The art of the lifesaving deal: MenAfriVac team wins award

People lined up to be vaccinated at the MenAfriVac launch in Burkina Faso.

The MenAfriVac vaccine, shown being administered at its launch in Burkina Faso in 2010, has already been used to immunize more than 151 million people, and is expected to prevent more than 1 million cases of meningitis A by 2020. Photo: PATH/Gabe Bienczycki.

On a recent night in San Francisco, an elite group gathered: leaders who orchestrated one of the most creative and innovative intellectual property business transactions recognized this year. Think of it as the Oscars of intellectual licensing, where the top winners are typically titans of their industries celebrating mergers, acquisitions, and joint ventures.

So what brought PATH to the stage at this gala, alongside the likes of Google, Lenova, and ConocoPhillips?

Making a pact to save people’s lives

The event was the prestigious “2014 Deals of Distinction Award” ceremony, organized by the Licensing Executives Society (LES) Inc. As the title suggests, the recipients of these awards were honored for notable deals with their partners.

MenAfriVac "Deals of Distinction" 2014 award winners.

From left to right: Mark Bloom, past chair of the Industry-University-Government Interface (IUGI) Sector of LES – USA and Canada; Peter Soukas, senior licensing and patenting manager, National Institutes of Health (NIH) Office of Technology Transfer; Colleen Ottoson, deputy general counsel, PATH; F. Marc LaForce, director, Technical Services, Serum Institute of India Ltd.; Steven M. Ferguson, deputy director, Licensing and Entrepreneurship, NIH Office of Technology Transfer; Thierry Musy-Verdel, IUGI Deals of Distinction chair. Photo: Design Interface Inc.

In this case, PATH, along with the National Institutes of Health (NIH), US Food and Drug Association (FDA), and Serum Institute of India Ltd. (SIIL), were recognized for an intellectual property licensing deal and technology transfer negotiated about a decade ago. The technology? Development and manufacture of the low-cost MenAfriVac® meningitis vaccine designed for use in sub-Saharan Africa. To date, the deal has helped lead to the vaccination of more than 151 million people. By 2020, the vaccine is expected to protect more than 400 million people, preventing 1 million cases of meningitis A, 150,000 deaths, and 250,000 cases of severe disability.

What made this partnership especially unique was an early pact to make a vaccine affordable and accessible without requiring constant refrigeration. In other words, the vaccine had to have a low production cost and be able to survive hot, long-distance transportation to the remote towns and villages where it was badly needed.

Marc LaForce smiling and talking to a young boy outside his village, with a crowd in the background.

As founding director of the Meningitis Vaccine Project, Dr. Marc LaForce led the successful development, licensure, and introduction of MenAfriVac®. Photo: PATH/Gabe Bienczycki.

The lifecycle gets flipped

Typically, to bring a new vaccine to market, a long set of conventional milestones are reached before a price point is even considered. These milestones include, but aren’t limited to, test trials, product design, manufacturing, shipping, and market promotion. In this model, costs can add up rapidly, and lead to vaccines being marketed at prices that put them out of reach in many economies.

When the World Health Organization (WHO) came to PATH looking for low-cost solutions to address the most common form of bacterial meningitis, serogroup A, it was clear that the traditional manufacturing process would prove challenging. Testing, licensing, and manufacturing a new vaccine with specific cost limits meant new partnerships would have to be developed. And so, the search went global.

An effective vaccine technology had been developed by Dr. Che-Hung Robert Lee and Dr. Carl Frasch of the FDA’s Center for Biologics Evaluation and Research, and through a partnership organized by PATH, the NIH Office of Technology Transfer licensed it for this project. PATH then worked with Serum Institute of India Ltd., a pharmaceutical manufacturer based in in Pune, India, that agreed to scale up the technology in exchange for the technical know-how they would gain during the process.

The result of this remarkable deal? The low-cost MenAfriVac was produced in India, making it affordable to the 26 African countries where serogroup A meningitis is most common.

This short video shows the dramatic lifesaving impact of the MenAfriVac partnership. Run time: 4:20. Copyright 2011, PATH.

Why is licensing so important?

This award calls out a rarely considered aspect of bringing critical lifesaving technologies to scale: the deals that facilitate the exchange of critical intellectual property that can unlock solutions with dramatic lifesaving impact.

“A successful collaboration requires much more than a few agreements. It requires vision, good will, aligned values, diligence, and more,” said Colleen Ottoson, deputy general counsel for Legal Affairs at PATH. “A complex, public-private partnership can only succeed if the technology licenses and related agreements set forth clear and complementary terms and objectives. Upon the achievement of these interdependent agreement objectives, the partnership will realize its larger public health goals.”

To understand the challenges facing PATH, WHO, SIIL, and other partners as they studied the best way to address the development of a new low-cost, easy-to-transport vaccine to fight meningitis in sub-Saharan Africa, it helps to understand the history of the disease.

Timeline of meningitis, from first reports in 1805 to first MenAfriVac vaccinations in 2010.

Timeline of bacterial meningitis and the MenAfriVac vaccine against it. Click to see full-size. Illustration: PATH.

