Transforming the Development & Governance of Pharmaceuticals - II

Abstract

Major changes are underway within the pharmaceutical sector that are associated with shifts in research, innovation and business models from blockbuster products intended for large patient populations to more niche products designed for smaller, more targeted populations. Innovation is underway in how drugs are being researched and developed, and how they are being manufactured, used, evaluated, licensed and paid for. While some of these changes are tied to genomics and the rise of personalized medicine, others result of patient activism and disease politics. These technical and political developments put pressure on public regulators and payers, resulting in novel forms of governance, including the use of real world data and conditional reimbursement.

This panel builds on STS scholarship on the socio-technical production of pharmaceutical knowledge, as well as its material and biopolitical impacts. We invite papers from a range of international perspectives that critically analyze these transformations, as well as those that highlight forms of alternative pharmaceutical practices and methods that are more sustainable and offer more just and equitable access to treatments. Topics may include but are not limited to:

– Forms of open pharmaceutical innovation

– Industry dynamics and changing business models

– Patient groups and new forms of knowledge production

– R&D partnerships across public, not-for-profit and/or private sector

– Drug repurposing and off-label use

– Changing regulatory knowledge and forms of evaluation

– Pharmaceutical pricing and access

– Novel access arrangement and alternative regulatory frameworks for coverage

– Future health care system sustainability and social solidarity.

Chair

• Paul Martin, Department of Sociological Studies, University of Sheffield

Individual Presentations

• In-House Hospital Manufacturing Of CAR-T Cells In Canada As A Emerging Form Of “Social Pharmaceutical Innovation” - Conor Douglas, York Univeristy; Faisal Ali Mohamed, York University, Toronto

• Moral Innovation without Market Incentives: The (Im)possibilities of Pediatric Drug Development Under Current Pharmaceutical Models - Kasia Tolwinski, McGill University; Margaret Chiappetta, York University

• Stalinist Citizen Science: Grassroots Drug Development in the Early Cold War USSR - Pavel Vasilyev, HSE University St. Petersburg

• Causing headwinds? How Dutch actors conceive situated futures for magistral preparation of pharmaceuticals - Tineke Kleinhout-Vliek, Copernicus Institute of Sustainable Development, Utrecht University; Marlous Arentshorst, Copernicus Institute for Sustainable Development, Utrecht University; Wouter Boon, Copernicus Institute of Sustainable Development, Utrecht University; Jarno Hoekman; Rob Hagendijk, Amsterdam Institute for Social Science Research, University of Amsterdam; Shona Kalkman, Copernicus Institute of Sustainable Development, Utrecht University; Ellen Moors, Copernicus Institute of Sustainable Development, Utrecht University

Session Organizers

• Conor Douglas, York Univeristy

• Paul Martin, Department of Sociological Studies, University of Sheffield

• Tineke Kleinhout-Vliek, Copernicus Institute of Sustainable Development, Utrecht University