2020 - Present                                                     

Innovative Pharma Solutions / DavosPharma

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Head of Technical Operations & Project Management / CMC Consultant

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Leading and managing the strategic, scientific and operational aspects of drug development. Oversight of all CMC tasks; small molecule drug design, cost-effective process optimization for high-value drug substance, GMP manufacture of API and drug product, IND-enabling studies including toxicology studies to support for regulatory filings. Science technical consultant, and business strategy to position companies for growth and success

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2017 - Present

BioLogic Insecticide

 

Co-Founder / Chief Scientific Officer

 

Creating short term and long term strategies for product development; science technical consultant, and business strategy. Scientific assessment and technical oversight on business activities of BioLogic Insecticide (BLI) and any other owned or operated affiliate business associated with BLI. Create strategy and execute on tasks to meet business timelines and regulatory requirements.

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2017 - Present

Academic Technology Ventures

 

Technical Advisor / Partner

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Bridging the gap between lab inventions & commercialization to create a better world: Hands on experience in CMC drug development from pre-clinical through full-scale manufacturing (broad and thorough knowledge of full development and manufacturing process). Key technical resource for drug synthesis process and process control measures, from creating New Chemical Entities to scale-up process and manufacturing. Due Diligence, scientific assessment and GAP analysis, from technology evaluation to technology transfer

 

• Successfully implemented multiple ideas from concept level to production

 

• Expert in creating short term and long term strategies for product development

 

• Expertise in business development and product development

 

• Brainstorm on disruptive technologies to assess of commercialization

 

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2017 - 2020

ThermoFisher Scientific

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Sr. Manager: Business & Project Management / Sr. Sales Operations Analysis

 - Pharmaceutical Manufacturing (API Global)

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Oversee and coordinate all small molecule chemical development. Technology transitions of active pharmaceutical ingredients (API) to manufacturing quantities. Responsible for generating, tracking, and communicating quoting activities for drug development. Scientific & business assessment, and technical oversight that include facilitating quoting activities, approving inputs, ensuring manufacture ability, and managing projects.

 

 

2005 - 2015

Forest Laboratories   

 

Associate Director, Chemical Development (2014 - 2015)

 

Chemical development leader for the development of a novel liver selective Glucokinase Activator for the treatment of type II diabetes , TRV-027, Eluxadoline)

 

• API development leads for Phase II diabetes program. Responsibilities include drug substance, regulatory filings, drug substance scientific development, cost analyses, budgeting in preparation for the commercial launch

 

• Developed & employed supply chain & sourcing strategies for raw materials, regulatory starting materials and final APIs

 

• Managed laboratory research, scaled-up, optimization and technology transfer to ensure optimal product quality

 

• Identified and optimized scalable synthetic route for cost-effective toward Eluxadoline. IP and lifecycle management opportunities

 

• Managed CRO/CMO activities: Regulatory Starting Materials and API process development; technology transfer

 

• Drafting and review of API related regulatory submission documents

                                                                                                         

 

Manager R&D / Principal Scientist (2011 - 2014)

 

Group leader and chemical development leads for Eluxadoline (IBS) project. Team member in benefit / risk assessment of in-licensing, acquisitions, and lifecycle prospects. Designed and synthesized octapeptide protein (TRV-027). Ensured manufacturing routes for scientific validity and integrity for all contract chemistry projects. Participated as member on cross-functional CMC development teams for multiple projects (Bystollic®, Armour® Thyroid, Fetzima®, Teflarro®, Nebivolol, TRV-027, Eluxadoline)

 

• Ensured critical milestones were met. An Active Pharmaceutical Ingredient (API) did not meet specifications and could delay NDA filing. Reviewed existing synthetic manufacturing routes. Reworked the process by improving multiple work-up conditions and streamlining most steps. Engaged new CRO. Doubled overall yield for the API process, reducing cost of goods, filing NDA on time. Patented new process.

 

• Provided due-diligence for licensing opportunity. Client lacked internal capabilities to address Control Manufacture Chemistry (CMC) issues or prepare Post-IND documents. Evaluated development status, delineated commercialization road map, and analyzed timeline, quality of submissions, costs. Company continued negotiations for license, securing for $250M. Established robust supply chain, and eliminated at risk suppliers from launch plan.

