NCI, Drug Companies Unveil Effort Today To Speed Up Approval of Oncologic Drugs
Speed seems to be the theme these days when it comes to approval of medications. The first step is knocking down the obstacles that delay getting new, potentially life-saving medications to the market. That’s especially true in oncology.
As STAT reports, researchers who want to combine therapies made by two drug companies for use in a clinical trial must negotiate contracts with each company. A lot of details must be worked out, including data sharing and intellectual property rights.
To address that problem, the National Cancer Institute today announced a partnership with six drug companies that will allow scientists to more quickly and easily access data to conduct novel research. It’s part of Vice President Joe Biden’s cancer moonshot initiative.
The six drug companies involved are: Bristol-Myers Squibb, Eli Lilly, Genentech, Kyowa Kirin, Loxo Oncology, and Xcovery. They will add 15 therapies to the project. Organizers hope that a lot more drug companies will participate. In fact, that’s crucial to the effort’s success because there needs to be a lot more agents included than the initial 15. Other potential members of the new and hopefully growing coalition will be watching the initial stages closely, STAT reports.
George Demetri, a bone oncologist at the Dana-Farber Cancer Institute and member of the American Association for Cancer Research, tells STAT: “It’s got to work well, it’s got to work fast, it’s got to be frictionless.”
Getting the government involved seems like it could do a lot to speed the approval process. As Managed Care reported last October, clinical trials are becoming more challenging to conduct, as they must comply with often costly and inefficient federal and state regulatory requirements, according to researchers from several universities and institutions.
As we reported then, when federal and state governments take notice, it can become like the old E.F. Hutton commercial where everybody freezes. That’s because “institutions and sponsors often interpret these requirements conservatively and thereby add to the complexity and perceived (but often highly theoretical) risk of conducting clinical trials,” according to a report issued jointly last year by the American Society of Clinical Oncology and the Association of American Cancer Institutes.