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NCI SBIR Peer Learning and Networking (PLAN) April 30 Webinar

NCI SBIR Peer Learning and Networking (PLAN) April 30 Webinar image showing Navigating FDA Pre-Submission Meetings: INTERACT, Pre-IND, and Q-Sub Explained title and date and time of webinar which are Thursday April 30 at 2 pm ET

April 30, 2026 | 2:00 PM – 3:30 PM

Virtual

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Are you looking for insight on how to approach the FDA pre-submission process? Join us on Thursday, April 30, 2026 from 2:00 pm to 3:30 pm ET for the upcoming NCI SBIR Peer Learning and Networking (PLAN) webinar “Navigating FDA Pre-Submission Meetings: INTERACT, Pre-IND, and Q-Sub Explained”.

Speakers from NCI SBIR-funded startups and NIH SEED Entrepreneurs in Residence will share advice on determining the right timing for FDA engagement, preparing effective briefing materials, and using FDA feedback to shape development strategy, reduce risk, and support fundraising and commercialization.

Additional topics to be covered include:
•    Differences across drug, biologic, and device regulatory pathways
•    When to engage FDA across INTERACT, Pre-IND, and Q-Sub pathways
•    Preparing effective briefing packages and questions
•    Using FDA feedback to de-risk development and inform strategy
•    Leveraging FDA engagement to support fundraising and SBIR applications

Watch the recording here.

The 2-part PLAN webinar format consists of (1) watching short, pre-recorded videos from the panel speakers to prime attendees with topic-related content and (2) a live virtual Q&A panel session where attendees can ask questions in real-time.

Explore the NCI SBIR PLAN webinar series to discover best practices to incorporate along your commercialization journey. For more information, please contact NCI SBIR Program Director William Bozza at william.bozza@nih.gov.

Cordance Medical

Slide with PLAN webinar title and Cordance Medical.

Watch this video to learn about:

  • Navigating device regulatory pathways
  • Sequencing Q-Subs for maximum impact
  • Using Q-Subs to shape IDE and clinical strategy
  • Breakthrough Device Designation strategy
  • Leveraging the TAP program

Myosin Therapeutics

Slide with PLAN webinar title and Myosin Therapeutics.

Watch this video to learn about:

  • Timing your Pre-IND meeting
  • Building an effective Pre-IND briefing book
  • Key questions to ask at Pre-IND
  • Using regulatory consultants effectively
  • Orphan Drug and Fast Track designation strategy

Vaxiion Therapeutics, Inc.

Watch this video to learn about:

  • Novel CBER-regulated modalities
     
  • How INTERACT meetings can de-risk development
  • The right stage for engaging in Pre-IND meetings
  • Leveraging FDA engagement to support fundraising
  • Building regulatory strategy as a lean startup
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