Cell and Gene Therapy: Creating Connections Amid Complexity

In Partnership With: AmerisourceBergen

Product developments in cell and gene therapy are both among the most groundbreaking and the most complex. Cell and gene therapy product launch success hinges on investment in the right technology and data solutions, and that also means finding the right partner.

AmerisourceBergen sits in the middle to streamline and connect what is complex, said Doug Cook, the company’s president of commercialization services and animal health.

“These therapies require a higher degree of integration between all the components—between specialized logistics, between the patient programs, between health outcomes and evidence needed to support and drive physician adoption and even payer coverage—all those become amped up and more important than ever,” explained Cook.

In speaking with Fierce Pharma, Cook explained his role in manufacturer offerings, from the clinical trials stage to consulting through patient support and payer strategy.

Hear more from Cook in his interview with Fierce Pharma. After watching, if you’re looking for more information, visit https://www.amerisourcebergen.com.

Rebecca Willumson: Hello everyone, I'm Rebecca Willumson. I'm the publisher of FiercePharma and I'm here today with Doug Cook, President of Commercialization Services and Animal Health at AmerisourceBergen. Doug, thanks for joining me today.

Doug Cook: Hi Rebecca, thanks for having me. Great to be here.

Rebecca Willumson: Doug, to kick us off, why don't you tell us a little bit about yourself and your role at AmerisourceBergen?

Doug Cook: Sure. Again, Doug cook, I head up the Commercialization Services and Animal Health business segment here at AmerisourceBergen. Animal Health is a group onto itself, and then the other piece of that is our complete suite of commercialization service offerings for manufacturers that includes offerings from the clinical trial stage, especially with our World Courier and our clinical trial transportation business, to some of the consulting work that we do that starts in the clinical phases through our commercialized solutions set of offerings. Our health outcomes and payer strategy consulting work that we do through our patient support services, all that that makes up the suite of manufacturer services is essentially what I head up here at AmerisourceBergen.

Rebecca Willumson: That's great. I think we can jump right in. We've seen a number of cell and gene therapy approvals in recent years. What are some key commercial considerations for planning a successful cell and gene therapy product launch?

Doug Cook: Well, first off the cell and gene therapies represent some of the most groundbreaking innovations in patient care that we've ever seen. That said, what comes with it are some very complex products that introduced new challenges throughout the commercialization journey from reimbursement and access barriers to supply chain and distribution considerations. These are very complex therapies. Given those complexities within the supply chain, these therapies require a higher degree of integration between all the components, between specialized logistics, between the patient programs, between the health outcomes and the evidence needed to support and drive physician adoption and even payer coverage. All those become amped up and more important than ever and so the ability to be a connector as a result of all of this.

Doug Cook: You've got to have a seamless ecosystem at the end of the day. We think a lot about that, plan a lot for that and think about our unique value proposition and ability to be in the center of all that. We're connecting every day. If we think about our unique place in this space, we're shipping every day, we're touching pharmacists, health systems, physicians, working with manufacturers to do that. The ability to sit in the middle of all that and connect it, take what is complex and be a connector in this complex space, that's incredibly important. It requires a lot of forethought and not a lot of advanced planning with all those complexities. The stakes are higher you've got to plan in advance, that's certainly a key takeaway that we've seen here.

Rebecca Willumson: Talk to me a little bit about the unique logistics challenges that innovators need to prepare for?

Doug Cook: You have to think about this where the patient's not just on the other end of the supply chain now. The patient actually is part of the supply chain now. Many times you taking a sample from the patient, it's a manufacturing process with the patient's own cells. There really is no room for failure in a really complicated logistics process. We know for example, that having to think about pre-conditioning storage units or transportation units, essentially that we're going to be putting these cells into. It's not about having a box there on the day for the treatment, the coordination with the provider, knowing weeks in advance of when the patient is going to be there so you can be ready with a preconditioned storage unit timed there. The logistics is really complex and again, there's no room for failure here knowing that again, the patients become part of the supply chain.

Doug Cook: There's not another vial on the shelf, is why there is no room for failure in this complicated logistics supply chain backdrop, where the patient is part of the therapy. If something goes wrong, you can't grab another vial off the shelf. In some cases, it's a matter of life or death. If not having to start the process over with the patient. Complicated logistics, you really got to know what you're doing, investing in the right technology solutions, investing in the right data solutions and connectivity solutions to be able to pull that off because the stakes are so high.

Rebecca Willumson: Can you tell me what are some of the lessons that AmerisourceBergen has learned while working with cell and gene therapy manufacturers in recent years?

Doug Cook: There's been a few before today, we've provided in some form of fashion support to every manufacturer that's launched the cell and gene therapy today. We're engaged in multiple facets of the pipeline, whether it's the specialty logistics support or the market access consulting. We're thinking a lot about the ability to support manufacturers at every stage. It's a multifaceted challenge, so we think about our ability to work with these manufacturers at every stage they're in. So again, that starting in the clinical through the commercial challenges that'll happen.

