Renal and Hepatic Impairment Studies: Optimizing Strategies in Clinical Development

From study design to feasibility assessment to patient enrollment, many important considerations factor into achieving timely completion of renal/hepatic impairment studies. As traditional renal and hepatic impairment studies have shifted, efficiently conducting these studies to understand the effect of a treatment and achieve regulatory approval requires a comprehensive, cross-functional strategy.

Join this webinar to hear from four specialists in the field as they share their insights for optimizing a clinical development plan, identifying key protocol parameters, best practices for managing the medical and scientific aspects of impairment studies and how to choose the right sites and perform start-up quickly. They will also cover practical considerations for handling the complexity of Phase I studies, conducting a “reduced PK study” per the FDA guidance and working with dialysis cohorts.

Register today and expand your knowledge about improving efficiencies in your renal and hepatic impairment programs.

Speakers

Jane Royalty, MD, Senior Medical Director, Clinical Pharmacology Services, Covance

Dr. Jane Royalty is an Internal Medicine Physician, ABIM Board-Certified, with 20 years of experience in clinical research and internal medicine. She has broad therapeutic area expertise in early phase protocol design and development including FIH through early patient trials, for small and large molecules, and all submission supporting studies. She also supports the oversight of special population clinical trials, including renal and hepatic impairment populations.

Message Presenter

Thomas C. Marbury, MD, President, Orlando Clinical Research Center

Dr. Thomas Marbury has served as Principal Investigator in over 1,000 Clinical Trials since 1978. He has published extensively in scientific and clinical journals and is regarded as a thought leader in the area of renal and hepatic trials. He has presented on various panels with other clinical pharmacology experts and FDA leaders at the industry’s national meetings. He is the founder and President of Orlando Clinical Research Center since 1990. As the President of Orlando Clinical Research Center, his main areas of research are Phase I clinical trials.

Message Presenter

Jackie Miller-Giles, MS, Senior Clinical Scientist, Clinical Pharmacology Services, Covance

Jackie Miller-Giles has over six years of experience in fundamental research and laboratory science and over 14 years of clinical research experience focusing on early phase and clinical pharmacology protocols across a wide range of therapeutic areas. She has supported extensive renal and hepatic impairment trial design and protocol development.

Message Presenter

Jasmine Ropers, Senior Project Manager, Covance Clinical Pharmacology Services

Jasmine Ropers has 20 years of industry experience. She began her career in Data Management and transitioned over to Project Management twelve years ago. She has been overseeing renal and hepatic impairment trials for 11 years and is the impairment study operational subject matter expert at Covance.

Message Presenter