WCG(R) (WIRB-Copernicus Group(R)) Clinical Services Division, the world's leading provider of solutions that measurably improve the quality and efficiency of clinical research, has entered a strategic partnership with InformedDNA(R), the nation's largest independent provider of genetics expert services. Through this partnership, the companies will create the "Center for Genetics and Precision Medicine in Clinical Trials" to support biopharmaceutical companies, contract research organizations (CROs), institutions and investigator sites in the design and conduct of clinical trials that use genetics.
"Precision medicine demands that we rethink the traditional drug development process," said Donald A. Deieso, PhD, Executive chairman and CEO of WCG. "The disease, as well as the proposed treatment, must be carefully considered in the context of the patient's individual genetic makeup. To that end, we are delighted to partner with InformedDNA to introduce genetic-oriented clinical trial solutions that will support our clients as they work to deliver the extraordinary promise of precision medicine."
Under the strategic partnership, WCG and InformedDNA will launch the Center for Genetics and Precision Medicine in Clinical Trials, which will unite InformedDNA's substantial genetics resources and expertise with WCG's global network of 550 experts in clinical trial optimization and its proprietary industry Knowledge Base(TM). WCG combines its deep understanding of 95% of all industry-sponsored protocols with InformedDNA's industry-leading team of 50 nationally-distributed genetics specialists and its extensive genetic database across all therapeutic categories. Together, the partners will deliver unparalleled insights and guidance regarding the optimal application of genetics in clinical trials. Specifically, they will tackle the challenges and opportunities of applying genetic information in trial and protocol design as well as harness the power of genetics to identify, recruit, and manage patients in clinical trials.
"With the rise in precision medicine, protocols have become increasingly complex," said David Nixon, chairman and CEO of InformedDNA. "This complexity presents challenges in the design of clinical trials that include genetic components, but also the opportunity to uncover greater value in the process through a proper genetic focus. Through our partnership with WCG, we will teach research sponsors how to effectively apply genetic expertise to their studies so that they can derive the most value from their research."
The companies will offer a genetics and clinical development solution to optimize the design of protocols and to ensure that all genetic information is appropriately applied to study design. The solution will enable sponsors to identify hard-to-find patient populations, reduce their exposure to risk, identify broader potential therapeutic indications, and increase the overall value of each trial subject.
Rebecca Sutphen, MD, FACMG, InformedDNA's Chief Medical Officer, added, "As the focus of clinical research increasingly shifts toward rare and orphan diseases, as well as greater personalization, patient recruitment becomes a significant challenge: How do you find and engage the right patients to participate in these studies? Obviously, trial sponsors and clinical research sites must harness the power of genetic information. But first, they must access the expertise and infrastructure to collect that genetic information, and then apply it to enhance and manage different methods of recruitment."
WCG has a proven record of driving study enrollment in rare disease and hard-to-reach populations. InformedDNA maintains a global network of genetic datasets that facilitate the rapid identification of patients with unique or rare conditions. Together, they offer a patient engagement solution that leverages both of these strengths, as well as the power of genetic testing and counseling to identify patients for clinical studies based on genotype/phenotype requirements. They will also offer genetic counseling and genetic test interpretation services to patients and investigators, which are proven to increase provider satisfaction and patient retention.
"Forging new pathways to support clinical development in genetics and precision medicine is critical to help create a world where no life is limited by genetic disease," said Ron Philip, head of Commercial at Spark Therapeutics, a fully integrated, commercial gene therapy company that worked with InformedDNA as Spark prepared for the first FDA approval for a gene therapy for a genetic disease. "The efforts of WCG and InformedDNA to ensure access to genetic testing and counseling are an essential step to support the clinical development of genetic medicines and could benefit millions of patients suffering from rare and genetic diseases."
About WCG (WIRB-Copernicus Group)
WCG (WIRB-Copernicus Group) is the world's leading provider of solutions that measurably improve the quality and efficiency of clinical research. The industry's first clinical services organization (CSO), WCG enables biopharmaceutical companies, CROs, and institutions to accelerate the delivery of new treatments and therapies to patients, while maintaining the highest standards of human subject protections. For more information, please visit www.wcgclinical.com or follow us on Twitter @WCGClinical.
About InformedDNA
InformedDNA helps individuals and healthcare providers accurately interpret family health history and genomics, bringing the promise of precision medicine to life. InformedDNA is the authority on the appropriate use of genetic testing – leveraging the expertise of the largest full-time staff of independent board-certified genetics specialists to help ensure health plans, hospitals, employers, community clinicians and patients all have access to the highest quality genetic services. In addition to supporting clinical trials, InformedDNA's key offerings include clinical genetic counseling, genetic testing utilization management, and personalized hereditary risk assessment and prevention solutions. For more information, visit InformedDNA.com.
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