Funding future research
The adoption of the Millennium Declaration by 189 countries and subsequent mobilization of development agencies around the Millennium Development goals renewed focus on the resources required to advance healthcare in general, and research and development in particular. Public sources of funding are not adequate and it has become increasingly clear that the gap must be bridged from other sources.
Novartis has been in the front ranks of neglected disease research and development for decades initially with programs against leprosy and development of the pioneering antimalarial drug Coartem. More recently, Novartis established research institutes in Singapore and Italy, focused on medicines and vaccines, respectively, which would be provided to patients in developing countries at affordable prices.
A vaccine against Salmonella typhi, the bacterium that causes typhoid fever, has begun clinical testing at the Novartis Vaccines Institute for Global Health (NVGH). A novel treatment for malaria discovered at the Novartis Institute for Tropical Diseases (NITD) could enter formal development later this year if ongoing toxicology studies are completed successfully.
Novartis isn't alone in creating nonprofit research institutes: both GlaxoSmithKline and Eli Lilly & Co have similar operations. "But we need more pharmaceutical and biotechnology companies to do the same," Dr. Herrling added.
Advancement of these initial neglected disease projects by Novartis has increased the urgency of securing funding for clinical development. Over the past three years, Dr. Herrling has been the driving force in design of a new financing mechanism – The Fund for R&D in Neglected Diseases, or FRIND – to support development of medicines and vaccines against neglected diseases. Funding would come primarily from a pool fed by donors ranging from industry and non-governmental organizations to private charities as well as governments, which increasingly are rechanneling existing funds already reserved for developing countries into research and development.
The FRIND model would apply principles of portfolio management refined by major pharmaceutical companies to the neglected disease portfolio. “It is crucial to allocate the money that is available to the most promising projects,” Dr. Herrling said. “In drug development, there are always more failures than successes and the largest single cost in developing a pipeline is the money invested in projects that never reach the market.”1
Another core principle of industrial portfolio management is to allocate funding on a stage-by-stage basis, rather than as a lump sum. When an experimental medicine or compound passes one of six key decision points during development, sufficient funds are released to pay for activities needed to reach the next decision point.
- Nature Reviews, Drug Discovery, Volume 8, February 2009