Co-hosted by the Engelberg Center and R Street, this panel discussion focused on innovation during the COVID-19 crisis.
Co-hosted by the Engelberg Center and R Street, this panel discussion focused on innovation during the COVID-19 crisis.
Moderator: Chales Duan, Director of Technology and Innovation, R St. Panelists: Michael Weinberg, Executive Director, Engelberg Center; Alicia Gibb, Executive Director, Open Source Hardware Association; Matt Lane, Executive Director, Coalition Against Patent Abuse; Ana Santos Rutschman, Professor, St. Louis University School of Law. This podcast is licensed under a Creative Commons Attribution Share-Alike 4.0 license.
You can watch the full video here:
Charles Duan (00:04):
Hi everyone and thanks for joining us for our panel on innovation and in the time of COVID 19. I'd like to thank our sponsors, the R street Institute and the Engelberg Center on Innovation Law & Policy at New York University Law School. During this COVID 19 pandemic. I think that we've seen technology and particularly innovation policy. Take a take a number of interesting directions, everything from open source ventilators to 3D printing and of course some drug development in vaccine development. So we'd like to talk about some of these developments, how innovation has changed and on what lessons we can draw for the future of technology. We've got a great panel here to talk about these issues. I'm going in alphabetical order. Well I'll start with myself. My name is Charles Duan. I am the Director of the Technology and Innovation Policy department at the R Street Institute where I focus on patents and innovation policy.
Charles Duan (01:01):
Going in alphabetical order. We have Alicia Gibb who is the Executive Director of the Open Source Hardware Association. We have Matthew Lane who is the Executive Director of the Coalition Against Patent Abuse and an expert on drug law policy and policy. We have at Ana Santos Rutschman, a Professor of Law at the St Louis University School of Law. And we have Michael Weinberg who is the Executive Director of the Engelberg Center. So you know, I'd like to, I'd like to just jump into the topics. Let's start off with talking a little bit about vaccine development because I know that that's been something on everybody's mind. Ana you're obviously the expert on this topic. Can you tell us a little bit about what the landscape of vaccine development and policy has looked like over the last couple of weeks?
Ana Santos Rutschman (01:49):
Sure. Well first, thank you very much to the R street Institute into the Engelberg Center for this invitation. It's exciting to be discussing vaccines outside the vaccine context outside of the broader context of innovation. So I thought that as a way of answering your question for self perform a feat of technology by sharing my slides, something I've never done before. And second, I'll start by just giving you an idea of what vaccine development does look like if we subtract COVID 19. So how that looks like without a pandemic. Enough things are changing right now for the, and for the worst I would say. So let me attempt this and can you see my slides right now? Yes. All right. So just a couple of preliminary things on vaccine development, which really under normal circumstances, so quiet and like what we're experiencing right now is sort of the ugly duck of biopharmaceutical innovation apart from one or two very popular vaccines that make some money.
Ana Santos Rutschman (02:51):
You can see in this graphic something I've been mapping for a while. This is the number of vaccine manufacturers in the West of the largest vaccine markets in the world. And we went from the golden age of vaccine, so that peak around the forties, we had over 50 different manufacturers in the US and we get to the single digits and the nineties. Today, I'm not going to go into the reasons behind it, but that's the lens Skype. Right now absence and epidemic like this, you can count on private sector manufacturers to be in the low digits below 10. So we've gone from a period in which we really focused strategically on vaccine basic R and D and in vaccine development to a, a stage in which there's much less involvement from the public sector. I think Matt has something to say about that in, in more general terms two vaccines being considered, some something that's not very attractive from an R and D perspective.
Ana Santos Rutschman (03:50):
And I'll say more about this in the relationship to patent law in just a second. To give you an idea now in in the 21st century vaccines are the tip of them graphic here at the tip of each one of the columns. This one shows a FDA drug approvals for the past two decades or so with 2018 being incomplete. Vaccines are sort of demo, I'll call it teal at the top. So the dark gray is biologics, which technically is the category of vaccines belong to. The light gray, the light blue, I should say is new molecules. And in vaccines, it's just very tip of the top. And as you can see in some years, we don't have new vaccines entering the U S market, so that was 2004 and 2015. So really we're talking about something that absent the COVID 19-like event is not particularly vibrant as a field of research, even though we have very interesting projects going on.
Ana Santos Rutschman (04:48):
From a scientific perspective all the time. Finally, to put things into perspective from an IP angle even though you've seen the number of manufacturers sort of plummeting, and even though it's not by any means, the drugs for which we're or the type of products we're for, which we're seeking regulatory approval with the FDA worldwide, worldwide, and also in the U S the number of patent applications and the number of patents granted patents granted governing vaccine related technology has gone up exponentially. So as market attrition increased and as vaccines kept you know, becoming sort of a peripheral product in biopharmaceutical innovation, the patent culture actually thickened around vaccine technology. Now let me briefly sketch out for you how this plays out in the particular context of the pandemic. So when we talk, when I talk about IP and patents, culture, I mean two things, IP as incentives.
Ana Santos Rutschman (05:48):
So the default mechanism for innovation and the idea that primarily relying on patenet-based incentives plus a couple of few other things such as prizes, grants or the like, we'll hopefully get to meaningful levels of innovation that has not been decades. As you can imagine in the field of vaccines. Most of the vaccine technology we've had so far is relatively simple. It has been relatively simple. We've had inactivated vaccines, you know, you kill the pathogen, weaken the pathogen and things like that. Those things particularly in the context of infectious disease. Research one, if you're relying primarily on bad things, you're not going to get a lot of money back. So far, we had not really had a global algebraic like this one. So really in the aftermath of Ebola a lot of people, have an intiuition, sense that we were lacking an incentives regime other than IP, really one that has to interact with IP, but something that focused directly on vaccines.
