As the biopharmaceutical industry increasingly focuses on discovering and delivering targeted, personalized medicines, we have stepped up our personalized medicine services to help sponsors conduct biomarker-driven oncology trials. The stakes are high for our clients as their drugs move through clinical development. Many of the old, well-tested strategies for developing cancer drugs are no longer relevant, and biomarkers are becoming an integral part of the story. More and more, oncology clinical trials are focused on biomarker strategies in which selecting the right patients is critical to a trial’s success.
The following article is an excerpt from an interview conducted by Clinical Leader with Mark Roberts, Ph.D., Director of Diagnostics Development at Covance. (http://www.clinicalleader.com/Doc/covance-cro-partner-rxcdx-co-development-0001#)
Personalized medicine presents a complex technological challenge. Combining an in vitro test for patient diagnosis and selection with a specific drug therapy — each traditionally the product of a separate industrial sector — requires the integration of two somewhat disparate development tracks, as well as all the skills needed to navigate both paths. It is hardly a theoretical conundrum. Short of producing a mass-market blockbuster with unprecedented safety and efficacy, the fate of the typical pharma company may hang on whether it can achieve superior outcomes by using biomarker tests to match new, targeted drugs to the right patients for the best-possible therapeutic management and response. Despite the innate challenge of integrating drug and device development inside traditional pharma companies, personalized medicine has them rushing to develop and commercialize companion diagnostics (CDx) products. Continue reading
The ‘promise’ of personalized medicine is quickly becoming a reality, as the biopharmaceutical industry increasingly turns its focus to discovering and delivering targeted, personalized therapeutics. Companion diagnostics are at the core of this personalized medicine shift, helping provide more effective and efficient treatments in smaller numbers of patients. In fact, indications are that a companion diagnostic will accompany up to half of all future drug launches boosting the worldwide companion diagnostics market to an estimated $3.45 billion by 2015 (www.visiongain.com).
Contract Research Organizations (CROs) which are uniquely positioned to span the gap between pharmaceuticals and their companion diagnostic partner assays have a critical role to play in the process of drug and companion diagnostic co-development. Continue reading
Effective drug development requires a thorough understanding of diseases, especially as we produce ever more targeted drugs. In addition, with the 65+ age group growing worldwide (estimated to reach 40% of the population in Japan by 2050), hospitals may find it increasingly difficult to cope using current capabilities alone. Novel, collaborative approaches using biomarkers, assays and sampling, technology platforms, imaging and studies will therefore be key.
In Sweden, we are working on major biobanking initiatives and biomarker studies to identify the different stages of diseases, as drug development targets these. We also examine links between disease and treatment and characterise the drugs together with pharmaceutical companies. The U.S. government is supporting new technologies such as genomics, proteomics, genetics, linking databases and bioinformatics and sharing clinical data. Continue reading
Imagine a simple clinical test that can not only diagnose a disease, but that can also identify the exact, personal therapeutic regime to cure it. Not only that, imagine tests that can accurately predict the potential of developing a disease and provide an individualized roadmap on how it will progress. Now imagine that all you had to do was spit in a vial, or have a few hairs plucked for the analysis. While the promise of “personalized medicine” is technologically a reality, it relies on the development of disease and progression biomarkers. Continue reading
As the biopharmaceutical industry increasingly turns its focus to discovering and delivering targeted, personalized medications, the companion diagnostics field is rapidly advancing. By 2015, the worldwide companion diagnostics market will be worth $3.45 billion, according to London-based market research firm Visiongain. The involvement of central laboratories in the companion diagnostics space is also growing, as they increasingly play a role as partners with, and facilitators between, biopharma and diagnostic companies. Continue reading
In March 2011, Covance’s Seattle-based Genomics Laboratory (CGL) collaborated with the Institute for Systems Biology (ISB), also based in Seattle, to collectively unravel the complex regulation of gene expression in Glioblastoma Multiforme (GBM), one of the most common and aggressive forms of brain cancer. By applying Covance’s expertise in genomics and next-generation sequencing (NGS) with ISB’s expertise in complex genomics networks, the researchers’ goal is to gain a greater understanding of GBM. Since joining forces, CGL and ISB have made significant headway towards elucidating the genetic mechanisms behind GBM.
Although considerable efforts have been applied to unravel the complicated genetic background of GBM – the most common and malignant of all gliomas − it still has an average survival time of a little more than one year after diagnosis. Currently, the best available therapy for treating GBM consists of surgery, radiation, and chemotherapy. However, the survival time for those inflicted with GBM remains low due to its highly invasive and infiltrative nature, which makes complete eradication of the tumor via surgical resection challenging.