Taking A Pulse for Biotech

Speaker 1:
Welcome to TD Cowen Insights, a space that brings leading thinkers together to share insights and ideas shaping the world around us. Join us as we converse with the top minds who are influencing our global sectors.
Yaron Werber:
Thank you for joining us for another exciting episode in our Biotech Decoded podcast series. I'm Yaron Werber, biotechnology analyst at TD Cowen, and I'm super excited to be joined by John Crowley in this episode, Taking A Pulse: What's Ahead For Biotech, to discuss his path to becoming a biotech CEO, working for patients with rare disorders, what compelled him to join BIO as president and CEO, and what is ahead for the biotech industry given political headwinds. John Crowley is the president and CEO of the Biotechnology Innovation Organization, or BIO. He was most recently founder, executive chair and CEO of Amicus Therapeutics. Previously he was founder and CEO of Novazyme Therapeutics, which was acquired by Genzyme. John has decades of biotech experience and passion for patients and entrepreneurship, which made him uniquely suited to represent and lead BIO. He has received many prestigious awards, and along with his family, was a subject of a book and movie about developing drugs for Pompe disease for the benefit of his afflicted children. John also served as a commission officer in the US Navy Reserve and served in Afghanistan.
John, so great to see you and thank you so much for joining us, especially during these times of challenge and opportunity for the biotech industry. And I have to tell you, I've been doing this for almost 25 years. I think you've been doing this even longer than me, and this feels like sort of the worst for biotech. It does really feel like we're at the rock bottom. So having you on is really pressing timing. You've had somewhat of a personal journey to the biotech CEO role, which is really unique. Can you tell us about that?
John Crowley:
Yes, happy to, and thank you again, Yaron, for having me here. You're right, there are lots of threats and lots of opportunities in these unique times, so happy to share the work that we're doing and some perspectives. But maybe I can take you back to the beginning. So you mentioned you've been doing biotech for about 25 years. I've been doing, I guess, biotech for 25 years, but in the life science world for 27. And that takes us back. And I never intended to. I wasn't particularly good at science subjects through all my schools.
But in March of 1998 when our two youngest children were diagnosed with a rare form of muscular dystrophy, Pompe disease, that many people know now, but back then it was virtually unheard of. And Eileen and I, my wife and I, are silent carriers, so recessive carriers for the disease, no history in our family. And Megan, by about a year of age, wasn't pulling up in the crib, wasn't taking her first steps. And we began what was actually a fairly brief diagnostic journey from pediatrician to pediatrician to neurologist, from blood tests to scan to deep muscle biopsy at the time. And they told us that the biopsy showed that in the muscles there was a sticky form of sugar, glycogen, building up in the lysosome and devastating muscle cells. And I remember asking the doctor in that appointment, the neurologist, "Is it serious?" And he said, "Yes, it's very serious."
By that point, our greatest fear was knowing that something wasn't right with Megan's muscles that maybe a doctor would tell us she'll never walk. But instead he said she'll only live another couple of years and she'll get very sick very quickly, and there was a 25% chance our then seven-day-old son -- Megan was only 15 months at the time -- that our seven-day-old son, Patrick, would have the disease, and he was tested. So that's what launched us into the whole world of science and medicine and research.
I remember even that first weekend, going to the library and pulling every book I can, just doing research. Google didn't even exist. I think I used Netscape Navigator. And by the end of that weekend I had come across an academic paper from Duke University, Dr. Y.T. Chen, and the work he was doing to develop an experimental enzyme therapy. And he had given it to a naturally-occurring animal model of the disease, Japanese quail of all things, and showed that they can restore muscle strength, and actually that birds began to fly again. There was a video online I looked at. And I was so excited. It was about 2:00 in the morning when I read that paper. It was the first of many, many research and scientific papers that I've read since.
