“When it comes to public health,” says Lilliam Rosario, director, Office of Computational Science, Office of Translational Sciences, at FDA’s CDER, “the U.S. Department of Health and Human Services (HHS) recognizes that innovation drives success.” As part of the HHS Innovates program, explains Rosario, in her recent FDAVoice blog entry, HHS Secretary Sylvia Mathews Burwell and Deputy Secretary Bill Corr acknowledge excellence in the field with the “Secretary’s Pick” Award, an honor, she says, 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” Rosario says, “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.”
According to FDA, the JumpStart program provides CDER’s new drug review teams with clinical trial data analyses early in the review process at the time 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,” explains Rosario.
“We are proud of the team effort involved in making the JumpStart program a success, Rosario says, “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.”