Drug Development Global Program

PATH in San Francisco, Debbie Naguwa

PATH’s team in San Francisco works to advance transformative global health innovations to improve the lives of women and children, primarily through our work in drug development. In this post, we learn more about Debbie Naguwa, project administrator for PATH’s Drug Development program.

Photo: Debbie Naguwa.

How would you describe your role? Primarily, I manage financial data and budgets for our projects. I also assist with the initiation of new contracts and act as a liaison with Seattle headquarters to ensure compliance with PATH policies and procedures.

Where are you from? I am originally from Hilo, Hawaii. The picture featured here is Akaka Falls on the Big Island of Hawaii. A previous employer moved me from Honolulu to San Francisco. I love that people ask me questions about Hawaii before they go on vacation there!

At the Drug Development program retreat earlier this year, you became the first recipient (and namesake!) of a new award, recognizing “generosity of spirit, a bringing in of those who may otherwise be on the outside, and compassion.” Can you tell us about this special recognition? I’m a bit embarrassed about this, but I was honored and flattered to receive the inaugural “Deb Naguwa Aloha Award.” I was blown away to have an award named after me and look forward to recognizing another team member next year!

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WHA Roundup: a new WHO head, the demise of an R&D pooled fund, and the access debate rages on

This post originally appeared on the Global Health Technologies Coalition (GHTC) Breakthroughs blog.

By Matthew Robinson, MA, policy and advocacy officer, GHTC

Photo: World Health Organization/L. Cipriani.

As the 70th session of the World Health Assembly (WHA) winds to a close, memberstate delegates and civil society advocates are collectively taking a moment to catch their breath and reflect on an extremely eventful WHA. In a single week, the World Health Organization (WHO) gained a new Director-General—Dr. Tedros Gehbreyesus of Ethiopia—increased mandatory contributions from member states, and passed a landmark cancer resolution, just to name a few key decisions. In addition to these seismic shifts in the landscape of WHO, health research and development (R&D) was also featured prominently across a number of WHA agenda items, some of which saw highly consequential developments.

Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG)

The long-running CEWG process finally appears to have reached its end. After more than a decade of exploring approaches to support R&D for neglected diseases and actions to stand up a voluntary R&D-pooled fund at WHO, Assistant Director-General (ADG) Marie-Paule Kieny notified the Assembly that no further work would be done on either the pooled fund or the initial round of demonstration projects associated with it.

Her comments came at the close of a lengthy session in which both member states and civil society organizations universally echoed the call for more resources to enable the fund and demonstration projects to operate effectively, as well as bemoaning the lack of contributions to date. In justifying the decision to cease work on these projects, ADG Kieny noted that no additional funding has been raised for the fund beyond the US$11 million pledged over three years ago. With that level of funding, the programs were simply not sustainable, she explained.

On a positive note, the WHO Global Observatory on Health R&D—which was created to facilitate R&D coordination and guide prioritization—was spared the ax. While resources are not available to expand its database of R&D projects and data immediately, it is now operational and can be expanded at any time, as additional data and funding become available.

Access to medicines

As expected, the debate around access to medicines continued to rage at this year’s WHA. Although there was not a dedicated agenda item on follow-up to the United Nations Secretary General’s High-Level Panel on Access to Medicines (HLP) report, a number of countries, including Brazil, India, and Argentina, took every opportunity to raise the report in their remarks on other agenda items. In particular, agenda item 13.3 Addressing the Global Shortage of, and Access to, Medicines and Vaccines—which has historically focused more on supply chain issues—saw particularly heated debate, as well as intricate parliamentary maneuvering.

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Member Q&A: Robert Choy, PhD

This post originally appeared on Inside American Society of Tropical Medicine and Hygiene (ASTMH).

