Participants Will Discuss Advances to Improve Patient Safety and Pipeline Process
The DIA conference Drug-Induced Injury of Liver, Heart, Kidney, and Skin: Employing Recent Advances to Improve Patient Safety and Speed Up the Pipeline will be held Oct. 15 to 17, at the Bethesda North Marriott Hotel & Conference Center in North Bethesda, Md., at 5701 Marinelli Road. The conference will focus on risk assessment of drug toxicity and address the obstacles faced by those working in pharmaceutical safety across the drug life cycle.
“Establishing the safety of new drug candidates remains a challenge in the development process. This conference will explore new strategies for risk assessment and mitigation and provide the latest updates on drug-induced organ injury from the United States, Europe and Japan,” said Susan Cantrell, director of DIA North America.
The two-and-a-half-day conference aimed at drug safety professionals will kick off with a welcome address by William W. Gregory, Ph.D., senior director of safety and risk management at Pfizer. The first session, “Impact on Drug Development of Novel Translational Safety Biomarkers for Improved Detection of Drug-Induced Acute Kidney Injury,” will be chaired by Aliza M. Thompson, M.D., a clinical team leader with the Center for Drug Evaluation and Research, Food and Drug Administration, U.S.
Workshop sessions will include:
- Prediction and Prevention of Serious Drug-Induced Skin Injury, Oct. 15, 1:30 p.m.: Serious skin reactions are rare but can be life-threatening and leave people with lasting disabilities. Experts will discuss what is known about biomarkers for risk of serious skin reactions and the identification of patients at—and drugs with—the greatest risk. Edward Stewart Geary, M.D., senior vice president of corporate medical affairs at Eisai Co., Ltd., Japan, will chair this session.
- Drug-Induced Liver Injury: Models and Biomarkers, Oct. 16, 8:30 a.m.: One of the key challenges for the prediction and assessment of idiosyncratic drug-induced liver injury in drug development is the lack of suitable models and safety biomarkers. This session will present examples of recent advances in both areas based on collaborative research. Michael Merz, M.D., director of discovery and investigative safety at Novartis Institutes for BioMedical Research, Switzerland, will chair this session.
- Risk Factors for Idiosyncratic Drug-Induced Liver Injury, Oct. 16, 3 p.m.: Master clinicians will discuss whether underlying liver diseases of various types can be distinguished from drug-induced injury and if the diseases may either enhance or diminish drug effects. This session will be chaired by John R. Senior, M.D., associate director for science, Office of Surveillance and Epidemiology, Food and Drug Administration, U.S.
- Models and Biomarkers of Drug-Induced Cardiac Injury, Oct. 17, 10:30 a.m.: This session will explore bench-to-bedside approaches to identifying and monitoring drug-induced cardiac injury as well as innovative approaches to in vitro modeling. Brian R. Berridge, DVM, Ph.D., director of worldwide animal research strategy at GlaxoSmithKline Research and Development, U.S., will chair this session.
DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org