And I remember waking up my wife and trying to explain it, and I didn't even understand most of it. And she finally said, "Slow down. What are you talking about?" I said, "Eileen, what it means is that there's some hope." And that's what launched us into this whole world of research and development and finding doctors and scientists and not-for-profits. And I didn't realize it at the time, but we were in the very early days of beginning on that virtuous circle of innovation. So it took me a long time to figure that out. But that was our initial entry into biotechnology. So in many ways I was kind of an unintended entrepreneur in biotech.
Yaron Werber:
And that led you to then essentially start Novazyme, which was ultimately acquired by Genzyme, and ultimately got to-
John Crowley:
That's right.
Yaron Werber:
[inaudible 00:05:31] therapeutic enzyme replacement for Pompe disease. And since then, you've obviously started Amicus as well, again, staying on the orphan track. What's the single most important learning from your experience that you can impart maybe first to biotech CEOs?
John Crowley:
I think what I've learned over the years is that there are a couple of key essential characteristics of entrepreneurs that are particularly relevant in biotechnology. The first is you've got to start with a vision. And vision is the fun part as we build our companies, and vision is different than mission or strategy, right? Vision is looking out 5, 10, 20 years and imagining, envisioning what your organization is going to look like. At the end of the day, our job is not to build a technology or even to build a drug product. For most all of us, the goal is to build a lasting, sustainable, enduring company, organization. And that's building and infusing that culture. So having that vision is so important. And to think big, to think bold and big. Then the hard part comes, right? Then you've got to identify all the barriers to achieving that vision. And there are many in our industry as we know. So think having that vision is the first part.
I think the second part, and this took me a long time to realize, is that our job, it's true in many businesses, but particularly so in biotech, our job is about solving problems. And the more senior you get in these organizations, the harder the problems get until if you're sitting in the C-suite or you're the CEO, every day, people are bringing you problems and you've got really bright people on your teams and they're solving most of the problems before you ever even know they exist. Many of them you never even see.
And so you've got the smartest people in the room who come into your office throughout the day and basically in one way or another say, "Hey, boss, we've got this issue and we need help." It took me years to figure this out. I remember, and I would come home at night and tell my wife, Eileen, I'm like, "Can I just have one good day at work? Could somebody knock on my office with, 'Hey, look at all these experiments worked and manufacturing went off without a glitch. And the P-value in that study is 0.001.'" Those days are few and far between. So I realized your job is to solve problems all day, every day.
And if you think your job as an executive of an entrepreneur or CEO is to sit in a nice corner office and tally the value of your stock options at the end of each day and have people bring you reports and good news all day, good luck. So I think those lessons of having that vision and realizing that that's your job, to solve really tough problems. And because of that you need to fundamentally be an optimist. You need to be unbelievably persistent and resilient and realize this industry is not for the faint of heart.
Yaron Werber:
So let's maybe switch. And last year you took on the very important role of being president and CEO of BIO, of the Biotech Innovation Organization, essentially flying into probably one of the more times of change or dynamic times in the industry, just given all the factors that are at play right now. What compelled you to take this important role?
John Crowley:
When I started in biotech, I used to think every day about science and clinical research and manufacturing biology. I didn't think about the policy environment, maybe sometimes around FDA and working through the regulatory process. Now our greatest barriers are not science technology. We've come so far. When I started in Pompe, I had to scour the world for a year to find three researchers who knew anything about the disease. Today in Pompe alone, I can name 30 academics working in Pompe and a half a dozen companies. And that's just in Pompe alone. The problems though now, our greatest challenges, are all manmade. It runs the spectrum. Dysfunction of the capital markets in some ways is symptomatic of the underlying problems that it just takes too long and it costs too much money to develop our medicines. We have to rapidly evolve past that model.
