Former Global Regulatory Chief Laurie Smaldone, MD, Tapped as PharmApprove President

Online, September 17, 2011 (Newswire.com) - Laurie Smaldone, MD has been named President of PharmApprove, a leading strategic regulatory communications firm that helps maximize outcomes during the most critical milestones of the development cycle for drugs, biologics, and devices in the US and abroad.

Dr. Smaldone, formerly Senior VP of Global Regulatory Science at Bristol-Myers Squibb, will lead PharmApprove's expert team of regulatory communications and product development specialists in expanding not only the company's services, but its geographical reach as well, said PharmApprove founder and CEO Pete Taft.

"Laurie is a seasoned drug development and regulatory expert who brings an extraordinary range of expertise to the table," said 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."

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 US and health authority hearings in Europe.

After completing training in Internal Medicine and Medical Oncology at Yale University, Dr. Smaldone joined Bristol-Myers Squibb in clinical cancer research, immediately advancing development programs through to registration. 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 CEO of a clinical phase biotechnology company.

Dr. Smaldone brings to PharmApprove broad experience in global regulatory approval processes, regulatory communications, and brand development. In addition, she has prepared numerous teams for FDA Advisory Committee hearings as well as key regulatory meetings in the US, Europe, and Asia.

"PharmApprove offers real added value in assisting product development teams in sharpening complex data presentations and core messages during the most critical moments in the registrational process," Dr. Smaldone explained. "Having worked with PharmApprove as a client, I have experienced the power of their approach. I am thrilled to be a part of a team that has shaped and defined this consulting segment so necessary to the approval process."

For more information, or to arrange an interview, contact Katherine Zimoulis at 609-683-0700 or [email protected].

About PharmApprove™
PharmApprove™ is a strategic communications consulting firm that helps drug, biologic, and devices development teams prepare and deliver their product's key messages at critical stages of the development cycle including high-profile regulatory events in both the United States and Europe. Over the last decade, PharmApprove™ teams have helped to create and deliver over 60 drug, biologic, and device development communications programs across 18 therapeutic areas both in the US and overseas, including more than 45 Advisory Committee preparation projects. Find out more at www.pharmapprove.com.

PharmApprove™ is a division of Taft and Partners, an advertising, marketing, and digital media firm located in Princeton, NJ. Find out more at www.taftandpartners.com.