 A ton of great stuff to chew on there. So I'm going to call Colleen Chen. When I was in government, I spent a little time working on reforming the patent system. Most of what's interesting that I know about the patent system, I learned from Terry Fisher. But when I was sort of thinking about the patent system and the America Invence Act, I started researching who are the people who are writing interesting things about the patent system. I came across the scholarship of Colleen Chen, which I just thought was so fascinating that I started to call her up and ask her for advice when I was working in the White House. And that went so well. She gave me so much insight that when I was leaving the White House, and I had an opportunity to try to help choose who would take over my portfolio, I said there's one and only one person that I want to see in the White House, and that's Colleen Chen. And luckily, they listened to me. And she took on the portfolio I'd been working on. And in her time there, she succeeded beyond my imagining. So I was telling Christine the other day that I'm the chair of the Colleen Chen fan club. So I'm going to turn it over to Colleen to be the last speaker on this panel. And then I want to leave a few minutes at the end so that we can talk a little bit amongst the panel before we have our discussion sessions. Thank you, Quentin, for that overly generous introduction. And Quentin succeeded in getting me to commute across the country for 16 months between California and DC. And he did it again last night. I took a red eye to be here. But I think that says something about his power and the power of the ideas that are going to be discussed today to get people to come out. A lot of people here could be doing many things at this time, have a lot of responsibilities. So I hope that we take the opportunity to spend this time and try to get some concrete next steps out. So I really appreciate the introductory remarks about what this convening is about and what we can actually achieve in a day, which I do think is possible. So I will speak as I am currently a professor at Santa Clara University School of Law. But I will draw upon my experience in the White House working as senior advisor, innovation, and intellectual property. And I will note that my successor, or a successor of Quentin and my successor, Nancy Weiss, also registered to be here. So I'm not sure if she'll come later, but she's aware of the convening. And I know if you raise your hand if you're in the US government, are there any folks? There are a couple of people in the room here. So it was great to see Peter and Emily. So it's terrific to see some of the people here that are engaged on this in the databases. And many of you are. So I'm just going to focus on one campaign on the innovation side. Quentin talked about three different objectives for today. And this is something I was part of in 2014. And I think what's relevant to it is not so much the substance of what I was involved in. I'm not a scientist. I'm not a public health specialist. I happen to be somebody who really cares about access to medicines and works on patents. But this was much more about the process of coming up with something among a group of people who all have awareness of different aspects of what's urgent within their area. How can we figure out what can be something to be worked upon? And the process we used to develop this initiative, which was around development of pediatric formulations of AIDS drugs. So if you have kids or if you've ever tried to babysit anybody and try to give them medicine, you know that the flavor is very important and that if it's not something that they're going to want to take, they're very resistant. So just imagine for a young mother who has a child who has AIDS and is trying to keep this child alive and wants to give the medicine and doesn't have the right dosage, has to feed them something that tastes bitter. This is a life and death proposition. And the gap in terms of thinking about the market because it's so fragmented with over 3 million children with AIDS, but only a quarter of them by 2014 when we started this initiative, being on treatment now or up to a third, this is an urgent problem. But it was a huge market gap as well because there weren't sufficient incentives to manufacturers either originator or generic to overcome the challenge of coming up with the formulations, getting them registered, and then getting them in the field and distributed and dispersed. So what was also important about this kind of problem is that it was discreet because at the time that we started working on it, which was right after the African Leaders Summit in the White House, we tended to work by events, we knew we had three or four months until World AIDS Day on December 1, 2014. And so we thought, what can we look at within that period of time and try to focus on? Now there are a number of things that we looked at also that we worked on very hard that we didn't make any headway in. So it was a matter of trying to find the right kind of bite-sized initiative that we could launch realistically within that period of time. And it could have taken many forms. We worked on, for example, trying to look at unified, harmonized registration, which is something many people in this room probably have worked on over the years within the African continent. And this is obviously a much multi-year, maybe approaching decade project that's going on. And