Gene therapy no longer science fiction: IRB launches biosafety committee service

01-May-2017 - Last updated on 02-May-2017 at 16:54 GMT

NIH Guidelines require both IRB and IBC review for gene therapy research funded by NIH or taking place at sites that receive NIH funding. (Image: iStock/Ca-ssis)

Schulman IRB has launched a new service to ensure sponsors, CROs, and others are compliant when conducting genetic engineering research – “given the diverse risks,” says committee lead.

The institutional biosafety committee (IBC) service will be headed by Dr. Daniel Eisenman, Ph.D., RBP, SM(NRCM), CBSP, who told us the service provides “a means of obtaining regulatory approvals to perform gene therapy research and research involving genetic engineering.”

“The field of gene therapy is no longer science fiction as the US, Europe, and China have started approving genetically modified therapeutics in recent years,” Eisenman added.

“Technological advances have created a wealth of potential genetically modified therapeutics that are either ready or on the verge of being ready for clinical trials, and many clients have been asking us to provide a commercial IBC service.”

As Eisenman explained, IBC review often comes as a surprise to clinical researchers not familiar with gene therapy research requirements – though IBC review “shouldn’t be an obstacle to conducting innovative research,” he said.

A coordinated review process

Eisenman explained NIH guidelines require approval from both an IBC and an IRB “given the diverse risks associated with gene therapy research.” As such, Schulman will offer its IBC services as well as central IRB services for a coordinated review process.

“Rather than having to wait for one committee’s approval before the other review can begin, conducting the reviews concurrently means the committees work together collaboratively, which accelerates the regulatory approval process,” said Eisenman.

The new IBC service offers complete setup, registration support, and administrative resources for sites to operate an NIH-compliant IBC.

“The service will support clinical, pre-clinical and non-clinical research, providing all components to complement an existing IBC or build and administer an entirely new IBC from the ground up,” Eisenman added.

“After conducting a risk assessment, the committee focuses on the associated containment and safety practices while looking at occupational safety as well as the protection of the community and environment surrounding the research site to ensure a comprehensive risk mitigation plan is in place.”