Newsletter - July 21, 2016
NIH’s Single IRB Policy to Impact Non-NIH Funded Clinical Trials Too
Last month, NIH announced the final policy for IRB review of multi-site clinical trials funded by NIH. Starting next May, all multi-site clinical trials funded by NIH must use a single IRB for all sites. This creates a new paradigm for IRB review of clinical trials aimed to reduce the redundancy and cost of IRB review. The goal of this policy is the address common complaint regarding multiple IRBs reviewing the same protocol with minor differences in opinion leading to unnecessary administrative work for the trial operations. Read More..
Manufacturers of Biologics to Increasingly Use Single-Use Technologies
Biologics manufacturing facilities using traditional stainless-steel bioreactors have to deal with significant manufacturing suite unavailability between production cycles due to expensive cleaning technology, extensive cleaning validation, and the associated loss of productivity and revenue. The use of single-use and disposal technologies such as single-use bioreactors (SUB) can greatly increase the production efficiency by reducing the need for the same. Read More..
NIH’s Single IRB Policy to Impact Non-NIH Funded Clinical Trials Too
Last month, NIH announced the final policy for IRB review of multi-site clinical trials funded by NIH. Starting next May, all multi-site clinical trials funded by NIH must use a single IRB for all sites. This creates a new paradigm for IRB review of clinical trials aimed to reduce the redundancy and cost of IRB review. The goal of this policy is the address common complaint regarding multiple IRBs reviewing the same protocol with minor differences in opinion leading to unnecessary administrative work for the trial operations. Read More..
Manufacturers of Biologics to Increasingly Use Single-Use Technologies
Biologics manufacturing facilities using traditional stainless-steel bioreactors have to deal with significant manufacturing suite unavailability between production cycles due to expensive cleaning technology, extensive cleaning validation, and the associated loss of productivity and revenue. The use of single-use and disposal technologies such as single-use bioreactors (SUB) can greatly increase the production efficiency by reducing the need for the same. Read More..
