Bruce Kendall Burnett

Journal Article J Allergy Clin Immunol Pract · 2017 BACKGROUND: Oral immunotherapy (OIT) is an investigational therapeutic approach for the treatment of food allergies. Characterization of the drug product used in oral immunotherapy trials for peanut allergy has not been reported. OBJECTIVE: To quantify rel ... Full text Link to item Cite

Preclinical toxicity evaluation of a novel immunotoxin, D2C7-(scdsFv)-PE38KDEL, administered via intracerebral convection-enhanced delivery in rats.

Journal Article Invest New Drugs · April 2016 D2C7-(scdsFv)-PE38KDEL (D2C7-IT) is a novel immunotoxin that reacts with wild-type epidermal growth factor receptor (EGFRwt) and mutant EGFRvIII proteins overexpressed in glioblastomas. This study assessed the toxicity of intracerebral administration of D2 ... Full text Link to item Cite

ClinicalTrials.gov reporting: strategies for success at an academic health center.

Journal Article Clin Transl Sci · February 2015 The Food and Drug Administration Amendments Act of 2007 (FDAAA 2007, US Public Law 110-98) mandated registration and reporting of results for applicable clinical trials. Meeting these registration and results reporting requirements has proven to be a chall ... Full text Link to item Cite

Comprehensive hands-on training for influenza vaccine manufacturing: a WHO-BARDA-BTEC partnership for global workforce development.

Journal Article Biochem Mol Biol Educ · 2014 The critical need for enhancing influenza pandemic preparedness in many developing nations has led the World Health Organization (WHO) and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human S ... Full text Link to item Cite

Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine".

Journal Article Clin Invest Med · December 1, 2013 PURPOSE: This study highlights Warning Letter (WL) findings issued to sponsor-investigators (S-Is) by the Food and Drug Administration (FDA). METHODS: The online index of WLs issued from October 1, 2007 through September 30, 2012 was reviewed [1]. Through ... Full text Link to item Cite

Novel adenoviral vector induces T-cell responses despite anti-adenoviral neutralizing antibodies in colorectal cancer patients.

Journal Article Cancer Immunol Immunother · August 2013 First-generation, E1-deleted adenovirus subtype 5 (Ad5)-based vectors, although promising platforms for use as cancer vaccines, are impeded in activity by naturally occurring or induced Ad-specific neutralizing antibodies. Ad5-based vectors with deletions ... Full text Link to item Cite

Cell therapy for lung diseases. Report from an NIH-NHLBI workshop, November 13-14, 2012.

Journal Article Am J Respir Crit Care Med · August 1, 2013 The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health convened the Cell Therapy for Lung Disease Working Group on November 13-14, 2012, to review and formulate recommendations for future research directions. The worksho ... Full text Link to item Cite

Co-delivery of antigen and IL-12 by Venezuelan equine encephalitis virus replicon particles enhances antigen-specific immune responses and antitumor effects.

Journal Article Cancer Immunol Immunother · November 2012 We recently demonstrated that Venezuelan equine encephalitis virus-based replicon particle (VRPs) encoding tumor antigens could break tolerance in the immunomodulatory environment of advanced cancer. We hypothesized that local injection of VRP-expressing i ... Full text Link to item Cite

A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure.

Journal Article Acad Med · March 2012 Prior to human clinical trials, nonclinical safety and toxicology studies are required to demonstrate that a new product appears safe for human testing; these nonclinical studies are governed by good laboratory practice (GLP) regulations. As academic healt ... Full text Link to item Cite

Application of biomarkers in the development of drugs intended for the treatment of osteoarthritis.

Journal Article Osteoarthritis Cartilage · May 2011 OBJECTIVE: Osteoarthritis (OA) is a chronic and slowly progressive disease for which biomarkers may be able to provide a more rapid indication of therapeutic responses to therapy than is currently available; this could accelerate and facilitate OA drug dis ... Full text Link to item Cite

Support for investigator-initiated clinical research involving investigational drugs or devices: the Clinical and Translational Science Award experience.

Journal Article Acad Med · February 2011 PURPOSE: Investigator-initiated research involving investigational drugs and devices is key to improving health. However, this requires the investigator to serve as a "sponsor-investigator," which can be complex and overwhelming. The Investigational New Dr ... Full text Link to item Cite

An alphavirus vector overcomes the presence of neutralizing antibodies and elevated numbers of Tregs to induce immune responses in humans with advanced cancer.

Journal Article J Clin Invest · September 2010 Therapeutic anticancer vaccines are designed to boost patients' immune responses to tumors. One approach is to use a viral vector to deliver antigen to in situ DCs, which then activate tumor-specific T cell and antibody responses. However, vector-specific ... Full text Open Access Link to item Cite

Development and preclinical evaluation of an alphavirus replicon vaccine for influenza.

Journal Article Vaccine · November 23, 2007 We used a propagation-defective, single-cycle, alphavirus replicon vector system to produce virus-like replicon particles (VRP) expressing the hemagglutinin (HA) and neuraminidase (NA) proteins from influenza A/Wyoming/03/2003 (H3N2). Efficient production ... Full text Link to item Cite

Development and preclinical evaluation of an alphavirus replicon particle vaccine for cytomegalovirus.

Journal Article Vaccine · October 16, 2007 We used a replication-incompetent, single-cycle, alphavirus replicon vector system to produce virus-like replicon particles (VRP) expressing the extracellular domain of human cytomegalovirus (CMV) glycoprotein B or a pp65/IE1 fusion protein. Efficient prod ... Full text Link to item Cite