CELEBRATING 6 YEARS AT CBSET... Michael joined CBSET in 2016 as Director of Business Development, bringing significant biomedical experience and specialized expertise to the role. Previously, he was employed by Neural Stem Cell Institute (NSCI), where he oversaw development of a cell-based therapy for macular degeneration under an award from the New York Stem Cell Foundation.


1: He has successfully directed many complex preclinical studies for regulatory review.

Prior to joining CBSET as Director of Business Development, Michael had spent his career in the preclinical research industry, primarily as a study director, surgeon, and project manager. “We were very pleased to have Michael join CBSET,” recalls Peter Markham, President and CEO of CBSET. “His significant hands-on experience in managing complex preclinical studies in a variety of animal models placed him in a unique position to interact on CBSET’s behalf with our Sponsors about their study goals and regulatory requirements. His life sciences industry experience in general, combined with his extensive knowledge of cell-based and biologics therapies in particular, have made Michael an essential part of CBSET’s success as a translational research institute.”

2: He has access to cutting-edge assets.

“I joined CBSET because the traditional CRO business model isn’t designed to support novel technologies or complex programs for which no clear regulatory pathway has been defined. CBSET has an outstanding reputation in the life sciences industry as a CRO that not only has high-level scientific and technical expertise, but that also possesses ample regulatory compliance experience for supporting novel technologies and collaborating with regulatory authorities,” says Michael. In addition to expertise and experience, Michael explains that CBSET’s competitive positioning is bolstered by its 40,000-square-foot, GLP- compliant, AAALAC-accredited facility that includes vivaria, procedure rooms, catheterization/imaging labs, surgical
and necropsy suites, histopathology, SEM, and a wide range of other technologies. “CBSET is a high-quality, science- focused partner for medtech and biotech companies who are looking for a preclinical partner to support their product development efforts, differentiate their technology from competitors’, and fortify their regulatory submission — all under one roof.”

3: He is a published scientist.

Michael earned an MS degree in neurobiology and anatomy at the University of Tennessee Health Sciences Center and a BS degree in biology/biological sciences at the University of Mississippi. In addition, he holds certificates in Medical Device Regulatory Affairs and Biologics Regulatory Affairs from Colorado State University, and is a co-author of 10 scientific papers published in peer-reviewed journals including: Advances in Experimental Medicine and Biology, Brain Research, Cancer Chemotherapy and Pharmacology, Journal of Ocular Pharmacology and Therapeutics, Stem Cell Reports, and The FASEB Journal. “Scientific progress in the cell therapy and regenerative medicine world has advanced rapidly in the last decade, a promising development that nonetheless poses some potential problems as both the science and the regulatory approaches are in constant flux. The need for the experienced preclinical support services with translational and regulatory experience that CBSET provides has never been greater for investigators in these fields.”

Michael Naimark presents at Innovations in MedTech 2021.

Michael Naimark presents Cell Therapy Regulation to the Tufts CTSI meeting.

Michael Naimark discusses benefits of "pre-pre" IND meetings with the FDA.

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