 

• Identified and optimized scalable synthetic route for cost-effective toward Eluxadoline. IP and lifecycle management opportunities

 

• Established supply chain for sourcing starting materials, intermediates and API

 

• Developed & improved an enantioselective process for preparing Pleuromutilin derivatives

 

 

Senior Process Chemist (2009 - 2011)

 

Served as process chemistry project leader for development programs and participated as key member on cross-functional CMC development teams. Responsible for project scope, timelines, and deliverables: Hands-on experience in scale-up of lab procedures to pilot plant manufacturing and tech transfers.

 

• Slashed costs. Dutogliptin, treatment for Type 2 diabetes in Phase 3 clinical development, was at risk of being cut due to high production costs. Designed / synthesized of API using novel method that included: 1) The first chemical preparation of chiral boronic acid-pyrrolidine 2) Efficient way to make amide bond via less expensive coupling reagent 3) Developed method to recycled starting material and 4) Streamline the overall process to reduce labor cost. The alternate manufacturing route reduced the COGs from $15,000/kg to $1,400/kg for 100 metric tons production ($1.36 billion in saving)

 

• Initiated in-house process research. Saw opportunity to save time and money by bringing process research in-house before transferring new techniques to Contract Research Organizations (CRO). Prioritized / expedited projects, and retained ownership of research. Filed five patents in three years, and cut R&D related CRO costs.

 

• Assisted with process optimization of TTP399; synthesized a glucokinase activator chiral sulfoxide and its impurities. IP and lifecycle management

 

• Developed a scalable route to 6-amino-3-cyclopropyl-1-propylpyrimidine-2,4(1H,3H)-dione, a key intermediate in the current route to ATL-800, a potent and selective A2B receptor antagonist

 

• Responsible for synthesis development, scale-up, and plant support for the GMP API production of clinical drug candidates

 

• Coordinated transfer of projects from chemical development into pilot plant

 

 

Senior Research Scientist (2007 - 2009)

 

Defined optimal methods for in-process monitoring and collaborated with analytical chemists to identify structure and origin of process impurities. Devised, developed, and scaled numerous chemical steps from mgs to 100 g in support of a variety of programs. Expeditiously developed and scaled up new processes for drug candidates.

 

• Developed first chemical preparation of chiral boronic acid-pyrrolidine for Dutogliptin, key for patent filing

 

• Developed manufacturing processes of key intermediates of Dutogliptin; helped demonstrate process ruggedness on scale; cost saving

 

• Designed new route toward deuterium labeled compounds to support for analytical and bio-analytical; reference standard for use in metabolism studies

 

• Prepared technical documents such as reports, operating procedures and methods

 

 

Medicinal Research Scientist (2005 - 2007)

 

Process research / development of safe, practical, and efficient processes, suitable for multi-gram preparation of investigational drug substances; fragment-based lead discovery; investigated process chemistry of beta lactamase inhibitor, and other exploratory research

 

• Identified and optimized scalable synthetic route for lead compound GRC-3887

 

• Designed a synthetic route toward a flexible scaffold for 5HT2c project

 

• Conducted structure-based drug design approach for multiple projects (CB2, p70S6K, m-TOR, and Akt)

 

 

2004 - 2005

Serono Research Institute                                                                    

 

Post-Doc / Research Scientist

 

• Synthesized small molecules / radio labeled materials. Participated in MEK project, providing compounds with acceptable in vitro toxicology profile.

 

• Synthesized small molecules. New compounds were needed to support p70S6K kinase inhibitor program. Designed synthetic route toward a flexible scaffold, allowing modifications without redoing every step. Synthesized 10 to 15 compounds weekly for biological testing. Identified two compounds for Pre-clinical development, and a patent was filed. Recognized as Most Outstanding Chemist.

 

 

1998 - 2004

Montana State University

 

Teaching / Research Associate (2000 - 2004)

 

• Designed and taught a new advanced undergraduate-and graduate-level course covering natural product biosynthesis, biocatalysts, and total synthesis

 

Teaching assistant – A.R. Johannson Teaching Fellow  (1998 - 2000)

 

• Taught an updated undergraduate organic chemistry course that integrates biochemistry and mechanistic organic chemistry for premedical students and life sciences concentrators