“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.”
According the FDA, the JumpStart service is modernizing the drug review process because medical reviewers are using it to quickly and thoroughly assess data from drug clinical trials, ensuring safe and effective products are approved for public use.
What is JumpStart?
JumpStart runs a series of drug clinical trial data analyses early in the review process to assess data composition, quality, analyses options, and tools for the analyses, so reviewers better understand the data and have the information to conduct an effective evaluation of the drug submission.
JumpStart, says FDA, provides these data findings to reviewers within two weeks of the receipt of a new submission, giving reviewers time to clarify issues or make requests of the organizations developing the drug before proceeding in the review process. JumpStart also provides data analyses that highlight areas of concern and may warrant further attention.
JumpStart is transforming the scientific regulatory review process in several ways says FDA:
• The JumpStart data fitness assessment and exploratory safety analyses are improving the review process for getting safe and effective drug products to the market.
• The initial assessment on data fitness gives reviewers and sponsors the opportunity to address potential issues early on in the review cycle and avoid delays.
• By providing targeted exploratory safety analysis, JumpStart enhances the efficiency of safety signal identification and risk analysis. This has a direct impact on patients who expect the approval of safe and effective products that are appropriately labeled for marketing.
• JumpStart work session discussions encourage collaboration and communication among different disciplines and informatics experts. By building and enhancing these ties with one another, reviewers and informatics experts can improve and speed communication with sponsors to resolve data issues or questions.
• JumpStart provides an opportunity for clinical reviewers to take advantage of modern tools and technologies, and expose more people to technical innovation.
“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.”