Almac launches package to speed up drug development
Integrated outsourcing services company Almac, based in Northern Ireland, has launched a package of solutions to accelerate entry into early stage clinical development.
Integrated outsourcing services company Almac, based in Northern Ireland, has launched a package of solutions to accelerate entry into early stage clinical development.
Named rapidd (Accelerated Process Integrated Drug Development), the service aims to address obstacles that arise during early phase development and halve the time taken from selection of pre-clinical candidate to Phase I regulatory submission to less than 12 months.
By meeting CMC requirements from a single team operating from a single site, rapidd eliminates an estimated three months of downtime by integrating the project team and setting up a strong communications network between the client, Almac and its CRO partners, one of which is Covance.
The concept can be tailored to meet individual client requirements and offers a single contract, one point of contact and dedicated programme management. Among its main benefits are earlier achievement of milestones and a reduction in cash burn.
Part of the time-saving comes from initiating work earlier by anticipating certain steps, for example ordering some materials in advance to cut out lead times. Any risk involved would be shared among the project partners. However, Almac was quick to stress that reducing development timelines did not involve cutting corners; regulatory affairs experts would be involved in any project from the outset.
