Host Carrie Nixon talks about Biotech and Life Science opportunities with innovation attorney Tommy Miller, who works with these types of companies every day and often serves as an expert speaker and commentator for the industry.

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In this episode you’ll discover:

• Biologics, including reimbursement, accelerated FDA approval pathways, what sector of the industry can speed growth for everyone, and the push for developing mRNA and gene editing therapeutics for difficult or rare disease states;

• Software as a Medical Device (SaMD) and how the new “remote therapeutic monitoring” CPT codes revealed last week in the proposed 2022 MFPS will increase reimbursement options for mood and pain management—as well as the FDA’s investment in the Digital Center for Excellence to improve the regulation of SaMD;

• Decentralized trials and home digital health tools and how these trends are expanding recruiting options and returning more realistic data because people are accessing and using these products at home.

Keep scrolling for a transcript of this episode.

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Read the transcript:

Tommy Miller (00:00):

The opportunity here is for companies who are sitting on academic medical centers or researchers that are sitting on these advanced and clean manufacturing technologies to really start pushing for funding, really start pushing for an advancement of their technologies. The more of that we have available, the more that these pharmaceutical companies can rely on that technology and the more comfortable the FDA is going to get.

Announcer (00:25):

You're listening to Decoding Healthcare Innovation with Carrie Nixon and Rebecca Gwilt, A podcast for novel and destructive healthcare business leaders seeking to transform how we receive and experience healthcare.

Carrie Nixon (00:37):

Hello everyone, and welcome to the latest episode of Decoding Healthcare Innovation. I'm Carrie Nixon, and today I'm joined by Tommy Miller, chair of the Life Sciences Practice at Nixon Gwilt Law. In this episode today, we'll be talking about the latest trends and innovations that Tommy's seen in the life sciences space. So Tommy, welcome to the podcast.

Tommy Miller (00:58):

Thank you, Carrie. Happy to be here to talk about those things today.

Carrie Nixon (01:03):

Great. Well, before we dive into the subs substance, I'd like for you to tell the listeners a little bit about your background because you're very passionate in this space and in this sector and I think it's helpful for them to know what drives that passion.

Tommy Miller (01:16):

Sure. I started my career in healthcare representing healthcare providers and hospitals and health systems. I started gravitating toward a lot of really innovative technologies that those clients were implementing in their facilities. I also had a little bit of a personal issue that my wife went through that really drove me to look toward advances in technology around life science. So that personal interest and then my attraction toward innovation really pushed me into learning more about the law and regulation and life science products the really cool inventions that the vice makers are working on, and then the day-to-day innovation around drug discovery and treatment prevention diseases, all those things. Working with those, those people, you feel like the dumbest person in the room because everyone's so brilliant and working on some amazing technology. So it really does help to be around clients like that and innovators like that to really bring out the passion in it. So I've been working now with you guys and our clients move the needle on innovation and life science, and happy to talk about what I'm seeing recently in the life science industry and where I see the innovation heading there.

Carrie Nixon (02:44):

So there's nothing like a personal experience or a healthcare experience with someone in your family to drive passion in this area. I totally get that. It's part of what drives me as well just in healthcare innovation in general. So I totally get that and I'm looking forward to the conversation. So you and I have spoken a little bit in the past about how life sciences and innovation are practically synonymous because the sector has always been about inventing something new that treats diseases that saves lives every day. But there are certainly some current trends in the space, and I'd love to hear from you a little bit about those. What's kind of top of mind for you in these recent days?

Tommy Miller (03:28):

Yeah, sure. Really top of mind, and I don't think you can really talk about life science innovation right now without talking about biologics. I think with Covid19 and the attention that it brought to not just drug development because we sprinted toward vaccines but also what's involved in creating safe and effective treatments, I think everybody's talking about, and for a while the industry's been heading toward more toward biologic products. With the recent vaccines and the attention that's been paid to them, I think we're going to see more of a push in the biologic atmosphere, and that's with these mRNA technologies, vaccines, CAR T and gene editing. I think we're going to see a huge push and desire to see advancements in those technologies.

