Latest / Making Medicine / Inside Biotech Leadership: Bill Newell on Innovation, Capital, and Policy at Sutro Biopharma
Transcript
- 0:00Speaker 1: At Making Medicine. We're reporting on the headlines, not making
- 0:03Speaker 1: medical recommendations. For personal health questions, always consult a doctor.
- 0:08Speaker 1: Nothing in this episode constitutes investment, financial, or legal advice,
- 0:12Speaker 1: and please consult your own advisors before making decisions. Hello everyone,
- 0:23Speaker 1: and welcome back to the Making Medicine Podcast or Science
- 0:27Speaker 1: Policy and Innovation Meet. As always, I'm your host John Stanford.
- 0:32Speaker 1: This week we were joined by special guest Bill Noule,
- 0:35Speaker 1: who has recently served as Sutro's chief executive officer from
- 0:38Speaker 1: two thousand and nine to earlier this year in twenty
- 0:40Speaker 1: twenty five. He's got a lengthy career of experience that
- 0:44Speaker 1: we get into the show, and has even been an
- 0:46Speaker 1: advocate testifying before Congress, and has leadership roles at a
- 0:50Speaker 1: number of trade associations. He's just the right person to
- 0:53Speaker 1: talk about today's policy environment. So with that, let's get
- 0:56Speaker 1: into the show. Bill, Welcome to the show.
- 1:00Speaker 2: Thanks John, delighted to be here.
- 1:02Speaker 1: Well, our listeners. Number one ask is always about people's
- 1:06Speaker 1: paths into the industry and then pads navigating industry, and
- 1:11Speaker 1: with so many people coming from the investment community or
- 1:15Speaker 1: the scientific community, let's start by saying what led you
- 1:18Speaker 1: into the biotech industry and what were some of the
- 1:21Speaker 1: pivotal decision points along the way that went into your
- 1:24Speaker 1: years leading SUTRA.
- 1:25Speaker 2: You know, I had a prior career before getting into
- 1:28Speaker 2: the industry. I was a corporate lawyer representing companies in
- 1:33Speaker 2: a variety of different industries, and I felt like I
- 1:37Speaker 2: was not fully realizing the full potential of an impact
- 1:44Speaker 2: that I could make as an attorney. And in the
- 1:47Speaker 2: Bay Area, which is where I live, the biotech industry
- 1:53Speaker 2: really offers people a mission driven business model, and somebody
- 1:58Speaker 2: with a legal background, not a scientific background, but a
- 2:01Speaker 2: legal background can play a very important role in the
- 2:05Speaker 2: development of companies and in the medicines that those companies make.
- 2:10Speaker 2: And so I would say I was drawn to the
- 2:13Speaker 2: industry because I felt like my skill set could help
- 2:17Speaker 2: in a way that I couldn't as a lawyer. My
- 2:20Speaker 2: skill set could help others make medicines that reach patients
- 2:25Speaker 2: and have a profound benefit on their lives. So that
- 2:28Speaker 2: was really the primary motivation. I had the benefit of
- 2:32Speaker 2: working alongside some great CEOs early in my career in
- 2:37Speaker 2: the industry. I've been in the industry for twenty seven years,
- 2:40Speaker 2: and I didn't start as a CEO, but in two
- 2:44Speaker 2: thousand and nine, I had the opportunity to become the
- 2:47Speaker 2: CEO of Cuitro Biopharma. Sutra Biofarma at that point was
- 2:51Speaker 2: a nineteen person company, early stage venture financed and had
- 2:56Speaker 2: a disruptive platform technology, self repro and synthesis that we
- 3:01Speaker 2: thought could offer a way to make better medicines for patients.
- 3:05Speaker 2: And to the challenge, and this was in two thousand
- 3:09Speaker 2: and nine, was how do you keep capital in the company,
- 3:13Speaker 2: How do you keep raising capital, how do you figure
- 3:16Speaker 2: out what you should do with your platform technology, how
- 3:19Speaker 2: do you find partnerships that realized full value for the company?
