The NCI SBIR Peer Learning and Networking (PLAN) webinar series provides an interactive forum for oncology biotech startups to hear best practices from NCI SBIR standout companies who have achieved success in product development and technology commercialization.
As part of each webinar, participating small businesses share expertise on a specific topic and highlight resources that can support others on their journey from lab to market. The PLAN webinar is delivered in a two-part format: (1) short, pre-recorded panelist presentations that introduce key concepts and experiences, followed by (2) a live virtual Q&A session where attendees can engage directly with speakers.
Part I. Video Recording:
Watch short ~10-minute panelist presentations in advance of the webinar to gain background on the topic and prepare questions.
Part II. Live Virtual Q&A Session:
Join a live interactive session to ask your questions and hear directly from the panelists and the moderating NCI SBIR program director.
This session will focus on how companies can effectively navigate FDA pre-submission meetings, including INTERACT, Pre-IND, and Q-Sub. Panelists will share practical, experience-based insights on when to engage FDA, how to prepare high-quality briefing materials, and how to apply feedback to inform development strategy, reduce regulatory risk, and advance toward key milestones. The discussion will highlight real-world lessons across drug and device programs to help companies make more informed regulatory decisions.
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
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
NIH SEED EIRs
For Drugs and Biologics
Watch this video to learn about:
• FDA Guidance Early in Therapeutic Development
• Overview of INTERACT and pre-IND meetings at the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER)
• Preparation Tips for INTERACT and Pre-IND Briefing Packages
• Resources at CBER and CDER
For Devices/Diagnostics
Watch this video to learn about:
• Key interaction pathways for medical devices at the FDA
• Overview of the Q-Submission (Q-Sub) program and Pre-Sub meetings at the Center for Devices and Radiological Health (CDRH)
• Preparation Tips for Pre-Submission Meeting
• Resources at CDRH
Previous PLAN Webinars
To access content from previous PLAN series, click on the link below:
- Biotech Funding & Entrepreneurial Support in Emerging States
- CEO Perspectives on Launching & Growing Biotech Start-Ups
- How to Write a Strong Commercialization Plan
- Keys to a Successful IND Filing
- First Steps for Starting a Small Business
- Implementing a Quality Management System (QMS)
- How to Write a Good Specific Aims Page
If you have topic suggestions for the PLAN series, please email us at ncisbir@mail.nih.gov.