“Big Pharma as a Catalyst for Change”: GSK “Open Innovation” strategy

It’s estimated that one-third of the world’s population go without essential drugs–often drugs for treating diseases that disproportionately affect the world’s poorest. The pharmaceutical world proves to be especially difficult to navigate for those seeking to provide such medicines to underserved populations, however. Pharmaceutical science is a field with billions of dollars in R&D, ironclad patents and intellectual property rights that are prohibitive to making drugs available to the poor. Andrew Witty, CEO of GlaxoSmithKline, claims that he’s looking to change this nature of big pharma, in the same way that the open source movement has revolutionized the tech world.

I love the word “innovation” combined with anything related to global health, so the prospect of sitting in on a blogger’s roundtable with GlaxoSmithKline CEO Andrew Witty was exciting enough just from the topic at hand: “Breaking Down Barriers to Innovation and Access to Medicines in the Developing World.”

The ante was upped in a press conference this morning, when Andrew Witty announced GSK’s “Open Innovation” strategy to make drugs more available and break down barriers to access. This strategy includes several components.

“Open Lab” initiative
$8 million in seed funding has been provided establish an “Open Lab” at GlaxoSmithKline’s research facility in Spain. As many as 60 scientists from around the world will be able to work at this lab, which will be devoted to research for drugs that target diseases of the developing world.

13,500 malaria-combating compounds in the public domain
This is perhaps the most exciting announcement. GlaxoSmithKline has been collaborating for years with PATH and other organizations in the development of a malaria vaccine. Scientists at GSK have screened all compounds that have ever been created in their labs, and identified 13,500 compounds that successfully combat P. faciparum, the deadliest form of malaria. The big news? The chemical structures and other recorded data regarding these compounds will be open sourced, in hopes that malaria vaccine research will be accelerated.

New pricing model for GSK’s malaria vaccine candidate
GlaxoSmithKline is in the process of developing the world’s most advanced candidate for a malaria vaccine—it’s the only vaccine in Phase III clinical trials, and could be available to the public as early as 2012. Maintaining that a tiered pricing model simply isn’t feasible for a drug which is needed almost exclusively by the world’s poor, Witty announced a pricing model for the vaccine which covers the cost of the vaccine with a marginal return for GSK, all of which will supposedly be channeled back into R&D for “next-generation” malaria vaccines.

It goes without saying that some present at the roundtable were wary of the corporate world’s ability to selflessly decide change the mechanics of drug information and pricing in order to benefit the world’s poor. Witty has struck a nice balance between acknowledging that GSK is a profit-driven company but maintaining that he strives to keep a “restless” socially-conscious agenda.

And let’s be honest—GSK won’t be suffering much financially with this move. First of all, the malaria drug market isn’t very competitive to begin with, because of the very fact that it is a poor person’s disease. Secondly, GSK is already the developer of the leading candidate for a malaria vaccine. It’s unlikely that, even with the compound information made publicly available, anyone can come up with a vaccine to rival GSK’s in any short amount of time.

Indeed, as Witty acknowledged, making drugs and drug knowledge more universally available is an investment in the future. Drugs will not be provided for free, he stressed, but rather provided at a marginal price that won’t completely alienate other pharmaceutical companies from healthy competition for lifesaving drugs.

Regardless of motivation, it’s refreshing to see big pharma recognizing the issues of access to medicines for the world’s poor. Moreover, Witty’s emphasis on being in step with progressive intellectual property movements is laudable. Whether or not GSK’s initiatives will stimulate other pharmaceutical companies to follow suit remains to be seen.

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• Glaxo’s Witty Tries To Fix An Industry Problem (invivoblog.blogspot.com)
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• Glaxo offers free access to potential malaria cures (guardian.co.uk)
• GSK offers to share data to help fight malaria fight (telegraph.co.uk)
• GSK offers scientists labs, data to fight malaria (seattletimes.nwsource.com)
• Malaria researchers given crucial data (cbc.ca)
• GlaxoPfizer tieup opens new era in Aids battle (telegraph.co.uk)

In early 2009, Oxfam released a report Blind Optimism critical of the private sector’s role in healthcare in poor countries. It drew attention to the cause of those who believe that any private involvement in healthcare in these countries is harmful. The arguments, evidence, and position of the report were flawed in numerous ways; sound responses to the report were provided by April Harding and the World Bank:

• Oxfam — This Is Not How to Help the Poor
• World Bank responds to new Oxfam health report

The reasonable conclusion one would come to from working in the field and from studying health systems is that a mix of private and public approaches will be most effective – and that the need for different approaches should be dictated by local context. Ideological extremism – pro-private or pro-public – doesn’t serve anyone, most especially the people who need access to health.

