Lawrence Trost

Toxicologist and Preclinical Development Strategist

About

Preclinical strategist with core expertise in safety assessment of drugs and biologics. Expert in Animal Rule-based drug development. I have 29 years of experience in pharmaceutical development. Before consulting, I spent 17 years learning my trade at CRO's as well as small and mid-sized pharma. My primary service is nonclinical development strategy, specifically timing, design, execution, reporting and integration of GLP-compliant ADME, toxicology and disease animal model studies into regulatory submissions. I offer complete preclinical development services and consultation including due diligence, strategy, gap analysis, toxicology and PK/ADME protocol development, CRO selection, study management, monitoring, authoring/review of sections and compilations for regulatory filings and summary documents (PIND, CTA, IND, NDA, BLA, etc). Translational medicine services and consultation including identification/development of critical path preclinical development plans, indications and target product profile. To date, I have contributed to more than 200 drug, biologic, device and combination development programs across many therapeutic areas. Many of these represent multiple programs with the same clients and I am happy to say I am still working with my first client. I am a company of one. I don't advertise and I don't have a web site. My business is driven entirely by relationships and networking. I listen carefully to your needs and I apply my experience to create solutions to help you to more forward quickly and efficiently to IND, NDA or other goal.

Country

United States

City

Durham

Industry

Pharmaceuticals

Skill

Toxicology, Drug Development, In Vitro, Drug Metabolism, ADME, Pharmacokinetics, Pharmaceutical Industry, FDA, Infectious Diseases, Pharmaceutical Research, Clinical Research, IND, Drug Discovery, Clinical Development, CRO, GLP, Pharmacology, Regulatory Submissions, In Vivo, Good Laboratory Practice (GLP)

Experience

Toxicologist and Preclinical Development Strategist

Belleropharm, LLC

2015-6 - Present · 11 yrs 3 mos

Raleigh-Durham, North Carolina Area

Consultant to the pharmaceutical industry with expertise in toxicology, ADME, pharmacokinetics and the conduct of GLP-compliant animal efficacy studies.

Executive Director, Toxicology and Pharmacokinetics

Chimerix, a Jazz Pharmaceuticals Company

2011-4 - 2015-6 · 4 yrs 3 mos

Durham, North Carolina

As Smallpox Project Team Leader: Lead Brincidofovir project team to an FDA indication for treatment of smallpox. Conceive and execute smallpox development plan including all nonclinical and clinical studies necessary for approval under FDA’s “Animal Rule”. Make presentations to FDA, funding agencies, stakeholders and at scientific meetings to raise awareness of the drug, the company, the disease and the regulatory pathway. As Principal Investigator of an $81M grant, manage interactions with BARDA. As Head of Safety Assessment and DMPK: Provide strategic and operational direction to ensure all nonclinical studies serve company goals and objectives and are conducted in accordance with the appropriate guidelines and regulatory test standards. Oversee and evaluate preparation of protocols and final reports for nonclinical studies as well as summations of nonclinical development programs for regulatory submissions and business development. Responsible for resource planning, maintaining current departmental procedures, employee performance monitoring, budget planning and setting of corporate goals and objectives. Conceive nonclinical in vitro and in vivo studies to support regulatory filings. Analyze and summarize data for regulatory submissions. Participate on research teams to identify discovery candidates for development. Review regulatory submissions including annual IND reports. Summarize and present research findings orally and in writing to varied audiences including management, consultants/collaborators, investors, and regulatory authorities. Shape development strategy using scientific training and experience in toxicology, pharmacology, metabolism and pharmacokinetics.