HERSPIEGEL COMMERCIAL CONVERSATIONS
Watch this episode of Herspiegel Commercial Conversations to hear Beth Schurman, COO, and Kate Reedy, Commercial Executive discuss the challenges and lessons learned from launching cell and gene therapies.
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Blueprint for Commercializing Cell and Gene Therapies
How advanced medicines commercial readiness differs from traditional drug launches.
Discussion
Beth Schurman:
We’re excited to be here today and talk about cell and gene therapy commercialization. To level set, I’d love to get your perspective on the marketplace. We talk about it as advanced therapy and cell and gene therapy as one conglomerate thing, but there’s really a difference.
Kate Reedy:
Yes, that’s absolutely right. The lexicon is important, especially when you are defining the market. What we think of as cell and gene therapy therapies that are intended to cure disease or intended to significantly modify the disease. I bucket into four categories within the advanced medicine space itself. I think about it as far as personalization, is it autologous approach or is it allogeneic approach? The therapeutic intervention, is it really gene mediated, and gene related or immune related? The type, is it regenerative, is it replacement, is it silencing, is it editing? And then the technology and delivery mechanism where the delivery would be either vector or non-viral vector in nature.
Beth Schurman:
It is a marketplace with a lot of complexities and certainly differences. Now, from the traditional commercial approach of oral or biologic medicines, how would you characterize the challenges that commercial leaders face in cell and gene therapy, especially thinking about building that go to market strategy and how does it differ from traditional marketing?
Kate Reedy:
That is a common question with the big overarching theme here is that the commercial lens has got to be scrutinized and applied to decision making as early as phase two. Certainly, by phase three and absolutely before BLA submission. There is a complexity in the process that these decisions are made in, whether it’s what sites of care that need to be trained or what does the manufacturing supply chain start to look like and how does that evolve. Those decisions that are made prior to BLA submission are going to absolutely impact your commercial operating model and also ultimately it will affect demand generation.
Beth Schurman:
We have done a lot of launches, we try and get involved at 18 months, maybe 24 months before a BLA or an NDA. We’ve done it as short as three months. But in the case of cell and gene therapy, it really is that those commercial decisions have to be part of the clinical program, have to be part of the process, especially with autologous products where the patient is part of the raw material and manufacturing process. Do you have any examples of “A-HA” moments for you as you were going through that process in your most recent role?
Kate Reedy:
Sure, one of the big “A-Has”, if you will, our organization was preparing for our clinical trial and the scale for our clinical trial to be able to handle the manufacturing and the throughput for our clinical trial. What we needed to also focus on, was to look at it from a larger scale perspective. How are we going to be able to use the same process to implement on a larger scale? Even though it is rare disease, it still needed to be scaled in a much larger manner. And we weren’t thinking like that initially as it relates to just our clinical trials. That is going to be really important and affect all of the supply chain, the throughput. In fact, there was an article last year in Future oncology talking about a Car-T for multiple myeloma and from end to end it took 177 days for the patient to receive treatment. 46 healthcare providers were involved and ten sites of care. That gives you an idea of the complexity, so any of these decisions made prior to BLA submission or really prior to phase three have to be scrutinized from a commercial lens because it’s going to be a different ballpark once you get there.
Beth Schurman:
Wow, 46 healthcare providers, we’ve seen with some of the work that we’ve done, a new approach to the field force and having to reevaluate the kinds of roles who are the stakeholders that will be customers to engage. What has that looked like for you in your prior role or in talking to colleagues in cell and gene therapy?
Kate Reedy:
That is an interesting question, because that role in commercial has really never previously existed. So when your PDUFA date comes in traditional products, people are generally right out the door, off selling, hitting their targets. The salesforce can go to community doctors, to institutional doctors, to key early adopters, all the above. If you’re selling gene therapy, what’s happening is these institutions have to be certified or qualified. They have to have the right capabilities to actually administer the product. And so instead of the PDUFA date approval, go sell model that we’re used to, it becomes PDUFA approval, then we have to train those sites of care and all of those HCPs that we just discussed for administering the product. And there are only so many places that want to do that. And the educational component becomes really critical, which will certainly impact your launch ramp and your launch timing upon.
Beth Schurman:
Approval and defining what that certification process looks like. We’ve also heard from the treatment centers themselves that every product has its own process. So it can be really cumbersome if they’re offering multiple products, multiple gene therapies or multiple cell therapies. Everyone is a unique process they have to learn and manage, which is really complex for these centers.