“The ASTMH Annual Meeting is one of the only times we can reliably expect that most, if not all, of our partners will gather in the same place.” –Robert Choy, PhD

Robert Choy, PhD, was randomly selected for a Q&A from among five members who correctly answered our trivia question in March during TropMed History Month. (The question: Besides Hurricane Georges in 1998, what other time was the Annual Meeting canceled? The answer: 1918, due to an influenza pandemic.) Dr. Choy is Associate Director, Research and Preclinical Development, with PATH’s Drug Development program, based in San Francisco. He received his PhD from the University of Washington in Molecular and Cellular Biology and is the world’s foremost authority on the effects of Prozac on C. elegans. In more than six years at PATH, he has worked with various industry, academic and government collaborators to advance drug development projects for enteric and diarrheal diseases. He recently contributed to a range of projects in the PATH portfolio, including a CFTR chloride channel inhibitor for cholera, novel inhibitors against various targets in Cryptosporidium, tribendimidine for soil-transmitted helminths, and nutritional interventions for environmental enteric dysfunction. In his spare time, Dr. Choy enjoys speaking to students and post-docs at local universities such as UC Berkeley, UC Santa Cruz and Santa Clara University about what it is really like to work on drug development for neglected diseases.

How did you know the answer to the TropMed History Week trivia question?
I found a copy of Dr. Stephanie James’s Presidential Address from 1998, the year that the Annual Meeting planned to be in Puerto Rico but was canceled by Hurricane Georges. In her address, she mentioned the cancelation of the 1918 meeting due to the influenza pandemic.

What are the global health R&D innovations that you are most excited about right now? 
I’m most excited about the FDA’s Priority Review Voucher (PRV) program, an innovative approach to incentivize global health R&D by offering a reward (the PRV) for registering a new treatment for a neglected tropical disease. The vouchers enable Priority Review (typically six months, as compared with the usual 10 or more months) for another drug application and are transferable. Since the program was initiated in 2007, at least six vouchers have been sold, with the most expensive going for $350 million. The potential payoff has attracted the attention of venture capital firms that have historically not been interested in tropical disease treatments because of the lack of commercial value. PATH recently was able to leverage the potential value of a PRV to secure a $25 million investment from Clarus Ventures and the Global Health Investment Fund to support the development of tribendimidine, a new treatment option for soil-transmitted helminths. In collaboration with Swiss Tropical Public Health Institute, the Chinese Center for Disease Control and Prevention, and Shandong Xinhua Pharmaceutical Company, we are working to advance tribendimidine for use in global deworming campaigns, and we are optimistic that this innovative funding model will provide a new source of support for other global health R&D innovations as well.

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How we measure the true impact of diarrheal diseases

By Ibrahim Khalil and Puja Rao, Institute for Health Metrics and Evaluation, University of Washington

The problem: One-time illness or lifelong impairment?

When a child experiences a single episode of diarrhea, they typically feel uncomfortable for a short period of time, but with appropriate care, they recover and continue to live a life free from disability. But when access to safe water and sanitation is limited—and children are constantly exposed to an assortment of bacteria and viruses—what happens when a child experiences frequent bouts of diarrhea without proper remedy? To answer this question, we need to better understand the cyclical relationship of diarrheal diseases and enteric infections during the crucial period of early childhood development and related poor health outcomes that can result over a lifetime.

Close-up of infant

Repeated enteric infections, such as diarrheal diseases, can impair a child’s growth and development and negatively impact long-term well-being. Photo: PATH/Gabe Bienczycki.

We know that repeated and persistent exposure to enteric infections like diarrhea may lead to intestinal inflammation and damage in the gut. Compromised gut health inhibits nutrient absorption in the body and can lead to malnutrition and eventually long-term health consequences, such as stunted physical growth, impaired cognitive development, and/or increased susceptibility to opportunistic infections, including pneumonia, the leading killer disease of children younger than five years. The more we understand about this vicious cycle, the better we are able to make meaningful policy decisions to break the cycle of poor health using primary and secondary prevention strategies.

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Meet the amazing cast behind a life-changing drug

This post originally appeared on the PATH blog

How one consortium is expanding drug options to fight parasitic worms worldwide.

Eugenio de Hostos, seated, holds a mug and talks to a colleague off camera.

