Artificial Intelligence Can Help Researchers Develop New Drugs, MRDC Regulatory Experts Forecast

FORT DETRICK, Md. – Artificial intelligence is dramatically reshaping the way new medicines are developed, allowing researchers to accelerate the discovery of new drugs, improve their accuracy and effectiveness and reduce development costs – advances that researchers at the Medical Research and Development Command are employing to conduct studies, design clinical trials and bring safe and effective drugs to more patients, more quickly.

“Although it is still in its infancy, we see potential applications of AI in all stages of drug development,” said Valeria Sena-Weltin, a regulatory affairs scientist at MRDC’s Office of Regulated Activities, during a recent presentation to MRDC staff. “Drug design has entered the era of AI and personalized precision medicine due to the advent of high-performance computing power and advanced graphical processing.”

Sena-Weltin explained that the number of applications for new drugs and biologics that incorporate AI and machine learning components being submitted to the U.S. Food and Drug Administration has increased significantly in recent years, passing 300 submissions as of the first quarter of this year. As a result, the FDA is actively developing new frameworks, guidance and processes to accommodate the use of AI tools in ways that ensure safety, efficacy and compliance with federal regulations. Last year, the FDA published a discussion paper for using AI and ML in the development of drugs and biologics as a way to encourage discussion among industry, academia and stakeholders.

One of the reasons that AI and ML are being embraced by drug developers is because they promise to help reverse a trend that has seen drug companies experience steep declines in returns on their investments in new drug research and development. Ten years ago, drug developers could expect to see a return of 10 cents for every dollar invested in R&D. Today, that return is less than two cents. Sena-Weltin said that AI could reduce development costs by up to 70% while potentially generating billions of dollars in revenue for drug development firms and reducing the cost of treatments.

Military medicine R&D at MRDC is no stranger to AI. Researchers who develop vaccines and therapeutics for combating infectious diseases, biological agents and chemical weapons work with academic and industry partners that have incorporated AI tools into their drug development and manufacturing processes, enabling them to gain first-hand experience with the efficacy of those tools. Several recent landmark medical devices developed at MRDC, such as the Automated Processing of the Physiological Registry for Assessment of Injury Severity Hemorrhage Risk Index, which uses vital-sign data from trauma patients to assess their risk of hemorrhage, and SeptiBurnAlert, which identifies whether burn patients are at risk of experiencing life-threatening complications from sepsis, use AI to help clinicians and first responders make timely and life-saving health care decisions. The Operational Telemedicine Laboratory at MRDC’s Telemedicine and Advanced Technology Research Center is also incorporating AI in a number of advanced robotics and telemedicine projects currently in development.

Dr. Barima Frempong, a senior regulatory affairs analyst at ORA, explained how AI’s ability to analyze vast datasets of genomic, proteomic and clinical data enables it to identify potential target drug candidates faster and more accurately than traditional methods that relied on manual evaluation and extensive lab and animal testing.

“Back when I was an undergraduate doing research in the lab, you would spend weeks or even months testing one potential drug compound that you think could be a hit, only to find out that it’s not viable and you have to start all over again,” said Frempong. “With AI, you can reduce the time it takes to identify drug candidates by almost half.”

AI can also be used to streamline patient recruitment for clinical trials by using algorithms to scan genomic data and health records to match eligible patients, which can take years using traditional labor-intensive data collection and analysis techniques. Frempong said AI could even potentially be used to forecast potential regulatory hurdles and suggest optimal pathways for obtaining FDA approvals for new drugs.

“A smoother, more predictable regulatory process is crucial for timely market entry,” said Frempong.

Navigating the regulatory environment is what ORA’s expert regulatory affairs, compliance and clinical support professionals specialize in. They work with MRDC researchers who develop FDA-regulated medical products to guide them through the regulatory review process to mitigate risk and accelerate the delivery of their products to Service Members.

Scott Murray, a senior regulatory affairs analyst at ORA, noted that AI-powered drug discovery and development also introduces a host of ethical considerations that researchers need to take into account when incorporating the technology into their drug research and development projects.

“We need to ensure that AI algorithms are free from bias and discriminatory outcomes, that privacy and security measures are in place to protect sensitive information, that there is transparency in AI-driven discoveries, that strategies developed by AI platforms are accessible and affordable, and that there is a robust framework for regulatory oversight,” said Murray.

Murray emphasized that the use of AI in drug discovery is an evolving process, and success requires active participation by everyone involved in the process from bench to bedside.

“Open dialogue is needed to create effective policies and guidelines, and regulations must be updated to address privacy concerns and ensure ethical AI use,” said Murray. “It is by working together that these efforts can lead to a safer and more successful future for drug discovery and development.”

The presentation on the use of AI in drug development was part of a series of bimonthly “lunch and learn” sessions conducted by ORA for MRDC staff as a way to share the latest regulatory guidelines from the FDA related to drugs, biologics, and medical devices, and how they apply to medical research and development efforts at MRDC.