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Meet Our Experts

Mike McGrew, P.E., MSME

Vice President of Operations

Mike McGrew has more than 30 years of experience working with medical devices. His experience spans diverse disciplines, including business strategy, site/plant management, program management, quality, and engineering. Before joining WuXi AppTec, Mike held several leadership positions with Covidien/Medtronic, Hospira and Abbott Laboratories.

Mike earned a master’s degree in mechanical engineering from Tufts University and a bachelor’s degree from Southeastern Massachusetts University. Mike is also registered as a professional engineer in California. Mike is WuXi AppTec’s vice president of operations, focusing on operational excellence and streamlining client services to pursue world-class performance.

Gabe J. LeBrun

Senior Director Testing Operations, Biocompatibility

Gabe LeBrun is WuXi AppTec’s senior director of testing operations, responsible for the operational leadership of North America’s WuXi AppTec biocompatibility business. He has more than 35 years of technical and business leadership experience in the testing services industry. His team provides defendable data and solutions in the highly regulated EPA, FDA, GLP, GMP and ISO environments.

Mr. LeBrun earned a bachelor’s degree in biology and chemistry from the University of Wisconsin-Eau Claire, with extensive coursework in the MBA Operations Program at the University of Wisconsin-Madison. He has been a senior leader of testing services companies spanning multiple disciplines for more than three decades.

Sandi Schaible

Senior Director of Analytical Chemistry and Regulatory Toxicology

With over 25 years’ experience, Ms. Schaible is responsible for oversight and direction of WuXi AppTec’s Analytical Chemistry department in St Paul, Minnesota. The analytical staff she manages is responsible for providing custom chemistry testing services including extractables/leachables, materials characterization and target analysis testing, method development, method validation as well as standardized testing including compendial testing.

Ms. Schaible received her Bachelors of Science in Chemistry from Winona State University, and has experience working in the pharmaceutical, medical device, environmental and R&D industries, including over 15 years of analytical experience in GLP, GMP, FDA and ISO regulated laboratories. Ms. Schaible provides technical guidance and testing program design, and is an international and U.S. delegate for TC 194, the technical committee for ISO 10993.

Dr. Kimberly Ehman, Ph.D., DABT

Technical Director of Regulatory Toxicology

Dr. Ehman has over 18 years of toxicology and medical device experience, with expertise in toxicological risk assessments for medical devices, food and beverage products, and electronic nicotine delivery systems. She received her Ph.D. in parasitology from McGill University and conducted postdoctoral research at the US EPA in developmental neurotoxicology. In her current position as Technical Director of Regulatory Toxicology, Dr. Ehman provides medical device manufacturers and suppliers with technical and regulatory support for biocompatibility test programs and conducts quantitative toxicological risk assessments to support product safety and risk management decisions.

 

Mark Cabonce

Principal Toxicologist

Mark Cabonce serves as a principal toxicologist at WuXi AppTec, focusing on medical devices and combination products. Before joining WuXi AppTec, he was a toxicologist managing regulated in vivo and in vitro acute toxicology studies, assessing formulation dossiers for G.H.S. classification and labeling, and preparing risk assessments supporting domestic and international product registrations. Mr. Cabonce also managed pharmacokinetic and preclinical safety evaluation studies for a broad range of pharmaceutical and agrichemical clients under prevailing EPA, FDA and OECD guidelines. He earned a master’s degree in biology from St. Louis University and has been a Diplomate of the American Board of Toxicology since 2005.

 

Dan Fowler

Principal Reprocessing Scientist

Dan Fowler is the group manager of reprocessing and sterilization validation services for medical devices, biologics, and combination products at WuXi AppTec. He is also a member of the AAMI Sterilization Standards Committee.

With more than 20 years of experience in medical device third-party reprocessing, Dan is an expert in the interpretation and application of AAMI TIR30, overseeing the following modalities for sterilization: radiation, moist heat (gravity or prevacuum), ethylene oxide (EO), and dry heat. Dan’s experience allows him to streamline identification and validation of analytical laboratory assays and develop the best practices in method development for inoculation/extractions and efficient cleaning/disinfection strategies for reusable medical devices.

Britt Jones

Chemistry and Package Testing Manager

Britt Jones is the group manager of the Chemistry and Package Testing services for medical devices, biologics, and combination products at WuXi AppTec. He serves on the ASTM Committee on Packaging (ASTM D-10) and is a member of and certified by the International Safe Transit Association (ISTA) and the Institute of Packaging Professionals (IoPP).

With over 20 years of operations and project management experience at WuXi AppTec, Britt’s broad knowledge in microbiology, chemistry, sterility, bioburden, microbial ID, and packaging, enables him to provide the scientific and regulatory advice that medical device development needs to avoid pitfalls and failure points. As an industry expert, Britt excels in packaging validation and cold chain transportation studies.

Mark R. Cunningham, Ph.D.

Mark R. Cunningham, Ph.D.

Senior Director of Science and Technology

Dr. Mark Cunningham joined WuXi AppTec in 2018, as Senior Director of Science and Technology. With a career spanning more than three decades in the biopharmaceutical and medical device research and testing industries, he has vast scientific experience in discovery, development and characterization of biopharmaceutical, medical device and combination products.  Dr. Cunningham’s area of expertise is the physiology, pharmacology and pathobiology of cardiovascular disease, with a specific interest in preclinical models of inflammation, cardiovascular disease and safety pharmacology.

Dr. Cunningham received a B.S. in BioMedical Science from Grand Valley State University in Grand Rapids, Michigan, a Ph.D. in Pharmaceutical Sciences from the University of Kentucky, and completed his post-doctoral training at the University of Michigan Medical School.  Over the course of his career he has published over 65 papers and abstracts, and presented at national and international scientific meetings.

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Cindy Dingee, D.V.M

Histopathology Operations Manager and Veterinary Pathologist

Dr. Cindy Dingee serves as WuXi AppTec Medical Device Testing’s histopathology operations manager and veterinary pathologist in the Lab Testing Division. Dr. Dingee maintains timelines and first in/first out processes in her managerial role. She also manages laboratory planning, development, and equipment installation and qualification, responding to client inquiries about study capabilities and department capacity. She leads and participates in cross-functional process improvement projects and evaluates toxicological, intramuscular and subcutaneous custom studies, and wound-healing and osteoinduction studies. As a staff pathologist, Dr. Dingee creates study pathology reports per G.L.P. and G.M.P. guidelines, develops histopathology protocols, consults with principal investigators and validates pathology systems. Dr. Dingee earned a doctoral degree in veterinary medicine from Ross University, West Indies. She spent a clinical year at the University of Minnesota, where she completed a residency in anatomical pathology.

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