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Dr Jeffrey Moe (Duke University), Dr. David Ridley (Duke University) & Dr. Nick Hamon (IVCC)

Dr Jeffrey Moe (Duke University Institute of Global Health)

Dr. David Ridley (Duke University Fuqua School of Business)

Dr. Nick Hamon (IVCC)

Interview by Kamran Rafiq (ISNTD)

In a historic move, the US Food & Drug Administration has this month awarded accelerated approval for a paediatric drug treating Chagas disease in 2 to 12 year-olds as part of its Tropical Disease Priority Review Voucher framework (PRV), designed to incentivise research and development in therapeutic areas where market incentives can be insufficient. In this interview, the ISNTD speaks with Dr. Jeffrey Moe and Dr. David Ridley from Duke University, who with Dr. Henry Grabowski originally proposed the PRV system in 2006 to encourage innovation for neglected diseases, as well as to Dr. Nick Hamon, CEO at IVCC, about applying the PRV mechanism to challenges in vector control innovation, in particular through the newly proposed Vector Expedited Review Voucher (VERV).

The pharmaceutical industry underwent a transformation in the late 80s & early 90s following the completion of the human genome mapping project - many analysts called this era the death of the blockbuster drug model and the genomic/proteomic approaches bought with them innovation and novel drug filings. In your opinion, can the improved understanding of vector genetics catalyze the vector control marketplace and initiate the move away from the traditional models based on organic chemistry?

David Ridley (Duke University, Global Health Institute): The shift from chemistry to biology was an important change in the pharmaceutical industry, but so were economic incentives. In the 1970s, drug manufacturers were largely uninterested in developing drugs for small markets, but the Orphan Drug Act of 1983 made drug development for rare diseases more lucrative. Likewise, we think new incentives would be useful for combating tropical diseases, including incentives for developing new insecticides.

Jeffrey Moe (Duke University): Building off Eric Topol's comments in "The Creative Destruction of Medicine " the genomics revolution in medicines has underperformed against the expectations that were hyped. I think the same is true for vector control. The public and scientists have concerns about the safety and unintended consequences of the wide scale use of genomics to kill insects. Chemistry based vector control agents are needed in the near term as we wait to see how much usable innovation genomics can actually provide.

Outside of the technology landscape, what kind of environmental changes are needed for this evolution? What are your views on this from a research, regulatory and finance perspective?

Nick Hamon (IVCC): The challenges to bringing innovation to market and impact are significant. Public health needs new tools and technologies with improved performance as well as addressing the problem of resistance development. This means creating a toolbox of solutions that enable selection of best technical options that allows for active product/mode of action rotations. It needs to be done quickly, but without any compromise in safety, and it needs to be at a cost that resource-poor countries can afford. Public health is a small and unpredictable market, with a high cost of entry, low profit (a dilutive EBIT), with significant regulatory hurdles that create long development timelines comparable or in excess of drug development. At the same time, the market is reluctant to or cannot afford to pay a premium for innovation. The importance of vector control in eradicating malaria and neglected tropical diseases has been well-documented and recognized in the last few years and there is increasing focus on tackling some of the challenges through initiatives such as IVCC, I2I (Innovation to Impact) and the UNITAID funded NgenIRS project. A VERV will potentially go some way to addressing the imbalance between vector control needs and delivery by keeping innovators engaged. The recognition that modern agricultural technology has and will continue to save lives is also important. The development of novel chemistry targeted only at public health is a financial challenge. Even with development costs supported by IVCC through its funders such as the Bill & Melinda Gates Foundation, DFID, USAID and the Swiss Agency for Development and Cooperation, it is almost impossible to create a positive NPV. However, although difficult to calculate, the corporate social responsibility value of life-saving agricultural chemistry is important, allowing a company to move from being ‘best in the world’ to ‘best for the world’.

You've just published work on a new funding mechanism based on the Priority Review Voucher (PRV) - the VERV - could you please describe this briefly?

DR: We propose a new mechanism for encouraging development of insecticides. It's called the VERV: the Vector Expedited Review Voucher. If you develop a new insecticide you'll be rewarded with a voucher for faster review at the EPA for a different product, say a more profitable herbicide. So 2 products are involved. We think the vouchers could be worth around $77 million dollars. A reward of that magnitude could encourage development of new insecticides.

JM: VERV can be used to develop existing chemistries as well as discover new chemistries to show if either can be effective against insects. We may have an existing crop agent that can be re-purposed for vector control. We may need whole new classes of chemistry to fill this unmet need. VERV will provide the incentive for discovery under both conditions.

We've had the Priority Review Voucher in place now for several years - some of the negative press around the PRV was due to the novelty criterion in place - how is the VERV different to this and have lessons be learned and experiences channelled into the construction of the VERV?

DR: The eligibility question is important for both the PRV and the VERV. If the eligibility criteria are too broad, then we’ll reward development of some products that offer little value. On the other hand, if the eligibility criteria are too narrow, then we’ll deter development of products that could help many people. We need to decide whether we prefer more type I or type II errors.

JM: The parallels between VERV and PRV regarding "novelty" are pertinent. At the advent of VERV manufacturers will be sceptical re-garding government administration of the incentive and curious as to its actual value. Therefore our first criteria "not previously registered by EPA or another stringent regulatory authority" that leaves the possibility that an in-market agent could be brought to EPA and be awarded a VERV. This level of novelty criteria for VERV is appropriate, as it was with PRV, as a proof of principle to show how the incentive works and to determine the actual costs borne by manufacturers to meet EPA VERV criteria, and thus convince manufacturers that VERV is "real." We also know from PRV experience that the novelty requirements may need to be changed in future. As Ridley wrote there will be much discussion in the coming months about setting eligibility criteria at the right level of balance making Type I errors (giving a VERV to a compound that doesn't need to be incentivised) v. Type II errors (not awarding a VERV to a compound that should have received the incentive). The goal is to set the right balance between these types of errors.

Due to the very small # of manufactures in vector-control the value of the voucher is different. We forecast that a manufacturer in a small competitive landscape holding a VERV will keep it, the value may be more akin to an option v. a sale on the open market.

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