For a drug product to be approved for use in Europe, it needs to be approved and licensed by the European Medicines Agency (EMA). This is often conducted through national regulatory agencies, which can sometimes be a lengthy process. Part of this is based on requisite safety tests (conducted through clinical trials); however, other reasons are tied up in a labyrinthine process of documentation and review.
In order to streamline this process, a new initiative, ADAPT SMART, has been launched. This is an acronym for “Accelerated Development of Appropriate Patient Therapies: a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes” — a rather lengthy name for something designed to make a process faster and more efficient.
The ADAPT SMART project is designed to create what are called Medicines Adaptive Pathways to Patients (MAPPs). These pathways are designed “to foster access to beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion.” This essentially means bringing new medicines to market faster so patients who need them can benefit from the drugs earlier.
The typical time from development to market for a medicine is 10 years. The MAPP frameworks aim to measure and record how long this process is taking and to examine how this can be streamlined. It also aims to foster greater co-operation between pharmaceutical companies and regulators.
The initial pilot is a 30-month project, and it falls within the Innovative Medicines Initiative (IMI), which itself falls under the EU Horizon 2020 framework. This somewhat hierarchical arrangement is being supported by a private sector body called TI Pharma.
Commenting on the new arrangement, Hans-Georg Eichler, a senior medical officer at the EMA, told PharmaFile: “With the challenges facing healthcare in Europe, we see MAPPs as a vital tool to make the increasing number of promising new therapies available at the earliest appropriate time for patients with unmet medical needs. We need to do so in a way that is sustainable for all stakeholders in the healthcare ecosystem. ADAPT SMART is a vital programme to help achieve this goal.”
The first drug product to go through the pilot programme is from the biotech firm Immunocore. The product is IMCgp100, designed to treat of patients with metastatic uveal melanoma, a rare and fatal cancer.
