The single most frequent reason for safety-related drug withdrawal is organ toxicity. Although drug-induced liver injury (DILI) tops the list of potential causes, kidney and other organ toxicities are also of major concern for drug developers, particularly because they can have significant and serious impact when discovered in the post-marketing phase.
But what are the best ways to incorporate and monitor these types of safety parameters in your clinical trial?
When considering the latest regulatory guidance on organ toxicity, and the increased availability of effective biomarkers, drug developers have the opportunity to adopt a more proactive strategy for assessing a drug’s adverse effect on vital organs. An important element of this strategy is the real time surveillance of critical laboratory results, designed to identify study subjects at risk of developing drug induced organ toxicity (DIOT). In addition to the rapid and accurate identification of potentially troublesome patterns of test results, judicious assessment of DIOT requires evaluation and consideration of underlying etiologies and other factors which may be causing or contributing to the pattern of test results. In order to eliminate other etiologies for the elevated laboratory results, ACM will consult with the client in the laboratory assessment of these subjects.
Join ACM Global Central Lab for this webinar to learn the operational and analytical considerations for early detection of potential organ toxicity, including:
- Operational considerations and best practice standard operating procedures for specimen collection, handling, and shipping to ensure sample and ultimately test result integrity.
- Development of improved strategies that can identify early signs of potential drug-induced organ toxicity (DIOT) and understanding the rules that can help predict severe organ injury.
- Development of patient assessment indicators to identify underlying factors and etiologies that may impact or cause observed patterns of test results apart from drug induced toxicity.
- Integrating organ toxicity surveillance into clinical trial design and protocol development.
- Developing flexible safety biomarker panels in collaboration with your central lab, in which available biomarkers testing, best suited for the study, will be offered.
This webinar is part of ACM Global’s “Navigating Global Clinical Trials with your Central Lab” series of informative and interactive events.
Mark Engelhart, Chief Commercial Officer, ACM Global Central Laboratory
Mark has more than 25 years of experience within the pharmaceutical and drug development industries, with extensive experience in sales, marketing, strategy, and global commercial operations. He has held commercial and general management roles across the continuum of drug development and commercialization, from pre-clinical and clinical development through post-approval marketing and sales. As Chief Commercial Officer at ACM, Mark manages our global business development, marketing, commercial analysis, and bids & proposals functions.
Andrew Botham, PhD, Research & Development Manager, ACM Global Central Laboratory
Andrew is a state registered biomedical scientist and has a Masters degree in biotechnology and a PhD in medicine. He has worked within the NHS and in Private Pharma as well as academic research. Andrew is the Research and Development Manager for ACM Global Central Laboratory;primarily, his role focuses on the identification and development of new analytical practices within ACM Global, in advising project management and business development of scientific, clinical and technical aspects of our procedures, and in to promoting and maintaining scientific excellence throughout ACM Global Central Laboratory.
Maria-Magdalena Patru, MD, PhD, Scientific Affairs Medical Liaison, ACM Global Central Laboratory
Dr. Maria-Magdalena Patru received her MD degree from Iuliu Hatieganu University of Medicine and Pharmacy in Cluj-Napoca, Romania and her PhD in Microbiology and Immunology from University of Rochester, NY. She joined ACM Global Central Laboratory after a two year fellowship in Clinical Microbiology completed at Strong Memorial Hospital, Rochester, NY. During this fellowship, she gained experience in clinical trials, laboratory management, molecular diagnostics, and infectious disease. The Medical Liaison position at ACM utilizes her medical and laboratory background in providing scientific direction and support for clinical trials.
ACM Global Central Lab
ACM Global Central Lab offers a flexible approach and a focus on precision to optimize the clinical study outcomes for our clients.ACM Global’s services extend to more than 60 countries, with all tests conducted and managed from central lab facilities and a seamless data management process providing a single global database. ACM performs 20 million diagnostic tests each year, offering more than 1,500 individual assays, spanning virtually all medical disciplines, including pathology, microbiology, flow cytometry, and pharmacogenomics. Combining comprehensive safety, efficacy and pathology testing from a single lab ensures clients receive consistent, accurate test results with faster and cleaner reporting.