he was co-owner of Care Research, a preclinical research organization where he provided operational, sales, and marketing oversight as Director of Surgical Models. Prior to founding Care Research, he helped launch Preclinical Research Services Inc., and served as senior study director for several years. Mr. Naimark earned a master of science degree in neurobiology and anatomy at the University of Tennessee Health Sciences Center, and a bachelor of science degree in biology/biological sciences at the University of Mississippi. He holds certificates in “Medical Device Regulatory Affairs” and “Biologics Regulatory Affairs” from Colorado State University and is the co-author of seven peer-reviewed scientific papers.
Rami Tzafriri, PhD - Director of Research and Innovation
Dr. Rami Tzafriri joined the CBSET team in the spring of 2009. He leads the development of novel quantitative methods for evaluating complex therapies and in vivo models in support of high-profile research and publications, integrating institutional efforts and the direction of CBSET's internship and fellowship programs, which are dedicated to training the next generation of interdisciplinary transnational researchers. He is particularly well known for his work and publications in the fields of local drug and RF energy delivery, specializing in the development of mechanistic computational models of these processes and their coupling with quantitative histopathological and bioanalytical correlates. He received his Ph.D. from the Hebrew University of Jerusalem for his research on biodegradable controlled-release devices and their use in the treatment of gingivitis and mammary tumors. He later held a postdoctoral research position in Elazer Edelman’s laboratory at MIT, with a focus on the development of ex-vivo and computational models to examine how blood flow and receptor-ligand interactions affect drug distribution in arteries and in the myocardium.
Nicola Parry, Bsc, Msc, BVsc, DACVP, FRCVS - Director, Pathology Laboratory Operations
Nicola joined CBSET in January 2023. Throughout a career spanning academia, industry, and research consultancy, her collaborative research interests have focused on the One Health initiative, especially in animal models of inflammation and cancer in humans. Dr. Parry now enjoys applying her experience to the many transdisciplinary studies led by CBSET that advance human and animal health. She is active in organized veterinary medicine and currently serves on the Board of Directors of the American College of Veterinary Pathologists (ACVP). Since 2005, she has also served on numerous other ACVP committees, as well as serving as Chair of the American Veterinary Medical Association’s Council on Education Selection Committee. Dr Parry was also awarded Fellowship of the Royal College of Veterinary Surgeons, by Meritorious Contributions to the Profession.