Best Practices for Clinical Labs in Turbulent Times

Presented By: Michael J. Donovan, Ph.D., JD, Travis Schlappi, PhD & Mara G. Aspinall, MBA Speaker Biography: Michael is currently an Assistant Teaching Professor in the biomedical diagnostics program in Arizona State University’s College of Health Solutions. Michael teaches courses related to a variety of diagnostics-related topics, including immunoassays, applied bioethics, regulation of diagnostics, and is a mentor for the BMD program’s applied projects. For the last 14+ years, Michael has been a registered patent attorney (BS – Microbiology; PhD Immunology) specializing in patent prosecution and intellectual-property licensing/commercialization for life sciences-related technologies. After leaving private practice, Michael worked as the Intellectual Property Counsel for The Translational Genomics Research Institute (TGen) and recently served as the System Director for Intellectual Property at CommonSpirit Health. He has protected and commercialized a multitude of different technologies, including medical devices, biomedical diagnostics and therapeutics, among other technologies. Travis S. Schlappi, PhD, joined the College of Health Solutions at Arizona State University in 2023 as an Assistant Teaching Professor in the Biomedical Diagnostics program. Dr. Schlappi received his B.S. from Brigham Young University in 2011 and his Ph.D. from the California Institute of Technology in 2017, both in chemical engineering. For his Ph.D. research, Dr. Schlappi was selected as the silver medalist in the National Inventors Hall of Fame Collegiate Inventors Competition and awarded Diagnostics World’s Early Innovator Award. While an assistant professor at Keck Graduate Institute, he received a K Award from the NIH for his research, which uses microfluidics to develop point-of-care medical diagnostics that benefit patients in limited-resource settings without access to hospitals or modern healthcare technology. Dr. Schlappi has developed expertise in teaching methodologies and practices due to experience with a wide variety of student demographics and subjects, having taught pre-calculus to high school students as part of the Teach For America program, Portuguese to college-aged students, and medical diagnostics to graduate level students. Mara Aspinall is a healthcare industry leader and pioneer committed to active civic engagement. Mara is Partner at Illumina Ventures, the leading independent venture capital firm focused on genomics and precision health. Aspinall is editor of Sensitive & Specific: The Testing Newsletter, a weekly publication in industry innovations. Aspinall is a member of the board of directors of OraSure and Blue Cross Blue Shield of Arizona. Webinar: Best Practices for Clinical Labs in Turbulent Times Webinar Abstract: The FDA’s landmark final rule on Laboratory Developed Tests (LDTs) is set to transform the regulatory landscape for diagnostic laboratories. This webinar will provide biomedical diagnostics professionals with a comprehensive overview of quality system requirements (QSR) and key compliance deadlines for the final rule. Actionable strategies to improve quality, which help a lab increase effectiveness, reduce costs, and prepare for the phase-out of enforcement discretion will be discussed. Our expert panel will clarify and outline the FDA’s quality system requirements and highlight the potential global implications of these regulatory changes. Attendees will gain insights into the impact on clinical laboratory operations, including ISO 15189 and ISO 13485 considerations, registration and labeling mandates, and premarket review timelines. Whether you are a laboratory director, regulatory affairs specialist, or diagnostics manufacturer, this session is designed to equip you with the knowledge needed to improve your quality systems and navigate the new compliance landscape. Earn PACE Credits: 1. Make sure you’re a registered member of Labroots (https://www.labroots.com/) 2. Watch the webinar on YouTube or on the Labroots Website (https://www.labroots.com/ms/webinar/practices-clinical-labs-turbulent-times) 3. Click Here to get your PACE credits (Expiration date – April 3, 2027): https://www.labroots.com/credit/pace-credits/9294/third-party Labroots on Social: Facebook: https://www.facebook.com/LabRootsInc Twitter: https://twitter.com/LabRoots LinkedIn: https://www.linkedin.com/company/labroots Instagram: https://www.instagram.com/labrootsinc Pinterest: https://www.pinterest.com/labroots/ SnapChat: labroots_inc