Medical Device Safety Team

Charles Rivers medical device experts offer an integrated approach to medical device studies with a commitment to scientific excellence, an appreciation of client-specific, and an understanding of regulatory considerations.

Guy Leclerc, MD

Senior Science Director, Medical Devices

Head shot of Dr. Guy Leclerc.

Dr. Leclerc founded Accellab, a preclinical CRO focused on medical devices, in 2004 and was CEO of the company until being acquired by Charles River Laboratories in 2019. He is now a senior director for medical devices supporting the emergence of the Medical Device Safety group.

Meet Dr. Leclerc

 

François Bergeron, M.Sc.

Director of Business Development

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As a trilingual senior BD strategist and deal-maker, with over 30 years of experience in the health sector within small, medium and large companies, Francois has successfully realigned business strategies and concluded significant business partnerships on four continents.

Meet Francois

 

Amy Stricker-Hume

Business Development Director

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Amy Stricker-Hume has been in the preclinical CRO environment since 2001, working with innovators of medical devices and combination products from early feasibility through GLP safety and post-market assessments.

Meet Amy

 

Michel Assad, PhD

Executive Orthopedics and Biomaterials Director

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Dr. Michel Assad is an accomplished biomaterials scientist with over 25 years of experience in preclinical research and product development.

Meet Dr. Assad

 

Gerald Poeltl, MBA

Business Development Director

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Gerald is a seasoned business development professional with more than 10 years of experience in senior business development and site management roles at mid-sized and global CROs. In his role he builds the bridge between science and market for medical technologies.

Meet Gerald

 

Nancy Doyle

Scientific Advisor

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Nancy Doyle is a Scientific Advisor in Medical Devices, with almost 25 years of experience in the conduct and design of studies in cartilage/bone toxicology and a variety of medical devices with a good understanding of the different related guidelines. She has authored and co-authored several publications in peer reviewed journals.

Meet Nancy

 

Louis-Georges Guy, PhD

Director of Science

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Dr. Guy established the scientific program for the preclinical evaluation of medical devices in the fields of cardiology, ENT, orthopedics, and others. As an expert in bioabsorbable scaffolds, he has authored many articles, presented for sponsors in scientific meetings, and was invited as preclinical expert at a workshop at the FDA and a biodegradable metal symposium.

Meet Dr. Guy

 

Maureen O’Brien

Veterinary Pathologist

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Dr. Maureen O’Brien is a board-certified veterinary pathologist with training and experience in the preclinical safety assessment of medical devices and pharmaceuticals.

Meet Dr. O’Brien

 

Scott Wilson, BS

Associate Director

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Mr. Wilson has performed a broad range of GLP and non-GLP surgical and targeted drug delivery studies. His areas of expertise include interventional cardiology, cardiovascular device safety and efficacy testing, hemostatic materials testing, and internal medicine.

Meet Scott

 

Aurore Varela, DABT, DVM, MSC

Scientific Director

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Aurore Varela has over 15 years of experience in preclinical radiology, imaging, bone biomarkers, biomechanics, and study design and conduct in musculoskeletal research and toxicology. She has co-authored several research papers in peer-reviewed scientific journals, contributed to chapters in several books related to musculoskeletal research and bone pathology, and edited a book on bone toxicology.

Meet Aurore

 

Lyn M. Wancket, DVM, PhD, DAVCP

Veterinary Pathologist

Head shot of Dr. Lyn M. Wancket.

Dr. Wancket joined Charles River as a Veterinary Pathologist II in late 2018. Dr. Wancket has over five years of experience in medical device pathology, with a publication focus on musculoskeletal pathology and medical device models.

Meet Dr. Wancket

 

Miriam Rosario

Associate Director

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Miriam is a trained quality systems professional with extensive experience in FDA and ISO quality systems requirements and an extensive background in cGMP environments for medical devices. She is a subject matter expert for industry regulations including ISO 9000/13485/14971 and the Medical Device Directive.

Meet Miriam