In previous posts on this blog, our scientists have described the current state of precision medicine, particularly how it relates to companion diagnostics (CDx) and immuno-oncology. As an enterprise, we have been focused on this area of medicine essentially from the beginning, more than 20 years ago. LabCorp Diagnostics developed the clinical trials assay and served as the central lab for the testing of HER2-positive breast cancer during the development of trastuzumab. The company provided analytical testing data for the associated immunohistochemistry laboratory test resulting in the first companion diagnostic approved by the FDA. More recently, Covance was instrumental in supporting the drug development efforts for pembrolizumab, the therapy used successfully to treat former President Jimmy Carter’s melanoma, and its associated companion diagnostic. Continue reading
Drug developers are increasingly incorporating a CDx development (companion diagnostic) strategy into their programs to deliver safer, more effective and appropriate therapies to the right patients. While the end result can be significantly beneficial for patients, and development partners, the path from analytical and clinical validation to demonstrating clinical utility and obtaining regulatory approval is often challenging. It requires a comprehensive understanding of clinical trial design, regulatory submission strategies both for the therapy and the diagnostic assay, and also a line of sight for successful commercialization. Continue reading
Companion Diagnostics: The New Engine
Companion diagnostics’ impact on pharmaceutical development is like dropping a new engine into a classic car. Faster speed. Better performance. More efficiency. Companion diagnostics is changing the way we develop, test and market new therapies—with full-throttle power.
Today, we often have the ability to test a patient to see what drugs will work—or not work—and watch for mutations and triggers down the road. But back up a bit: we can also design drug trials to include subjects with the correct biomarkers for the treatment. And back up a bit more: we can develop drugs and biomarker tests together for the most effective combinations of disease targets, drugs and patients. Continue reading
In the effort to reduce attrition rates and improve approval rates of new molecular entities by regulatory agencies, there’s no doubt that biomarkers can make a big impact. But it’s not as simple as tacking on additional studies. Biomarker development requires an insightful strategy and consideration of specific opportunities and needs throughout the drug development pipeline.
A quality biomarker starts at the source—the sample itself. Sample collection and handling protocols must be standardized to specify the minimum volume requirement in the proper container along with the most optimal temperature during transportation and storage. These requirements should be backed and driven by validated processes. To further ensure biomarker stability, it’s equally critical to include the maximum allowed time in transportation. Continue reading
As the pace of companion diagnostic innovation continues to accelerate, the drug development industry faces several headwinds. Numerous patent ‘cliffs’ are affecting the sales of blockbuster drugs; competition is increasing for a limited clinical trial population in increasingly global trials; and health outcomes pressures from patients, payers and healthcare providers are transforming the drug development process.
Over the past 10 years, advances in analytical technologies have provided new tools to identify patients who are more likely to positively respond to a certain drug or, conversely, experience a negative reaction to the particular therapy. These tools, known as companion diagnostics, are laboratory tests for biomarkers that, once commercialized, are designed to be an accompaniment to the safe and effective use of a particular therapy. 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
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