- 3:24Speaker 2: And then how do you make a medicine when a
- 3:27Speaker 2: company that is a platform company really doesn't know how
- 3:30Speaker 2: to make medicines. And so those were some of the
- 3:33Speaker 2: challenges that we had to work our way through. Now
- 3:36Speaker 2: you don't work your way through those overnight, it's a progression.
- 3:40Speaker 2: And I was privileged to lead Sutro for sixteen years
- 3:44Speaker 2: as CEO. And you know, around the end of my
- 3:48Speaker 2: time at Sutro, we had about three hundred and fifty
- 3:51Speaker 2: employees and we had two pivotal Phase three trials ongoing,
- 3:54Speaker 2: and so it's a series of steps you take along
- 3:57Speaker 2: the way, and you need a little uck, and you
- 4:01Speaker 2: need good science, and you need to have a rationale
- 4:04Speaker 2: for why your medicine is going to be impactful. And
- 4:07Speaker 2: if you have that, then I think you have the
- 4:09Speaker 2: wherewithal to make a difference in patients' lives. And that
- 4:12Speaker 2: was really my raison dutchra for being in the industry.
- 4:16Speaker 1: Which I think is a good call out because I
- 4:18Speaker 1: would say some of the you know, use the word
- 4:21Speaker 1: mission driven. You probably could have gone on to be
- 4:24Speaker 1: successful in any sector, but you picked this one. And
- 4:29Speaker 1: I think that's something that gets lost. And another thing
- 4:32Speaker 1: that gets lost that I want to spend some time
- 4:34Speaker 1: with is you know, if I I think if we
- 4:38Speaker 1: went to the layman and said, I want you to
- 4:40Speaker 1: have a conversation with Bill about his sixteen years running Sutro,
- 4:46Speaker 1: you know, I think in the layman's head they'd say
- 4:49Speaker 1: must but it must have been five or six drugs
- 4:51Speaker 1: that came out during that time. And the reality is
- 4:55Speaker 1: that billion billion plus later, still moving forward on these
- 5:00Speaker 1: out of able assets, but not across the finish line yet.
- 5:03Speaker 1: And I would just like your perspective because people short
- 5:07Speaker 1: change just how long a career long effort to even
- 5:11Speaker 1: bring one medicine forward. So I wonder if you have
- 5:13Speaker 1: thoughts on that.
- 5:14Speaker 2: No, you're you're absolutely right. I think Sutro is one
- 5:19Speaker 2: of the more fortunate companies because we were able to
- 5:21Speaker 2: move very far down that pathway. A lot of companies
- 5:26Speaker 2: never get that far and they run out of capital.
- 5:29Speaker 2: We raised through financings and through partnerships about a billion
- 5:34Speaker 2: six during my tenure as CEO of Sutro, and even
- 5:38Speaker 2: at that lofty level, we still did not have the
- 5:43Speaker 2: wherewithal to get a drug of medicine across the finish
- 5:48Speaker 2: line because even more capital was required. Now. That medicine
- 5:52Speaker 2: that was in phase three was first studied in the
- 5:57Speaker 2: clinic in twenty nineteen, so six years from entry into
- 6:02Speaker 2: the clinic, you're starting a pivotal trial. And you know,
- 6:07Speaker 2: in our industry, phase three trials are not one hundred
- 6:10Speaker 2: percent successful. As a matter of fact, the success rate
- 6:13Speaker 2: is about fifty percent. So along the way, we had
- 6:16Speaker 2: to build the platform technology, We had to build a
- 6:19Speaker 2: manufacturing capability, even though we didn't have a product to
- 6:22Speaker 2: sell yet, we had to hope that our science was
- 6:26Speaker 2: right and that this medicine would actually benefit women with
- 6:29Speaker 2: a variant cancer as well as a very rare form
- 6:33Speaker 2: of pediatric AML, And we had to find ways to
- 6:37Speaker 2: capitalize the company, and that is a very expensive, long,
- 6:41Speaker 2: high risk undertaking. And whenever I actually have a chance
- 6:44Speaker 2: to talk to people about it, especially members of Congress,
- 6:48Speaker 2: I let them know that this industry is fundamentally different
- 6:52Speaker 2: than any other industry in the United States, and it's vital.
