Anavex Life Sciences Corp (AVXL)

[rocalinda]

THE USES OF GENOMIC INFORMATION

The development of personalized healthcare approaches depends substantially on the strength of the hypothesis being developed, said Jane Fridlyand of Genentech. Where a strong diagnostic hypothesis exists, a strong scientific rationale allows for patient selection through all stages of development. This situation can provide a relatively fast development path and a relatively straightforward path to approval.

Without a strong diagnostic hypothesis, patient selection is much more difficult. In that case, retrospective data exploration and planning for future data collection need to be emphasized, Fridlyand said.

In many cases, a biomarker and drug have been developed, but it is not clear in which population the drug will work. In this situation the three key challenges are label-enabling trial design and analysis, biomarker cutoff and refinement, and multiple biomarkers and multi-marker tests. The developers of drugs and diagnostics need to decide which patient populations should be tested. These decisions ultimately depend on the scientific rationale and clinical context, Fridlyand said. Key questions include:
What is the clinically meaningful treatment benefit level?
What is the magnitude in benefits between diagnostic-positive and diagnostic-negative patients?
What is the risk benefit evaluation in diagnostic-negative patients, and what are their unmet medical needs?