Paul A. Lapchak
Global Head of Translational Development @Paradigm Biopharmaceuticals
Signup · Get unlimited contacts
WORK HISTORY
Global Head of Translational Development @Paradigm Biopharmaceuticals
Global Head of Translational Development (Remote) 10/2022-present Non-clinical support for all preclinical studies to support IND and NDA. Integration of data from clinical biomarker analysis, ADME, pharmacokinetics, and translational animal models. Assay development for biomarkers, pharmacokinetics, and drug metabolism. Ensuring that the early development portfolio is aligned with disease area strategy and prioritizing suitable activities. Creating and sustaining a culture of rigorous data-driven decision-making with full transparency. Guidance, planning and decision-making across many functions to support clinical programs. Evaluating early-stage prospects to improve the Company\'s portfolio. Develop timelines and milestones for IND submission and fund raising. Direct pre-clinical, translational, carcinogenicity, and toxicology studies for IND and NDA. Gap analysis for IND and NDA filing- Type B and D FDA meetings. Direct and implement translational research plans internally and with CROs and consultants.
EDUCATION
McGill University
Doctor of Philosophy (Ph.D.)
Concordia University
Bachelor's degree
ABOUT PAUL A. LAPCHAK
Summary: Develop translational programs and logistics across multiple preclinical and…
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.