Eugenio de Hostos leads PATH’s work in drug research and preclinical development. Photo: PATH/Erika Amaya.

It was well after midnight in San Francisco when Eugenio (“Geno”) de Hostos picked up the phone—but when his colleagues in China answered, he felt the familiar jolt of excitement.

He’d felt the same thrill at dawn, talking to his colleagues in Switzerland. At five, in a call to Maryland with the US Food and Drug Administration (FDA). And the previous week, chugging a cup of coffee while furiously scratching notes in a 6:00 a.m. conference call with project partners.

Geno leads PATH’s work in drug research and preclinical development, and for the last two years, he and his team—with pivotal support from colleagues at Swiss Tropical and Public Health Institute (Swiss TPH), the National Institute of Parasitic Diseases (NIPD) at the Chinese Center for Disease Control and Prevention, and Shandong Xinhua Pharmaceutical Company (XPC)—have been building a cast of global experts, partners, and funders to do something remarkable: get an underutilized, life-changing drug into the hands of communities affected by a debilitating neglected tropical disease.

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Breathing life into medical oxygen ahead of WHO committee decision

By Adam Lewis

This post originally appeared on The Huffington Post.

Mount Kilimanjaro stands nearly 20,000 feet above sea level, its snow-capped peaks providing a stark contrast against northern Tanzania’s otherwise equatorial backdrop. As Africa’s tallest mountain, it draws tens of thousands of climbers a year: some of whom reach the summit successfully, many of whom must stop short because of low levels of oxygen in their blood (the peak’s atmospheric pressure offers about half the breathable air as at sea level). The irony, however, is that in Tanzania – and nearly every country in sub-Saharan Africa – you don’t need to climb a mountain to reach an environment with too little oxygen; you just have to walk into a hospital.

Oxygen is one of the most frequently-required medical interventions in the world, yet it remains in critically short supply in low-resource hospitals. The World Health Organization (WHO) estimates that less than half of health facilities in Africa have reliable access to medical-grade oxygen – let alone the trained staff, supplies and infrastructure to deliver it.

Without medical oxygen, health providers are unable to treat critically ill patients with low levels of oxygen in their blood – an effect of conditions such as trauma, obstetric complications, heart failure and respiratory diseases like pneumonia, a leading cause of death for children globally. As one Tanzanian doctor recently explained to me, oxygen is essential throughout the entire hospital because low blood-oxygen levels – known as hypoxemia – can be both ubiquitous and, in many cases, fatal.

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Time to “decrypt” a wily parasite

By Robert ChoyAssociate Director of Research and Preclinical Development for Drug Development, PATH

Cryptosporidium harms children—we need research and development to stop it.

A still from the video, “DefeatDD: Superheroes vs. Villains.” Cryptosporidium is one of the featured bad guys. Image: PATH.

A lot of ugly things in nature are relatively harmless (Exhibit A: the star-nosed mole)—but Cryptosporidium isn’t one of them.

Unsettling under a microscope and dangerous in the human body, this tiny parasite is one of the most common causes of diarrheal disease (DD) worldwide. Yet for years, attention and research for “Crypto,” as it’s often called, has lagged.

Here’s the story of this “hidden spore”—and why research and development for effective tools should be a global priority, now.

The long-term consequences of diarrheal diseases

Worldwide, DD is a leading cause of death among children under five. Even when children survive the disease itself, repeated rounds put them at risk for long-term health and developmental consequences, including malnutrition, stunting, and deficits in cognitive development. Over time, persistent DD can also cause a kind of gut damage known as environmental enteric dysfunction, which contributes to malnutrition and can prevent some vaccines from working properly.

Together, these factors make children more vulnerable to opportunistic infections. In impoverished areas with limited sanitation, hygiene, and clean water, that can kick off a vicious cycle of illness, malnutrition, and reinfection.

