U.S. Food and Drug Administration–approved gene therapies have long been an elusive goal for medical science. However, “the climate is right for advances in clinical trials involving human gene transfer, particularly for oncology research,” says Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, Biosafety Officer at Schulman IRB.
Such clinical trials involve the deliberate transfer of engineered genetic material to humans, with the goal of compensating for genetic mutations, conferring the capability to produce potentially therapeutic substances, or eliciting immune responses to fight disease.
Federal requirements for human gene transfer studies receiving federal funds or taking place at sites receiving federal funds require review by an institutional review board (IRB) and institutional biosafety committee (IBC) prior to registering with the National Institutes of Health (NIH). Given the NIH’s single IRB policy, market conditions are ideal for a central IRB associated with an IBC.
To date, approximately 2,400 clinical trials involving human gene transfer have been initiated.1 Approximately two-thirds of these clinical trials involve oncology studies,1 a number that is likely to grow, given the aging baby boomer demographic and initiatives such as Cancer Moonshot 2020, a national coalition formed to accelerate next-generation immunotherapy in cancer. Led by the team at NantKwest, a clinical-stage immunotherapy company, the initiative includes leaders from large pharma, biotech, major academic cancer centers, community oncologists, and a pediatric consortium.
Schulman IRB is the IRB of record for the private sector arm of the Cancer Moonshot, and is responding to the increased demand for human gene transfer research by launching a commercial IBC service later this spring, says Dr. Eisenman. While IRBs are focused on human subject protection, IBCs focus on assessing the risks associated with research involving genetic engineering.
“In the case of human gene transfer, the IBC reviews the risk to the study personnel, community, and the environment, and advises the IRB to aid in the assessment of risks to the study subjects,” says Dr. Eisenman. The IBC service line is intended to complement Schulman’s existing service offerings, including its Central Oncology Review division, but will be open to other areas of genetic engineering research.
Prior to joining Schulman IRB, Dr. Eisenman served as Biological Safety Officer, Alternate Responsible Official for CDC select agents, and Institutional Contact for Dual Use Research at the University of North Carolina at Chapel Hill.
1. The Journal of Gene Medicine: Gene Therapy Clinical Trials Worldwide (public access database, accessed 1/17/17)