Jeffrey D. Alder, Ph.D.

  • 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.

Contact information

cell: +1.607.238.6354