Drug Development Global Program

Drug development news digest—June 2014

While global health headlines didn’t garner nearly as much attention as the World Cup this past month, there was still plenty to get excited about. From a new initiative to expand treatment options for children with HIV to the power of “disruptive innovation” and the “race against time” to defeat malaria—below is a selection of stories sure to get you worked up.

Exciting news from our program as we recently announced we’re expanding the search for new drugs to treat deadly diarrhea in partnership with our colleagues at Saint Louis University’s Center for World Health and Medicine. Bioresearch Online

A new initiative, at once “ambitious and overdue,” seeks to close the gap in treating pediatric HIV by pooling the resources of industry, civil society, and government. Science Speaks

Pharmaceutical companies attempt to tackle the lack of treatments for children with HIV by producing more child-appropriate formulations and sharing intellectual property. The Washington Post

An innovative, integrated approach to deadly diarrhea could mean a brighter future for children in the poorest, most rural regions of Africa. The Guardian

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Shared goals to accelerate drug discovery

Guest post was contributed by Marvin Meyers, PhD, who directs medicinal chemistry for the Center for World Health and Medicine (CWHM) at Saint Louis University.

Interventions for diarrheal disease include vaccines, ORS, and safe, new, effective drugs

A few months ago, this blog provided an overview of the drug discovery and development process. What is very clear is that, while drug discovery is a very difficult and risky business, the potential benefit for millions of people worldwide makes it all worthwhile. Large pharmaceutical companies have significant resources to help absorb the failures that are inevitable in the drug discovery business. As nonprofit groups working to discover new drugs for diseases in developing countries, we need to do everything in our power to minimize the risk for failure and improve the likelihood for success. This requires partnering between groups that have complementary expertise and resources.

Moving beyond the lab bench

CWHM at Saint Louis University is a relatively new player in the rapidly expanding “academic drug discovery center” phenomenon. Formed in 2010, CWHM is made up of a group of drug discovery scientists with more than 200 years of collective experience in the pharmaceutical industry. This group is essentially a complete drug discovery project team embedded in an academic environment, with expertise in translation of basic science into new drug candidates for clinical trials.

This model of a drug discovery team in an academic environment takes advantage of CWHM’s expertise in drug discovery—that is, the teamwork and scientific proficiency needed to successfully identify a potential new drug. However, to be truly successful, CWHM needed collaborators that have expertise in 1) the broad spectrum of diseases that directly affect people in low-resource settings and 2) the design and execution of clinical trials. This is why partnering with PATH through its Drug Development program is critical to the successful identification of a new antidiarrheal drug. PATH has the expertise in both diarrheal diseases and implementation of clinical trials for potential new antidiarrheal drugs.

Targeting diarrheal disease

In 2010, CWHM initiated a project that sought to reposition high-quality inhibitors of neutral endopeptidase (NEP) that had previously failed to reduce blood pressure in clinical trials, yet were demonstrated to be safe for humans. We established preclinical models of diarrhea and began investigating NEP inhibitors for antidiarrheal effect in those models.

Early on, we partnered with PATH’s Drug Development program to advance this project. Our collaboration was instrumental in guiding our efforts at a very early stage, and helped to focus our efforts in a manner that kept the need for a clinically relevant agent at the forefront of our thoughts. After working together for a little over two years, we have now identified three high-quality clinical compounds that have demonstrated antidiarrheal effects in preclinical models.

Maximizing impact

What has contributed to our success is teamwork. We discuss results and strategy monthly with our drug development colleagues at PATH. This ensures that our efforts are aligned with the common goal: to identify an excellent treatment for acute secretory diarrhea that will be widely available and convenient for those who need it so that it becomes a drug that will be used to save lives.

The best way to prevent needless deaths from diarrhea in developing countries is through a productive and synergistic team effort that combines the strengths of each partner. As we continue our partnership with PATH, we are eager to see what other successes we can achieve together.

Photos: PATH, except for bottom right, Jonathan Torgovnik©.

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Drug development news digest—May 2014

Some common themes emerge in our round-up of global health news from the month of May. For instance, two stories expose the virulent nature of cholera devastating two different regions of the world. In another two stories, India takes center stage, as the health inequities between urban and rural, rich and poor are explored. See what other common threads emerge in the selection of stories below.

