worked for a year at a patent law firm as a jack of all trades and messenger, and having translated an Argentinian patent into English (I am professionally proficient and fluent in written and conversational Spanish). What are the expert witness services you provide? Expertise in Chemical and Pharmaceutical Development • Evaluation and optimization o synthetic routes to drug candidates • Adaptation of discovery chemistry routes for scale-up • Chemical process development and optimization • Creation and execution of fit-for purpose R&D, production and cGMP manufacturing strategies and plans • Design of syntheses of stable isotope and radiolabeled molecules for in vivo studies • Physicochemical characterization • Solid state chemistry – polymorphism, salt screening and selection • Sourcing of raw materials, excipients and standards Vendor Selection, Engagement and Management • API, drug product, analytical, custom synthesis, QA and regulatory support • Creation of requests for proposal • Definition of scope of work, deliverables and timelines • Facilitation of performance and completion of work • Technology transfer - assembly of tech transfer packages, performance of tech transfer to and between vendors and organizations • Excellent vendor network Problem Solving • Troubleshooting of chemical process development and API manufacture, drug product process development and manufacture, analytical method development • Leadership of expert teams in the solution of complex technical problems • Broad, multidisciplinary consultant network 36 LAWYER MONTHLY JUNE 2024 Assistance with Strategy and Management of Drug Development Programs • Coordination of CMC activities • Liaison between technical functions, regulatory, QA; Effective, clear communication across disciplines Technical and Regulatory Documentation • Drafting, review and editing of development reports • Authorship, review and editing of CMC regulatory documents, including INDs, NDAs, amendments, biowaivers Regulatory/QA • Interpretation and application of FDA and ICH guidance pertaining to CMC development activities • Practical experience in quality audits and mock PAIs in US, India and Japan I’ve worked with a range of Organizations: • Entrepreneurial start-up biotechs • Medium-sized established biotechs • Small and large CMC vendors – API, solid state, drug product, preformulation, formulation development, solids manipulation (production and manufacture of DP intermediates, particle engineering and particle size reduction), analytical • Big Pharma • Venture Capitalists • Private Equity Firms • Other interested parties • Expert witness recruiters (indirect engagement), law firms and their clients (direct engagement) Duties • Technical expertise and support • Strategic and tactical expertise and
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