China is, and China has said they are going to be the world's center of excellence and dominate in biotechnology, and they're going down that path. So we need to continue to be the world's leader. So that's why it was so important as I thought about that. I had been involved as a board member at BIO and rose to become the vice chair of the board. And when we were looking for a CEO and realizing we wanted somebody who had the experience of what it takes to start and build a biotechnology company, all the challenges that you go through, have that perspective, and then have some reasonable familiarity with politics in Washington DC, I said, "I think this is important enough," and was blessed that the board asked me to join. And so it's been a little over a year, and I'm really, really happy I did because I do think we really are at an inflection point for the industry now.
Yaron Werber:
So as you think through some of the headwinds that the industry is now facing, whether it's potential tariffs on one side to question about drug pricing, to a question about re-shoring and importation, national security measures, competition from China, as you noted, a year from now as we look back, how have things shifted, and what's been resolved?
John Crowley:
Part of my job at BIO early on was I came in with the themes of focus and impact. BIO had done a lot over the years, and realizing that the climate was changing, and this was long before the election back in November, that we really needed to think about, what are the handful or so of things that we care most about? And then we put them in categories of where are the threats, and where are the opportunities? And often, many times the opportunities were answers and better answers to some of the threats.
So I'll give you some examples of what we're focused on today. Right in front of us, obviously tariffs. And we've spent a lot of time, and this is a key part of... The philosophy of our approach here has been one of constructive engagement, finding common ground, building, maintaining relationships with the administration. And Congress will continue to play a very important role. But thus far in the first few months of the Trump administration, this has been a very White House focused series of policies that have brought lots of uncertainty, lots of challenges and threats, but also some opportunities.
And then with respect to tariffs, the unique role that we can play is to show the effect of proposed tariffs on the entire ecosystem of innovation, biomedical research, and ultimately, access for patients. We can humanize who we are and what we do. And we start with the fundamental premise on all of these threats and opportunities that you need to care, policymakers, lawmakers need to care about biotechnology for the public health as a great engine of economic growth and for our national security. And national security means both for advancing, protecting a healthy workforce and population, but also as an instrument of national power as well to show what free and democratic societies can do in making the world's most advanced medicines and technologies. So that's the approach we take.
And so for tariffs as an example, we can share with the team doing the 232 investigation, and we've been doing this, sharing with them real life examples of the impact across the ecosystem from our largest companies to our early startup companies to early stage commercial companies, and to show them the downstream unintended consequences on research and development, the broad biotech ecosystem, and on patients. We can give them very specific examples of programs that will come to a halt if tariffs are implemented as envisioned. And then we can pivot to, "Okay, we don't think that's the appropriate tool." There's a very good policy reason, series of reasons why pharmaceutical, biotech products have never been subject to tariffs.
So we emphasize that, and then we pivot to if the goal of the tariffs is to force manufacturing back to the United States, we're all in on that. And that was one of our key priorities a year ago when I started that we had completely in the last few decades lost control of the bio manufacturing supply chain. We saw it during COVID. We see it today. It puts us at great risk. I thought, honestly, this would be a five-year argument I have to make. And people get it now. They get the importance of biotech. And there, I think we are very aligned with the administration, that we have to win and we have to advance biotechnology. It's that important.
For instance, if you care about semiconductor chips, which they do, we don't need semiconductor chips if we don't have the world's most advanced medicines when the next pandemic or worse comes. So that's the way we approach an issue like tariffs. Same thing with index pricing.
I understand the president's concern that we are subsidizing R&D, we subsidize the consumers of medicines around the world. How do we close that gap? Well, one way we close it is by transparency on PBMs, de-linking of their incentive structures with the price of medicines. We take that down, there'll be much more economics in the system. Potentially you could bring down list prices in the United States, which closes that gap. What are the incentives tools? We have to think about other ways to close that gap. I think on index pricing, we've got a series of arguments. Much of this happens behind closed doors here in Washington. There is an element of leadership that talks about strategic patience, finding the right time, the right opportunity and the right relationships to bring the data, to bring the stories, to bring the examples, and that's a lot of what we're doing. And then when appropriate, we certainly do that publicly.
