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credit: Jonothan Torgovnik ©
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Institute for OneWorld Health— About Us: Our Story
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 of the Board of Directors
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.
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