RESEARCH IN ONCOLOGY

Nearly 14 million people around the world learn that they have cancer every year. Another 8 million people die from the disease (according to the National Cancer Institute). To help in the mission to find a cure, the WIRB-Copernicus Group® (WCG) has created WCG Oncology, a comprehensive solution to enable the highest quality review of cancer research and to ensure the rights and welfare of research participants.

Through our access to WCG Oncology, New England IRB is able to provide a deeper level of support to researchers around the world in their mission to eradicate cancer.

THE THREE FACETS OF WCG ONCOLOGY INCLUDE:

GEORGE DEMETRI, MD
Dana-Farber Cancer Institute

JOHN M. FALLETTA, MD
Duke University Medical Center

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

JOHN E. NIEDERHUBER, MD
Inova Translational Medicine Institute;
Former Head of the National Cancer Institute

JAMES ROTHMAN, PHD
Yale University; Recipient, Nobel Prize in Medicine, 2013

HOWARD SCHER, MD
Memorial Sloan Kettering Cancer Center

each of whom is deeply knowledgeable in a specific oncological discipline or area of research, to assist in the review of complex and scientifically challenging research.
focused wholly on the ethical and regulatory oversight of research in oncology.
RESEARCH INVOLVING rDNA

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 recombinant DNA, to help our clients safely manage increasing volumes of this complex and potentially hazardous research.

Through our relationship with WCG, we have evaluated over 250 human gene transfer protocols to date – more than any organization outside of the Food and Drug Administration (FDA) and the National Institute of Health (NIH).

Our review Boards are 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.

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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