“The license and collaboration have turned out to be an interesting model for vaccine development to address public health needs in developing countries. The vaccine was tailored to a particular population, developed at a modest cost, and structured from the start with provisions to ensure sustainable access,” said NIH Office of Technology Transfer Director Mark L. Rohrbaugh.

Added IUGI Deals of Distinction Chair Thierry Musy-Verdel, “It also demonstrates that it is possible for research organizations such as federal laboratories and universities to license their technologies to organizations other than traditional pharmaceutical and biotech companies and to successfully achieve product commercialization and thus public utilization of their research.”

MenAfriVac was launched in a vaccination campaign in Burkina Faso in December 2010. To date, more than 151 million people in 12 African countries have been vaccinated.

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MenAfriVac is a registered trademark of Serum Institute of India Ltd.

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Dancing in the streets: Global Female Condom Day around the world

Two dancers perform in front of Dance4Demand banners.

Female condom supporters show off their choreographed Dance4Demand routine to hundreds of shoppers at the Rosebank Mall in Johannesburg, South Africa. Photo: PATH.

Guest contributor Claire Topalian is a freelancer writer who has previously posted on the PATH blog.

Why were women and men around the world dancing on September 16?  For female condoms, of course.

Global Female Condom Day (GFCD), founded in 2012 by the National Female Condom Coalition with support from PATH and other partners, is an annual day of advocacy, education, and awareness for female condoms. Despite its unique standing as the only available woman-initiated protection from unplanned pregnancy and sexually transmitted infections, the female condom remains out of reach for most people—something that GFCD is trying to change.

This year, PATH and its partners celebrated GFCD on September 16 in six countries by supporting an international “Dance for Demand” (Dance4Demand) movement. The event encouraged communities to dance as a visible and fun way to show the world that people want improved access to female condoms.

So how did this look around the world? Let’s check it out.

Kenya

PATH offices in Kenya hosted a brown bag session for more than 50 PATH staff to educate and drive awareness around female condoms, including the Woman’s Condom. Attendees performed a spirited dance routine to celebrate Global Female Condom Day. Janet Shauri, local coordinator for PATH’s Dance4Demand efforts, says: “The female condom puts the power of self-protection in the hands of women and can prevent both sexually transmitted infections and HIV. I got involved in the Global Female Condom Day because I knew that I wanted to be part of a move that would eventually empower Kenyan women.”

China

Meanwhile, women and men at two universities in China became stars of their own choreographed music videos to promote Dance4Demand.

PATH offices in China partnered with Marie Stopes International/China to host local events at Nanjing University and Guangxi University, which continued to run through September 26 (World Contraception Day) for ten full days of awareness for contraceptive options, including female condoms.

A group of young men from Nanjing University of Posts and Telecommunications demonstrate their impressive dancing skills to the song “Rise” by Shaprece:

A group of young women from Guangxi University show off their numbers and colors in support of Dance4Demand:

Zambia

Zambia’s GFCD fun took on a competitive edge in a community essay contest. PATH offices in Zambia and the Zambia Health Education and Communication Trust hosted a ceremony to celebrate essay winners. Local dancers performed at the event and key government officials attended to give speeches and present awards.

Woman writing at a table full of packaged female condoms.

In partnership with the Zambia Health Education and Communication Trust, PATH supported a ceremony for essay contest winners and awareness for Global Female Condom Day. Photo: PATH.

South Africa

In South Africa, PATH offices supported a range of Dance4Demand events at six universities and in public spaces. In addition, PATH partnered with Populations Services International to host a variety of public events as a way of engaging with new community members. For instance, a rooftop salsa dance party in Johannesburg drew over 400 participants, and an advocacy event at the Rosebank Mall drew over 500 attendees who were able to speak with promoters and take product samples.

DJ Yanga Luassa and two supporters holding a Dance4Demand sign.

The Nelson Mandela Metropolitan University GFCD event attracted over 100 students and staff. The audience was livened up by celebrity DJ Yanga Lusasa, who explained during the event why female condoms are important and directed students to the stands to learn more. Photo: PATH.

PATH staff wearing orange Dance4Demand shirts.

Employees at the PATH office in South Africa show their spirit for GFCD 2014. Photo: PATH.

Woman wearing orange Dance4Demand shirt and holding a microphone.

Participants gather at the Rosebank Mall in Johannesburg, South Africa to “Dance for Demand” on Global Female Condom Day. Photo: PATH.

India

Utilizing PATH’s Delhi office as a central point for GFCD, participants danced to show their demand for the female condom, an instrument that they believe to be empowering for women in India.

The dance routine below was performed by choreographer Himanshi Karol and produced by AK$ FILMS to celebrate Global Female Condom Day:

Seattle, Washington

This year, PATH employees and community members gathered to Dance4Demand in a “flash mob” routine in the public space outside of PATH’s headquarters in Seattle, Washington. The flash mob drew a lot of support and attention and was featured in The Seattle Times.

PATH hosts a Dance4Demand flash mob to generate awareness for Global Female Condom Day. Photo: Bettina Hansen/The Seattle Times.

