Gene Therapy & Biosafety

Gene Therapy & Biosafety 2017-05-26T20:39:35+00:00

Human gene therapy is one of the fastest-growing areas of medical research, and one of the most promising. The advances made by scientists and clinicians in the field of gene therapy have enabled us to target disease at the genetic level. As gene therapy research moves increasingly into the clinic, we must ensure that our clients are well prepared to safely and confidently manage this new type of research. Through WCG Gene Therapy, our clients have access to the best and most current thinking in this new and emerging field.

WCG Gene Therapy combines our unmatched review and consulting capabilities with the insights of experts from diverse backgrounds with specialized knowledge of the clinical development, regulatory oversight, and clinical application of products involving gene therapy, to help our clients to safely manage increasing volumes of this complex and potentially hazardous research.

OUR SERVICES INCLUDE:

  • IBC review and assessment services
  • Transitional support (internal IBC administration to external IBC administration)
  • Clinical trial protocol development for recombinant materials (subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acids)

Through our relationship with WCG, we have evaluated over 300 human gene transfer protocols to date – more than any organization outside of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).

WCG Gene Therapy is supported by:

A GENE THERAPY ADVISORY BOARD that is comprised of experts from diverse backgrounds with specialized knowledge of the commercial development, regulatory oversight, and clinical application of products involving recombinant DNA. They provide guidance and strategic counsel to WCG and our clients, ensuring that knowledge and best practices are reflected in the company’s oversight of human gene transfer research, which involves the careful coordination of IRB and IBC reviews, and preparing clients to manage increasing volumes of this type of complex and potentially hazardous research.

WCG Gene Therapy Advisory Board Members

MARK BAGARAZZI, MD
Chief Medical Officer, Inovio Pharmaceuticals

CARL JUNE, MD
Director of Translational Research, Penn Medicine

HANS-PETER KIEM, MD, Dr MED.
Chair, Recombinant DNA Advisory Committee (RAC);
Head of Heme Malignancy Program, University of Washington/
Fred Hutchinson Cancer Research Center

ARNOLD J. LEVINE, PHD
Professor, Institute for Advanced Study, School of
Natural Sciences

TONY REID, MD, PHD
Chair, Association of American Cancer Institutes; Professor,
University of California San Diego

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