For over a century, no cases of cholera were reported in Haiti. By 2014, the rate of infection represented nearly one in every 15 people in the country, with over 8,500 Haitians killed. The stark reality of the introduction and rapid spread of the disease is explored. Foreign Affairs

Despite declaring itself malaria-free 50 years ago, Venezuela is seeing the disease re-emerge for the first time in urban areas, a development that could take years to reverse. The Guardian

The divide between rich, poor, urban, and rural in India reveals deep inequalities in access to quality healthcare and a stark difference in the newborn mortality rate. The New York Times

A “sexy” new ad from Save the Children is drumming up controversy around diseases that disproportionately affect the world’s poor, including diarrhea and malaria. NPR

“Toilets before temples”! Taking the cue from a pledge made by India’s newly-elected prime minister to prioritize economic development and address the country’s perpetual sanitation crisis, the United Nations launches a global campaign to improve access to toilets for the 2.5 billion people without basic sanitation. Inter Press Service

The Food and Drug Administration is incentivizing drug development for neglected diseases with a “golden ticket” that could be worth hundreds of millions of dollars to drug companies.  NPR

The similarities between a newly recommended therapy for HIV prevention and the Pill for birth control go beyond taking a once-daily dose of medication, especially in terms of stigma. The New York Times

In case you missed it, nine important takeaways from the recent World Health Assembly, including the first-ever global action plan on newborn health and a resolution intended to boost financing for health research and development. Devex

Over a hundred years ago, Rudyard Kipling reported the devastating effects of cholera on the British infantry in India in “Cholera Camp.” Today, devastation and “desperate love” persist. Pacific Standard

Changing the reality of diarrheal disease

Our new video “Defeat diarrheal disease? Together, we’ve got it covered” shows how an integrated approach to tackling diarrheal disease can save thousands of children’s lives each year. In this guest post, Geno de Hostos, who directs our research and preclinical development work for antidiarrheal drugs, comments on some of the video’s themes and offers his insight on what it will take to defeat diarrhea.

The uneasy reality

When you walk into a diarrheal disease health clinic in a place like Bangladesh, the reality of the disease strikes you immediately. It’s the rows of bright orange bed covers drying in the sun, long lines of women with children waiting to be seen, and the patients—most of them too young and vulnerable to be already fighting for their lives.

A mother administering ORS to her child

Photo: Jonathan Torgovnik©.

The onslaught of diarrhea is sudden and loss of fluids is copious. Mere inconvenience quickly turns to a daily struggle for life as you fight off dehydration that diarrhea causes. A child is rushed to a hospital where lifesaving oral rehydration solution (ORS) is administered, usually by a mother or a care provider. Spoon by spoon, lost fluids are slowly restored, though weakness can persist for several weeks, and repeated bouts of diarrhea are common.

The reality is that despite rapid progress in reducing child deaths from diarrhea over the last decade—a decrease by more than 50 percent, from almost 1.3 million in 2000 to approximately 600,000 in 2012—there is a lot more to be done. And as long as diarrhea continues to take the lives of more than 1,600 children every day before they can grow to see their fifth birthday, there is no time we can allow ourselves to waste.

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ICYMI: #DefeatMalaria blog series

To coincide with World Malaria Day, we hosted a #DefeatMalaria blog series last month that highlights the work being done around the world to bring an end to this deadly, yet preventable and treatable, disease. Below is a round-up of stories from organizations working on behalf of millions to defeat malaria once and for all.

Displays of bednets in a Kenyan grocery store.

Photo: PATH/Hope Randall.

Making malaria history for everyone, everywhere
By Hope R., MACEPA, PATH

As a first-time traveler to Africa, Hope Randall wasn’t sure what to expect. Here, she shares her experience with the ever-present threat of malaria.

I believe in Tanzania!
By Troy M., PATH MalariaCare project

In the last ten years, Tanzania has halved the prevalence of malaria among young children! Troy Martin discusses what’s worked and what can be improved as Tanzania continues to roll back malaria.

Investing in the future and defeating malaria in the Asia Pacific
By Brittany Z., Malaria Elimination Initiative, UCSF

Brittany Zelman highlights successes and challenges in the the last mile toward malaria elimination for Bhutan, Republic of Korea, and Sri Lanka, and explains why surveillance of new cases will be key.

