FDA

In late 2014, the FDA announced that, starting December 17, 2016, all new clinical and nonclinical studies must be submitted electronically and contain data in conformance with the standards specified in FDA’s Data Catalog. This is part of an effort to accelerate the regulatory review process.

At the time of this writing, that deadline is only nine months away. So, the big question looms: Are you 100% ready for FDA submission? Because when December 17th comes, any doubt you have may represent a risk of slowing down the review process. More importantly, you’ll be missing out on an opportunity to get your new drug to market faster than ever before.

Pinnacle 21 is pleased to announce that we’ve been awarded a renewed contract to provide software and services in ongoing support of the FDA’s DataFit program.

According to the FDA’s Center for Drug Evaluation and Research (CDER), which made the decision:

In the Beginning

It was late 2007. Mad Men was the hottest show on TV. The BlackBerry was still the most popular smartphone. Senator Barack Obama was securing his party’s nomination for the next presidential election. And a young clinical data exchange specialist named Max Kanevsky was contemplating the future of the biopharmaceutical industry.

During his tenure at Merck, Max had been responsible for integrating the company with many external partners (e.g., laboratories, CROs, joint ventures, technology providers), working with many non-standardized sources of data. Though the norm, gathering all that disparate data and mapping it into Merck’s internal standard was a huge challenge. When the Clinical Data Interchange Standards Consortium (CDISC) started to make headway in its mission to develop a global set of standards, it marked a new beginning. CDISC would eventually define the standards for the entire industry.

But Max wondered how sponsors would possibly manage such a sea-change. At the time, software options to help ensure a submission’s compliance with FDA business rules were limited. WebSDM offered limited performance and capabilities, at a price point that was prohibitive to many. Meanwhile, Max was helping Merck with its early manual implementations of CDISC standards, including LAB, ODM and SDTM, which were difficult and time consuming. And each new challenge provided an obstacle that could threaten FDA approval of any given drug. There had to be a better way. But what?

It was a long time coming. But, finally, on December 17, 2014, the FDA announced that applications must be submitted electronically, and that submissions will be required to contain study data in conformance with CDISC standards.

The industry has been given 24 months from the publication of the final guidance documents to comply. Not wanting to waste any precious time, Pinnacle 21 hosted two webinars — on January 7th and 8th, 2015 — to help guide you through the new processes.

There has been a lot of buzz about DataFit of late. The FDA announced it as a new project that will enable the organization to “effectively leverage standard data to advance the review process.” But this new project is more than ten years in the making.

You’ve probably heard of JumpStart by now. The FDA is describing it as a “service [that] is modernizing the drug review process.” But how, and why? And how can the pharmaceutical and biotech industries benefit from it?

One of the big drivers of this change was time. Currently, when the FDA receives a submission, reviewers spend up to 45 days just to assess the quality of that submission. They have to first churn through enormous files — some of which are gigabytes in size — to determine if the data quality and content are strong enough to support the review. Between the time spent by the FDA to conduct this “pre-review,” and the time spent by the submitting organization to fix these issues and resubmit, valuable months are often wasted.

Thanks to all who attended the first OpenCDISC Live Forum in Boston, MA!

This inaugural CDISC and FDA educational event was a resounding success. Topics covered included the challenges and opportunities presented by JumpStart, DataFit, and the modern FDA approval process.