Drug Development Global Program

Innovating against HIV, part 1

Despite significant progress in the past 30 years, HIV continues to be a major global health issue, having claimed more than 39 million lives to date. According to UNAIDS, in 2013, there were 35 million people living with HIV and 1.5 million who died of HIV-related illnesses worldwide. In particular, women and young girls bear the brunt of HIV globally, accounting for 22 percent of new infections. From the ages of 15 to 24, young women face HIV infection rates twice as high as young men.

Reimagining Global Health (a recently published report by the Innovation Countdown 2030 initiative) features 30 high-impact innovations selected by independent experts for their promise to save lives. The report identifies three HIV-specific innovations that could help turn the tide of the epidemic—broadly neutralizing antibodies (bNAbs) in HIV vaccines, oral pre-exposure prophylaxis (PrEP) for HIV prevention, and long-acting injectable antiretroviral (ARV) drug therapy.

We are providing an open forum on this blog for leaders from the HIV/AIDS community to offer their opinions on the ways these and other technologies could advance HIV prevention and treatment and potentially change the trajectory of the AIDS epidemic worldwide. Contributions will be published over the next two weeks as a three-part series entitled “Innovating against HIV.” In our first installment below, AVAC, the International AIDS Vaccine Initiative (IAVI), and CAMI Health kick off the discussions.

Views expressed are those of the contributors and may not be shared by PATH.

It's an exciting time for HIV prevention...

BNAbs capable of neutralizing a wide range of HIV strains...

"...innovations in reproductive health and disease prevention are key to prosperity and the health of families across the globe."More from AVAC

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Crypto, the new old threat

By Robert Choy, Associate Director for Research and Preclinical Development, PATH

An infant is carried in a sling by his mother.

The magnitude of Cryptosporidium’s effects worldwide has only recently begun to be understood. Photo: PATH/Felix Masi.

Still a taboo in polite discussion, diarrhea is more than just unpleasant. It’s deadly. The World Health Organization estimates that each year there are nearly 1.7 billion cases of diarrhea around the world. While most people will survive with proper care, another 760,000 children under the age of five will lose their lives to diarrhea, due to effects such as dehydration and intestinal damage.

Though diarrhea is the second leading killer disease of children under five worldwide, its causes have not always been well understood. In 2013, the Global Enteric Multicenter Study (GEMS), a major clinical and epidemiological survey conducted across Africa and Asia, made a surprising discovery about one of the three major causes of deadly childhood diarrhea and one of the key contributors to the global burden of diarrheal disease. In 2015, another major international study, The Etiology, Risk Factors, and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development Project (MAL-ED) corroborated and extended the surprising findings of GEMS.

The unexpected twist—Cryptosporidium

First identified as a human pathogen as recently as 1976, Cryptosporidium, a protozoan parasite affecting gastrointestinal (GI) health, became recognized as a widespread and significant public health threat in the mid-1990s. By then, it had been linked to waterborne diarrhea outbreaks in high-income countries, chronic life-threatening diarrhea in AIDS patients, and diarrhea in malnourished children in low-income countries. In the United States, the most common route of exposure is swimming pools where chlorine is ineffective at controlling “Crypto.” However, the most deadly cases occur in rural, impoverished areas, largely in sub-Saharan Africa and South Asia.

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A Father’s Legacy

David Shoultz leads drug development at PATH. This Father’s Day, David reflects on the influence his father had on his future global health career and his own efforts to impart values of health and community service to his two sons.

My father Steve retired last year after nearly 50 years as a dentist in Hawai’i. Growing up, I learned from him about the essential role that health plays in productivity and quality of life. I also saw that his career was about more than his practice, and even the dental health of his patients—it went beyond that, into his role in the community and in his patients’ lives.

We often take dental health for granted in the United States, even though it can play a crucial role in our overall sense of well-being. There were countless times I witnessed how something as simple as an infected tooth could impair a person’s ability to go to work every day, get proper nutrition, or enjoy time with their family. I saw how important my dad’s contributions were for children and older patients, especially.

My dad Stephen (left) and I (right) pictured on a mountain bike ride on Snoqualmie Pass near Seattle in May 2015. During this visit, I was able to give my dad and mom a tour of our PATH headquarters, including our product development labs in Seattle. My dad’s comment: “It’s amazing what you’re all are doing for people around the world.” Photo: David Shoultz.

