Drugs Need Friends Too

At the BIO CEO & Investor Conference, industry leaders will address how new technologies fit into the biotech business model.

Drugs approved with companion diagnostic tests represent the next wave of personalized medicine and have the potential to significantly improve patient outcomes.

Companion diagnostics are changing the face of drug discovery and development and clinicians and investors alike are coming together for partnerships focused on the development of therapies for specific patient populations.

As biomarkers are discovered, using a companion test to predict if a specific drug or therapy will work in individual patients, and determining the appropriate dosage, can improve health care safety and drug efficacy.

The Personalized Medicine Coalition, a nonprofit advocacy group, reports that there were 72 prominent examples of personalized medicine drugs, treatments, and diagnostics products available last year.

Last year, there were two significant drug approvals in companion diagnostics:

• Pfizer’s Xalkori: Approved to treat patients with late-stage lung cancer who have an abnormal ALK gene in August.  Comes with a companion diagnostic test to screen potential patients for the ALK mutation.
• Daiichi Sankyo (Acquired when the company bought U.S. based biotech Plexxikon last year ) and Roche’s Zelboraf:  Approved in August for BRAF V600E-mutation positive melanoma.  Also comes with a companion diagnostic test to screen patients for the mutation.

Regulatory challenges associated with an unclear oversight process have slowed timelines and thwarted progress. Obviously, the FDA must address the complexity of personalized medicine as it is not a one-size-fits-all approach to drug discovery and development.

Delivering new and improved treatments and cures to patients should be the primary focus of companion diagnostic R&D, without question. Partnerships hold the key to advancing drug development and delivering on the potential of companion diagnostics.

At next month’s BIO CEO & Investor Conference, industry leaders will address how these new technologies fit into the biotech business model and how companies can best leverage companion diagnostics to enrich products and expand therapeutic opportunities.

The session, Drugs Need Friends Too – Companion Diagnostics and Drug Development, will be moderated byPatrick J. Mahaffy, President and CEO of Clovis Oncology.  Boulder, CO-based Clovis Oncology is a biopharmaceutical company focused on companion diagnostics that direct their product candidates to the patients most likely to potentially benefit.  The company has three product candidates in the pipeline.