Those are some of the key things we're working on. And maybe one last comment we can get into perhaps more deeply is the FDA and the regulatory work. We, from day one of the administration, even before day one, advocated for a strong FDA. We need to be regulated in our industry. We need our drugs to be proven to be safe and effective. But the model that we have now and the regulatory science and tools are outdated. Again, it just takes too long, costs too much money. So implementing a vision where we eliminate redundancies, break down bureaucracies, and also just fundamentally take into account not just a look at the safety and efficacy of medicines, but in that regulatory benefit-risk assessment, look at the urgency of time. And we did that very clearly during Operation Warp Speed. We should bring that mindset and that tool set to all of drug development.
And here I'm actually very encouraged. And even just in the last few days, we've seen some very positive signs, I think from the commissioner that the FDA understands this and wants to work to accelerate the regulatory review and approval process while keeping the gold standard. So I think you're right. We can comment about where we are in biotech and how dark the days have been, but I'm actually hopeful that we're kind of at the bottom of that and that we have more solutions and answers to the policy questions in front of us than we've ever had before, and I think some common ground, and again in terms of the importance of our industry.
Yaron Werber:
I can tell you, sitting from where someone like me sits and the conversations we're having both with corporates investors and board members and certainly operators, the good news is sentiment is troughed out. Valuations to a certain degree have also kind of bottomed out. So we can only get better from here. And we've all seen these times of turbulent change. And I want to unpack some of that. Inevitably with change, as you said, comes opportunities. I actually choose to be optimistic. I think there's going to be some changes, some of them hopefully, and many, better. The first question that we're getting a lot, and I know many of the listeners are going to want to hear your views on, are tariffs. And so that's an overarching central focus for the administration very broadly, right?
John Crowley:
Yes.
Yaron Werber:
Biotech is one of the fastest and important one, obviously has been completely walled off and will have its own strategy. There's a lot of confusion whether tariffs, are they typically levied on drug substances or are they going to be levied on drug products? I mean, do you have any view on that at all?
John Crowley:
That's unclear. And I think we have to start with why is the White House on pharmaceuticals proposing tariffs? In the initial round on Liberation Day back in early April, we were exempted. We knew it was coming. The 232 investigation is very important. That's a statutory tool where policymakers are looking at the impact of trade through the lens of national security. And that's incredibly helpful for us here. And in fact, just a couple of days before beginning the 232 formal investigation, the National Security Commission on Biotechnology issued its report. And that was to great attention here in Washington, DC.
And to remind everybody, these reports are very serious. Congress stood this up in 2022, the commission. They've done this for AI. They did it for cyber and they did it for semiconductor chips, now for biotechnology. And it frames the entire ecosystem in terms of the national security importance of a strong and vibrant biotechnology industry. It's bipartisan from Congress, 49 specific recommendations. And while it doesn't touch on tariffs per se, very strongly implicit in there is that anything that is a barrier to innovation in a strong biotech system has to be revisited through this lens.
So again, because we've been through, we've met with the team doing the 232 investigation. We've shared our perspectives. We have a very detailed document that we're going to provide to them as well. On tariffs, the ultimate purpose, I'm certain... I literally just came out of the White House about an hour ago, so it's very relevant. I'm certain that the purpose, the president's purpose, the White House purpose here, is to use this as a tool to force as much re-onshoring of biomanufacturing in the United States as possible. We're all in on that. We think that's necessary. You may not be able to do or desire to do it all in the United States, but a vast amount of manufacturing. Again, great for job creation, the economy, all the governors want biomanufacturing. We've seen the announcements of our largest companies. When I tally up what's in the pipeline, it's hundreds of billions of dollars of manufacturing commitment. And that's really important for a whole host of reasons. And the White House is very pleased with that level, and I think there's even more to come.
