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Getting Your Gates

How one company used the growing nonprofit funding pot to jump-start its development program, and how you can do the same.

Juhi Yajnik
<figcaption> Credit: © DANIJEL MICKA</figcaption>
Credit: © DANIJEL MICKA

In the 1980s, Toronto-based Polydex Pharmaceuticals was developing dextran products, including a high-viscosity cellulose-dextran compound intended for developing Polaroid film. The film company, however, eventually chose to use another chemical. Some years later, research showed that dextran-based compounds were an effective contraceptive that also killed the herpes and gonorrhea viruses as well as HIV. Polydex CEO George Usher had a hunch that the cellulose-dextran compound stored in his warehouse might work. Usher tracked down initial funding from a now-defunct nonprofit organization to do animal studies, and the results looked promising.

Over the past five years, nonprofit funding organizations have greatly increased their presence in drug R&D.

The company already had the infrastructure and expertise in working with dextran-based products, and the compound had initially been developed as an industrial product, so production costs had been tightly managed. But the company had only $2 million in annual...

Four Tips for a Winning Proposal

Nonprofits and their inter­mediaries have varying funding models, but some common approaches can increase chances for a successful proposal.

1. Conduct significant fact-finding in your chosen area of R&D to understand the needs and issues of third-world development projects you are targeting. While you may be using this type of project ultimately as a stepping stone to for-profit goals, the solutions you are proposing must reflect a practical knowledge of third-world needs. "I went to Africa and saw the destruction of HIV," says Polydex CEO George Usher. He adds that he started to understand the cultural issues and how Ushercell could be a practical solution.

2. Stress speed in your approach to R&D, and what your company will do to expedite the process. "The bottom line is that we want the groups who can do it the fastest and most efficiently ... and we will pay them to do it," says Zeda Rosenberg, CEO of the International Partnership for Microbicides.

3. Include specific goals rather than broad aims, and make sure the project is milestone-driven, as you would for a partnership proposal with another biotech or pharma company. "We were used to NIH-style grants with specific aims and areas of exploration," says Jack Newman of Amyris. "Having specific milestones provides insight and clarity to the project."

4. Include input from people in different functions throughout your company. This will not only give the proposal a well-rounded science, business, and operational focus, but also get your staff thinking about other in-house programs that could be leveraged with this type of funding. Items considered in proposals, says John Wecker, director of immunization solutions at the Program for Appropriate Technology in Health, include the reputation of the company, its economic viability, and its scientific and technological capabilities.


Other companies have also taken the leap into nonprofit. Amyris Biotechnologies, based in Emeryville, Calif., used an agreement with the nonprofit pharmaceutical company One World Health - via $42.6 million in funding from the Gates Foundation - to develop an antimalarial drug for developing countries. The drug, called artemisinin, is a product of synthetic biology. The company has designed microbes to make the active form of the drug and can scale up production to get hundreds of grams of very pure compound at a fraction of what it costs to laboriously extract the chemical from wormwood, its natural source.

"We work with partners to ensure availability and affordability. The key is that the end products reach people." -John Wecker

Such a strategy is appealing to nonprofit organizations. "We work with partners to ensure availability and affordability.­ The key is that the end products reach people," says John Wecker, director of immunization solutions at the Program for Appropriate Technology in Health (PATH), a nonprofit based in Seattle. Amyris used the funding to build its drug development platform and improve its technologies - crucial elements in developing artemisinin. The company will see its drug distributed in developing countries, a laudable goal that boosts the morale and focus of an already good place to work, says Jack Newman, director of research at Amyris. The company retains the R&D experience as well as the rights to the technology, and it will use them to create products intended for the US market.

jyajnik@the-scientist.com

Gates Gatekeepers

Institute for OneWorld Health
San Francisco
Seeks: 1) Drugs for dysentery, cholera, and other diarrheal diseases; 2) expert scientific volunteers to help design clinical trials and drug testing. The institute funds an average of one to two development projects per year in amounts ranging from $250,000 to $14 million.
Contact: Initial letters of inquiry require a three-page summary of the proposed project. For information: parternships@oneworldhealth.com
"We are not set up like a venture fund," says James Hickman, vice president of communications. "Once we identify technology or product leads from industry or universities that would benefit the developing world and fit into our portfolio, we seek the philanthropic funding necessary to accomplish the project."
more >>

Program for Appropriate Technology in Health (PATH)
Seattle
Seeks: 1) Discovery and/or preclinical and clinical development of specific pneumococcal vaccine candidates; 2) collection and characterization of pneumococcal­ strains or sera; 3) four-year projects to improve maternal and newborn health, either by household/community involvement or the proposal of a theme-based intervention in India.
Contact: To view requests for proposals, go to www.path.org/rfp-index.php
"When we partner with small biotechs or large pharmaceutical companies we sometimes provide financial support or cost-sharing to run clinical trials," says John Wecker, director of immunization solutions at PATH. "Sometimes, we give money to small biotechs developing a new approach for a new drug or vaccine," he adds.
more >>

Global Alliance for TB Drug Development
New York City, Brussels, Cape Town
Seeks: Partners to develop compounds with novel mechanisms of action and demonstrated efficacy that work against validated targets in tuberculosis. New treatments should be effective against drug-resistant TB strains as well as compatible with antiretroviral treatment for HIV. The TB Alliance is also interested in projects that advance the science of TB drug development.
Contact: Zhenkhun Ma, R&D, info@tballiance.org
more >>

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