FDA officials see benefits of pandemic-driven digitalization

FDA’s greater reliance on digital tools during the pandemic showed the agency how these tools could be used to expand the size and diversity of clinical trials, improve post-approval monitoring of drugs and enhance the use of real-world data, FDA officials said yesterday at the BIO International Conference.

The need to harmonize with other regulators around the globe is another pandemic lesson that was mentioned in a wide-ranging “FDA Town Hall” discussion with Patrizia Cavazzoni, Deputy Director for Operations of the FDA Center for Drug Evaluation and Research (CDER), and Peter Marks, Director of the FDA Center for Biologics Evaluation and Research (CBER), interviewed by Cartier Esham, Chief Scientific Officer of the Biotechnology Innovation Organization (BIO).

The FDA’s increased use of remote working during the pandemic meant increased investigation into tools needed for virtual clinical trials, according to Mark. He said he hoped more development in this area would allow a larger population to participate in the trials and could facilitate more diverse trials that include communities that have been neglected.

Another digital issue is the need to make the best use of real-world data, which can facilitate a faster and more thorough approval process for drugs. Mark said hefty data transfers are now a standard part of applications for approval.

“People are starting to submit really large amounts of data. In the current system they’re having to submit on hard drives, because they are submitting terabytes of data,” Marks said. He added that the FDA needs to expand the infrastructure to accept this data, as well as the human capacity to analyze the data.

Cartier said the proposed “PDUFA VII” legislation that will guide the FDA for the next few years addresses the Sentinel System, FDA’s digital tool for monitoring the safety of drugs after they have been approved. During the pandemic it was an essential part of collecting information on the COVID-19 vaccines that received FDA Emergency Use Authorization, Marks and Cavazzoni noted. They said they are hoping to expand the way they use the Sentinel System, to allow for more detailed patient feedback, faster reaction to problems and better monitoring of special situations and patients, such as pregnant women and their children.

Global harmonization of drug regulators

On harmonization with other regulatory authorities, both officials said the pandemic taught the FDA about the need to cooperate with the World Health Organization, the European Medical Agency and regulators in other countries to speed approval of drugs. Marks said harmonization could facilitate development of drugs for rare diseases, as the ability to serve a global patient population after only one regulatory approval process could make development of rare-disease drugs commercially viable.

Still, Marks cautioned that, especially when it comes to complex new gene therapies, other regulators need to build capacity to understand the science. They also need to agree on a global set of standards for approval. “There’s international education needed. There’s international convergence. And then we can have international harmonization,” he said.

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