At Forum 2009, there was much stronger representation of the private sector than at the previous meetings. In addition to pharma and biotech, there were several sessions and plenary speakers dedicated to talking social entrepreneurship. One of these speakers was Al Hammond, Senior Entrepreneur-in-Residence at Ashoka. Al spoke during Wednesday’s plenary - Enhancing national environment for innovation: perspectives on low- and middle-income countries (TropIKA.net post about the session) – about Ashoka’s Healthcare for All pilot Punjab, India.

During Q&A Claudio Schuftan of the People’s Health Movement criticized Dr. Hammond and Ashok [sic] for: (1) bringing electronics to people where there is no electricity or way to repair devices, (2) supporting the interests of multinational corporations, and (3) making people dependent on products. Dr. Hammond began his response by saying, “We are aware that there is hostility towards private sector approaches”. He explained that they use market approaches to achieve efficiency and that all the programs he presented are social enterprises started by NGOs. Based on the success of the three pilots so far, the Punjabi government has requested 600 additional units. “Take what you will from that”, he ended.

Dr. Schuftan’s comments are well-aligned with the Blind Optimism ideology. Such comments attempt to polarize policymakers, donors, and implementers. In doing so, they actually keep us from thinking critically about the private sector and social entrepreneurship. Fortunately, this was not the overall tone of the meeting.

At the end of a session examining the role of governmental policy in supporting social entrepreneurship, Julius Mugwagwa of the Open University (UK) asked a question about the “backlash” that might occur if something went very wrong with one of these social entrepreneurial models. This is the type of balanced discussion we really need.

So I was thrilled to see recent developments in accountability – the Stop the Stockouts campaign, and the creation of the Budget and Expenditure Monitoring Forum in South Africa.

Power to the People: Stop the Stockouts

Stop the Stock-outs , a multi-country Africa campaign, is using text messages sent by activists and members of the public to expose stock-outs of essential medicines at public health facilities and put pressure on governments to address the issue. It was launched in Kenya, Uganda, Malawi and Zambia by Health Action International (HAI) Africa. During Pill Check week in June, facilities were surveyed, and a map of stockouts was created. The image below incorporates July 2009 data. It was found that many government health facilities were routinely running out of, or just not stocking essential medicines to treat common diseases such as malaria, pneumonia, diarrhoea, HIV and tuberculosis (TB).

“We were finding availability levels in rural, lower-level health facilities of 40 or 50 percent for essential medicines,” said Christa Cepuch, a pharmacist at HAI Africa. Read more from IRIN here

Show me the Money: HIV Policy AND the Budget and Expenditure Monitoring Forum in South Africa

With a new government in South Africa as of May, there have been some very positive signs. Celia Dugger of The New York Times reported that the new health minister, Dr. Aaron Motsoaledi, had accepted the strong critique of South African HIV policy reported in this Lancet series: Health in South Africa. He is a brave man, and needs all of our support as he tackles the challenge of rebuilding the healthcare system.

Gap in Treatment Access and Re-estimating the Need

One of the most daunting challenges Dr. Motsoaledi faces is that less than 50% of people who need ARVs in South Africa have access to treatment. And this may be an understatement of the actual need. Why? The government uses the Actuarial Society of South Africa ASSA model to project need, but ASSA uses 10 years from seroconversion to the time of first AIDS definining illness, whereas research evidence now supports 7 years. Dr. Francois Venter and Dr. Pierre Barker created the HAART calculator which uses 7 year period to AIDS, and estimates a higher patient need for HAART at this point in the epidemic than that projected by the National Strategic Plan. So, the gap is even bigger than reported.

Budgeting Failures threaten HAART program

This week, the Treatment Action Campaign released a press release on the creation of the Budget and Expenditure Monitoring Forum. Read the IRIN report here.

The Forum plans to put pressure on the national departments of health and finance to provide better budgeting and oversight of health expenditure in the country’s nine provinces, and ensure that there are no further moratoriums on ARV treatment. Last year, the most visible of budget cut decisions was the moratorium on the initiation of patients onto HAART in the Free State from November 2008 through March 2009. The Southern African HIV Clinicians Society estimated that at least 30 lives a day were lost as a result of this decision.

