Skip to main content
An official website of the United States government
Government Funding Lapse
Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.

The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.

Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Email

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

 

If you would like to reproduce some or all of this content, see Reuse of NCI Information for guidance about copyright and permissions. In the case of permitted digital reproduction, please credit the National Cancer Institute as the source and link to the original NCI product using the original product's title; e.g., “Keys to a Successful IND Filing was originally published by the National Cancer Institute.”

Email