Anavex Life Sciences Corp (AVXL)

[Steady_T]

The term biomarker is used on this board as if there was only one type of biomarker and in fact there are 7 different types of biomarkers.

Add to the list surrogate endpoint which is a different beast although it is frequently referred to as a biomarker.

One of the key differences is that a surrogate endpoint is deemed acceptable on a case by case basis.

The acceptability of these surrogate endpoints for use in a particular drug or biologic development program will be determined on a case-by-case basis. It is context dependent, relying in part on the disease, studied patient population, therapeutic mechanism of action, and availability of current treatments. A particular surrogate endpoint that may be appropriate for use in a particular drug or biologic clinical development program, should not be assumed to be appropriate for use in a different program that is in a different clinical setting.

Presently there are no qualified biomarkers for Alzheimer's disease and one accepted surrogate endpoint. The accepted surrogate endpoint is reduction of Ab plaques.

According to section 507(e)(9) of the FD&C Act “[t]he term ‘surrogate endpoint’ means a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not itself a direct measurement of clinical benefit, and—

‘‘(A) is known to predict clinical benefit and could be used to support traditional approval of a drug or biological product; or

‘‘(B) is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with section 506(c).’’

It is helpful to describe which of the 7 types of biomarker is being referred to. Each type has a different function and application.

Biomarker Categories: BEST Glossary
BEST defines seven biomarker categories: susceptibility/risk, diagnostic, monitoring, prognostic, predictive, pharmacodynamic/response, and safety.

How can qualified biomarkers improve the drug development process?
Qualified biomarkers have the potential to provide valuable information that may reduce uncertainty in regulatory decisions during drug development.
When a biomarker is qualified, it means that it has undergone a formal regulatory process to ensure that we can rely on it to have a specific interpretation and application in medical product development and regulatory review, within the stated context of use (COU) . It is important to note that a biomarker is qualified, and not the biomarker measurement method.