Ana Santos Rutschman (06:46):
So enter CEPI, the coalition for epidemic preparedness innovations, the are a public private partnership they are the first public private partnership gets entirely dedicated to vaccine development and already the creation of CEPI in 2017 has had some meaningful and I think positive impact on the current outbreak. So they're one of the major funders of vaccine development right now. So we had a big hole in the incentives landscape and one of the positive lessons of the outbreak is that, again, IP fails spectacularly in this particular field and its perspective function. But there are some ways of incentivizing innovation. CEPI has a public private partnership, and as, as a large scale, one is demonstrating that that can be done. It's not the end all, it's not the, we haven't solved all the incentives problems. Once the outbreak starts going away, but it's a positive sign.
Ana Santos Rutschman (07:42):
And now for the not so positive sign what I call transactional IP. So emerging IP rights are things that we need to use that are protected by patents rights. Again, in this patent intensive cultural surrounding vaccines, odds are the emerging products are going to be patented possibly more than one patent covering vaccine technology. This is a statement that you see here saying that there's no guarantee that a Kronos vaccine will be affordable. Now, I've been looking extensively for years now since ebola and zika out breaks at the patent law landscape. And I really find no reason for us to say that the system does not guarantee this. I think the system has been designed in a way that's balanced enough to guarantee this. But that the student but Secretary Azar was a very vocal saying that if we guarantee that emerging coronavirus vaccines will be affordable to all indicated populations, there might be chilling effect for the pharmaceutical industry.
Ana Santos Rutschman (08:42):
They might not respond to an outbreak as they did this. This time around. And right now we have over a hundred different vaccine development projects. That's a very good think obviously they are going to start consolidating very quickly, just this week, the West and now that it would consolidate around 14 vaccine R and D efforts. So we've temporarily solved the incentives problem that's normally solved or formally selves through IP. We've gotten best stats that does not mean we will be good proactively. So we have not solved the problem. But the next outbreak, which we don't know yet about, and probably we have some vaccine technology that can be adapted for whatever the pathogen is we have not solved at primarily we're having transactional IP problems. So as technology moves around and as new things get patented right now, and this is not specific to vaccines, but it's very pronounced in the vaccine field.
Ana Santos Rutschman (09:38):
Every time there's an outbreak beside this with Ebola, we, beside us with Zika we have trouble guaranteeing the affordability of vaccines because of the existence of fattens rights and some concerns voiced about chilling effects on the pharmaceutical industry. Should the government or any other mechanisms intervene in terms of price controls. So this is the core of my presentation. I'm happy to expand on these, on any of these points. This is my email if you'd like to get in touch with me and I'll just stand by saying that this relates to, I think a number of the topics we'll be discussing today. Vaccines are specific and you know, they're very peculiar and the way they work economically and even scientifically. But I think we're seeing some of these issues throughout the biopharmaceutical area in this outbreaek. So I look forward to learning more about their, about that from your presentations.
Charles Duan (10:29):
Thanks. And that's a, that's actually a great transition. Because I think that, you know, vaccines are obviously a very important part of this conversation, but you know, the, the, the field of medical treatments has been receiving a lot of attention. Matt, that's something that I know that you, you spent a lot of time looking into. I'm wondering if you can give us some, you can give us some, some more of the picture of what policymakers are looking at in terms of, in terms of pharmaceutical innovation, what should they be thinking about in terms of pharmaceutical innovation and particularly Ana mentioned that, you know, for a long time patents have kind of dominated landscape and you see that as changing or if you see that staying the same.
Matthew Lane (11:07):
Yeah. So let me go ahead and share my screen too. Okay. So I wanna thank R Street and the Engelbeerg Center for inviting me. I think this is a, an amazing panel and a good time for this. We are in the middle of what I think is a very interesting and robust conversation on what drug policy should be. And it, it comes at an interesting time. So before I start my presentation, I need to give a disclaimer cause I am a lawyer. So I'm speaking today in my personal capacity. What I say does not necessarily represent the views of my organization cause the coalition gets bound to abuse or any of its members. So let me go ahead and dive right in. So in the outbreak, obviously everyone is paying a lot of attention to drug discovery and what's going on in the drug market.
Matthew Lane (11:58):
And we're all getting a crash course in how drug discovery works. So drug discovery is a public private partnership. The public end of that is there's a lot of publicly funded research that goes into basic medical stuff, identifying biological processes that can be targeted with drugs. This is the foundational research that drug discovery is built on. And then you identify specific molecules or you know, biologics. And then you go into the clinical trial process and testing. And then that eventually comes a drug. And this is, you know, a multiyear process. So in the public end of that, the us government to the NIH spends about 41 point $7 billion on medical research. They are the largest public funder of biomedical research in the world. There's been a lot of studies on the public's role of this. All 210 new drugs from 2010 to 2016 were associated.
Matthew Lane (12:55):
What's NIH funded research that represented a hundred billion of NIH funding. Another study just came out, found that in a decades worth of you know, drug approvals, they found a 25% of the new drugs actually had publicly funded research. Take a role in the later stage research. That's the actual identifying of the target drugs and clinical trials, stuff like that. On the private side this is a very expensive industry. You know, these major drug companies are huge R and D spenders. The top one and this particular chart shows, I think this is actually from 2015. So we have a little bit of lag here, but Roche was the biggest vendor with 11 billion. I think it's interesting to note that, you know, even with all of the spending in this industry, if you would match the U S contribution to this, we would be the number one spender in the world.
