AREAS OF EXPERTISE

Overview
Extensive experience in formulation development, clinical manufacturing and drug delivery systems. Sterile Product Subject Matter Expert and Former Head, Sterile Product Formulation Development at Roche, Nutley. Peptide/Protein formulation expert. Substantial GMP, FDA R&D and manufacturing experience. CMC Technical Leader. Advise pharma, legal and investment firms. Consultant in thirteen litigation cases and Expert Witness. Consultant/Writer for Criticality Analyses of development and marketed drug product. Professional Blogger for medical journal and registered pharmacist.

Areas of Expertise

• Formulation Development • Technology Transfer • Drug Development • Excipient and Package Selection • Sterile Products • Injection Devices• Drug Delivery• Solubilization • Aseptic Processing • Criticality Analysis • Sustained Release Parenteral • Common Technical Document • Clinical Manufacturing • ICH Q 8, 9 and 10 • Development Pharmaceutics • Patent Infringement/Validity • Excipients • Claim Construction • IND/NDA • Inter Partes Patent Review• Expert Reports • Testimony in Patent Litigation