How can identical twins, with the same genetic makeup, experience different diseases? Scientists believe this is due to epigenetic marks or chemical tags that play a role in controlling the activities of genes. The study of the epigenetic landscape has already generated recent breakthroughs in the detection, treatment and prognosis of many diseases, including cancer.
These breakthroughs are due in part to large-scale mapping efforts of cancer genomes coupled with the rapidly dropping costs of high-throughput next-generation sequencing technologies. Identification of mutations and epigenetic analysis are the next frontier for finding reliable biomarkers and developing targeted therapies.
Next-generation sequencing platforms are particularly powerful for mutational and epigenetic studies due to their ability to quickly analyze the entire genome through multiple methods of sequencing, such as DNA, RNA, miRNA, whole genome, exome, targeted, ChIP-Seq, methylome and epigenome. As a result, researchers obtain comprehensive, clinically relevant data sets.
With these resulting data, computational biologists can mine both open source data sets along with data sets from clinical trials to narrow down options for prospective biomarkers. Continue reading
First established as a standard practice in clinics, in vivo imaging also benefits translational or preclinical research. For the past 25 years, many studies have relied on in vivo imaging as a method to quantify treatment response and gain early insights on efficacy. Now, as the technology advances, researchers can expect to benefit from greater spatial resolution and software advancements that allow faster, cost-effective translation of study results.
“Imaging often gives you unique information that can’t be obtained any other way. The phenomena that you would observe preclinically may be the same disease state in the clinical trial,” says Michael Cockman, Senior Scientist and Manager of the Imaging Center at Covance. “It’s common to hear from a client who wants to test a type of imaging, called a modality, in a particular disease state to find out if it is appropriate for clinical development later.” Continue reading
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.
Early clinical research continues to be a high stakes industry requiring increasingly complex studies, procedures, and protocol designs all of which take longer to complete, which in turn drives up cost. The introduction of combined protocol designs—also called umbrella protocols—is gaining popularity among drug developers as a way to bring the first subject visit for the all-important proof-of-concept study forward by months, as well as saving significant cost.
Introducing a drug into the human body for the first time is an important milestone. Considerable investment goes into preparing for this day, with more to follow — 70% of the R&D cost needed to bring a drug to market is spent after Phase I. With so much at stake, human safety and early efficacy are now driving more go/no-go decisions than ever before.
Early Clinical Research Centers
With clinic locations throughout the US and Europe, we recruit a diverse healthy and patient population to participate in your clinical study. You have access to over 350 beds for fast and flexible study startup and a dedicated team of recruiting specialists for success in filling panels. In addition to the stability and reputation for quality that underscores all clinic operations, each clinical research unit offers you specialized capabilities such as a glucose clamp unit in Dallas, a human appetite lab in Leeds, and a dedicated cGMP pharmacy support team for radiolabeled AME studies in Madison. A clinical site will be selected based on your study needs and preferences, site experience conducting similar studies and site capacity. For more information about the clinics, please visit our website. Continue reading
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
Pharmaceutical manufacturers are operating in a highly competitive, complex and regulated market where the effective management of contracts, pricing, and rebates is vital to the overall health of their business. Without the right contracting infrastructure and processes in place, companies risk losing visibility and control over the contract lifecycle management, which can ultimately lead to revenue loss and non-compliance with government regulations.
Currently, the economic environment is challenging pharmaceutical manufacturers to grow amidst the reality of budget cuts and staff reductions. As contract scenarios become more complex, and companies lack the resources they once had, greater visibility into contract performance is even more critical. Administrative costs for pharmaceutical manufacturers are also increasing. A study conducted in 2012 by Deloitte confirmed that the cost for managing chargebacks and the rebate process is targeted to increase approximately 54% over the next five years. Continue reading
Data analysis, interpretation, and integration of high volumes of multidimensional data are the key to elucidating the mechanism of action of pharmaceutical compounds, understanding the pathways to disease onset and progression, biomarker and target identification. In today’s era of large data sets, biopharmaceutical companies are utilizing computational biology to comb through these massive sets of genomic data to find links between specific genotypes and diseases, screen drug data to identify therapeutic candidates, as well as identify responders to the treatment. Continue reading
Successful drug development is increasingly dependent on a robust “fail fast” strategy that includes incorporation of safety / toxicology endpoints into lead optimization pharmacology studies. This early marriage of pharmacology and toxicology will provide insight into the margin of safety that is critical for advancing the molecule, the design of the GLP studies and the clinical plan. Biopharmaceutical companies that employ a “fail fast” strategy can make safety decisions from the integration of toxicology into pharmacology studies, which markedly reduces lead optimization cycle times and overall spend during this phase. Continue reading
When we provide sample concentration data for submission with new drug applications, clients have an expectation that those data will meet regulatory agency expectations for quality, accuracy, and precision. Those expectations have been evolving since the first US consensus AAPS/FDA workshop (Crystal City I) in 1990. Subsequent workshops and the resulting white papers have formed the basis for guidance documents on conducting method validations and sample analysis. These documents are published by regulatory agencies such as the US FDA and the European Medicines Agency. Continue reading