Key Technical Staff

The following profiles provide short summary backgrounds of the key WuXi AppTec personnel who will help ensure a successful testing program for your biopharmaceutical.

Vice President, Service Development and Virology Services
Over 30 years’ experience in virology, molecular biology, product development in pharmaceutical and biopharmaceutical industries • Provides scientific and regulatory advice for process development and testing issues for biologic products • Manages the Virology Group, which provides design and performance of cell bank, lot release and raw material testing, and the Viral Clearance Department, which provides custom validation studies • Co-chair for PDA Committee and serves on other industry committees on viral safety • Ph.D. in Microbiology-Virology.

Director, Virology
Over 12 years’ experience providing analytical support for new vaccines and technology transfer for vaccine and recombinant products • Responsible for standard and custom viral detection and potency assays • Designs and implements studies for cell line characterization, lot release and stability programs • Provides client consults for risk analyses with specific virus safety needs • Ph.D. in Microbiology and Molecular Virology.

Director, Molecular Biology
Over 12 years’ experience in molecular biology and virology with extensive experience in product development for gene therapy and genetic vaccines using viral vectors, and other biotherapeutics • Manages group that provides viral and mycoplasma PCR-based assays/methods, as well as assay development/validation, and assists with viral clearance studies • Ph.D. in Microbiology and Molecular Genetics.

Senior Director, Toxicology
Over 25 years’ experience in designing/directing studies and preparing regulatory submissions • Expert in ISO/FDA 10993 testing • Leader in the area of custom in life testing of therapeutics including toxicology, implant tests and biodistribution studies • Member U.S. ISO Technical Advisory Group (TAG) for Biological Evaluation of Medical Devices • Ph.D. in Animal Nutrition/Toxicology; M.S. in Animal Physiology.

Director, Custom Studies – In Life
Over 25 years’ experience in applied research for in life safety and efficacy tests, including pathology, bioengineering, and combination products • Provides expertise in the area of study designs, regulatory consultation and data analysis for submission for multiple therapeutics • Previously Instructor, Harvard Medical School, Dept. of Surgery • Ph.D. in Pathobiology; M.P.H. in Epidemiology.

Director, Custom Studies – In-Life
Over 25 years’ experience in biomedical research and clinical pathology • Manages all aspects of in vivo safety and efficacy evaluations, with particular focus on biologics and combination products • Responsible for study design, consultation, protocol development, study direction, analysis/interpretation of study data, and final report • Ph.D. in Microbiology, Immunology, and Cancer Biology; M.S. in Nutrition-Metabolic Research.

Vice President, Testing and Cell Services
Over 30 years’ experience in biosafety programs for cell-based products, and development, quality control and manufacturing for innovative biopharmaceutical products and cellular therapies • Provides regulatory and quality control advice • Manages cGMP manufacturing of cell-based products and cell therapies for clinical application and supporting analytical characterization and stability programs • Participated in development of regulatory guidance documents for monoclonal antibodies and recombinant protein products as well as cellular therapies • B.S. in Biological Sciences, Research Option.

Director, Assay Development
Over 20 years’ experience in viral safety testing and immunology • Responsible for developing and optimizing cell- and virus-based assays • Provides consulting and research for risk assessments, and establishment of viral detection assays for raw materials, cell and viral banks, lot release, and optimizing processes for viral inactivation or removal • Author and reviewer for reference virology texts • Ph.D. in Virology.

Director, Viral Clearance
Over 17 years’ of biosafety and bioprocessing expertise • Oversees the Viral Clearance Department and has served as Study Director for more than 500 viral clearance studies • Technical and regulatory advisor for design of viral clearance studies, including client scale-down and resin-cycling processes • Manages programs to improve growth, purification and QC analyses of viruses, and the development of assays for new emerging viruses • M.S. in Biological Sciences.

Associate Director, Viral Clearance
Over 10 years’ experience in viral clearance; has directed laboratory operations on hundreds of studies • Responsible for overall conduct of viral clearance studies, design of studies with clients, generation/testing of samples, and creation of final reports • Developed Certificate of Analysis/Release program for stock virus production; oversees qualifications/validations of new virus strains • B.S. in Biology.

Senior Director, Operations
Over 11 years’ experience in managing viral clearance programs and virus safety testing for cell line or lot release – from early phase development through commercial approval • Directs overall operations for the Philadelphia facility • Oversees project management staff, which works closely with clients, scientists and regulatory professionals to design custom programs for biosafety development and testing • M.S. in Microbiology.

Director, Business Development
Over 18 years’ experience with biosafety evaluation programs for biotherapeutics • Provides regulatory/consulting information for clients, including risk assessments of biotherapeutic processes/products, and custom viral and other biosafety testing programs • Business development experience with clinical research and member in good standing of the Bar in PA and NJ • Ph.D. in Biological Sciences (Microbiology).