- 6:56Speaker 2: It's a vital strategic industry for the United States. But
- 7:00Speaker 2: you need to understand why we're different, and the capital
- 7:03Speaker 2: requirements and the risks that investors are asked to take,
- 7:07Speaker 2: that your partners are asked to take, and then you
- 7:09Speaker 2: ask your employees to take. It's not for the faint
- 7:13Speaker 2: of heart, but it has an ultimate goal of improving
- 7:18Speaker 2: the lives of individuals who are suffering from serious diseases.
- 7:22Speaker 1: That last point there about employees. Next week I'm heading
- 7:26Speaker 1: off to Japan to meet with some of their sort
- 7:29Speaker 1: of ministers about what it would take for them to
- 7:32Speaker 1: have a more robust ecosystem. And one of the points
- 7:36Speaker 1: there about their labor protections, which are very a key
- 7:41Speaker 1: part of sort of their culture, but they don't allow
- 7:44Speaker 1: people to grow and shrink and grow and shrink, and
- 7:48Speaker 1: so you know, for a biotech if you miss on
- 7:51Speaker 1: a data point, you might have to substantially reduce the workforce.
- 7:56Speaker 1: And then as things heat back up or you find
- 7:58Speaker 1: you get some good data, you scale very quickly. And
- 8:01Speaker 1: so that's always sort of been an anathema. Do you
- 8:06Speaker 1: think you could have led the company if you didn't
- 8:07Speaker 1: have the flexibility of your size of workforce. I'd be
- 8:12Speaker 1: curious if reducing that headcount is a critical thing to
- 8:16Speaker 1: make it through such a long period.
- 8:19Speaker 2: You know, capital is so vital to any biotechnology company,
- 8:25Speaker 2: and capital seems to come in waves. There were times
- 8:28Speaker 2: when there was an abundance of capital, and there were
- 8:32Speaker 2: times when capital was pretty hard to come by, and
- 8:36Speaker 2: you have to really navigate as you build a company,
- 8:40Speaker 2: as you grow your portfolio, as you try to achieve
- 8:44Speaker 2: a regulatory approval for your medicine, you really have to
- 8:47Speaker 2: be mindful that at the end of the day, you
- 8:50Speaker 2: can only do what the capital you have allows you
- 8:52Speaker 2: to do. And so if it comes to a point
- 8:55Speaker 2: in time where you don't have adequate capital, then you
- 8:57Speaker 2: have to make a tough decision, which is we'll have
- 9:01Speaker 2: to trim back. We're going to have to focus, and
- 9:03Speaker 2: we're going to have to unfortunately let some people who
- 9:07Speaker 2: are doing very good work have to go and find
- 9:10Speaker 2: another position. And that's a difficult decision to make, but
- 9:14Speaker 2: it's fundamentally important that you be able to make that
- 9:17Speaker 2: decision because otherwise you'll run the company into the ground,
- 9:21Speaker 2: and if you run the company into the ground, no
- 9:23Speaker 2: patient benefits at all. So it's at tension and one
- 9:28Speaker 2: that you have to take seriously and have a long
- 9:31Speaker 2: view of so that you can avoid that to the
- 9:34Speaker 2: maximum extent possible. But as you know, many many companies
- 9:39Speaker 2: in the biotechnology industry over the last three or four
- 9:41Speaker 2: years have had to trim their work staff, had to
- 9:46Speaker 2: focus down on a particular asset or two, and SUTURE,
- 9:51Speaker 2: by the way, is no exception to that. So it's
- 9:54Speaker 2: part of the era that we're living in right now.
- 9:57Speaker 2: But it's a reality of the industry that we're a
- 10:01Speaker 2: little bit like an accordion. Sometimes we can pull it out,
- 10:05Speaker 2: but then there are other times when you have to
- 10:06Speaker 2: press it back in.