My dad Stephen (left) and I (right) pictured on a mountain bike ride on Snoqualmie Pass near Seattle in May 2015. During this visit, I was able to give my dad and mom a tour of our PATH headquarters, including our product development labs in Seattle. My dad’s comment: “It’s amazing what you’re all doing for people around the world.” Photo: David Shoultz.

In our community, my dad always demonstrated a deep commitment that went beyond his practice to include church, our local Kiwanis club, bicycle safety on the island of O’ahu, and volunteering with programs such as “Dentists with Heart,” which provides patients with dental services at no charge.

As I look back at my education and career choices, I know that in many ways it was his passionate approach to caring for people that first sparked my interest in global health, a field that gives me the chance to help people around the world lift themselves out of poverty and poor health. His example inspired me to stake out my own path, energized by his passion and dedicated to improving the lives of as many people as possible. I was very fortunate to grow up in a family where both parents demonstrated a deep commitment to the health of other people and also made sure that my brother and I were encouraged to pursue our own passions and career paths. Perhaps not surprisingly, my brother also chose a career in health education, currently overseeing the Head Start program for children living in low-income families on O’ahu.

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Seven takeaways on the post-2015 negotiations

This post was originally published on Breakthroughs, a blog from the Global Health Technologies Coalition (GHTC).

Trying to navigate and understand the post-2015 negotiations can be a challenge, so to help add some clarity, last week the GHTC convened a panel of experts to help explain the ongoing debates and where the negotiations stand and how health innovation is reflected in the agenda.

Here are my seven takeaways from that discussion.

1. There are still a lot of TBDs

Sustainable development goals

Six essential elements of the SDGs. Credit: UN.

Although we’re only five months away from September 2015 when the Sustainable Development Goals (SDGs) will be approved by United Nation (UN) member states, there is still much to be determined and worked out. While it’s expected that the goals and targets will look similar to those proposed by the Open Working Group (OWG) with some refinement of the targets, the process for determining the indicators has just begun and will likely continue through March 2016.

While member states work to finalize the goals, targets, and indicators, countries are also discussing financing and means of implementation for the agenda and how to build an effective monitoring and accountability framework.

2. The proposed SDG framework is comprehensive in a way the MDGs were not

The process for determining the SDGs was much more inclusive and consultative than the process for determining the Millennium Development Goals (MDGs). There were a range of opportunities for all member states, civil society representatives, nongovernmental organizations, other stakeholders, and even individuals to have their ideas and voice heard. The result is a proposed agenda that is much more comprehensive (and bigger) than the MDGs (17 goals and 169 targets in SDGs, compared to 8 goals and 21 targets in MDGs).

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When Diarrhea Gets Personal: One Girl’s Fight Against Rotavirus

By Laura Edison, Scientific Communications Associate, PATH

This post is part of the #ProtectingKids blog series and was first published on the DefeatDD blog. Read the whole series here.

A blonde, baby girl, just shy of two years old sits on a lap and smiles at the camera.

Me in December 1991, just a few weeks before getting sick. Photo: Laura Edison.

There was once a healthy little girl who, just a few months before her second birthday, started to feel sick. Her tummy hurt, her forehead began to burn up, and then aggressive diarrhea and vomiting started. The girl became weak, pale, and severely dehydrated: although the girl was crying, her tears had stopped flowing. She was listless and limp, lying on the couch like a rag doll.

Her parents tried both juice and Pedialyte, a type of oral rehydration solution (ORS), but nothing would stay down. They were terrified. After 36 hours, they decided to bring her to the hospital. Doctors ran a few tests and quickly determined that the diarrhea was due to rotavirus. Since there is no treatment for rotavirus other than rehydration, they gave her intravenous (IV) fluids—a feat for the nurse, given that the girl’s dehydrated veins were so tiny.

That girl was me in January 1992. I only learned the full story recently. I had known I was hospitalized as a toddler, but I had no idea it was due to rotavirus, and I had never heard my parents’ testimony of how horrible it was. This came as a surprise because, at the time I learned about it, I had been working at PATH for about a year on rotavirus vaccine advocacy and communications. I had been telling my parents about our newest projects when my dad remarked:

“We felt so helpless when you had rotavirus.”

“Wait… what?!” I said, stunned.

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In-depth: Why isn’t oral rehydration solution defeating diarrheal disease?

A hand spoons ORS into the mouth of an infant held by her mother.