A patient in a hospital bed is attended by two health workers

Photo: Friends Africa.

How governments can help in the fight against vector-borne disease
By Akudo I., Friends Africa

Akudo Ikemba discusses local health advocacy efforts to fight malaria and the role that national governments (and Nollywood stars!) can play against vector-borne diseases.

 

Our goal: defeat malaria forever
By Kent C. and Bindiya P., PATH

Kent Campbell and Bindiya Patel discuss PATH’s multipronged approach against malaria and the reasons why the strategy doesn’t end at controlling the spread of the disease. 

Half of a Yellow Sun

Photo: Malaria No More UK.

World Malaria Day: Malaria No More UK seeking your ideas
By James W., Malaria No More UK

An insider’s perspective from James Whiting on the very busy life of a malaria advocate during the month of April.

World Malaria Day 2014: The overlooked side of the global malaria fight
By Karen G., American Society of Tropical Medicine and Hygiene

Karen Goraleski celebrates champions in the fight against malaria and offers their personal perspectives on big challenges and potential game changers in malaria research and development.

Tackling malaria overdiagnosis through interactive training
By Débora M., ACT Consortium

The results of a recent study showed that interactive training programmes for health workers could reduce overdiagnosis of malaria by half and, as Debora Miranda points out, help prevent valuable drugs from being wasted.

Learning to bite back
By Juliane C., Malaria MISSION

Taking lessons from the Global Malaria Eradication Plan of the 1960s, Juliana Chaccour describes a potential malaria control tool that could counter resistance and behavioral plasticity of vectors.

"Count us in to make malaria elimination a reality in Senegal." –In Tiabakh, Senegal, message from the village leader's grandchildren.

Photo: Speak Up Africa.

Zero Malaria! Count Me In!
By Yacine D., Speak Up Africa

Senegal’s progress toward reducing malaria mortality has been impressive, yet they aren’t stopping there. Yacine Djibo introduces a mass communication campaign intended to mobilize key malaria champions and empower leaders to commit to a malaria-free Senegal.

The #DefeatMalaria blog series was published between April 16-May 2, 2014. 

Zero Malaria! Count Me In!

Guest contributor Yacine Djibo is president of Speak Up Africa.

Senegal calls upon its population to cross the finish line and eliminate malaria.

April 25, 2014—On World Malaria Day, Senegal marked the success of decades of combined efforts from individuals and the public and private sectors in the fight against one of the deadliest, yet most preventable and treatable diseases still affecting millions each year, malaria. In the past ten years, Senegal has reduced malaria mortality rates by 62 percent and saved almost 30,000 children’s lives.

While the fight continues, a movement for new dedication is beginning in Senegal. Zero Malaria! Count me in! (“Zéro Palu! Je m’engage!” in French) is a new, innovative campaign designed to give ownership in the fight against malaria to every Senegalese citizen. This inclusive mass communication campaign aims to launch a national movement in favor of malaria elimination in Senegal. The campaign will help mobilize key champions and identify and empower leaders to help create and grow malaria-free zones, while building commitment to a malaria-free Senegal.

Zero palu

Image: Speak Up Africa.

Launched at the second consecutive Jambars (Champions) event in Senegal, just days before World Malaria Day, well over 300 members of the private and public sectors, including The Honorable Awa Marie-Coll Seck, Senegal’s Minister of Health, Mme. Anta Sarr Diacko, the Minister of Women, and leaders from the community, joined together to stand side by side to support the fight for a malaria-free Senegal. Each supporter enthusiastically wore their “Zéro Palu! Je m’engage!” pin, as they stood alongside leaders who echoed the same promise. Also featured at the event was the traveling Zero Malaria! Count Me In! photo exhibition, featuring everyday malaria champions from the community and leaders from all sectors.

It is country ownership of malaria as a health priority that will buttress our win in the malaria fight. “We engage today more than yesterday the reinforcement of Senegalese efforts to put at the disposition of each Senegalese man and woman, the effective ways of prevention and treatment against malaria,” said TH Awa Marie Coll-Seck, Minister of Health and Social Welfare.


How Senegal’s National Malaria Control Program rallied all partners around malaria elimination.