- 10:08Speaker 1: You know, the tough decisions aren't appreciated that market based forces,
- 10:16Speaker 1: and I know you've had some of these conversations with Congress,
- 10:19Speaker 1: and we'll get into that in a second. But you know,
- 10:21Speaker 1: from some stakeholder's perspective, there's just this glut of funding,
- 10:26Speaker 1: and if that were true, why would we have to
- 10:30Speaker 1: make tough choices? Why would we have to leave somewhat
- 10:33Speaker 1: promising assets on the shelf and really say, look, all
- 10:36Speaker 1: we can afford is being laser focused on this one
- 10:39Speaker 1: or two programs that we're doing. Now. You took over
- 10:43Speaker 1: in two thousand and nine, certainly not a great time
- 10:47Speaker 1: in the economy. The biotech economy the last several years
- 10:53Speaker 1: has been very tough. How do you compare the two
- 10:59Speaker 1: windows of really challenging fundraising times? And did lessons coming
- 11:03Speaker 1: out of two thousand and nine allowed you to shepherd
- 11:06Speaker 1: Sutro from say twenty two to twenty five that a
- 11:10Speaker 1: lot of biotechs haven't made it.
- 11:12Speaker 2: Yeah, I think two thousand and nine was not a
- 11:15Speaker 2: great time to be raising capital. I was fortunate that
- 11:20Speaker 2: the investors who had seeded the company in the early
- 11:24Speaker 2: venture rounds believed in the promise of the technology and
- 11:28Speaker 2: gave me enough money to last for eighteen months and
- 11:33Speaker 2: try and focus the company. In that eighteen months on
- 11:36Speaker 2: something that could ultimately grow to and achieve what we
- 11:39Speaker 2: did at Sutro. But the key question you really always
- 11:45Speaker 2: have to bear in mind is how do I make
- 11:50Speaker 2: certain that I have the right people doing the right
- 11:55Speaker 2: job at the right time. And do they always have
- 11:58Speaker 2: to be employees or can they be concerts where we
- 12:00Speaker 2: have some flexibility? And then how do we look at programs.
- 12:06Speaker 2: I'm going to use this word ruthlessly because I think
- 12:11Speaker 2: that's what you have to do. You have to say
- 12:13Speaker 2: is this good enough? Is this going to make a
- 12:17Speaker 2: difference in patients? Yes, there is risk all along the way,
- 12:21Speaker 2: but you have to be very clear sighted in the
- 12:24Speaker 2: opportunity and not see it with rose colored glasses, but
- 12:30Speaker 2: really make certain that you have fully understood, to the
- 12:33Speaker 2: best of your ability, what that medicine is capable of
- 12:37Speaker 2: doing and whether it's worth continued investment. Because even if
- 12:42Speaker 2: you believe that, you then need to persuade others who
- 12:45Speaker 2: are going to give you capital to believe that too.
- 12:48Speaker 2: And so you know, by being hard on the programs
- 12:53Speaker 2: to ensure that they're making a difference, you give yourself
- 12:57Speaker 2: the best opportunity to continue to raise that next out
- 13:00Speaker 2: of capital that gets you to the next milestone.
- 13:03Speaker 1: In addition to navigating all of these challenges of being
- 13:06Speaker 1: a CEO, and I think they inform the question I'm
- 13:10Speaker 1: about to ask. You've also worn the advocacy hat very
- 13:14Speaker 1: heavily through organizations, You've testified before Congress, You've regularly met
- 13:19Speaker 1: with these folks. You know, the topic du jour for
- 13:23Speaker 1: the last couple of years is should we be embracing
- 13:26Speaker 1: price controls from a access and affordability standpoint? And you
- 13:32Speaker 1: know in the IRA, those price controls manifest themselves after
- 13:35Speaker 1: nine and thirteen years. We've talked a lot about that,
- 13:38Speaker 1: this most Favored Nation concept that President Trump is putting
- 13:42Speaker 1: out there. You know, they're all different shades of price
- 13:48Speaker 1: controls that would not let the market set a price,
- 13:51Speaker 1: but let the government set a price. I'm curious, in
- 13:54Speaker 1: a world of price controls, how would what would be
- 14:00Speaker 1: What are the consequences of saying we're going to put
- 14:02Speaker 1: a price control on Sutro's eventual product. How would that
- 14:07Speaker 1: play out on hiring, the go no go of programs,
- 14:11Speaker 1: trial design, and even your ability to recruit investment or partners.
