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Bringing Biotechnology to Developing Countries
Nonprofit Set Up to Overcome Barriers to Addressing Neglected Diseases

By Lois M. Baron

BIO, in conjunction with the Bill & Melinda Gates Foundation and the Rockefeller Foundation, has formed a nonprofit entity to bring biotechnology into the global health arena. BIO Ventures for Global Health (BVGH) is charged with accelerating the development, distribution and accessibility of biotech products that address developing-world diseases.

People often attribute industry's underinvestment to the lack of available funding and poor expected market returns. But other conditions complicate operating in these markets. Fragmented networks of resources and information needed to support product development and companies' inexperience with testing, purchasing and distribution channels in these different markets create substantial barriers to entry.

BVGH will tackle these issues as it finds ways to make global health "business-friendly."

The idea for BVGH evolved from BIO's Global Health Partnering Conference held with the Gates Foundation in late 2002.

"It was really encouraging to see so many companies' genuine interest and desire to work on developing world diseases," says Wendy Taylor, an organizer of the 2002 conference and now BVGH executive director.

"We saw a gap," says Russell Howard, CEO of Maxygen and a BIO board member, "between philanthropic funding for discovery and the large pharmaceutical companies that have the funding to actually manufacture the [products]."

Dr. J. Leighton Read, a biotech entrepreneur and BVGH board member, says, "BVGH represents the first organization focused on bringing private sector companies into the challenge of global health in a way that understands the economic responsibilities to shareholders."

In a recent interview with BVGH Report, Dr. Richard D. Klausner, director of the Gates Foundation Global Health Program, acknowledged the difficulty of operating in these markets. It's not just about "who is going to pay," he says. "It's about prices and volume and predictability. We need to develop predictable markets and make sure there are pathways, so products can get to the people who need them."

Getting Started
BIO Ventures will do the legwork to focus biotechnologies on the developing world's health problems. Howard, who helped shape BVGH, predicts that with a very focused approach, BVGH will deliver on its initial goals, thereby attracting more philanthropic funds and companies wanting to work through it.

"BVGH is not a quick fix," he says. "It's a five- to 10-year plan." He expects it to succeed because it's building on three strong entities — the Gates Foundation, the Rockefeller Foundation and BIO.

An initial BVGH priority is to create a series of business cases for developing-world products. "These business cases will identify viable markets where they exist and map out clinical, regulatory and distribution pathways for the products," Taylor says. The cases will also describe partnership strategies and potential financing options.

"We hope these business cases will serve as important catalysts for product development, highlighting real business opportunities for companies with relevant technologies," she says.

BVGH also recognizes the urgent need for R&D funding. It is establishing a financing mechanism to help companies access new funds. Guided by the same priorities used in selecting the initial business cases, BVGH will identify the most promising development projects and seek funding from foundations to support product development. For example, if BVGH does a business case on a cholera vaccine, it will also seek to fund a cholera vaccine project.

Funded projects will receive scientific, financial technical assistance and support tailored to their individual needs.

But assistance is not limited to projects sponsored by BVGH. The nonprofit also plans to create an online resource for product developers that pulls together a wealth of information, including market assessments, funding sources, ideal product profiles, a global health R&D pipeline and other useful tools.

In addition, the organization will produce a quarterly newsletter, BVGH Report, to highlight R&D progress, successful business models and new business opportunities.

A Vision of Success
BIO President Carl B. Feldbaum calls BVGH's approach to the global health problem "a whole new concept." Although solving the global health issue is a tough nut to crack, in terms of the R&D and distribution, in the long run, Feldbaum believes the foundation will find a way to make underfunded and neglected diseases viewed as a commercial opportunity.

"By being able to access BIO's extensive experience and expertise in the field and business connections, BVGH has an important head start in accomplishing its mission," he says.

BIO's tools, resources and networks — including in-licensing, partnering, regulatory and financial opportunities — will be extremely valuable in demonstrating to companies and investors market-based solutions for developing world products and will greatly expand opportunities for companies working through BVGH.

Klausner is optimistic about BVGH's effectiveness: "The biggest lesson we've learned [from other private-public partnerships] is the importance of having a neutral and trusted forum where multiple partners can sit down and exchange honest information about needs, resources, anxieties, barriers and problems. That is one of the purposes BVGH will serve."

Taylor encourages businesses and individuals to volunteer with BVGH. "Finally, more attention is being paid to global health issues," she says. "Now we need to put the best minds to work across many different sectors to ensure our efforts are successful."

Companies can get involved as advisers as BVGH builds its business cases, Read says. "And a company with technology it suspects would be useful against neglected diseases, but where investment is being delayed, should seek BVGH help in understanding if there's a credible business case to be made."

Howard says, "Biotech people want to change the world. We have the technology, enthusiasm, and infrastructure." BVGH will help provide a fiscally responsible way for biotechnology companies to enter this arena.

For more information regarding BVGH, go to www.bvgh.org or contact (202) 312-9260.

Lois Baron is a freelance writer based in Arlington, Va.