In a recent issue of SBIA Chronicles, the agency is encouraging sponsors to request type C meetings early in the development process when they plan to use novel surrogate endpoints (SE) as primary measures of efficacy in trials for a new drug. These SE are biomarkers that have not previously been used as the primary basis for approval in the context of use. A sponsor must submit a background package at the time of the request which should meet certain requirements to enable the agency to assess the utility of the meeting. Among these requirements are inclusion of data clarifying

• The relationship of the SE to the clinical outcome,
• The relationship of the SE to the therapeutic product,
• The reliability of the measurement tool(s) used to detect the SE.

Other details may be found in the guidance for meetings between sponsors and the agency. Once the request is made, the agency will accept or deny it within 21 days. If accepted, the meeting will be held with 75 calendar days of the request.

Along with the table of SE that were the basis for approval (see my previous post), these meetings should help companies plan for the use of novel biomarkers in their efficacy studies. They also help the agency meet some requirements of the 21st Century Cures Act.

Text Copyright © 2018 Katrina Rogers