- 14:16Speaker 2: You know, I use the word ruthless before, and I'm
- 14:20Speaker 2: going to use it again here the capital markets are ruthless.
- 14:25Speaker 2: And you know, if you see a medicine that's a
- 14:28Speaker 2: potential benefit to patients, you have to have thought through
- 14:33Speaker 2: how much it's going to cost to develop it, how
- 14:35Speaker 2: much it's going to cost to commercialize it. How are
- 14:38Speaker 2: you going to do those things? Are you doing it alone?
- 14:41Speaker 2: Are you doing it in collaboration with a partner, or
- 14:44Speaker 2: are you handing it off to a partner to allow
- 14:46Speaker 2: them to do that. You have to ask yourself what's
- 14:50Speaker 2: the ultimate return on investment at the end of the day.
- 14:54Speaker 2: And the market is ruthless about all of those things. Now,
- 14:59Speaker 2: the Good and Suture, like many other companies, had some
- 15:04Speaker 2: marvelous partnerships with companies like Merk Stellis, sell Gene back
- 15:12Speaker 2: in the day and others that we were very proud of.
- 15:16Speaker 2: And they provided the lion's share of the capital. That
- 15:20Speaker 2: one point six billion dollars that I referred to our
- 15:23Speaker 2: partners provided the lion's share of that capital. Now, where
- 15:26Speaker 2: did that money come from? That came from the profits
- 15:30Speaker 2: that they made in the selling of the medicines that
- 15:33Speaker 2: they were out there selling. And if you put price
- 15:36Speaker 2: controls on the industry, what's going to happen is there's
- 15:42Speaker 2: going to be less profitability for those pharmaceutical partners, which
- 15:46Speaker 2: means they'll have less money to invest in companies like
- 15:49Speaker 2: Sutro and in medicines like the ones we were delivering,
- 15:53Speaker 2: which means I have less money to be able to
- 15:55Speaker 2: do things. Instead of doing a pipeline of five or
- 15:59Speaker 2: six program which is what we had as I was
- 16:04Speaker 2: ending my term as CEO, you might have a pipeline
- 16:07Speaker 2: of two programs. Now there's no reason why you should
- 16:12Speaker 2: have that constraint on you, and I am very worried
- 16:16Speaker 2: that the extent price controls come into play, the market
- 16:21Speaker 2: will discount the potential economic opportunity that investment in a
- 16:28Speaker 2: company like Sutro represents, and discounted in such a way
- 16:32Speaker 2: that you frustrate our ability to actually do the work
- 16:35Speaker 2: that's required to demonstrate that this medicine has value to
- 16:38Speaker 2: patients and that it's got a good safety profile given
- 16:42Speaker 2: the underlying condition that you're trying to address. So I
- 16:46Speaker 2: can't think of anything worse than price controls. Now, we
- 16:49Speaker 2: can argue about access and affordability. I think there are
- 16:52Speaker 2: ways that they can be handled different from price controls,
- 16:58Speaker 2: but fundamentally, capping what you can charge for a medicine
- 17:03Speaker 2: is a recipe for disaster and really will drive many
- 17:07Speaker 2: companies into the swirl where you swirl down, down into oblivion.