Administered spoonful by spoonful, oral rehydration solution is an effective treatment for childhood diarrhea. Photo: PATH/Heng Chivoan.

Oral rehydration solution (ORS), a simple mixture of salt, water, and sugar, was first introduced in the 1970s to reverse dehydration caused by severe diarrhea. Due to its simplicity, low cost, and high effectiveness, it was heralded as one of the most important medical achievements of the last century. Since its introduction, it is estimated to have saved a whopping 50 million lives from diarrhea.

A persistent threat

While the world has witnessed a dramatic decline in preventable child deaths over the past two decades, more than half a million children each year still lose their lives to diarrhea, and it remains the second leading killer disease of children worldwide. For children who survive, a bout of diarrhea can have persistent effects. The World Health Organization (WHO) estimates that 50 percent of malnutrition is associated with repeated diarrhea. In addition, when a child is malnourished or regularly ill during the first few years of life, there are associated negative effects on future cognitive development, education, and productivity.

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International Women’s Day: empowering women to transform lives as social entrepreneurs

Women and girls candid photos side-by side in Maharashtra, India. Photo: PATH.

Women and girls in Maharashtra, India. Photos: PATH.

Lorelei Goodyear is a senior program officer at PATH and a committed advocate for women’s health. Her work on PATH’s Healthy Households Initiative empowers women through entrepreneurship that enables their communities to live healthier lives. Lorelei, and the women reached through this project, truly know how to #MakeItHappen. This post was originally featured on the DefeatDD blog

My whole career has focused on increasing options for women and girls so that they can achieve their full potential. I have focused primarily on reproductive health because deciding if and when to become a mother is such a pivotal point in a woman’s life. Eight years ago, I became a mother and took on a new role leading PATH’s research and evaluation on safe water technologies. I quickly learned that diarrhea caused by unsafe water is a leading killer of children and safe water plays a crucial role in maternal and child health.

There are many effective water treatment methods, but getting people to use them is a big challenge. After experimenting with a variety of market models, we had the best results (highest rates of adoption) by training local entrepreneurs to sell water filters in their communities and providing consumer loans that made filters affordable through small payments over time. In nine months, we tripled the use of water filters in a community in Cambodia. We tested the same approach with latrines, and Cambodian customers were four times more likely to buy them when offered a loan.

For our Healthy Household Initiative (HHI), we built on this success and added clean cookstoves and solarlights (to reduce indoor air pollution that contributes to respiratory illnesses). By selling a product bundle, homes would become healthier and social entrepreneurs would have an incentive (profits) to sustain and scale up without relying on donor support.

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A fresh perspective: introducing David Shoultz

David Shoultz recently joined PATH as the program leader for drug development. Before PATH, he served as the Director of Grantee and Partner Engagement at the Bill & Melinda Gates Foundation, where he worked to deepen engagement between partner organizations. We spoke to him recently to find out what first drew him to global health, what inspires and motivates him, what opportunities and challenges he sees, and what he envisions for PATH’s Drug Development program.

David Shoultz plays with a child from the Garifuna community on a small island near Roatan, Honduras.

Enjoying the chance to play with some kids from a Garifuna community on a small island near Roatan, Honduras, 2013. Photo: David Shoultz.

Who inspires you?

I draw a lot of inspiration from Marc LaForce’s work to develop MenAfriVac®, a new vaccine for meningitis. Marc started by putting a lot of trust in end users and potential customers—ministries of health and community clinics—by asking what they needed most from a new vaccine. Overwhelmingly, he heard that it had to work against meningitis A (the most common type of meningitis in the region), it had to be safe and effective, and most importantly, it had to be inexpensive.

Keeping these requirements at the forefront, Marc and his team were able to develop a vaccine in record time and at one-tenth the cost of a typical vaccine. With more than 217 million people vaccinated so far and plans to include MenAfriVac® in routine childhood immunization programs, it has the potential to wipe out a disease that has been a scourge in the region. I truly admire Marc’s vision, persistence, and leadership on this project.

What first drew you to global health?

David Shoultz stands on the Great Wall of China, with the length of the wall extended behind him.

On a remote section of the Great Wall of China in the Beijing Region, 2009. Photo: David Shoultz.

