How do you solve a problem like malaria? Or dengue fever? Or Chagas disease? The global health community has been at it a long time and while much progress has been made, these and other neglected diseases still plague the developing world. What's needed is something new. Actually, somethings new.

In the words of Dr. Rajiv Shah, Administrator of the U.S. Agency for International Development, "We cannot simply seek to do more of the same in an effort to provide services using currently available tools and technologies. Instead, we need to focus our efforts on facilitating a continuum of invention and innovation from bench to bush."

"Facilitating a continuum of invention and innovation" -- helping to create those somethings new -- is at the heart of the 2011 Partnering for Global Health Forum, held on June 27 at the Walter E. Washington Convention Center in Washington, DC. This Forum will bring together leaders in the biopharmaceutical, global health, academic, non-profit, investor, government, and funder communities to discover innovative ways to drive new product development for neglected diseases. This year's meeting features panels on topics that are integral to that new product development, followed by breakout sessions designed to advance the discussion to a deeper level.

Dr. Shah will lend his expertise to the meeting's opening panel: Knowing is Half the Battle: Parsing the Global Health Value Chain. Joining him on the panel, among others, will be Dr. Hassan Mshinda, Director-General, Commission for Science and Technology for the Government of Tanzania, and Dr. Regina Rabinovich, Director, Infectious Disease Program, for the Bill & Melinda Gates Foundation. These panelists will discuss the unique challenges of global health product development and illuminate the steps needed to take a potential product from the lab to patients.

The second panel, Blueprint for the Future: Exploring R&D Incentives, will delve into the need for mechanisms, complementary to traditional grant funding, that engage industry in global health research and development. With other panelists, Dr. Orin Levine, Executive Director, International Vaccine Access Center, will explore the lessons learned from both past and ongoing research and development incentive design efforts -- such as the Advance Market Commitment and the efforts of the WHO Expert Working Group on R&D Financing -- and discuss how this knowledge can help in designing future research and development incentives.

The third panel, Accounting for Global Health: Understanding Funding Opportunities, will chart the current landscape in global health funding philanthropy. During this session, panelists including Dr. Yves Ribeill, CEO of Scynexis, and Dr. Mary Moran, CEO of Policy Cures, will answer the questions: What funding for global health projects is currently available? and How do companies access this funding?

In addition to the panels and breakout sessions, the 2011 Partnering for Global Health Forum will feature a keynote address by NIH Director Dr. Francis Collins, and will provide ample opportunities during the day to network with panel experts as well as hundreds of attendees who are experts in their fields.

Don't miss these critical debates and the opportunity to meet Dr. Shah and others who are working to address unmet medical needs in the developing world. Register online today!

While it's not a new problem, antimicrobial resistance is becoming increasingly prevalent. In fact, WHO focused this year's World Health Day on the need for urgent efforts to stem the widespread trend of antimicrobial resistance across multiple diseases. Antimicrobial resistance is a consequence of the overuse and misuse of antimicrobial drugs such as antibiotics; this allows microorganisms to mutate or acquire a drug resistance gene, making them capable of withstanding treatment. This kind of drug resistance is particularly alarming because widespread failure would impact health universally.

 

In order to preserve the utility of new antibiotics, they need to be reserved to treat only confirmed drug resistant infections and not widely introduced into use, posing a major hurdle for new antibiotic development from a biopharmaceutical industry perspective. This strategy, while essential for global health, is difficult for traditional biopharmaceutical companies to adopt because they rely on sales of a new product to recoup development costs. We spoke with Dr. Heddini to learn more about how ReAct is working to engage the biopharmaceutical industry to overcome this hurdle and curb the global problem of antibiotic resistance.

One of the issues compounding antimicrobial resistance globally is misdiagnosis, especially among children in the developing world. Can you offer some solutions?

I absolutely agree with you, and I think that it is a big problem that we still are relying on 19^th century technology -- we grow our bacteria on old culture plates. We really need to step up efforts to invest more in R&D innovation to develop novel and much more rapid diagnostic tests and associated technologies. That would clearly help a lot in guiding specific treatment and also avoiding unnecessary use of antibiotics. If we had good and affordable rapid diagnostic tests for common bacterial diseases, for example, it would mean a lot. At present, we have to treat children in resource-poor areas empirically and often with multiple drugs -- we cannot afford not to do it because we risk losing lives.

At BVGH, we often hear from companies that would like to engage in global health R&D, but cannot because of the significant financial barrier of working in developing markets. ReAct is working on creating novel incentives to spur industry efforts to develop new antibiotics. What have you learned through those efforts thus far?

Last year, at the request of the Swedish government, we organized the Global Need for Effective Antibiotics meeting. This was the first time where we've heard from pharmaceutical companies that they really support the notion of a new model for developing antibiotics: one where investments in R&D should be delinked from marketing and sales [i.e., the incentive encourages the company to develop new antibiotics but to hold them in reserve even from potentially profitable developed world markets]. This would ideally boost necessary innovation while limiting the use of new antibiotics. Now we are working to move this process another step forward with the European Union to work out what such a model would look like.

And how would that model look?

At this point, it is not 100 percent clear. Of course, there is ample experience to draw upon from efforts to develop new drugs and vaccines -- from TB and malaria, to HIV -- but there is also a difference because these diseases are poverty related, whereas the common bacterial infections and the need for effective antibiotics is truly a global problem. Finding the right mix of incentives will be challenging but necessary.

 

From ReAct's perspective, we would caution against efforts such as patent extensions or data or market exclusivity for antibiotic incentives, because we don't think that such approaches would serve the interests of consumers in developed and developing countries. You need some new, really novel thinking incorporating multiple partners in an efficient, meaningful way.

 

Sometimes we follow the dictate of industry that tells us what we need to do to work with them [by providing a profitable market in which to sell their product, for example], but maybe we have to give them what they need for them do something else. Rather than provide them with a market for their product, what would we need to give a for-profit company to hold a product in reserve?

These are very interesting developments, indeed. At BVGH, we are currently working on designing a "pay for success" prize that would lead developers toward creating a critically needed fever diagnostic to be delivered at the point of care in the developing world. Do you have any advice you could give us?

This is clearly a very important area. You need to find a mix of incentives that allow R&D partners to overcome barriers posed by the specific diseases you are targeting. In drug development, there are some interesting Indian experiences from early stage development of TB drugs, where an open source model has been employed to significantly reduce costs at this stage, whilst producing promising leads. Furthermore, I believe that the use of target product profiles (TPPs) is valuable. If used properly, a TPP can help address issues early in the product development process and prevent late-stage development failures. A TPP also provides various parties and stakeholders a clear statement of the desired outcome of the product development program.