- 17:13Speaker 1: There are three pieces of that really great answer that
- 17:16Speaker 1: I want to just sort of restate on. One is
- 17:19Speaker 1: we get the sense. I'm curious if you picked up
- 17:21Speaker 1: on this in your times coming to Washington, or I
- 17:25Speaker 1: know you do some work in California on AVAC, the
- 17:27Speaker 1: idea that you can beat up on big pharma but
- 17:32Speaker 1: preserve small biotech. You know, it's funny some policymakers put
- 17:37Speaker 1: them in two camps, and I think your point of Hey,
- 17:41Speaker 1: these R and D partners that were coming in murk
- 17:44Speaker 1: estellis others they're in the large pharma camp. But the
- 17:47Speaker 1: partnerships that they enable and they put their funds into
- 17:52Speaker 1: directly develop this not small, mid size biotech of three
- 17:58Speaker 1: hundred and fifty people in Sutro and so one is
- 18:01Speaker 1: just another great example that that's not true, but they're
- 18:04Speaker 1: kind of two death knells. Price controls off. For one
- 18:09Speaker 1: is if you price control drugs now that the large
- 18:12Speaker 1: pharmas have out there, and you cap their profit, you
- 18:16Speaker 1: are capping their ability to do these R and D
- 18:19Speaker 1: partnerships with small biotech. But you're also telling the investors
- 18:25Speaker 1: separate from the large pharmas, hey, this may not be
- 18:28Speaker 1: worth it. Down if it all works out and they
- 18:32Speaker 1: start selling a product or get acquired, it may not
- 18:35Speaker 1: be worth what you needed it to be for your NPV.
- 18:37Speaker 1: So two actually distinct threats posed by that. If that
- 18:41Speaker 1: is that a fair way to say.
- 18:43Speaker 2: Exactly right, John, you know you've got it, And that's
- 18:46Speaker 2: the that's not appreciated well by policymakers and members of Congress.
- 18:51Speaker 2: That's just not appreciated, and our job is to do
- 18:54Speaker 2: a good job of communicating that well.
- 18:57Speaker 1: I think this conversation here today, we're going to make
- 19:00Speaker 1: sure it gets in front of a handful of them.
- 19:02Speaker 1: I want to do a quick round, Robin. You've been
- 19:04Speaker 1: very generous with your time. Another one you've spoken out
- 19:07Speaker 1: on is the importance of intellectual property. We're in a
- 19:11Speaker 1: very strange world of intellectual property proposals, including a concept
- 19:18Speaker 1: of percentages of equity or patent fees or others coming
- 19:23Speaker 1: out of our Commerce Secretary Howard Lutnik. These seem a
- 19:27Speaker 1: little far flung and not fully baked, not fully baked,
- 19:31Speaker 1: I'll just say it. But if they were put in place,
- 19:34Speaker 1: what are the consequences of weakening IP or increasing patent
- 19:40Speaker 1: equity or patent fees? How do you see those playing
- 19:43Speaker 1: out or having consequence?
- 19:45Speaker 2: I think those are incredibly bad ideas, and let me
- 19:49Speaker 2: give you a few reasons for that. One is, in
- 19:52Speaker 2: order to raise capital, investors need certainty, and they need
- 19:57Speaker 2: certainty on your intellectual property because if you can, if
- 20:04Speaker 2: you can just take someone's intellectual property away prematurely, then
- 20:12Speaker 2: the value of my investment in creating that intellectual property
- 20:16Speaker 2: gets reduced dramatically, And why would I do that. Secondly,
- 20:20Speaker 2: I think that I've seen instances where people have a
- 20:25Speaker 2: really interesting product concept, the medicine concept, but there's no
- 20:29Speaker 2: intellectual property protection for that. And it may be a
- 20:32Speaker 2: very good medicine. Guess what happens. No one gets that
- 20:36Speaker 2: medicine because it never gets developed, even though it should.
- 20:40Speaker 2: But there's nobody to step in when you can't make
- 20:43Speaker 2: any money on selling a medicine because there's no protection
- 20:46Speaker 2: for it. Thirdly, we pay patent fees all the time.
- 20:51Speaker 2: It's a well established regime and it's predictable and We
- 20:56Speaker 2: know what we pay in the United States, we know
- 20:57Speaker 2: what we pay in Europe, we know what we Payepan.
