Drug Development Global Program

The crucial role of drugs against Cryptosporidium

Children hospitalized for diarrhea.

New and improved treatments for diarrheal disease, as well as improved access to existing therapies, could keep children safe from severe illness. Photo: PATH.

Cryptosporidium, a protozoan parasite, became recognized as a widespread and significant public health threat in the mid-1990s, but only recently has its scope and potential for long-term harm begun to be better understood. In 2013, the Global Enteric Multicenter Study (GEMS) revealed two key new pieces of information: (1) Cryptosporidium is the second leading pathogen associated with moderate to severe diarrhea in children under two years and (2) it is the leading pathogen associated with death in toddlers (ages 12 to 23 months). Because of the difficulty associated with targeting a parasite for vaccine development, new drugs and expanded access to existing therapies will play a crucial role in countering this leading cause of morbidity and mortality among young children.

Missed goals and new opportunities

While large gains have been made toward helping children survive past the age of five since the launch of the Millennium Development Goals (MDGs) in 1990, the two-thirds target for reduction in mortality was missed in 2015. More children can be saved from preventable causes, such as diarrhea, and child survival remains a focus of the post-2015 development agenda.

Continue reading »

Looking back at 2015

We can’t say goodbye to last year just yet. Join us as we look back at some of the moments that gave our team cause for celebration in 2015.

Launch of Diarrhea Innovations Group

Diarrhea Innovations Group

Image: PATH.

This year, we helped to launch the Diarrhea Innovations Group (DIG) in partnership with our colleagues at icddr,b in Bangladesh. Based on the successful Pneumonia Innovations Team, DIG will focus attention on innovative approaches in diagnostics, therapeutics, and nutrition to reduce children’s deaths from diarrhea in low-income countries. Learn how you can get involved.

Semisynthetic artemisinin used in millions of treatments

Figure: PATH.

Figure: PATH.

Since the first large-scale batches of ArteSunate AmodiaQuine Winthrop® (ASAQ Winthrop, fixed dose artemisinin-based combination therapy [ACT]) made with a new semisynthetic artemisinin derivative began reaching patients in 2014, there have been more than 39 million treatments shipped to 23 countries across sub-Saharan Africa. We’re incredibly proud of our role in helping to supplement and stabilize the global supply of artemisinin for antimalarial drugs.

Continue reading »

PATH in San Francisco, Bridget Brennan

Photo: Bridget Brennan.

Photo: Bridget Brennan.

PATH’s team in the San Francisco Bay Area is improving the health of women and children worldwide, primarily through our work in drug development. In this post, we learn more about Bridget Brennan, PATH’s senior manager of outreach and development.

My role is to represent PATH in the Bay Area. I work to increase PATH’s visibility, raise philanthropic dollars, and develop partnerships that support these aims as well as strengthen PATH’s programs.

How were you introduced to PATH? I have known of PATH since my undergrad days of studying international development and population science. Many years later, I ran across PATH exhibiting at a public health conference in San Francisco in the early 2000s. Earlier this year while talking to the policy director at local nonprofit Living Goods, PATH came on my radar again—I learned at that time that PATH had a Bay Area presence. Through a mutual colleague, I was connected to the team at PATH, and here I am!

Continue reading »

Can you DIG saving the lives of children?

By Dr. David Shoultz, Program Leader, Drug Development and Devices and Tools, PATH, and Dr. Shams El Arifeen, Director, Child & Adolescent Health, icddr,b

This post was originally published on the DefeatDD blog.

Photo: PATH.

Photo: PATH.

How are we going to save the 550,000 children who still die of diarrhea each year? It’s a daunting question. While vaccines against the leading cause of severe childhood diarrhea are key to prevention, treatment should also remain an important focus. We know that oral rehydration solution (ORS) and zinc are the cornerstone treatments for diarrhea and that this combination already saves many children. While we still need to improve awareness about, access to, and use of ORS and zinc, we also need to identify the underlying causes of severe diarrhea in children and develop new approaches and innovations in treatments, diagnostics, and nutrition to address those causes. In fact, a recent report by Innovation Countdown 2030 highlighted new treatments for severe diarrhea as having the potential to save an estimated 251,000 children’s lives. That’s a very attractive opportunity!

Continue reading »

A brainstorming session with one of PATH’s global leaders

This post by Drug Development program leader David Shoultz originally appeared on the PATH blog.

