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
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