How Drugs Get on the Pipeline

The Drug Development Pipeline features an extensive list of drugs that are in development or approved for treating cystic fibrosis. For a drug or program to be shown on the pipeline, it must meet certain conditions.

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The Drug Development Pipeline shows three main categories of drugs — those that are in preclinical development, clinical trials, or approved for use.

The image contains a screenshot of the top of the Drug Development Pipeline page.

 

Preclinical development refers to laboratory testing that is done before a drug is tested in people in clinical trials. The Cystic Fibrosis Foundation lists companies that are developing the drugs instead of specific drugs at this stage, as the company sponsor may not have chosen which drug to move into clinical trials.

To be listed as a preclinical program on the pipeline, a program must have received funding from the Foundation committing at least $2 million or have received funding that includes payments that depend on the drug reaching clinical trials.

In order for drugs to be listed in Phases 1-3 on the pipeline, they need to be tested within the CF Foundation-funded Therapeutics Development Network (TDN) and/or be funded directly by the Foundation. Some programs may conduct initial Phase 1 safety studies in healthy volunteers before a drug is studied in people with CF. Specific information about a drug's status can be found by clicking on the drug name from the main pipeline page.

Programs need to demonstrate progress to remain on the pipeline. At each stage of research, the data must support the decision to move forward with further study. For preclinical programs, this means showing proof in the lab that a new drug or technology could work. For clinical trials, the results must indicate that a drug is safe and potentially effective in people with CF.

When a program is no longer advancing forward, it moves into the discontinued section of the pipeline. (Click on the “discontinued” status box to see discontinued drugs displayed in gray.) Programs may be discontinued in any of the following scenarios:

  • The research program was stopped early.
  • The funded research was completed, but there are no current plans to conduct further research.
  • A clinical trial was completed through the TDN, but there are no current plans to conduct further trials within CF.

Not every experimental drug or technology will result in an approved therapy for people with CF; failure is a natural part of the drug development process. That is why we continue to fund a robust pipeline of programs that tackle CF from every angle.

Medical devices such as pumps, nebulizers, and airway clearance devices are not listed on the pipeline.

To advance drug development and a search for a cure, the Cystic Fibrosis Foundation has contracts with several companies to help fund the development of potential treatments and/or cures for cystic fibrosis. Pursuant to these contracts, the Foundation may receive milestone based payments, equity interests, royalties on the net sales of therapies, and/or other forms of consideration. Resulting revenue received by the Foundation is used in support of our mission. 

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Topics
Drug Pipeline | Research
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