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Angie Drakulich was editorial director of Pharmaceutical Technology.
A Focus on Creative Strategies to Help the Developing World.
New drugs, vaccines, and diagnostics are desperately needed for millions that suffer from infectious diseases in developing countries. The challenges of meeting this need are endless, but leaders at the Biotechnology Industry Organization (BIO) and BIO Ventures for Global Health are optimistic.
"The fact is, that while challenges are tremendous, they are not insurmountable," said Lila Feisee, BIO's vice-president for global intellectual property policy. "The goal of getting products to the people who need them is a shared goal. It's the approach that varies, and respect for each approach is crucial in order to have progress in this area."
BIO is taking a few approaches of its own. In May 2010, the organization developed a policy statement to educate its members about how they can improve access to medicines outside of their own borders. One approach encourages companies to use creative strategies when entering into license agreements with commercial and noncommercial entities for their inventions. Examples of creative strategies would include considering licensees in the developing world as well as facilitating sublicensing agreements and incentives that are designed to improve access to drugs in the developing world. Another approach highlights the importance of working to identify compounds or technologies that can have useful application in the developing world, rather than focusing only on research and development of drugs only for the broader marketplace.
BIO is also educating its members about the whole picture, so to speak, with regard to increasing access to drugs in the developing world. Says Feisee, "The greatest challenges in improving health outcomes in the developing world are not related to the availability of health products, though clearly more can be done in this area, but are related in large measure to the lack of adequate infrastructure (e.g., trained personnel, roads and hospitals, and legal and regulatory policies) and distribution capability in the developing world. It is not simply enough to make or manufacture a product. There are many products both on and off patent that are available for many existing developing world diseases. But in many instances, the products cannot get to where they are most needed due to inadequate roads and delivery systems, or when they do reach their destination, there is no way of monitoring their uptake due to the lack of trained healthcare professionals or consistently available clinics or hospitals."
She notes that local governments and NGOs are the best entities to handle these types of infrastructure problems, and that they can also encourage early-stage research domestically. The global biotech industry can be of assistance in helping to develop medicines that require little or no follow up monitoring (e.g., single dosage formulations, sustained release formulations), or products that are temperature-stable, says Feisee. "Several of our companies are already working to address some of these types of concerns.... Agricultural biotechnology companies, for example, are helping to increase food security and nutrition throughout the world, and BIO's industrial and environmental companies are working on developing new ways to purify water and clean the environment."
BIO also has been working with BIO Ventures for Global Health, which was spun out of BIO in 2004 with the help of a Gates Foundation grant. BVGH's mission is to save lives by accelerating the development of novel drugs, vaccines, and diagnostics coming from the biotechnology industry to address the unmet medical needs of the developing world. According to BVGH's CEO Melinda Moree, "People want to help other people—the desire is there to help save the lives of people in poor countries." Although the desire is there, the financial incentives are harder to find. According to Moree, "It's mostly poor people who suffer from these diseases and there is little market to drive the investment needed. This lack of commercial incentive has resulted in a very slow pace of drug development for these diseases."
BVGH has been heavily involved in the implementation of FDA's Priority Review Voucher (PRV) Program, which creates an incentive for investment in the development of new drugs and vaccines for neglected tropical diseases, such as malaria, tuberculosis, and intestinal worms. The agency grants a PRV to the sponsor of a newly approved drug or vaccine for these diseases. The voucher applies to accelerate the review of any other drug. A voucher can save a company several months of FDA review time, which for a blockbuster product could be worth up to hundreds of millions of dollars.
This resource savings is important especially because recent economic times have led to a shortage of investments in new medical treatments. A way to correct this market failure, according to BVGH, is to reduce the risk companies face both by providing additional information to illuminate market demand, and by providing new incentives to motivate investment in global health. BVGH is developing a pay-for-success prize to address these needs. Countries and donors have to work together to prioritize and identify demand, says Moree, so that they can work within the health systems to deliver new products and higher quality of care to those who need it most.
In March 2011, BVGH released an updated Global Health Primer, which provides online information about familiar drug targets and vaccine technologies associated with developed world diseases and those associated with relevant neglected diseases. Product needs and opportunities are listed for disease-specific profiles. "By connecting the dots between neglected disease product needs and biological pathways and technologies that are well known to the biopharmaceutical industry, this new release of the Global Health Primer provides not just a rich source of information but also a roadmap for action in the neglected disease space," says Moree.
This month, June 2011, BIO and BVGH are cohosting the Partnering for Global Health Forum in Washington, DC, which will be colocated with the 2011 BIO International Convention. The forum will bring together leaders from global health, biopharmaceutical, academic, government, and donor communities, and funders supporting global health R&D. Presentations will feature speakers developing and funding technologies and products that will save lives in the developing world. Francis Collins, director of the National Institutes of Health, will provide the keynote address on how ground-breaking biotechnology innovations can serve the health needs of the world's poorest. Collins oversees the work of the largest supporter of biomedical research in the world, spanning the spectrum from basic to clinical research. He is a physician-geneticist noted for his landmark discoveries of disease genes and his leadership of the international Human Genome Project. More details are available online at www.bio.org/pgh/.