Here’s an excerpt (with some editing by me) of the press release from TAC:

A further problem is that the quality of financial and programmatic information about the HAART and PMTCT programmes is poor. This makes it difficult to assess implementation progress and leaves civil society largely dependent on what we can find out from our own investigations and anecdotal reports. For example, there is no publicly available information of the volumes purchased against the antiretroviral tender. We have received a report that the volumes being purchased are substantially less than predicted. If this is correct, then the treatment target set in the HIV & AIDS and STI Strategic Plan for South African, 2007 – 2011 (NSP) is not being met.

The Minister of Health, Dr. Aaron Motsoaledi, has already confirmed that nationally, there is a billion rand shortfall ($135 million USD) in HIV programme budgets for the current financial year. We have received reports indicating that provinces are facing financial constraints which could lead to a cut-off or slow-down in putting patients onto HAART. This will lead to more avoidable deaths.

If I can get a .pdf of the TAC press release, I’ll post it.

Mayo Clinic, Global Health and Design Thinking. You might be wondering what those three terms have to do with each together. This is my partial recap on time spent at the Mayo Clinic this past week where I saw one potential vision of what the future of healthcare might look like. It was a great privellege to hang out at the Mayo Clinic for what was the best conference I have attended in a long long time or maybe ever (Amy Tenderich at Diabetes Mine also has a recap that I encourage you to read). The Mayo Center for Innovation hosted a TED style event – Transform, a collaborative symposium on innovations in health care experience and delivery, all the videos are online (highly recommended viewing). It is going to take me a few months to digest what happened there and wrap my mind around everything I heard. There were over 430 people from 23 states, 7 countries and over 1,350 tweets. The caliber and just genuine niceness of every person I interacted with was on some other level, the conversations were rich, deep and thoughtful. The conference organizers *created an open purposeful environment* that led to an incredible experience. The folks at Mayo certainly shaped and designed a great space to achieve the symposium goals (this all reminded me of the Winston Churchill quote – “We shape our buildings and afterwards, our buildings shape us”).  Let me stop before you think I have joined a cult. The direct connection to global health here – it was discussed by keynote speakers and my first tweet from Mayo was “this place reminds me of Aravind (Aravind Eye Care System). Jaspal, Mahad and I have written several articles and cases studies on Aravind and I continue to believe it is a premiere model for innovation and care delivery. More on this in a bit.

The Global Health Convergence: “Design Thinking” and Innovation
There were many things that made this event great, however, in terms of extending your horizons and making you think, one of the most refreshing things was to see some convergence of disciplines and people from a variety of backgrounds. This is very hard to do and cannot be underrated. We all live in a sea of fragmentation,  in systems, in professions and fragmentation in how we solve problems. This is even reflected on a micro level – look at the mainstream peer reviewed journals in healthcare where you see severe fragmentation amongst the physician, nursing and pharmacy focused journals (some of this is for good reasons and some of it’s not). This conference was in part about ditching that fragmentation and about a convergence of ideas, people and relationships working collaboratively. In addition to innovative projects, new models of delivering care and how the process of innovation can be conceptualized, managed, and enabled was discussed. Much of this was encompassed under the umbrella of Design Thinking (innovating and problem solving using various methods). Tim Brown, CEO of IDEO, was a headliner on this front and re-emphasized a call for design to big, an ethic of design for social impact/change, which Jaspal and I have covered on this blog before (see our previous post – 8 Links for Design and Global Health).

If you were too look at the methods of design thinking you would see an amalgamation and convergence of mostly existing methods from a variety of disciplines (from engineering to ethnography to epidemiology to psychology to health services research to name a few examples). As Tim Brown said in his talk: “Design thinking begins with integrative thinking which is the ability to hold opposing constraints and opposing ideas and from those create  new solutions…this means balancing societal needs (desirability) with what’s possible (feasibility) and what’s sustainable (viability)“. When Tim Brown said “Design should not be left in the hand of designers” he hit the nail on the head – design thinking can be incorporated by non-”designers” to help innovate and solve problems. What we do has to be a participatory, collaborative effort. Tim Brown wrote more about this participatory perspective (How to Design a Participatory System in a post crisis economy world). There are many critically important reasons why this is a key factor, one of which goes back to Paulo Freirean educational tenets – people who participate in their own education, become engaged in the transformation of their own world. The other reason is because even though as brilliant as Tim Brown is, (and all the people working at organizations like his) he doesn’t have all the answers, or even the correct ones (read his other piece at FastCompany on HSAs where his point is highly debatable about the solution and at best has over simplified the problem).

