Interview: Increasing advanced therapies’ connectivity and speed to market through partnership

What are the challenges facing the advanced therapies industry at present?
Matthew Lakelin: One of the major challenges is that advanced therapies tend to fall across a wide range of different stakeholders to get the products to the patients safely and efficiently. The challenge really is to try and find a way to unify these stakeholders, exchange information about the supply chain, and provide the data that individuals need to deliver the therapy correctly.

For advanced therapies, specifically autologous therapies, one of the challenges concerns chain of identity, being able to demonstrate that when a drug product is given to a patient, it has been generated from their starting material and from no one else's. Chain of identity is also important for matched allogeneic therapies, making sure that the recipient's biological profile matches the donor's biological profile for the drug product. For some gene therapies, these are high value products, potentially being dispensed on a named patient basis. Being able to demonstrate that the recipient of that product is indeed the person for whom that product was dispensed is critical.

Then, as part of managing the supply chain, there is also a need to manage integrations and how the data flows between different stakeholders. Across this disparate supply chain, we find different groups, usually using different systems to record their activities. Being able to unify those is a real challenge for the industry.

Jeff Buck: When we look at patient support services for advanced therapies, there are unique qualities that really challenge the infrastructure to support the patient and provider.

For instance, consider the timetable for the actual product. If a patient is delayed or if a provider is delayed, or if a benefit verification or prior authorization is delayed, when dealing with a traditional specialty product the pharmacist or provider can just put it back in inventory and wait for those barriers to be reduced. With advanced therapies, there is a very strict timetable. The orchestration and coordination of moving all those logistics up and down the supply chain and getting all the administrative requirements in place is of the utmost importance because minutes, hours and certainly days are going to have a material impact on getting that product to the patient.

In addition, this is such a new model for the industry, especially products that are taking over traditional products and advanced therapies are a huge part of that specialty drug chain. These are a completely different model from what we are normally used to. And, in many cases, the price points are very large. This is not just about managing a chronic condition but about curing it or slowing its progress. It really places a completely different financial model over the cost for care. Therefore, the payer market is having difficulties in understanding how this challenge is going to be addressed. The benefit verification and prior authorization processes are completely different. Tracking and understanding the outcomes to ensure the large investment made up front actually has the expected outcomes is key.

How can partnerships help to overcome key industry challenges?
Jeff Buck: Partnerships are critical because, not only the manufacturing of the drug is highly complex, but so are the other steps that come after. Those steps are highly specialized and the complexity carries through the supply chain. For a single entity to have a deep understanding and the required level of quality to support and advance therapies, is not realistic.

AmerisourceBergen has been looking at the cell and gene market for some time now. As we assessed our assets and capabilities though, we identified a need for more expertise in the orchestration and chain of identity functionality to complement our patient support, transportation, and third-party logistics services. As we scanned the market, TrakCel quickly became a top partner, converting both companies in the fusion of some of the best-in-class capabilities required to support new therapies.

Matthew Lakelin: At different steps of the supply chain and supporting ecosystem that is required to deliver these therapies, there is an AmerisourceBergen solution. What we can do with a partnership and the integrations we have built together is really simplify the journey a drug product goes on and give the greatest chance of success for a patient to receive that therapy.

"Having solutions such as payer verification and patient approval through the integration with the Fusion system is fantastic because it does not only simplify the challenges associated with the front-end part of the process, it also expedites it."

Some of the recipients of these advanced therapies can be gravely ill. Time is of the essence in these situations. Logistics needs to be carefully understood, planned, and handled. From personal experience, before we started TrakCel, I had used AmerisourceBergen’s logistics company, World Courier, to move these advanced therapies products. What I find useful about the integration with World Courier, is the fact that we have a ready-to-use system with a company that has a cultural understanding of what is required to deliver these therapies.

