Now more than ever before, it’s critical for pharmaceutical manufacturers to use data and analytics to drive product success and enhance patient access.
In today’s complex and competitive landscape, leaders at Innomar Strategies, Xcenda and IntrinsiQ Specialty Solutions—all a part of AmerisourceBergen—help manufacturers leverage real-world evidence (RWE), data and analytics to build successful commercialization and market access strategies.
In a video interview with Fierce Biotech, the AmerisourceBergen experts explain the value of data and RWE throughout the product journey—from the pre- to post-launch phase.
Rebecca Willumson: Hello and welcome. I'm Rebecca Willumson. I'm the publisher of Fierce Pharma and I'm joined today by Michael Eaddy, Vice President of Scientific Consulting at Xcenda, Alison Drinkwater, Senior Director of Strategic Consulting at Innomar Strategies, and Jill Walton, Vice President of Commercial Analytics at Intrinsiq Specialty Solutions, which are all a part of AmerisourceBergen. Today we'll be discussing how data and analytics drive product success, enhance patient access and help us move healthcare forward. So, Michael, Alison and Jill, I want to thank you all for joining me today.
Jill Walton: Thank you.
Rebecca Willumson: So before we dive in, can each of you provide a bit of background on yourselves and your companies? Michael, why don't we go ahead and start with you?
Michael Eaddy: Yeah, thanks Rebecca. Well, you know the commercialization journey for products is complex, is competitive, and is very unique to every part product starting with how you design your clinical trials, what should be the standard of care that you include in your trials? So as you approach launch, what tools do you need to demonstrate the value to all of the stakeholders. We help manufacturers generate and execute strategies using robust evidence-based insights throughout the commercialization journey. And we leverage real-world data and data analytics to really help create and communicate this value. Our goal is to help manufacturers bring their innovative products to market so that patients nationwide have access to these critical therapies.
Rebecca Willumson: Okay. And Alison, do you want to go ahead and introduce yourself?
Alison Drinkwater: Thanks Rebecca. As you said, I work at Innomar Strategies and I lead the consulting team here. We provide solutions across the product life cycle, through unparalleled relationships and valued expertise in market access, health economics, market research, and real-world evidence. We help enable existing manufacturers as well as those new to Canada to develop and execute effective commercialization strategies, ensuring patients efficiently gain access to the latest advances in healthcare. At Innomar strategies, since 2001, we have provided an unparalleled balance between patient care and market access and continue to deliver innovative solutions to specialty manufacturers. And what we're really trying to do and enable is produce and product access, increase, supply chain efficiency, and ultimately enhance patient care.
Rebecca Willumson: Very good. And Jill, how about you?
Jill Walton: Hi. So Intrinsiq Specialty Solutions is what we call a data analytics and business intelligence company within AmerisourceBergen, and we actually serve two distinct customer bases. So half of the organization focuses on specialty provider as the customer, and we have proprietary technology that includes data analytics and business insights as a part of that technology platform. And then we have the manufacturer pharma-facing part of the organization that focuses on using clinical data outputs for many of those proprietary systems or other systems to support the teams, whether it's the brand team or market research in their analytics approach.
Jill Walton: So in leading up commercial analytics team, our organization only focuses on manufacturers and the pharmaceutical partner, and we're really supporting them throughout the phase of a product life cycle. And our solution set is mixed. So it's a mix of syndicated product solutions that project U.S. Market share, for example, that you can subscribe to, to customize analytics solutions that are brand or even therapeutic indication within a brand specific that provides reports. And we can do data integration. If the pharmaceutical partner has their own, where they're integrating data sets, we can provide components to that to make a more comprehensive solution. And then last but not least, on the real-world evidence on medical affairs side, Mike's team very often from Xcenda, in doing outcome studies, clinical trial recruitment, a variety of elements, whether again is in the clinical trial phase or in the post-launch and maybe a phase four or subsequent analysis.
Rebecca Willumson: Very good. All right. So I'm moving into our discussion. Let's break the product journey to three phases: pre-launch, launch, and post-launch. Michael, I'll start with you. What role do data and real-world evidence play in the pre-launch phase and how has that evolved in recent years?
