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.
PETER'S PROFILE

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.
JOHN'S PROFILE

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).
MISTY'S PROFILE

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.
MICHAEL'S PROFILE

Rami Tzafriri, PhD - Director of Research and Innovation

Dr. Rami Tzafriri joined the CBSET team in the spring of 2009 Principal Scientist focusing on development of computational and experimental methods for predicting the local pharmacokinetics of novel drug eluting stent designs. In 2016 he assumed his current position as Director of Research & Innovation. His work has led to landmark insights, such as: the first published preclinical demonstration of lesion preparation enhanced drug delivery to calcified human arteries; novel imaging methods for visualizing balloon-delivered coating onto arterial surfaces and, and integrative experimental-computational models of sympathetic denervation. He has published and presented extensively on CBSET’s behalf and has served as Faculty in over 10 international conferences. Several of his is publications have been highlighted by the editors of JACC, Science Translational Medicine, Hypertension and the Journal of Controlled Release. 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.
RAMI'S PROFILE

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.
NICOLA'S PROFILE