CONCEPTUAL ADVANCES 

In this workstream, we focused on developing conceptual frameworks that would guide the research activities of the project. We began by articulating the yardstick against which alternative innovation models could be measured, by defining what pharmaceutical R&D in the global public interest means, in collaboration with heads of major research institutions from around the world. We also co-authored a paper on the need for new business models to achieve fair pricing of medicines as well as a concrete conceptualization of what ‘fair pricing’ means. We also clarified the concepts of “new/alternative” and “traditional/mainstream” “business models”, and iteratively defined and re-defined these as we collected and analyzed the data; as a result, in 2023 we shifted the project’s terminology from “new business model” to “alternative innovation model (AIM)”, which better captured the key concepts of interest. . We also developed a conceptual framework of the overall pharmaceutical innovation system and the place of AIMs within it, drawing insights from the literature on complex adaptive systems, alongside a theory of how AIM niches emerge and could be solidified.

Mainstream R&D Systems

In this workstream, we deepened our understanding of the mainstream R&D business model, including how this model has evolved over time. We developed conceptualizations of how the mainstream business model operates, building from the literature available, which we published as part of a technical report for the WHO European Region’s Oslo Medicines Initiative. 

In this report, we conceptualized the mainstream business model as a multi-player relay race that increasingly involves small- and medium-enterprises and non-commercial actors such as academic institutions, in contrast to the more traditional vertically-integrated private-sector model of pharmaceutical R&D. 

We also conducted literature reviews on 11 strategically-selected topics on pharmaceutical innovation (4 of which focus on the current R&D system (R&D Costs, R&D Time and Success Rate, the Role of Small and Medium Enterprises, Public Funding of R&D; the remaining 7 are described under Alternative Innovation Models (Advanced Market Commitments, Biosecurity R&D, Patent Pools, Priority Review Vouchers, Product Development Partnerships,  Benefit Corporations, Rare Diseases ). 

We made these publicly available (together with 18 other literature reviews on medicines-related issues) at a website we built to make data and literature syntheses more accessible, the Knowledge Portal for Innovation and Access to Medicines. 

ALTERNATIVE INNOVATION MODELS 

In this workstream, we focused on original empirical data collection and analysis. We began by synthesizing what is already known about alternative innovation models via literature reviews and created spaces for broader discussion in the policy/practice communities through a webinar series. We published literature reviews on seven approaches to alternative innovation models: Advanced Market Commitments, Biosecurity R&D, Patent Pools, Priority Review Vouchers, Product Development Partnerships,  Benefit Corporations, Rare Diseases . We also organized 15 webinars (as part of a broader webinar series) with external experts, including on antibiotics, biosecurity (e.g. outbreaks, potential and actual pandemics), public funding of R&D, R&D costs of cancer medicines, drug development costs, and non-commercial pharmaceutical R&D (full list at knowledgportalia.org/webinars). In total, our webinar series was attended by almost 1,400 unique participants from 98 countries, with a mix of scholars, advocates and practitioners often having a high degree of expertise on medicines policy.