Medicines adaptive pathways to patients: Why, when, and how to engage?

Medicines Adaptive Pathways to Patients (MAPPs) seeks to foster access to novel beneficial treatments for the right patient groups at the earliest appropriate time in the product life‐span, in a sustainable fashion. We summarize the MAPPs engagement process and critical questions to be asked at each milestone of the product life‐span. These considerations are of relevance for regulatory and access pathways that strive to address the “evidence vs. access” conundrum

Medicines adaptive pathways to patients: Why, when, and how to engage?

Medicines Adaptive Pathways to Patients (MAPPs) seeks to foster access to novel beneficial treatments for the right patient groups at the earliest appropriate time in the product life‐span, in a sustainable fashion. We summarize the MAPPs engagement process and critical questions to be asked at each milestone of the product life‐span. These considerations are of relevance for regulatory and access pathways that strive to address the “evidence vs. access” conundrum

Заинтересованный разговор о будущем философии и социальной ответственности философов

Copyright Springer. [Full text of this article is not available in the UHRA]Peer reviewe

European perspective for effective cancer drug development

Health systems and the clinical research landscape evolve continuously owing to increased risk aversion, scrutiny by funding bodies, and costs of clinical trials. In this context, however, current drug development procedures are far from optimal, as exemplified by the late-stage failure of several drugs. The identification of new drugs urgently requires approaches based on a solid understanding of cancer biology, and that will support the design of robust confirmatory trials. The complexity and the costs of drug development are now beyond the knowledge and operational capacity of single organisations, therefore, a drastic deviation from the traditional path of drug discovery and new forms of multidisciplinary partnerships are needed to succeed in this sector. The European Organisation for Research and Treatment of Cancer (EORTC) proposes the use of collaborative molecular screening platforms (CMSPs) as a new approach to tackle this issue. These CMSPs have the advantage of optimizing the expertise of several partners and combining efforts alongside with cost-sharing models for efficient patient selection. This article describes some of the challenges to advancing drug development and improving medical treatments and how these hurdles can be overcome