 We began about 20 minutes late, so I'm going to ask the organizers for at least five additional minutes. And what I'd like to do is actually open the floor first to all of you, because you've been sitting quite patiently through a number of different presentations. Let's take a first round of comments and questions, and if we have time, we'll go through two rounds with the panelists. So any questions or comments from the floor? I just want to ask Kevin to talk a little bit about the sustainable systems of finance. Just elaborate a bit more on that part of the presentation. I'm sorry, Jamie, to talk about the sustainable one. I couldn't quite hear you. The sources of money. Ah, yeah, yeah. So the most elaborated version of financing for antibiotic delinquents is found in the O'Neill report, the AMR commission, jointly sponsored by the Prime Minister of the United Kingdom and by Wellcome Trust. There were a couple of components. One was called the pay or play, which I think qualifies as the one that the companies like the least. And the payer play says that without antibiotics, good luck selling oncology drugs or doing a lot of other things, so that a lot of the industry has left antibiotics. A few have stayed, Glaxo and Pfizer to an extent, and a couple of others, AstraZeneca. But the ones who have left would have to pay their fair share. And the ones who've stayed would get credit for what they're investing. So the pay or play says that the rest of the industry is free-writing on the few that are still doing antibiotic R&D and they should pay. A second idea, which is also described, I believe in the O'Neill materials and is also being discussed, but is not decided within DriveAB, is some sort of a tax or user fee, perhaps on just on animal or agricultural use of antibiotics. So for example, a group of us have modeled a $25 per kilogram tax on bulk API antibiotics would raise several hundred million dollars a year, and it wouldn't drive out, it wouldn't eliminate low value use of antibiotics in that cultural sector, but wouldn't make it less economic. And so farmers that are using it as a feed additive with a low economic value would be incentivized to stop doing that. And the high value uses to a sick cow would still be quite economical, and that would raise money as well. The other ideas are straight out of general fiscal budgets, out of health budgets in Europe, and the final idea is for the U.S. government on the U.S. side to sell patent vouchers, which would then be used to fund antibiotic innovation. I think those are the four that are being discussed, and I'm sure there's others, but I don't want to take up too much time. Let me take the moderate as prerogative to note that there are actually some interesting commonalities between the debates around AMR and the potential creation of some kind of global R&D fund to which the U.K. government and the Chinese government have already announced a commitment of funds. At the same time, there's been a lot of discussion around the potential creation of a fund called CEPI for investment into R&D for outbreaks and diseases of epidemic potential. I think one of the questions that has come up as, excuse me, the third one, which is of course the creation of a global R&D fund at the TDR, which has a very long name, Special Program for Research and Training in Tropical Diseases, based at WHO. So after many years of many people pushing for the creation of global R&D funds primarily financed with public money, there are suddenly three that are very much on the table and part of a very live debate. But one of the questions that we've not yet heard a lot of discussion around is what principles should drive the way those funds are invested, and can we take some of the lessons from these experiments to innovation and access over the past 10 to 15 years to inform the way that money is deployed. So let me actually first throw this question to Tom since you're looking at outbreak-related R&D and what kind of suggestions would you make to those who are putting together CEPI, for example, and that may also include by the way governments from the north and south in the same way that the AMR debate has spurred potential contributions from governments across the income level. Great question. A funny thing about the debate over and there are not many funny things about the debate over the Zika emergency funding program, the politics of which mystify me. But the one thing that people do seem to agree on is that funding for R&D. The House of Representatives came forward. The President, as I think most people perhaps know, requested $2 billion in an appropriation for emergency funding for Zika. The House of Representatives came up with $612 million, almost all of that for R&D. So while that's not an acceptable response to the Zika outbreak, I do think it suggests there's some political consensus around support for R&D, which hopefully will be a starting point for addressing the other needs that have to happen to respond to that outbreak. So in terms of funding, ideally what you would like to see is instead of serial emergency appropriations of funding, which is what we've seen so far and leads to this kind of political conflict, clearly unsustainable, creates a lack of predictability, which is important both for the R&D side, but quite frankly for a lot of the downstream response also, people need to know their support, is you would like to see this galvanize the creation of a fund of some kind that Suri mentioned. There have been other programs I mentioned too very briefly because I went too long on my presentation at the end in terms of looking at access principles that can drive how those funds might work. What they've traditionally involved is some acknowledgement that the entities, the commercial entities that come into the space, or even non-commercial entities into the space can keep their existing IP to their project IP, but that the milestones being set, the licensing being set, the eventual pricing that emerges out of this favors access in low- and middle-income countries and a commitment to do that, and that is a condition of either receiving the grant or the participation in the fund. I think that's sensible in this space. I think what will be interesting to me, I'm little less concerned about how we navigate the R&D upstream side. I think there are a lot of interesting models of doing that. You've heard some from Kevin. There's hundreds of law review articles and economic papers on different innovation models at this point. What I do think is a real problem is the manufacturing access. What happens in the downstream? Because I do think there is a tremendous risk in the midst of a quite serious outbreak, and as I mentioned, Ebola at the end of the day is a very hard disease to catch. Zika has had a terrible impact, but you could easily see something much worse, and I think the temptation for governments to nationalize their manufacturing capacity is real and monopolize. What ends up happening in low- and middle-income countries in that setting is problematic. People