Expert Details
Organic Chemistry, Biocatalysis, Fermentation, Industrial Biotechnology, Chemical Process Development, Patent Liaison, Expert Witness for Patent Litigation
ID: 733450
New York, USA
Expert has run his own consulting firm since 2002, where he lends his expertise to startups in pharmaceuticals; renewable and bio-based chemicals; and industrial biotechnology.
His core competencies include chiral chemistry, biocatalysis, industrial biotechnology, organic synthesis, molecular biology, and natural product fermentation.
Expert provides due diligence on technology that is being considered for acquisition, licensing, or investment.
Expert provides expert witness service over the disciplines of organic chemistry, molecular biology, microbial fermentation, protein expression, natural product recovery and purification, and biocatalysis.
Expert has created and defended intellectual property as a scientist in the pharmaceutical and chemical industries, both in the prosecution of patent applications, as well as litigation of granted patents.
Expert has appeared as an expert witness in federal and state court. Expert has written opinions and affidavits, and has been deposed or cross-examined multiple times.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1986 | Degree: Post-doctoral Work | Subject: Molecular Biology | Institution: University of Colorado, Boulder |
| Year: 1984 | Degree: Ph.D | Subject: Organic Chemistry | Institution: University of Toronto |
| Year: 1979 | Degree: M.Sc | Subject: Biorganic Chemistry | Institution: University of Toronto |
| Year: 1977 | Degree: B.Sc | Subject: Chemistry and Biochemistry | Institution: University of Toronto - University of Trinity College |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2002 to Present | Employer: Undisclosed | Title: Independent Consultant | Department: |
Responsibilities:Provide strategic technical planning and hands-on project management to the pharmaceutical, industrial biotech, and biobased/green chemical industries. Provide CTO-level service to small and start-up companies at interface of chemistry, molecular biology and fermentation. Provide day-to-day and strategic direction of scientific staff in these disciplines, including academic contacts. Executed contracts with over 30 clients since 2002; two projects ended with licensing of the project by large pharma houses, and a nonpharma client was acquired for their IP. Organized, moderated and chaired multiple conference panels andsessions seating senior industry executives. Completed and current projects include: • Senior technical executive for small entities: - interim CTO service; management of science program, responsible for lab build-out, expansion of technology base, contract work & staffing - technical direction of chemists, biologists and engineers, from broadly strategic to highly detailed - identification and presentation of technical opportunities to the fund, ranging from white-papers for specific technical areas to identifying contract sites and equipment for virtual companies - IP strategy and competitive analysis, patent liaison - significant experience with academic founders, university licensing groups, and senior management in an interdisciplinary start-up environment; presentations to regional development committees • Project Management; organic chemistry, molecular biology, fermentation and microbiology: - development and scale-up of both fermentation and chemical processes for pharma and biobased chemicals projects including strain development, molecular biology, organic synthesis and chemical route selection, biocatalysis and downstream processing - provide RFPs for bidding both fermentations and total chemical syntheses, plus CMO selection - draft batch records and process validations, CMC sections for IND & NDA filings - single point of contact for clients’ outsourced projects after project awarded to contractors; direct technical support of CMO for client including on-site meetings at foreign locations - single point of contact with academic faculty advising or performing services for clients - technical transfer of processes and analytical methods, including documentation - management and technical support for total syntheses, fermentations and strain development • Technical due diligence for multiple clients in both bio-based chemicals and pharmaceutical industries • Service on Scientific Advisory Boards; technical presentations to Corporate Board and investors • Co-founder of Pronghorn Renewables and SriyaDXI • Expert witness service primarily for litigation for patent infringement, or contract disputes concerning chemical and biological operations and processes - experience in opinions, depositions, affidavits, and cross-examinations; court experience |
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| Years | Employer | Title | Department |
| Years: 1999 to 2001 | Employer: BRISTOL-MYERS SQUIBB CO | Title: DIRECTOR | Department: FERMENTATION & BIOCATALYSIS DEVELOPMENT |