PATH hosts a Dance4Demand flash mob to generate awareness for Global Female Condom Day. Photo: Bettina Hansen/The Seattle Times.

To check out GFCD on social media, look for hashtags #Dance4Demand, GFCD#2014, and #femalecondoms. Thank you to the many communities around the world who Danced for Demand with us this year!

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Getting gold-star nutrition to a million Brazilians

Maricio de Sousa and his daughter Monica holding a cardboard figure of a cartoon mother, her child, and the Vitaminado seal.

Right to left: Arroz Vitaminado champion Mauricio de Sousa with brand ambassador “Turma da Mônica” and de Sousa’s daughter Monica (the inspiration for Turma da Mônica). Photo: PATH/Greg Salibian.

Guest contributor Laura Anderson is an editor at PATH.

In Brazil, where rice is a staple food, shoppers have choices when it’s time to stock up. Increasingly, they’re buying a group of products that look and taste just like the rice they’ve always used—but with a crucial addition: a boost of the vitamins and minerals their families need to thrive.

Standing out by blending in

The products, sold in stores across Brazil under the Arroz Vitaminado (“Vitamin Rice”) quality assurance label, contain a blend of traditionally milled rice and fortified grains manufactured without genetically modified ingredients using PATH’s Ultra Rice® fortification technology. It’s a unique approach that is helping families worldwide get nutrients, including iron, vitamin A, and zinc, that don’t always make it into their diets. By curbing chronic but often invisible nutritional deficiencies, Arroz Vitaminado products have the potential to strengthen Brazil’s families long into the future. As of this year, they have reached more than a million Brazilian consumers—and the number is still growing.

This video explains how fortified rice, Arroz Vitaminado, is made, including which vitamins and minerals are added. Video: Arroz Vitaminado.

The perfect mix

So what does it take to get better nutrition to a million people? Too often, health solutions, especially those designed to reduce hunger and boost nutrition, are manufactured far from the people who need them and then either given away or subsidized through food support programs. That approach has helped many people, but it isn’t always sustainable or efficient. PATH overcame this barrier by helping fortified rice reach consumers a different way: as an affordable and appealing product available on grocery shelves countrywide. Doing so required a wide suite of activities. Together with partners, we bolstered local production of fortified rice, established a quality assurance system, and increased its appeal and visibility countrywide.

Homemade

Consistently and safely manufacturing fortified foods requires the right tools for the job. Iron, for example, is a crucial micronutrient that must be provided in just the right amount. Some methods can also affect the color or texture of fortified grains, which consumers don’t like. To ensure a steady, high-quality supply of fortified rice, we worked with the Global Alliance for Improved Nutrition (GAIN) to enable Brazilian rice millers to produce and distribute the grains. With the right tools and support millers learned to consistently mix the ingredients (primarily rice flour, water, and micronutrients); shape and dry the grains so that they won’t break; and blend them with milled rice at the right proportions. The producers also brought another “ingredient” to the table: their existing rice distribution networks. Together with supportive retailers, those networks help to ensure a consistent and reliable supply of fortified rice throughout Brazil.

Bags of fortified rice stacked on a grocery shelf under a bright yellow price tag.

Consumers can find bags of fortified rice with the Arroz Vitaminado quality assurance label on grocery shelves countrywide. Photo: PATH.

Quality assured

We also collaborated with the Federal University of Viçosa, (a founding member of the Institute for Food Fortification and the Fight Against Hidden Hunger [Instituto de Estudos e Pesquisas em Fortificação de Alimentos e Combate à Fome Oculta, or IPAF]) to create the quality assurance system that gives the Arroz Vitaminado seal its reliability and appeal. Under the system, fortified rice producers go through on-site quality audits and submit samples to IPAF for quality evaluation. When a producer passes the test, the Brazilian rice millers association, Abiarroz, allows it to use the Arroz Vitaminado seal on its product. And to keep that distinction—and the consumer trust that goes with it—millers must continue to meet high standards over time.

Vitaminado seal.

With the Arroz Vitaminado (“Vitamin Rice”) quality assurance label, consumers know they’re giving their families the nourishment to thrive. Photo: PATH.

Familiar

Today, Arroz Vitaminado guarantees consumers that the fortified rice they buy has the quality and nutrients they expect. But generating widespread appeal took insightful marketing, too. PATH partnered with producers and retailers to conduct promotional taste tests and market demonstrations throughout Brazil, and launched a social marketing campaign spotlighting fortified rice through television interviews, promotional videos, a website, and other outlets. Compassionate and inspiring product ambassadors also sparked interest.

For example, soccer star Lucas Moura championed Arroz Vitaminado and the importance of better nutrition. Artist Mauricio de Sousa, Brazil’s most respected cartoonist, also joined the campaign. De Sousa, who calls the product “a magical rice that marks the difference between having a healthier population or a less healthy one,” contributed the support of his “Turma da Mônica” family of characters. Together, these efforts have earned fortified rice a warm and lasting welcome in hundreds of thousands of Brazilian homes—giving children and their families the nutrients they need to learn, play, grow, and thrive.