This is not just about collecting a consignment, but it may be someone's life chance. It is critical to ensure the shipment is moved correctly, managed correctly, handled correctly, and delivered on time. With the integration that we have built, we have actually made it simpler and easier for sponsors and owners of these therapies to get those products to the right patient at the right time, whilst driving down the associated administrative costs. By doing so, we reduce the cost of goods and contribute to democratizing these therapies. 

What are the most important characteristics of a successful partnership?
Jeff Buck: First and foremost, trust. Everybody needs to come into a partnership with a clear expectation of what both parties are responsible for. Then you can start getting into the collaboration and sharing of the ideas. Secondly, the mutual understanding, respect and appreciation for what expertise both parties bring to the table. This will help identify the problem areas, prioritize them, and really get focused on fixing the prioritized areas or, at least, developing them to bring the current integration and potential future integrations to market.

Matthew Lakelin: One important part of our great partnership was the fact that both parties were bringing significant expertise from their own fields as well as taking the time to develop the best way forward, was key. TrakCel cannot be an expert on every part of the process. So, to be able to leverage the expertise that AmerisourceBergen has, was just fantastic. 

What advice do you have for companies looking at forming productive partnerships?
Jeff Buck: When getting involved in a partnership in any industry and especially with health care, there can be successful partnerships, and the AmerisourceBergen-TrakCel partnership is a great example, and there can be less successful ones. The expectation management and understanding the roles that both parties are playing are critical. Getting a good judgment on the culture of the two organizations is critical, especially with companies that might have different structures and sizes. There can be a culture clash in bringing two organizations together. Getting a good understanding of what those cultures are, setting those expectations, building that trust, and caring for that relationship over time, is essential.

Matthew Lakelin: Continuous communication is a key to success. When you look at the size of the AmerisourceBergen group versus the size of TrakCel, it could have been a little bit intimidating. But what we found is that we were working with great people and there was a clear vision.

As to the benefits that the collaboration brings, we are all focusing on a common goal, which is getting something that works for the patient, the supply chain, and the owners of those therapies. I think it is a perfect collaboration.

How can successful partnerships enable acceleration of advanced therapies?
Matthew Lakelin: When we first started TrakCel, we thought our software would be a standalone tool for managing change of identity and chain of custody. But the industry has evolved and its needs changed.

 "Connectivity is now important for advanced therapies. They have the most complex supply chains of any pharma product. They have some of the greatest demands as well, from the patient needs to the management of the drug products."

It would be foolish to think that a single group can do it all without any collaboration. To enable acceleration of advanced therapies, it is essential to look at the drug product journey and the patient journey, think about the risks inherent to the supply of that product and then think about partners that can drive down that risk, whether it be the way in which that product is moved and handled or perhaps in finding payer approval.

By identifying those areas of risk, you will be able to identify those partners that will bring the greatest value to the supply chain. And thus, develop the necessary synergies and collaborations.

Jeff Buck: My approach to partnerships has always been “fail early and fail fast.” Conferences like the Advanced Therapies Week allow us to engage with so many stakeholders in the industry. Understanding their goals and using that voice of customer approach to understand what is working, what is successful and where is that next opportunity, is important. As a single organization, we can only place so many bets and we can only experiment so much. Having the collaborations and the partnerships, talking to people and seeing what they are doing in the industry really just accelerates the next opportunity and just really help connect the dots and advance the industry. 

Could you give an example of a project where your partnership has been especially successful?
Matthew Lakelin: What tends to happen in the supply chain for commercially available therapies is that once a patient has been identified and enrolled into the TrakCel software, there is a long pause while waiting for payer approval to come through. This can be quite distressing for the patient and their families. Also, because of the challenging way in which advanced therapies are financed, due to their high value, it can lead to significant delays. But thanks to our integration with AmerisourceBergen, we can transfer that authorization and insurance data instantaneously once a patient has enrolled and allows AmerisourceBergen to undertake their activities.

