Workshop B – Federal Government Market Access: A Guide to Successfully Selling New Drug Products to the “Big Four” Agencies
Cheryl Nagowski
Vice President, Federal Markets
D2 Consulting, LLC
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