Specialization areas include; (1) discovery support to select optimal NCE, (2) portfolio mgmt from rapid-to-FIH through loss of exclusivity, (3) non-clinical testing strategy for study designs, and working with CRO vendors, (4) regulatory interaction and issue resolution (US, EU), and (5) develop effective outlicense-codevelopment agreements with 'big pharma' partners.
Experience
30 years pharmaceutical industry R&D, drug developmentInvestigative pathology-toxicology (animal models) Issue resolution (general tox-path, photobiology, impurities) Regulatory toxicology, registration in US, EU, Asia