Jeff Buck: That connection between TrakCel’s OCELLOS and AmerisourceBergen’s Fusion system, which is our Premiere CRM system, enables our patient counsellors to see cases in detail and start working from a benefit verification or prior authorization perspective. That system gives OCELLOS access to some of our advanced technologies that we have had a lot of success with. For instance, it grants access to our EBV Smart Point technology, which is a best-in-class predictive analytics modelling tool that lets us understand major medical benefits in the market for specific patients and specific plans, as well as to our electronic prior authorization technologies, which automate prior authorization submission and tracking.

A patient either just got diagnosed with something very scary or they knew about a disease and they are now going on a very provocative treatment that is new in the market. And to be sitting in an office or even at home, waiting to understand what this path looks like, is quite a traumatic event for a patient. By having the integration with OCELLOS, we can accelerate getting transparency of that information back to the provider, back to the payer or back to the patient, and really give them an update on the status. There is always transparency in the information as we through some of this administrative burden to get them access to the therapy.

This first integration is really focused on benefit verification, but it does give us access and the jump off point for us to advance the relationship and the connectivity that we can have further downstream. We can then look into access to affordability options like commercial co-pay or patient assistance and some of our adherence services and access to some of our nursing and telehealth staff for coaching and ongoing support to the patients. 

What does the future hold for the advanced therapies industry?
Matthew Lakelin: I see the advanced therapy market growing over the next few years. What we are seeing now is that a few years ago, there were challenges around manufacturing these products. There were challenges around administering these products and certainly the manufacturing challenges have been to some extent solved. What this leads me to believe is that over the next few years, more of these therapies will come to market. More will be approved. There will be more indications being addressed and we will see more curative therapies coming along, which is very different from the standard pharma model, which is normally treating symptoms. Now we have these curative treatments coming along.

I also believe autologous therapies are here to stay, but we may also see some allogeneic off-the -shelf therapies coming, as well as more challenging therapies, which will address solid tumors. This opens up a floodgate for new types of therapy modalities and also potential increased challenges around cost of goods. Because the more complex these therapies are more expensive there will be.

But ultimately, we'll see more and more patients having treatment options where they didn't have them before. I think that's really that sort of exciting part for me, which is the part that gets me out of bed every day.

Jeff Buck: I think now that we have this first integration in place, some of our short-term goals are really to focus on getting some customer feedback and some preliminary market data around the effectiveness, as well as ensuring that the integration is meeting the need. As we progress our relationship, the uniqueness of the advanced therapies may require benefit verifications and updates to that information over time. As the raw materials move through the supply chain, ensuring that we understand that benefit verification and the prior authorization status is critical, and also continuing to have the same data elements that we originally saw.

With regards to the other service lines AmerisourceBergen has within the patient support services market, affordability is going to be a huge issue with these products. Our Free-Goods Pharmacy team and our ability to support patient assistance programs is going to be a significant asset as more and more of these therapies come out, to make sure that for any patients with affordability issues, we have solutions in place to get them on therapy and do it quickly. It will also be pivotal to integrate into the process the nursing staff. We have a large footprint of telehealth and field nurses that support our adherence services. We already talked about the fact that these patients are going through a very traumatic time and having ongoing coaching and support with clinical staff that has expertise in these therapeutic areas is really going to be high-priority. And having that communication and connectivity back to those patients will be very helpful.

From an industry trends perspective, this is still a young market, especially in the United States. We don't have a lot of therapies fully commercialized. Everyone is still trying to understand how best to support them. As more and more come out, there is going to be a lot of opportunities for standardization and getting some standards around how are we measuring outcomes? What are the data elements, what are the critical integration points and how does it all fits together? How payers are going to treat these therapies is a huge opportunity as we look at our services in an area where there is still so much uncertainty. Given the high price point and the fact that the therapies cure over a certain time period, there is going to be a lot of movement around outcomes-based contracting with payers and how we are actually managing that, and monitoring and validating those outcomes to ensure that the payments that they need are valid.