Name
Lawrence Trost
Educational Degrees
BS, MS, PhD
Certifications
DABT - Diplomate American Board of Toxicology
Education
B.S. - Chemistry - The University of Minnesota, Duluth
M.S. - Pharmacology - The University of Minnesota, Duluth
Ph.D. - Toxicology - The University of North Carolina at Chapel Hill
Expertise
Chemical Warfare Agents, Drug/Pharmaceutical Development, GLP Study Auditing, Pharmacokinetics/Toxicokinetics, Product Safety Assessment, Regulatory Toxicology
Specialties
Infectious diseases, antivirals, Animal Rule, GLP-compliant animal efficacy model studies, IND-enabling safety assessment, preparation of briefing packages and other regulatory submissions, preclinical study monitoring, interactions with government agencies (regulatory and funding), preparation of CTD tables and written summaries, PK/ADME protocol development, CRO selection, study management, input, completion of sections and compilations for regulatory filings and summary documents (IND, NDA, CTD, ISS/ISE, etc). Translational medicine services and consultation including: identification/development of critical path preclinical development plans, indications and target product profile.
Experience
20 years of experience in pharmaceutical development focused primarily on preclinical strategy and program management. This includes assessing the need for (ie timing), designing, executing, reporting and integrating into regulatory submissions; GLP-compliant ADME, toxicology and disease animal model studies. I am broadly experienced with nonclinical studies ranging from simple in vitro toxicology screening assays to pivotal animal efficacy studies designed to serve as the basis for product approval. Before becoming a consultant, I headed safety assessment and nonclinical pharmacokinetics at my previous employer while simultaneously serving as the Principal Investigator and Project Leader on an $81.1 million contract with the Biomedical Advanced Research and Development Authority (BARDA) to support the development of Brincidofovir to a smallpox treatment indication. In this role, I wrote briefing packages in support of and led both BARDA and FDA product specific meetings, addressed FDA and WHO Advisory Committee’s, served on expert panels on matters pertaining to biodefense, and presented educational symposia on Animal Rule based drug development.
City
Durham
State
NC
Zip Code
27707
Country
USA