- 21:00Speaker 2: All of that is well understood. But to try and
- 21:04Speaker 2: extort a company because it's got a patent that could
- 21:08Speaker 2: be valuable someday is just ridiculous. I mean, Sutro was
- 21:12Speaker 2: founded in nineteen eighty three and so some of our
- 21:18Speaker 2: patents go way back then, and you know, to be
- 21:21Speaker 2: charging exorbitant thees on patents that were foundational to the
- 21:24Speaker 2: company is just a recipe for disaster and a recipe
- 21:30Speaker 2: to blow up the whole industry. So, you know, I
- 21:36Speaker 2: think half baked is the best way you can characterize
- 21:40Speaker 2: those those ideas, and I think they're just not worthy
- 21:44Speaker 2: of real consideration.
- 21:45Speaker 1: Well, price controls IP concerning like to leave on a
- 21:50Speaker 1: positive note, you get the magic wand of policymaking. Is
- 21:56Speaker 1: there a change at FDA, at CMS in the process.
- 22:00Speaker 1: More broadly, is there something you wish could change that
- 22:04Speaker 1: would speed up development or increase access? What would you
- 22:08Speaker 1: do proactively to sort of benefit this space.
- 22:13Speaker 2: You know, I'm going to say that I wish I
- 22:17Speaker 2: had fifty magic wands because there's so many things to
- 22:20Speaker 2: point the magic wand at the pill penalty for example,
- 22:23Speaker 2: as one. But let me tell you what I think
- 22:26Speaker 2: we need to make certain of and that really has
- 22:28Speaker 2: to do with FDA. Hey, we need consistent policy and
- 22:34Speaker 2: a review procedures at FDA, and when you change the
- 22:40Speaker 2: team there in dramatic ways, consistency is at risk. And
- 22:46Speaker 2: if you don't know what the game is going to
- 22:50Speaker 2: be when you get in front of a regulatory body,
- 22:54Speaker 2: you're very much playing with fire and not giving investors
- 22:57Speaker 2: and not giving your medicine a full opportunity to achieve
- 23:01Speaker 2: its regulatory approval if it's successful in development. I think
- 23:05Speaker 2: the other thing that the agency has started to do
- 23:09Speaker 2: and then backtracked on was understand that there should be
- 23:13Speaker 2: pathways for accelerated approval under certain circumstances, and that was
- 23:18Speaker 2: a really foundational change in the way FDA gave companies
- 23:23Speaker 2: an opportunity to develop cancer medicines and other medicines. But
- 23:28Speaker 2: I see backtracking on that, and I see that as
- 23:31Speaker 2: dangerous because a number of medicines are desperately needed by patients,
- 23:38Speaker 2: and if we can use surrogate endpoints as a way
- 23:41Speaker 2: to establish the benefit and the safety of the medicine,
- 23:45Speaker 2: then I think that's a reasonable basis to give the
- 23:48Speaker 2: company an opportunity to sell that medicine and allow for
- 23:51Speaker 2: continued clinical development of it to establish a more robust
- 23:57Speaker 2: data set cancer trials, which rely on overall survival at
- 24:04Speaker 2: the end of the day, I take a long time
- 24:06Speaker 2: to read out. Now, if you've got good surrogates that
- 24:09Speaker 2: suggest the patient is benefiting and that their disease is
- 24:12Speaker 2: under control, why wouldn't we want to give that medicine
- 24:15Speaker 2: available to patients while we take the time to understand
- 24:18Speaker 2: the long term benefit of that. Now, not every medicine
- 24:21Speaker 2: is going to pan out, and what happens in that
- 24:23Speaker 2: instance is the medicine then gets pulled or additional work
- 24:27Speaker 2: needs to be done before that medicine can really be
- 24:30Speaker 2: more broadly available. So I think if FDA could really
- 24:34Speaker 2: embrace the accelerated approval process and understand that more development
- 24:39Speaker 2: work will be necessary, and not only do it in cancer,
- 24:41Speaker 2: but for other diseases as well, because we're better able
- 24:44Speaker 2: to assess and understand surget endpoints, I think that would
- 24:48Speaker 2: be a great benefit to the industry and a great
- 24:50Speaker 2: benefit to patients. You know what I mean.