The bottom line that I took away is that we need more of a participatory system, we should be open to new ways of approaching problems (“design thinking”) and we can provide some structure to the process of innovation. Besides design thinking the other major theme I want to point to is global health – as I said above in the keynote presentations global health made an apperance. Both Clay Christensen and Tim Brown mentioned the Aravind Eye Care System and Jaspal spoke entirely about global health. We have said on this blog before that there are many lessons that can be learned from outside our system where innovation is taking place due to extreme necessity, it’s not a choice (a lot of this is taking place over the web and with mHealth – mobile phones for health). In Global Health, there are hundreds, maybe thousands of innovative experiments going on using a wide area of technology (devices, drugs, the web, mobile phones, etc.), however, how we track these experiments, talk about failure, and share what has been learned seems to be highly inefficient and lacking.  We have covered a lot of this ground over the past three years, the easiest summary of examples can be found in this post:

42 “Extremely affordable” Innovations in Global Health

Clay C, Tim B, and Jaspal all pointed to global health as a place we can learn from. While there are some serious limitations, there is a ton to learn from the use of mobile phones in developing countries and how that might apply here – because overseas usage of phones is far beyond what is being done in the US. The other area to keep an eye on is chronic diseases. In some places, there is going to be an explosion of chronic conditions and new models will have to be devised to handle that tidal wave. I would love to see Amy Tenderich and her community do a brainstorming session on design for diabetes in developing countries. On this front see two previous posts:

1. Reverse South to North innovation – Borrowing innovation: health services, financial services, and clean tech
2. A massive wave of chronic disease in India and China

Let me leave you on a note of caution, a “design thinking” approach (remember using existing methods) can offer some powerful alternatives. However, there can also be something seductive about design thinking and a rapid approach (we’ve cautioned this on the graphics/visual side before). If you fall into that seduction, then this is just a fad for you, it’s on us to be rigorous, thoughtful and corrective when need be:

“The myth of innovation is that brilliant ideas leap fully formed from the minds of geniuses. The reality is that most innovations come from a process of rigorous examination through which great ideas are identified and developed before being realized as new offerings and capabilities.” IDEO website.

I have many more thoughts on this, if I get the time I’ll jot down a few more notes and quotes from the conference, in the meantime, it is well worth watching the videos from Transform.

My PictureRx is designed for the domestic US market, but I thought I would post it on the off chance that it might stir up some ideas for situations in low resource settings. Not clear if they have gone mobile with this. While there are a slew of SMS pill reminders (first used in a widespread way in the “South”) it is important to think about this in development context due to the coming wave of chronic diseases – how well do SMS only medication remdiners work for people with co-morbidities and complex drug regimines? Also important to note – this is just one type of tool among many, and doesn’t seem like it helps with remembering whether you took your pill or not (have you ever looked at your watch for the time and then forgotten the time 10 mintues later?). The design looks slick and you can sign up for email reminders, however I am not sure what the efficacy is. Other issue to keep in mind with SMS reminders or something like this – while you can improve pill popping rates (adherence), there are many situations where people don’t want to take their meds (side effects or getting plan fed up with the polypharmacy).

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1. Secret global health gathering underway, link
2. Fauci: New TB research agenda desperately needed, link
3. Fighting TB in the mountains of Lesotho, link
4. Photographs from the TB front-lines, link
5. Calls for strengthened lab capacity, service delivery and better policy, link
6. Newsmaker: Seeking partners in Russia to fight MDR-TB, link
7. The question of universal access for TB patients, link
8. At MDR-TB summit’s end, expressions of frustration, link

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• Data on investigational drug TMC207 for MDR-TB published in New England Journal of Medicine (scienceblog.com)
• How Bill Gates caught the global health bug (crosscut.com)

Social media – Twitter, conference blogs, and Flickr – played a more important role in this year’s conference, although it’s clear increased participation will be required for it to provide meaningful value to conference participants. The conference was essentially about new technology and impact on community, and Twitter certainly fell into this category – it was the most successful technology used to form micro-communities for those at the conference and for those who could not attend. Jaspal used Twitter effectively for micro-blogging and through that we both met people we probably would have not otherwise. The use of Twitter (search.twitter.com “#GHC36″) for this meeting was a great example of crowdsourcing, idea exchange and getting strangers to chat with one another (invaluable).

