Drug Development for Small Molecules, Biologics and Devices
-
Provide strategic support for licensing and Due Diligence activities
-
Conduct Gap Analysis for new partnerships and acquisitions in Oncology, Metabolic Disorders, Neurodegenerative/Pain and Cardiovascular Disease
-
Provide Nonclinical Strategy for early or late development of small molecule programs,
-
Provide Safety and Risk Assessment
-
Provide Scientific Program Management including Contract Research Organization Interactions, Study Monitoring, Study Design and Study directing; Edit and review study protocols; Review and edit study reports
-
Manage GLP Studies (Toxicology, Safety Pharmacology, Pharmacology, Assay Validation)
Author and/or Review Regulatory filings (US-FDA, EU-EMA, Health Canada, Australia TGA, CFDA)
-
Nonclinical Sections of CTDs, INDs, CTAs, DSURs and IBs
-
Provide research , literature searches and White Papers to support filings
Principal, Stephanie Greene, PhD
Drug Safety Scientist
-
Nonclinical Safety - Strategy, Safety, and Risk Assessment
-
Licensing, Due Diligence, Gap Analysis
-
Scientific Program Management including Contract Research Organization Interactions,
-
Study Monitoring, Study Design and Directing
-
Clinical Pharmacology
​