When high-powered innovators talk global health issues with PATH’s David Shoultz, health equity rises to the top.

PATH’s 40-year record of successful partnerships has led to transformative health innovations such as the MenAfriVac® vaccine. Where the vaccine has been introduced through mass immunization campaigns, group A meningitis outbreaks have disappeared. Photo: PATH/Gabe Bienczycki.

PATH’s 40-year record of successful partnerships has led to transformative health innovations such as the MenAfriVac® vaccine. Where the vaccine has been introduced through mass immunization campaigns, group A meningitis outbreaks have disappeared. Photo: PATH/Gabe Bienczycki.

I recently had the privilege of meeting with a group of entrepreneurs, engineers, attorneys, inventors, and donors at an Innovation Salon hosted by PATH in San Francisco. Our conversation touched on recent advances in global health and the opportunities and challenges that lie ahead in the quest to achieve greater health equity around the world. I particularly enjoyed chatting with an inventor whose innovative approach to taking an electrocardiogram using a device that uses simple finger-pads and connects to a mobile phone might be a useful diagnostic tool in low-income settings.

Continue reading »

Support for drug registration to fight visceral leishmaniasis in Bangladesh

Patients sickened by visceral leishmaniasis lie in a hospital ward.

Patients sickened by visceral leishmaniasis (VL) endure fever, weight loss/decreased appetite, enlargement of the spleen, and anemia. Left untreated, VL is almost always fatal. Photo: ©Jonathan Torgovnik.

Neglected disease of poverty

Visceral leishmaniasis (VL), also known as kala-azar or black fever, kills up to 30,000 people every year, mostly in low-resource settings in countries of the Indian subcontinent and East Africa. The disease is transmitted through the bite of a sand fly. Smaller than mosquitoes, these tiny insects can pass through most netting and inflict a bite a victim rarely even feels. The disease affects the visceral organs, causing chronic fever, weight loss, and anemia; left untreated, it is most often fatal.

Paromomycin, an off-patent aminoglycoside antibiotic, is an established drug with an extensive history of use and a well-characterized safety profile. In partnership with others, PATH developed paromomycin intramuscular injection (PMIM) as a new, safe, effective, and affordable treatment option for VL and worked with leading clinical researchers and an Indian pharmaceutical company to manufacture the drug and register it with India’s national drug regulatory agency in 2006.

Shifting focus to Bangladesh

Following regulatory approval and a large-scale phase 4 clinical study of PMIM in India, PATH sponsored a phase 3(b) study in Bangladesh, in partnership with the Bangladeshi Ministry of Health and the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b). This study was initiated in 2011 at two government health clinics in Mymensingh District and enrolled 120 patients between the ages of 5 and 55.

Close-up of vials of visceral leishmaniasis.

Vials of paromomycin intramuscular injection (PMIM). Photo: ©Jonathan Torgovnik.

The study contributed to the safety and efficacy profile of PMIM, as well as to the national VL elimination strategy. Considerable efforts were also made to build capacity for local staff to conduct clinical research according to international quality standards.

The work was recently highlighted in the article “Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh,” published in PLOS Neglected Tropical Diseases. Excerpt from the Author Summary:

Although sodium stibogluconate, miltefosine, and paromomycin are included in the National Essential Drug List for VL, only miltefosine is currently registered in Bangladesh. Paromomycin is a low-cost drug that was demonstrated to be an efficacious and safe treatment for VL in endemic areas of India, which led to approval of paromomycin IM injection (PMIM) for the treatment of VL in India in 2006 and inclusion of PMIM in the WHO Essential Medicines List in 2007. A subsequent Phase IV trial in India revealed a similarly high efficacy and safety profile coupled with high treatment compliance in a rural outpatient setting. We confirmed the effectiveness, safety, and high compliance of PMIM when used in an outpatient setting in Bangladesh. This study supports the registration of PMIM as a low-cost treatment option for VL in Bangladesh.

Read the full article.

More information:

Diarrhea deaths are falling but ORS use still stagnant

This post originally appeared on the Global Health TV blog

A mother administered oral rehydration salts to her child in Kenya. Photo: PATH/Tony Karumba.

A mother administered oral rehydration salts to her child in Kenya. Photo: PATH/Tony Karumba.