Carrie Nixon (04:22):

You mentioned the impact of covid and I think that this has been true across the board, the impact of covid. I miss everything in life, but particularly in healthcare and life sciences. You of course also just mentioned the mRNA vaccines that we saw develop at an incredibly rapid unheard of unprecedented pace in response to this crisis. And we saw the FDA put the pedal to the metal and do what it needed to do to get those vaccines authorized for emergency use. To me, this seems kind of revealing. It underscores what we can really do when we have to. So I guess my question to you is, can we expect this type of a timeline going forward where we're seeing vaccines and other therapeutics develop much more rapidly and be approved by the FDA or at least under some sort of authorization much faster than we had in the past? Or are we really going to go back to the same old same old where it takes an extraordinarily long time to get a biologic to market?

Tommy Miller (05:40):

Sure, yeah. I mean, I think there's definitely going to be industry demand for faster approval of these technologies. mRNA technologies have been around for at least 20 years now, and outside of a public emergency, the emergency use authorization framework just doesn't exist. And so remember, we have to keep, have that framework in mind when we're talking about the approval process here. So the emergency use authorization framework really allowed the FDA to scale back on some of its enforcement and evaluation procedures, but they still took a very measured approach in how they approached the vaccine development. But I do think that they're seeing at least the two mRNA vaccines now in this mass real world clinical trial almost through this emergency use authorization pathway. And I do think it's going to yield some changes to the way that future mRNA technologies are reviewed. The other pathways that exist outside of an emergency use, there are these accelerated approval pathway, which really takes what it would be a standard phase one, two, and three development process and cut it down to a phase one plus a combined phase two and three process and then with a most likely a confirmatory phase four or second phase three study after the drug has been approved.

(07:13):

Carrie, I know that you know had mentioned Biogen's Alzhe drug. Very controversial. Right. And that was the pathway that that drug was approved under. It did, and it used a surrogate endpoint. And so through that accelerated approval process, the FDA can choose to have novel endpoints surrogate endpoints, which are endpoints that suggest some clinical benefit, but the benefit is not necessarily known at the end of the trial with this particular product, it showed a reduction in these Alzheimer pipe causing plaques. But whether or not that reduction leads to a clinical benefit is going to be reserved to a later phase four trial. So there are going to be, I think, pathways for mRNA. You see it in CAR T therapies, which is a cancer, which is really more cancer kind of treatments, as well as CRISPR and gene editing for these really awful rare diseases.

(08:20):

I think in those aspects, the big push there is the rare disease aspects. You see a lot of CAR T and rare cancers, CRISPR, and a lot of really rare diseases where populations are small and there are no other treatments available. So outside of a pandemic response I do think there's going to be opportunities for people, for industry leaders to really engage with the FDA and say, look there are no treatments available. These are awful diseases and we've seen this played out. We know we can do this. Now that we've come through covid-19 and we saw it happen the FDA's obviously going to always be balance speed to market with relative safety and effectiveness. And that's always kind of been the historical hangup there is whether or not how long these things are going to be effective. We hear that now with booster shots being proposed for vaccines and those sorts of things, but we're seeing a relatively good safety profile coming out of these two mRNA vaccines and I think we can expect more of that going into these technologies in the future.

Carrie Nixon (09:30):

Yeah, I mean, you mentioned this being particularly appropriate for rare diseases, but also absolutely for diseases, Alzheimer's where we have hit a wall, there's nothing that there has been nothing new that came out for Alzheimer's for the past, what, 20 years just crazy. So from my perspective anyway, when there is a glimmer of hope that something is going to move the needle and maybe that's something will be combined with other things, I feel like we need to go for it. And I do hope personally that this will sort of ramp up the pressure on FDA to speed up the process in a way that they can still keep things safe, cool, but to speed up the process to get some new things out there in the market.