Here are a few paraphrased thoughts and quotes that capture some of the flavor of the conference (if anyone has a list of best quotes or best things they saw at the conference let us know in the comments or by e-mail):

Technology & Systems
These innovations are not magic bullets – larger supporting systems need to be in place for them to be effective, and there are opportunities for improving outcomes by improving the usability of products.

Technology & People
One of the key challenges Mitul Shah highlighted during his talk was better understanding the relation between people and technology..we need more “basic market research” and “impact evaluations”… and an understanding of how cultural perceptions of technology impact social desirability bias seems to be a critical gap…context matters. It’s not just a matter of phone vs no-phone – culture, age, gender all matter, too.

Mobile Phones, Sustainability, Outcomes & Scale
Paul Meyer – mHealth strategies have been around since 2001.  And sustainability?  They’re already sustainable – over 4 billion mobile phone subscriptions exist worldwide, we should all think a little bit harder about our models of improving health outcomes and design them so they can be scalable.

Ashifi Gogo – 20% of deaths associated with malaria could be prevented with mHealth strategies…In rural Ghana, when individuals are sick, the first point-of-contact for health care and/or treatment are often chemical sellers, which can be fake or licensed…One solution – mPedigree has developed an SMS system to verify whether or not a drug they purchased is legitimate (”Yes”) or fake (”No”).

Project Masiluleke (mah-sah-loo-lick-ay) has sent 1 to 1.5 million “Please Call Me”s a day through SMS. Misinformation and competing narratives of HIV/AIDS have all played a role in fueling the stigma that has made HIV and AIDS so difficult to prevent, treat, and mitigate.   Through the power of “Please Call Me” tactics, Project M has increased the average call volume to the National AIDS hotline by threefold.

Hans Rosling:
“War does not explain the high rates [of HIV in Africa]“…“We have to start to use data in global health”…“People should be forbidden from talking about ‘HIV in Africa’”

Global Health Progress has a full list of our posts over this period.

Paul Meyer was a great speaker to have at the top of the lineup.  It was great to be reminded that mHealth strategies have been around since 2001.  And sustainability?  They’re already sustainable because the subscriptions are already paid for, but now that people are beginning to recognize how over 4 billion mobile phone subscriptions exist worldwide (to complement the world’s population of ~6.7 billion), we should all think a little bit harder about our models of improving health outcomes and design them so they can be scalable.

To complement this blog post regarding the same session (http://www.capacityproject.org/hris/blog/index.php/2009/05/ghc-conference-talking-about-mobile-health/), I want to draw some attention to some critical concepts presented by each of the individuals above.  The first remark is to develop some thoughts on counterfeit drugs after this morning’s session, as well as to express the importance of strong collaboration as exhibited by Project Masiluleke.

Back in February, I had the privilege of meeting Bright Simons and Kathryn Boateng, who are both on the mPedigree team with Ashifi Gogo.  What they are doing is a huge undertaking with complex dynamics.  The market system of drugs and medications are only becoming increasingly complex with further globalization, and current information and supply management systems are not in place to withstand this expansion.  Not only is the infrastructure weak to withstand worldwide drug pressures, but counterfeit drugs have important public health implications.

Malaria control, for example, consists of drug treatment – once chloroquine, now artemisinin and sulfadoxine-pyrimethamine.  Gogo made the statement that 20% of deaths associated with malaria could be prevented with mHealth strategies.  As more counterfeit drugs infiltrate the market, clinically effective drugs will be crowded out on the individual level, the community level, and the population level – perpetuating the difficulty for disease control.  On the individual level, drug resistance aggravated by cross resistance among different drugs which then requires chemically different drugs to be in the R&D pipelines at pharmaceutical companies – that is, if pharmaceutical companies have an incentive to divert funds to malaria control.  On the community level, some regions are more at risk than others.  In rural Ghana, when individuals are sick, the first point-of-contact for health care and/or treatment are often chemical sellers, which can be fake or licensed.  Only recently has the government and other agencies made an active effort in pushing licenses on chemical sellers with proper training in symptom-based treatment and drug selling.  In Nigeria, a similar drug market exists with what are called patent medical vendors, and as Gogo mentioned, a study in Lagos, Nigeria found 4 out of 5 drugs to be counterfeit.  Lastly, on the population level, a flood of counterfeit drugs inhibits the ability for herd immunity to occur, further complicating malaria control.  mPedigree is working on the issue of counterfeit drugs by collaborating with drug makers who are producing real drugs, and offering individuals the opportunity to send a text message to verify whether or not a drug they purchased is legitimate (“Yes”) or fake (“No”).

