Get Your Study Enrolled – Designing Your Impairment Protocol to Prevent Challenges

As drug development progresses, regulators require clarity on how products are metabolized in the human body, and the risks associated with compounds that may linger in critical organs.

Renal impairment studies are a challenging area to recruit, especially for moderate and severe subjects. Therefore, making informed decisions about the design of a study protocol is important, as overly complex protocols can quickly narrow the patient population.

This webinar will draw on experiences from both the site and clinical research organization (CRO) perspectives to inform sponsors about how protocols might be written better to maximize patient enrollment opportunities, thus balancing the practicalities of achieving study goals while also satisfying the needs of regulatory bodies around the world.

The webinar will discuss observations from the presenters’ collective history of working with regulators and help guide design decision-making to successfully enroll patients and keep drug development on track.

Register for this webinar to understand how impairment study protocols can be improved to maximize patient enrollment.

Speakers

Barbara Gillespie, MD, MMS, FASN, VP and Therapeutic Head of Nephrology, Fortrea; Adjunct Professor, Division of Nephrology and Hypertension, University of North Carolina School of Medicine

Barbara Gillespie, MD, MMS, FASN, is a board-certified nephrologist who  has been collaborating with sponsors on renal clinical development, protocol design and execution since 2006.  She is  on the board of directors at the Kidney Health Initiative, a public-private partnership between the FDA and American Society of Nephrology. She also serves on several advisory boards including the NKF Patient Network (CKD Registry) Steering Committee and various NephCure Steering Committees. Dr. Gillespie has served as an associate medical director at a small local dialysis unit until recently.  She completed her internal medicine residency at the University of North Carolina and nephrology fellowship at Duke University.

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Jasmine Ropers, Associate Director of Project Management, Fortrea Clinical Pharmacology Services

Jasmine Ropers is Associate Director of Project Management and Strategy Lead for Phase 1 Renal and Hepatic Impairment Studies at Fortrea. She brings 24 years of clinical research experience, 7 years in data management and 16 years specializing in Phase 1 renal and hepatic impairment project management.

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Stephen Flach, MD, PhD, Executive Medical Director, Clinical Pharmacology, Fortrea

Stephen Flach, MD, PhD, is a board-certified internist who has worked in Clinical Pharmacology since 2005 as a Principal Investigator, Medical Monitor, and Consultant on a wide range of early phase drug development projects. He has helped design and execute numerous renal and hepatic impairment studies since 2017. He is an author on over 40 peer reviewed publications. He was an internal medicine resident on the Osler Medical Service at the Johns Hopkins Hospital and subsequently was a fellow in General Internal Medicine at the University of Pennsylvania. Prior to working at Fortrea, Dr. Flach was on the faculty at the University of Iowa College of Medicine.

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

Dr. Thomas Marbury is board certified in Internal Medicine and Nephrology and 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.

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