FDA’s Temple to speak on clinical trials on March 6

February 26, 2008
photo, Dr. Robert Temple

photo, Dr. Robert Temple

Robert Temple, MD, often described as one of the most influential officials in the U.S. Food and Drug Administration’s drug regulatory process, will speak at the UNC School of Public Health at 3 p.m. Thursday, March 6, in the Rosenau Auditorium (133 Rosenau Hall).

As director of the Office of Medical Policy in the FDA’s Center for Drug Evaluation and Research, Temple is responsible for regulating how clinical trials are promoted and how the quality of clinical trials is assessed.

Temple will discuss the “FDA Drug Approval Process, Potential Efficiencies and Active Control Trials.” His lecture is sponsored by the School’s UNC Center for Innovative Clinical Trials, which is the first Gillings Innovation Lab (see www.sph.unc.edu/clinical_trials).

Dr. Joseph G. Ibrahim, Alumni Distinguished Professor in the School’s department of biostatistics, directs the Center.

“We are delighted to have Dr. Temple come share with us his thoughts about clinical trial efficiencies and controls,” Ibrahim said. “Our goal at the center is to find better ways to design, conduct and analyze clinical trials. We hope to bring together FDA officials, researchers from many different academic disciplines and scientists conducting clinical trials at pharmaceutical companies and clinical research organizations. If we combine our perspectives and insights, we can find ways to get innovative treatments to patients faster and safer than anyone can do today.

“Thanks to his knowledge and experience, Bob Temple is one of the key people who can help us find better ways forward. I’m excited about the opportunity to hear his perspective.”


Register online for Dr. Temple’s seminar, or call (919) 966-0198 for more information. A reception will follow the presentation at 5 p.m.

School of Public Health contact: Ramona DuBose, director of communications, (919) 966-7467 or ramona_dubose@unc.edu.