Case Study: A Race to Approval
Drug development is a marathon, not a sprint. But, as you are approaching your marketing application and know a competitor is close on your heels, those last few miles require a faster pace and, when the race is on, meeting or beating timelines is a necessity. Thoughtful preparation and execution of your program will set you up for success and having a partner you can rely on as you approach the finish line gives you a better chance of crossing first.
This is exactly what we were able to do by supporting one of our pharma partners, as they were trying to submit their NDA prior to a competitor. Nine months before submission, we were asked to support the ISS and ISE for a program containing approximately 30 clinical trials. Our scope was to provide data remediation of the study-level submission packages; create and finalize the ISS and ISE SAPs; get FDA buy-in for the approach, given not all studies were run by the Sponsor; and deliver all statistical deliverables for the ISS and ISE.
Throughout the nine months, our scope continued to increase as the Sponsor saw our quality and was comfortable with our work, at one point stating that they “trusted Rho more than ourselves.” With thousands of subjects’ data in the ISS and over 500 ISS displays being requested, Rho worked with the Sponsor to strategize the best approach to meet their needs and the FDA’s requests, while still meeting their submissions timeline. This included supporting the Sponsor with interpreting the FDA comments into a plan that was pragmatic and executable and helping narrow the focus of analysis to points most salient to the review. Our collaboration was a success and our Sponsor was able to submit on-time and win the race to submission, with technical acceptance being confirmed within the 60-day filing period.