A good question was asked during Q&A (side note: the session moderator prioritized questions through twitter over questions directly from the audience) about how mPedigree was assuring that the sellers couldn’t trick or take advantage of the system.  Gogo remarked that the goal of mPedigree is to make it economically difficult to counterfeit, and that if a counterfeit drug was masked to be legitimate, the system could quickly deactivate its authenticity.  I believe this is definitely a step in the right direction.

Andrew Zolli from Pop!Tech described another mHealth strategy in South Africa called Project Masiluleke (mah-sah-loo-lick-ay) which has a wise approach towards reinvigorating HIV/AIDS messages by sending 1 to 1.5 million “Please Call Me”s a day through SMS.  Zolli mentioned how misinformation, disinformation, and competing theories and narratives of HIV/AIDS have all played a role in fueling the stigma that has made HIV and AIDS so difficult to prevent, treat, care, and mitigate.   Through the power of “Please Call Me” tactics, Project M has increased the average call volume to the National AIDS hotline by threefold with the help of MTN mobile network service provider, and has done a remarkable job at enhancing the meaning of collaboration to have a global and local impact.  Project M should be applauded because of its large-scale effectiveness, tailored approach to the population it targets, and active exploration of user friendly, at-home HIV testing kits.  This last element, working with frogdesign, is an exhibition of the movement towards ultra low-cost, distributive diagnostics.  The collective interest of all those involved in Project M is impressive (http://www.poptech.org/project_m_partners/), and the global collaboration has made a service – the largest of its kind – that has broken through the difficult barrier of stigma.

(If you are still curious, check this – http://www.frogdesign.com/services/project-masiluleke.html – out for a closer peek at how collaborations and collective interest can target effective behavior change.  At the bottom is an imbedded presentation designed by frogdesign that is great to flip through.)

So, in summary, what is important for new strategies and proven technologies?  Context.  Collective Interest.  Strong Collaboration. [Measured Impact.]

Registration here

The letter:

Dear colleague,

Forum 2009: Innovating for the Health of All is this year’s milestone event in research and innovation for health. Organized by the Global Forum for Health Research, it will take place from 16-20 November in Havana, Cuba, at the invitation of the Ministry of Public Health.

What exactly is “innovation”?* How can decision-makers and practitioners work together to foster innovation for health and health equity? What can we learn from innovation policies and initiatives around the world? These questions will be answered in Forum 2009‘s interwoven discussions of social innovation and technological innovation.

This event will bring together some 800 leaders and experts from around the world to share ideas and forge new partnerships. It will include a unique mix of stakeholders from health and science ministries, research agencies and institutions, development agencies, foundations, nongovernmental organizations, civil society, the private sector and media.

As you expand your networks, you will also be able to learn from discussions on social entrepreneurship for health, public-private product development for neglected diseases, eHealth, knowledge-translation platforms, national health innovation systems, donor-country harmonization and coherence, and innovative financing strategies.

With the theme “innovation,” we are challenged to be innovative in the programme itself including new session formats that are more interactive, new ways to network and share information, and new opportunities for inclusion.

So please join us. Registration is now open on www.globalforumhealth.org. We very much look forward to seeing you in Cuba.

Yours sincerely,
Professor Stephen Matlin
Executive Director
Global Forum for Health Research

The early microbicide discussions took place almost 15 years ago (International Working Group on Vaginal Microbicides, source). Over half that amount of time, from 2000-2007, $1.1 Billion has already been invested in microbicide R&D! It takes anywhere from $200M to $1 Billion to bring a single novel drug to market. Let’s hope one of these compounds works and makes it through phase III. But how much will we have spent? $2 Billion, $3 billion? If it works, it will have been worth the money, however, we must ask if we took the most efficient financial route to get to the end point and if there were better financial models – that is a valid question.