Matthew Lane (13:55):
About four times higher than the top company or a little under four times or about as much as the, the top four spenders put together. So that's where we're at. And so the truck policy conversation leading up to the pandemic was something that was driven a lot by the access issue of how this works. So to give a little bit of context, last at the end of last year, a Gallup poll was conducted of all the industries and they found farming to be the least popular industry in America with a net positive ranking even below the federal government. It was the only industry below the federal government. And just March the JAMA network, which is this major publisher of a medical journal, they did an issue that was almost entirely dedicated drug prices and articles and editorials contained within talked about whether these large pharma companies are making too much money, where the cost to bring a drug to market, including failures were lower than what the industry was telling us it was.
Matthew Lane (14:59):
And you know, there was a, an editorial on the relentless drug price increases in the promises, affordability. There's been a number of polling and studies showing that people can't afford to take all their medication and they're skipping doses. And the access issue was a major issue. Cut to March 13. We have a national emergency declared with the coronavirus and the drug industry is the sort of main solution to our problems. So, you know, also I just want to give this chart for context. U S is the highest drug spender per capita in the world. We are that orange line at the top. So where are we at today? There's a repost conversation about how to support the good of the target industry and reduce the bad in the current model. Now, there are twin goals here. First is we want to encourage a rapid pace of innovation.
Matthew Lane (15:52):
That's traditionally where patents have come in. The idea is, is that you provide a guaranteed return and that encourages large outlays in R and D spending. But the other goal is we need access. We need patients to be able to afford the drugs they're prescribed. And this is especially important when you have a pandemic because access to medicines is a global health issue. We need everyone to be inoculated immune in order to build up that herd immunity that's going to stop pockets of the virus from proliferating and maybe mutating. So these issues are even more important today. So what does that mean? It means that today we have a pretty big debate going on about, you know, questioning whether certain foundational principles versus some are working, how to do things better, how to tweak things. It's interesting that there isn't a one size fits all approach to any of this, that you might have different policies suitable for different areas of drug development.
Matthew Lane (16:53):
So here are the things that seem to be staying the same right now. There's still a tremendous amount of public support for the research and these kinds of treatments and in vaccines. So there was nearly 700 million given since the last SARS outbreak towards coronavirus virus research. And then in the first COBIT package, there was 826 million in it for further development of testing vaccines and treatments. This is, you know, an obvious aspect of system. Public health is a public interest and it's good that the public is continuing to support this type of research. And in addition to that, it seems like for the currently existing potential treatments out there, we are mainly keeping the traditional drug model. So as an example around just severe was just, you know, approved as emergency treatment and to best in class treatment for those suffering from chronic virus.
Matthew Lane (17:57):
They're in the hospital. They have patents on this, they have exclusivity of our manufacturing. We don't know what kind of pricing there's going to be cause Gilliam donated all of his current supply and there's a lot of questions going on about how they're going to price it. But you know, this is all pretty typical for what we see in the drug market. But you know, even then there's a lot of questions being raised. Just recently we saw Representative Doggett with Schakowsky and eight other representatives. They sent a letter to Gilliad asking them to disclose the public sources of funding for rent as severe over its life to explain their plans to ramp up production. And you know, whether or not they're contracting with manufacturers to just think yesterday there was an article where people were questioning whether if they couldn't meet the supply there would be some sort of exercise of marching rights or other rights by governments who would sort of, you know, force open these patents as other manufacturers can ramp up the production.
Matthew Lane (19:02):
These are all questions that are currently being debated that you would not typically see in a normal environment. And you know, there's also lots of folks that are conducting studies to try to see if there are better ways of doing things. One study said that it would cost about a dollar a day for, they would cover the cost of production and a reasonable profit. And there was another study that, you know, had that same $1 a day, but also said that the the under a different models of value can be up to $4,500 per patient. So there's lots of studies questioning what sort of prices are reasonable. And then another thing that we seem to keeping is traditional forms of licensing. The use PTO just put up a database of all the patents related to COVID that were available for licenses as a way to sort of reduce the frictions that are necessary and licensing those patents and, and using these patents for COVID response.
Matthew Lane (20:05):
And these things are all pretty normal, but you know, in addition to this, we have these bigger debates about whether we want major changes in the drug system. So Costa Rica put out our proposal to the world health organization that we should put this big patent pool together for all countries working on this so that they can have quick and rapid access without any sort of friction on the intellectual property rights, on developing vaccines, producing those vaccines. There's also been the Open COVID pledge that was put together by a few professors and I think have a few tech companies to sign up to it that basically says, if you're using any of our technologies to solve the COVID problem, then you have free access to it. There's also a lot of questioning going on about whether or not we are demanding the right return on our public investment.
Matthew Lane (21:00):
So for example, senators, Chris van Hollen, Rick Scott had the lead paid act, the digs into this idea that the public the government pays a lot for this research. Are we getting the right kinds of returns? Should we demand reasonable prices and response or an exchange for these technologies? And another thing that, you know, just sort of popped up in part of this is that Galia had sought designation under the orphan drug act for reemdesivir. There was a huge backlash to that. And now we're talking about whether the orphan drug act needs to be revisited. So, you know, this is bringing up old issues that are now back in the spotlight. Some other important policy issues that are being discussed are wood has been brought up before, which is, you know, can we meet the production capacity and what role does the governments have in making sure we can scale production?
