Preclinical Medical Device Safety Evaluation in 2022
August 3, 2022
Shayne C. Gad, PhD, DABT
About the Speakers:
Dr. Shayne Gad has more than 40 years of broad-based experience in toxicology, drug and device development, statistics, and risk assessment. He has specific expertise in neurotoxicology, in vitro methods, inhalation toxicology, immunotoxicology, and genotoxicology. A past president of the American College of Toxicology and the Roundtable of Toxicology Consultants and the recipient of the 2008 ACT Lifetime Achievement Award, Dr. Gad has authored or edited 50 books, 64 independent chapters and more than 350 papers and abstracts in the above fields. He has contributed to and has meaningful personal experience with IND (114 successfully filed to date), NDA, BLA, ANDA, 510(k), IDE, CTD, dietary supplement and PMA preparation. Dr. Gad is fully experienced with the design, conduct, analysis, and reporting of preclinical and clinical safety and pharmacokinetic studies for drugs, devices combination products and dietary supplements, and with regulatory submissions associated with them. Gad Consulting Services holds SAS, DEREK, and Leadscope licenses and capabilities and has successfully provided computational analysis of PK/TK data and qualified impurities, intermediates, residual solvent, and excipient levels in existing and under development drugs for many of its clients, as well as leachables and extractables for device clients. GCS has established and current experience in CAPA safety assessments preparing F-value classifications, and providing both GLP and GMP audits.
Samantha Gad is a Senior Consultant at Gad Consulting Services, where she has supported clients with risk assessments of both drugs and medical devices for the last 13 years. She holds a degree in chemical engineering from the University of Cincinnati, a background which led to her strong interest in the use of QSAR methods and material chemical characterization for the evaluation biological risk. Sam has a broad knowledge of Leachable and Extractable testing for both pharmaceuticals and medical devices, from study design through risk assessment. She frequently consults with companies to ensure device biocompatibility evaluation, testing, and risk assessment methods meet current regulatory expectations. Samantha has a strong drive to learn and loves to share her knowledge and experience at every opportunity. She is a member of both ACT, where she currently serves on the Podcast Subcommittee, and SOT, and enjoys attending the Extractable & Leachables USA Conference annually. Prior to her current position Sam had a career advising production teams in a GMP manufacturing setting. Heavily involved in training and process documentation, and able to efficiently troubleshoot formulation and equipment issues; she soon fulfilled her goal of working on a team to startup a new production facility. Since transitioning to consulting, Samantha still performs the occasional cGMP facility audits of CMOs.
Over the last decade, testing requirements for medical devices have evolved immensely. Many device companies do not have internal toxicology or biocompatibility support to guide them through the testing and interpretation of the results. This webinar starts with a brief history of risk evaluation for medical devices, then dives into the fundamental principles of biocompatibility assessment. Topics include device categorization per ISO 10993-1 to determine what, when, and why some biocompatibility endpoints should be evaluated through testing, some evaluated via alternative methods, and some will require hazard analysis to identify risks not addressed through the prescribed testing. In the second half of the webinar the focus turns to chemical characterization (ISO 10993-18) and gas emissions testing (ISO 18562 series). What biocompatibility endpoints can be addressed through extractables testing with tox risk assessment, interpretation of test results to ensure risk is adequately addressed, and how to work with the data for estimating patient exposure and assessing risk -including when to use the TTC. This webinar will provide insight on medical device testing and methods that comes after years of practical application, spanning several generations of regulatory guidance and expectations.
View Webinar Recording
Webinar materials are property of the speaker and the American College of Toxicology and are intended for use by the host society and cohost societies' members for educational purposes only. Any distribution or copy of the materials is prohibited. By downloading from the link provided you agree to the terms expressed above.