I’m grateful to Chelsea Clinton for her admission that she is “obsessed with diarrhea,” and her total lack of embarrassment in bringing it up repeatedly. In an interview with Fast Company, it was the first thing she wanted to talk about.

I’m grateful to her because she is, as far as I know, the only well-known public figure to champion the prevention and treatment of diarrhea, the world’s second biggest killer of children under five years old, even though we have cheap and effective ways of dealing with it.

“It’s completely unacceptable that more than 750,000 children die every year because of severe dehydration due to diarrhea,” said Clinton last year. “I just think that’s unconscionable.”

We need more champions of the diarrhea issue.

Four years ago, I wrote a blog bemoaning the fact that oral rehydration therapy (ORT) seemed to be on life support, even though The Lancet once called it “the most important medical advance of the 20th century.” ORT and its practical application, oral rehydration solution (ORS), have long been found to be both effective and cost-effective in treating the dehydration caused by diarrhea.

Continue reading »

PATH in San Francisco, Robyn Leslie

Robyn Leslie

Photo: Robyn Leslie.

PATH’s team in the San Francisco Bay Area is improving the health of women and children worldwide, primarily through our work in drug development. In this post, we learn more about Robyn Leslie, PATH’s outreach & events coordinator based in San Francisco.

In my role, I am building relationships with a wide range of stakeholders in the Bay Area, managing event logistics, and contributing to social media. My work helps build awareness about PATH’s work and support for our projects around the world.

How were you introduced to PATH? I first learned about PATH growing up in Seattle, but actually got to experience the impact of PATH’s work while living in Chengdu, China, when I received the single-dose Japanese encephalitis (JE) vaccine that PATH helped develop. I had the opportunity to travel and work in China over the past two years, but the opportunity came up suddenly, without much time to plan my vaccinations in advance. The only JE vaccine approved for use in the United States is a two-dose variety that I would have had to space out over a month. I traveled to China without having been vaccinated against JE, and I was able receive the single dose vaccine in China for a fraction of the cost.

Continue reading »

Innovating Against HIV, part 3

We continue to explore the potential for new HIV treatment and prevention innovations (broadly neutralizing antibodies [bNAbs] in HIV vaccines, oral pre-exposure prophylaxis [PrEP] for HIV prevention, and long-acting injectable antiretroviral [ARV] drug therapy) identified in the recent Reimagining Global Health report issued by the Innovation Countdown 2030 initiative, as well as other new technologies in the pipeline. In this installment, we hear from AIDS Foundation of Chicago (AFC), International Rectal Microbicide Advocates (IRMA), the International Partnership for Microbicides (IPM), and the Microbicide Trials Network (MTN). Read on to learn how new technologies could change the trajectory of the HIV/AIDS epidemic in the next 15 years.

Catch up on part one and part two of our series.

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

 

"...we are excited about new items in the pipeline being created for the prevention buffet, such as vaccines with bNAbs and long-acting injectables for both prevention and treatment. We are equally enthusiastic about daily oral PrEP—a currently available intervention that has been proven to work exceptionally well to prevent HIV..."With exciting technologies like injectable ARVs and a vaccine on the horizon, the next big breakthrough in HIV prevention for women could be a monthly vaginal ARV ring developed by IPM. Self-initiated, long-acting, and discreet products are an especially urgent need for young women in sub-Saharan Africa, who are at an increasing risk of infection.

More from AFC/IRMA

Continue reading »

Innovating Against HIV, part 2

We are continuing our conversation about HIV treatment and prevention innovations, including those recently identified in the Reimagining Global Health report (broadly neutralizing antibodies [bNAbs] in HIV vaccines, oral pre-exposure prophylaxis [PrEP] for HIV prevention, and long-acting injectable antiretroviral [ARV] drug therapy), as well as other technologies, that could change the trajectory of the epidemic in the next 15 years. In this installment, we hear from PATH, CONRAD, and the US Agency for International Development (USAID).

Catch up on the first part of our series, featuring AVAC, CAMI Health, and the International AIDS Vaccine Initiative.

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

"An effective vaccine is the true silver bullet...""The global response to HIV is shifting from an emergency phase to executing evidence-based programs embedded in sustainable systems that will accelerate gains in preventing infections and saving lives."Whether it is oral PrEP, long-acting ARVs, or HIV vaccine research and development...More from CONRAD Continue reading »