Case Study

Successful Submission Of A Complex NDA For A Breakthrough Therapy- Designated Product

By Genna Kingon, Ph.D., RAC, Associate Director, Regulatory Strategy

Gears workflow process management

A Sponsor with whom we have a long-standing relationship asked our regulatory and biostatistical experts to lead the NDA submission efforts for their breakthrough therapy designed product. The Rho team provided cross-functional project management, biostatistical and programming support, and regulatory authoring. This included collaborating on the integration strategy, executing database integration and providing authorship of key modules for the program, which included 18 clinical studies (11 phase 1, three phase 2, and four phase 3), and providing analysis and discussion on 12 supportive studies consisting of formulations for different indications..

The Challenge

Keeping the NDA submission on time despite delays in the phase 3 program database locks.

Months after agreement on the overall NDA submission timeline, delays in the phase 3 studies’ database locks occurred. Once the databases were locked for the double-blind portion of the second pivotal registration study, the open-label extension portion of the 2 pivotal studies, and the final open-label phase 3 study, the Rho team had to strategically plan the timing of medical coding, data integration, and regulatory authoring to stay on the target NDA submission timeline. To guarantee the submission met the agreed upon timeline, we implemented a series of approaches and activities, which are outlined below.

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