So that's happening. And if you put in tariffs, particularly for emerging companies where that's going to be actually an enormous disincentive and sap the capital that they would need to put any parts of their manufacturing in the United States, that runs counter to the purpose of the policy. You can have tariffs as a negotiating tool with other countries. You can have tariffs as a source of revenue generation, or you can use them for ancillary purposes. And here, I think that is the main thrust of pharmaceutical tariffs. And there, since we're aligned on the common goal of re-domiciling manufacturing in the United States, and so much of it is already happening, I think hopefully we'll be in a good place. I think we've got a month or two of work ahead of us with a number of the different policy makers, lawmakers, but they're really engaged in the discussions. They're listening. They're taking the meetings at the White House from a number of different vantage points. So more work to do. We're not out of the woods, but I'm cautiously optimistic that we can find a solution here.
Yaron Werber:
That's really reassuring and very much encouraging. As you said, reshoring is a win-win pretty much all around.
John Crowley:
It is, yes.
Yaron Werber:
And that's going to be [inaudible 00:21:28].
John Crowley:
We're aligned. We're aligned on that goal.
Yaron Werber:
And from now on... I mean, even through the first Trump administration with a reduction in the corporate tax rate, that incentive to onboard to offshore was already decreased tremendously.
John Crowley:
Exactly right.
Yaron Werber:
Since then, many products are now made here. Many facilities have obviously been open in the US. The next question then becomes, this is potentially, and I'm going to make kind of a broad statement, it's probably more of an issue for legacy products that are already commercial, that are already being made in Ireland or Switzerland, et cetera. And it's very, very important for the API for small molecules, essentially the entire generic industry. And that's not something you can tariff starting in the week or in 90 days.
John Crowley:
No.
Yaron Werber:
There will need to be a multi-year process to reshore. You've been very effective during the BIOSECURE legislation process to negotiate an eight-year sort of process. Where do you think this is going to end up here as part of this process?
John Crowley:
And that's a great analogy to what we did a year ago when there was the threat of BIOSECURE. The concept we aligned on and supported the act, but we said, "You can't disassociate and decouple from Chinese manufacturing companies in a year or two. You'll actually destroy what you're trying to accomplish." And we went out, we surveyed our members. We provided that quantitative data to Congress as they were drafting that bill, but we also did about a dozen deep-dive case studies that we never shared publicly, but we took to Capitol Hill to show again the real life effects of that policy. And that had a real effect. And that I think was the driving force for making that about eight years for the phase-in. Now, obviously BIOSECURE as an act didn't get enacted, but the concept goes forward.
But the analogy here to tariffs is absolutely right. And that's what we've been doing is we meet with the White House, we meet with policymakers. I bring CEOs in. I give real-life examples to show that we want to do this. We need incentives, particularly for emerging companies to do it where we don't have billions, tens of billions in profits to repatriate. There are other systems and incentives we can put in place to encourage manufacturing centers and excellence here in the United States, but we need time. Even if we start today, it's going to be call it a seven-year timeframe to take a plant that's overseas, recreate it here, train the workforce, install the equipment, validate the processes.
One of the things we're doing is working with the White House, looking at what are the barriers? How can we accelerate that timeline? Are there policies we can work with, regulations that we can work with, for instance, with the EPA that can be then promulgated down at the state level that can accelerate the building permit process? Workforce development training, what can we do to accelerate that as well? And the White House there, I will tell you, they say, "Come to us with your ideas." They take furious notes. We provide the position papers. So I'm hopeful that that will be part of their view on how do they break down the red tape, the bureaucracy that could allow more of the biomanufacturing. And to your earlier point, you're right, it is the entire spectrum. We think of building perfusion bioreactor systems and the more advanced cell and gene therapy, and it's certainly part of it, but it's every part of the supply chain, which is incredibly complex, from API to the filters that go in our bioreactors and our centrifuges and systems.
Yaron Werber:
One of the elements, I think that it goes hand in hand, once you sort of reshore a API and you do that through... 90% of prescriptions, are written for generics.