Matthew Lane (21:57):
So are we going to let the private market work or our government's going to intervene and start, you know, using various levers they have to, to sort of force open this IP and increased manufacturing capacity. And then, you know, another big topic is how are we going to prepare for the next pandemic? What public sort of information and transparency measures do we need so that we can look at this study and improve our response to the next health crisis. And then, you know, I think a really interesting topic of conversation has popped up is how are we supporting truck innovation and how we're rewarding innovation and w our patents the best reward for that innovation. So some folks are now talking about putting into the cash prize pools. So instead of getting a manufacturing exclusivity where you are the only one to can make and sell, it would if we just give you a large pot of money as a reward for the innovation and then and then allow everyone to make and sell that drug, bringing the price down immediately.
Matthew Lane (23:05):
And then there's also a lot of talk about balancing safety, efficacy and immediacy of these. These are like the right to try conversations. The issues with whether or not trucks are safe, whether they are effective. We see this with the hydrochloricquine in early stages of the remdesivir conversation about whether we should be giving these drugs to the patients now in the hopes that they do something or do we want to hold off because they might actually do more harm than good. And so these are all the big policy questions that have arisen thanks to this pandemic and you know, everyone wants to help and everyone wants to improve things. So that's where a lot of the focuses right now. So I have all of this sources for this information. My slides, if you want a copy of them, just email me.
Matthew Lane (23:57):
And that's, that's it for my presentation. All right,
Charles Duan (24:00):
Thanks man. That was, you know, a lot, lots of really, really interesting information. Definitely a lot of things going on. You know, I think one of the most interesting things that we see in, during during, during the last couple of weeks is the, the degree of grassroots innovation. We've seen people talking about about open source ventilators. As we've seen three D printing come up people are pulling out their sewing machines and making and making homemade masks. This I think is a, is a sort of different world when it comes to innovation from the one that we normally talk about. And so I'm glad to have Alicia from the open source hardware association to talk about some of these issues. Can you, can you give us an overview for kind of what open source innovation looks like particularly in the in the hardware space that you work in?
Alicia Gibb (24:40):
Absolutely. So I am the executive director of the Open Source Hardware Association and I'm just going to kind of give a broad overview of what open source hardware is and how it's been, how it's affected the covert response. So just a really brief timeline. OSHWA did not create open source hardware. But we're kind of the organization that put the, got the community altogether, herded all the cats and, and ended up coming up with some standards for open source hardware and ways that people can put all those standards, apply those standards to their hardware. So a couple of things that I just want to point out is that CERN has been one of our big backers from the very beginning. They created one of their open hardware licenses in 2011 right after we created the open hardware definition.
Alicia Gibb (25:33):
And just this year they created the 2.0 license for for their first license. This year as well, we hosted our 10th annual summits. We've been around for 10 years now. And in 2016 we were invited to the white house to talk about open source hardware through the office of science and technology. So what opensource hardware means is that you allow other people to remix, remake, remanufacturer, redistribute, resell and study and learn from your design. And we consider hardware, anything that com is comprised of atoms versus bits. So I say that it's atoms versus bits rather than anything that it's patentable because software can get patents. And so that kind of really muddies the waters on what we mean when we say open source hardware. So we consider anything with atoms versus bits. So that means a vaccine things that have to do with biotech are considered hardware bias.
Alicia Gibb (26:31):
So what is the source? What is the source that you need to open in order to be considered open source hardware? It's really anything needed for someone to make a copy. So if you have done open source correctly people will be able to copy your hardware. This sometimes includes schematics, CAD files, code and firmware but can also include things like hand drawings. So it's not always something that is, you know electronic spaced or has software and code along with it. And the source largely is comprised of copyrightable things more or less. And just for an example this is one of the face shields that was created at the university of Wisconsin and this was created in one of their makerspaces. And this is the source for that face shield. This source is what Ford is using to create a hundred thousand face shields a week currently.
Alicia Gibb (27:31):
So that's just I think one of the success stories in terms of the maker movement coming up with ways that we can kind of all share and we're all in this together and we can all make these face shields no matter if you're forward or not, they have the capacity to make a hundred thousand, but you can make one or two at your own house at the benefits of open sourcing. You get attribution or citation. So, you know, we, we want to give credit where credit is due. And we've kind of baked that into the open source hardware definition. So this creates a provenance to your hardware so you kind of know where the hardware has come from and how it is derived from earlier hardware. There's a share like clause that you can apply so that you can force people to use the same license that you used on, on your hardware.
Alicia Gibb (28:24):
It encourages collaboration and feedback. This isn't always something like it's, it's you know, sometimes the misnomer is that you get free engineering with open source hardware. It's not always that, but if your project is popular enough, you might get free engineering. But at the very least, you seem to always get lots of feedback whenever you share your designs and source code. There's always somebody who knows how to do something a little bit more efficient or a little bit better or a little bit different or more personalized or whatnot. It really encourages community and that's what we've seen from the covert response with our makers. Is that there's all kinds of people who want to help, who are just sitting at home with their three D printer with their laser cutter, with whatever, and they really truly just want to be helpful.
Alicia Gibb (29:09):
I think another area that we've seen this in the face of disaster has been the Fukushima disaster created a whole network of people who are making their own Geiger counters that were opensource Geiger counters. And finally this incentivizes innovation for businesses. This is profitable and that is why they do open source hardware. It's more profitable than getting IP because it costs a lot of money. And as makers are often just one or two people in their own homes, they don't always have the capacity to actually get a patent because it's so expensive. Limitations of the source hardware consists of many parts. And we don't always have control over all the parts. So at OSHWA we just ask that you your intention matters on what you produce, so you're only able to produce you know, one part of the hardware.
