Role at ICON:
I am responsible for strategic planning, oversight and implementation of all medical and safety activities at ICON Clinical Research.
Background:
I have spent nearly 20 years in drug development and clinical research. I received my medical training at Boston University Medical Center, became board-certified in internal medicine and taught medical school for eight years. During that time I performed clinical studies sponsored by the pharmaceutical industry as well as investigator-initiated studies and studies sponsored by the National Institutes of Allergy and Infectious Diseases (NIAID).
Originally my area of expertise was HIV and AIDS. I worked with Burroughs Wellcome on AZT, the first effective treatment for AIDS, at the University of Miami. I also led investigator-initiated research on the treatment of Pneumocystis pneumonia, which at that time was the most common cause of death in AIDS patients. I was subsequently recruited to work with Dr. Jonas Salk, the developer of the polio vaccine, in an early attempt to find an AIDS vaccine. It was the vaccine trials that led me into the industry, first at Rhone-Poulenc Rorer (currently Sanofi-Aventis) and then eventually into the CRO industry.
Why she finds pharmacovigilance and drug safety so interesting:
As a physician you are committed to preserving health. Pharmacovigilance gives you the opportunity to impact many lives in a very important way. It’s the job of the pharmaceutical physician to ensure that the requirement to show that a product “…is safe for the purpose for which it is intended…” is met. Since no product is ever 100% safe, seeking to balance the benefit a product can provide against risk associated with the use of that product is an interesting and constant challenge.
On the future of drug safety:
The last few years have been a wake-up call both to the FDA and to the industry. The public is ready to hold accountable those institutions (both public and private) that are remiss in their duties to monitor and report safety issues. The responsibility can no longer be passed from one stakeholder to another. In some instances this is a correction back to where the industry needs to be.