Team 4 - Clinical Operations/Regulatory Affairs (CORA;development of the clinical protocol, preparation, submission and obtaining approval from the IRB, IBC, NIH OBA/RAC and FDA, and preparation of SOPs and collection of documents)

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01NS066920-02
Application #
8382192
Study Section
National Institute of Neurological Disorders and Stroke Initial Review Group (NSD)
Project Start
Project End
2015-08-31
Budget Start
2012-09-01
Budget End
2013-08-31
Support Year
2
Fiscal Year
2012
Total Cost
$91,797
Indirect Cost
$37,479
Name
Weill Medical College of Cornell University
Department
Type
DUNS #
060217502
City
New York
State
NY
Country
United States
Zip Code
10065
Rosenberg, Jonathan B; Kaminsky, Stephen M; Aubourg, Patrick et al. (2016) Gene therapy for metachromatic leukodystrophy. J Neurosci Res 94:1169-79
Rosenberg, Jonathan B; Sondhi, Dolan; Rubin, David G et al. (2014) Comparative efficacy and safety of multiple routes of direct CNS administration of adeno-associated virus gene transfer vector serotype rh.10 expressing the human arylsulfatase A cDNA to nonhuman primates. Hum Gene Ther Clin Dev 25:164-77