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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

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