As with our national “leaders,” I am kicking the can down the road this with week with a replay of a posting from the first week of 2014.
Recently I got around to reading two reports that were released in early December  on what funding levels and targets are needed to continue the progress toward eliminating one of the big three global diseases, malaria. The reports, “From Pipeline to Product: Malaria R&D Funding Needs into the Next Decade” and “Estimating Costs and Measuring Investments in Malaria R&D for Eradication” (copies here and here), were written by staff of Policy Cures, a global heath contract research group based in Australia and best known for its annual survey of funding for global disease product development, G-FINDER. Although Policy Cures’ focus is on governments, philanthropic funders (e.g., the Gates and Wellcome Foundations), and global health advocacy groups (their clients), the organization generates data and reports that can be used by companies looking for product and funding opportunities in global health. These reports provided me landscape view of malaria R and D and product development but unfortunately make recommendations aimed at their main clients and overlooked the role and value of commercial product development.
Here’s a quick summary of the “Pipeline” report. After noting the progress that has been made since 2001 (274 million fewer cases and 1.1 million fewer deaths, a reduction of 26%), the authors reported on the past funding on malaria R and D (which has increased from $131 million in 1993 to $610 million in 2011) and its distribution (25% in research and 75% into development). Of this amount, the public sector (governments, primarily the US) accounts for around half of all funding, the philanthropic sector for a third (primarily the Gates Foundation but also the Wellcome Trust), and industry for a fifth. The authors also stated in general but provide no specific details, that there are “at least 96 malaria products in development, including 13 new vector control active ingredients and new formulations, 37 drug candidates, and 46 vaccine candidates.” Then for each of four areas (basic research, diagnostics, drugs, vaccines, and control agents [insecticides]) the report provided a breakdown funding by product type or stage of development and the types of products needed based on “globally-agreed R&D targets.” The authors then summarize their projections of funding needs in each of these areas, but more useful to companies were the details of the projections were given in Annex 2.
In Annex 2, the authors listed the products (“ideal portfolio targets”) that are needed as determined by the main malaria research and public health groups: Foundation for Innovative New Diagnostics (for diagnostics); Medicines for Malaria Venture, Malaria Eradication Research Agenda Consultative Group, and Malaria Eradication Scientific Alliance Task Force (for drugs and vaccines); and the Innovative Vector Control Consortium (for control agents). Then using information the phase of development of the products, an estimate of the costs of completing each phase, and the probability of success at each phase (defined as percentage of candidates successfully reaching the next phase), the authors projected the required funding. To account for failures, the authors assumed that the goal was one successful product for each target within a decade and added in the cost of backup R and D required to account for attrition to reach desired number of successfully registered products. While this approach is sound, I did not verify the underlying data (e.g., probabilities of success vary by indication with cancer having a higher failure rate) and confirm that their methods were widely accepted (I noted that of the ten or so consultants used by the authors only one was from industry).
As for the recommendations made, not surprising, the primary one is that funders need to come up with an average of $700 million per year over the next decade, or about $100 million more than was allotted in 2011, with more of a slant toward product development. They also recommended that more coordination of basic research and product development is needed, but, again not surprising, made no recommendations on increasing incentives for involvement of companies. Although R and D spending by companies is only 17% of the total, companies like Novartis, GSK, and Ranbaxy have played and are playing key roles in the development and deployment of new drugs and vaccines and many smaller companies have made possible the widespread availability of inexpensive rapid diagnostics. Also, as the authors noted on page 39, public and private funders and need to act more like for-profit product developers: “Unfortunately, funding decisions are often disconnected from the product development occurring on the ground. Ideally, funding should be flexible and should respond to changes in the pipeline: if a malaria vaccine candidate enters late-stage clinical trials, then the funding required is significantly higher than in the earlier stages of the development pipeline. Industry, and to an extent, philanthropic funders (particularly those with the resources to closely follow R&D developments or whose funding contracts are milestone based) tend to be responsive to these fluctuations in the pipeline and in funding needs. Public funders, however, are often much less responsive. Funders should be aware of R&D developments in the global portfolio and progress against agreed-upon goals in order to direct their funds to the areas where they are most needed.”
The good news in the world of product development for malaria is that it has been funded fairly steadily over the past ten years by a diverse group of funders (pubic, private, and corporate) and that is likely to continue, and that there has been a lot of effort into identifying what products are needed. Less good news is that two of the funding groups (pubic and private) are also footing the bill for on-going malaria control efforts, now about $ 1.5 billion per year (said to meet only about half the need) and that up-coming stage of bringing products into use will require expensive trials and registration. Hence, some one or some group needs to make funding decisions based on return on investment and triage of less promising programs, something companies are good at but governments and foundations are not. My recommendation is that the global malaria eradication community would benefit from forming up a “commercialization agenda consultative group” soon.