Project Summary

The U.S. Food and Drug Administration has articulated its vision for a next-generation data system that serves as the central clearing house for ingredients in medical products. Meanwhile, the National Center for Translational Sciences at NIH has created its own substance tracking system, GINAS, to facilitate research efforts. Working with the FDA, this team will pilot deployment of the software into the FDA environment.

Project Team

Team Members
Noel Southall (Project Lead), NIH
Lawrence Callahan, FDA
Dac-Trung Nguyen, NIH
Tyler Peryea, NIH
Frank Switzer, FDA
Timothy Sheils, NIH

Project Lead’s Supervisor
Ajit Jadhav, Director of Probe Development, Division of Pre-Clinical Innovation, National Center for Advancing Translational Sciences, NIH

Technical Advisor 
Kurt Heisler, Research Analyst, ACF


Project Details

FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

The National Center for Advancing Translational Sciences (NCATS) is the newest of 27 Institutes and Centers (ICs) at the National Institutes of Health (NIH). This Center was established in December 2011 to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster.

It is a daunting challenge to track and organize all of the ingredient information that FDA is responsible for, including chemicals, polymers, proteins, and botanicals, because the definitions for these ingredients are so complex. Without such a system, ingredient data related to drug safety, drug labeling, and drug recalls is left segmented and unstandardized, and may be called by many different names using different definitions.

The FDA has articulated its strategy for handling these ingredients based on fundamental science rather than naming conventions. To implement this strategy, FDA approached NCATS about repurposing software that existed at NCATS to support FDA’s needs.

Developing the technical implementation required to meet FDA’s standards was challenging, but navigating the regulatory landscape to deploy the application proved to be equally daunting.  At the start of the HHS Ignite process we had prototype software, and FDA colleagues who were eager to use it, but no simple mechanism to let them. In the last 3 months, the increased visibility and support of HHS Ignite has led to a full working software deployment on the FDA servers, and we are now deeply involved in integrating it with their existing infrastructure.

We now have a fully functional deployment at the FDA, with end-users already employing it to save considerable daily time and effort. Due to the support and visibility of HHS Ignite, FDA has found collaborators willing to invest in this solution, working across regulatory environments, across research institutions, and across the world. There is a common interest in maintaining the best in ingredient data, and an opportunity to leverage community expertise to globally coordinate the exchange of ingredient data to significantly improve health care delivery, the proper use of medications, and the management of risks involved in their use.


Background

HHS Ignite is an “incubator for new ideas” run out of the HHS IDEA Lab. Selected teams are introduced to startup methodologies for problem identification and project implementation. In the entrepreneurial spirit, Ignite projects are iterative, their impacts measurable, and their solutions scalable. This is one of 11 projects in Ignite’s second round which began on June 9, 2014 and goes until mid-September 2014.