Ultra Rice is a registered trademark of Bon Dente International, Inc. in the United States.

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Vaccine Resource Library: a new look for PATH’s one-stop-shop for vaccine information

This post’s author, Allison Clifford, is a communications officer for the Vaccine Development Program at PATH.

Screenshot of VRL banner with infant receiving oral vaccine drops.

The popular online Vaccine Resource Library just debuted a brand new look and mobile-friendly design. Photo: PATH/Mike Wang.

One of the top go-to resources for information on vaccines, diseases, and immunizations just got easier to use.

PATH’s online Vaccine Resource Library (VRL) debuted a brand-new look and mobile-friendly design this week. The redesign enhances the site’s accessibility and features engaging new photos. What hasn’t changed is the extensive database of high-quality, scientifically accurate materials on specific diseases, vaccines, and topics in immunization addressed by PATH’s work.

Young girl watches a health worker fill a syringe with vaccine in Khouang Province, Laos.

Health workers around the world can access resources in 11 different languages in the VRL. Photo: PATH/Aaron Joel Santos.

This user-friendly, database-driven site grew out of PATH’s Children’s Vaccine Program, back in 1998. Since then, the VRL has gone through a number of changes and iterations to reach its current status as a well-respected, centralized repository for key global immunization resources.

Today, the site is a WHO-approved source of accurate vaccine information and one of the most popular sections of our website.

Finding resources and exploring topics just got easier

The redesigned VRL features easy-to-find resources and links to information on a wide range of issues and diseases. And there are hefty sections on a variety of topics related to specific illnesses such as rotavirus, the biggest cause of severe diarrhea (for which vaccines already exist), and the top bacterial causes of diarrhea, enterotoxigenic Escherichia coli and Shigella (for which vaccines are still under development).

Icons from PATH's Vaccine Resource Library.

The redesign enhances the site’s accessibility. Photo: PATH.

We also have broader resource sections that aren’t disease-specific on topics related to vaccines, such as advocacy and communications, childhood immunization, vaccine safety and performance, introduction and service delivery, and the major organizations and coalitions working in the vaccine arena.

So, whether you’re looking for something specific or just browsing, we invite you to check out the new VRL.

A version of this post originally ran on the Defeat DD blog.

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Dr. Manjari Lal: an award-winning formula

Portrait of Manjari Lal.

Dr. Manjari Lal. Photo: PATH.

Two of PATH’s leading female scientists were recently honored for their contributions to global health: Tala de los Santos, MBA, MS, as a Washington Global Health Alliance (WGHA) Rising Leader, and Manjari Lal, PhD, with a 2014 William Hunting Award. We’re proud to support the outstanding achievements of our technical teams, who often work “behind the scenes” to develop and advance transformative health care innovations for public health impact.

Part two: Today we feature Dr. Manjari Lal.

Manjari Lal, PhD

Manjari Lal, PhD, one of PATH’s scientists working in vaccine and pharmaceutical technologies, was recently awarded the 2014 William Hunting Award for her and her team’s crucial work to develop a heat-stable fast-dissolving tablet (FDT) formulation of Newcastle disease vaccine.

Each year, Veterinary Record, the prestigious peer-reviewed journal of the British Veterinary Association, bestows the Hunting Award to a research paper considered to have made the most useful contributions to veterinary science. The award-winning paper, “Development of a Low-Dose Fast-Dissolving Tablet Formulation of Newcastle Disease Vaccine for Low-Cost Backyard Poultry Immunisation,” was penned by Manjari, as lead author, in collaboration with authors from the University of Washington, the Southeast Poultry Research Laboratory of the United States Department of Agriculture, and the Global Alliance for Livestock Veterinary Medicine.

Newcastle disease is viral and highly contagious. It is capable of destroying entire chicken populations in a short period of time, and it has been identified as one of the biggest threats to rural poultry and livelihoods globally. It can also be transmitted to humans. The technical work described within Manjari’s paper reflects one of the many ways PATH is helping to build the evidence base for needle-free and thermotolerant vaccine and drug delivery technologies of critical importance to human and animal health in developing countries.

Manjari adjusting a spray dryer, which is drying a container of liquid vaccine.

Manjari uses a spray dryer to convert a liquid vaccine formulation into a powder. Photo: PATH/Scott Areman.

“Vaccines and essential medicines take up a lot of space. They involve many packaging and delivery parts, especially if they need to be refrigerated and/or reconstituted with a diluent prior to administration with a needle and syringe. By simplifying the equation, for example, by formulating vaccines as heat-stable tablets that can be swallowed or dissolved under the tongue, we believe we can achieve even greater public health impact in low-resource settings,” explains Manjari.

Manjari moved to the United States from India in 1995 through an exchange program for young scientists. Although she originally dreamed of being a medical doctor and helping people in a clinical setting, she hit her stride in bench research and stayed in the US to pursue additional opportunities. When Manjari interviewed with PATH in 2008, she says she knew immediately, “this is the place where I want to be.” At PATH, she could leverage her expertise in the biomedical sciences to improve health outcomes.