Alicia Gibb (30:01):
That's the part that you can open source. You cannot open source all the other parts such as integrated circuits or something that you may not own the IP to what makes all this tick, especially in the current environment. Materials are getting cheaper. People are finding community. Global markets are becoming accessible. Of course with the internet. Also with the internet networks are defaulting to sharing. And as we're seeing at times it's just necessity. We just need a lot of people to make these innovations the most efficient they can be. And as far as, you know, government funding in vaccines and things like this, our government knows how to do this. They do this all the time. Point in case is NASA JPL opensource, do it yourself or over there. And I really love the the tagline that they've got on this describes open source hardware perfectly.
Alicia Gibb (30:50):
It's, we provide all the parts. We provide the parts list and the build instructions. You provide the hands, brains and elbow grease to put it all together. That's what open sources. Asha also created a certification platform that you can certify your hardware with if this coached and trademark law. And really the reality of coven 19 means that people have been certifying and open source, open sourcing hardware for this disaster. So there's a this creator device completely bags food without human hands touching it and shoots it out the door to the delivery person or to the person who's gonna eat the food. And then there's also an open source ventilator that's been certified as well. And just to note the certification only speaks to the IP. It does not speak to, you know, the quality of advice or FDA approval or anything else like that.
Alicia Gibb (31:48):
There's been a number of maker groups. These are just the first two certified projects that have come to us from covert. But there's a number of groups that are helping makers kind of coalesced together. There's make for covert, they've together created 25,000 units of PPE and they've gotten over $500,000 in funding. Medtronic has also opened a bit of their licensing, so they have an open source, any of their designs, but they recognize the fact that Hey, they need help with lots of brains. Right? More heads are better than one. And so they've relaxed some of their limitations to their license so that other people can help them out. And really what I think open source is, is it's, it's really the sharing that you learned about in kindergarten garden applied to adulthood. So just act more like kindergarteners
Charles Duan (32:40):
I'm sure that a lot of us who have kindergarten at home can appreciate some of the, the, the intricacies of working with working with folks and dealing with the, the concepts of sharing. And that was absolutely fascinating. I didn't know about the the Geiger counters in, in Japan after the second world war. So so I guess, Michael, we'll turn it over to you. Can you tie this all together? You know, it seems like we've got all of this sort of innovative potential that we've now discovered. How do we channel that? How do we use that to, to make it the most effective during, during this time and in the future?
Michael Weinberg (33:12):
Yeah. And this is, I think one of the most interesting parts of what's happening is, is seeing all these sort of presentations we've already had about how this process works. Generally what the normal regulatory barriers are and where the are open source parts of it comes in. And I think, I mean, this is crazy to say this, but it's, it's hard to remember a month ago when our, or a month and a half ago when all of this really started to hit the United States and there was a real concern, but it's still a concern. But I think it's evolved slightly that there was a shortage of all sorts of materials that people feel like they needed right now to respond to the crisis. And so what we saw was a distributed movement of people who were just kind of coming together as individuals and small groups to try and address those concerns and we should touch on a number of them.
Michael Weinberg (34:04):
And they were really looking to fill specific voids that there were that were existing in their community, but they were doing it in a way that linked in with those larger global networks that Alicia was talking about. And so this is amazing. I think that there were a lot of, there were projects to build a PPE at home that then got peds that was just picked up by large companies like Ford. They were attempts to design ventilators, attempt to design all sorts of stop. [inaudible] or a shortage in the supply chain for all of these things. And people came together and said, I think I may be able to find a solution that gets us at a minimum, gets us to where those supply chains can be aligned and potentially can change how we think about this equipment going forward.
Michael Weinberg (34:53):
And so I think this is a really positive example of this kind of distributed open source hardware that, that we've been talking about where you have these groups that come together at the same time. I think that some of those efforts were imperfect and they could have really benefited from additional help from from the, from the government and additional policy interventions, the two that I think are most important. And then we can get into the questions a little bit more or first why of these groups were made up of nonmedical professionals, right? They were engineers. And so what they tended to do and of engineering related people is they address the problems as they understood them to exist and focused on solutions that made sense for them as engineers, but not necessarily that were informed by deep expertise in public health or as medical professionals because they weren't those, they didn't have those skills.
Michael Weinberg (35:53):
And so it would have been incredibly hard, hopeful for guidance to come down from the government, not even necessarily as to what they should specifically do, but how they should be prioritizing and what kinds of challenges they should really be focusing on. Because I think at that time a lot of the groups, they were going full steam ahead. But if they had been given some direction, some of that full-steam could have been used a little bit more efficiently. The second thing, and this is related was people were really trying to figure out what they were and were not allowed to do within the context of federal regulation. I mean, thinking about the FDA in particular or just as a specific example, the FDA obviously is set up to interact normally with large medical companies and so their guidance and their policies were not oriented towards a small groups of people making things, you know, in their basement online spaces.
Michael Weinberg (36:47):
Now on some level you might say, that's right, we actually don't want people, they're making medical devices in their basements or in small groups. But I think at that moment, certainly it was very valuable and the challenge was then out to the FDA to figure out how to communicate to those groups again. What was, what, what could be, what could be potentially safe, what certainly wasn't safe, how they should prioritize things and what steps they should go through to make sure that when they deliver these things to local health facilities, local hospitals, that they were, they were as safe as they could possibly be and they were as close as they could be to following the rules when those rules were expressed in ways they could understand. So there was a lot, there's a lot going on there, but I think from a policy and regulatory perspective, those were the two biggest missed interventions early on and the kind of thing that I would hope to see prepared for the next time we need an intervention like this.
