Senior Director Bioprocess Development in Northern California Resume Venkatesh Srinivasan
Venkatesh Srinivasan is a highly motivated biotech executive with broad-based experience in leading process development, business development and IP management efforts.
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Venkatesh Srinivasan, PhD Telephone: +1 (408) 482 8861 E-mail: [email protected] Summary Highly motivated biotech executive with broad-based experience in leading process development, business development and IP management efforts. • Over a decade of leadership in commercial Bioprocess Development: Expert in high throughput process development, taking cell culture processes from laboratory to pilot and manufacturing scale. Process optimization. Transfer of technology. Process investigations/debugging. Regulatory review and compliance. • Ten years of intellectual property management experience. Worked with in-house and external counsel to shepherd numerous patents through prosecutions, oppositions and appeals in all major jurisdictions. • Directed Business Development efforts for 2.5 years. In-licensed two key glycoengineering platform technologies. Technical lead in M&A discussions leading to offer to buy a potential competitor. Key member of team charged with spinning out biotechnology business. • Hired and managed expertise across all academic and skill levels. Led teams to success. • Founded biopharmaceutical company to advance a novel technology. • Communicate effectively across educational and expertise spectrum - senior corporate management, scientific advisory boards, non-technical leadership including financial and business development and technical experts Experience GlycoRx Partners, LLC (Founder) Nov 2009 – present
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Founded biothereapeutics company (GlycoRx) to advance innovative technology for development and manufacture of long acting peptide therapeutics. Developed business plan and financing strategy. Negotiated option-to-license agreement with academic technology transfer office Developed product strategy in key disease indications with large market potential Presented technology to over 100 potential strategic and financial partners across US, Japan and Europe leading to technical due diligence activities (in progress) Substantial discussions in progress with major biotech/ pharma companies to develop collaborative relationships Jan 2009 - Present
Independent consultant
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Consulting to enable R&D partnering for endocrinology portfolio for a small biotech company Debugging large scale manufacturing issues for biotech company, advising on process optimization and cell line engineering
Consultant: DFB Pharmaceuticals
March - October 2008
DFB Pharmaceuticals commissioned a core group of executives to spin out Phyton Biotech into alternative ownership. • Key member of team responsible for partnering efforts • Helped create business and technical plan for investor review • Very active in helping to negotiate key license to broaden technology access in glycoengineering space • Presented technology and business plan to numerous potential investors – corporate and venture, at JP Morgan Investment Conference in 2008, and other venues • Secured one corporate offer and top-tier lead VC Phyton Biotech 1996-2008
A pioneering biotechnology company developing and commercializing a novel plant cell culture technology platform for the production of small molecule and protein drugs. The company successfully produced the plant-derived cancer drug – taxol, the first ever commercially produced therapeutic from plant cell cultures at large scale and then leveraged this success to produce novel glyco-engineered biopharmaceuticals to improve their therapeutic efficiency. Senior Director, Bioprocess Development, Phyton Biotech 2006-2008
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Led Molecular Biology, Cell Line Development and Process Development groups responsible for developing fermentation processes for the production of novel glyco-engineered protein drugs. Directed a team of 20 people including six PhD-level scientists and engineers, seven Masters-level scientists and seven Bachelors-level Associate Scientists. • Chief internal consultant to director of pilot plant to define scope of pilot plant build-out and procuring bioreactors and recovery equipment. • Developed plant cell fermentation process producing a glycosylated hGH receptor antagonist from tobacco cell cultures. Improved process yield by over two orders of magnitude in 9 months – well ahead of schedule. • Worked collaboratively with downstream processing group to define centrifugal harvest, TFF concentration, IEX capture, HIC purification and SEC polishing steps • Successfully transferred the process from laboratory scale to non-GMP pilot plant (30 L) and cGMP operations at 1,500 L scale, en-route to scale up at 7,500 L at manufacturing site in Germany. • Contributing member of the senior management team; participating in all business decisions, setting short and long term R&D objectives, developing strategies to accomplish these objectives, determining capital and operating budgets, and making presentations to the corporate board and investors to secure funding. • Key member of in-licensing team for two key glyco-engineering platform technologies responsible for assessing technical and business potential. Acquisition of technologies effectively ensured company’s leadership in production of complex glycosylated biopharmaceuticals from plant cells. • Responsible for strategy to outsource manufacturing preclinical and clinical supplies for protein product. Screened potential manufacturing partners to determine site for implementation of plant cell process. Director Business Development, Phyton Biotech 2004-2006
Led Business Development efforts following acquisition by DFB Pharmaceuticals in November 2003; leveraged subject matter expertise to market the technology to diverse audiences including internal and external stakeholders. Performed technical and IP due diligence on an M&A target leading to an offer for the company; evaluated patent portfolio and compatibility of the technology with in-house technology and manufacturing processes.