John Crowley:
Generic, right.
Yaron Werber:
25% tariff. If it's a 25% tariff on the API, that's one thing, but the margins there, as you know better than me, are razor-thin to begin with.
John Crowley:
They are.
Yaron Werber:
If it's a 25% tariff on the cost of the drug, that's going to be a big issue to actually maintaining supply here. So trying to reshore is going to be critical. And that's also going to be... leads to another question, which is what we've talked about so far is the stick. We haven't talked about the carrot. Ireland, Singapore, Switzerland, the UK to a certain degree, have done an amazing job historically providing the carrots, providing the incentive to put IP there, and then develop drugs at risk from those subsidiaries and then undertake the manufacturing either locally or globally. But again, that rolls back to the IP sitting locally. What do you think the administration will do? Are there going to be incentives essentially to take risks here and manufacture here?
John Crowley:
It will be, and they're very much open to that. We frame it similarly to semiconductors in terms of the urgency and the strategic importance. But what we don't want, we don't need... We're never going to get a CHIPS Act for biotech. We don't need those encumbrances. There is a lot of private capital that will come because the good news is we've got great technologies, we've got a great pipeline, and there is enormous demand for our treatments and cures, vaccines, all of that. So we just need to make sure that we're developing this ecosystem and providing the right incentives that can drive private capital dollars to these projects.
And again, if we could work with FDA and EPA to break down barriers, reduce the time, maybe even the cost of these facilities, work with governors who want these programs, on state government grants and workforce development initiatives... We've got some great blueprints on how to do that when you look at states like North Carolina and Massachusetts and others. But when you look at the entire supply chain, again, we tend to think about the most advanced biologics manufacturing. But take a look at plasmids, for instance. Plasmids, Aldevron, they're made in North Dakota. You can train a workforce that doesn't have a lot of expertise in biotech manufacture, and train high school STEM students, associate degree programs in community colleges. These are great jobs, great businesses, and they provide an important part of the supply chain.
So yes, I do think you'll start to see a series of incentives, some of which could come about in this large tax bill that we'll need to do this year, but other more creative incentives. For instance, could you have an extra period of exclusivity for medicines made in the United States? Are there market-based incentives that could drive private capital? Because we are on a path now, certainly for our largest companies... I think in the next several years, the vast majority of medicines for Americans are going to be made in America, including all key components. I think, again, to your point, it's going to be phased and take some time for some of it, but we did this. We did this before as manufacturing was moving out of Europe. It moved to Puerto Rico for a long time, and then at the end of the '90s, the tax laws changed and it all left Puerto Rico, and it kind of disseminated around the world. I think it's important that we bring key parts of this back, and so there I think we'll find solutions, policy ideas that are aligned with the administration's goals.
Yaron Werber:
Can we talk about BIOSECURE Act, which was, I think, widely expected to have been ratified by Congress last year. And it was surprising at the end, given the bipartisan support, that it wasn't ratified, and given China's growing prominence and potential competitive aspect that that implies to our industry. What happened with BIOSECURE? Why wasn't it ratified, and is there a chance that it's going to come back to the fore?
John Crowley:
I think there's two ways to look at BIOSECURE. One is as an act, a piece of legislation, potential law. The other is as a concept. There was great alignment, intense focus, bipartisan in Congress, House and Senate, on the concept of biosecurity. In fact, a lot of the early stages of what led to this National Security Commission report that really was just at the end of 2023, first quarter or two of 2024. So the concept has continued and has been incredibly helpful for us. The act itself, there's some people in Congress who voted against it because they thought it overstepped boundaries of the role of Congress. There were some who voted against it because they didn't think it was strong enough. I think the lesson there is that in this global rivalry with China and in this world where biotechnology is so critically important for our national security, there are limited tools that we have to stop the advance of Chinese biotech companies, Chinese CDMOs, the sticks, if you will.