Charles Duan (37:46):
Yeah. You know, I think that those are really, really interesting points. And you know, I'd like to open this up to more discussion. I first like to make a note to any of the participants. If you'd like to if you'd like to put a question to any of the, the panelists on, feel free to use the the Q and a feature of this webinar. And, you know, if you, if you put it in there, then you know, I'll, I'll try to read the questions as they come in and address them to the panelists. But, you know, I think the themes that I've noticed are, you know, looking at our, our, our innovation policy incentives, we've talked a lot about how happens you know, how have been sort of like the primary model, but now we're looking at different sorts of ways of doing things using public funding using, using prizes or patent buyouts, other sorts of strategies. And we've also, we've also talked about, you know, how is the regulatory environment changing since have these sorts of consumer innovators who are now potentially you know, not, not interacting with government oversight or sort of, sort of public health directions in the same way that, you know, you could deal with a small group of, of large companies. What do, what, what, what should people be thinking about these days on those two axes? I don't know if any of you particularly want to want to go first.
Charles Duan (39:02):
I, I guess since you went first, do you have thoughts on these? Ana, you're still on mute.
Ana Santos Rutschman (39:13):
Several of us mentioned the next pandemic, the next outbreak. And an important thing is that it doesn't have to be a pandemic for us to mobilize, you know, in many of the positive ways with mobilized around deck development right now. I think that some of the solutions and the innovative solutions we're seeing both on the legal front and just, you know, grassroots organization from a tech development perspective. Those are value, very valuable lessons. In the short term. But really I think at some point some of us need to start thinking about the next pandemic and what some of the solutions we're adopting right now. Or just, you know even without considering the policy angles as we adopt these solutions, what will transfer well into not the next outbreak but the preparedness stage. So we'd talk about pledges and bet and donations and you know, a number of things that normally are not deployed as widely in, not just in vaccine innovation, but all the things we need to prepare for an outbreak.
Ana Santos Rutschman (40:15):
And my guess is that some of the lessons are valuable. So when I mentioned the formation of public private partnerships in a slightly different way from what we normally see, so a group that's it comes together ad hoc to think about say, vaccine development, I think some of these solutions will endure. Now that's into pledge. On the other hand, much as I would like to see, one that's a permanent fixture of our innovation regime and says anything that you conceivably might need for a pandemic preparedness or to fall under this umbrella from a political economy perspective, if nothing else, I don't see this as as a longterm solution. So I think it's, it's also time right now as we worry about imminent challenges to begin thinking about what preparedness ought to look like literally next year when we hopefully, you know get to a lower stage of the curve and we started disappearing. What needs to be done legally and policy wise to increase preparedness so we have fewer problems to contend with. When the next COVID 19 hits.
Charles Duan (41:14):
Alicia, what do you think would be the most important kind of policy, next steps to try to encourage more of these open source developers to, to engage in public health problems and kind of the big picture issues that Mike was talking about?
Alicia Gibb (41:27):
Yeah, I mean it's a moonshot, but I would really love to see the U S PTO somehow recognize
Alicia Gibb (41:34):
Open source hardware because there's just too many innovators that patents just do not work for it. The entire system does not work for it's too expensive. It's too cumbersome, it's too slow. Innovation moves a lot faster than the patent market does and some people just don't want to be burdened by that. So I think another way that people can be incentivized to have some kind of IP cause, you know, open source hardware is is intellectual property. It's not just putting it in the public domain, so it does have some protections to it. So I think having having larger groups and entities really recognizing open source hardware would be fantastic. And, and similarly, you know, we're talking about public funding in terms of vaccines and things like that, but there's all kinds of public funding in academia and in grants and, and, and other places that I think also need to be reformed and apply a really public thinking kind of way of this. And I think this comes kind of from my public library and background, but I want to see things that are publicly funded, really truly available to the public. That innovation should be the public's we've paid for it. It should belong to all of us, not just a company that's raking in billions of dollars.
Charles Duan (42:51):
Yeah. Matt, I know that that's something that you've looked at a lot. In terms of some of the public funding for the, for the medical research and drug treatments. Do you see similarities there?
Matthew Lane (43:02):
Yeah, I think that this is a major area of conversation right now and it's one that, you know, some lawmakers are leading and it's, it's an interesting question. It's you know, the public is funding these, you know, huge investment in these kinds of research, a lot of research that really needs public funding because there's not enough incentive in the private market to do the research, you know, think about drugs that we want to have but don't want to use like antibiotics. So the question is what the, what is the appropriate return for a public government? And that is investing in as this is it, you know, to sell the patent and get a cash universal payment for that? Or is it to make conditions on the transfer that it has to be a reasonable price? And that's the question that I think that Senator span hall and Rick Scott are addressing the we paid act which I would recommend anyone to go look at. They're curious about where this conversation is heading.
Charles Duan (44:01):
Yeah, I think the, you know there, there's definitely a lot of legislation that's people are looking at these days. So to try to address some of these issues. I guess Mike, you know, having sort of the overview of innovation policy in a number of different areas, what do you think are the main things that that lawmakers should be looking at? I know you mentioned some of the regulatory issues as well.
Michael Weinberg (44:20):
Yeah, I mean, one thing, one thing I worry about is our regulatory responses that, that skip over the first kind of six or eight weeks of the of,
Michael Weinberg (44:32):
Of, of a crisis. Right. and so, and this is also true from a legislative standpoint, right, to thinking about who you interact with. What we're seeing right now with a lot of the more distributed design responses to Kobe is as you'd expect, they're starting to come together into larger and more formal groups. And a couple of them are being positioned as the kind of primary interlocutors between various regulatory agencies. And that's great because a lot of those agencies have mechanisms to interact with large but not kind of medical device companies, but sort of patient groups and things like that. And so they feel like, okay, we have a system that we can slot some of these groups into and that's certainly a good step forward. But I worry that they, the one of the lessons that our regulators and legislators will take from that is, okay, we actually have the systems in place to be able to communicate and interact with some of these distributed responses to a crisis.