Manjari and her team have additionally developed fast-dissolving tablet (FDT) formulations for an enteric diarrheal disease vaccine candidate and oxytocin, a WHO-recommended injectable drug for reducing and preventing postpartum hemorrhage. Their heat-stable oxytocin tablet for sublingual delivery will soon be assessed in a first-of-its-kind clinical study set to launch in 2015. The study, a collaboration with the South African Medical Research Council, is part of PATH’s newly formed Global Health Innovation Accelerator—a key first step for expanding access to oxytocin in sub-Saharan Africa, where postpartum hemorrhage remains one of the leading causes of maternal mortality.

FDT formulations hold promise for transforming the means by which vaccines and essential medicines like oxytocin are typically packaged, stored, and delivered. Heat-stable tablets do not require refrigeration to ensure product quality (potency) during transport and storage. The novel product presentation also eliminates the need for safe injection equipment and training—an important feature for patients who may have limited access to skilled health workers or health care facilities.

Box full of blister packs of fast-dissolving tablets.

Manjari and her team have developed fast-dissolving tablet formulations for a veterinary vaccine for Newcastle disease, an enteric diarrheal disease vaccine candidate, and the injectable drug oxytocin. Photo: PATH/Patrick McKern.

We’re honored to have Manjari at PATH. Her transformative work is helping to resolve some of the most vexing challenges associated with health care access and delivery in low-resource settings.

Congratulations to Manjari!

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Tala de los Santos: a rising leader in diagnostics

Tala de los Santos works with her team on onchocerciasis diagnostic tests. Photo: PATH/Patrick McKern.

Tala de los Santos and a team member working in PATH’s laboratory. Photo: PATH/Patrick McKern.

Two of PATH’s leading female scientists were recently honored for their contributions to global health: Tala de los Santos, MBA, MS as a Washington Global Health Alliance (WGHA) Rising Leader, and Manjari Lal, PhD, with a 2014 William Hunting Award. We’re proud to support the outstanding achievements of our technical teams, who often work ‘behind the scenes’ to develop and advance transformative health care innovations for public health impact.

Part one: Today we feature Tala de los Santos.

Tala de los Santos

Portrait of Tala de los Santos.

Tala de los Santos. Photo: PATH.

Tala de los Santos, MBA, MS, was recently honored as a Rising Leader by the Washington Global Health Alliance (WGHA) through their Pioneers of Global Health award series. The Rising Leader award recognizes a creative and inspirational leader under 40 who has shown unique dedication to solving global health inequity.

As leader of the Diagnostics Group at PATH, Tala oversees a team of scientists, public health specialists, and business strategists focused on developing and introducing accurate point-of-care tests and assessment tools for use by people and health care programs in developing countries. This critical work requires multiple steps. Taking the three key phases of PATH’s product introduction framework—to innovate, introduce, and integrate—Tala and her team are able to advance a concept of health care to actual product implementation and use.

Exterior of a diagnostic device, similar to a short thermos, and the interior, containing insulation, PCR tubes, phase-change material, and a disposable pouch.

PATH is developing a self-heating device to help diagnose several diseases in low-resource settings without the need for electricity or batteries. Photo: PATH.

Advancing diagnostics for use in low-resource settings is challenging because of substantial resource and infrastructure limitations. It is extremely difficult work to take innovative ideas and transform them into affordable, user-centered products that help ensure health is within reach for everyone. Yet, Tala has guided her teams to strengthen and unify internal processes to better leverage collective efforts into impact. “At PATH, I work alongside talented and driven professionals making an impact on the greater good. I encourage young women in science and technology to consider applying their training to a mission-driven career. It is a privilege to work in a field as rewarding as global health,” says Tala.

Gloved hands holding a small, rectangular rapid test for onchocerciasis.

PATH is developing a rapid test for onchocerciasis, commonly known as river blindness, that is faster and less painful for diagnosing this neglected tropical disease. The product launches in November. Photo: PATH/Dunia Faulx.

Despite growing up with limited financial resources, Tala was a dedicated student and secured scholarships to leave her home in the Philippines at 16 to attend United World College USA in New Mexico. She found inspiration in the mission of the United World College movement—to build a healthier, more peaceful world by promoting the international exchange of ideas. In pursuit of this goal, Tala demonstrated strong personal motivation to apply herself academically and later attend some of America’s best universities, where she excelled.

Every day at PATH, Tala translates this inspiration into on-the-ground work to improve health care and health outcomes in developing countries. The WGHA announcement describes Tala as someone who “embodies success as a pioneering woman in science. She is a role model for other young women who seek to pursue scientific careers, especially mission-driven careers that combine rigorous scientific training with business expertise on behalf of the greater good.”

We’re honored to have Tala at PATH. Her transformative work is helping to resolve some of the most vexing challenges associated with health care access and delivery in low-resource settings.

Tomorrow we’ll feature Dr. Manjari Lal, whose work is helping to improve human and animal health in developing countries.

