WCG Biosafety Expert Dr. David Emery to Discuss Regulatory Changes to Gene Therapy Research Reviews at the ASGCT Annual Meeting
PRINCETON, N.J., Apr. 29, 2016 – WIRB-Copernicus Group® (WCG™), one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research, today announced that David Emery, PhD, its director of institutional biosafety committee (IBC) services, will present at the American Society of Gene & Cell Therapy (ASGCT) 19th Annual Meeting, which will be held from May 4-7 in Washington, D.C.
Dr. Emery’s presentation will be part of a symposium titled “Navigating the New National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC) Review for Gene Therapy” on Thursday, May 5, from 8:00-10:00 a.m. ET.
“Human gene transfer is an extremely promising new therapeutic approach. However, research in this area is evolving at such a rapid rate that one needs a cadre of biosafety experts to review the research protocols to ensure that they meet the requisite risk: benefit standards, and have all the appropriate protections in place to safeguard patients, their families, the clinical research staff, and members of the general public,” commented Joan Robbins, PhD, Senior Vice President, Biosafety and Gene Therapy, WCG.
Prior to April 27, 2016, the RAC – which is composed of an independent group of scientific and ethics experts – was required to review the majority of clinical trials involving human gene transfer in the US. Mandatory review by the RAC has now been replaced by mandatory review by local institutional oversight bodies, followed by a simple registration with the NIH. The RAC is now only reviewing human gene transfer clinical trials at the request of these local oversight bodies and subsequent vetting by professional staff at the NIH.
“This change was designed to reduce the regulatory burden for this exciting new technology, but in doing so, has placed an additional burden on local oversight bodies which, in at least some cases, may be ill equipped for the task,” said Dr. Emery. “Institutional review boards and IBCs will need to be able to consult with biosafety experts on topics as diverse as DNA plasmids and CAR T, modified T-cells so they can pre-review these protocols appropriately and decide whether they need RAC review.”
Dr. Emery’s fellow symposium speakers will include Jessica Tucker, PhD, program director and health scientist administrator at the NIH and Dale Ando, MD, vice president, therapeutic development and CMO at Sangamo BioSciences, Inc. Dr. Ando is also an industry member of the FDA Office of Cellular, Tissue and Gene Therapy Advisory Committee. Dr. Emery has more than 30 years’ experience in gene therapy research and genetic engineering. He also has been actively engaged in ASGCT for almost 19 years. Previously, Dr. Emery was the primary reviewer of clinical gene transfer studies for the University of Washington IBC for more than 15 years, and he served as the committee’s chair for 11 years.
The ASGCT Annual Meeting will take an in-depth look at human gene transfer and cell therapy research, including the use of novel vector designs, stem cells, oligonucleotides and vaccines in clinical trials. For more information about this conference, please visit http://www.asgct.org/meetings-educational-programs/asgct-annual-meetings.
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.