Master Alliance Provisions Guide (MAPGuideⓇ)
The Background of the MAPGuide
Following the Ebola outbreak of 2014, government and industry players mobilized resources and funding to develop a vaccine and several companies announced the formation of consortia through which to do so. Such a rapid response was significant given the high-cost threshold for R&D and the lengthy timeline for therapeutic development. Consequently, at Duke University, GHIAA began to research this phenomenon, mapping the partnerships that were formed in real-time between the public, private, and nonprofit sector in response to the spread of Ebola. As the outbreak evolved, GHIAA worked to understand the unifying factors that brought players together and the roadblocks that they faced. Over the following year, GHIAA interviewed numerous representatives from each partner organization. This investigation illustrated the diversity of players involved in vaccine development. Innovators hailed from an array of research backgrounds, including private companies (small and large), academic institutions, and federal agencies. Discussions revealed that stakeholders were motivated by the public health imperative of EIDs, but were challenged by the dearth of financial support for R&D.
Individual organizations typically take 10-15 years to fully develop a drug; a timeframe that was insufficient given the swift spread of Ebola throughout Africa. Players attempted to streamline the R&D process by forming alliances to share costs and resources. This unprecedented effort produced tangible success, with the first clinical trials set to begin after a mere eight months. However, the remarkable progress of stakeholders was hindered by a lack of legal clarity regarding alliance structures, technology transfer, and data sharing. Clinical trials were first delayed and then rendered insignificant as the patient population diminished.
The Ebola outbreak exposed significant gaps in pandemic preparedness, and highlighted the need for collaborative investment in R&D for future outbreaks. Conversations with players revealed a desire for legal tools to facilitate alliance formation. Using samples of agreements and contracts from representative organizations, GHIAA worked to develop templates for licensing intellectual property (IP) in order to expedite multi-stakeholder negotiations.
The first model agreements were presented in November of 2015 to key members of the Ebola consortia, who were gathered by GHIAA for a workshop on pandemic preparedness in Washington, D.C.. Draft templates were positively received by workshop participants, who also provided GHIAA with important perspective about how the needs and wants of individual players differed based on their context. Members pledged to continue sharing existing provisions and agreements so that GHIAA could build a glossary of licensing terms and expand its chart of EID provisions. In late 2015, GHIAA was invited to work on the WHO’s Pandemic Preparedness Initiative and began developing a database of pathogens and partners to facilitate alliance formation for future epidemics