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Making the case for health research and innovation

In this post, Claire Wingfield, product development policy officer at PATH, writes about a new paper (2.34 MB PDF)
exploring why research and development (R&D) of high-priority health tools for diseases and conditions affecting low- and middle-income countries (LMICs) should be a critical component of the post-2015 development agenda.

A young girl receives an innoculation from a health care worker.

The new paper makes the case for the inclusion of health research and innovation as a central component of the post-2015 agenda. Photo: PATH/Gabe Bienczycki.

A lack of adequate health technologies and interventions targeting poverty-related diseases means millions of people in LMICs continue to die each year from preventable and treatable diseases and conditions. Progress on developing new interventions has faltered because diseases such as HIV/AIDS, malaria, tuberculosis, and neglected tropical diseases occur almost exclusively among the world’s poorest and most marginalized populations. There continues to be little or no perceived commercial market encouraging companies to develop products targeting LMICs.

One major goal of the post-2015 development agenda is to achieve health for all within one generation, but the health burden imposed by poverty and social vulnerability remains far too high.

Bridging the divide

Cover of 'The Role of Research and Innovation in the Post-2015 Agenda' publication.

Click the image above to view The Role of Research and Innovation in the Post-2015 Agenda (2.34 MB PDF).

A new paper (2.34 MB PDF)—developed in partnership by the Council on Health Research for Development, the Global Health Technologies Coalition, the International AIDS Vaccine Initiative, and PATH—makes the case for the inclusion of health research and innovation as a central component of the post-2015 development agenda. The paper describes the impact increased investments in innovative health R&D have had—particularly for the world’s poorest—toward achieving the Millennium Development Goals (MDGs).

These investments have helped create a stronger environment for research in LMICs by increasing demand for new health technologies, expanding coverage of proven interventions, and strengthening their innovation infrastructure. And yet, much more needs to be done.

Building on the work of the Lancet Commission on Investing in Health—a group of renowned economists and global health experts—the paper discusses the need for increased R&D investments by all countries to achieve the dramatic health gains envisioned in the post-2015 agenda.

Adequate investment levels are critical for spurring the development of new health tools, provided they align with financing needs in R&D—notably predictability and flexibility. But investment alone does not guarantee that innovative products will be developed; ones that are suitable, acceptable, affordable, and accessible to populations most in need. It is essential that indicators for R&D for health tools primarily affecting LMICs address a comprehensive set of needs including financing, infrastructure and human resources, enabling policies, necessary partnerships, capacity strengthening, and access requirements.

Creating opportunity

Poor health and disability contribute substantially to poverty, while health research and innovation are linked to eradicating poverty and improving economic prosperity. Ultimately, the success or failure of the post-2015 agenda relies just as much on how the goals and targets are implemented as it does on how the progress will be measured.

The post-2015 development agenda is an opportunity for LMICs to set their own health agendas and research priorities and to assert their leadership in strengthening the R&D landscape focused on the poorest and most marginalized populations. There must be broad agreement among all of the relevant stakeholders that health research and innovation—which includes the scale-up of proven health interventions as well as the development of new and improved high-priority health technologies—is critical to meeting the ambitious goals of eradicating poverty and ensuring sustainable development for all within a generation.

Over 150 organizations and individuals recently signed a petition to United Nations (UN) Secretary General Ban Ki-moon and Member States urging the UN to keep the research, development, and delivery of new and improved health tools for diseases and conditions impacting LMICs at the heart of the post-2015 development agenda. It is our hope that the Member States and other UN officials shaping the agenda will advocate for this support.

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Accelerating innovation: a diverse and dynamic discussion in New York

Three panelists in conversation.

The event’s speakers included (l to r) Financial Times editor Andrew Jack, maternal and newborn health advocate Princess Sarah Zeid, and Manu Prakash, a TED fellow and assistant professor at Stanford University. Photo: Financial Times.

In a conference room filled beyond capacity atop a New York hotel this week, attendees were tweeting like mad. Why? Because they were on board with this simple directive: innovation matters when it comes to transforming global health.

Cover of Innovation Matters publication.

The Innovation Matters publication features articles from global leaders from multiple sectors exploring the critical role innovation can play in accelerating solutions to the world’s most urgent health challenges.

On September 24, the Financial Times and PATH hosted a high-level forum titled “Transformative Innovations for Health.” The event unveiled Innovation Countdown 2030. Led by PATH, the initiative is identifying and showcasing technologies and interventions with great promise to dramatically accelerate progress toward solving the world’s most urgent health issues. Participants received a copy of the initiative’s new publication Innovation Matters and were directed to the initiative’s website at www.ic2030.org.

Moderated by Financial Times editor Andrew Jack, the forum presented a diverse group of speakers including PATH CEO Steve Davis, maternal and newborn health advocate Princess Sarah Zeid of Jordan, Norway’s State Secretary Hans Brattskar, and Manu Prakash, a TED fellow and assistant professor at Stanford University. (You may have seen Dr. Prakash’s TED video on the 50-cent folding cardboard microscope.)

The crowd was engaged during the roundtable chat and presentation, asking bold questions, discussing opportunities, and lingering long past the event’s timeline. Amy MacIver, director of Communications at PATH, observed, “People stayed and talked, well after final call. It was one of the most diverse and engaged groups we’ve witnessed.”

