Independent Consultant, Livermore, CA. June 2015 – Present Principal
Focusing on preclinical development and CMC for biologics in Phase I – through commercial stage. Extensive experience in development and manufacturing of naked antibodies, ADCs and radiotherapy conjugates.
Takeda California, San Diego, California 2009-2015
Vice President Core Sciences and Technology 2012-2015
Reported to President / CSO and managed 5 Director level direct reports. Focused on providing strategic and tactical leadership to diverse functional groups supporting both NCE and Biologics preclinical development. Overall responsibility and accountability for CMC preclinical development of mAb and ADC candidates leading to technical transfer for manufacturing and IND filings for clinical development.
- Developed and implemented Global Biologics strategy for Takeda in collaboration with VP Biological Sciences. This led to an increased investment in Biologics for collaborations, in-licensing deals, technology licenses, equipment and headcount. Facilitated the transition of Takeda from a small molecule company to one with a balanced portfolio of both traditional small molecule drugs and Biologics.
- Led portfolio review and management in collaboration with President / CSO, VP Biology and VP Chemistry as part of Research Committee. The research portfolio was refocused to only the most promising assets and resources were realigned to prioritized programs. Number of IND candidates from San Diego site increased 3-fold in one year.
- Facilitated and managed successful rebuilding of Oncology Biologics strategy and inter-site collaboration with Takeda Boston. The end result was a highly functional collaboration in which roles, responsibilities and accountabilities were clearly assigned. Clinical development candidates were delivered on time with high quality data packages to the CMC development team in Boston.
- Guided the re-establishment of Biologics capabilities in San Diego. After overseeing the complete shut-down of the South San Francisco labs, the equipment and all critical reagents were packed and moved to San Diego. The labs were up and running within 6 weeks of arrival in San Diego.
- Directed Executive Steering Committee for external collaboration with 3rd party biotech company. Ground breaking site specific labeling technology for cytotoxic drugs (ADC) was reduced to practice with efficacy demonstrated in vitro and in vivo across multiple tumor models.
Vice President Core Sciences and Technology, South San Francisco, California, 2009-2012
Reported to President / CSO and managed 7 Director level reports in San Francisco and San Diego.
- Acted as Site Head from 7/11-7/12, leading site closure and successfully re-establishing Biologics capabilities in San Diego in collaboration with TCAL President and VP Biological Sciences.
- Established preclinical ADC development capabilities in collaboration with Takeda Boston. Capabilities allowed for a thorough evaluation of multiple ADC platforms in parallel and facilitated the selection of the best option for Takeda’s first home grown ADC program.
- Led CMC IND filing team for first Takeda-developed clinical ADC candidate.
- Directed process development and tech transfer team to on time delivery of GLP toxicology and Phase I material using a 3 CMO network
Neugenesis Corporation, Burlingame, California 2008-2009
Chief Operating Officer
Second in command reporting to the CEO, responsible for the day to day operations.
- Led development and implementation of operational plans and budgets at departmental and corporate level. Organization became more focused and delivered on higher percentage of critical technical milestones.
- Provided Scientific/Technical leadership for Process and Analytical Methods Development Groups – fungal expression systems for mAbs and other therapeutic proteins. Process evolved to a higher level of productivity and robustness acceptable for a GMP operation.
- Senior management leader for all CMO relationships. Established a CMO network for Phase I clinical supply.
- Lead contact along with CEO and CSO for Department of Defense counterparts in managing multi-million dollar DOD contracts for BioDefense applications. Interactions through reports, teleconferences and face to face meetings were efficient and effective.
GENITOPE CORPORATION, Fremont, California 2005-2008
Vice President Manufacturing
Responsible for all manufacturing operations, leading a 65 person organization with 7 Director level direct reports. Primary objective was the Phase III supply of a personalized anti-cancer vaccine for Non-Hodgkin’s lymphoma.
- Delivered consistent performance to timeline and annual manufacturing budget of $10-15MM. Phase III trials supplied successfully under challenging manufacturing conditions. The product was a personalized vaccine derived from patients’ primary tumors therefore each product was unique. Improved the productivity and robustness of the manufacturing process working directly with manufacturing and quality department heads.
- Co-Executive Lead on $60MM / 200,000 s.f. new facility construction project – completed 10/06 on time and on budget. One of a kind facility specifically designed to deliver a personalized anti-cancer vaccine.
- CMC Lead for BLA filing team & for all CMC interactions with FDA
Corixa Corporation, South San Francisco, California 2003-2004
Vice President-Bexxar Operations
Led global supply chain operations for Bexxar for both commercial and clinical trial supply. Supervised manufacturing and materials management groups. Technical and strategic lead for development of new market opportunities in Europe and Asia through licensing and cooperative contract manufacturing relationships. Because of the radiolabel, the product had no shelf life and no inventory the end result was Just in Time manufacturing that required rock solid manufacturing, quality and supply operations.
From 1996-2003, led a multi-disciplinary team in developing the first centrally manufactured radiopharmaceutical-Iodine-131 Anti-B1 Antibody (Bexxarä) for the treatment of Non-Hodgkin’s Lymphoma. Directed the formulation development and process scale-up to support clinical trial and commercial supply. Principal author of BLA CMC section submitted to FDA to support commercial licensure of Bexxarä. Pre-Approval Inspection Team Leader.
Product approved by US FDA in June 2003
ADDITIONAL RELEVANT EXPERIENCE – Last 20 Years
Corixa Corporation, South San Francisco, CA:
Senior Director Production, 2001-2002
Director – Product Development, 2000-2001
Associate Director – Product Development – (Corixa – formerly Coulter Pharmaceutical Inc.) 1996-2000
EDUCATION
Ph.D., Immunology
UMDNJ Graduate School of Biomedical Sciences, Department of Pathology, Newark, N.J.
Bachelor of Arts, Biology
The College of Wooster, Wooster, Ohio