FDA’s JumpStart program: Supporting drug innovation

By: Lilliam Rosario, Ph.D.

When it comes to public health, the U.S. Department of Health and Human Services (HHS) recognizes that innovation drives success.

Lilliam RosarioAs part of the HHS Innovates program, HHS Secretary Sylvia Mathews Burwell and Deputy Secretary Bill Corr acknowledge excellence in the field with the Secretary’s Pick Award, an honor that identifies and celebrates internal innovation by HHS employees.

I’m proud that this year, the winner of one of three Secretary’s Pick Awards was the Food and Drug Administration’s Office of Computational Science (OCS), part of the Office of Translational Sciences (OTS) in the agency’s Center for Drug Evaluation and Research (CDER). OCS received the award for its work in developing CDER’s JumpStart program, an innovative initiative dedicated to enhancing the efficiency of CDER’s new drug development and review process.

The JumpStart program provides CDER’s new drug review teams with clinical trial data analyses early in the review process when they assess quality, data composition, exploratory analyses, and tools for the analyses. It gives the reviewers a “jump start” on their review providing the information on the quality of the submission as well as analyses to support an effective and efficient evaluation of the medical product submission. You can learn more about JumpStart here. 

Our congratulations to the two other Secretary’s Pick Award recipients, the “Breast Cancer Startup Challenge,” led by the National Cancer Institute, and “Whole Genome Sequencing: Future of Food Safety,” led by the Centers for Disease Control and Prevention. It is a great honor to be recognized side by side with these two innovative programs!

We are proud of the team effort involved in making the JumpStart program a success, and look forward to continued efforts and innovative actions that will help bring safe, effective, and high quality new drug therapies to the American public as efficiently as possible.

For more information on HHS Innovates, visit HHS Innovates Celebrates 7th Round of Innovations!

Lilliam Rosario, Ph.D., is Director, Office of Computational Science, Office of Translational Sciences, at FDA’s Center for Drug Evaluation and Research

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