Tommy Miller (10:18):

And the FDA will be persuaded by that. And again, I think the opportunity here now that there's this awareness and there's a thirst for a more reliable approval process in these areas are companies out there that are in advanced manufacturing, that are in clean room technologies. Because biologics are historically have a really good promise, but they're historically hard to manufacture, they're expensive to manufacture, and they have to be done in a very aseptic and clean way. And so when you're talking about living tissues and cells and that sort of thing, they're very susceptible to spoiling if you don't have good manufacturing processes. And so the opportunity here is for companies who are sitting on academic medical centers or researchers that are sitting on these advanced and clean manufacturing technologies to really start pushing for funding, really start pushing for an advancement of their technologies. The more of that we have available, the more that these pharmaceutical companies can rely on that technology and the more comfortable the FDA is going to get that production of these medications is not just going to be done in an unsafe way that this mass production and of these therapies can be done safely and with really high quality.

Carrie Nixon (11:38):

So Tommy, we saw the Covid vaccines, the mRNA vaccines happen during a pretty short timeframe during Covid. What has prevented such vaccines or other types of biologic or therapeutics from getting into the market from developing more rapidly? I mean, this is a whole new disease. Covid was a whole new disease. We start from finish, start to finish, came up with a vaccine for it, and it's out in the market. How come we can't do that more?

Tommy Miller (12:15):

Yeah. Well, like I mentioned, the technology for around mRNA has been around for quite some time. And so the science behind mRNA has been there. What happened with Covid is you had an immediate need and then you had an influx of government funding which pushed the barriers reside. And those barriers have traditionally been stable manufacturing customers who are going to adopt the technology. And then you had government influx of cash for providers to disperse this vaccine. You think about the two mRNA vaccines, and you have to remember that the supply chain issues that we were going up against at the very beginning of this were very real. And those have to do with their, because these vaccines have to be kept at a very cold temperature. And so what you saw is an access issue to even storing these vaccines at provider locations. I've worked with clients before who have a cold chain product and they want to put it into a hospital.

(13:20):

And the hospital's asking the manufacturer, well, can you pay for the refrigeration? Well, that's a capital investment that a lot of manufacturers just can't make into the providers. But what the government solved that they said, we are going to fund putting refrigerators on provider locations. We are going to set up mobile refrigerated units to alleviate some of that issue. So those problems that we would see in these technologies in normal times we're alleviated in a lot by just the investment that the government made into this. And again, as I mentioned, I think the opportunity here is to continue to invest in programs that will increase the market access availability to these products. And now that the government has gone in and more providers have refrigerated units, for example, they're going to be able to use that for future technologies. And some of that barrier's now going to be broken down. So I think we can see just coming out of covid, the infrastructure's going to be a little bit better. The coal chain supply infrastructure's going to be bolstered up the extreme temperatures that vials have to be kept at. We have new glass products and new glass vials coming out of some of these packaging companies. So covid not just highlighted some of the areas that were perceived barriers to these products entering market, but in a way, the funding that came out of it might have gone a long way in correcting some of it.

Carrie Nixon (14:55):

That's, that is definitely good news. What a small silver lining, right from such a crisis. Yeah. Great. Yeah, that makes perfect sense. So you know, and I have talked also before about the growing interest in the community around software as a medical device. I wondered if that's a trend that you're seeing as well and would love to get your thoughts on that.

Tommy Miller (15:21):

Absolutely. A trend. I think it only has been exacerbated by covid-19. I mean, covid-19 pushed everybody into a digital world, whether we're on Zoom, whether we're we're relying more on email or anything like that. But it also pushed healthcare and devices and software altogether because people weren't going to the doctor, they weren't going to in-office visits, but we were still sick. We still needed care. And so we had a great swell of interest in developing technologies that could be considered software as a medical device.

Carrie Nixon (16:00):

Yeah, I mean it pushed not only healthcare, but it pushed the regulators too.

Tommy Miller (16:04):

Right. And I think the regulators have been sitting on software as a medical device and moving it pretty slowly and they're taking their measured approach to precert and we've seen a couple of products come out of there and they're giving me updates and that's all good. And now we have the FDA's Digital Center of Excellence, which is a hybrid group of all the different centers that play a role in drug and device review, really lending their experts in digital health to come together and answer these questions for the industry. You're like, what are the right endpoints for clinical trials? What are the right regulatory pathways for relatively safe software products that can be used? The more investment that the FDA puts into that center of excellence and the more input that industry can give that center I think we're going to see a lot more change and quicker change come out of how these products are regulated.

