Our Story

How OneWorld Health was Founded
 

In the spring of 2000, I was chatting with a cab driver about my work. When I told him I was a pharmaceutical scientist he burst into laughter and said, “You guys have all the money.” It wasn’t the response I normally received when I spoke about my career, but I realized he was right. The pharmaceutical industry did have all the money and did make all the decisions about which drugs to develop -- and we made those decisions based on the bottom line, the profit margin. The pharmaceutical industry is a business, and that is how a good business must operate. But what would happen if we took profit out of the equation? I began my pharmaceutical career, as most scientists do, with a desire to improve and save people’s lives. I was proud to align myself with the remarkable advances of the pharmaceutical industry. But I also realized that these advances often did not reach people in the developing world. Numerous promising drug and vaccine leads are left sitting on the shelf because they will not make enough money to justify additional research needed to bring them to market. 

When I returned home from that fateful cab ride, I found an essay I had written two years before. It was a manifesto on five disease areas that I thought could benefit from more aggressive drug development efforts, but which would not be chosen for research because of a lack of profit margin. That manifesto became the initial business plan for the Institute for OneWorld Health. The premise is straightforward: find promising potential candidate medicines in areas of great unmet medical need; partner with the right experts and institutions to take these medicines through development, clinical trials, and regulatory approval; and finally, deliver safe, effective, and affordable medicines to the patients who need them.
 
One can view the world in two ways: from the perspective of the problem, or from the perspective of the opportunity. I cannot imagine a greater challenge than addressing the devastating burden of infectious disease among the world’s poor. Nor can I imagine a more noble opportunity to fundamentally improve the lives of millions of people worldwide.

OneWorld Health is a new model for global health. We are entrepreneurial. We generate unique opportunities and invent creative solutions. We are ambitious, we are exacting, we are passionate, and we will change the face of the world, one disease at a time.

Sincerely

Victoria G. Hale, Founder & Chair Emeritus

OneWorld Health Milestones
 

2007

OneWorld Health launched the Phase 4 Program of Paromomycin IM Injection in India with the goal of developing a scalable, transferable access model for treatment of visceral leishmaniasis in India. We selected Odyssey Research, a Bismarck, North Dakota-based clinical trial management organization (TMO) with offices in New Delhi, India, to perform regular monitoring of seven clinical sites for the pharmacovigilance module in the study.

Paromomycin IM Injection was designated by the World Health Organization (WHO) for inclusion on its Model List for Essential Medicines. The WHO List of Essential Medicines provides a model for countries to select medicines addressing public health priorities. Paromomycin IM Injection was also voted ‘Product of the Year’ by BayBio, Northern California's Life Sciences Association.

The story behind Paromomycin IM injection was featured in the BBC documentary, titled Kill or Cure? Visceral Leishmaniasis and voted best documentary of the year by BBC World viewers.

The iOWH Diarrheal Disease Program (DDP) team formed two key advisory bodies: a Strategic Advisory Board to provide world-class expertise to advise on the overall strategic direction for the DDP and a technical advisory committee which provides technical and drug development expertise to the ongoing CFTR inhibitor discovery efforts.

In collaboration with Amyris, our Artemisinin Project partner, the malaria team completes due diligence and selects a contract manufacturing partner to join this effort to provide fermentation and chemistry process development expertise and scale-up the process for development.

Dr. Victoria Hale is elected to membership in the Institute of Medicine of the National Academies. Members are elected through a highly selective process by the incumbent membership on the basis of professional achievement and of demonstrated interest, concern and involvement with problems and critical issues that affect the health of the public. Dr. Hale was also named one of Glamour magazine’s Women of the Year.

2006

OneWorld Health receives approval for Paromomycin IM Injection from the Drug Controller General of India (DCGI) for the treatment of Visceral Leishmaniasis. Gland Pharma will make the medicine available at-cost, or approximately $10 per treatment course, a significantly lower price than currently approved VL therapies.