Kate Reedy:
Yeah, it’s like a double-edged sword, actually. The healthcare providers or the sites of care have their own process and manufacturers have our own process separate from each other. Nobody’s really creating consistency, so it gets even more complex as more products get approved.
Beth Schurman:
Yeah. And now competing for clinical trial site access as well as commercial site access, there’s a lot of challenges. It’s such a new space, advanced medicines. There are challenges to be faced in access and commercial planning and customer engagement. What are some of the ways that commercial leaders can address these new challenges?
Kate Reedy:
Yeah, look, a lot of the planning remains very similar to what we see in traditional marketing positioning, identifying customer insights, resource allocation and so on and so forth. But I think what becomes really different is operationalizing the strategy. So, as an example, one of the key components that we just discussed a bit here was the ordering or the manufacturing process for autologous products where the patient is the source of raw material itself. So the ordering of that product, which ultimately comes from the patient to produce the product to get the finished goods to go back into the patient is a really complex process. Imagine if you’re one company and you have one product for pretty rare condition, genetic or cell gene therapy.
The healthcare provider office has to learn a whole new set of ordering components. They have to go on to figure out how do I order this? How are they biopsied or how is the blood collected? Where does the packaging happen, where do I drop it off? And then similarly on the back end, it’s all about when is it delivered? When is revenue recognized here and how does the patient receive? Is it inpatient, is it outpatient? So that’s all connected, including that patient services component. It becomes this integrated value chain.
Beth Schurman:
Well, that is interesting. That leads me to, as commercial strategy experts here at Herspiegel, approach commercial planning through the lens
of critical business questions. Our playbook defines the appropriate questions based on the product archetype, the market situation and time to launch. Do you
think teams supporting advanced medicines like Cell and Gene Therapies are looking at a need for different business questions?
Kate Reedy:
Absolutely, yes. I think there’s a base foundation of questions and we kind of established that before, but there is a whole other set. There are certain components that are going to be inserted into the existing Playbook because the one that exists today is not complete. For cell and gene therapies, it needs to be expanded and I think we’re still learning on what are all the right business questions are because I don’t think there’s one product out there that’s done it perfectly the first time. Even with the advances we’ve seen, like from Spark or from Novartis, I think there is much more room for improvement and those business questions have to be asked and answered early in the process, not post FDA approval. So, with advanced medicines you have to think about the playbook, the commercial operating model has to identify new key capabilities that the commercial team has to execute or operationalize upon.
The way we I’ve approached it in the past is taking the playbook that’s currently in view and rewriting it because there are good components there and certainly already the base foundational questions. We have to think about it with fresh eyes and we have to think about the critical capabilities that are needed and incorporate those into our launch strategy and planning?
Beth Schurman:
How do you see a strategic partner like Herspiegel helping advanced medicines commercial teams who are in that early commercial, early clinical planning, phase two, phase three, or even at the regulatory submission stage?
Kate Reedy:
Well, the first teams that launched cell and gene therapies five years ago were really taking business questions as they came and probably a little bit of dodging and weaving and figuring out, oh, this decision was made and now we’re going to have to execute that way and thus set expectations appropriately. Now there are partners, like Herspiegel that are taking that larger playbook and thinking about it from the perspective of these new advanced medicines and incorporating business questions and solutions for those ahead of time, tailored to specific gene therapy products. I think in general, especially in this new space, there’s so much to learn and there’s a lot of things we know we don’t know, but there’s also a lot of things we don’t know that we don’t know. That is where a partner, like Herspiegel provides their experience with other cell and gene therapies that they can build on. That is where I think having a partner here is really going to be beneficial in the overarching planning for your launch strategy.
Beth Schurman:
I appreciate that. We have had the great experience to be able to work on a number of cell and gene therapy launches already, and we have gotten in late in some and earlier on others. And that ability to really bring the new business questions and experience earlier to organizations as they’re in the planning process is the value we can bring to teams.
Kate, thank you for your time today. It’s been really interesting to learn from you and your experiences. It’s such an exciting time for commercial leaders and patients who are gaining access to life changing and life saving treatments. With the new cell and gene therapies and with so many in development now, we look forward to the opportunity to help teams commercialize and launch more of these in the future.
Kate Reedy:
Thank you, Beth, I really enjoyed the conversation.
Blueprint for Commercializing Cell and Gene Therapies
In this paper, we share a few insights related to unlocking non-clinical barriers to demand generation and enabling a runway for a CGT launch:
- Map patient navigation by treatment center and its network facilities
- Identify and prioritize treatment center sites of care
- Establish a process for treatment center certification/qualification
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