Earlier this year, the U.S. Food and Drug Administration (FDA) published a discussion paper entitled “Using Artificial Intelligence & Machine Learning in the Development of Drug and Biological Products,” including a request for feedback on a number of questions related to these technologies and topics.
As a company working at the intersection of technology and biology since 2013, we commend the FDA on this proactive approach to facilitating insightful discourse with the collective goal of treating patients safely and effectively.
Biology is extraordinarily complex, and despite millions of incredible scientists having dedicated their lives to uncovering its truths, we so far only understand a tiny fraction of all there is to learn on the subject. Moreover, human bias is often a major threat to the drug discovery process, as we are limited in the size and scale of data we can interpret and are prone to seeing the data that suits us and justifies our hypothesis. AI and ML may give us the ability to better approach biology’s complexity in a less biased manner, opening a new frontier in prevention or treatment for various complex diseases.
We recognize the FDA's dedication to transparent and informed decision-making, and we are committed to supporting this process by providing well-considered comments that stem from our experience as a leader in the space.
