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Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of reaction stereoselectivity; tracking of chiral integrity in chemical processes; chiral analysis of starting materials, intermediates and product APIs; sourcing of optically active raw materials; understanding and exploitation of epimerization and racemization; resolution using chiral chromatography and fractional crystallization of diastereomeric salts.

Although Expert's industrial career has been concerned mostly with chemical and pharmaceutical development, he has also made significant contributions to discovery efforts at a number of organizations at which he was employed. Based on his postdoctoral studies, Expert has maintained an active interest in the area of prodrugs. One product that Expert worked on in his career that has been approved by the FDA is Fospropofol, a phosphate prodrug of the sedative propofol. He has also been an active participant on discovery projects while at Elixir Pharmaceuticals, assisting in the management of the outsourced work on the synthesis of compounds for testing and development of SAR, and as the leader of the new target sourcing effort while at PPD Dermatology. Expert has demonstrated the ability to identify new therapeutic targets in a given area, and to assess the chemical tractability of a given target. He was involved in a business development capacity while at PPD Dermatology, to identify and contact organizations and institutions deemed to be doing early discovery work in areas that were relevant to the establishment of a drug pipeline. Expert also had responsibility for the performance of due diligence on chemical matter and evaluation of the viability and merit of in-licensing, investment and partnering opportunities while employed at Elixir Pharmaceuticals, and Magen Biosciences/PPD Dermatology over the past five years.

During the last thirteen years, Expert's responsibilities have expanded to include all aspects of CMC development, including analytical method development and pharmaceutical development. He is proficient in leading efforts in preformulation, including salt screening and selection, polymorph screening, development of stability-indicating methods, forced degradation studies and physicochemical characterization of lead drug compounds. Expert's experience has extended to formulation development, including excipient compatibility studies, prototype generation and evaluation, and scale up to production scale. He has overseen the production of GLP suitable tox lots and GMP manufacture of Phase I supply for two NCEs, and has been involved in Phase III and registration lot manufacture for the commercialization of a type II diabetes drug that is already on the commercial market in Japan. This work involved significant strategic planning and management of a partnering relationship with the business and CMC functions of a major Japanese pharmaceutical company. It included auditing of API manufacturing facilities in Japan and preparation for a pre-approval inspection (PAI) by the FDA. Evaluation and interpretation of drug product stability data was also integral to this project. He has also worked on the development of a fixed dose combination for a tablet. Expert has direct experience in leading development efforts for drug products administered orally (tablets and capsules) and topically (creams and ointments). The above work resulted in the filing of two INDs, which were accepted by the FDA with no CMC questions. Expert was a key author on the CMC sections of both submissions. He was also a key author on the pre-NDA briefing book for the commercialization effort described. The FDA had no questions on the CMC section of this submission, even though it was a legacy product.

Expert has also worked on solid oral dosage formulation development efforts for drugs that are poorly water soluble.

Expert had responsibility for the evaluation, selection and management of drug product vendors for the projects summarized above.

Expert's industrial career has been extensively involved in the solution of challenging problems in the area of chemical process development. He has worked in the laboratory on multistep syntheses of multiple classes of chemical compounds, including amino acids, carbohydrates, nucleosides and nucleotides, polyazamacrocycle chelating agents for MRI, peptidomimetics, heterocycles, alkaloids, ionophores, dyes, cannabinoids, organophosphorus compounds. His accomplishments have included development of novel practical synthetic routes to target compounds, development of scalable, robust processes for production and manufacture, process optimization, improvement of yield, stereochemical purity, API quality and operational simplicity and transfer of technology from R&D into kilo labs and then into pilot and multipurpose manufacturing plants. Expert has participated in and led multidisciplinary scientists charged with solving complex chemistry problems and delivering scientifically sound results in a timely and efficient manner.

In the course of his academic training and industrial career, Expert has enhanced and deepened his capabilities in his core technical area of synthetic organic chemistry. His primary expertise is in the area of chemical route selection for the multistep organic synthesis of small molecule drug candidates. He draws from his knowledge of synthesis and reaction mechanism to troubleshoot and solve problems in the synthesis of discovery scaffolds, development of chemical processes, introduction of stable and radioisotopes into molecules for bioanalytical applications. Expert is currently a regular reviewer for the ACS journal Organic Process Research and Development.

For 19 of his 23 years in industry, Expert has worked at organizations for which chemical process R+D, production and manufacturing were at least partly, if not completely, virtual. As a consequence, he has acquired expertise in the selection, engagement and management of contract organizations devoted to custom synthesis, production and manufacturing of API for preclinical and clinical bulk drug supply. Expert has experience leading and managing work at every phase from late discovery through Phase III registration and validation lots. His hands-on experience in the laboratory at biotech pharmaceutical companies and as an employee at API vendors (Ricerca and SERES Laboratories) informs his ability to have the full perspective from both sides of the fence, and has made him an extremely effective leader and manager of outsourced chemistry efforts. Expert performed numerous manufacturing runs under cGMP at SERES laboratories, and was a project leader for the process development and manufacture of the initial clinical supply of a drug that is now FDA-approved while at Ricerca. He has a thorough understanding of the practical application of GMP to the manufacture of APIs and drug product. Expert is also an expert in the preparation and assembly of technology transfer packages for outsourced work, and has demonstrated repeated success in the timely and efficient implementation and execution of chemical technology transferred to API manufacturing vendors.

