Bill Gates has spent a lot of time lately talking about the magic of vaccines. In his recent annual letter, he referred to vaccines as the most efficient and cost-effective health tool ever invented. And he's right. The World Health Organization estimates that vaccines save more than 2.5 million lives every year -- across all diseases -- and protect millions more from disease and disability. But despite the number of vaccines already available, many children are still dying from diseases for which no vaccine exists. New vaccines would not only save these young lives but could also lessen disease and suffering among a variety of populations, and investment in their development represents a potential area of opportunity for vaccine manufacturers and donors worldwide. BIO Ventures for Global Health (BVGH) teamed up with PATH to evaluate the business case for investment in vaccines against Enterotoxigenic Escherichia coli (ETEC), a leading global cause of bacterial diarrhea.

An effective ETEC vaccine could have a significant impact on global health, saving the lives of hundreds of thousands of children each year and preventing considerable physical suffering and malnutrition due to repeated bouts of illness. In the last few years, momentum has been building in both the public and private sectors around research and development efforts to develop new diarrheal disease interventions, including an ETEC vaccine. Public funding for diarrheal diseases from high-income country governments and multilaterals has increased substantially, and several biopharmaceutical companies have recently shown an interest in ETEC vaccine development.

The purpose of our ETEC vaccine market assessment is to provide relevant information for product developers interested in the development of these vaccines. Specifically, we aim to increase the awareness of biotechnology and pharmaceutical companies in Europe and the United States, as well as companies in emerging markets like China and India, about the opportunities and potential markets that exist for low-cost and effective ETEC vaccines. In addition, we hope to provide donors and commercial investors with a better understanding of the potential risks, rewards, and gaps in knowledge relative to these opportunities as they consider their own investment strategies. Given the myriad investment scenarios that can arise in this market, this report focuses on the primary inputs to financial return scenarios.

The market-assessment report provides detailed background information, including an overview of ETEC illness, disease burden, current treatment and prevention methods, and the scientific feasibility and current status of ETEC vaccine development. In addition, PATH and BVGH share the market assessment itself, detailing the key assumptions used in the analysis and resulting estimates for potential pricing, market penetration, and revenue for each of the markets we analyzed. Finally, we outline challenges and opportunities in developing ETEC vaccines and recommend next steps for moving the development process forward and making affordable, safe, effective, and accessible ETEC vaccines a reality for each of these markets

To download a full version of the ETEC market assessment, visit the BVGH website.

  

The Global Health Primer provides a source of complied and synthesized information on neglected tropical diseases of the developing world and the drugs, vaccines, and diagnostics in use or in development for management of these diseases. The Primer also examines products in development based on their target or technology, across multiple diseases. Below we ask questions to reveal some of the lively conversation that occurred during the broadcast.

If you had the information synthesized in the Global Health Primer in the past, could it have helped you meet your company's goals?

Carol A. Nacy, PhD, founder and CEO of Sequella, Inc., recounted her company's previous experience bidding for an abandoned drug to treat leishmaniasis and Chagas disease, citing how difficult it is to quickly raise funding when all the relevant data is spread across several disparate sources:

"[...] if I had the Global Health Primer, I probably would have been able to raise the extra $1 million we needed to win the auction. For those of us focused on global health, having a Primer that helps us do the market opportunity will be invaluable."

That is exciting to hear. But some say raising capital is only half the battle. Is this true?

Erick Rabins, former Senior Vice President of C3 Jian, Inc., thinks so. For biotech executives, Rabins said just as important as researching market opportunities up front is being able to recruit and cultivate internal champions at their companies.

"Those are the people that have to make the case to the investors and the board of directors to take resources that are otherwise allocated to the core mission of the company and turn them toward neglected diseases. [...] Information is the key to that recruitment... information that's available here in the Global Health Primer."

And what about external funding? What do funders need to consider a global health project a success?

According to Hannah Kettler, Senior Program Officer and Economist at the Bill & Melinda Gates Foundation, it's not just internal funding that can be elusive without the type of data available in the Global Health Primer. Donors, too, need accurate information to fully vet funding opportunities. At the Gates Foundation, they strive not only to fund project startup, but also to further enable success of projects by bringing more donors to the table.

