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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 - Key to a Successful Investigational New Drug (IND) Filing

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 - Key to a Successful Investigational New Drug (IND) Filing

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 - Key to a Successful Investigational New Drug (IND) Filing

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 - Key to a Successful Investigational New Drug (IND) Filing

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

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