Carrie Nixon (17:09):

Yeah, I totally agree. I will say though, that my hope is that there will be a much more concerted effort for coordination between FDA and CMS, right? The body that decides the reimbursement constructs for things like software as a medical device past history has demonstrated a real lack of coordination between CMS and FDA. And that is problematic. You know, mentioned that there were a lot of things like software as a medical device percolating around out there pre covid. We need to be sure that CMS is clearly signaling reimbursement opportunities for innovations because we know that things that don't get paid don't get done. So it is incredibly important that we also, that CMS and FDA work together to create the appropriate incentives around innovation artificial intelligence and healthcare is another example of this, where there are often components of AI that go into software as a medical device. And we have just started to see some reimbursement opportunities for artificial intelligence. But I will say the reimbursement amounts that we're seeing on that thus far are broadly viewed as insufficient. So what are your thoughts about FDA and CMS coordination or what are the other issues you see on that front?

Tommy Miller (18:52):

Yeah, so I've seen, which is interesting cause I've seen a fair amount of coordination between FDA and CMS in the drug development sphere. CMS routinely asks for manufacturers to come to them when designing clinical trials and creating clinical trial programs to ensure that senior populations are included in these trials because CMS wants to know that these products are safe and effective in their populations. I think they, in the same vein, CMS is looking at software as a medical device and these digital technologies and saying, well, we see these things. We see these things out there where, where's the evidence that they are working in Medicare populations or that Medicare populations are going to adopt them and are they going to be effective for them? So I think that's one opportunity I think that a lot of these software developers can take advantage of is creating software programs and software as a medical device and platforms that make sense for a 65 plus aged community and how they're living and how they're interacting with these technologies.

Carrie Nixon (20:07):

Little bit of chicken and egg though, right? What needs to happen first? CMS is saying, we want to see demonstrated results before we reimburse. And the innovators are saying we need to be, make sure there's going to be a revenue stream here or it's not worth our while to spend the time on.

Tommy Miller (20:25):

And we just saw that with the MCIT rule that has been delayed till the end of the year. Part of CMS'S push there. And for those aren't, who aren't familiar with MCIT, it was a initiative for devices who that are approved under a breakthrough status to gain immediate reimbursement under Medicare and for have that reimbursement last for four years previously. These breakthrough devices that don't necessarily get reimbursement, and this includes software that don't necessarily usually get, can get reimbursement immediately without filing for hick picks, codes and coverage determinations, et cetera. This was a huge opportunity. What CMS said is they said, well, this doesn't allow us to evaluate whether or not these things are effective, and that's what CMS wants to know. And so now they've delayed that. But you also see some really cool pilot programs that pop up have and then you have new technology add-on payment. But all of those are very lengthy processes. And so to your point, Carrie, I do think that it is kind of up to folks like us and the clients that we work with to demonstrate, Hey, yes, these products are very helpful and they're useful. We just need for the regulators to have some faith that this will make sense when we're deployed to a Medicare population.

Carrie Nixon (21:53):

Absolutely, and I'll bring it back to software as a medical device for a moment because about a week ago actually, CMS released the proposed Medicare physician visa scheduled for 2022. And that proposed feed included new CPT codes, which are the way that healthcare providers get reimbursed and medical practices get reimbursed for what's called remote therapeutic monitoring. And that is basically looking at things monitoring things like medication adherence, adherence to a physical therapy or occupational therapy regime. Things like measuring the impact of pain or maybe mood on people's health who are dealing with a health issue. And software as a medical device is going to be critical for incorporating metrics like pain or mood that are not typically captured by a standalone peripheral connected device, right? You have patient monitoring which requires a standalone connected device with physiologic metrics. This is more there are opportunities here to really incorporate software as a medical device into a platform for remote therapeutic monitoring these new codes and potentially receive some reimbursement for that software as a medical device. So okay, let's move on to one more sort of hot area that you're seeing. Tommy, can you give us the last one and we'll talk through that?