My mother, Janice Shoultz, was an early influence. She recently retired, but for many years, she was a professor of community health nursing at the University of Hawaii. She focused on issues affecting rural communities, including domestic violence and nutrition. Watching her career develop, I saw the passion and the reward, and I got to know more about the critical work she did. She spent a month working in rural health care in China in the early 1980s, and it was a mind-expanding experience to begin to understand what rural health care is and how it compares between China and the United States. Her stories and pictures from that trip helped to fuel my early interest in global health.

Later, I was drawn into global health by Dr. King Holmes at the University of Washington. In the 1990s, global health was considered a niche field, primarily known as tropical medicine and hygiene. King drew me to global health as we know it today, teaching me the critical value of understanding the knowledge, attitudes, beliefs, and practices of the people that we intend for our global health interventions to benefit. I was—and am to this day—inspired by his ingenuity, generosity, and work ethic.

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Top moments in 2014

As 2014 comes to a close, we spent some time reflecting on the moments that helped set this year apart. Take a trip down memory lane as we count off our most memorable highlights.

1. Innovation. Transformation. Inspiration.

We kicked off 2014 with an in-depth examination of ways the public and private sectors can work together to save lives. Three guest contributors penned posts for our blog addressing topics such as factors for success in public-private partnerships, the arc of product development and the potential for global innovation hubs, designing for the poorest of the poor, and more.

2. Perspectives on defeating malaria

Infographic showing, "I raise my hand to #DefeatMalaria," written on an open palm.

An infographic from the campaign illustrating one of the ways to participate. Photo: PATH.

To commemorate World Malaria Day in April, we joined with a group of organizations to launch the #DefeatMalaria campaign on social media. Campaign participants were asked to contribute photos and tweets using the #DefeatMalaria hashtag with messages of support and statements about their work.

In addition, we hosted a month-long blog series featuring a range of perspectives in the fight to end malaria. The blogs included personal experiences, exciting scientific advances, and reports from the field from individuals including Karen Goraleski of the American Society of Tropical Medicine and Hygiene, James Whiting of Malaria No More UK, and many others.

3. Changing the reality of diarrheal disease

Snackable promoting the campaign to #DefeatDD.

A still from our recently released video highlighting an integrated approach to defeat diarrheal disease. Photo: PATH.

In collaboration with our colleagues at DefeatDD, in June, we introduced a new video, “Defeat diarrheal disease? Together, we’ve got it covered.” The video highlights the simple solutions we can stitch together now—such as exclusive breastfeeding, good nutrition, handwashing, safe drinking water, vaccines, and effective treatments—to bring an end to preventable childhood deaths from diarrhea. Eugenio de Hostos, our head of research and preclinical development, also offered his thoughts on what it will take to defeat diarrhea.

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Drug development news digest—October/November 2014

Two pre-exposure prophylaxis (PrEP) trials demonstrating unexpectedly early success, a Muppet that talks about poop, new lessons in drug resistance gleaned from a soldier dead for 99 years, and more… Dive into this unusual collection of recent media highlights to get caught up on your global health news!

At the recent HIV Research for Prevention (HIVR4P) conference in Cape Town, South Africa, a major focus was placed on the need to develop a range of prevention options and put more prevention tools into clinical practice, as well as close gaps in care, to curb the epidemic. DispatchLive

Six-year-old Raya isn’t shy about poop. As the newest addition to Sesame Workshop (the global health arm of the Sesame Street series), Raya’s job is to break the taboo around open defecation and educate kids about using toilets and proper hygiene to protect against sanitation-related diseases. NPR: Goats and Soda

Faced with drug shortages, the Indian government has joined with pharmaceutical companies, the World Health Organization, and others to provide medicine to 150,000 HIV/AIDS patients at risk of missing dosages. Reuters

As coordinator of the President’s Malaria Initiative, Rear Adm. R. Timothy Ziemer has been credited with helping to reduce the burden of malaria worldwide and fostering closer collaboration between malaria organizations. He discusses lessons learned from experience (including a childhood bout with malaria), his approach to zeroing in on malaria, and his motivation to serve. The New York Times

Exciting (and unexpectedly early) results from two PrEP trials in Europe demonstrate that oral Truvada used as PrEP significantly reduces HIV infection among men who have sex with men, adding to the growing body of evidence showing the effectiveness of this prevention tool. All men in PROUD (United Kingdom) and IPERGAY (France and Canada) trials will now be offered PrEP to protect themselves from the virus. The IPERGAY is also significant because it tested an “on-demand” PrEP regimen, which can be seen as an effective and versatile alternative to daily dosing. AIDSmap

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