He’s a urologist, but Daniel Shames, MD, has actually had three careers: practicing urologist, FDA official, and pharmaceutical industry consultant.
Dr. ShamesHe’s a urologist, but Daniel Shames, MD, has actually had three careers: practicing urologist, FDA official, and pharmaceutical industry consultant.
Dr. Shames’ first career was in clinical practice in Columbia, SC, which spanned about 20 years. For personal and professional reasons, he left clinical medicine.
“I applied for non-clinical positions and got a job at the FDA in 1996, not knowing exactly what I was going to do,” he said. “It was an extremely interesting and educational experience.”
Dr. Shames started as a urologist medical officer, eventually moving up to director of the FDA’s Division of Reproductive and Urologic Products, a post he held for 6 years. He was also the head of the GI division for a time and “continued to move further up the supervisory chain,” he recalled.
Consulting was next. “As I had grandchildren in New York and the FDA is in Washington, I left the FDA in 2008 to set up a consulting practice. I have been lucky and things have gone very well,” he said.
Dr. Shames currently works with pharmaceutical companies of all sizes on clinical trial design and FDA interactions. “I do due diligence,” he added, “evaluating companies and drugs for investors, as well as some litigation work, which mainly has to do with issues surrounding FDA regulatory concerns.
“I have been very happy with my three careers. I never knew when I started out that other options were available besides clinical medicine; now, I can see there are lots of opportunities.”
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