Publications

• Establishing Establishment of Successful Non-GMP Material Supply Chains for Outsourced API Development and Manufacturing – Evolution of a Phase-Dependent Strategy
• Form Selection in API Development and Manufacturing, In the Context of “Phase-Appropriateness”
• The Role of Chemical Development and Drug Substance Manufacturing in Early Integrated CMC Development at Emerging and Virtual Pharma
• Fluidity Versus Certainty in Early Small Molecule CMC Development
• Development of a Multi...

CMC/Chemical and Pharmaceutical Development Expert

Specialties & Experience of this Expert Witness

Additional Information

HIGHLIGHTS • Twenty-eight years of industrial experience in all aspects of chemical development • Twenty-four years of experience in oversight of external vendors performing chemical development, custom starting material production and API manufacturing, preformulation, formulation development, drug product manufacturing, and all associated CMC activities • Eighteen years of experience in devising and executing integrated CMC development programs • Hands-on, results-oriented leadership of CMC development and multidisciplinary teams • Innovation in the conception of practical synthetic routes to pharmaceuticals, development and implementation of chemical processes for the manufacture of APIs and chemical process troubleshooting. • Expertise in technology transfer and oversight of chemistry from the research laboratory to kilo labs, pilot plants and multipurpose plants at contract development and manufacturing organizations • Experience in the development and manufacture of solid, semi-solid (topical administration) and sterile dosage forms • Significant accomplishments in many areas of organic synthesis and drug candidate development: small molecules, chelating agents, bioconjugate chemistry, nucleosides and nucleotides, amino acids and peptidomimetics, heterocycles, alkaloids, cannabinoids, dyes, asymmetric synthesis and catalysis, self-assembly mediated by nanoparticles, organophosphorus chemistry. SERVICES OFFERED: • Expertise in Chemical Development o Evaluation and optimization of synthetic routes to drug candidates o Adaptation of discovery chemistry routes for scale-up o Chemical process development and optimization o Creation and execution of fit for purpose R&D, production and cGMP manufacturing strategies and plans o Design of syntheses of stable isotope and radiolabeled molecules for in vivo studies o Physicochemical characterization o Solid state chemistry – polymorphism, salt screening and selection o Sourcing of raw materials, excipients and standards • Vendor Selection, Engagement and Management o API, drug product, analytical, custom synthesis, QA and regulatory support o Creation of requests for proposal o Definition of scope of work, deliverables and timelines o Facilitation of performance and completion of work o Technology transfer - assembly of tech transfer packages, performance of tech transfer to and between vendors and organizations o Excellent vendor network • Problem Solving o Troubleshooting of chemical process development and API manufacture, drug product process development and manufacture, analytical method development o Leadership of expert teams in the solution of complex technical problems o Broad, multidisciplinary consultant network • Assistance with Strategy and Management of Drug Development Programs o Coordination of CMC activities o Liaison between technical functions, regulatory, QA; Effective, clear communication across disciplines • Technical and Regulatory Documentation o Drafting, review and editing of development reports o Authorship, review and editing of CMC regulatory documents, including INDs, NDAs, amendments, biowaivers • Regulatory/QA o Interpretation and application of FDA and ICH guidances pertaining to CMC development activities o Practical experience in quality audits and mock PAIs in US, India and Japan Responsibilities for past clients include: Acting Head, CMC, Nimbus Therapeutics, January, 2019 – December, 2020 Led a virtual team of CMC experts in development of a candidate to treat inflammatory diseases, from vendor selection through filing of IND, and then facilitated the transition of both the API and DP manufacturing to Phase II clinical supply • Extended implementation of the development strategy to support a Phase Ib clinical trial using a second, optimized clinical dosage form • Led activities to supply CTM for pivotal Phase IIb clinical trials Led a second team in the development of a practical API production route to a cancer drug