> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Woodcock: CDER Trying to Fill Translational Science ‘Chasm’
- URL: https://www.fdaweb.com/woodcock-cder-trying-to-fill-translational-science-chasm/
- Published: 2016-05-11T12:00:00.000Z
- Updated: 2026-09-14T21:01:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135642

CDER director **Janet Woodcock** says there is a knowledge chasm in translational science that CDER is helping to fill. Speaking on a Director’s Corner [podcast](http://www.fda.gov/Drugs/NewsEvents/ucm500442.htm?ref=fdaweb.com), she says that every disease should have its own translational program and natural history studies that look at disease progression over time. (Woodcock defines translational science as taking discoveries that are made in the laboratory and turning them into products that will help people.)

She says that patient groups are helping to fill in the knowledge gaps by doing natural history studies, pushing researchers to collaborate more, pooling data, having bio banks, and doing other things necessary not just for research but to improve disease outcomes.

For its part, she says, the agency needs to work on better trial designs and incorporating adaptive designs. It also needs to work on patient-focused drug development, she says, and on developing evidentiary standards for biomarkers “so that people know what gate they have to get over.”