Each individual’s promise to invest in the health and safety of themselves and their families counts. In addition, all must contribute to the mobilization of the domestic resources that can support the malaria effort in the long run and push Senegal to become malaria-free.

Zero Malaria! Count Me In! aims to create a national policy environment that enables the introduction of new approaches and strategies for malaria parasite elimination as a part of the national strategy. The ultimate goal of the campaign is to use evidence generated in Senegal to inform national policy and practice for malaria parasite elimination and to mobilize resources. It will engage citizens via blogs, statements, photos, testimonials, m-health related programs, and key multi-sectoral partnerships to bring home the fact that we are at a critical moment in time where all needs to be invested in order not to lose all the progress we have made over the last decade.

"Count us in to make malaria elimination a reality in Senegal." –In Tiabakh, Senegal, message from the village leader's grandchildren.

“Count us in to make malaria elimination a reality in Senegal.” –In Tiabakh, Senegal, a message from the village leader’s grandchildren. Photo: Geneviève Sauvalle.

About Speak Up Africa

Headquartered in Dakar, Senegal, Speak Up Africa is a creative health communications and advocacy organization dedicated to catalyzing African leadership, enabling policy change, securing resources and inspiring individual action for the most pressing issue affecting Africa’s future: child health.

This is a part of the #DefeatMalaria blog series published between April 16–May 2, 2014.

Learning to bite back

Guest contributor Juliane Chaccour is a part of the science team at Malaria MISSION.

A child sits in the grass smiling.

“The lesson drawn [from the Global Eradication Programme of the 1960’s] is that wherever mosquitoes persist, malaria epidemics are always possible.”1

The Global Malaria Eradication Programme (GMEP) was formally abandoned in 1969, after only little more than a decade. At the time, the World Health Assembly had realized that eradication had not been feasible with the tools and funds available. In their ambitious endeavors, the GMEP had relied heavily on few interventions and applied them universally.

The failure of the programme was very costly both in terms of finances and lives, but it served us well in teaching us valuable lessons. Research and development for malaria control have experienced an unequaled boost in the past decades and hope has risen again for the disease’s elimination in many countries, with Sri Lanka, the Maldives, Tunisia, and the United Arab Emirates leading the way. We need to avoid the mistakes of the past and continue our investment in making this disease history.

Modern insecticides and new effective antimalarials have decreased malaria deaths worldwide by a quarter—an impressive reduction since the year 2000. Concerted global efforts and community-led approaches have meant that nowadays, fewer and fewer parents see their children die of a preventable disease. While the GMEP shied away from high-transmission areas, current efforts with modern tools are doing a great deal in reducing the burden of disease. Yet, more tools are needed.

The adaptability of malaria vectors remains an especially large problem for the further reduction in the number of malaria cases. Insecticide resistance and behavioral plasticity pose a threat in regions where long-lasting insecticide-treated nets (LLINs) and indoor-residual spraying (IRS) have meant such a dramatic improvement for people’s lives. Varied vector behaviour threatens the containment of drug resistance in regions where bed nets do not protect all people alike, such as in Southeast Asia. Circumventing our currently most effective tools, mosquitoes could thrive again and with them, malaria.

We are working on a long-lasting endectocide that could, if proven safe and effective, be incorporated in malaria control efforts. The drug ivermectin has been used safely in the fight against onchocerciasis and more recently, has been found to kill blood-feeding mosquitoes for a few days after its administration. What if the half-life of ivermectin could be prolonged, so that it would have a lasting effect on malaria transmission? What if we were able to target mosquitoes not only inside human dwellings at night using IRS and LLINs, but also anywhere and anytime else mosquitoes bite?

At Malaria MISSION, we use silicone technology for an implant aimed at maintaining mosquitocidal levels of ivermectin for months at a time. We have created an environmentally-friendly approach, which could complement control strategies independent of when or where the mosquitoes find their human prey. Specifically, it could become a possible tool in the containment of emerging drug resistance in Southeast Asia.

This April, we have witnessed some amazing campaigns to #defeatmalaria. Like many others, Malaria MISSION is exploring an additional tool in the fight against malaria. Because we cannot afford a reversal of the hard-earned progress of the past decade.

Learn more about our work: www.malariamission.org.

