Andrew M.

WORK HISTORY

EDUCATION

ABOUT ANDREW M.

Ph.D in Bioanalytical ChemistrySenior bioanalytical scientist with experience supporting both large and small molecule programs from early discovery through post marketing commitments across a wide range of therapy areas. Currently working within a Precision Medicine organization, partnering with Clinical Pharmacology and biomarker leads to ensure appropriate bioanalytical methods are selected to support decision making. Along with Clinical Pharmacology, review development strategies and mitigate risk to PK/PD data exchangeability across studies and indications including those with a Model Informed Drug Development (MIDD) approach. Extensive knowledge in developing and validating ligand-binding assays for the measurement of biopharmaceuticals for pharmacokinetic (PK/TK), pharmacodynamic (PD) and immunogenicity (ADA) assessments, as well as liquid chromatography-mass spectrometry for both small molecule and protein pharmacokinetic assays across preclinical and clinical development. Experience supporting various molecular scaffolds, including humanized monoclonals, recombinant proteins, domain antibodies, antibody drug conjugates, peptides, fusion proteins and small molecules. Team player with proven ability to work in a matrix environment with colleagues within and outside of my department to bring medicines to market. Engaged with stakeholders, constantly managing expectations, to deliver data to enable decision making. Actively involved in due diligence review of business development opportunities and responsible for asset integration post deal closure to ensure knowledge and materials are transferred to enable development. Experience with regulatory authorities including audits, pre-NDA regulatory interactions and submissions including BLAs and response to regulatory questions (RTQs). Actively engaged with industry experts through presentations, publications and industry working groups.