Find episode transcript below.
GLENN HUNZINGER:
00:00:03:01 Welcome to PwC’s Next in Health podcast. I'm Glenn Hunzinger, PwC’s Health Industry Leader. On today's episode, we'll be diving into a topic that's top of mind across the pharma and biotech industries, the ongoing disruption at the FDA and how companies can respond with agility and intention.
00:00:22:10 Joining me today is Matt Rich, PwC’s pharma and life science R&D leader. Matt had recently put together some insightful views on this topic and he is here to share the big takeaways.
MATT RICH:
00:00:35:07 Thanks Glenn. Happy to be here.
GLENN HUNZINGER:
00:00:36:08 Let's hit the big picture here, Matt. There's a lot of noise going around about the FDA changes, what's actually happening. Why should pharma and biotech leaders pay close attention? Can you share some light about this?
MATT RICH:
00:00:49:04 Yeah, Glenn, the big picture is pretty challenging right now. The FDA has announced a bunch of layoffs, kind of downsizing or right sizing depending on your point of view. That is causing perceived and actual approval delays. And it's not just the small biotechs or the large pharma med device
00:01:07:03 and anybody that has to go through any sort of FDA process to get their drugs or devices approved are starting to feel a little bit of the pain. And my expectation is that pain to continue and worsen maybe over time. Right? So it's kind of an unpredictable landscape.
00:01:22:05 There are obviously big risks, not just ROI risks to the companies, but obviously, the patients that are waiting for some of these innovative drugs to come to market are the ones that I think have the highest risk.
GLENN HUNZINGER:
00:01:35:10 And speaking of patients, Matt, listen, our patients need us now more than ever. You've built a career on sort of navigating very dynamic landscapes. Can you talk a bit about what companies can do to take control of this, keep their programs moving forward during this period of uncertainty?
MATT RICH:
00:01:52:07 That's a great one, Glenn, because there's not much we all can do at this point to control or even influence significantly some of the regulatory side of things. So you got to look internal, you got to look in and control what you can control within your own company, right?
00:02:07:07 And a couple of those are like looking at speed and efficiency. How can I get all of my information together succinctly? How do I focus on those primary endpoints that are the most important and not have my submissions be too large and complex? Making sure that those submissions are kind of right first time.
00:02:27:20 The streamlining is going to be super important to make sure that there's not amendments and other regulatory interactions that have to happen after final protocol approval and other things. So really minimizing any sort of back and forth and streamlining what you can on your side in your own company is going to be very, very important.
00:02:46:05 It might in the future, kind of look at maybe the FDA uses more AI and automation or things to make themselves more efficient, but until that we have to look internally to how are we going to make ourselves more efficient.
GLENN HUNZINGER:
00:02:58:00 And I think that's right, Matt. And so you're kind of hitting on it, but what can companies do to avoid getting stuck in this backlog?
MATT RICH:
00:03:06:10 I think the first one, and I talked about this in the article a bit, is the foot fault concept, right? So there are preventable mistakes. We all make them, right, but trying to minimize those preventable mistakes and submissions, whether it's maybe not having enough of the right data, maybe it's something that happened where you're not tracking to the endpoint
00:03:26:00 the way that you thought you were and maybe the submission is not supporting the evidence in the right way. So the FDA has to come back or questioning your safety profile that you're presenting. All of these things we've all seen over the past decade. The issues when you're submitting and the FDA is reviewing and then coming back with a bunch of questions.
00:03:45:09 So having that submission be airtight, again, simplified and streamlined, not maybe having as many endpoints as you had in there before and having it reviewed rigorously internally. So there's just less chance of that, right? And that comes down to that strong internal regulatory function to be able to understand
00:04:05:07 what the questions were in the past, understand maybe some of the footfalls that you have in the past and making sure to check the data, the submission package, everything before you submit.
GLENN HUNZINGER:
00:04:16:20 I like that. Let's get on the front foot, let's tighten up, let's see around corners and you're right, control what you can control. So it's great from a leader's perspective, obviously, keeping the ball moving forward and sort of really looking at things you can control, but what can people do and what can leaders do externally? How do they think about that?
