Drug formulary looks to accelerate clinical trial start up

By Melissa Fassbender contact

- Last updated on GMT

(Image: iStock/JK1991)
(Image: iStock/JK1991)

Related tags: Clinical trial, Pre-clinical development

The “NCI Formulary” enables investigators to obtain investigational agents for testing in new preclinical or clinical studies.

The Formulary is a partnership between the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), as well as pharmaceutical and biotechnology companies.

Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Kyowa Hakko Kirin, Loxo Oncology, and Xcovery Holding Company LLC, are among the first six companies involved, which together offer fifteen targeted agents​ to the Formulary.

We hope to have double that number by the end of the year​,” Jason Cristofaro, J.D., Ph.D., Intellectual Property Program Manager, Office of the Director, Division of Cancer Treatment and Diagnosis, NCI, told us.

How it works

The Formulary​ enables the NCI to act as an intermediary between investigators, NCI-designated cancer centers, and pharmaceutical companies – streamlining access to pharmaceutical agents.

As such, Sherry Ansher, Ph.D., Associate Chief, Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, NCI, told us “there won’t be a need for negotiations between the pharmaceutical company and cancer center​.”

Because we already have these creatives in place, as well as the template, that it should really speed up the process … because a lot of things can go on in parallel​,” Ansher explained.

After receiving company approval, investigators will be able to attain the available agents for testing in new preclinical or clinical studies.

According to Cristofaro, negotiations for these agreements and getting the studies up and running can normally take more than a year. “We hope to cut that process down to around six months​,” he said.

However, “the real strength of the program will allow investigators to initiate combination studies​,” added Cristofaro – as the program also allows investigators to conduct combination studies of formulary agents from different companies.

The NCI is currently in the process of negotiating more agreements to create a “larger menu​” of investigational agents.

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