Tech’s Outlook to Advance New, Generic Drug Development

Offices within the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) are developing new tools to advance drug development and evaluation processes of generic and new medicines.

CDER’s Office of Generic Drugs is developing a new data and text analysis tool, called Bioequivalence Assessment Mate (BEAM), to address the need for more efficient, consistent and high-quality bioequivalence assessments — or review and approval of generic drugs.

FDA considers two drugs to be bioequivalent when “the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.”

The current bioequivalence assessment process includes four stages: straightforward information retrieval, information retrieval based on semantic understanding, information summarization and reasoning, said Dr. Meng Hu, staff fellow with CDER, at FDA’s Science Forum last week.

Since information retrieval and data preparation are labor-intensive processes, emerging technologies like artificial intelligence, data analytics tools and natural language processing have the potential to expedite data collection and preparation within the assessment process, Hu said.

BEAM has only recently entered its pilot stage, which includes near-term goals of identifying labor-intensive work during a typical bioequivalence review and applying the tool to automate various data functions and provide user-friendly interfaces and reports.

Future phases will include near-term and long-term goals, including leveraging natural language processing to realize semantic information retrieval and text summarization, and generating draft comments and conclusions, Hu said.

“The next steps will certainly save a lot of time for our reviewers,” Hu added.

CDER is also exploring how emerging technologies can streamline drug development overall.

Under a new pilot program called Innovative Science and Technology Approaches for New Drugs (ISTAND), CDER’s Office of New Drugs is seeing how technology can encourage development of new drug development tools that all outside the scope of current programs but may still be beneficial in the long run.

“We’re trying to bring forward innovation within drug development as a tool, but what we’ve found over the years … is that there are many different novel technologies, but they didn’t have a home,” said Dr. Christopher Leptak, CDER’s Office of New Drug’s regulatory science program director, at the forum.

The tools could ultimately help enable remote trials, advance understanding of drugs and leverage more digital health technologies.

“There’s an interest in bringing forward these novel technologies for many different reasons to provide supplemental information,” Leptak said. “In digital health, there’s the use of AI-based algorithms to evaluate patients, develop novel endpoints and inform study design.”

The program is working to centralize the conversation around drug development by creating a shared communal knowledge within FDA’s workforce and bring forward standardized recommendations to assist with external parties.

“By centralizing this, it also reduces the workload and expectations for individual groups because we can help to simplify and augment the conversation. Hopefully that will be able to speed the decision-making process,” Leptak said.