“As the leaders in biosafety and in the review of research with gene therapy we felt it was imperative to bring the leading minds in this field together to advise us on this area,” WIRB-Copernicus Group (WCG) Chief Medical Officer and President of Consulting Services Lindsay McNair, MD, MPH, MSB, told us. “We believe that we can best provide reviews of cutting-edge science by seeking the advice of those who are on the front-lines of this research.”
Human gene therapy is a fast growing area of research, which shows much promise; however, it is still a relatively new field.
“This research sheds light on complex, fundamental mechanisms within cells which the science community is just starting to understand, and learning more about every day,” added McNair. “For that reason, assessing the potential risks and potential benefits of this research can be a complicated analysis, requiring true expertise.”
According to McNair, because gene therapy is such a specialized endeavor, it will require equally specialized expertise to support the clinical trial process. WCG claims that outside the NIH and FDA, it has reviewed more human gene transfer protocol than any other organization. McNair explained this makes the company “uniquely able to provide that highly specialized advice and counsel to biopharmaceutical companies, CROs, and institutions involved in the conduct of gene therapy research.”
The WCG Gene Therapy Advisory Board will “provide guidance and strategic counsel to the company, ensuring that knowledge and best practices are reflected in the company's oversight of human gene transfer research,” according to the company. This involves coordinating institutional review board (IRB) and institutional biosafety committee (IBC) reviews.
Additionally, the board will help the company prepare its clients to manage increasing volumes of this type of research.
"Both the promise – and complexity – of this field are astounding," said Joan M. Robbins, PhD, WCG Senior Vice President of Biosafety and Gene Therapy. "Advances in the application of gene therapy, gene editing, genetic-based precision medicine, and immunotherapy are announced almost weekly; it can be a challenge to keep current. Medical researchers who participate in this field – or who would like to participate in the future – must make continuing education a priority."
The board convened yesterday and is comprised of experts from various backgrounds with knowledge in commercial development, regulatory oversight, and clinical application of products involving recombinant DNA.