WIRB-Copernicus Group Biosafety Expert to Present at the Inaugural Sargon Research Annual Conference
Dr. Chris Jenkins will outline the best strategies for managing gene therapy clinical trials
PRINCETON, N.J., Aug. 14, 2015 – WIRB-Copernicus Group® (WCG™), the world’s largest provider of regulatory and ethical review services and software to support clinical research, announced today that its Senior Vice President of Biosafety and Gene Therapy Chris Jenkins, PhD, MPH, RBP, CHMM, will discuss best practices for the oversight of clinical trials involving human gene transfer at the inaugural Sargon Research Annual Conference. This meeting will be held at the Pro Football Hall of Fame in Canton, OH from Aug. 14-15.
“Human gene transfer is a rapidly evolving and promising therapeutic area, especially for certain cancers and rare genetic diseases,” commented WCG Chairman and Chief Executive Officer Donald A. Deieso, PhD. “However, these clinical trials require more complex oversight than those involving drugs or medical devices. These protocols have to be approved by an Institutional Biosafety Committee (IBC) as well as an Institutional Review Board in order to protect not only the participants and research team but also their families and the general public.”
“WCG’s mission is to safeguard human participants in clinical research. I am delighted to have this opportunity to share my biosafety knowledge and human gene transfer experience with other clinical research professionals,” said Dr. Jenkins.
He will address gene therapy as a subset of immunotherapy, and discuss the clinical trial challenges it presents during the session entitled: “Human Gene Therapy: Coming of Age” at 10 a.m. ET on Aug. 15.
Dr. Jenkins specializes in providing biosafety consulting services and overseeing research compliance with higher-risk biological materials ranging from human gene transfer to select agents and toxins. He oversees more than 200 IBCs in universities, private research institutes, and clinical settings.
Sargon Research, which is Gabrail Cancer Center Research’s (GCCR’s) clinical research network, studies the clinical trial process from patient enrollment onward. GCCR reports that during the past 16 years, it has enrolled more than 2,800 patients, conducted more than 320 clinical research trials, and hosted three FDA audits. It plans to share some of the knowledge it has gained during the conference.
Topics to be covered include patient identification and recruitment, securing informed consent, enhancing data collection, managing insurance issues, preparing for FDA audits, and increasing public awareness of clinical trials. This new show is expected to attract clinical trial investigators, and research staff from pharmaceutical companies and contract research organizations.
For further information about this conference, please visit www.sargonresearch.com/conference.
About WIRB-Copernicus Group
WIRB-Copernicus Group (WCG) is the world’s largest provider of regulatory and ethical solutions for clinical research. The company provides Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) reviews, and Human Research Protection (HRP), Good Clinical Practice (GCP) and Biosafety consulting services. Its technology offerings include IRB workflow management solutions (IRBNet), clinical trial management software for sponsors and contract research organizations (ePharmaSolutions), and Part-11 compliant online learning solutions for research professionals (WCG Academy).
The pioneer of independent ethical oversight, WCG continues to drive progress in the clinical research space. WCG empowers clients to accelerate life-saving advancements, while ensuring that the risks of progress never outweigh the value of human life.
For more information, please visit www.wcgclinical.com or follow us on Twitter @WCGClinical.
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