AI's Role in Shaping the Future of Pharmaceutical Development

In a video interview with Pharma Commerce, James Shehan, chair of the FDA Regulatory practice at Lowenstein Sandler, discusses the potential impact of upcoming tariffs on pharmaceutical supply chains, focusing on Canada, Mexico, and China. He believes that tariffs on Mexico and Canada would have minimal effects on supply chains, as the pharmaceutical industry sources relatively little from these countries. The real concern lies with China, which is a major supplier of active pharmaceutical ingredients (APIs) and finished drug products. A significant portion of recent pharmaceutical deals has involved licensing Chinese drugs, which could be affected by tariffs if they disrupt supply chains.

If the relationship between the United States and China worsens, tariffs could have a more substantial impact. Specifically, they might increase the cost of generic drugs, since China is a crucial supplier for these products. Despite this, Shehan notes that many generic drugs are already extremely cheap, with some prescriptions costing just a few cents. Even if prices doubled, it may not drastically affect consumers. Specialty generic drugs, however, could see more noticeable price increases.

He also points out that if trade tensions extend to regions like the EU, India, or Japan, the situation could change. A broader trade conflict could influence drug prices, especially for certain medications. Overall, while tariffs on China may increase drug prices in the short term, the full impact will depend on the nature of global trade relations and the extent of supply disruptions.

Shehan also comments on how he believes the new administration will influence FDA approval processes for commercial products, other specific regulatory updates that drug developers should be closely monitoring in the current landscape, and much more.

A transcript of his conversation with PC can be found below.

PC: How do you anticipate the evolving regulatory environment impacting the future of pharmaceutical development, especially in the context of emerging technologies like AI?

Shehan: To me, AI is an extension of technology that already exists out there, an improvement. But, like in some other applications, I don't think it's as big a change, because people have been using advanced computing techniques in this area for quite a while. It'll be interesting if we're able to shorten development times. I think that can be very promising area.

Perhaps you're able to use AI to better define the patient populations that drugs should be tested in and approved for, so you end up in a world where you have more customized drugs, and perhaps those have a shorter development pathway and an approval process. That's pretty exciting. I go to conferences, and you hear a lot of talk about the possibilities. Now, we just need to kind of conceptualize them.