Michael Weinberg (45:33):
And if they learn that lesson, then they will, they will have missed the fact that it took us, you know, however long, two months to get to the point where those kinds of groups can interact with regulators. And in a lot of ways, that's the point where those groups are still really important. But also the more traditional players have been able to retool and refocus. The, the moment of the kind of critical moment of their response is the period between when we recognize that we don't have what we need from those large players and when those large players can realign. And so if I'm a legislator or regulator and I'm thinking about what to do about the next crisis, right? Or with the next peak, if we see a kind of double wave of this is what can I do to be really agile and really nimble to get information to those smaller distributed groups who are not going to be able to come and do a meeting with me or even have a kind of single point person who represents hundreds or thousands of people have a conversation.
Michael Weinberg (46:36):
But to know that they're going to be a bunch of independent groups who are excited about helping and have a lot of expertise but needs some sort of governance and some sort of guidance from government to be able to move forward. It's gonna be, I think it's gonna be increasingly easy to forget about that phase as we move further into this process. And that's going to be the moment where we may really regret forgetting about that phase. The next time we see this misalignment between what our existing capacity is and what it turns out our needed capacity is.
Charles Duan (47:09):
Yeah. It's, it's interesting that you mentioned that because you know, I think that the thank you for a long time has been that the sort of front end incentives the sort of front end motivation to, you know, get projects done in the right direction have been just sort of fiscal instead of just one, one sounds like patents or research grants or things like that. And then, you know, the governor will just come in and in the back end and just kind of make that everything is okay. It seems that we need to spend a little more time thinking how to direct those front ends. Those front end developments and channel research is the right place where you have people who are incentivized by different sorts of motivations than just, you know, having patents and, and making, you know, making a lot of money. I guess in on the drug development side, do we see similar sorts of sorts of needs for for trying to channel investment and channeling research into, into certain directions where, you know, we might need to explore different incentive models besides patents. Well, I guess maybe Matt, do you want to do I take that out?
Matthew Lane (48:07):
I can kick this one off. I do think that there's probably not a one size fits all for patents. I mean the system works until it doesn't. And so, I mean, there's a lot of success stories about patents being a good incentive. There's a lot of stories about patents being a D's to take more than was the intention of Congress and, and creating a lot of these regulatory structures. And there's a lot of examples of resources not being spent it where it needs to be spent. And I think that's why you see a lot of public funding in front of Coronavirus research in other areas. I do think that there should be conversations on alternative methods like cash prizes. I do think that there should be conversations on whether collaborative research instead of you know, competitive research would produce faster results for some of these things. You know, pandemic time is different than normal drug discovery time. And that's something we're seeing right now.
Ana Santos Rutschman (49:09):
And if I could just jump in, Charles was, I think one of them, hopefully one of the lessons of this pandemic is that we talk about drugs or even subcategories of drugs often without proper nuance. I mean, I don't mean in this particular forum, but policy makers and the public and in general, in my very small fields you know, I talk about vaccines. One of the lessons of to break is that there's really no such category as vaccines that from a policy and innovation perspective should be treated. In a, in a new form way. We have the vaccines I was talking about it are relatively easy to develop and that's why you see these timelines. But something that's specific to go vet 19, we're seeing companies using the outbreak as an opportunity to do work on DNA vaccines. This is something completely new from a technology perspective, from an innovation ecosystem perspective.
Ana Santos Rutschman (50:02):
And the types of incentives that would apply to DNA vaccines if we choose to pursue that route are completely different. It's a platform technology that we will need without an outbreak occurring as well. So I, I see the algebraic as an opportunity for pursuing those discourses. There's, there's a lot of debate on, you know, how technology specific is patent law, even within fields like biotech. And I think it's probably the time for us to begin looking into the characteristics of the goods we are talking about because there's, there are unifying threads between all of the things we've been discussing today and there are battened and regulatory responses that shared the same shortcomings, but these are wildly different technologies and ultimately patients and public health goals we were trying to accomplish. And I would like to see both the policy response in terms of preparedness and considerations about defect and system or non patent incentives that are more finely attuned to those differences. And that's something we haven't quite had a, when you think of all the technology that conceivably we'll need for the next pandemic. And conversely, I think thinking about what doc technology is really ought to go into the record of preparedness and how do they differ from one another and how do we tailor things a little bit better. That should be something that we should be able to talk about you know, right now or as we prepared for the next pandemic.
Charles Duan (51:22):
Yeah. And you mentioned something about when we talked previously, you mentioned sort of the increased use of CRISPR as a technology for for, for research and development. That, that seems like a particularly interesting example of how policy needs to change to adapt to you know, different modes of innovation.
Ana Santos Rutschman (51:42):
Charles, I think I mentioned that when we were geeking out the other day. And not on this presentation, but that's absolutely right. So I think what we were discussing back then was the fact that CRISPR is a regulatory problem. I, so how do you solve a problem like CRISPR from a regulatory problem? And a lot of people have written on this, but it's also a relatively cheap and simple form of technology. Meaning, as you know, with many of the things we've seen in this pandemic it's not particularly hard to use CRISPR technology at home. So we were talking about the phenomenon of do to yourself, CRISPR technologies and one, how do you regulate, can you even regulate that? Is it feasible? And how do you deal with such phenomena? And just I think goes into the, the bites we've been having today, which is how do you respond to all these communities which might have very valid concerns from both a public health perspective and an innovation perspective. How do we respond appropriately and timely from a regulatory perspective. So I think that that adds definitely to the debate.
