Planning for Unique Challenges Faced by Cell & Gene Therapy Developers

PE: What are some of the unique challenges that CGT developers need to plan for and overcome when building their channel strategy?

Lattanzi: Channel strategy is probably one of the most important things you can consider when you're thinking about your commercialization efforts. It has one of the most direct impacts on patient access to product. I think the first thing I usually think about when I'm thinking about what a channel strategy might need to look at is where and how are the patients being treated today? Are they being seen by a community physician? Are they going to a local hospital? Or are they raveling to a specialist at a center of excellence somewhere? Are physicians doing treatments in office today or within their facilities? What kinds of treatments are they already doing? Are they doing infusions? Or is it something more complex than that? I think that really gives a base then, that you can build off of once you identify exactly who is seeing these patients today, who's interacting with them, both from an overall care perspective and a treatment perspective. You can build off of that with any potential clinical or logistical considerations. I already mentioned some of the ultra-low or cryogenic capabilities. Not all facilities have that ability. You can store product within the doors and some of them have viability to keep product up to 10 days. But they're really big and bulky. A lot of these centers don't have the space to hold that.

It's important to understand what the AE profile is. Is it a safety profile, or do you maybe need to have a crash cart? Some products also have longer observation times, which might necessitate doing inpatient versus outpatient.

Injection is not the same as infusion. Obviously, a surgical procedure would need you to then do something in more of a surgery center or hospital setting. Sometimes, people might need to partner with an external third-party vendor who can do the mixing and then ship it to that facility. I think once you take the base of who's seeing the patients and layer on some of those considerations around the clinical and just logistical requirements, then you need to look at the patient population so you can size your network. If you only expect to have maybe 50 patients a year, you don't want to have a network of 100 facilities. But alternatively, you want to make sure it's big enough so that you're not creating any capacity constraints, which could ultimately impact patients accessing the product.

The fourth thing I would look at is really the geography and the markets. You want to make sure you're looking at where the patients are and that you have facilities spread out so that they're able to get to those facilities. But also, you need to make sure you're able to get the product there within the time restrictions and the temperature restrictions that you might have with your product. This is especially true if you are looking across multiple markets, such as EU against the US. If you have to go through customs, you lose a lot of time. That’s something else that needs to be layered in when determining this. Ultimately, how is it going to change over time? Products launched with one indication might be expected to receive another one or two down the line. A lot of companies now are working off of different platforms as well. You could have additional products that could be launching that might have some different nuances, but if you set up your channel strategy to be able to scale with that, you can create efficiencies downstream with your network.