Senior Scientist, Phyton Biotech
1996-2003
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Extensive experience in time/cost-efficient scale-down models of large scale processes, process simulation in multi-well plates, multi parameter batch and fed batch process definition in multi-well plates with demonstrated performance through scale-up to manufacturing scale (75,000 L), statistical experiment design and analysis, creating specifications for robust process operation. Processes developed have been performing stably for over a decade in large scale cGMP environment. • Led process team to define first ever commercial plant cell culture process for manufacturing taxol API. Developed small-scale simulations of manufacturing scale processes to scale up from multiwell plates to 75,000 L manufacturing scale. The process has been licensed to Bristol-Myers Squibb under a global supply agreement • Managed transfer of technology from lab scale to pilot plant (1,000 L) and to manufacturing (up to 75,000 L) at manufacturing facility in Germany. Worked extensively with German and US teams to implement manufacturing process at the German site. Ensured faithful interpretation of process steps through the translation from English to German SOPs • Created CMC documentation (as part of sNDA) for review by regulatory authorities in the US, EU and Japan. Put together key technology documents for FDA preview meetings. • Actively managed post-approval process investigations and optimization efforts to maintain compliance and expand regulatory benchmarks • Initiated a small molecule discovery program to identify compounds of pharmaceutical interest from plant cell cultures • Led a team of up to 20 comprising scientists and engineers. Intellectual Property Management 1996-2007
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Actively managed patent portfolio for over 10 years as in-house technical expert Worked extensively with in-house and external US and foreign patent counsel through patent prosecution in numerous jurisdictions Appeared as technical expert in numerous opposition and appeal proceedings in Europe, Korea and Japan
Post-Doctoral Research Post-Doctoral Associate (1994-1995): School of Chemical Engineering, Cornell University with Prof. Michael L. Shuler. Improvement of taxol production from plant cell cultures of Taxus species; mathematically modeled the production kinetics and using various metabolic probes, determined a potentially rate-limiting reaction in taxol biosynthesis. Post-Doctoral Associate (1992-1993): Antibody Engineering Laboratory, UC Davis with Prof. Prabhakar V. Choudary.
Studied the expression of monoclonal antibodies, growth factors and insecticidal proteins in bacterial and insect cells and methods of isolation and purification of these molecules Education Ph.D. Chemical Engineering, State University of New York, Buffalo, 1992 - Studied biosynthetic rate-limitations in the production of pharmaceutical compounds from plant cell cultures of L. erythrorhizon and invented new nutrient-supply and process modes to improve production. M.S. Chemical Engineering, State University of New York, Buffalo - Studied the production of monoclonal antibodies from hybridoma cell cultures cultivated in hollow fiber bioreactors and determined the effect of dissolved oxygen and role of convective mass transfer in this system in improving monoclonal antibody yield. B.S. Chemical Engineering, Indian Institute of Technology, Madras, India Other languages: Fluent in multiple Indian languages, and beginner-to-intermediate skills in spoken and written German
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Founded biothereapeutics company (GlycoRx) to advance innovative technology for development and manufacture of long acting peptide therapeutics. Developed business plan and financing strategy. Negotiated option-to-license agreement with academic technology transfer office Developed product strategy in key disease indications with large market potential Presented technology to over 100 potential strategic and financial partners across US, Japan and Europe leading to technical due diligence activities (in progress) Substantial discussions in progress with major biotech/ pharma companies to develop collaborative relationships Jan 2009 - Present
Independent consultant
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•
Consulting to enable R&D partnering for endocrinology portfolio for a small biotech company Debugging large scale manufacturing issues for biotech company, advising on process optimization and cell line engineering
Consultant: DFB Pharmaceuticals
March - October 2008
DFB Pharmaceuticals commissioned a core group of executives to spin out Phyton Biotech into alternative ownership. • Key member of team responsible for partnering efforts • Helped create business and technical plan for investor review • Very active in helping to negotiate key license to broaden technology access in glycoengineering space • Presented technology and business plan to numerous potential investors – corporate and venture, at JP Morgan Investment Conference in 2008, and other venues • Secured one corporate offer and top-tier lead VC Phyton Biotech 1996-2008
A pioneering biotechnology company developing and commercializing a novel plant cell culture technology platform for the production of small molecule and protein drugs. The company successfully produced the plant-derived cancer drug – taxol, the first ever commercially produced therapeutic from plant cell cultures at large scale and then leveraged this success to produce novel glyco-engineered biopharmaceuticals to improve their therapeutic efficiency. Senior Director, Bioprocess Development, Phyton Biotech 2006-2008