Michael Weinberg (52:45):
If I could. Just to build on that, I think that, you know, one of the things that, and Alicia had this in her slide is we saw this open source hardware community come together in part because it got easier and cheaper to deal with to use hardware and design hardware and to build hardware at home. And so very similarly with the CRISPR and the bio box and the kind of ability to, you were at the point where you kind of, if you're at home you can just like order the pieces of a virus and spinning all together. But it's not like a crazy thing right now. And so as the barrier to entry goes down, there are a lot of knock on effects from that. But one of it is that a smaller of kind of like an informal group can really make meaningful contributions to an emergency by doing research or thinking about vaccines or thinking about at least designing vaccines. And so from a, if I'm a legislator, from a policymaker, from a regulator, understanding that those are players that it can have a significant impact and so need to be part of the design when you think about the landscape of options is really important.
Charles Duan (53:54):
Yeah. You know, it's interesting that you mentioned that because I think that there are, you know, there are at least some people within industry who would say that, you know, those are potentially dangerous developments that, you know, we don't know what one of these people are gonna make something out that's gonna like create some sort of super bug around the world. How, how do you, how do you respond to that? That sort of concern?
Michael Weinberg (54:10):
Yeah. I mean, look, it is a potentially dangerous development, right? I mean, having, having this power within individuals is, means that you can take it in all sorts of different directions. And that makes it all the more important that we have policies and rules and regulations that not only recognize the existence of these technologies but are also written with an awareness that these people will probably be doing these things. And so to, to regulate that behavior and to provide clear rules as to what people should and shouldn't be doing. And then also making sure that those rules are published and explained and distributed in a way that those communities can actually understand them and can actually respond to them. Cause I think, you know, there's always bad actors and it's important to think about how to handle bad actors. But I think one of the things that we've learned over for the last couple of weeks and months is there a lot of good actors and those good actors are really hungry for a clear rules and for guidance as to what's a good idea and what's not, not like such a good idea.
Michael Weinberg (55:12):
And so if a policymakers are able to communicate to them in a way that is easy for those groups to understand, it can be a real force multiplier, but you need to take them seriously and you need to recognize what they will and will not be able to do and what they will not be able to internalize.
Charles Duan (55:31):
All right. So we're just about or four minutes to the, to the hour. So I wanted to give each of you a chance to give kind of a little closing statements. I guess the prompt I would have for you is, you know, what lessons can we take from all this COVID 19 crisis and how it's changing innovation. What lessons will you take for the future, especially for times of non-crisis, you know, are there are the lessons that we can learn about how innovation happens and how policy should interact with that, those sorts of new faces of innovation that we're seeing more exposed today. I guess let's go on the same order as we did the opening statements. So Anna, could you, would you like to go first?
Ana Santos Rutschman (56:06):
Sure. So I think I would just reiterate the point that I would like us to think about pandemic preparedness before the next COBIT. And that pretty much entails considering everything we've been discussing so far from, you know, what are the players really in this field, which are not the traditional ones. So just piggybacking off of what Michael was saying with regard to CRISPR and other technologies, same thing with three D printing, right? Which is by and large and regulated at so many levels. And we need guidance. We need guidance before we need to make ventilator parts again or PPP and the like. So I, I'm under no illusion that we will have a complete understanding of everything we might need for pandemic preparedness. But I think there's a set of things that we can anticipate with some certainty. And I would like to see, again, a nuanced debate at the policy, at the legislative at the regulatory levels about how to best anticipate the next outbreak and make sure the moment there's a declaration of crisis, of pandemic, of anything like that we have the systems in place as opposed to creating you know, our responses on undergo.
Charles Duan (57:17):
All right. Thank you Matt. Yeah,
Matthew Lane (57:20):
I don't want to sound like I'm down on patents. I think that patents are an effective tool that we have in the toolbox, but they're not the only tool we have in the toolbox and they have their weaknesses. So I think it would be nice if we come out of this with a, an honest conversation of what other tools we have. I think patents have been overly relied on. I think there are other ways to reward innovation and encourage innovation and sort of collaborative innovation. It might work on faster time. Second person at the patent office doesn't get the patent and the whole, their R and D cost is, you know, loss basically. So we needed to figure out other ways that we can use to do things. And I also think that we need to make sure that we talk more about access being one of our core you know, policy goals because as you can see in COVID access matters a great deal.
Charles Duan (58:12):
Alicia Gibb (58:15):
I'll take this from the open source hardware perspective and my perspective and open source hardware is it empowers exploration and personalization and really invention. So I think if we can take, like Michael kind of said, take that more seriously, recognize that open sourcing your hardware is an incentive to a lot of people out there. I think we'd be in a better place.
Charles Duan (58:43):
Great. Thanks. Mike?
Michael Weinberg (58:45):
Yeah. Let me take that thread of taking things seriously and say, I hope that we take both distributed design and distributed manufacturer more seriously and incorporate the existence of it into our policy thinking because I think we've learned that it is a real tool that exists and that can be very powerful. And so as policy makers, we need to think about it and incorporate it into our planning.
Charles Duan (59:15):
All right. Wonderful. Well thanks for, thanks for all of your thoughts. This was an absolutely fascinating discussion and I've learned a lot from
Charles Duan (59:22):
It. I hope that everyone else on the call has as well. We should have all of these slides put up as well as a video of this presentation put up if you'd like to share it. In the meantime, if you have any questions, feel free to email me or any of the panelists. We certainly look forward to continuing this discussion in in any number of forums. Thanks again for joining. Okay, thank you. Thank you.