will remember the pandemic influenced the preparedness framework that emerged from this Indonesia concern. That only extends to pandemic influenza. It doesn't extend to seasonal influenza. It doesn't extend to other diseases. And even in that context where you had a country holding up the whole process with holding samples, it didn't include advance purchase agreements. The political consensus that you have out there for commitments to access is really limited in other circumstances, and I don't see progress being made unless you see more distributed manufacturing, at least regionally. Any other questions or comments? Tom, I actually had a question related to that because on the one hand I take your point about having a manufacturing base at the ready in the case of pandemic outbreak, but on the other hand, I think it was noted earlier this morning that this is an industry that is characterized by pretty large-scale economies of manufacturing. And I wonder if that sort of approach of wanting to have, we're trying to have a multiplicity of manufacturing centers around the world, and particularly in places that don't have a very large manufacturing or technical base, isn't going to build a lot of more cost and efficiency into the system itself? Yeah, no, it's a real concern. I mean, I will say it is the way in general global health is going. Increasingly, funders, you know, I was at the Gates Foundation every year, holds these product development forums, and it's filled with entities that come and talk about how these products will be developed and how they'll be delivered, and the Chinese presence was just massive at these. I mean, I think there is an increasing interest in emerging countries to have a manufacturing base, and global health is one way to develop that. That, in my view, is really the only sustainable way, long-term way, to address neglected diseases as if you see a greater set of actors in the space. There are some real systemic concerns that need to be managed for sure. Manufacturing controls have not always been great in this context, and I think people need to talk about painful things to acknowledge. In global health conversations, we need to acknowledge there have been real problems. There's also not a lot of support for global post-market safety monitoring at all on the budgets for these manufacturers as tiny in that space. So there needs to be support extended. But particularly in these contexts, you see a pandemic influenza that even looks half of what you saw in 1918. If there's not more distributed manufacturing, and first of all, you can't respond to it, but secondly, there's just not a lot of incentive for other countries to participate. If the manufacturing is going to be overwhelmingly in high-income countries. Okay, thanks. We have... Tom, so this is continuing on the distributed manufacturing question. I think it's a very serious risk in many ways, especially for more complex manufacturing. I think for oral solids and small molecules, we are at a stage where we can do a lot more distributed manufacturing. One company in particular has BODs, which we've seen a lot of success out of. So for small molecules, I think we can address it through distributed manufacturing. But for more complex things, the challenge is that if in North America and Europe, we don't have political buy-in for sharing product across, and if Europe says we want our own manufacturing and we in North America want our own, then that sets an example where every country says we want to have our own manufacturing for these pandemic products. And that's not sustainable from a cost standpoint. That's not sustainable from a quality standpoint. So I think something needs to happen in the OECD club for this to trickle down and translate into how this will be viewed by industry ministers and industrial policy and health intersections in developing countries. At least I haven't seen much of that happen. No, and clearly you're not going to have a manufacturing base in every country. But one can imagine an arrangement where for funding support of a manufacturing capacity base you need to enter into advanced purchasing agreements or the types of commitments people weren't willing to enter into in the pandemic influence of preparedness framework negotiations if there is support from that. So you can imagine that. What you would like to see is some synergies between the broader research development happening in global health which is investing in manufacturing these places. So I mentioned Manafrabak in my presentation. It is the first novel vaccine registered by emerging country manufacturer. They are now doing more of that. And that I think there's a reason why these governments, these countries are engaged in these activities but I think it's a good thing in terms of system. People talk a lot about resilience and global health. This is resilience. It's important. Okay, last comment. We'll take two last comments and then we're going to... Partly a follow up and partly this is actually this is for Jamie in following up. So your new business model and your new set aside business how do you explain or design the business model internally that that makes sense? And I was just about to ask so will that actually involve doing manufacturing more of your global projects across different regions than you've been doing in the past? In other words, how will it change things and why is it of benefit to internally enough that they were willing to create this? So in the interest of time let's get the last two questions and then we'll go across the panel. Thanks. So I just wanted you to think about the outbreak preparedness and where the pandemic influenza framework comes in where it doesn't... For us at MSF in here I can speak for MSF and not in my personal capacity. It starts very early on with just data sharing and specimen sharing which frequently comes up in I would say a slightly imperialistic way where we try and bash the heads still for not sharing specimens or bash Indonesia's heads for not sharing specimens but they have very real fears because in fact these will come back and now in the US you can't necessarily patent the virus itself but back in the day you could and they found out that that was happening and so they were reasonably upset knowing that they wouldn't get any access unless they really raise the issue. In the Ebola outbreak the specimens off the country are definitely doing some really fantastic work but really with no true accountability to anybody and we've been disappointed to see how the CDC has not been more forthcoming in how they're using the specimens and agreeing to use these very precious specimens according to agreed global research priorities and so what we're working on at MSF is thinking about the access issues from a very early stage to have provisions attached to use the data to transfer any specimens that originate from MSF so that we can create standards for a broader outbreak preparedness along with WHO and this is where the blueprint comes in that they've introduced at the last World Health