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What you need to know about the next generation of clinical products

Radio Advisory's Rachel Woods sat down with Advisory Board expert Fanta Cherif, Optum Rx senior director of pipeline and drug surveillance Bill Dreitlein, and Pear Therapeutics CMO and head of development Dr. Yuri Marcich at Advisory Board’s 2022 Service Line Summit in St. Louis, to have a conversation about disruptive clinical products and how organizations can prepare for and embrace next generation diagnostics and therapeutics.

Read a lightly edited excerpt from the interview below and download the episode for the full conversation.

Rachel Woods: There's a huge, huge range of what we could be talking about when we say, next generation therapeutics and diagnostics. Fanta, what do we actually mean when we're talking about this?

Fanta Cherif: So, through my research stream, we've kind of identified seven different buckets of what this actually means. So we've broken it down into, at-home diagnostics, biomarker testing, deep brain stimulation, psychedelic assisted therapy, pharmacogenomics, and ultra-high cost drugs.

So typically, when we're looking at these products, they really just require a higher level of stakeholder interaction and collaboration. They also, typically, are higher cost, they are indicated to treat really rare and severe disease, sometimes they may be indicated for individual treatment decisions, so maybe deferring, depending on which individual you're actually treating, and then lastly, they really, really, really are changing the routes of administration.

So whether that's through infusions, deep brain stimulation, as we said before, so like helmet caps, brain surgery, et cetera. So really just changing the way we are thinking about care delivery, how we generate evidence, and collect evidence, and how we use evidence, looking at differences in payment models, and then lastly, really challenging how we regulate these things, because there's so much flexibility.

Woods: But all these things, to me, they sound great, as somebody who's a patient. We're all also patients. These sound like something that I would welcome, when I think about my own future of health care treatment.

My question for you, Bill, and for you Yuri, is, why is this a problem? Why is this going to be disruptive for the industry, if we're not prepared for these next generation products?

Bill Dreitlein: Why is it a problem? Well, I guess, in some ways it is, and some ways it's not. I mean, in some ways it helps us do our jobs better, but how it can be a problem, is if we're not aware of it.

I think those are the things that are truly disruptive, when something new and revolutionary comes and we just get blindsided by it. That's the thing that can really upset your business and even put you out of business. Thinking back to the hep C drugs, innovative, disruptive technology that nobody saw coming, and the byproduct of that was that there were some plants that, almost went out of business, because they weren't prepared for the volume, they weren't prepared for the costs, they weren't prepared for, how do you deal with a one-time course of treatment, that could actually cure an infectious disease, something we have real problems with?

Woods: But cost a ton of money.

Dreitlein: Yeah, but cost a ton of money. So there was no question about the value, right? It was clearly valuable to wipe out hepatitis C, we want to do that, but at the cost, then it got to the point where we have to figure out, well, who do we prioritize?

Woods: Or value to whom? Valuable to the patient, but yeah. Yuri, what's your take? Why will this be disruptive for the industry?

Yuri Marichich: I think also just looking historically. This is to me, one of the great paradoxes of health care is, we have, basically, a whole sector that has been driven by innovation, by new things, but the challenge is we are now starting to, I think, really confront what is astronomical, slash, exponential growth in terms of cost.

And so, to your point, Bill, then there's these questions of value. I think on the provider's side, even though, historically, we've changed a lot and adopted a lot of new things, it's also hard for each one of us as an individual, or for health systems or clinics to say, yes to one more thing. There are too many things for any individual clinician, let alone an organization to do. And so, now we're saying, "Oh, and guess what? We're going to add one more thing."

The second thing, on the payer side, is trying to really understand these questions of value and balance the concern about over-utilization, with also the fear of not adopting things soon enough, and that's also the paradoxical situation that each payer finds themselves. And so, that's also why you see a lot of both fear of missing out, but fear of being first, at the same time, and everyone's looking around the room to see, who's going to make the first move.

Woods: Why should we be focusing on this now? Right? We've all been at Advisory Board's summit event, hearing about all of the challenges and all of the opportunities in health care.

Why is it that in 2023, very soon, we need to be prepared for a world where we're going to have more of these products? Why now?

Dreitlein: It's not theoretical. All these things, the list that you gave at the beginning, deep brain stimulation, gene therapy, pharmacogenomics.

It's here, and that's one of the differences between, the conversation today, and the conversation we might have had 10 years ago. It's here. There are already four gene therapies on the market. Next year there's going to be eight more.

We already have CAR T therapy, we got eight of them, and then they're bleeding into other disease states, and that understanding is now, carrying over into other areas. So it's important to plan for it, because it's here. It's just going to come in greater quantities in 2023.

Cherif: Yeah, I was going to say something similar. It's almost inherently flawed that we talk about these things, as the next generation, because they're already here. So they're not a problem of the future, they're actually things that we should be preparing for now. It's not enough to just be aware of them, but we actually need to take the steps to make strategic implementation.

Marichich: And maybe I'll just add, I think the pace of what is here now, is moving faster. We definitely saw that with Covid, which is organizations who are like, "Yeah, we do a little bit of telemedicine," and all of a sudden that became mainstream, but now we're grappling with, is that still the best way to do it, is the right thing and what case?

So in many situations, we're having organizations, who are already above capacity, now trying to figure out how do they be become continuous learning organizations and continuous adopting and continuously evaluating, what works and what doesn't.

So it means we also then have to figure out, how do we analyze and run killer experiments to say, yes or no to things, at a scale before, that we never were able to.

Cherif: And on the note of Covid-19, it's also just exacerbated the mental health burden, behavioral disorders are on the rise, lifestyle diseases are on the rise, so a lot of these patients who are facing very severe diseases, need alternative treatment options, so the market is booming because of that.






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