STEERING COMMITTEE
The GTRP Steering Committee is comprised of the Chair (appointed by the NHLBI Gene Therapy Group), the Principal Investigators of the GTRP Clinical Coordinating Center and each of the GTRP Core Laboratories, the leader of the NHLBI Gene Therapy Group, members appointed by the NHLBI Gene Therapy Group with specific scientific expertise relevant to GTRP activities, representatives of the U.S. Food and Drug Administration (FDA) and a representative of the NIH Office of Science Policy (OSP). The committee chair may request that others serve as expert consultants on an ad hoc basis.
The GTRP Steering Committee reviews Request for Service Application (RSA) submissions and the assessments provided by the Scientific Review Board and recommends to the NHLBI Gene Therapy Group disposition of RSAs for:
- Pharmacology/Toxicology Testing
- Clinical Trial Funding Assistance
The Steering Committee meets twice a year to review RSA submissions and conducts business via conference calls.
In addition, the Steering Committee reviews program Standard Operating Procedures and provides oversight of monitoring of clinical protocols that are partially funded through the GTRP.
TRENDING NEWS
REGULATORY UPDATES
- INTERACT Meetings (formerly pre-pre-IND meetings)
- FDA INTERACT Announcement 2018
- CBER INTERACT Meeting Process Overview (PowerPoint | Word)
- Revised NIH Guidelines (April 2019)
RESOURCE CENTER
- GTRP Request for Service Application (RSA)
- NHLBI Home
- Future Directions and Resource Needs for NHLBI Gene Therapy Research
- Funding Resources – NIH and Other Programs
- GTRP FAQs
- Regulatory Resources
- Training Resources - NIH and FDA
- Publications and Presentations by GTRP Investigators
- American Society of Gene and Cell Therapy (ASGCT) Homepage
- Archived GTRP Newsletters