"That means governments, other philanthropists, individuals who may be looking to make an investment...and not unlike companies, these groups are also lacking information that can now be quickly found within the Primer."

From everything that's been said, it seems the real challenge is not convincing executives that contributing to global health is the right thing to do, but rather giving them the tools to be successful in their efforts.

This is 100% true, according to all the panelists. Executives want to make a difference using the tools at their disposal, but it takes good data to make it happen. That's what the Global Health Primer provides.

Says Kettler, "You want to get more funders involved, but you also want to keep them involved. And the benefit of the Primer being available online is that it'll show if something's happening. It's a very valuable tool for funders as well as companies."

Rabins agrees, "Fortunately, I don't think people need much encouragement to know [contributing to global health] is the right thing to do...but what they need is to have those tools in their hands. And what they don't have time to do is compile data...they need a concise information source. [...] The Global Health Primer has tremendous potential in educating people in that way."

Now that the updated Global Health Primer is freely available online, how should those interested in global health R&D make use of it?

BVGH Board Chair Carl Feldman ended the webcast by inviting industry leaders to visit the Global Health Primer soon and recognize that it's an organic resource that depends on their feedback to maintain its value.

"Please examine the Primer and feel free to reach out to us with questions or answers that you may have. Most importantly, thank you for joining us in this quest."

To see more of this conversation, please watch the Global Health Primer webinar here.

To learn how you can get involved in neglected disease drug, vaccine, or diagnostic research and development, or to provide updates, changes, or corrections to the Global Health Primer website, please visit the Primer online or contact us at globalhealthprimer@bvgh.org.

  

On March 28, BVGH published the first in a new series of quarterly features that translate patents contributed to the Pool for Open Innovation against Neglected Tropical Diseases into more concrete opportunities to access intellectual property and knowledge and enable research for neglected diseases. In this first feature, BVGH highlights a family of patents contributed by GSK that cover small molecule inhibitors of DNA gyrase, an enzyme that is essential for bacteria to replicate their DNA. These patents were contributed by GSK because the compounds they cover have activity against Mycobacterium tuberculosis, the bacterium that causes human tuberculosis. This same family of molecules is likely to also target the bacteria that cause leprosy and Buruli ulcer -- two neglected tropical diseases that are difficult to treat but are caused by bacteria related to M. tuberculosis, as well as Plasmodium falciparum, the parasite that causes human malaria. In fact, at least one small molecule covered by this patent family is included in GSK's public dataset of over 13,000 compounds with antimalarial activity.  More information is available in this blog post and in the feature itself.

 

The Bill & Melinda Gates Foundation is accepting letters of inquiry for the new grant program Biomarkers for the Diagnosis of Tuberculosis. This grant program is part of the Grand Challenges in Global Health initiative. With up to $12 million of funding, the program seeks to validate biomarkers for use in developing a low cost, simple to use test that can quickly and accurately diagnose tuberculosis in low-resource settings. The term biomarker is intended to include all types of markers that have potential utility for tuberculosis diagnosis and can include markers associated with either host or pathogen biology. Letters of inquiry are being accepted online until March 31, 2011 10:00 am PT. Details and application instructions are available at http://www.grandchallenges.org/biomarkers/eb.

NIH's TRND Program Now Accepting Applications for Collaborative Projects  

 

The second solicitation for collaborative projects in the National Institutes of Health (NIH) Therapeutics for Rare and Neglected Disease (TRND) program is now open at the online application website ProposalCentral. The application deadline is April 26, 2011. TRND carries out development of drugs for rare and neglected diseases, and develops new technologies and paradigms to improve the efficiency of drug development. TRND provides in-kind pharmaceutical R&D support to promising therapeutic programs that have at least reached the lead candidate stage. In these partnerships, TRND works to advance the therapeutic candidate to human clinical trials and external adoption. Currently TRND develops small molecule, therapeutic antibody, protein, and stem cell therapeutics; but does not support the development of vaccine, gene therapy, animal models, or diagnostics.