Woodcock Update on New Drugs Modernization Efforts
CDER director Janet Woodcock told the Food and Drug Law Institute’s annual meeting in Washington DC 5/2 that the Center has six active initiatives ongoing as part of its new drugs regulatory program modernization. These include integrated review for marketing applications, IND review management, and post-market safety management.
One of the most significant initiatives is CDER’s work on integrated review for marketing applications that has already started with three NDAs under the program, Woodcock said. It uses an “already-designed, streamlined issue-based integrated review process and a template for documentation that results in an integrated FDA assessment,” she said. The issue-based process is intended to foster an interdisciplinary collaboration for each issued identified. “The plan is not to produce those very long documents that we currently produce, but to produce one issue-based assessment that includes a benefit-risk analysis,” she explained.
Woodcock said CDER is developing a tracking tool to be utilized from pre-NDA through the end-of-review cycle, allowing for systematic tracking of review issues for the entire review team. “So when an application is filed, we will understand what issues have been identified already,” she said. And, CDER is adding new expertise roles to allow reviewers to focus on the science and regulatory aspects of the application. For example, Woodcock said clinical data scientists with advanced analytical skills have been hired to perform exploratory analyses to support a safety analysis, and the addition of medical editors has become popular at the Center. “I can’t tell you how many clinicians have said they don’t know how to manipulate a .pdf file or make a table which these experts can do in their sleep,” she told FDLI. The editors will also help manage the single document/assessment that is produced.
The integrated review also calls for various scoping working meetings with early involvement of leadership to discuss known benefit and risk issues, and joint assessment meetings focused on specific review issues, Woodcock said. “We have changed the cadence of the review,” she said, adding that CDER expects to be done with much of an assessment by the midpoint of the review timeline “so that we can spend much of the rest of time working on the label, any REMS or post-marketing commitments. I think that will be a big improvement, and we hope that by January we will have that done.”
The modernization effort, Woodcock continued, is also creating a standardized post-market drug safety framework that will include “cross-disciplinary, collaborative, science-focused assessments and information technology-enabled processes to enhance knowledge management and fit-for-purpose analytic tools to promote optimal evaluations. We need an overarching drug safe program that is able to respond to many threats to public health in a timely manner. We have that now, but a lot of it is too ad hoc because of all the different ways safety problems can enter the system and get dealt with.” She said soon CDER will begin implementing some of the steps, but overall this is longer term project.
Additionally, CDER’s Sentinel safety program is up for a remake and bid proposals are being accepted until 5/24. Woodcock said the new vision for Sentinel is looking at three or more associated centers. An operations center would coordinate the data partner network, infrastructure management and data curation, conduct regulatory analysis, and manage its fledgling real-world evidence generation test bed. An innovation center would coordinate methods development, data science and advanced analytics, she said. And, a community outreach center for community development.