WCG Biosafety Webinar to Discuss Implications of Regulatory Changes to Gene Therapy Research Reviews

Prior to April 27, 2016, the RAC – which is an independent group of scientific and ethics experts – was required to review clinical trials involving human gene transfer in the US. After that date, mandatory review by the RAC was replaced by mandatory pre-review by the institutional review board (IRB) and institutional biosafety committee (IBC) at the first trial site/s in the study, followed by simple registration with the NIH. The RAC now only reviews human gene transfer clinical trials following the request of the IRB/IBC and subsequent vetting by professional staff at the NIH.

This change was intended to reduce the regulatory burden for this technology, but it has placed a significant additional responsibility on IRBs/IBCs who now must decide if a protocol requires RAC review, prior to conducting their usual review.

"While this change could reduce the regulatory timeline for low-risk studies, sponsors, IBCs and IRBs need to understand all the ramifications of these new guidelines on the review process," said WCG Senior Vice President of Biosafety and Gene Therapy Joan Robbins, PhD. "This webinar will help all stakeholders understand their new role, and the additional expertise needed to ensure the safety and integrity of these studies."

This webinar will have three co-presenters, including the chair of the NIH RAC, and will be moderated by Dr. Robbins. All the speakers are expert advisors in this field and possess in-depth knowledge of the new regulations.

• Hans-Peter Kiem, MD, Dr. med – chair of the NIH RAC, chair of the American Society of Gene & Cell Therapy Stem Cell Center, associate head of the Program in Transplantation Biology and associate head of the Heme Malignancy Program at the Fred Hutch Cancer Consortium
• Dale Ando, MD – advisory committee industry member at the FDA Office of Cellular, Tissue, and Gene Therapy, and chief medical officer at Sangamo BioSciences
• David Emery, PhD – WCG director of IBC services

To register for this complimentary webinar, please visit https://goto.webcasts.com/starthere.jsp?ei=1101603.

About WIRB-Copernicus Group
WIRB-Copernicus Group (WCG) is one of the world's leading providers of solutions that measurably improve the quality and efficiency of clinical research. The industry's first Clinical Services Organization (CSO), WCG enables biopharmaceutical companies, contract research organizations and institutions to accelerate the delivery of new treatments and therapies to patients, while maintaining the highest standards of human subject protections.

WCG solutions include contract and budget negotiation, study start-up acceleration, regulatory and ethical review services, oversight of research involving gene therapy, and lab safety consulting. Powered by a suite of proprietary technologies, WCG solutions help clients to increase regulatory compliance and support the digital management of clinical trials. For more information, please visit www.wcgclinical.com or follow us on Twitter @WCGClinical.

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SOURCE WIRB-Copernicus Group

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