Over 25 years of experience in infectious disease research and clinical development.
Directly contributed to multiple drug approval filings to the Food and Drug Administration [FDA], European Medicines Agency [EMA], As well as in China (cFDA) and Japan (PMDA).
Leading Presenter at 3 FDA Advisory Committee meetings for approval of new drugs (2) and review of prior drug safety and efficacy (1).
Global Clinical Leader for clinical development of anti-infective drugs at Bayer HealthCare (3 programs) including clinical strategy, operations and regulatory filings.
Leading role in final negotiations with the FDA and EMA for several anti-bacterial products.
Presenter at FDA, EMA, cFDA, and PMDA for clinical trial design and analysis.
Presenter and panelist at FDA workshops on various anti-bacterial development issues.
Managed 50+ person group of multidisciplinary scientists, including high throughput screening, fermentation, isolation and medicinal chemistry, molecular biology, microbiology, and pharmacology, and clinical microbiology in Drug Discovery.
Responsible for in-licensing evaluations of drug products, from preclinical through clinical stages, from corporate and academic sources. Contributed to the licensing of multiple products for different companies.
NIH/NIAID and grant Reviewer for Biodefense; session Chair for Biodefense contract review.
Has held positions of increasing responsibility at Abbott Labs, Cubist Pharmaceuticals, and Bayer HealthCare.
Worked in multiple fields, with focus on infectious diseases, but also experienced with diagnostics, and immunoscience.
Voting Member of the Clinical Laboratory Standards Institute for setting breakpoints and testing standards for antibacterial products 2012-2016.
Chairperson, Antimicrobial Chemotherapy Division, American Society for Microbiology, 2011 – 2014.