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Led Molecular Biology, Cell Line Development and Process Development groups responsible for developing fermentation processes for the production of novel glyco-engineered protein drugs. Directed a team of 20 people including six PhD-level scientists and engineers, seven Masters-level scientists and seven Bachelors-level Associate Scientists. • Chief internal consultant to director of pilot plant to define scope of pilot plant build-out and procuring bioreactors and recovery equipment. • Developed plant cell fermentation process producing a glycosylated hGH receptor antagonist from tobacco cell cultures. Improved process yield by over two orders of magnitude in 9 months – well ahead of schedule. • Worked collaboratively with downstream processing group to define centrifugal harvest, TFF concentration, IEX capture, HIC purification and SEC polishing steps • Successfully transferred the process from laboratory scale to non-GMP pilot plant (30 L) and cGMP operations at 1,500 L scale, en-route to scale up at 7,500 L at manufacturing site in Germany. • Contributing member of the senior management team; participating in all business decisions, setting short and long term R&D objectives, developing strategies to accomplish these objectives, determining capital and operating budgets, and making presentations to the corporate board and investors to secure funding. • Key member of in-licensing team for two key glyco-engineering platform technologies responsible for assessing technical and business potential. Acquisition of technologies effectively ensured company’s leadership in production of complex glycosylated biopharmaceuticals from plant cells. • Responsible for strategy to outsource manufacturing preclinical and clinical supplies for protein product. Screened potential manufacturing partners to determine site for implementation of plant cell process. Director Business Development, Phyton Biotech 2004-2006
Led Business Development efforts following acquisition by DFB Pharmaceuticals in November 2003; leveraged subject matter expertise to market the technology to diverse audiences including internal and external stakeholders. Performed technical and IP due diligence on an M&A target leading to an offer for the company; evaluated patent portfolio and compatibility of the technology with in-house technology and manufacturing processes.
Senior Scientist, Phyton Biotech
1996-2003
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Extensive experience in time/cost-efficient scale-down models of large scale processes, process simulation in multi-well plates, multi parameter batch and fed batch process definition in multi-well plates with demonstrated performance through scale-up to manufacturing scale (75,000 L), statistical experiment design and analysis, creating specifications for robust process operation. Processes developed have been performing stably for over a decade in large scale cGMP environment. • Led process team to define first ever commercial plant cell culture process for manufacturing taxol API. Developed small-scale simulations of manufacturing scale processes to scale up from multiwell plates to 75,000 L manufacturing scale. The process has been licensed to Bristol-Myers Squibb under a global supply agreement • Managed transfer of technology from lab scale to pilot plant (1,000 L) and to manufacturing (up to 75,000 L) at manufacturing facility in Germany. Worked extensively with German and US teams to implement manufacturing process at the German site. Ensured faithful interpretation of process steps through the translation from English to German SOPs • Created CMC documentation (as part of sNDA) for review by regulatory authorities in the US, EU and Japan. Put together key technology documents for FDA preview meetings. • Actively managed post-approval process investigations and optimization efforts to maintain compliance and expand regulatory benchmarks • Initiated a small molecule discovery program to identify compounds of pharmaceutical interest from plant cell cultures • Led a team of up to 20 comprising scientists and engineers. Intellectual Property Management 1996-2007
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Actively managed patent portfolio for over 10 years as in-house technical expert Worked extensively with in-house and external US and foreign patent counsel through patent prosecution in numerous jurisdictions Appeared as technical expert in numerous opposition and appeal proceedings in Europe, Korea and Japan
Post-Doctoral Research Post-Doctoral Associate (1994-1995): School of Chemical Engineering, Cornell University with Prof. Michael L. Shuler. Improvement of taxol production from plant cell cultures of Taxus species; mathematically modeled the production kinetics and using various metabolic probes, determined a potentially rate-limiting reaction in taxol biosynthesis. Post-Doctoral Associate (1992-1993): Antibody Engineering Laboratory, UC Davis with Prof. Prabhakar V. Choudary.
Studied the expression of monoclonal antibodies, growth factors and insecticidal proteins in bacterial and insect cells and methods of isolation and purification of these molecules Education Ph.D. Chemical Engineering, State University of New York, Buffalo, 1992 - Studied biosynthetic rate-limitations in the production of pharmaceutical compounds from plant cell cultures of L. erythrorhizon and invented new nutrient-supply and process modes to improve production. M.S. Chemical Engineering, State University of New York, Buffalo - Studied the production of monoclonal antibodies from hybridoma cell cultures cultivated in hollow fiber bioreactors and determined the effect of dissolved oxygen and role of convective mass transfer in this system in improving monoclonal antibody yield. B.S. Chemical Engineering, Indian Institute of Technology, Madras, India Other languages: Fluent in multiple Indian languages, and beginner-to-intermediate skills in spoken and written German
