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Established successful interdisciplinary consultancy serving small/start-up pharma, biotech, and industrial biotech companies. Work with academics, company scientists, and business-development in start-ups and non-profit research organizations. Directed multi-disciplinary process development groups in major pharmaceutical corporations. Built new, practical technology base within both small company and large corporate environments. Delivered profitable IP, process scale-up, and novel automation. Extensive project management experience covering process chemistry, molecular biology, biotransformations & biocatalysis, plus fermentation of natural products and recombinant enzymes. Developed and scaled processes for the biological production of commodity chemicals from biomass, including cost-analyses. Extensive experience under GMP; supported CMC sections of IND & NDA filings. Excellent communication skills; frequently invited to explain technical issues to patent, licensing, regulatory, and business groups, and to serve on due-diligence teams. Expert witness experience. Service as North American Editor of international peer-reviewed journal and as Chairs of international symposia in the field of biocatalysis. United States and Canadian citizenships.

INDEPENDENT CONSULTING; DODDS & ASSOCIATES LLC www.techdiligence.net		2002-
Founded Dodds & Associates to provide strategic technical planning and project management to the pharmaceutical, biotech, and chemical industries. Work with small and start-up companies needing interdisciplinary experience at a senior level to establish technical strategy and execute project management. Extensive industrial and academic network. Executed contracts with over 15 clients since 2002. Client references available. Completed and current projects include:
	Service on technical Advisory Boards; technical presentations to Corporate Boards and investors
	Intellectual property review and strategy, technical assessment and due-diligence
	Project Management:
	-process review, development, and scale-up for both pharma and non-pharma projects including industrial biotechnology -contractor selection, site visits and reporting, technology transfer -drafting CMC sections for IND & NDA, batch record drafting and review for GMP production -develop and run biological/fermentation processes for production of non-fuel commodity chemicals from biomass
	Interim technical executive for small entities:
	-PI on multiple grant applications, presentations to regional development committees -interim CSO for zuSyn; responsible for lab build-out, technology base, contract work & staffing -experience with venture fund for industrial biotechnology
	Expert witness; experience in depositions and cross-examination
BRISTOL-MYERS SQUIBB CO. , SYRACUSE, NEW YORK DIRECTOR, FERMENTATION & BIOCATALYSIS DEVELOPMENT ASSOCIATE DIRECTOR, ENZYME DEVELOPMENT		1999 - 2001 2000 - 2001 1999 - 2000
Invited to BMS to lead a new group of 50 scientists organized into chemical process development, molecular biology, fermentation development, and GMP analytical functions. Managed $4 million in annual operating and capital budgets. Achieved cost-savings by applying biocatalysis in chemical syntheses and evaluated these with outsourcing group. Developed chiral chemical processes, plus fermentations for natural products, enzyme production, 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 to meet specifications.
	Developed process to chiral intermediate for HIV therapeutic via biological reduction, allowing significant cost-savings over vendor pricing of tonne quantities.
	Developed natural product fermentation process that gave a three-fold increase in production within 12 months. Re-wrote and updated all documentation necessary for GMP compliance.
	Conceived and managed chemical gene synthesis and expression project to replace bovine enzyme and eliminate TSE/BSE regulatory issues in an existing commercial process.
	Directed submission of six chemical and fermentation process patent applications in 18 months.
	With neither a budget nor formally assigned project, managed preparation of an existing facility - designed for other purposes - for first half of TAXOL® cell culture production process. Included facilities issues, writing and reviewing all SOPs, master batch records, plus equipment calibration and validation protocols to permit GMP operation.
	Supported filing for commercial antibiotic synthesis using biocatalysis. Advised patent counsel on cross-licensing of production technology, avoided patent conflicts and preserved future rights.
SCHERING-PLOUGH RESEARCH INSTITUE. , UNION, JERSEY MANAGER, BIOTRANSFORMATIONS GROUP		1991 - 1999
Invited to SPRI to establish a new group for the development of biocatalysis for more efficient and cost-effective 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 in over a dozen projects, (including POSACONAZOLE® antifungal) and handled all downstream processing required for product isolation and purification. Projects were at scales ranging from the lab-scale synthesis of metabolites, to plant processes providing 100s of kgs of intermediates in the synthesis of clinical material under GMP.
	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. To date, six have issued as patents, and one has been kept a trade secret. Group had a total of 37 public releases (papers or presentations)
	Planned new laboratory facilities and relocated the entire group from one site to another - twice.
	Independently proposed and initiated automation of enzyme screening activities, resulting in the approval of a $1.25MM project.
	Planned and ran the first company-wide poster session for Development Operations, with over 90 presentations from chemical, biotech, formulations, and engineering development groups. Managed legal clearance and publicity.
SEPRACOR INC. , MARLBOROUGH, MASSACHUSETTS SENIOR PROTEIN BIOCHEMIST		1986 - 1991
Responsible for biocatalysis research, reporting to the VP R&D. Mission was to create commercial opportunities for Sepracor's core membrane technology by identifying opportunities for the company's membrane bioreactor device. Included design and 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 intermediate, including enzymatic transformation of waste by-product to a commercially valuable fine chemical.
	With VP R&D, wrote all patent applications for enzyme processes, and assisted in their prosecution. Chief technical witness in patent interference suit, settled in favor of Sepracor.
	Solely responsible for NRC licensing, radiation safety compliance, and de-commissioning of company's radio-isotope lab.