Overview
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
Adjunct Associate Professor in the Department of Medicine
·
2024 - Present
Medicine, Clinical Pharmacology,
Medicine
Core Faculty in Innovation & Entrepreneurship
·
2018 - Present
Duke Innovation & Entrepreneurship,
University Initiatives & Academic Support Units
Recent Publications
Preparation and Analysis of Peanut Flour Used in Oral Immunotherapy Clinical Trials.
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 CitePreclinical 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 CiteClinicalTrials.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 CiteRecent Grants
CN105 improves surrogate and functional outcomes after intracerebral hemorrhage (Subaward to AegisCN)
ResearchCo Investigator · Awarded by AegisCN LLC · 2024 - 2026Consultation for the Stanford Microbiome Therapies Initiative
ResearchPrincipal Investigator · Awarded by Stanford University · 2019 - 2024Bruce Burnett IPA
ResearchDirector · Awarded by National Institutes of Health · 2019 - 2020View All Grants
Education, Training & Certifications
Massachusetts Institute of Technology ·
1982
Ph.D.