Wide shot of conference room with speakers and attendees.

The crowd was engaged during the roundtable chat and presentation, asking bold questions, discussing opportunities, and lingering long past the event’s timeline. Photo: Financial Times.

How can we reach across sectors to “bend the curve?”

Topping the list of conversation points during the roundtable and forum was how to identify which high-potential innovations can accelerate dramatic improvements or “bend the curve.” In short, how do we disrupt the status quo, make lifesaving innovations “real,” and scale them more rapidly?

Dr. Prakash brought a synthesis of research, innovation, and political science to the table by identifying the links between health, education, energy, and funding. He requested global health partners quickly “take technologies into the field.” Oftentimes, successful processes happen at the frontline between trailblazers who are working on parallel projects. By recognizing all the variables at play, he suggested we could tap into unique processes and perhaps leap forward toward solutions.

“We can talk a lot about gadgets and about delivery, but there is a huge gap between those two places,” said PATH CEO Steve Davis. To narrow that gap, health care workers need to be trained to use innovative tools and technologies. Sometimes innovation isn’t a new gadget; it may be a new process to organize health systems or a novel way to encourage behavior change.

Another theme discussed during the forum was that health care workers need more support beyond the latest gadgets. They are the key component to getting the right technologies out there along with the tools they need. Dr. Adrian Thomas, vice president of Global Market Access at Global Commercial Strategy Operations and Global Public Health (GPH), touched on a partnership with PATH that intends to create diagnostics that will inform health workers what disease they’re dealing with before patients are taken to a health care facility.

Christopher Egerton-Warburton speaking a gesturing as Steve Davis listens.

Christopher (Edge) Egerton-Warburton, fund manager for The Global Health Investment Fund, explored the futurist’s perspective of innovation. Photo: Financial Times.

What’s the world going to look like in 2030?

Christopher (Edge) Egerton-Warburton, fund manager for the Global Health Investment Fund and founding partner of Lion’s Head Global Partners, launched into the futurist’s perspective of innovation, positing on global health challenges in 15 years’ time. He believes health care leaders and partners need to line up capital to address the world of 2030. The community needs long-term vision to anticipate the challenges faced in a decade and a half.

Sharing thoughts in real time

Participant’s tweets in the hashtag #IC2030 provided a real-time summary of the conversation as it unfolded. You can read a collection of the tweets here.

As the night wound to an end, Davis was quick to point out that we’ve only begun to change the world by tapping our radical potential. We invite you to be a part of the change by taking PATH’s Innovation Countdown survey.

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Three reasons why PATH is celebrating World Contraception Day 2014

Kenyan woman in red shirt

A recent analysis of unmet need for family planning estimates that 222 million women worldwide who want to avoid pregnancy aren’t using modern contraceptives. Photo: PATH/Eric Becker.

Need a reason to celebrate World Contraception Day on September 26? PATH’s work in women’s contraceptives reached three milestones recently, one of which got thousands of people dancing:

  • US FDA cleared the Caya® contoured diaphragm for marketing.
  • Sayana® Press, an easy-to-transport injectable contraceptive, was launched in Africa.
  • People around the world kicked up their heels for the Global Female Condom Day Dance4Demand campaign.

OK, it’s fairly obvious which milestone got people dancing, but all three helped to make lives better by improving women’s health. And when women do well, their families, communities, and countries benefit. World Contraception Day is all about educating women and men on the range of options to prevent unintended pregnancy, space births, plan for the future, and reduce sexually transmitted infections.

Take a closer look at PATH’s recent contraception milestones:

Hand holding the SILCS diaphragm.

The neat thing about this one-size-fits-most diaphragm is that a woman doesn’t need a fitting exam to figure out which size she should wear. Photo: PATH/Glenn Austin.

The Caya® contoured diaphragm, a single-sized, nonhormonal contraceptive barrier, was cleared for marketing in the US by the United States Food and Drug Administration (USFDA). The diaphragm is easy and comfortable to use, already available in Europe and Canada, and is expected to be available to US consumers next year.

Learn more about Caya® in this recent short NPR interview with PATH staff.

Uniject injection system, a small, prefilled syringe.

Sayana® Press is a long-lasting contraceptive delivered in the single-use Uniject™ autodisable injection system. Photo: PATH/Patrick McKern.

It’s a challenge getting injectable contraceptives to women in hard-to-reach areas of sub-Saharan Africa and South Asia. This year, the Sayana® Press project launched in Burkina Faso as part of a four-country, public-private partnership to reach women in Senegal, Burkina Faso, Niger, and Uganda. Sayana® Press combines a lower-dose formulation of the widely used contraceptive Depo-Provera® with the BD Uniject™ injection system. Uniject, which PATH developed, is a small, prefilled syringe that is easy to transport, easy to use, and designed to reach people wherever they live.

PATH staff dancing outside of our headquarters.

The Dance4Demand flash mob outside PATH’s Seattle headquarters on September 26 caught the attention of our neighbors and the local media. Photo: PATH/Patrick McKern.

