You can’t get away from personalized medicine, Harry Glorikian told attendees at the Evolution of Advanced IVDs conference in San Diego this week. “Everyone is on board . . . it’s unprecedented . . . but there is no alignment. Pharma and IVD companies are in an awkward dance . . . the system is broken,” said Glorikian, founder and managing partner of Scientia Advisors.

 

The disconnect between pharma and IVD companies in the companion diagnostics (CoDx) space was a recurrent theme at the conference, which was held at the San Diego Convention Center on September 19 and 20, 2012. A big part of the problem, said Glorikian, is that “drug companies just don’t understand diagnostics. They will say, ‘can't you just throw together a CoDx? We need it right now.’ It happens all the time.”

 

Mollie Roth, Chief Operating Officer, Diaceutics, concurred, and then some. Speaking on the second day of the conference, Roth explained to attendees that pharma has difficulty grasping the profit structure and stakeholder chains of diagnostics companies. Diaceutics is dedicated to developing effective business models for the personalized medicine (PM) space, and Roth has a background in managing patent and product liability litigation for the pharmaceutical industry, so she understands the mindset on both sides of the divide. She cited the pricing of CoDx as a huge factor in the successful commercialization of PM products, calling out as examples the companion diagnostics developed in conjunction with Pfizer’s Selzentry and Xalcori.

 

In pharma/IVD partnerships, timing is crucial for pharma companies, pointed out Mya Thomae, founder and CEO of the Myraqa consultancy. Approval for the diagnostic must occur prior to or simultaneously with therapeutic approval, she stressed. Ideally, you often need “approvals for the drug and CoDx at the same time.” Know that early in the process and make sure you have all of your ducks in a row.

 

Several speakers noted that diagnostics companies must make an effort to educate their pharma partners about what they do and, in particular, explain the complexity of their business.

 

Change won’t come overnight, but you’re in this for the long haul, right?

 

Produced by IVD Technology and organized by UBM Canon, the conference on the Evolution of Advanced IVDs was held at the San Diego Convention Centre on September 19 and 20.