Malaria MISSION logo

1. Peter D. Crompton, Jacqueline Moebius, Silvia Portugal, Michael Waisberg, Geoffrey Hart. 2014. Malaria Immunity in Man and Mosquito: Insights into Unsolved Mysteries of a Deadly Infectious Disease. Annu. Rev. Immunol. 2014. 32:157–87.

Photos: Malaria MISSION.

This is a part of the #DefeatMalaria blog series published between April 16–May 2, 2014.

Tackling malaria overdiagnosis through interactive training

Guest contributor Débora Miranda is technical communications officer at the ACT Consortium, based at the London School of Hygiene & Tropical Medicine, UK.

Did you know that most people who receive antimalarials don’t actually have malaria, and most people who have malaria don’t have access to treatment?

It’s a known fact for many in the malaria community, but I was certainly surprised to hear about it when I first joined the artemisinin-based combination therapy (ACT) Consortium, an international research collaboration that investigates ways to optimize access, targeting, safety, and quality of antimalarials.

On World Malaria Day we announced the results of a study published in The Lancet Global Health, which can help tackle this problem. The research showed that interactive training programs for health workers could reduce overdiagnosis of malaria by half and help prevent valuable drugs from being wasted on patients who don’t have malaria.

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World Malaria Day 2014: The overlooked side of the global malaria fight

Guest contributor Karen A. Goraleski is executive director of the American Society of Tropical Medicine and Hygiene (ASTMH).

As we pause to reflect, celebrate, and look forward this World Malaria Day, I would like to share an often overlooked aspect of malaria—one I get to see every day.

It’s not a new piece of data, and it’s not a new development. But it is one of the most permanent aspects in the global fight against malaria.

What is it? The better question is: who is it? The dedicated and caring men and women who commit their lives to ending the pain and suffering of malaria. No sound bites, no political messaging—but like a dog with a bone: they have a singular focus on stopping this killer. Plain and simple.

On this World Malaria Day, I want to share my insider vantage point. We’ve asked some of our esteemed members and colleagues at the forefront of malaria research and development for their personal perspectives—why do they do this? What do they see as the big challenges and potential game changers?

Portrait of Alan Magill

Alan Magill, MD, FASTMH, ASTMH president

“Every aspect of malaria, its history, biology, pathophysiology, ecology, and clinical management is endlessly fascinating for me,” ASTMH president Alan Magill, MD, FASTMH, told us. “Once I understood that malaria is a completely preventable, treatable, and eradicable disease, I could not understand why it caused so much suffering globally. I am committed to end this inequality.”

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World Malaria Day: Malaria No More UK seeking your ideas

Guest contributor James Whiting is the executive director of Malaria No More UK.

April has been quite a month. Our efforts to make malaria no more have seen an eclectic array of activity.

High-fiving Kim Sears

Kim stormed round the London Marathon in aid of Malaria No More UK, cheered on by her boyfriend, the UK’s Wimbledon champion, Olympic medalist, and our Leadership Council member, Andy Murray.

Lining up 30 MPs

8th April 2014: To mark World Health Day, MPs got involved in Getting Malaria? This experiential event inspired, engaged and thanked supporters of all political parties for backing UK action to fight malaria. It gave MPs, an opportunity to find out more about the traansformational difference being made to millions of people around the world thanks to UK leadership and increased global action to save lives from malaria, one of the world’s most deadly yet preventable diseases. Houses of Parliament. Westminster. London

James Whiting with members of Parliament at the World Health Day malaria information session.

MPs queued up for a bout of pugilism with our giant mascot, Mozzy Man at a “Get malaria?” interactive information session in Parliament. The event helped to celebrate the UK’s key role in halving deaths from malaria since 2000—that’s an incredible 3 million children’s lives saved. The parliamentarians left knowing this is a cause that the UK must see through to the end.

Half of a Yellow Sun for malaria

Half of a Yellow Sun

Thandie Newton and Chiwetel Ejiofor at the BAFTA screening event for Half of a Yellow Sun.

Director Biyi Bandele worked with us and Soda Productions to host a sell-out special preview screening of his new film Half of a Yellow Sun at BAFTA. The film, based on the wonderful book by Chimamanda Ngozi Adichie, and starring Thandie Newton and Chiwetel Ejiofor, was shot in Nigeria and several of the cast and crew contracted malaria and typhoid during filming, so the event was very personally resonant for them.

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