we said, well, can we kind of give some infusion to give a lot of energy to that? We thought that was a huge issue. But there wasn't anything that could come together in that period of time. So we put that one aside. That would have been potentially higher impact if we could have done something there. But this is something where we're trying to look around and see, well, what can we do in the present? And I will note that we started that initiative again around August of 2014, knowing that December 1, 2014 was going to be coming up in a couple months. We're right now only in June. So we have six months if we wanted to focus on December 1, 2016 and try to see something come about just to keep that. And the back of the mind. So what happened after we decided, let's think about this issue. And a thing, another important part of this, obviously, was that we were working with the intergovernmental working group within the US government, especially looking at the needs of PEPFAR, which in that position of procuring and wanting to buy product that they thought would be a high impact, was a very important constituent and trying to think about what is going to help them as people who are actually delivering product give them make them more effective. And we had the great, I think, also support of NGOs like the Medicines Patent Pool. And I'm really happy that Ethan Guillen now with MSF is here. He was a wonderful partner, as well as a number of the other pharmaceutical companies, again, also people from other parts of the government who were encouraging us, people who were thinking about innovation more broadly, not just in the space, but in general, how do you solve problems? And how do you actually incentivize people to do things when you don't have a pool of resources? And often when you're thinking about the perspective of what is your particular thing that you can add? We have a lot of academics here who can write things, who can give good feedback in the press, can write op-eds, who can do deep articles. We have those who are in corporations, who have purse strings, who have boards they have to account to, but that also have huge resources, amazing scientists. People actually can get things done and in the market. We have strategists who are at foundations and at Harvard and elsewhere who have a bunch of different networks that they can tap in to get things done. Now, what did we have at the White House? We didn't have a budget, it had no budget to do anything there, didn't have any particular deep expertise within our kind of group within the chief technology officer's office, but what we did have is the ability to call on people, to ask them for advice, to convene them, people of diverse backgrounds who may otherwise not always want to be talking to each other, maybe enemies in the public eye and to may we have people here who are openly critical of each other in the public, but we're here together in this room to discuss what is possible. So being able to do that and also being able to, this is of course different special thing about the White House, but being able to use the bully pulpit to raise up and give public recognition to efforts that we think are important. So in that case, pharmaceutical companies wanted to work in pediatrics, but what's their incentive? What's their incentive to do that when they barely can make a little margin, maybe working with generics or they are getting criticized for a lot of things from the government? What is their incentive to do something in this room? Of course it is, there's, you can hear from the motivation of our speakers already that there is a lot of personal passion and also probably culture in the companies that want to do the right thing, but beyond that, what can you provide as additional incentive? So in the White House, we could provide a platform for whether it's just writing a blog post, celebrating achievement and try to provide some kind of incentive for this to happen. So ultimately, through a number of convenings, we looked at things like, again, think about what are the incentives? And we've heard about things like the Access to Medicines Initiative that Gilead was number one there. We've heard about things like different awards that can be given. I don't remember what was mentioned today, but we had again this opportunity to say, we have this platform on December 1st and we're going to try to have something that's announceable in that timeframe. So we thought about, well, we can give public recognition, we can do things like also have prizes. What if we do a prize for the company that comes up with kind of pediatric formulations of these three key fixed-dose combinations that we need to see in the market? Should we do a prize? And how do we price it? Or should we do, do we know exactly who needs to do what and so do we need to actually then have pooled procurement and say, if you make it, we will buy it, right? We want to get the purchasers, whether it be Chai or PEPFAR, or others to say we express this treatment target, though if we can see this happen in the market, we're going to buy it. Is that what we need to solidify? So in each case, it's trying to come up with what is kind of the critical thing that will then catalyze the actions that need to happen, whether it be incentive in terms of, oh, what we need to know is that if we make the drug, it's actually going to be going through the regulatory authorities in a clean and smooth way