Director R&D
CurrentDirect preclinical research and drug development of novel gallium-based antibiotics. Primary responsibility involves overall management of gallium R&D program, fulfilling role of technical lead for multi-year contracts with NIAID and the CF Foundation. Additional responsibilities include managing GMP manufacturing and analytical programs at external CROs and CRLs, managing drug supplies for IND-enabling GLP toxicology studies, preparing regulatory filings with the FDA, patent applications, corporate presentations, and monthly company reports to clients.AccomplishmentsoIdentified lead candidate and developed a simple synthetic procedure for production of material at a 1Kg scale for R&D studiesTransfer synthetic method to CMO for production of over 10Kg of API under GMP of the lead clinical candidate (AR-501) for use in GLP nonclinical IND-enabling testing and manufacture of drug substance for clinical studies.Management of analytical program at vendors for phase appropriate, validated methods for API and drug product.Management of CRLs for testing of drug levels in nonclinical and clinical samplesSetup and management of ongoing stability programs for API and drug substancesPrepare CMC and Nonclinical sections of IND application for AR-501.Present data on a regular basis to senior staff, clients, consultants, and CROs/CMOs.Supervised discovery project team to investigate potential new gallium-based antibiotics (siderophores).Helped establish animal pharmacology laboratory for in vivo studies.Member of company IACUC teamInstallation and administration of electronic notebook system (Labguru)Set up and administration of online data management (e.g. Box) for employees and external consultantsOperate, maintain, and train staff on laboratory equipment – AAnalyst 800 GFAAS, Analytical HPLC and IC systems.