catalytic chemical transformations (asymmetric, stereoselective, redox, chemocatalytic and biocatalytic), development and technology transfer of syntheses/scalable/scaled up processes for production and manufacturing of raw materials, custom reagents including catalysts, raw materials, key and regulatory starting materials GMP process intermediates and final APIs. Full spectroscopic characterization and identification of APIs, intermediates, starting materials, raw materials and impurities, impurity control strategy and implementation, development of sufficiently sensitive and specific analytical methods (HPLC, XRPD, LC-MS, KF, IR, NMR (dynamic, and structural), analytical method troubleshooting and distinction between true attributes and artefactual data in key raw materials, regulatory starting materials, APIs, drug product intermediates and drug products, as well as specialized reagents that have limited stability. Drug product preformulation and development (for solid oral, parenteral/ injectable, suppositories topical and other types of administration to patients), controlled release and other specialized means of drug delivery, drug product intermediates (spray dried dispersions, extrudates from hot melt and related processes, blends, granulations, semi-solids, process development, and manufacturing, packaging, Global import/export of starting materials, intermediates, APIs and drug products. Radiosynthesis of radiolabelled APIs for whole-body autoradiography, metabolic distribution and human clinical PK-ADME studies. Regulatory CMC – drafting, reviewing and editing of written submissions (pre-IND, IND, pre-EOP2, EOP2, pre-NDA, NDA, SUPAC biowaivers, supporting memos and R&D reports and summaries), high-level regulatory CMC advisors to regulatory CMC and quality assurance leadership and groups, writing/reviewing of SOPs, facility quality/technical audits, mock-PAIs, responses to feedback and questions from regulatory agencies, particularly FDA and EMA, but any others as well. Oversight and leadership – regularly hired to be de facto Senior/Executive VP of CMC and to devise and implement entire CMC program strategies, brought in at C-Level/Board/VC/Investor level, range of oversight can include vendors, internal R&D and production, regulatory CMC, quality, import/export specialists, reg CMC, CMC, drug product, analytical, API, and quality consultants, tech ops, procurement and supply chain. Significant interactions with adjacent functions – clinical, pharmacology, toxicology, quality, regulatory, program leadership and management, C-level executives, CEOs, boards, and investors/ VCs/PE firms. How did you become an experienced expert witness? I became a CMC/pharmaceuticals/ chemistry expert witness by realizing that the quality of my testimony at a disposition as a former employee at PPD Dermatology, as determined by a review of the deposition transcript, disposes me well for expert witness work. In addition, I was strongly encouraged by my elders in the industry, who were, in fact, very successful expert witnesses, to position myself to accept this type of work based on what they knew about me and saw in me. I was also very interested in breaking into expert witnessing, having
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