Michael Eaddy: Yeah. You know, from a prelaunch perspective, the last five years have been really exciting from a manufacturer perspective, being able to leverage real-world data. The 21st-century Cures Act, which was signed in 2016 was designed to help accelerate product approval, allowing manufacturers to use evidence-generation techniques beyond that, of just traditional clinical trials. And we've been able to leverage real-world data to identify historical controls outside of the clinical trial. Generally you have to randomize patients to your treatment of interest and a standard of care.
Michael Eaddy: And for orphan diseases of the sample size of populations are just so small that randomization could be problematic and require for your trial to go over a longer period of time. Being able to select controls outside of your clinical trials has that potential to reduce time, cost, and the patient burden associated with clinical trials. And given to technical and regulatory challenges related to proper RWE development, it's essential that manufacturer seeks partners that understand this process and have very good experience where evidence and providing that type of strategic guidance. Our goal is really to leverage real-world data to help accelerate and make this process of regulatory approval more straight forward and more efficient and having the right partner to help you do that.
Rebecca Willumson: Jill, do you want to comment on this as well?
Jill Walton: Yeah, I was going to say one thing I would add to that is a key capability that we have in working with, again, our provider partners and members is to supplement the real-world evidence and analysis that the extended teams does is accessing what we call the unstructured data within an electronic medical record. So what I mean by unstructured is it's not in a discrete set of words. So something of stage one, stage two, or metastatic, where it's a discreet element, but it could be something like a 25-page PDF with a variety of lab results for a particular patient, or often it could be that dictated physician notes after the patient leaves and the physician dictates into the chart, his or her assessment of the patient's status. And all of that free text is stored in the electronic medical record. So our team of clinicians works with, often Mike's team and the sponsor client, to build out discrete elements from that unstructured data.
Jill Walton: So mining those lab results, curating that to identify which patients qualify it because they have particular biomarker results. Or within unstructured data, a key example of that could be looking at when there's a regimen change. And what was the reason for that change? Was it because the patient progressed and in the physician's notes, they said, patient failed therapy, disease has progressed? Or did they say alternatively patient had toxicity, a side effect, we need to switch that regiment? Well, that difference is critical to how you analyze the data of the success of a drug and the treatment. And so being able to pull that out from the unstructured is a key attribute that we have and a team of experts that's able to do that in conjunction with the client's protocol.
Rebecca Willumson: Jill, what other provider insights can you share with manufacturers prior to product launch?
Jill Walton: Really we've heard from the manufacturers and there's a lot of information about this in the media right now, that a key issue to getting to market is clinical trial, patient recruitment. And so pharma has that issue. There's been quotes in the specialty markets up to 20, 25% of trials can fail because the sponsor was not able to get enough patients in the trial. And on the flip side, again, we hear from our provider side of the business, that particularly in the community setting, these practices want to participate in a clinical trial. They're not part of a large academic medical center or a hospital system that typically is where the trials focused. And so we've developed what we call the advanced IQ network, and that is offered up to our 5,300 specialty provider practices. And they opt in to be part of the network. As part of that, then they're providing us access to their clinical data.
Jill Walton: And based on that study protocol, we're able to identify for them that this patient may be a candidate for a trial and to the pharma manufacturer, they're getting that insight that, okay, this site has a potential patient and they're able to recruit them in. And so it's really kind of a win-win-win in that the manufacturers getting access to a broader set of sites where they can recruit for patients to go hopefully fill and successfully complete the trial. The providers in a particular segment that weren't often participating now have better access. And then of course, the patient. We now are getting patients that are treated in the community setting that are going to get access to novel therapies much more quickly, and be able to be a part of a trial where they wouldn't have particularly been a candidate before. So it's not as much an insight to your question, but I did want to call that out as a key opportunity, solution that we have to meet both of those customer bases.
Rebecca Willumson: Sure. And so one final follow up on that, Jill. So is there a specific example you can share of how your team supported a manufacturer as they prepare to launch a product?
Jill Walton: Absolutely. And that's really where our engagement outside of real-world evidence picks up. And we spend a lot of our activity with those brand teams as they're preparing for launch. So an example I can give right now, we've been working with the CAR T team as prep for the six months prior to their planned FDA approval date and did a couple of things. So back to kind of those insights, the first was identifying practices and providers that had patients that were potential candidates for the CAR T therapy. And so if this is something that's going to be used after a certain set of treatments, these are practices and providers that have patients that could fail. And so then we're able to work with them to conduct primary market research on understanding more from the provider base, how do you identify progression? How do you monitor patients?