- 24:52Speaker 1: Cheat I said that was the last one. But I
- 24:54Speaker 1: just want to go back to something you said on IP.
- 24:57Speaker 1: You know, I'm curious what you think of this. A
- 25:00Speaker 1: lot of anti IP advocates point out the occasional medicine
- 25:08Speaker 1: from one hundred years ago that wasn't patented or the
- 25:13Speaker 1: patent was given away, and that's what we should be
- 25:17Speaker 1: doing when we stumble across these things. I think we
- 25:21Speaker 1: need to offer some clarity, and so I'm curious how
- 25:23Speaker 1: you react to this statement. It still costs a billion
- 25:27Speaker 1: or two billion dollars because the FDA takes long, you
- 25:30Speaker 1: have to do these trials, and that if the IP
- 25:32Speaker 1: isn't around, if we gave it away to society. We
- 25:35Speaker 1: listen to some of these provocateurs and say, you know what,
- 25:39Speaker 1: we found something interesting. We're going to give it away.
- 25:42Speaker 1: Do you think that drug would ever get developed?
- 25:45Speaker 2: No, the answer is it would not. But let me
- 25:48Speaker 2: just go back and make sure people understand when I
- 25:51Speaker 2: get a patent that gives me the exclusive right to
- 25:54Speaker 2: make that medicine for a defined period of time when
- 25:58Speaker 2: that period of time run, and that's not forever. When
- 26:01Speaker 2: that period of time runs, any other company can use
- 26:05Speaker 2: the understanding that was demonstrated in that patent to make
- 26:09Speaker 2: a competitive molecule. That's what the whole generics industry and
- 26:13Speaker 2: biosimilar industry are based on. So our drugs do effectively
- 26:18Speaker 2: go out of our control and to a lower cost
- 26:22Speaker 2: developer after the patent period runs. But if you knew
- 26:27Speaker 2: from the day you got your medicine approved that a
- 26:30Speaker 2: generic company could come in and make that medicine and
- 26:33Speaker 2: undercut you without having put in the investment to develop
- 26:37Speaker 2: that medicine, to manufacture that medicine, no one would invest
- 26:42Speaker 2: in medicines under those circumstances. It's just an untenable situation. Well,
- 26:47Speaker 2: we'll have to.
- 26:47Speaker 1: Do our job of steering policy makers to the good
- 26:50Speaker 1: ideas you had here, maybe shelves some of their half
- 26:53Speaker 1: baked ideas. Bill. I am so grateful of the time
- 26:57Speaker 1: that you took away. You have such a crew worth
- 27:00Speaker 1: of experience that we've leaned into for this episode. Thanks
- 27:03Speaker 1: again for joining us.
- 27:05Speaker 2: Thank you, Jona. It's a pleasure to be here and
- 27:07Speaker 2: keep up the good fight.
- 27:09Speaker 1: That's all for this week's episode of the Making Medicine Podcast.
- 27:12Speaker 1: A special thank you to Bill Newell again for joining
- 27:14Speaker 1: us today and providing some incredible insights for our listeners
- 27:18Speaker 1: have a thought or question about today's topics, drop a
- 27:21Speaker 1: comment and we'll feature it in next week's episode. Speaking
- 27:24Speaker 1: of next week, Making Medicine is Going Global, we'll sit
- 27:27Speaker 1: down in Tokyo with some of the leading life science
- 27:30Speaker 1: investors after they spend a week with us visiting leaders
- 27:33Speaker 1: of the ecosystem in Japan. You'll not want to miss
- 27:36Speaker 1: this one, so don't forget to subscribe on YouTube, follow
- 27:39Speaker 1: us on LinkedIn, X and Instagram using the links in
- 27:42Speaker 1: the description. Thanks for listening, Thanks to Bill, and as always,
- 27:47Speaker 1: keep innovating.