MCRA Expands Biocompatibility Division With Board-Certified Toxicologist Hire

MCRA LLC has expanded its biocompatibility division to include full toxicology services and has hired Sharlee L. More, Ph.D., as associate director of Toxicology to support its growing biocompatibility service offerings for the medical device industry.
 
A board-certified toxicologist, More leads MCRA’s new toxicology service line within the Biocompatibility Division. She joins MCRA at a crucial time when changes to ISO 10993-17, a key international toxicology standard that influences device toxicology regulatory requirements, are imminent. Her toxicology expertise enables MCRA to provide state-of-the-art device toxicology services that remain in line with current and future regulatory expectations.

“Dr. More’s addition to MCRA’s Biocompatibility division allows us to better serve our clients and provide critical expertise to ensure regulatory success. This vital service will allow our clients to continue to receive the highest-level of expertise MCRA offers. Clients can now work with Dr. More on critical toxicology assessments throughout the medical device lifecycle,” said Glenn Stiegman, senior vice president of Clinical and Regulatory Affairs.
 
More joins MCRA from Stantec ChemRisk (formerly Cardno ChemRisk), where she spent seven years performing toxicology and human health risk assessments in various fields including medical devices, electronic nicotine delivery systems (ENDS), and consumer products. More has extensive knowledge and experience in toxicology including toxicological risk assessment (TRA), benefit-risk assessments of Carcinogenic, Mutagenic, and toxic to Reproduction (CMR) materials, pharmacokinetic modeling, state of the science reviews, and responding to deficiencies / non-conformities from the U.S. Food and Drug Administration (FDA) and European Union (EU) notified bodies. More also has experience designing and evaluating in-vitro and in-vivo biological testing (including following OECD guidelines) for devices and products used in biotechnology, ENDS, personal care products, and drugs. Additionally, More is an author in a series of recent publications that review the reproductive toxicity and carcinogenic potential of Cobalt-containing alloys and evaluate their benefits and risks.^1,2
 
More joins a biocompatibility team of former FDA and industry biocompatibility experts. Eric Sussman, Ph.D., a former FDA biomedical engineer and consultant reviewer for chemistry, toxicology, biocompatibility and nanotechnology, will work closely with More to support the new toxicology service arm. 
 
“I am excited to join MCRA’s world-class Biocompatibility team. This is an interesting time in medical device regulation and I am confident that I can use my extensive experience in toxicology to assist our clients throughout the medical device lifecycle,” More stated. “I look forward to enhancing our offerings and being a vital resource to our clients and the entire MCRA organization.”
 
MCRA is the leading privately held independent medical device, diagnostics and biologics clinical research organization (CRO) and advisory firm. MCRA delivers to its clients industry experience, integrating its six business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics to provide an effort from innovation conception to commercialization. MCRA has offices in Washington, D.C.; Hartford, Conn.; New York, N.Y.; and Tokyo; and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in-vitro diagnostic (IVD) devices and medical device cybersecurity. 
 
Viscogliosi Brothers LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specialized in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. 

References 
¹ Kovochich, Michael, Andrew Monnot, Daniel G. Kougias, Sharlee L. More, Jared T. Wilsey, Qing-Qing Qiu, Laura EL Perkins et al. “Carcinogenic hazard assessment of cobalt-containing alloys in medical devices: review of in vivo studies.” Regulatory Toxicology and Pharmacology 122 (2021): 104910. Doi: https://doi.org/10.1016/j.yrtph.2021.104910
² Eichenbaum, Gary, Jared T. Wilsey, Gion Fessel, Qing-Qing Qiu, Laura Perkins, Philippe Hasgall, Andrew Monnot et al. “An integrated benefit-risk assessment of cobalt-containing alloys used in medical devices: Implications for regulatory requirements in the European Union.” Regulatory Toxicology and Pharmacology 125 (2021): 105004. Doi: https://doi.org/10.1016/j.yrtph.2021.105004