CBSET MANAGEMENT TEAM

Peter Markham is a founder of CBSET and has served as President and CEO since 2006. He 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.

Dr. Adam Groothuis is the Vice President and COO of CBSET. He is considered an expert in pre-clinical science and has advised many medical device companies. His research focuses are on cellular and extracellular response to mechanical arterial injury, on how inflammatory cells participate in vascular injury, and on how specific parameters of endovascular instrumentation or device implantation may dictate biological repair. Projects include studying chemoattractant expression in injured vessels, evaluating novel technologies for modulating the events of vascular repair, and studying new endovascular technologies. Dr. Groothuis has earned a Bachelor of Sciences degree in Biology at University of California Irvine (1996), a Masters of Sciences in Physiology and Biophysics at Georgetown University (1997), an MBA in Salem State College (2003) and a Ph.D. in International Business in Southern New Hampshire University (2010). He has authored or co-authored 13 original publications and is frequently invited as faculty to national and international congresses.

With over ten years experience in comparative anatomic pathology and a specialty in the preclinical assessment of biomedical materials and devices, Dr. Stanley has provided oversight to CBSET’s pathology services since the company’s foundation. Through exposure to a broad range medical devices, including cardiovascular, Dr. Stanley’s background allows for the development and implementation of the novel procedures and protocols essential for adequate macroscopic and microscopic evaluation, and successful regulatory submission, of new/unique medical devices.

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.

Lynn Bailey joined the CBSET team at its inception in 2006. She has worked in the field biomedical research for over 20 years specializing in the development of catheter-based medical devices for the treatment of vascular and cardiovascular disease. She began her career at Walter Reed Army Medical Center, Washington, DC; and furthered her work at the Heart Institute at Borgess Hospital, Kalamazoo, MI; Cardiovascular Research Foundation (CRF), Washington, DC; Stanford University Medical School, Palo Alto, CA; and Charles River Laboratories, Southbridge, MA. Lynn received her degree from Moorpark College, Moorpark, CA.

Philip Seifert is currently Director of Histopathology at CBSET. His scientific interests include in the field of medical device pathology and vascular biology. Some of the specialty histopathology methods in which he has extensive experience include immunohistochemistry, plastic resin processing of tissues, EXAKT micro-grinding, and scanning/transmission electron microscopy. In addition, Mr. Seifert strives to ensure the technical and scientific quality and timeliness of the histopathology data when collaborating with CBSET colleagues and consulting with sponsors, MIT students and researchers, and members of the National Society for Histotechnology. Mr. Seifert has applied his skills to various studies in the field of medical device pathology and vascular biology at MIT for the past 17 years both as a MIT employee and during his employment at CBSET.

Dr. Tzafriri joined the CBSET team in the spring of 2009. He has worked in the field of local drug delivery for over 15 years, specializing in the development of mathematical models of controlled drug release and tissue distribution. 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 six-year 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. His work at CBSET brings together all these themes in support of the evaluation of novel drug eluting stent prototypes.

Dr. Zani joined the CBSET team in 2010. His biomedical research background ranges from molecular cardiology and cancer biology to cardiovascular physiology and tissue regeneration. Dr. Zani holds an M.S. and Ph.D. in Cellular and Integrative Physiology from Indiana University School of Medicine and performed his post-doctoral training in cardiovascular and respiratory tissue engineering in the laboratory of Dr. Elazer Edelman at the Massachusetts Institute of Technology. He has co-authored 11 abstracts and peer reviewed articles, and is a co-inventor of 2 patents pending. Dr. Zani writes reports for studies in support of regulatory submission and is intimately involved in the development of medical devices and new analytical methods for sponsors.

Dan Howell joined the CBSET team as Director of Sales and Marketing in February, 2009. Having worked for over a decade in the Cardiology Departments of Boston’s Brigham and Women’s Hospital and Beth Israel Deaconess Medical Center, Dan brings a strong medical device background to CBSET. During his time there, he served with many of the key opinion leaders in cardiovascular medical device innovation, as well as many of the top medical device manufacturers developing early-stage technologies prior to regulatory approval. Dan works with many of CBSET’s sponsors on their on-going projects and programs as well as leading business development efforts.