Assay Sciences: A Model for Improving Efficiency Through Centralization
Jonathan Wingfield, Ph.D., Team Leader,
Darren Jones, Senior Scientist, Roger Clark, Senior Scientist,
Peter Simpson, Ph.D., Associate Director of Assay Sciences
AstraZeneca
Introduction
The pharmaceutical industry is facing increasing external market pressures to reduce costs and deliver the next generation of therapeutics cost effectively. Pharmaceutical R&D faces the challenge of streamlining all stages of the drug discovery process. Delivering high quality decision-making data at the earliest opportunity serves to accelerate research and maintain product pipelines that are critical to business success. Reducing the time between Hit to Lead, whilst operating in an increasingly challenging business environment requires a different approach when deploying resources.
Secondary screening in the pharmaceutical industry has traditionally been carried out within project teams, in many cases biochemical and cell screening are carried out by the same bioscience resource. This typically results in a serial approach to screening where biochemical data is gathered before or during the development of any cellular assays. In a post high throughput (HTS) environment the level of automation applied to support screening has often been quite limited as there is no perceived benefit of automation when screening smaller numbers of samples. This model has the potential to delay project screening once the primary screening campaign has been completed, partly due to a hand over phase and repeat validation when the assay is handed back to project bioscientists. In some cases, screening may need to be suspended while adequate bioscience resource is redeployed from other on-going project support work. Moving away from the traditional project-centric lead identification to a centralised capability offers many advantages to both the bioscience and chemistry communities. Centralisation of both biochemical and cellular secondary screening activities enables flexible use of resources, allowing rapid responses to changing business demands.
Centralisation permits testing across multiple targets and increases the speed that data is generated. In addition focusing a small team on one aspect of drug discovery enables them to standardise the automation, technology, process and adopt best practices. This can result in a flexible, agile work team that can respond effectively to changing demand. Focusing teams in this way provides clarity around their expected delivery, which helps individuals maintain drive. On the counter side, there is a need to manage the perceived loss of project ownership of the assays that are centralised. The centralised team need to understand that their output will be subject to additional scrutiny. Initially there will need to be a considerable investment of time in managing customer interactions during the establishment of the capability, building customer confidence. Having a clear service level agreement (SLA) between the central screening team and each customer, which specifies the turn round time for data delivery, stringent QC process for data analysis, roles and responsibilities for individuals is important. The screening team then have to deliver against these SLA's.
Building the Capability
Within the Cancer Department at AstraZeneca, Assay Sciences was recently established as a capability. This encompasses focused teams dedicated to biochemical assay development,
biochemical screening, cell assay development, cell screening and protein supply (Figure 1). All routine secondary screening is carried out by one capability supporting all cancer projects from hit validation through lead optimisation.
Utilising a dedicated enzyme assay development team to support both HTS and secondary screening ensures a consistent standard of data generated through the life of any project.
Traditionally, HTS campaigns run for short periods, therefore the screens need only be robust enough to run for weeks. In contrast assays in the post HTS environment may have to run for several years. Building the assays that will support a project for the duration of the pre-clinical phase requires long term supplies of reagents, therefore a protein supply team is embedded within Assay Sciences to maintain delivery.
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