The IMI (Innovative Medicines Initiative) funded project ADVANCE has published its recommendations for transparent governance structure supporting collaborative projects in the European vaccine post-marketing environment. The article was published in the peer-reviewed scientific journal, Vaccine.
The advantages and disadvantages of PPPs were also examined as part of ADVANCE’s work. Stakeholders’ concerns (e.g. scientific integrity and public trust) were addressed through recommendations about transparent decision-making rules and conflict of interest management.
“No one-size-fits-all solution for public-private-collaboration governance exists but our recommendations could be used to set-up tailor-made governance structures.
To allow the rapid establishment of robust projects, the next steps will involve this guidance being used by real-world collaborations to assess what works and what does not work and what added-value can be obtained from these collaborations.”
”DRIVE study platform governance was built using the ADVANCE Governance guidance. It is ‘real life’ testing that should provide relevant lessons learnt for optimal adjusted public-private governance to generate robust and trustworthy influenza vaccine effectiveness estimates for EMA (European Medicines Agency) assessment”, says Laurence Torcel-Pagnon, the first author of the article. Laurence works as WP1 co-lead of DRIVE working in the Vaccine Epidemiology and Modelling department in Sanofi Pasteur (Lyon, France).
The goal of the ADVANCE project was to help health professionals, regulatory agencies, public health institutions, vaccine manufacturers make more informed decisions based on the benefits and risks of marketed vaccines.
The 2009 influenza pandemic highlighted challenges for vaccine post-marketing monitoring in Europe, particularly the need to have appropriate infrastructures in place to strengthen public-private collaborations (PPCs) with suitable processes to improve stakeholder interactions and collection, as well as the analysis of safety and effectiveness data.
Read the article in Vaccine https://www.sciencedirect.com/science/article/pii/S0264410X19305614
Authors of the article: Laurence Torcel-Pagnon, Vincent Bauchau, Patrick Mahy, Myint Tin Tin Htar, Marianne van der Sande, Cédric Mahé,Tyra GroveKrause, Anne Charrat, François Simondon, Xavier Kurz on behalf of the ADVANCE Consortium.