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)
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 |