So for instance, export controls, they work really well for nuclear centrifuges. They don't work very well with biotechnology, in large part because it's just so vast what we do. Even semiconductors, very, very different type of supply chain. And so instead we've got folks refocused on, "Let's look at what we have." We still have the lead in biotechnology. We have to act boldly in today. And we've got to look again, the clinical trial paradigm, the regulatory review and approval process, the way in which we get paid for medicines. The example I use with folks is take a look at the cell and gene therapy space. It's largely broken today, every end of it, whether it's basic research, access to animal models, manufacturing, regulatory review and approvals. And when we run that whole gauntlet of uncertainty, it's really hard to get paid for our innovations and inventions. So we've got a task force at BIO looking at the cell and gene therapy space specifically, and I think that'll be really important.
But it all fits, again, when you look into it through the lens of national security. Even if somebody were to propose the... Now, hopefully, I think we're going to be in a good path with the IRA and address the disparity on nine versus 13. You saw that with the president's executive order last week. I think people understand the challenges and why that doesn't make sense for innovation and for patients. But every idea, whether it's the next IRA that comes up in the next administration, they need to look at it through the lens of biotech is important. Does this policy proposal advance, slow, or stop biotech innovation and our bio ecosystem?
Yaron Werber:
We're getting toward the end. I want to ask a question about the FDA and then I want to ask you a personal question as well. The FDA, you and I have seen the waxing and waning of FDA over the years.
John Crowley:
Yes.
Yaron Werber:
We've had a good 15 years of an amazing FDA, and I think we both remember the '04 to '06 or the '05 to '07 period.
John Crowley:
Yeah, kind of post-Vioxx, yes. Yeah.
Yaron Werber:
Exactly. It was fairly conservative, intransigent, not innovative, and fairly slow, and that had dire consequences to biotech. And now we're facing a lot of change. Change can be good in a way that may be merging some of the processes of CBER and CDER, could be a good thing, streamlining operations, streamlining approval pathways. But at the same time, there's been an awful lot of turnover, loss of institutional memory, loss of regulatory science. Maybe that can lead to some new thinking and progress forward, but certainly there's a lot of fear that in the meantime, while the late-stage reviews will proceed and get approved, that might have wide-reaching consequences for the earlier stage reviews and products in development. What are your thinking? How do you think this will shape up at the end?
John Crowley:
Yeah, there has been a lot of change. Of course. There needed to be change. We needed to reform and modernize the FDA, the whole drug review and approval process. I think what was difficult for investors in particular and innovators was that it was dramatic change. It was fast. There was loss of leadership, there was loss of institutional knowledge. And I was pretty vocal privately and publicly on my views there. Also advocated very strongly that we protect reviewers and inspectors. And there, we had good outcomes. But there's been a lot of change. And so I think the commissioner's job now is, what we've advocated for is really twofold. Fill those gaps in leadership and experience as soon as you can. And we're seeing steps toward that, and I'm encouraged that we'll continue and the commissioner will continue down that road, but you've got to fill it. You've got to have people who understand the complexities of regulatory science, the nuances of drug development, who bring that perspective and experience.
What you need to do is to also make sure there's increased consistency in the review process. We at the biotech world, we can deal with almost anything, but we don't like uncertainty because the basic concepts of our business are so uncertain, to the extent that we can control some of the regulatory paradigm will be very important. So the leadership, the experience filling that vacuum, those vacuums will be really important.
The second is policy. We've encouraged the commissioner to focus on policy. And you saw two weeks ago, a small but important step forward on changing the requirements for preclinical studies for monoclonal antibodies. One step forward. The Megyn Kelly podcast that the commissioner did the other day, I think there were some encouraging pieces in that as well. Talking for instance, in rare diseases about using... I think he meant accelerated approval pathways more and looking at what he described as biological plausibility. I think that implies a lot of the biomarkers, for instance. So the tool sets are there. It's the leadership and the guidance that's required and more of these policies and guidance documents to be promulgated. And I'm confident that that's going to be a very high priority for the commissioner. But those are the two things you need to focus on.
