Bruce Kendall Burnett, PhD

Associate Professor in Medicine
Core Faculty in Innovation & Entrepreneurship
Member of the Duke Clinical Research Institute
Campus mail 0311 Terrace Level Room, PO Box 17969, Durham, NC 27715
Phone (919) 668-7178
Email address bruce.burnett@duke.edu

I am the Director of Regulatory Affairs within the Duke Translational Medicine Institute.  This function provides regulatory, quality and preclinical GLP support for investigators here at Duke.

Education and Training

  • Fellowship, Genetics, Harvard Medical School, 1982 - 1986
  • Ph.D., Massachusetts Institute of Technology, 1982

Publications

Berglund, Jelena P., Nicole Szczepanski, Anusha Penumarti, Ayeshia Beavers, Janelle Kesselring, Kelly Orgel, Bruce Burnett, A Wesley Burks, and Michael Kulis. “Preparation and Analysis of Peanut Flour Used in Oral Immunotherapy Clinical Trials..” J Allergy Clin Immunol Pract 5, no. 4 (July 2017): 1098–1104. https://doi.org/10.1016/j.jaip.2016.11.034.

PMID
28132800
Full Text

O’Reilly, Erin K., Nancy J. Hassell, Denise C. Snyder, Susan Natoli, Irwin Liu, Jackie Rimmler, Valerie Amspacher, et al. “ClinicalTrials.gov reporting: strategies for success at an academic health center..” Clin Transl Sci 8, no. 1 (February 2015): 48–51. https://doi.org/10.1111/cts.12235.

PMID
25387802
Full Text

Ruiz, Jennifer, Gary L. Gilleskie, Patty Brown, Bruce Burnett, and Ruben G. Carbonell. “Comprehensive hands-on training for influenza vaccine manufacturing: a WHO-BARDA-BTEC partnership for global workforce development..” Biochem Mol Biol Educ 42, no. 5 (September 2014): 414–19. https://doi.org/10.1002/bmb.20817.

PMID
25132407
Full Text

O’Reilly, Erin K., M. E. Blair Holbein, Jelena P. Berglund, Amanda B. Parrish, Mary-Tara Roth, and Bruce K. Burnett. “Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine"..” Clin Invest Med 36, no. 6 (December 1, 2013): E290–96.

PMID
24309225
Scholars@Duke

Matthay, Michael A., Piero Anversa, Jahar Bhattacharya, Bruce K. Burnett, Harold A. Chapman, Joshua M. Hare, Derek J. Hei, et al. “Cell therapy for lung diseases. Report from an NIH-NHLBI workshop, November 13-14, 2012..” Am J Respir Crit Care Med 188, no. 3 (August 1, 2013): 370–75. https://doi.org/10.1164/rccm.201303-0522WS.

PMID
23713908
Full Text

Morse, Michael A., Arvind Chaudhry, Elizabeth S. Gabitzsch, Amy C. Hobeika, Takuya Osada, Timothy M. Clay, Andrea Amalfitano, et al. “Novel adenoviral vector induces T-cell responses despite anti-adenoviral neutralizing antibodies in colorectal cancer patients..” Cancer Immunol Immunother 62, no. 8 (August 2013): 1293–1301. https://doi.org/10.1007/s00262-013-1400-3.

PMID
23624851
Full Text

Osada, Takuya, Peter Berglund, Michael A. Morse, Bolyn Hubby, Whitney Lewis, Donna Niedzwiecki, Xiao Yi Yang, et al. “Co-delivery of antigen and IL-12 by Venezuelan equine encephalitis virus replicon particles enhances antigen-specific immune responses and antitumor effects..” Cancer Immunol Immunother 61, no. 11 (November 2012): 1941–51. https://doi.org/10.1007/s00262-012-1248-y.

PMID
22488274
Full Text

Adamo, Joan E., Gerhard Bauer, Marlene Berro, Bruce K. Burnett, Karen A. Hartman, Lisa M. Masiello, Diane Moorman-White, Eric P. Rubinstein, and Kathryn G. Schuff. “A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure..” Acad Med 87, no. 3 (March 2012): 279–84. https://doi.org/10.1097/ACM.0b013e318244838a.

PMID
22373618
Full Text

Kraus, V. B., B. Burnett, J. Coindreau, S. Cottrell, D. Eyre, M. Gendreau, J. Gardiner, et al. “Application of biomarkers in the development of drugs intended for the treatment of osteoarthritis..” Osteoarthritis Cartilage 19, no. 5 (May 2011): 515–42. https://doi.org/10.1016/j.joca.2010.08.019.

PMID
21396468
Full Text

Berro, Marlene, Bruce K. Burnett, Gregg J. Fromell, Karen A. Hartman, Eric P. Rubinstein, Kathryn G. Schuff, Lisa A. Speicher, and Lisa A. IND/IDE Taskforce of the Clinical and Translational Science Award Consortium. “Support for investigator-initiated clinical research involving investigational drugs or devices: the Clinical and Translational Science Award experience..” Acad Med 86, no. 2 (February 2011): 217–23. https://doi.org/10.1097/ACM.0b013e3182045059.

PMID
21169787
Full Text

Pages