How does a small, not-for-profit company work with large corporations, governments and multilateral organizations at the same time? Answer: with difficulty. But it can be done. Though the organizational ethos and cultures of these giants are a world away from that of the small organization, they can be equally remote from each other. As the Institute for OneWorld Health (IOWH) has found out, a small group with an entrepreneurial approach can help them work together in areas where each has a role to play.

The mission of IOWH is to develop new drugs for neglected diseases that afflict people in the developing world. To do this, we test drugs in clinical trials, working with developing world governments and regulatory authorities, pharmaceutical companies and the World Health Organization (WHO). That’s a very tall order for a new not-for-profit pharmaceutical company.

A go-between

IOWH’s function is to act as a bridge between large pharmaceutical corporations – the people who are in the business of discovering promising compounds[1] – and large global health organizations, principally WHO in our case, and governments, who can help get drugs tested and then distributed. Needless to say, there are vast differences between these institutions in culture, language, values, and even goals and objectives. Our task has been to bring them together through a common goal: reducing global health inequities.

Bringing industry, multilaterals and governments together is crucially important, especially now. Pharmaceutical companies need to do some good globally and, gratifyingly, many individual pharmaceutical scientists also want to make a difference. But historically, and with few exceptions, the pharmaceutical industry has been unable to work effectively with WHO and developing world governments to complete new drug development. So many diseases of the poorest people go without new therapies, decade after decade. This is where IOWH steps in, to manoeuvre around the difficulties these large institutions find in working with each other.

What are the most important lessons that we’ve learned from out first four years in the business? There are many. One is not to be afraid to make mistakes. Another is to be patient. A third is to be flexible and adaptable. Most importantly, trust and respect form the foundation for all of our work.

The importance of positioning

When we first began approaching pharmaceutical companies on the one hand and multilaterals on the other, we had to position ourselves very clearly and carefully. Specifically, we had to convince the pharmaceutical industry that we were not competing with them. And among global health players, including governments, we had to make it clear that we planned to address failures in the system.

The real needs for HIV, for example, are diagnosis, affordability, distribution and compliance. Since these are not our core strengths, we decided not to tackle HIV. Instead, we decided to focus on diseases that everyone had forgotten – diarrhoea, and parasitic diseases like visceral leishmaniasis (kala azar), malaria and Chagas disease, the most neglected diseases despite their enormous toll in death and disability.

Working with corporations

Let’s start with some encouraging words. We’ve had great experiences with small pharmaceutical companies and biotechnology firms. These partnerships have worked well mostly because small start-up companies need funding,[2] and because we’ve been able to clearly define and separate intellectual property (they retain Western markets, we secure the developing world, for instance).

The large pharmaceutical companies have been a tougher sell. It’s not surprising that they had trouble with the idea of a non-profit drug company! They doubted our capacity: if you’re a drug company, prove it by bringing a new drug to market. And we are going to: our first new drug, paromomycin to cure kala azar, is about to be approved in India, Bangladesh and Nepal. Further, we have raised real money – about $80 million from the Bill and Melinda Gates Foundation – to pursue several disease programmes. Needless to say, we’re now gaining the attention and respect of large pharmaceutical companies.

Of course, we’ll have to continue nurturing that trust. It’s important to remember that every corporation is different, and they change over time. Our strategy has generally been to approach individual pharmaceutical scientists, then mid-level executives, and finally the senior management. With the generous support we’ve received, we are now in a position to venture into more high-risk R&D (new drug development). When we are successful, large pharmaceutical partners have expressed interest in ‘adopting’ these new drugs as their own contribution to global health. Everyone wins.