Responsibilities:Invited to BMS to lead a new group of 50 scientists organized into chemical process development, molecularbiology, fermentation development, and GMP analytical functions. Achieved cost-savings by applying biocatalysis in chemical syntheses. Developed chiral chemical processes, plus fermentations for natural products, enzymes, and biocatalysis. • Solved production problems with enzymatic process experienced by an external supplier. Recovered over 3 tons of in-process material critical to launch supply. • Developed process to chiral intermediate for HIV therapeutic via recombinant enzyme system, allowing significant cost-savings over vendor pricing of tonne quantities. • Developed natural product fermentation process that gave a three-fold increase in production. • Conceived and managed chemical gene synthesis and expression project to replace bovine enzyme and eliminate TSE/BSE regulatory issues in an existing commercial process. • Group submitted six chemical and fermentation process patent applications in 18 months. • Responsible for multi-million dollar TAXOL® project with external partner. Reviewed all outside TAXOL® production technology and wrote technical reports as part of formal corporate response. • Supported filing for commercial antibiotic synthesis using biocatalysis. Advised patent counsel on crosslicensing of production technology, avoiding patent conflicts and preserving future rights. |
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| Years | Employer | Title | Department |
| Years: 1991 to 1999 | Employer: SCHERING-PLOUGH RESEARCH INSTITUTE | Title: MANAGER | Department: BIOTRANSFORMATIONS GROUP |
Responsibilities:Invited to SPRI to establish a new group for the development of biocatalysis for more efficient and costeffective syntheses of pharmaceuticals. Reported to VPs of both Chemical and Biotechnology Development.Responsible for budget (operational, capital, grant), staffing and equipping, physical plant requirements, and all regulatory compliance (environmental, S&IH, GMP) for the Group. • Successfully introduced biocatalysis under both aqueous and non-aqueous conditions in over a dozen projects, (including the approved POSACONAZOLE® antifungal) and handled all downstream processing required for product isolation and purification. Projects scales ranged from lab-scale synthesis of metabolites, to GMP plant processes providing 100s of kgs of intermediates for clinical material. • Successfully doubled the capacity of a fermentation used to perform a chemical reaction in an existing manufacturing process, including downstream extraction and recovery. • Directed group in filing of 13 patent disclosures. Six were issued as patents, and one was kept a trade secret. Group had a total of 37 public releases – extremely unusual for a development group. • Independently proposed and initiated automation of enzyme screening activities, resulting in the approval of a $1.25MM project. The project was completed and the equipment used for several years. |
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| Years | Employer | Title | Department |
| Years: 1986 to 1991 | Employer: SEPRACOR INC. | Title: SENIOR PROTEIN BIOCHEMIST | Department: |
Responsibilities:Responsible for biocatalysis research to create commercial opportunities for Sepracor's core membranebioreactor technology. Included design and chemical synthesis of substrates, design and implementation of enzyme/substrate screening assays, and technical support for engineering. • Discovered unique class of ester substrates unusually susceptible to hydrolysis by proteolytic enzymes. Technology was successfully applied to the resolution of clinical quantities of NSAIDs. • Established enzymology for multi-million dollar joint venture with Japanese pharmaceutical company for resolution of cardiac drug (DILTIAZEM®) intermediate, including enzymatic transformation of waste byproduct to a commercially valuable fine chemical. • Wrote patent applications for enzyme processes, and assisted in their prosecution. Chief technical witness in patent interference suit in which Sepracor prevailed. |
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Career Accomplishments
| Professional Appointments |
|---|
| Executive Officer, Committee E62 Industrial Biotechnology -- ASTM International (2014-present) Member, Scientific Advisory Board -- PureVision Technologies, Inc. (2012-present) Member, Scientific Advisory Board, zuChem (2002-present) Member, Scientific Advisory Board, Kent BioEnergy (2009-12) Senior Advisor, Draths Corporation (acquired by Amyris) (2009-11) Member, Scientific Advisory Board, CODEXIS (2002-08) Senior Advisor, MBI International (2003-06) |
| Publications and Patents Summary |
|---|
| Expert has over 25 publications and over 12 patents. |
Fields of Expertise
due diligence, enzymatic catalysis, biocatalysis, drug development, research and development, technology transfer, process development, fermentation, molecular biology, chirality, scale-up, biotechnology scale-up, industrial biotechnology, startup, pharmaceutical start-up plant, pharmaceutical industry, patent infringement, expert witness