How New CTP Regulations Could Shape Access and Adoption of 351 Biologics

As recent policy changes reshape the wound care and biologics landscape, the 351 pathway is emerging as one for innovation, rigor, and clinical confidence. While demanding in time and resources, these speakers share that they expect this pathway  to streamline provider decision-making and elevate the field toward more evidence-driven care.

• Policy changes are accelerating a shift for some companies toward 351-regulated products, encouraging manufacturers to pursue more rigorous development pathways that yield stronger, FDA-vetted datasets for providers.

• A more evidence-driven market is expected to simplify provider decision-making, replacing a crowded field of minimally supported products with a smaller number of biologics backed by robust clinical data.

• Although challenging to pursue, these speakers feel that the 351 pathway is poised to transform the biologics space, driving innovation, reducing long-term uncertainty associated with skin substitutes, and giving clinicians greater confidence in selecting the right product for each patient.

Please note: This content is a direct transcript, capturing the authentic conversation without edits. Some language may reflect the flow of live discussion rather than polished text. 

Nikolai Sopko, MD, PhD:

I think overall these changes in policy will actually facilitate adoption of 351 products and implementation of 351 products. I think if products want to become more innovative, they're going to be forced to go down to this 351 pathway. If products want to be billed separately, they're going to have to go down this 351 pathway, and I think because of that, it is going to promote it. Now there's naturally a pretty big barrier to get into the 351. The years of running these trials and the expenses and resources into that are quite large and it takes a very focused strategic plan to effort with supportive infrastructure and financing to do those kind of things. So there's going to be a little bit of a give and take. I think from a provider perspective, if as 351 products come out with that rigorous dataset required to get approved, I think that's going to make it easier for providers to use those products because there's going to be so much already review and development in other areas of medicine where drugs are really the most prevalent source of treatment.

All that data is generated before that product gets on the market, and then it's providers reviewing the data and using that product. So from a provider's perspective, it really becomes much more data-driven when you're dealing with a bunch of 351 products to choose from because there's so much more data to review. Whereas I think previously when there was a lot of different products out there, many in very similar classes, a lot of them didn't have really any data other than maybe some couple case series. It was much more challenging for providers to pick those out and understand which one is most beneficial for their particular patients. Whereas I think the 351 products will actually make it easier for providers to choose if that product's right for the particular patient that they want to treat.

Ned Swanson, MD:

Totally agree with what he sees unfolding here. Ultimately, all these changes I think are tough. Some people may think they were heavy handed, but agree that the field was getting a little out of control and something had to be done no matter where you fall. Within that spectrum ultimately is pushing the field to be more data-driven and evidence-based. So we see these as changes that were a long time coming. We sort of had this perspective even before they started putting out any suggested rule changes years ago, even before we went down the BLA pathway, you could see all the incentives that existed in the market, and we think this is really going to transform the field, whether it happens in the next year or it takes five years to really see the final effects of these changes.

We think this field's going to start to evolve into just handfuls of products that you're looking at, trying to find the right patient for each product based on the data that exists as opposed to kind of really being lost in a bunch of noise. There's a lot of very similar looking products and the prices are all over the place, and what's driving the incentives is a lot less related to really comparing the products head to head in the right patient populations they should be suited for. So we think it'll help drive adoption in 351 biologics. And as I said earlier, I think we're already seeing people looking to other solutions given all of the uncertainty with skin substitutes, all the audits going on, people wanting to avoid five years from now having a headache because of what they chose to do today. And I think that's just an early indicator that this will drive the field into the 351 biologics when more and more products come out along that pathway. But again, it takes a lot of innovation, a lot of rigor, and a lot of success to get through it. So we think it'll probably be a slower cycle of products hitting the market, but when they do, you're going to have that confidence that they're backed by pretty good evidence, and it's something to consider for your patient.

Dr. Sopko is the Chief Operating Officer and Chief Scientific Officer for PolarityBio.

Dr. Swanson is the President and Chief Medical Officer for PolarityBio.