The regulatory affairs industry has gone through dramatic changes due to the advent of electronic submissions and approval processes from the FDA. It’s more important than ever to have efficient regulatory processes in place to bring cutting - edge medical a dvancements to the public as quickly and efficiently as possible.

On September 23rd, DXC assembled regulatory affairs leaders to speak at Digitizing Life Sciences: Your Roadmap for Transforming Regulatory Affair s, an interactive panel discussion. The for ward - focused conversation was all about the future of drug approval and how AI and ML will impact drugs getting to market.

Here’s a taste of what our audience took away from the conversation:

1. Don’t be behind the curve

Adam Harris of Target Health shared that he was the first person at his company to electronically file a regulatory approval with the FDA two decades ago.

“I like looking much further down the road, seeing what’s coming, and making the changes now...don’t be behind the curve,” he said, refl ecting on this important moment in his career.

2. Focus on the data

Susant Malikr of AWS spoke extensively about minimizing approval cycles by maximizing your team’s data collection and analysis.

He encouraged attendees to think about the industries curr ently building robust, data - driven systems. Look at the data to help you “gather and analyze... so that you can generate innovative regulative strategies [and]increase the probability of success for your submission cycles.”

3. Covid - 19 has changed regulatory a pproval

Jake Doran of Bausch Health brought up the speed of the COVID - 19 vaccine approval process and how it will change expectations for other biopharma regulatory approvals in the future.

“This is miraculous how fast a vaccine has come around... it is going to turn things upside down... there are going to have to be ways to get things to market faster and I do think that’s gonna have to be an embrace around data,” he said.

4. Use AI to speed up regulatory approval

GAyse Baker of Almatica shared that she thinks global authorities will need to converge upon the right technology to create better, faster approval applications. All of the panelists agreed that the industry needs to embrace AI and ML to better utilize data, not in r eplacement of human brain power, but in supplementation.

5. Implement metadata tagging to improve efficiency

“Metadata tagging, and sharing of the data across the different systems within the enterprise as well as outside [the organization]is key,” claimed Manjunath Shanabag of DXC.

Efficient meta - data tagging helps an application stay organized, which is key when dealing with the vast amounts of data required for a regulatory application.

Want to hear more? Check out the full panel discussion and more topic - based video clips from the event by filling out the form at the top of this page.