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Pharmacovigilance Concerns with the Use of Experimental Medicines for Ebola and Enterovirus B-68
Session Chair(s)
Elizabeth E. Garrard, PharmD
Executive Vice President, Global Safety Operations
Clinipace Worldwide, United States
The race is on to find a cure for Ebola which has killed more than 8000 people in West Africa and remains the largest outbreak on record. Over the last several months, the United States has experienced a nationwide outbreak of enterovirus D68 (EV-D68) associated with severe respiratory illness. The CDC and/or state public health laboratories have confirmed over 1100 people in 47 states and the District of Columbia with respiratory illness caused by EV-D68. There are no proven treatments for people with the Ebola or enterovirus D68 virus or vaccines to prevent infection in the first place. However, progress is now being made on an unprecedented scale. Trials, which would normally take years and decades, are being fast-tracked on a timescale of weeks and months. This session will discuss how fast-tracking clinical investigations has obvious shortcomings, most notably required understanding of the safety profile of the agents used to treat these epidemics. Another issue is that of ethical considerations in providing treatment during epidemics with agents that have not undergone robust clinical trials.
Learning Objective : Discuss the impact of fast tracking the regulatory process including the possible downstream effects on patient safety; Describe the ethical impact of the use of experimental medications and vaccines that have not been formally approved or even tested in humans; Identify if we will gain insight on antimicrobial resistance during epidemics.
Speaker(s)
Antimicrobial Resistance: Issues and Concerns
Syed Rizwanuddin Ahmad, MD, MPH, FISPE
Drug Safety Consultant, United States
Ex-Consultant/Safety Reviewer, FDA, Assoc Prof (adjunct), Rutgers, Georgetown
Accelerating the Evaluation of Potential Treatments for Ebola
Raj Long, MEd, MSc
Bill and Melinda Gates Foundation, United Kingdom
Deputy Director, Safety and Pharmacovigilance
Expedited Development of Ebola Vaccines: Ensuring Safety
Bharat Khurana, DVM, PhD, MBA
FDA, United States
Microbiologist, OVRR, DVRPA, CBER
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