Progressing the patient-specific drug supply chain

July 27, 2021
Bill Burke, CEO and founder of Merit Solutions, discusses how transformative business models present both challenges and opportunities for biopharma manufacturers

Today's personalized, patient-specific therapies are a powerful extension of traditional approaches to the way we understand and treat disease. However, this new approach to medicine hinges on patient data and patient experiences. This is allowing biopharma manufacturers to use new, cloud-based digital platforms to extend new experiences to patients and their providers, all the while using the data captured to disrupt traditional business models.

As traditional healthcare boundaries blur, biotech and pharma manufacturers will serve patients in ways that previously didn’t exist or weren’t possible to address.

Pharma Manufacturing recently spoke with Bill Burke, CEO and founder, Merit Solutions, to get a better understanding of how implementing an end-to-end business solution platform can enable pharma manufacturers to smartly respond to the opportunities presented by both digital and patient-specific therapies.

Q: The business model for biopharma manufacturers is changing. What is driving this rapid evolution?

A. To begin with, the science behind drugs and therapies has advanced, enabling more personal, more efficacious treatments. So, on the one hand we have this kind of business model pressure because it’s driven by the science and the ability to have individualized therapies.

This has played out in the market as well. The first quarter of 2020 was the single largest quarter ever for biopharma venture funding in the U.S. (According to data from Pitchbook, the first quarter of 2020 topped in at $5.5B in aggregate funding across 171 financings.) The majority of that funding goes into immunotherapies and genetic therapies, both of which lend to patient-specific drugs and therapies.

As a result, biopharma manufacturers have to respond and determine what role they will play in the patient-specific biopharma supply chain, and determine the right business model for them.

And at the same time, new, cloud-based digital platforms are available, operating within compliance requirements of FDA regulations, that allow new ways for connections to exist, work to happen, and value to be conveyed to patients and providers. In the old world, we had these software apps and that’s where biopharma kept their patient data, product data, customer data, etc. And those sat on a server somewhere. There were all kinds of safety regulations around keeping those closed. Now biopharma can move to a cloud platform, which has infinitely higher level of security and threat detection, data protection and ability to extend experiences out to patients and providers using mobile and portal components.

Q: What new opportunities exist because of the availability of these cloud-based digital platforms?

A. What came with these platforms — and I’m really specifically talking about Microsoft Azure and Amazon Web Services (AWS) as the two predominant cloud platforms — is the ability to move from this view of “I have to have these software applications” to this new world where users are really focused on their data (cloud providers call these data lakes).

Once biopharma manufacturers get all of their data into a cloud platform, they can do things against it that they previously could not do, because now they have AI services and learning algorithms that can run against that data. Essentially, users get the data into a big data lake and literally turn on these learning algorithms and let them loose — then, three or four weeks later they come back and see what sort of patterns exist.

These software algorithms and tools are really the big enabling side of this digital equation. Because once the data is in there and the user is on this cloud platform, they can, for example, with very little or no code write a mobile app and hand it to a patient or caregiver and it will extend with security and compliance.

Using their own data, biopharma manufacturers can make new experiences happen —and those new experiences are what patients want.

Biopharma companies now have to think about, “How do I order my priorities?” These new digital strategies are becoming a strategic priority.

Regardless of how a company gets to that digital platform, once they’re in that platform, then they have all these opportunities — all these ways of interacting or delivering the value of change. Because the digital platform has the data and has built-in capability to discern patterns and point out recommendations, tremendous upside exists in terms of patient outcomes by doing this well.

Q: What problems or challenges will occur during this digital evolution?

A. Often companies don’t know how to approach this new digital business model yet because they are stuck in their existing business model, dealing with the typical problems that arise with rapid growth and technology changes. For example, they find themselves with disparate systems, security issues, duplicate processes, and personnel risks.

This first challenge is really difficult because it’s headspace and culture. Often the incumbents are the ones that lose in these sorts of times of transformation because they’re holding on to what they have and the profits they have and the relationship way that they interact — and they just get disrupted. And we’ve seen that in many other industries.

Most biopharma manufacturers today are defining their problem sets according to these existing patterns. One, how do I clean up this data and systems mess that is supposed to be supporting my existing strategy and two, how do I get operational efficiencies and better user experiences for my existing scenarios?

The new digital model means that companies need to collaborate and perform with speed and high quality simultaneously. This includes ways to better capture orders and perform customer readiness, better manage invoicing and shipping, plan and produce batches and manage variability, better manage approved suppliers, tackle NCRs and CAPAs, perform audits and meet compliance requirements and ensure repeatability.

Hence, biopharma companies need to start thinking about their problem set as: first, creating new scenarios enabled by a digital platform that fundamentally changes patient experience and outcomes. And then from that, work backwards to solving the clean-up and operational efficiency priorities.

While you can clean up some of your messy problems by getting onto a cloud platform as a tactical step, your real priority has to be “How do I connect in the digital space?” Some of the problems they think they have may actually no longer be relevant because they won’t be performing those scenarios in a new business model.

Most patients have already moved to digital, and a plethora of apps already exist to help them. As a pharma company, your digital platform has to connect and interoperate with those apps to provide a complete patient experience. Companies need to ask themselves, “How do I make myself part of the patient experience?”

Ultimately, all situations require a platform that’s built to support their business model today and in the future. To invest in long-term success, the most important piece is having a growth-ready platform that allows them to not only grow, but nimbly change and adapt.

Q. What’s on the horizon for pharma in this digital era?

A. The ability to use patient data to advance the science and the therapy itself is really exciting. Now drug and therapy makers have the ability to collaborate and syndicate data with others in a way that is not just advancing the science, but also protecting data.

With the data protected, there are some really interesting new opportunities that come into play enabled by blockchain and some of the other services that come on that digital platform that you couldn’t do before.

Both the ability to collaborate on data for cures and the simultaneous use of new digital models create these digitally-connected, collaborative patient experiences. Ultimately these step function increases will lead to better patient care and more lives saved.