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The 2025 Annual 505(b)(2) Platform Meeting

March 18, 2025
830am-12noon
at:
RSM Management
151 West 42nd Street, 19th Floor
New York, NY 10036

Demonstrating the Value: Exploring Alternative Development Pathways and Overcoming Reimbursement Challenges

The meeting will focus on “Demonstrating the Value: Exploring Alternative Development Pathways and Overcoming Reimbursement Challenges” and will include speakers and sessions geared towards value-added medicines with a particular focus on orphan/rare disease product development and reimbursement. We will release the speakers for each session shortly. 

8:30am-9am                     Continental Breakfast
9:00am-9:15am                Opening Remarks
9:15am-11:00am               
  • Keynote Speaker: Janet Woodcock, MD - Former Director of CDER and Former Acting Commissioner of FDA
    • Approving the needle not the haystack: Developing and disseminating policies aimed at encouraging regulatory and payer mechanisms that recognize the unique circumstances of rare conditions and treatments.
  • Session 1: Commercialization Begins at Concept: Learn from expert speakers in Product Development, Commercialization, and Market Access speak about the importance of market focused development and a comprehensive commercialization plan.  
  • Session 2: An Eye on the Prize: A multi perspective panel discussion on medicine access. The panel will explore the perspectives of manufacturers, patients and others in establishing product access. The discussion will surround known pitfalls and challenges in gaining access to get the right medicine to the right patient at the right time. Explore ways to avoid traditional and contemporary issues when moving along the product commercialization journey.
11:45am-12:00pm              Closing
This event has been sold out. Please try back again later for other meetings or become a member and receive notifications of the next meeting.

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