Jill Walton: How do you potentially make that change decision, particularly in the CAR T space, where that's a drug treatment that often is going to be only infused in the patient within the hospital? So if you're a community provider, you're not going to treat that you're going to refer them out. So doing research on that. And then right as we get to launch, so that was kind of the earlier, like the six months prior, as we're at the launch phase, we're providing data and analytics on a weekly basis to, and in a secure HIPAA approved manner, but these are sites that have potential patients that are in line of therapy, too. They could be candidates for treatment. And that's where then, the manufacturer is able to partner potentially with AmerisourceBergen GPO solution to do targeted marketing or with other marketing tactics that they may have, or even the traditional sales rep interaction to get to those providers and get the appropriate message to hopefully get those candidate patients for their therapy.
Rebecca Willumson: So Alison, I want to move over to you. How can manufacturers use data to build an effective real-world evidence plan and support their market access and commercial strategies?
Alison Drinkwater: Well, it's a great question. One of the unique things about Canada and Innomar is we actually manage over 120 patient support programs that really fill an unmet need in the Canadian marketplace across multiple therapeutic areas. The patient support program really can become that gold standard in that registry whereby we can collect data across the patient journey and the product life cycle. For example, there were various touch points that we can track data and the patient journey over time. The first is when they're enrolled in the program. We can also garner a pharmacy dispensing data, clinic visits if they're going for an infusion or an injection. And it's really during these clinic visits that we can collaborate with the patient to collect health outcome survey and even adverse event tracking. Over the years of our experience, we've really learned that there's some key components to launching a successful RWE strategy.
Alison Drinkwater: And you really have to ensure you have a robust plan that really examines all the different needs of the stakeholders who are really are going to leverage the data. One of the challenges in Canada is that it's very siloed in terms of how data is collected and aggregated. So our team really supports and looks across that patient journey and that product life cycle to see where all the data components and those points are so we can bring the data together and really look at what are the unmet needs that we're trying to address. We can also support across the product life cycle, say if a product was launched many years ago, when we want to look back retrospectively to see where are there different data sets and where we can capture data and maybe there's even gaps in the data and how can real world evidence address these gaps?
Alison Drinkwater: For instance, maybe it's a market access challenge they're having. Maybe they want to do a line extension or look for other clinical benefits. One of the things that we're going to be doing this year at Innomar is we're actually launching an RWE portal called RWE Connect. And really what we're trying to do is provide a platform for real-world evidence data collection, but that will include enrolling and prospectively following up with patients to generate real-world evidence for quality, life health outcomes, and economic impacts associated with specialty drug treatments of Canadian patients.
Alison Drinkwater: One thing I think that's really novel about RWE, it's the applicability to multiple stakeholders within your product life cycle. Evidence that is collected can really be leveraged for a market access challenge or reimbursement renewal if there's set criteria and also engagement with clinicians who are really important in terms of providing that forum for the patient voice in their own treatment plan. And RWE really provides a unique perspective on the ability to collect data through multiple sources and bring those insights together to really remove barrier. Because really at the end of the day, we want the patient to get the right treatment at the right time.
Rebecca Willumson: So Alison, you mentioned the patient support programs a couple of times. How can patients support programs help capture data that demonstrates adherence and persistence?
Alison Drinkwater: Patients or poor prims really are an integral part of the patient journey. They enrich the existing information because of the large ability for enrollment and patient capture and the multiple touch points with the patient where there's opportunities to collect PSP data. PSPs also have a direct communication with the patient's healthcare team, physicians, the payers, and also the caregivers representing even more opportunities for data collection. We've developed a number of tools here at Innomar to collect data, including analyzing our data from our CRMs, portals for data collection, connecting to EMR data, and also utilizing apps and digital tools to track patient outcomes, which we really see are the future now around patient apps and conducting market research and health economic studies. And we also use data sets to support the manufacturers to help them really make key critical business decisions and increase their uptake for potential commercialization.
Alison Drinkwater: So one of the examples I can provide is we had a client who had launched an oncology product that required monthly intermuscular injections conducted by a healthcare professional. Although clinics offer these injection services, adherence was really sub-optimal due to the patient's not maintaining clinic schedules and missing their appointments. The consulting team conducted a deep gap analysis to looking at the frequency of injections and tracked for a month over month analysis. The analysis revealed that patients who received injections at home had a much higher adherence and therefore Innomar built with the manufacturer, a strategy to increase promotion of Innomars at-home injection services to patients.
