PharmApprove Names President

Laurie Smaldone, M.D. has been named president of PharmApprove, a strategic regulatory communications firm. Dr. Smaldone, formerly senior vice president of Global Regulatory Science at Bristol-Myers Squibb, will lead PharmApprove’s team of regulatory communications and product development specialists in expanding both the company’s services and its geographical reach.

PharmApprove is an industry leader in helping to prepare drug, biologics, and device teams for high-profile regulatory hearings, including FDA Advisory Committees in the U.S. and health authority hearings in Europe.

“Laurie is a seasoned drug development and regulatory expert who brings an extraordinary range of expertise to the table,” said PharmApprove’s founder and chief executive officer, Pete Taft. “She’s the perfect choice to help deepen our core business, add to our service offerings, and extend our reach into both Europe and Asia. We couldn’t be more excited to have her lead us in this new phase of growth.”

After completing training in Internal Medicine and Medical Oncology at Yale University, Dr. Smaldone joined BMS in clinical cancer research. She then held a range of positions of increasing responsibility and scope in multiple disease areas, including executive director, HIV/AIDS, vice president, Infectious Diseases, senior vice president, Global Regulatory Science, and corporate vice president, Business Risk Management. Dr. Smaldone was most recently chief executive officer of a clinical phase biotechnology company and has worked with PharmApprove as a client.