During the last 5-6 years, Expert has worked on a number of late-stage manufacturing processes. He took a legacy process and oversaw and led the update of the R&D and manufacturing to meet current regulatory agency expectations. This work included the development of state of the art analytical methods, screening experiments to determine ranges investigated in DoE/PAR studies for all process operations, identification and the development of limit tests for all process intermediates and impurities that were designated potential genotoxic impurities, sourcing of key raw and regulatory starting materials, and re-validation of the manufacturing process. Expert also wrote all of the S sections of the New Drug Application (NDA) for this drug. Due to Expert's efforts, the manufacturer passed the FDA's pre-approval inspection (PAI), and the drug was approved.

Another project Expert was involved in was to write a development history report for a drug as part of its conditional marketing authorization (CMA) in the EU. This report covered all chemistry R&D and manufacturing, from the synthesis patented by the client through the registration manufacturing campaign batches, and formed the basis for CMA section 3.2.S.2.6, Manufacturing Process Development of the regulatory submission.

Devised and executed CMC strategy for the development of a drug candidate for topical treatment of inflammatory skin disease, including: API scale up, production and GMP mfr, topical formulation development, ointment drug product production for GLP tox studies and GMP ointment drug product for Phase I clinical trials, synthesis of 14C-radiolabeled API for in vivo PK/ADME studies, development of analytical methods for drug substance and drug product, and drafting, editing and finalization of relevant sections of the CMC section of the IND for this candidate. IND was accepted by FDA with no CMC questions.Functional project leader for an in-licensed small molecule candidate for the treatment of metabolic disease. Created and refined a detailed plan for the development of this candidate. Staffed and led a virtual development team composed of experts in areas other than API - formulation, toxicology, PK/ADME, quality, regulatory, analytical. Had responsibility for coordination and execution of all preclinical development activities, including direct responsibility for all CMC activities. Led production of >10kg API suitable for GLP tox studies, manufacture of 800g GMP API and 10,000 dry-filled capsules for Phase I clinical supply. Wrote API process CMC section of IND and made significant contributions to drug product, analytical and characterization sections of IND. IND was accepted by FDA with no CMC questions. Led CMC activities related to an effort to commercialize an in-licensed type II diabetes drug that was approved for use in Japan. Key author and reviewer of pre-NDA briefing book CMC section. Key author of successful request for biowaiver based on SUPAC guidance for in vitro dissolution testing. Led and managed the manufacture of Phase III clinical supply, registration lots and analytical method validation. Established and strengthened the relationship between CMC functions at the client company and the Japanese licensor. Led and managed the development of a fixed dosage combination tablet for this drug with another well known type II diabetes drug.Led and managed the CMC development effort for a discovery candidate for the treatment of metabolic disease. Provided scientific direction, leadership and management to the synthesis and scale up of the API, resulting in the production of >1kg of API suitable for GLP studies within < 5 months of candidate nomination. Managed and led two salt screening studies to give a water soluble API. Identified issues relevant to the formulation development of this candidate, including physicochemical properties and stability.Leader, new target sourcing team. Established a process for researching and evaluating new approaches to topical small molecule therapies for dermatologic diseases in order to build a dermatology pipeline. Identified biological mechanisms of action relevant to dermatologic diseases and determined tractability based on natural product and medicinal chemistry hits in the literature. Sought scientific collaborators and partners in industry and at academic and research institutions. Expert witness assignment - prepared a draft expert report for the damages phase of a Hatch-Waxman case that was instrumental in settling the case for the client. The subject matter of the case and the drug cannot be disclosed, since the report was never filed with the court and is thus not part of the public record. The drug in question was a "blockbuster" drug, and the stakes were very high.Transitioned an API manufacturing process from Phase I to pivotal Phase II, including process evaluation and gap analysis, vendor selection, engagement and management, in-depth solid state chemistry evaluation that resulted in an improved isolation of the final API, design and oversight of the development and implementation of a radiosynthesis for human AME studies, and transition of project away from previous vendor. Drug was approved 18 months ago.Oversaw the re-validation of a legacy process within 15 months. Activities included R&D screening experiments to better understand the process, DoE studies on each operation of process, update of analytical methods to meet current technical and regulatory expectations, registration manufacturing campaign, process validation campaign, writing of NDA S sections.Led investigation of viability of alternate chemistry for a manufacturing process that had reached its limit of scalability. Worked closely with specialized vendor to study and improve process steps to increase process yields and efficiency. Conducted sourcing of key starting materials and regulatory starting materials that needed to be custom-produced.Performed vendor selection for a second commercial manufacturer for a new drug headed toward NDA submissionLed and oversaw R&D and production during preclinical development of numerous small molecules, and transitioned the programs into early clinical development from the point of view of CMC development and API manufacturing