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Bruce K. Burnett, PhD, RAC (US, EU) is Director of Regulatory Affairs at Duke Translational Medicine Institute. Dr. Burnett received his undergraduate degree in organic chemistry from the University of California, San Diego and his PhD in organic chemistry/biochemistry from MIT working in the laboratory of Nobel Laureate Dr. Har Gobind Khorana. He completed an NIH postdoctoral fellowship in genetics at Harvard University and Harvard Medical School. Dr. Burnett brings over 25 years of experience in the pharmaceutical industry involving research and development, scientific affairs, quality control/assurance, and regulatory affairs. He came to Duke from AlphaVax, a vaccine biotech company where he served as Vice President of Quality and Regulatory Affairs. He has also held both senior regulatory and quality positions at BiogenIdec, Genetics Institute (Wyeth Pharmaceuticals), and Serono. Dr. Burnett’s regulatory experience includes working on license applications that have resulted in the US approval of Tysabri (natalizumab), Amevive (alefacept), Neumega (oprevelkin, IL-11) and Benefix (coagulation Factor IX). He has also been responsible for preparing and submitting many initial INDs to CBER or CDER, preparing for many pre-IND and End of Phase 2 meetings. Dr. Burnett and his group recently oversaw the preparation and submission of a Biologics License Application for the manufacture of Cord Blood at Duke University. FDA approved the license to Duke University in October 2012. Dr. Burnett’s responsibilities have included defining regulatory strategies that have resulted in Phase 1, 2 and 3 clinical studies both in the US and Europe. Dr. Burnett also brings 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. Dr. Burnett holds the Regulatory Affairs Certification (RAC) in both US and European regulations from the Regulatory Affairs Professionals Society.