• Biopharma/Biotech advanced research and development professional with 25+ years experience in vaccines, biologics and gene/cell therapy, including preclinical, clinical, manufacturing and business development.
• Lead discovery, preclinical development, manufacturing, process development and clinical development of novel vaccines, monoclonal antibodies, biotherapeutics and cell lines. Responsible for extensive pipeline of TB, HIV, Malaria, RSV, CMV, HPV, HCV, CHIKV, EBOV, Cancer and Biodefense vaccines and biotherapeutic products.
• Strong background in molecular biology, cell biology, bacteriology, virology, protein chemistry, bioinformatics and immunology.
• Highly experienced in R&D management, leading groups covering all aspects of product oriented biologics research, preclinical animal modeling, toxicology, assay development/validation, process and manufacturing development, regulatory and clinical development.
• Established, coordinated, and directed extensive successful biologics development collaborations with commercial (incl Merck, Otsuka, GSK, JNJ, Okairos, Themis, Emergent), academic (incl Harvard, JHU), and government partners (incl DoD, NIH, BARDA, Karolinska, IIBR). This includes the licensure of Mosquirix.
• Demonstrated track record of moving concept projects from discovery through all stages of development, including preclinical, manufacturing and clinical development through licensure/approval.
• Served on numerous cross functional teams covering all scientific and business functions of biotech/biopharma firms, including government and private financials.
• Demonstrated talent for technology evaluation.
• Won $500M IDIQ for manufacturing and clinical development of vaccines and therapeutics for the DoD and Pharma
• Served as senior advisor to the DoD on the development of the BPS/Merck ebola vaccine,
including licensure trials
• Served as senior advisor to the DoD on the launch of Ology Bioservices biomanufacturing facility and the development of monoclonal antibodies.
• Lead development and management of more than 200 programs.