Meet Our Experts

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.

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.

Dr. Jayshree Patel, Ph.D.

Director of Technical Services

Dr. Jayshree Patel is the Director of Technical Service at WuXi AppTec, where she spearheads programs to expand service areas and revenues, notably in microbiology and regulatory compliance. With an MBA specializing in organizational management and leadership, a doctorate in microbiology, and a career spanning more than 18 years across various leadership roles in pharma/biotech, Dr. Patel is a visionary in strategic planning and quality management. She has pioneered more than 100 test protocols, advanced CAPA and risk assessments, and implemented environmental monitoring and biosafety programs. Dr. Patel’s leadership in establishing microbiology labs and manufacturing facilities, coupled with her expertise in regulatory standards (e.g., USP, EP, ICH, ISO, FDA, etc.), position her as a key figure to lead WuXi AppTec’s technical and regulatory innovation.

Dr. Beverly Lundell, Ph.D.

Scientific Director of Custom Studies

Dr. Beverly Lundell is a Scientific Director of Custom Studies at WuXi AppTec, with a prolific career in biomedical science focusing on preclinical study designs, regulatory compliance, and innovative testing methods. She earned a doctorate in microbiology, immunology, and cancer biology from the University of Minnesota; a master’s degree in nutrition-metabolic research from the same institution; and a bachelor’s in medical technology from Augsburg College. Dr. Lundell’s contributions include developing over 600 study designs, authoring study reports for regulatory agencies, and pioneering in vivo and in vitro testing methods. Her work emphasizes reducing animal use in testing, improving biocompatibility assessments, and advancing toxicology risk assessment.