Michael Leonard

WORK HISTORY

EDUCATION

SKILLS

ABOUT MICHAEL LEONARD

email: m••••••••@gmail.comAs a leader with extensive experience in progressing drug development programs in biopharmaceutical industry. I am adept at overseeing bioanalytical method development/validation and sample analysis in addition to designing DMPK project plans that drive progression of drug candidates and ensure compliance with regulatory milestones. I have excellent communication skills that foster strong relationships with external vendors and internal project teams. I have a proven track record of providing guidance, expertise, and unique solutions to align project priorities, meet timelines and achieve milestones without compromising quality. I have demonstrated success in achieving project objectives and managing DMPK and bioanalytical resources supporting pre-clinical and clinical programs. I am an expert at directing multifunctional teams and collaborating with program leaders, individual contributors, and external service providersMy work as a team leader and research scientist included being responsible for developing and validating bioanalytical assays for drugs and metabolites for preclinical and clinical studies. As a DMPK project lead, I was responsible for GLP compliance, PK, ADME, drug disposition, and bioanalytical needs ranging from late discovery to full development of medicinal compounds. I have experience in protocol design, contributing to clinical outcomes, IND, IB, and NDA/MAA preparation.As a DMPK project lead I coordinated, led and executed first in human enabling studies; TK, PK, in-vitro and in-vivo drug metabolism (drug disposition) studies that supported pre-clinical and clinical programs. I worked extensively with other core team members; heads of departments, toxicologist, CMC and discovery units, to progress drugs, biomarkers and diagnostics to market. Specifically, I hold a global patent for development of a muscle measurement diagnostic tool.I have extensive experience developing and validating bioassays designed to determine drug efficacy, safety, diagnostic measurements of biomarkers, small molecules and peptide drug candidates.(Immunocapture, digestion, LC-MS and LC-MS/MS). I oversee bioanalytical method development and validation or transferring existing GLP assays to external CROs.My skills include:• Strong scientific acumen • Bioanalytical method development and validation • Drug-Drug interactions• Drug Development• PK/TK evaluation/reports• Drug metabolism• Radiolabeled synthesis and subsequent QWBA, Mass Balance, and metabolite studies