7 Pages

Assay Development Ideas

Evaluation of Feasibility

A formalized structure can be utilized to integrate assays into the HTS program. Critical factors in this process include feasibility evaluation and prioritization. In the scenario shown in Figure 2, biology sponsors initially apply to get their assays into the screening program. Prior to submission of an application to the screening program, discussions between the therapeutic area scientists and the lead discovery group should have occurred. Since the lead discovery group will be aware of the latest assay technologies, they will be a valuable resource to recommend the best approach in setting up a high throughput assay. For example, the lead discovery group may be able to convert a 14step ELISA assay into a 4-step radioactive proximity assay using Scintiplates (Braunwalder et a!., in press). It is more efficient to establish a collaboration when the assay is first being developed rather than having to re-design the assay after months of work are invested in setting up the ELISA. One way to formalize this process is to develop an application form for the HTS program, where the biology sponsor would apply to get an assay into the program.