In Washington, DC, today, participants at the BIO and BioVentures for Global Health Forum are discussing the so-called valley of death, the place where new therapeutics and vaccines come to a screeching stop because there are often no mechanisms for the product’s financing or delivery. People here are optimistic though–they say that bridges are being built over this valley, and that new biopharmaceuticals do have promise, especially in developing countries. Neglected diseases that affect populations in developing nations in large numbers represent a huge target audience for biopharmaceuticals, including vaccines, new and old. At this morning’s opening session, Regina Rabinovich of the Bill and Melinda Gates Foundation discussed some of the developments that have, for the most part, turned around the outlook biopharmaceuticals aimed at global health in the past 5 to 10 years alone.
One such success is the Global Alliance for Vaccines and Immunizations, otherwise known as GAVI. In decades past, if a new vaccine was developed, companies such as Merck would built a full scale facility in the US and then disassemble it and transport it to a country such as China for reassembly and production. With GAVI, the know how and ability and capacity to take a new product and introduce it to a market is far easier and faster, explained Mark Feinberg of Merck. Just last month, countries around the world committed $4.3 billion dollars to GAVI–this funding will, among other things, help provide vaccines for 250 million children. Another recent addition to the biotech financing toolbox is the priority voucher review program by FDA, which was enacted in 2007 by the FDA Amendments Act to help companies sponsoring a biologic or new drug that targets a neglected tropical disease.
Another positive change for biologics aimed at improving global health has been the increase in dynamic partnerships, representing industry as well as governments, nonprofits, civil society, academia, and more. All of these groups are needed to achieve global change and together they are able to better translate innovation into reality, said Rabinovich. One goal that these collaborative initiatives have been working toward is to increase political will to support global health efforts. In many countries, it’s easy to get the health minister to understand the value of introducing a vaccine and related healthcare training and therapies to his or her population. It’s another thing to get the finance minister to buy into the effort, said the panelists. But healthcare education and training have made and continue to make great inroads into this area. Surveillance, data retrieval, and follow-through of patients in developing nations also help in this regard. In the long term, sustainable financing will become possible for therapies and vaccines needed in developing nations. This kind of sustainability is crucial, pointed out Fred Were, chairman of the Kenya Pediatric Association, because there is often the fear that once a new vaccine enters the market, how will the country be able to deliver it and continue to afford/obtain it for future generations. The concern that there may not always be a Gates Foundation, for example, is valid.
Today and throughout the week, participants at the convention and forum plan to work through these issues, covering funding and R&D incentives as well as regulatory issues. On the regulatory side, a lack of harmonization with the development and commercialization of vaccines is particularly rough for manufacturing companies who have a product and want to get it to market. Philip Hosbach of Sanofi Pasteur for example noted that it took way too long to get WHO prequalification of its H1N1 vaccine, which had already received FDA approval. Such levels of bureacracy only add to costs and time, he said, when meanwhile, patients are waiting for treatment.