RESUMO
After nearly a decade of discussion, analysis, and development, the Medicines Adaptive Pathways to Patients (MAPPs) initiative is beginning to see acceptance from regulators, industry, patients, and payers, with the first live pilot project initiated under the guidance of the European Medicines Agency in 2014. Although it is a significant achievement to see the first asset being placed into human trials under an adaptive pathway, there is much to be learned regarding the multinational and multi-stakeholder effort that has driven the growing acceptance of MAPPs as a methodology and concept, as well as the need for continued and increasing international collaboration to foster the wider adoption of MAPPs. Changes in available science and technology, as well as a number of challenges in the current system, outlined in this paper, are transforming approaches to medicines development and approval. It is these challenges that have led directly to the groundbreaking MAPPs collaboration between the Massachusetts Institute of Technology Center for Biomedical Innovation's New Drug Development Paradigms Initiative, the EMA, patient, payer and health technology assessment groups, the European Federation of Pharmaceutical Industries and Associations, and the Innovative Medicines Initiative-a European public-private partnership. This article examines the development of MAPPs, from inception of the concept, to the establishment of this trans-Atlantic initiative, and examines challenges for the future.
RESUMO
Since its launch in 2008, the Innovative Medicines Initiative has catalysed the formation of many consortia to address challenges in drug development and regulation. As it moves into its second phase, we highlight key outcomes so far and the lessons learned.
Assuntos
Descoberta de Drogas/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , União Europeia , Parcerias Público-Privadas/legislação & jurisprudência , Pesquisa Biomédica/legislação & jurisprudência , Pesquisa Biomédica/tendências , Ensaios Clínicos como Assunto/legislação & jurisprudência , Ensaios Clínicos como Assunto/tendências , Descoberta de Drogas/tendências , Indústria Farmacêutica/tendências , Humanos , Parcerias Público-Privadas/tendênciasRESUMO
The European Regulation on medicines for pediatric use entered into force on 26 January 2007. It changes dramatically the way medicines are developed for children. This regulation will increase availability of and information on pediatric medicines through high quality, ethical research.