Doug Cook: It's interesting to point out that in many cases, in fact, this is the first time where if you think about the supply chain normally with a new drug, you've got your clinical logistics getting through the clinical trial and what the supply chain looks like. And then you've got what can be a completely separate supply chain, post commercialization. With cell and gene therapies the clinical trial supply chain is the exact same supply chain as the clinical supply chain, so it's the same. This is very unique where your success is moved earlier. You've got to be thinking about how you're mapping out and having a really vibrant, successful supply chain in the clinical stages, because that is essentially your commercial supply chain as well. That's certainly a key takeaway.

Rebecca Willumson: Something that we've all been talking about for months now, how has the COVID-19 pandemic affected the cell and gene therapy landscape, including development of new products?

Doug Cook: The COVID 19 pandemic, the pandemic has disrupted drug discovery and development. Well, overall we know that, but specifically the cell and gene therapies have been adversely affected prompting a shift towards more decentralized trials and causing some research sites to temporarily halt. In some cases, even clients canceled trials. Initially we saw some significant development impact, in fact nearly two thirds of the cell and gene therapy manufacturer surveyed expected their development programs to be delayed by more than three months. Doing part to patient recruitment and assessment challenges. However, we are starting to see that come back. Clinical development for cell and gene therapies has started to recover. Studies were reprioritize given the acuity of patients enrolled in these trials so obviously these life saving therapies, it makes sense that they would going to go to the top of the list as trials have picked back up and we've seen that.

Doug Cook: As manufacturing and their partners restart the trials in mid of pandemic, it's imperative that they establish highly flexible logistics programs to develop the flexibility and the ability to react, and have robust contingency plans that'll allow them mobilize and recover quickly because it becomes even more important. We know that oftentimes again, getting back to the theme of planning and experience, a lot of times it's being able to anticipate what's going wrong, but sometimes things go wrong. Having those relationships, we have a network in over 50 countries in the infrastructure with our World Courier business in over 50 countries. What we've found and seen is the ability when something does go wrong, to be able to intercede and work with local customs, in essence salvage the shipment and still get it to the patient and intercede when something does go wrong. The flexibility, the experience, the infrastructure, and having made those investments so that you can react in that way, that's really critical in the cell and gene space as well.

Rebecca Willumson: To wrap things up here, I would say, looking ahead, what do you anticipate the cell and gene therapy landscape will look like in the next three to five years?

Doug Cook: The cell and gene therapies represent a very fast growing category. There's more momentum than ever before bringing these innovative medicines to market. Today the FDA has approved 18 cell and gene therapies given the recent surge of products entering early development. The FDA anticipates the approval of another 15 to 30 products within the next three to five years. We're looking at potentially having 40 plus products on the market by 2024. The influx of products offers a tremendous promise and hope to patients with conditions where there are a few treatment options and in some case that there is no cure. The potential for these products it's great, but it could remain unrealized if manufacturers and their partners aren't prepared. We're acutely cognizant of that. We've continued to seek strategic partnerships, make investments in area of our businesses that will ultimately enhance support for our manufacturer partners and their development in this space.

Doug Cook: As an example within our Third-Party Logistics business, we just made a significant investment in cryogenic storage infrastructure. Because again, the solutions that are going to be needed, therapies, ultra frozen therapies you need the infrastructure to be able to do that. It's another reason we actually combined our Third-Party Logistics business with our World Courier clinical trial business, and a large driver for why we did that was thinking about the connectivity that's needed for a seamless experience. The ability to handle these ultra frozen therapies, not only in transit, but having a solution starting in with the storage needs and a logistics infrastructure from a warehousing perspective. That's one of the reasons that we were proactive and even combined two of our business units to provide a more seamless experience. I think it's really important to remember that while we talk a lot about the potential of these therapies, and they are bespoke therapies, they are custom individualized therapies per patient.

Doug Cook: Again, oftentimes using the patient's cells, customized to them, their bespoke therapy is no doubt. There is a scale challenge that we do worry about so as we think about 40 products being on the market and today there's been an almost custom supply chain for each one. If you think about a hospital system, as an example, they have to be scalable solutions. We don't want the provider, the physician, the patient worried about logistics infrastructure to be able to get on therapy. We want them worried about their care and getting better. We think a lot about taking this bespoke therapy that the patient needs and scaling it in a way, making the investments, thinking about the processes, the connectivity, making sure that we scale it in a way that is going to be good for the patient experience, good for the provider, getting them on therapy.

Doug Cook: We need bespoke therapy, these bespoke solutions, but we can't have bespoke supply chains, that's not going to work in the industry. We think a lot about how to pull it all together in a seamless way, be a good partner for everyone, our manufacturers, our hospital systems, our providers and ultimately the patients so they can get on these therapies as quickly and efficiently as possible.

Rebecca Willumson: I think that's a perfect way to wrap things up. That's all the questions that I have. Thanks so much for joining me today, it was really a pleasure speaking with you.

Doug Cook: All right, great. Thanks Rebecca.