Greenleaf Health assisted a mid-sized pharmaceutical company in developing a regulatory strategy to address safety and trial conduct issues in the phase 3 program for their lead compound for cardiovascular disease. During phase 3 trials, the client identified a consequential safety event and sought Greenleaf’s guidance on both addressing the safety event in the context of the trial and properly reporting the event to the FDA without impeding development. In addition, the client required Greenleaf’s compliance expertise to address issues at certain trial sites.
The Greenleaf Drug and Biological Products Team developed a regulatory communications strategy that emphasized the need for immediate transparency with the FDA regarding the safety event, while also allowing the client to establish the context and conditions in which the event occurred. Throughout the phase 3 program, the Greenleaf team continued to provide strategic guidance, conducting thorough reviews and edits of the client’s formal and informal communications with the Agency as well as preparing the client for their Type B pre-NDA meeting. Meanwhile, to address the trial conduct issues, Greenleaf’s compliance experts conducted good clinical practices (GCP) reviews of relevant sites, ensuring that the integrity of the development program was maintained.
With Greenleaf’s support, the client was able to resolve the safety and GCP issues and preserve the integrity and momentum of their phase 3 program. The client’s lead compound received a first-cycle approval — the first FDA marketing approval for the client.