Bruce Kendall Burnett
Associate Professor in Medicine
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.
Current Appointments & Affiliations
- Associate Professor in Medicine, Medicine, Clinical Pharmacology, Medicine 2021
- Core Faculty in Innovation & Entrepreneurship, Duke Innovation & Entrepreneurship, Initiatives 2018
Contact Information
- 701 W Main Street, Suite 500, Durham, NC 27701
- Duke Box 90535, Durham, NC 27715
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bruce.burnett@duke.edu
(919) 624-2167
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DTMI Regulatory
- Background
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Education, Training, & Certifications
- Fellowship, Genetics, Harvard Medical School 1982 - 1986
- Ph.D., Massachusetts Institute of Technology 1982
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Previous Appointments & Affiliations
- Member of the Duke Clinical Research Institute, Duke Clinical Research Institute, Institutes and Centers 2011 - 2021
- Associate Professor in Medicine, Medicine, Clinical Pharmacology, Medicine 2019 - 2020
- Assistant Professor in Medicine, Medicine, Clinical Pharmacology, Medicine 2012 - 2019
- Expertise
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Global Scholarship
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Research
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- Research
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Selected Grants
- Consultation for the Stanford Microbiome Therapies Initiative awarded by Stanford University 2019 - 2023
- Bruce Burnett IPA awarded by National Institutes of Health 2019 - 2020
- Biodosimetry High-Throughput Test RFP-16-100-SOL-00010 awarded by DxTerity Diagnostics 2017 - 2019
- Systemically administrered EGRFvIII-targeted bispecific antibody as an immunotherapeutic for glioblastoma. awarded by National Institutes of Health 2015 - 2019
- Duke CTSA (UL1) awarded by National Institutes of Health 2013 - 2018
- Immunology Quality Assesment Program Option 2 awarded by National Institutes of Health 2014 - 2017
- Regulatory Guidance for Academic Research of Drugs and Devices awarded by University of North Carolina - Chapel Hill 2017
- Point of Care Biodosimeter awarded by Department of Health and Human Services 2009 - 2016
- Phase I CTU Task Area A: Administrative and Overal Clinical Operations Support and Concept Development awarded by National Institutes of Health 2014 - 2015
- PTN Task Order #4: Hydroxyurea PK awarded by National Institutes of Health 2011 - 2014
- Clinical Trial Planning in Pompe Disease awarded by National Institutes of Health 2013 - 2014
- Novel Ondansetron Formulation for Combination Treatment of Psychostimulant Abuse awarded by National Institutes of Health 2009 - 2013
- CTSA UL awarded by National Institutes of Health 2006 - 2012
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External Relationships
- Immunity Bio (formerly Nantworks, formerly Etubics)
- LadeRx, LLC
- NIH
- Stanford University School of Medicine
- T3D Therapeutics Inc
- Publications & Artistic Works
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Selected Publications
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Academic Articles
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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 (2017): 1098–1104. https://doi.org/10.1016/j.jaip.2016.11.034.Full Text Link to Item
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Bao, Xuhui, Vidyalakshmi Chandramohan, Randall P. Reynolds, John N. Norton, William C. Wetsel, Ramona M. Rodriguiz, Dipendra K. Aryal, et al. “Preclinical toxicity evaluation of a novel immunotoxin, D2C7-(scdsFv)-PE38KDEL, administered via intracerebral convection-enhanced delivery in rats.” Invest New Drugs 34, no. 2 (April 2016): 149–58. https://doi.org/10.1007/s10637-015-0318-3.Full Text Link to Item
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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.Full Text Link to Item
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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 (2014): 414–19. https://doi.org/10.1002/bmb.20817.Full Text Link to Item
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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. https://doi.org/10.25011/cim.v36i6.20626.Full Text Link to Item
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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.Full Text Link to Item
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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.Full Text Link to Item
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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.Full Text Link to Item
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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.Full Text Link to Item
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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.Full Text Link to Item
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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.Full Text Link to Item
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Morse, Michael A., Amy C. Hobeika, Takuya Osada, Peter Berglund, Bolyn Hubby, Sarah Negri, Donna Niedzwiecki, et al. “An alphavirus vector overcomes the presence of neutralizing antibodies and elevated numbers of Tregs to induce immune responses in humans with advanced cancer.” J Clin Invest 120, no. 9 (September 2010): 3234–41. https://doi.org/10.1172/JCI42672.Full Text Open Access Copy Link to Item
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Hubby, Bolyn, Todd Talarico, Maureen Maughan, Elizabeth A. Reap, Peter Berglund, Kurt I. Kamrud, Laura Copp, et al. “Development and preclinical evaluation of an alphavirus replicon vaccine for influenza.” Vaccine 25, no. 48 (November 23, 2007): 8180–89. https://doi.org/10.1016/j.vaccine.2007.09.038.Full Text Link to Item
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Reap, Elizabeth A., John Morris, Sergey A. Dryga, Maureen Maughan, Todd Talarico, Robert E. Esch, Sarah Negri, et al. “Development and preclinical evaluation of an alphavirus replicon particle vaccine for cytomegalovirus.” Vaccine 25, no. 42 (October 16, 2007): 7441–49. https://doi.org/10.1016/j.vaccine.2007.08.016.Full Text Link to Item
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- Teaching & Mentoring
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Recent Courses
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