And most recently, PATH and partner organizations led the Global Female Condom Day Dance4Demand, a campaign designed to mobilize communities to show that women and men worldwide want to improve access to female condoms, the only woman-initiaited dual protection method available today. Thousands of people worldwide shook their tail feathers to show their support.

Join PATH in celebrating World Contraception Day 2014.

More information

Sayana® Press and Depo-Provera® are registered trademarks of Pfizer Inc. and/or its affiliates. BD Uniject is a trademark of BD.

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PATH’s commitment: improve access to diabetes care for people worldwide

Hands filling a syringe from a vial, three medicine bottles of tablets, and a person having their blood pressure taken.

This week, PATH begins a new Clinton Global Initiative commitment, in collaboration with Novo Nordisk, to help turn the tide of diabetes, one of the world’s most common and damaging noncommunicable diseases (NCDs). The effort, announced at the Clinton Global Initiative 2014 meeting in New York, is a first step toward making lifesaving diabetes medicines and technologies more available to people who need them most. We caught up with Helen McGuire, director of PATH’s NCD program, to learn more.

Why are noncommunicable diseases like diabetes in the global spotlight now?

Portrait of Helen McGuire.

Helen McGuire leads our work in noncommunicable diseases. Photo: PATH.

Diabetes, cardiovascular disease, cancer, and other NCDs aren’t new, but in recent years, they’ve risen to become the greatest cause of illness, disability, and death worldwide. There are many reasons for this shift, but overall, people are living longer and their lifestyles are changing. Less physical activity and increased weight, smoking, and alcohol are putting more people at risk. Today, two-thirds of all deaths are caused by NCDs; a staggering 80 percent occur in developing countries. In fact, in the next 15 years, the World Health Organization (WHO) predicts that NCDs will become the most common cause of death in Africa.

NCDs exact an enormous toll. Because they so often hurt people in their prime—their years to work and raise children—they push families into poverty and reduce the productivity of their communities and countries. We also know that they compound the burden of other diseases, potentially eroding progress against HIV, tuberculosis, and other threats worldwide. It’s been estimated that by 2030, NCDs will cost the global economy more than $47 trillion dollars in lost output.

Chart showing 4 primary risk factors for cardiovascular disease, diabetes, cancer, and chronic respiratory disease.

Selected noncommunicable diseases and their shared risk factors. Graphic: World Health Organization.

What are global health leaders doing to stop NCDs?

I’m encouraged that we’re finally seeing an increase in global attention to NCDs. For instance, WHO’s new global action plan on NCDs calls for a 25 percent reduction in preventable death from NCDs by 2025 and an 80 percent availability of essential [NCD] medicines and technologies by 2020. And this year, the United Nations held a high-level follow-up meeting to review progress on NCDs since 2011, recognizing challenges and calling for continued commitment and accelerated action.

At PATH, our work to root out and address the causes of health inequality worldwide has put us at the frontlines of health for decades, so working with partners to intercept NCDs early on is a clear priority for us. Our NCD global strategy builds on our legacy of combating breast cancer and cervical cancer in low-resource communities. It focuses on innovation, advocacy, integrating NCDs into health care systems, and increasing the availability of essential medicines and technologies to improve lives.

How does PATH’s Clinton Global Initiative commitment fit in?

Our new diabetes commitment, led by PATH in collaboration with Novo Nordisk, is a great example of the innovative partnerships we’ll need to meet the WHO targets and other goals. It combines PATH’s leadership and experience in NCDs, Novo Nordisk’s expertise in improving diabetes care, and our shared commitment to accessible health care. Together, we’ll work to reduce preventable death and illness from diabetes by improving people’s access to essential diabetes medicines and technologies.

How did you choose this project?

An estimated 382 million people had diabetes in 2013; 80 percent lived in a low- or middle-income country. Yet crucial tools for diagnosis, treatment, and monitoring still aren’t getting to people in these areas. Imagine that your child desperately needs medicine, the local clinic or pharmacy is out, and there is nowhere else to turn. That’s a helplessness no parent should face.

We must make lifesaving medicines and technologies more available to health care workers and people living with diabetes. It’s the only way we can reduce preventable complications.

PATH is gathering the information to close the gap. We’ll begin by collecting data and taking a look at what we already know at the global level, and then work to uncover the root causes of poor availability in two low-income countries where rates of diabetes are increasing rapidly—Kenya and Nigeria.

Kenyan men, women, and children posing for a group picture.

PATH will begin work in Kenya and Nigeria, where the rate of diabetes is quickly growing. Photo: PATH/Gabe Bienczycki.

What’s next?

First, our goal is to recommend specific actions that national and global leaders, health care workers, and others can take to increase the availability of crucial technologies and medicines. On a global level, we’ll continue to put PATH’s NCD strategy to work to reduce preventable death by increasing access to NCD prevention and care. That means finding innovative ways to push new approaches and tools forward in low-resource settings; advocating to increase demand for NCD innovations; integrating NCD prevention and care with existing platforms; and increasing the availability of essential medicines and technologies.

More information

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