NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

John Walker, MS

Practice Area Focus

  • Pharmaceuticals
  • Biologics
  • Combination Products
  • Monoclonal Antibodies
  • Regulatory Compliance
  • Clinical Development Strategy

Biography

Mr. Walker joined NDA Partners as an Expert Consultant in 2015. He has eighteen years of experience in pharmaceutical regulatory affairs including both US and global registrations, GCP/GMP compliance, and pharmaceutical sciences. Mr. Walker is proficient in both small molecule and biologic drug development and has experience in multiple therapeutic areas including inflammation, metabolic, cardiovascular, infectious diseases, and oncology. His expert services include developing global registration strategies as well as leading teams responsible for planning, managing, and preparing FDA briefing books, and functioning as the US Regulatory Lead and FDA liaison on client projects.

Mr. Walker held previous positions at Amgen, where he served as Director of Regulatory Affairs (Global Regulatory Leader), and at Pharmacia, where he held several positions including Associate Director of Global Regulatory Affairs, Senior GMP/GCP Compliance Specialist of Regulatory Affairs, and Quality Assurance Professional.