Assembly so that we can have a very expansive view thinking about this from the very beginning because often I think we take the attitude that's fairly paternalistic to developing country needs and I think that those need to be truly addressed to make sure that they are partners with us and just with regard to the ability of developing countries to manufacture, folks like Bob Cook Deegan and others have done really in-depth looks at expanding ability to manufacture vaccines and biologics in developing countries and I think that there's actually a lot of capabilities out there and that we shouldn't just sit here at Harvard and poo poo what can happen in the rest of the world so I think that may have been a question for okay let me pose one last question and then we'll start with Jamie and go down the panel and have some very very rapid closing remarks which is these new funds that I was just mentioning may be on the order of 100 million per year to 2 billion dollars per year so they are sizable if you were in control of these funds what big out of the box idea what innovative radical new practice would you want to put in place with this money or you can choose to answer a question that was posed to you so I'll start with Jamie and then we'll come down okay we'll all answer the question that was posed so I think the impetus for pulling together this business model innovation this new now highly connected one team around global public health was driven in part by the fact that we simply weren't being as effective as we could be against certain major global health challenges in which we've been heavily invested so for example we've we've given more than 100 million dollars in philanthropic funding to support the fight against HIV AIDS over the last 10 years and yet we see in adolescent populations especially in Sub-Saharan Africa rising rates of incidence and feeling ill equipped to to manage that we looked inside our company and said wait a second we have within our consumer organization a clean and clear portfolio and other products specifically geared toward adolescent consumers with treasure troves of knowledge about behavior change and influence of specific to adolescent girls and yet here we've given money to the fight philanthropic funds but we haven't tapped into our business resources those assets, that knowledge, that expertise and how can we create better connectivity for context about nine years ago when we started an access and affordability initiative within our pharmaceutical sector there were four people dedicated to it part time and we think about the breath of the issues the persistent issues that we've addressed today for people part time for a global commercial strategy organization that just doesn't work and that was separate from our HIV team working on providing access for a second and third line treatments through a global access partnerships and voluntary licensing program which was separate from strategic philanthropy separate from our government affairs organization and so on and so forth and it's really incumbent upon us as companies to look within our under underneath our own hood and say how can we bring more and how can we organize better and we organize better through the leadership of a global strategic design office which is a design about design thinking human centered design and as we began to pull together what we called grand challenges workshops and HIV TB and other areas of concern we place real patient stories at the center and then we brought leaders from across our sectors to bring strategies based on their own knowledge and expertise and resources and and it unveiled for us all of the potential in that and of itself was impetus for this new business model innovation which we would characterize I think in some sense common parlance as a shared value type of model again we've just launched it we're looking to evolve it but you're thinking about other pieces of the business that haven't been connected into this work our manufacturing lines for example are an important piece of that fold and we've now connected our vaccine work and our pandemic readiness work and our global health security work all together we're calling that the in the Ebola fight where there was this absence of organization internally at J&J and especially externally we made some emergency pivots to make available manufacturing lines we realized that we need to be better organized in order to help the external world be better organized and so that's part of our purpose and we hope you'll help us with it very briefly I'm really surprised about your comment about Harvard because I have to say Boston excels at paternalistic ideas for other people around the world the whole city we're good at this you know we can make fun of other countries saying that why do you want your own plant don't you know there's a good one in New Jersey and another one in Paris but for the United States we spent hundreds of millions of dollars through BARDA because we didn't like the fact that the only vaccine plant of a certain type was located in France and so we built it here using US government funds to have a second source within the territory of the United States of America which could be surrounded by our army you know it was a biosecurity decision by the United States so we should not easily dismiss the fact that other countries have similar concerns we put real money on the table what I would do with 4 billion dollars I upped the number is for antibiotics if we had the global market is 40 billion if we spent 10% of that 4 billion we could delink the entire market and transform the way that the whole system works from top to bottom and I think this useful for antibiotics of course also think that it would be a test in a discrete drug class as to whether delinkage was helpful or whether it was actually not helpful and we actually need to test this idea instead of just continuing to talk about it great well I'm tempted to build off Kevin's comment and use my one wish to ask for three more wishes and have more funding in this space I think 2 billion is too little for the size of the problem but leaving aside the comments I made in there about distributed or coordinated innovation occurring around vaccine platform technologies which you do want to see in the ways that we presented in that paper one thing that I didn't get much of a chance to talk about but Colleen mentioned was the issue of regional or joint approaches to regulatory pathways and I think using this that money and this opportunity to approach those in advance as a way of pooling capacity creating more definition ideally also expediting it's not a lot of money there's literally nobody in this space funding regulatory systems and one of the issues about the focus on global health security of course as was mentioned by Suri at the outset this is by no means the only big global health problem we have right now and investing in these kinds of systems can have a multiple purpose to it let's see more of that and with that let's break for coffee thank you very much