Keys to a Successful IND Filing

This NCI SBIR PLAN Webinar Series focuses on: Keys to a Successful IND Filing

When taking steps to commercialize the therapeutics, the company's clinical study sponsor must submit an Investigational New Drug Application (IND) to the Food and Drug Administration (FDA) in order to request permission to administer an experimental medication or biological product to human subjects. In the latest installment of this PLAN webinar series, a panel of SBIR/STTR awardees covers the key considerations when filing an IND application for your biotech innovation with the FDA.

The topics discussed include:

• Considerations for hiring regulatory consultants
• Pre-IND meetings
• Utilizing SBIR funds toward IND-enabling studies
• IND pitfalls
• Resources for process & product development
• Clinical Protocols

Please find advice videos from each panelist below.

	Linnaeus Therapeutics Watch video if interested in: Considerations for hiring regulatory consultants Clinical protocols Combining investigational product with FDA-approved product IND guidance documents
	Luminary Therapeutics Watch video if interested in: Utilizing SBIR funds toward IND-enabling studies  CAR-T cell therapies Resources for process & product development Pre-IND meetings
	Metaclipse Therapeutics Watch video if interested in: eCTD modules and electronic submission Personalized cancer vaccines In-house manufacturing INTERACT meetings and Pre-IND meetings IND pitfalls
	OncoC4 Watch video if interested in: Considerations for hiring regulatory consultants Tips for CRO/CDMO selection Toxicology studies Chemistry, Manufacturing, and Controls (CMC) Clinical site selection