The Scientific Computing Advocates Behind FDA’s Tech Transformation

A board that aims to bridge the needs of health and science regulators with scientific computing infrastructure at the Food and Drug Administration is a key component in fulfilling the agency’s upcoming overall tech modernization goals.

FDA is taking a unified, enterprise approach to data and technology modernization. As part of its 2022 fiscal year budget, the agency requested additional funds to modernize and prioritize its data infrastructure by using current technology innovations to more efficiently gather data, quickly identify and combat data challenges, and improve review times for medical products.

It’s clear that technology for public health agencies such as the FDA needs to involve close consideration of scientific missions, which is where the Scientific Computing Board comes into play.

The board’s key priorities include: recruiting and retaining scientific computing staff, improving and simplifying transfer of big data in and outside of the FDA, and streamlining FDA’s internal processes from the acquisition of scientific hardware, software and services.

The board accomplishes this by bringing together industry, academia, scientists and internal centers to collaborate on new ideas and facilitate discussion across the agency, board Co-Chair Errol Strain told GovernmentCIO Media & Research.

“We work as scientists across centers, trying to make sure the needs of both the research and review scientists are represented in these higher level IT discussions,” Strain said. “Part of the role of the board is the cross-center collaborations and knowledge of resources and activities across centers.”

Plus, not only does the group identify technology needs, but also helps teams and stakeholders understand the risks involved, Co-Chair Mark Walderhaug told GovernmentCIO Media & Research.

“We not only have to communicate the benefits to security and our IT management system, but also the risks so that we can appropriately evaluate new technology,” Walderhaug said. “This idea of security has always been one of the important components that can slow things down, but at the same time, I think the concerns are valid, and we work with [stakeholders] on those issues.”

Some of the group’s activities includes ensuring FDA’s centers have high-performance work stations that are approved for connections to instruments, supporting transfer of large data sets, acquiring scientific software and delivering IT resources to ensure the divisions can be effective in research and review processes.

“One example would be if our Center for Tobacco Products puts in place a wonderful mobile application for data collection, how can we leverage that across other centers … to solve large data problems?” Strain said.

For example, Raju Rayavarapu, technical information specialist at the center, has been developing a comprehensive inventory of existing FDA infrastructure to streamline workflows. Rayavarapu explained during FDA’s Scientific Computing Days last week that his team then will identify and develop a storage location for the infrastructure inventory and create protocols for future infrastructure needs.

The end goal of this project is to streamline access to databases, software and services to simplify workloads and tasks. Rayavarapu’s team surveyed members of FDA’s Data Science and Software Development Working Group to gain a holistic understanding of the needs of the community and develop an internal directory of experts within the working group to then be able to share solutions.

“If a request came in to use a specific tool [we would have] somebody with expertise that we could point people towards,” Rayavarapu said. “We will be using the platform to collect and analyze sentiments to identify successes and improvement and enhancement opportunities … then move them to other platforms or services or software that exists.”

The board is also implementing new technology tools to foster cross-center collaboration and enact transformational change. One priority is advancing what the co-chairs call the “scientific network,” which is the integration of improved IT systems so scientists can easily connect scientific instruments to a computer network. This ensures the instrument can really only receive or connect to specific shares or resources.

“We’re trying to figure out ways we can keep doing good science inside a continually changing IT environment, via security, via other factors that are changing for good reason, but just making sure we stay current with the science,” Strain said.

Moving forward, the board will continue to collaborate with FDA’s centers to identify, then fill, technology gaps. To do this, Walderhaug said the group looks to enhance training programs to expand skill sets and understanding of new technologies. It will also focus on hiring and retaining its workforce.

“A key thing that we want to do is to get the right people in, to hire recent graduates from universities that are pioneering the new technology, and provide these new fellows with the heart public health problems and the resources to discover solutions,” Walderhaug said.

Walderhaug also sees potential in quantum computing, natural language processing and evolving database technology, which provides an opportunity for better knowledge management. The board will also is eyeing modeling and simulation tools that would prepare FDA for future public health challenges.