Tommy Miller (23:40):

Yeah, and I think it's tied to software as a medical device and these connected health products that you're talking about. And I think that they're now being deployed in a way that at least the life science industry has been waiting for quite some time now. And that's in the area of decentralized trials and digital tools that are assisting with drug development and then drug a drug patient access. And so when I think about that I think about all the opportunities that we're seeing now with the connected health products and even down to a certain extent, some of the wearables that are collecting some of this passive data. But we're also seeing stethoscopes, heart rate monitors, those sorts of things that can connect into a platform and feed data to a drug or device manufacturer during a clinical trial process where you can start having non-centralized sites. And so people are living where they experiencing this product that's being developed in their own world, where they live, how they're interacting. So not only are you getting some real world data out of it, but you're also getting more reliable physiologic data coming out of it to support product development. I love that because the opportunity there is to be more inclusive in the individuals that have access to clinical trials. You're getting a more diverse patient population, which means your results are going to be more generalizable to the population as a whole.

(25:26):

And then it starts to open up real world evidence databases because I think the big push there is to make sure that these drugs aren't just effective in a lab, but they are working or device products aren't just working in a lab, but they're working in ways where people are interacting. And so you start and seeing people like going to work maintaining employment, less, fewer days missed on a job, as you mentioned, decreased pain, those sorts of things are outcomes that aren't necessarily usually measured but can be very telling to not just the effectiveness of a product but also the value that product adds to someone's life. And so those are things that I think that we can see coming out of decentralized trials which are being made more possible by increased technologies that are connected, that are reliable, valid and that the FDA can rely on to say that yes, these are meaningful endpoints and we trust their <laugh> trust with what they're they're telling us.

Carrie Nixon (26:32):

Yeah, and this underscores for me too, just as a side point the increase that we're seeing in sort of overlap in different areas of healthcare and life sciences writ large. So we used to talk about digital health tools and life sciences kind of in their own individual vacuum or their own silo. You were talking about digital health or you were talking about life sciences, and now I feel like we're starting to see some merging and overlapping in those two areas of the sector. And I think there's just a tremendous amount of opportunity there.

Tommy Miller (27:11):

And I think as you mentioned, as you start talking about these overlaps and mixing these populations which have not necessarily been interacting with each other very often, you getting software developers now interacting with the FDA and digital and device manufacturers interacting with pharma companies, which generally have not been at the same table before. We're starting to see a lot more collaboration in the industry on these topics. And as you mentioned, there have been some barriers and I think that we can start seeing industry come up against them as a united front and those are in healthcare delivery. How are we paying for it? How are people accessing it? I think there are definite things that can be done to increase the adoptability of these technologies in a way that makes sense in a way that makes it easier and less expensive for these products to get launched and makes it more meaningful to patients as they start using them. So I think that out of all those main gains run through these various topics that we've talked about, and those are how accessible is it? How much is it going to cost a patient, how much is it going to cost the government? And there's a lot of policy and legislative and regulatory issues that can get tackled on each one of those fronts to help make all of these different topics that we've talked about today more ripe for increased innovation.

Carrie Nixon (28:44):

Absolutely. I think that is a good place in which to wrap this conversation. I want to thank you for a great talk today. I also want to thank our listeners. We learned that after only four episodes, we have cracked the top 100 on Apple Business Podcast. And I'm really excited about that. I think it underscores the real interest in this area as a whole. And I appreciate our listeners joining us and encourage them to continue to share us. Thanks so much Tommy joining us today, and we'll talk again soon, I hope.

Tommy Miller (29:19):

Absolutely. Thank you for having me.

Carrie Nixon (29:20):

Take care.

Tommy Miller (29:21):

Bye-bye.

Learn More Here

Follow Life Science and Biotech Innovation Attorney Tommy Miller on LinkedIn and read more about Tommy here

From the Nixon Gwilt blog: Read more about the 2022 Proposed MFPS rule and the new remote therapeutic monitoring (RTM) CPT codes and reimbursement options for SaMD and digital health innovators

Find out how to share your input with the FDA Digital Center for Excellence to effect change in into how SaMD products are regulated