MATT RICH:
00:04:36:10 Well, I think that's one of the mitigating strategies here, right? Is obviously, some uncertainty in the US. There's still plenty of market out there in other geographies. So engaging with regulators like European Medicines agency, Japan's PMDA in parallel, to be able to do the parallel submissions, the parallel tracks of approval
00:04:56:20 and kind of diversify your regulatory risk is going to be very important. I mean, it's hard to do and maybe not every company is equipped to do that, but if you've got a really important drug that's going to help a lot of people, right? And we know that there's uncertainty in the US market, figuring out how to create that parallel submission,
00:05:14:06 monitoring the global timelines of your submission, all of that, that goes into really global regulatory submission excellence. And really, that's the way you're going to get it to the most patients. So that's something that we should all be looking at, but it's a hard thing to do. Very much easier said than done,
00:05:31:00 but that's one of the biggest ways to diversify your risk and obviously speed patient access.
GLENN HUNZINGER:
00:05:35:07 Yeah, that's interesting here on thinking about global to diversify things a bit. Obviously, it's not just a risk mitigation strategy, it helps build momentum. So how do you think about that when you think about sort of the broader FDA rebuilding and moving forward and what can companies do to help sort of guide that?
MATT RICH:
00:05:57:10 Yeah, this is an interesting one because I'm not sure that we've seen at least in the last 15 to 20 years, this much uncertainty. So there's not really a great playbook to say, okay, this is how we should engage a certain trade association or a certain advocacy group or whoever,
00:06:13:08 pharma companies, med device companies in the effort to influence what's happening at the FDA. I'm not sure that we've seen anything before that's this, I guess, potentially disruption focused and I guess this challenging. So it's a little bit new territory. We're kind of in uncharted waters, which is interesting but hard, right?
00:06:36:07 So I don't know that a single group is going to make the change. I think getting alignment across the different groups, the advocacy groups, pharma, med device, trade associations, getting everyone aligned and coming back with a common message to push is super important.
00:06:52:10 Maybe engaging like we've never engaged before with the FDA to support how they maybe review the submissions, how they look at the data, maybe giving them technology or providing them more automation and capabilities to do things with less, right? Do more with less people.
00:07:08:50 That might be one way. Again, we have never done that. It's kind of new territory, which again is interesting. But those two things are kind of the primary. Another one that might be interesting is using technology to help the FDA, but then having pharma companies offer them with their submission package, maybe some technology
00:07:26:05 to more quickly review a submission package from a certain company or easier to interpret data or being able to ask plain language questions to the data that's submitted. There are a lot of different ideas percolating, but again, this is a very challenging area, but also, again, time for the industry to revolutionize like it's done before.
GLENN HUNZINGER:
00:07:47:04 No, I think that idea of we're all sort of in this together and private and public kind of coming together, certainly we're going to see in other industries, and I feel like life science is pretty well poised for that. There's a common goal that everybody wants, and I think if we can team together, that certainly heads everything in the right direction.
00:08:05:20 So, Matt, before we wrap up here, I think you're sort of known as somebody that gives pretty practical, tangible advice that people can action. Any last sort of takeaways for the leaders out there?
MATT RICH:
00:08:16:00 Glenn, I think it comes back to really controlling what we can control, right? That's the pragmatic aspect of this, and part of it is the no footfalls, making sure everything is buttoned up, taking all the learnings, whether it's learnings in people's heads or learnings that we've seen through the information
00:08:33:10 and data and regulatory back and forth that we've experienced before. And building that into the submissions. There are things that we can do diversifying across geographies. There are some very pragmatic things here to do, but it's going to be an unprecedented time and a challenging time.
00:08:48:30 But like we've seen, our companies have always risen to the challenge. So I'm excited to be part of that.
GLENN HUNZINGER:
00:08:53:00 Thanks, Matt. I think the insight you give here is great and resonates, and it's no doubt that you help our clients do what they do best, which is save lives. So thank you for what you do to help sort of move the R&D landscape and to help our clients sort of navigate these challenging times.
MATT RICH:
00:09:09:00 Appreciate it, Glenn. Thanks for having me.
GLENN HUNZINGER:
00:09:10:07 We invite listeners to read Matt's blog linked in the show notes here. For more on these topics and other health industry insights driven by policy, innovation and care delivery changes, please subscribe to our podcast at pwc.com/US/Next in Health podcast. Until next time, this has been Next in Health.
FEMALE VOICEOVER:
00:09:33:04 This podcast is brought to you by PwC, all rights reserved. PwC refers to the US member firm, or one of its subsidiaries or affiliates, and may sometimes refer to the PwC network. Each member firm is a separate legal entity. Please see www.pwc.com/structure for further details. This podcast is for general information purposes only and should not be used as a substitute for consultation with professional advisors.
