NHLBI GENE THERAPY GROUP
The membership of the NHLBI Gene Therapy Group is comprised of the Group Leader, Project Officers from multiple divisions of the NHLBI, and members of the Grants Management Office and Office of Acquisitions. The GTRP Program was initiated under the leadership of the late Dr. Sonia Skarlatos. Dr. Cheryl L. McDonald, of the NHLBI's Division of Cardiovascular Sciences, was subsequently appointed Gene Therapy Group Leader and has been serving in that role since 2013. Ancillary members may be appointed by the group leader.
The Gene Therapy Group is charged with oversight and overall management of all components of the GTRP including development and maintenance of program infrastructure. This includes:
- Developing and implementing Bylaws and Policies of the GTRP
- Creating committees, review boards, and working groups as deemed appropriate including delegation of responsibility and authority
- Determining (as the sole review group) disposition of Request for Service Applications for Preclinical Vector Production and Regulatory Support Services
- Determining final disposition of Request for Service Applications for Pharmacology/Toxicology Testing and Clinical Trial Funding Assistance
Business of the Gene Therapy Group is conducted primarily through face-to-face meetings and teleconferences.
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