Alison Drinkwater: And I'm happy to report by six months, persistency was increased by over 70% and the medication was perceived by patients as easier to administer, offering competitive advantage among other products. And really at the end of the day, it was the overall increase in patient satisfaction as a result of at-home administration services. So I hope this example really provides you how with a robust real-world evidence strategy, you can really impact patient care.
Rebecca Willumson: That's great. Thank you. So Michael, focusing on the post-launch phase, how can manufacturers gather and integrate data to bolster their product value proposition?
Michael Eaddy: Yeah. Thanks Rebecca. So real-world evidence is just vital for continued commercial success in the post-launch phase. Generally, there are always questions that you can't address with your clinical trial. And as Alison mentioned, real-world evidence can help address a lot of questions for different stakeholders. From the peer perspective, peers are generally interested in it. Are they seeing the same type of outcomes and their real-world population, as you highlighted in your clinical trials and being able to leverage electronic health record data or claims data to show that real-world applicability in the real world for peers is very critical. But also as we talked about, as products are accelerated from an approval perspective, there's a need to follow those products to confirm the safety profile, to really look at long-term effectiveness data. And we are working with manufacturers to develop prospective studies that actually capture that data in a post-launch setting to kind of fill some of those evidentiary gaps.
Michael Eaddy: We've recently worked with a manufacturer who had a clinical trial, very revolutionary product, but the follow-up in that clinical trial was about eight weeks. And so, although this product brought a lot to the table for this very orphan indication, this very orphan patient population, the long-term effectiveness had not been confirmed with the clinical trials. So we helped them design a prospective study to capture that long-term efficacy data, as well as confirm the safety profile for this particular product. So leveraging those prospective studies, our perspective researchers to help really fill some of those evidentiary needs can be done after a product has been launched in the post-market setting.
Rebecca Willumson: So Michael, how, if at all, has the COVID-19 pandemic affected the way you gather data?
Michael Eaddy: You know, we were already using a lot of virtual study designs to help expedite a lot of our prospective studies. And now with the pandemic, we've been able to leverage those virtual options much more readily. And that's really minimize the need for all site physician visits and direct data entry. And then not also has saved manufacturers' time and money. As we have designed prospective studies here over the last year, we've been able to leverage a lot of digital platforms. And as the gentleman mentioned earlier, using electronic health record data to secure a lot of that clinical information, and from a resource perspective, we can combine that also with other data such as claims data. So over the last year, our virtual options really has allowed for data to be captured more efficiently and really paint a complete picture from outcomes, perspective, disease, burden, and treatment patterns.
Rebecca Willumson: And Jill, do you want to have a comment on this as well?
Jill Walton: Yeah, I was going to add, I think one thing that we're really excited about is, it's a benefit of COVID, is we've seen both patients and providers become much more comfortable at using data capture technologies. So whether that's a telehealth visit or the survey proceeding your telehealth visit, where you're tracking your current disease status. What are your side effects? How are you feeling? That data capture many were reticent to do and had to do with COVID. And so we're hopeful and we are fairly confident that that adoption is going to continue again, in both phases, the patients and the providers, and as patients in particular get more comfortable with data collection, then that advances a lot of the things that both Alison and Mike talking about. Patient reported outcomes now is something that they're much more open to.
Jill Walton: I'm tracking my symptoms, I'm tracking my side-effect profile. And so that then of course leads to more data, which then helps all of us in the different ways we're working with our manufacturer partners. And it also helps the providers. So again, what Intrinsiq tries to do, as much as we want that data to go to the manufacturers, Intrinsiq and AmerisourceBergen are investing in, how do you also make sure that that data gets back to the providers in an integrated platform so that they can more holistically identify the disparate pieces on the patient and proactively intervene as well. So again, going back to trying to benefit both segments of the base with this data collection that I think will continue to increase and improve.
Rebecca Willumson: Okay. And with that, I think we can probably close out. I want to thank you all for joining me today. Thanks so much for a great conversation.
Michael Eaddy: Thanks Rebecca.
Alison Drinkwater: Thank you.
Jill Walton: Thanks