Bringing the “hidden spore” to light

It turns out that Cryptosporidium (from the Latin for “concealed spore”) is the culprit behind many cases of DD worldwide—but we didn’t always know that. In 2013, a landmark study, the Global Enteric Multicenter Study, or “GEMS,” identified the viruses, bacteria, and parasites that most often cause DD.

Many of the usual suspects turned up. But so did Crypto—and that was a surprise. Continue reading »

PATH in San Francisco, Eugenio de Hostos

PATH’s team in San Francisco works to advance transformative global health innovations to improve lives of women and children, primarily through our work in drug development. In this post, we learn more about Eugenio de Hostos, director for research and preclinical development for PATH’s Drug Development program.

Eugenio de Hostos stands on a snowy mountain with a bright sky behind him.

On a ski trip in Switzerland. Photo: Eugenio de Hostos.

How would you describe your role? I lead our work on early-stage research and development (R&D) projects and build a pipeline of R&D opportunities.

Do you have any pets? My daughter has five fish in an aquarium. She outsources taking care of them to me.

What is one of your favorite sayings? The more you try to do, the more you actually do.

Who is one of your heroes? Albert Schweitzer, a French-German philosopher and physician. I am inspired by his selfless dedication to helping the sick and neglected, far away from his own home and in a time when few others cared about these things.

What was the last book you read? Lost City of Z by David Grann.

What do you like most about your job? The mission, the variety of things I get to do, and the opportunity to interact with a lot of interesting people.

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Oxygen for the most vulnerable: WFSA supports advocacy initiative

This post originally appeared on the World Federation of Societies of Anaesthesiologists (WFSA) blog.

We need to make this essential medicine available, affordable, and accessible so anaesthesiologists can work as safely and effectively as possible.

Consider a hospital and consider the patients. A child at the facility is suffering with pneumonia, while an elderly man has an exacerbation of chronic obstructed lung disease after his hernia operation. A woman struggles with acute bronchitis on top of a baseline lung disease, and a teenager arrives at the emergency department with abdominal wounds. What do all of these patients have in common? They are all going to need oxygen, because oxygen is an essential and lifesaving medicine.

But what happens when it’s not available? Continue reading »

Witness DREAMS in Kenya

By Heather Kelly, senior program officer, PATH, and Erika Amaya, digital communications officer, PATH

PATH staff gather together in the Kisumu, Kenya office.

PATH staff from the Drug Development, Reproductive Health, and Kenya country programs meet to discuss progress on DREAMS implementation. Left to right: Ellen MacLachlan, Jennifer Moronge, Oluoch Madiang’, Lovena Owuor, Juma Mwatsefu, Francis Onyango, Daniel Okumu, and Heather Kelly. Photo: PATH/Heather Kelly.

Heather Kelly, senior program officer for the Drug Development program, and Ellen MacLachlan, senior research officer with the Reproductive Health program, recently visited with Kenya-based PATH colleagues working on the rollout and implementation of DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe women), an ambitious partnership aimed at reducing HIV infections among adolescent girls and young women.* At the PATH office in the Western Kenyan city of Kisumu, Heather and Ellen had the opportunity to learn about progress on DREAMS, as well as the challenges and opportunities that lie ahead. Heather sat down with us to share highlights from the visit.

What prompted the visit to Kenya?

This was an opportunity to meet with our Kenya colleagues and discuss the multifaceted implementation of DREAMS, work that is funded through a PATH-led project called APHIAplus Western (short for AIDS, Population, and Health Integrated Assistance Zone 1). We came to this from the perspective of wanting to know what the learnings and challenges have been so far and also initiating discussions about building on DREAMS to integrate HIV prevention and reproductive health services for high-risk women and girls. We were particularly interested in learning about the rollout of oral pre-exposure prophylaxis (PrEP), which is a component of the DREAMS project. PrEP is an innovation in HIV prevention, and its use in developing countries is new. DREAMS is a great opportunity to see how PrEP works in real life with real people.

In safe spaces created by DREAMS, participants can access information, biomedical services, and a range of resources for training, education, and health. Photo: PATH/Oluoch Madiang’.

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