35 years of line and senior management of R&D in companies – large, medium, small, startup and incubators
R&D Champion and/or Project Leader/co-Leader through phases from preclinical R&D and entry to Phase 1 to licensure, including vaccines that became commercialized in US, EU & developed countries (current annual sales >$8.0B), in particular human papilloma virus (Gardasil®), rotavirus (RotaTeq®), hepatitis B (Recombivax HB®), Haemophilus influenzae type b (PedvaxHIB®) and varicella (VARIVAX®) vaccines.
Led R&D of other candidate vaccines, including Pneumococcal, Meningococcal, Influenza, MMRV, H. pylori, Group A & Group B Streptococcus, Cholera, S. typhi, and Enterotoxigenic E. coli.
Led development of therapeutic biologic products (fibroblast growth factor; toxin fusion protein for cancer; monoclonal antibodies for anti-adhesin, HIV, autoimmunity, and Alzheimer’s disease).
Brought 8 product candidates from preclinical into clinical studies as Project Leader.
Therapeutic fields of experience for biologics and SMCs include infectious diseases, immunology, inflammation, autoimmunity, oncology, metabolism, CNS.
Responsible for Merck’s vaccine research, and co-chaired development collaborations for pediatric combination vaccines with Pasteur-Merieux-Connaught (Sanofi Pasteur) and CSL.
Directed vaccine R&D programs at Astra Research and Avant.
Starting from empty building, designed and directed set up of vaccine and biologics development subsidiary at BioChem Pharma that continued into Shire & ID Biomedical, and led development programs. Served as Site General Manager. Set up GMP Pilot Plant and produced product for clinical studies. Developed and secured $9.5M NIH-NIAID grant for cell-culture Influenza vaccine.
Line management experience for groups up to 100 staff members.
Technical expertise and line management responsibility in all areas of research & development production & evaluation of biologic products and evaluation of SMCs – including preclinical, process, analytical, production, quality, regulatory, clinical, project management and strategy.
Extensive experience at strategic and technical levels in evaluating new project opportunities for biologics & SMCs and developing project plans