Yaron Werber:
Well, we're getting to my favorite part of every podcast, and that's a little touch of understanding the person personally and a little humor as well. John, I've obviously known you for a long time, but what's your life hack that served you well, and what can we learn from it, especially given your journey on the personal side? Certainly as an entrepreneur, you've also served in the National Reserve in the US Navy and were in Afghanistan, and now you're obviously serving a tremendous role for the biotech industry. What's your life hack?
John Crowley:
I think we tend to have to suffer our way to some measure of wisdom in life. And now that I'm entering my late 50s now, for me, one of the blessings has been we have three children. We have our Megan and Patrick, and thankfully with the medicines we and others have created, have extended enhanced their lives. The disease never affects their mind. They're brilliant. My daughter, Megan, went to University of Notre Dame despite being on a ventilator in a wheelchair, got her master's in social work. Seeing them thrive.
We have our older son, John, isn't featured as much. John lives with high-functioning autism. And during COVID, when we all sequestered together... And John made his way through college and just was always a little too shy to have a girlfriend or a lot of friends. But one of Megan's nurses sequestered with us. And over a number of months, they developed a friendship and then a relationship. And it was a little strange for us in the house at first, and then we realized they were falling in love, and they got married a number of years ago, and we now have a two and a half year old granddaughter, Stella, and a three-month-old, Scarlett.
Yaron Werber:
Wow.
John Crowley:
So for me to be a grandfather and to be a relatively young grandfather and to appreciate just the fullness and beauty of life and to see it through their eyes in a way that I didn't as a parent, and not just because our kids had very unique challenges, because you're worried about know, "Gosh, can I do that? Is my boss going to think this?" or, "I got to go to grad school next year," or, "I got to pay the rent next week." We're just letting the little things in life get in your way. "God, I whacked my car against something. It's the end of the world." I think as you get a little older in life and you've worked your way through a lot of challenges, and to now be a grandparent, to see that, to see the beauty of life through their eyes and their life is a real gift. So that's given me further perspective. I don't know if that qualifies as a life hack, becoming a grandparent, but it's certainly given us, Eileen and I, just immeasurable joy.
Yaron Werber:
Yeah. And perspective and the ability to translate hope into a real tangible benefit. I mean, absolutely. Your family is a living testimony to what's possible in biotech.
John Crowley:
It is. I remember my first day in biotech in 2000. We started that little company before I raised my million-dollar angel round at Novazyme that took me almost a half a year from 37 people to raise. Of the two and a half billion dollars I raised in biotech in 25 years, that million-dollar angel round was the hardest angel round. We were floating the company on credit card cash advances and a home equity loan. I went up to BIO, ironically to our BIO convention that I now oversee, and the keynote speaker that night was Christopher Reeves, who had played Superman, who was rendered a quadriplegic. And I'll never forget when he came out on stage, it was literally my first day in biotechnology, a little over 25 years ago, and he said, "Biotechnology, that's just a great big word that means hope." That's always stuck with me.
Yaron Werber:
Yeah, I'm going to carry that with me for a long time. I just watched his movie.
John Crowley:
Wasn't that powerful?
Yaron Werber:
I watched it on the way to JPMorgan, funny enough.
John Crowley:
That's great.
Yaron Werber:
John, always great to see you. Thank you so much.
John Crowley:
Yeah, thank you, Yaron. There will be better days. There will be better days. Again, these are all manmade problems, and we can solve these.
Yaron Werber:
I agree. I agree. Reality always turns out a lot better than people's greatest fears. So thanks for joining.
John Crowley:
I appreciate it. Thank you, Yaron. Thank you.
Speaker 1:
Thanks for joining us. Stay tuned for the next episode of TD Cowen Insights.

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