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Specialties & Experience of this Expert Witness

General Specialties:

Pharmaceutical Research and Chemistry & Chemicals

Keywords/Search Terms:

API process development, API manufacturing, Solid state and physicochemical characterization, enabled formulation development, drug product development, drug product manufacturing, stereochemistry, process impurity identification, control, synthetic route selection, preformulation, polymorphism


PhD, Chemistry, University of Illinois Chicago; BS, Biochemistry, University of Illinois Chicago

Years in Practice:


Number of Times Deposed/Testified in Last 4 Yrs:


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