Workshop B – Federal Government Market Access: A Guide to Successfully Selling New Drug Products to the “Big Four” Agencies

Jun 18, 2024 3:00pm – 05:00 PM

Cheryl Middleton
Independent Consultant

Drug manufacturers constantly strive to successfully sell new drugs to the US Government “Big Four” agencies. This post-conference workshop will explore what drug manufacturers need to know when trying to sell new drugs/drug products. Our speakers will walk you through the application process by using mock scenarios. Points of discussion include:

  • Examining the procedure for New Drug Applications (NDA) and understanding why this is important for Big Four contracting
    • Where can drug manufacturers look to find this info?
    • What is the timeline?
    • How should drug manufacturers submit NDAs
  • Assessing best practices for compiling and data storage practices
    • What kind of substantiation is needed?
    • What is considered sufficient data?
  • Reviewing the medication needs of “Big Four” agencies
    • Does your new product qualify?
    • What types of medications are in demand?
  • Understanding how to meet new drug qualifications
  • Identifying who to contact at the “Big Four” agencies about new drug products:
      • VA
      • DoD
      • Coast Guard
      • PHS
    • Where can manufacturers go to find this info?
    • Is there a specific person or team to reach out to?
      • What happens when there is turnover in Government agencies – ow do manufacturers now know who to go speak to?
  • Summarizing common reasons that US Government agencies use when declining NDAs
    • Understanding how to revise and revamp old rejected applications
      • Why was it rejected?
  • Examining mock scenarios to highlight key challenges in the application process