Press Release: CBSET expands its preclinical research services by adding GLP-compliant cell-based-therapies support capability

Company to launch new service at next week’s “ISSCR 2017 Annual Meeting”

“CBSET is the ideal partner in preparing, presenting, and defending GLP studies for regulatory review.”—Michael Naimark, CBSET

LEXINGTON, Mass., June 8, 2017  — CBSET Inc., a non-profit GLP translational research institute that specializes in the advancement of novel therapies, announced today that it has expanded its preclinical cell therapy offerings. CBSET recognizes the importance of preclinical partners capable of supporting the needs of the rapidly advancing cell therapy field by providing technical and regulatory support services in the cell therapy and regenerative medicine sectors.

In vivo assessments include (1) stem cell-derived lines, (2) engineered cell lines, (3) autologous strategies, (4) engineered tissues and tissue products, and (5) combination products.

“Scientific progress in the cell therapy and regenerative medicine world has progressed rapidly in the last decade, and the need for experienced preclinical support services with translational experience has never been greater for investigators in these fields,” said Michael Naimark, CBSET’s Director of Business Development. “Novel cell and tissue therapies require expanded technical and regulatory approaches to ensure an appropriate level of project support.

“Our status as a 501(c)(3) research institute and our long track record of safety assessments and successful regulatory submissions give our collaborations impeccable credibility,” Naimark added. “Applying this experience to support translational programs in regenerative medicine will allow our partners to focus on the scientific integrity of their technology, rather than the conduct and documentation of their critical preclinical projects.”

Prior to establishing the new service, CBSET appointed Michael Naimark as Director of Business Development in October 2016. Most recently, he had been employed by the Neural Stem Cell Institute (NSCI) as 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.

“Michael’s significant hands-on experience in managing complex preclinical studies in a variety of animal models puts him in a unique position to interact on CBSET’s behalf with existing and potential new sponsors about study goals and regulatory requirements. His industry experience and knowledge of cell-based and biologics therapies are a valuable addition to the CBSET team,” said Peter Markham, CBSET’s CEO.

CBSET will launch its new cell-based therapies service at next week’s “ISSCR 2017 annual conference” in Boston, June 12-16. Visitors to the CBSET Exhibit Booth (#843) can receive a copy of “Cell-Based Therapy and FDA Review: Partnering for Success at Your Pre-IND Meeting,” meet Mr. Naimark and learn more about CBSET’s multi-disciplinary paradigm for in vivo cell-based therapy assessments.

Expert Biomedical Research Services

CBSET was conceived to enable the advancement of novel therapeutics, devices and techniques through ongoing collaboration with its sponsors in the biomedical research community. CBSET provides a full range of GLP (Good Laboratory Practice) and non-GLP research services to support early target validation, lead optimization, and safety and efficacy testing. Whether a Sponsor is developing a new device, surgical model, or needs support for its drug development programs, CBSET offers a wide array of preclinical resources to meet these needs. For more information about CBSET, contact Michael Naimark, Director of Business Development: +1-781-541-5627,


CBSET Inc. — 500 Shire Way, Lexington, MA 02421 — is the preclinical research leader in critically important therapeutic fields such as interventional cardiology, renal disease and dialysis, chronic drug-resistant hypertension, women’s health, minimally invasive surgery, orthopedics, biological and synthetic tissue repair, drug delivery, bioresorbable devices, and combination medical devices and drug-eluting products. Learn more about CBSET’s expert preclinical research services, or please  contact us.