Bruce Burnett

bruce-burnett

Bruce Burnett, PhD, RAC

Director of Regulatory Affairs, DTMI
Assistant Professor of Medicine, Clinical Pharmacology
DCRI Quality Assurance/Regulatory Compliance (QA/RC) and Regulatory Services

Biography

Dr. Burnett is responsible for overseeing a variety of services designed to support investigators in determining the regulatory requirements that apply to their research endeavors and in meeting their obligations. These services include regulatory education, regulatory consultation, and support for regulatory submissions.

Having received his undergraduate degree in chemistry from the University of California, San Diego and his PhD in biochemistry from MIT, Dr. Burnett completed an NIH postdoctoral fellowship in genetics at Harvard Medical School.

With more than 20 years of experience in the pharmaceutical industry involving research and development, scientific affairs, quality control/assurance, and regulatory affairs, Burnett came to Duke from AlphaVax, a local vaccine biotech company where he served as Vice President of Quality and Regulatory Affairs (and previously as Director of Regulatory Affairs and Quality Control). He has also held positions with Biogen (Associate Director of Quality Control and Bioassay, Manager of Regulatory Affairs, and Associate Director of Regulatory Affairs), Genetics Institute (Manager of Clinical Quality Control), and Serono Laboratories (Manager of Scientific and Clinical Affairs).

Burnett’s regulatory experience includes working on license applications that have resulted in the U.S. approval of Tysabri (natalizumab), Amevive (alefacept), Neumega (oprevelkin, IL-11) and Benefix (coagulation Factor IX). He has also been responsible for preparing and submitting multiple initial INDs to CBER and CDER, preparing for many pre-IND and End of Phase 2 meetings, and leading numerous teleconferences with U.S. FDA reviewers. His responsibilities have included defining regulatory strategies that have resulted in phase I, II, and III clinical studies in the U.S. and Europe. Burnett has extensive experience with and knowledge of Good Laboratory Practice and Current Good Manufacturing Practice and their respective requirements for early drug development and clinical studies. Burnett holds the Regulatory Affairs Certification (RAC) in U.S. and European regulations from the Regulatory Affairs Professionals Society.