and also get into the field, that's the kind of information we need to prioritize and put time into that. What is the issue? So in the end, on December 1st, we announced this commitment to action kind of framework, and we weren't quite there yet, right? So we announced sort of a, here are the seven or eight principles of what's going to happen in terms of the goals to accelerate the development of these child adaptive formulations. We're going to publish reviews of this. We're going to have these awards, and we'll have regulatory approval that's going to be rapid and go on. We didn't have any specific commitments from this particular government to say we will approve it, but that's where we wanted to go. So we announced as much as we could then. I'm glad that Ethan is here. He can talk a little bit about what's happened since that time. It's a still ongoing project, but I want to stop here before I turn over to Ethan just to talk briefly about it from his side. It's that I think, again, what is important for our perspective here is to think about what can be, how can we use action enforcing events like an announcement opportunity, and again, where people in the government here, we have potentially the opportunity to at least raise this as an opportunity to lift up, but if we think about things like how do we create more sustainable, non-exclusive licensing partnership with generics? How do we replicate the Gilead model? If that is the goal, if we think that that is what every country, company should be doing, is creating this partnership, we want to ask why aren't more companies using this model? Should they be, and how do we get there, right? We saw there was an HBS case study, I think, that Greg flashed up here that's going to be going on with respect to Gilead. Is that what we need to try to help other companies who may want to replicate it, understand how to do the generic kind of partnerships, inter-country differential parsing, we talked about co-artem, three or four pricing points. If we feel like that is very important to scale or to explain how do we make the packaging be very efficient and help deal with these issues, is there stuff that can be translated? Does there need to be more awareness or do we need to fund certain things there? In each of these cases, or if we're talking about innovation, the third kind of platform here, releasing research failures, what is the kind of critical thing there that needs to happen? So hopefully some of that work can be done and discussed in small groups. So before I end, let me pass it over to Ethan to talk briefly again as our external validator. Keep things honest and I'd like him to comment as well. Hi, thanks, Khalid. I wasn't actually sure if I was going to speak, so I'll just be one second. Just to say that I do work with doctor stop orders, I'm here speaking in my sort of independent capacity today and I'm not speaking about the medicines patent pool, though I used to work there. So we, at the medicines patent pool at the time, had just been putting together a pediatric HIV treatment initiative. And so that dovetailed quite nicely with what Colleen had been working on at the White House. And so an important element for us was making sure that there would be people to buy the drugs once they actually were developed to create an additional pull mechanism. So just to give the very quick update, since that time in 2014, the PHTI, so it's continuing in collaboration with PEPFAR and the other folks in US government, it's been a partnership of the medicines patent pool, DNDI, the drugs for neglected diseases initiative, the Clinton Foundation and UNITADE. And that partnership has been working on a number of WHO recommended pediatric combinations that currently do not exist. It's worth mentioning that most of the WHO recommended pediatric formulations do not exist in the dosing and formulations that they should. So what's happening is each of those partners have taken on different formulations that they are spearheading the development of in collaboration both with the originator companies, all of the originator companies who hold patents have put those patents into the patent pool to enable sale and development. They're also helping by providing scientific expertise as needed in putting the formulations together and then generics are doing the actual development of the formulations. So we have four important formulations that have been under development that should be registered within and on the market, I think all within the next couple of years. Registration's gonna happen depending on, some of them are more complicated than others, 2016 to 2018. For instance, Lepinivir-Rutanivir has a lot of issues with taste, as Colleen was mentioning, which are really actually quite difficult innovation problems to work around. But with this sort of partnership with everyone coming together, particularly putting patents in and then working with the generics who really do a lot of innovative work on their own, we have these four formulations currently under progress and one of the newest HIV drugs, Lepinivir-Rutanivir will start into that same path very soon for pediatrics, which is actually quite a bit faster than normally happens for pediatric formulations. Thank you. Thanks so much, Ethan. I'm gonna actually invite Greg and Hans and Prashant back up for a moment. We have a few more moments before we end this session. I wanna ask a couple of questions to the panel.