Posternak Blankstein & Lund LLP is now Arent Fox. Read the press release

Drug Development in the Metaverse

“Metaverse” is no longer a mere buzzword. Many industries are discovering and developing applications for the Metaverse, and the pharma and biotech industry is no different.
Off

The many ways the Metaverse will change life sciences is not yet fully understood, but significant research and development is underway to utilize the Metaverse and its associated technologies for a wide variety of life science applications. This article discusses how the Metaverse may transform the drug development process, medical device development, and the legal and regulatory challenges that will need to be addressed.

What is the Metaverse?

The Metaverse is a digital environment implementing virtual (VR) and augmented-reality (AR) where users can interact with one another, run experiments, and transition between the physical world and the virtual realm. In simpler terms, a fully immersive internet.

Drug Development in the Metaverse

$1.4 billion USD: this is the mean investment required to bring a new medicine to market according to a 2020 Journal of American Medical Association (JAMA) study. One of the most costly and time-consuming stages of drug development is to design, staff, and run clinical trials. Clinical trials can comprise about 60 percent of the total cost to bring a new treatment to market. It takes a lot of time and resources to recruit a sufficient number of clinical trial subjects who have the appropriate disease, genetic, gender, age, and other characteristic profiles needed for a clinical trial.

The Metaverse introduces the amazing possibility of using digital twins to starkly reduce the cost and time required to run reliable clinical trials. A digital twin is a virtual model designed to accurately reflect physical objects, processes, or even a real-world person. Digital twins can “run any number of useful simulations in order to study multiple processes.” Using a digital twin would allow the experiment or trial to be run and studied much more quickly and safely. Moreover, unlike a conventional data analytics program, the Metaverse would allow for an immersive or AR visual representation of the effects of the proposed therapy on a digital twin, which could be an entire person, or specific organs and systems. Such a visual three-dimensional and interactive representation would be more user-friendly and likely more informative to a clinical researcher.

Although the technology to create an exact digital twin of a human individual is not yet developed, pharmaceutical companies are actively exploring this technology. When that technology is actualized, pharmaceutical companies will be able to complete clinical trials at a fraction of the cost and as quickly as a few weeks, rather than months or years.

Legal and Regulatory Challenges

While the Metaverse provides promising opportunities for improving drug development, legal and regulatory challenges remain. Because the technology is still developing, the details of the FDA regulations remain unknown. But the FDA has already begun working on potential regulations for this new frontier, and the use of digital twins in clinical trials is the biggest open question.

The FDA has already shown a willingness to implement computer-aided simulations in the drug development process through its Model-Informed Drug Development (MIDD) Pilot Program. The MIDD was designed to determine how quantitative modeling can be used to balance the risks and benefits of drug product development, particularly in dose selection or estimation studies, clinical trial simulations, and predictive safety evaluations. The FDA’s embrace of modern data analytics and statistical modeling is a promising sign for the deployment of digital twins.

Additionally, the FDA’s recent requests for public comment on medical devices with Metaverse technologies and its partnership with Siemens regarding digital twins in medical device development demonstrate the agency’s commitment to improve product review processes with Metaverse technologies. The FDA provided nearly $2 million to Siemens for a pilot program to show how digital twins could improve product quality, development, and commercialization. Siemens and other companies are focused on using digital twins to enable more efficient use of resources. While the current pilot program with the FDA is focused on medical devices, Siemens aims to demonstrate how digital twins could also be used for biologics and pharmaceuticals. The project is also likely to assist the FDA to improve industry guidance and regulatory tools, and prepare for new development and manufacturing processes.

At least one product using Metaverse VR technology has already been approved by the FDA. EaseVRx, is an immersive VR system that uses behavioral therapies to help with pain reduction. The EaseVRx system has a VR headset, a controller and a “breathing amplifier” that directs the patients breath toward the headset’s microphone for deep breathing exercises. This Metaverse treatment was granted the “Breakthrough Device Designation” by the FDA, which allows for a prioritized review. The FDA approval of EaseVRx demonstrates that the use of the Metaverse virtual environment to treat certain conditions is an area with a good likelihood of obtaining FDA approval. Approval of drugs or therapies that are shown to be safe and effective through clinical trial data obtained from digital twins is an area that may take longer to be blessed by the FDA. But as the pilot program with Siemens illustrates, using digital twins for clinical trials, is not mere fantasy.

The attorneys at ArentFox Schiff are maintaining a close watch on the developments of Metaverse technologies in the life sciences industry and the FDA’s guidance and regulations related to such technology. ArentFox Schiff’s multidisciplinary expertise in the life sciences industry, including regulatory, intellectual property, corporate, data privacy, and product liability issues facing the industry, allows us to provide clients holistic advice as they work to develop and implement Metaverse technologies.

Contacts

Continue Reading