The antimalarial drug precursor, artemesinic acid, was produced in engineered yeast. This great technical achievement resulted from the unique three-way partnership between the Institute for OneWorld Health, UC Berkeley and Amyris Biotechnologies. This achievement is an early proof of concept that the biosynthetic manufacturing strategy can be achieved at the laboratory scale.

A grant of US$46 million from the Bill & Melinda Gates Foundation funds OneWorld Health's Diarrheal Disease program to expand its unique research on new treatments to complement traditional approaches for fighting diarrhea (in developing countries).

OneWorld Health implements collaboration with BioFocus DPI; who will apply their medicinal chemistry expertise to identify new drug candidates for the Diarrheal Disease program.

Victoria Hale was named a 2006 MacArthur Fellow, honored as a Pharmaceutical Entrepreneur for creating a nonprofit model of drug development that is driven by the neglected health needs of people in the developing world.

2005

A grant of US$10 million from the Bill & Melinda Gates Foundation funds OneWorld Health's program for paromomycin, its promising drug for visceral leishmaniasis, through the approval and post-approval process.

OneWorld Health receives Orphan Drug Designation from the two leading regulatory agencies in the world, the US Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA), for paromomycin to treat visceral leishmaniasis.

The Sapling Foundation awards a second grant in support of OneWorld Health's outreach programs to collaborate with executives and scientists in the pharmaceutical and biotechnology industries.

A Skoll Award for Social Entrepreneurship is bestowed on OneWorld Health from the Skoll Foundation, whose mission is to advance systemic change benefiting communities around the world by investing in, connecting and celebrating social entrepreneurs.

A Lehman Brothers Foundation grant helps accelerate identification of drug compounds for pediatric diarrheal disease.

2004

OneWorld Health and WHO/TDR complete the largest Phase III clinical trial to cure visceral leishmaniasis, a deadly parasitic disease, in India using paromomycin. Expect to file for approval with Indian government in 2006.

The Bill & Melinda Gates Foundation awards $42.6 million to OneWorld Health for development of artemisinin through synthetic biology. OneWorld Health partners with UC Berkeley and Amyris Biotechnologies with the goal of providing unlimited, affordable supplies of first-line antimalarial ingredient using synthetic biology.

The University of California Santa Barbara donates a patent for a discovery involving the novel use of calcium channel blockers to control the schistosomiasis parasite.

The Bill & Melinda Gates Foundation funds the development of a vaccine for the prevention and treatment of malaria. OneWorld Health selects Sanaria, Inc. as a partner.

The Chiron Foundation award grants to further studies in visceral leishmaniasis treatment, and the Sapling Foundation awards a grant to study the feasibility of engaging pharmaceutical scientists in OneWorld HealthÕs drug development programs.

2003

Collective licensing agreement is signed with the Special Programme for Research and Training in Tropical Disease (TDR) of the World Health Organization (WHO) to develop a new cure for visceral leishmaniasis.

Largest Phase III clinical trial for visceral leishmaniasis begins in India for paromomycin, an off-patent antibiotic.

Promising new compounds to treat Chagas infections are in-licensed from Yale University and the University of Washington.

2002

The Bill & Melinda Gates Foundation funds the first two drug development projects (visceral leishmaniasis and Chagas disease). The National Institute of Allergy and Infectious Diseases (NIAID) collaborates with OneWorld Health to develop Chagas disease drug lead.

OneWorld Health receives first in-licensing of promising new drug lead for Chagas disease from Celera Genomics.

2001

The Institute for OneWorld Health is granted 501(c)(3) tax-exempt status, becoming the first nonprofit pharmaceutical company in the U.S.

2000

The Institute for OneWorld Health is founded in the U.S., and the first business plan is completed.

1998

Dr. Hale writes the strategic plan for nonprofit pharmaceutical company and invests seed money.

A coalition of pharmaceutical scientists is assembled and international parasitic disease experts are consulted.