Partnering with multilaterals

Working with WHO has also meant winning trust, and learning how to work within the system. There have been plenty of frustrations and a few major problems. But for social entrepreneurial organizations like IOWH, partnering with multilaterals like WHO or UN agencies is a must. Multilaterals can open doors around the world. By way of example, we met with the Bangladeshi Deputy Health minister for about 15 minutes to discuss our Indian R&D programme for his country. It was clear that we weren’t taken seriously until I said that WHO was our partner; we were then immediately invited to begin research in Bangladesh …

We’ve also had extremely rewarding experiences working with the WHO Surveillance and Control Unit, the group that did such an impressive job managing SARS a few years ago. One of their senior scientists actually pointed us to a drug that WHO’s Tropical Disease Research Unit (WHO/TDR) had abandoned: paramomycin, which became our first programme. We are now working with WHO to establish a Kala Azar Disease Elimination Programme in South Asia.

But we’ve also had our challenges. On drug development, we work mostly with WHO/TDR. Like all of WHO, this unit works by committee and consensus. It’s a very democratic process – and a very bureaucratic one. Bureaucracy means systems, procedures and processes. It also means lots of paperwork and frustrating delays. For example, it took us two years to obtain signatures on a Memorandum of Understanding – despite the fact that IOWH had obtained funding to begin the project more than 14 months before.

We had a bad experience with WHO/TDR in a recent partnership – but we eventually figured out why. WHO/TDR viewed IOWH as a funder and IOWH viewed WHO/TDR as a contractor. Neither view was accurate – a more accurate view would be that both groups brought competencies, knowledge and resources to the table. Our project initially suffered as a result, but we are moving ahead with the project now, in partnership.

Working by international committee and consensus is ill-suited to new drug R&D. Ideally, in product development, key decisions must be made by project team leaders who are intimately involved with the science.

But there is a bigger source of frustration for the social entrepreneur working with large multilateral agencies like WHO. Entrepreneurship by its nature includes creativity and flexibility – doing something new or finding a new way to do it. Large, entrenched institutions like WHO typically lack flexibility, creativity and imagination. They often resist the notion of taking a new path.

Working with governments

On balance, the past four years have been extraordinarily gratifying and productive for IOWH. Most of our work has been in India, and there have been surprisingly few impediments to getting the job done. Overall, I think, we owe our success to three factors:

• WHO helped open the doors of the Indian government and taught our new organization a few of the ropes. In the process, WHO controlled the situation and claimed the lion’s share of the credit, while they helped us launch our programme.
• Indian colleagues both in India and in the US worked on our behalf, making targeted calls to gatekeepers in India. They helped us to gain permission to do our work. Their scientific and social stature helped validate our mission and spoke of the importance of our work, as well as our integrity.
• We decided to make the Indian regulatory authority the ‘lead’ regulatory agency for our new drug around the world, and we have selected an Indian company to produce our drug for worldwide supply. This gave India an important stake in the programme and made it a source of national pride. It demonstrated our respect for the capacity and judgement of Indian government officials and Indian technology, a respect that must be mutual for such programmes to work.

No coordinated approach

I don’t mean to paint too rosy a picture, however. The outgoing President of the Rockefeller Foundation, Gordon Conway, described the state of global health as ‘anarchy’. The word is apt. There is no clear leader and few lines of communication between the players. Does the world need a single powerful oversight body to manage global health initiatives? Of course it does. But I cannot see how such oversight can be accomplished without stifling flexibility and creativity – the true gifts of social entrepreneurism.

So no one is steering the ship of global health intervention. That means few of us know what other groups in the field are doing, so we don’t learn enough about successes and failures. Exchanges like this special issue of Alliance offer an important way to share crucial information. We need to seek other ways to cooperate, share and leverage our work to meet our common goal: improving health for everyone in the world.

1 Compounds are potential new drugs that have not yet been through R&D, so they are ‘leads’.

2 To date we have brought Gates funding, which is a non-dilutive investment. This means that we do not own part of their company in exchange for the investment. We invest if the company licences us rights to new drug leads for the developing world; the company can keep Western markets.

Victoria Hale, PhD is Founder, CEO & Chair of Institute for OneWorld Health (IOWH) in San Francisco. She can be contacted at vhale@oneworldhealth.org

See http://www.oneworldhealth.org