What constitutes a good "fit?" That was the question being asked during the breakout session "Last Year's Clothes Just Don't Fit Anymore: New Approaches to Product Development Collaborations between Drug and Diagnostic Companies" at the BIO 2009 Convention in Atlanta. The session sought to address the challenges facing biotech and pharmaceutical companies co-developing drug and diagnostic products. Chair Eileen Smith Ewing from K&L Gates, LLP said the title of the session reflected the recognition of companies and the FDA that their standard solutions to companion technology problems are not working anymore, or are a "bad fit."
Panelists Mara Aspinall and Bob Goodenow brought their different perspectives to the discussion, with Aspinall describing regulatory issues from a diagnostic perspective and Goodenow tackling the issues from the perspective of a drug company working in the biomarker space. Aspinall, an advocate for a strong diagnostic industry, ended her presentation with a call to action and some suggested potential system reforms for the various stakeholders. She called for a higher threshold for drug approval, especially when a biomarker is known or suspected. She also suggested that payers require the use of a diagnostic when a test exists, and require drug “pay for performance” guarantees. She also recommended new standards for diagnostics, including a transparent regulatory pathway and value-based, transparent reimbursement.
BIO has long advocated that these systems be modified to reflect the value these products bring to the healthcare system. To read BIO’s Principles on Personalized Medicine, click here.
Ewing, Goodenow, and Aspinall all agreed that the old ill-fitting collaboration model needs to be revolutionized to “fit” the realities of the current time. The key areas in the discussion that need to be sorted out are: risk-based oversight mechanisms, value-based purchasing, performance-based business models…which are all related to: how do we get these valuable products to patients who can use them?
Laura Sambataro works on personalized medicine and federal research programs funding policy for BIO. For more information, email Laura at email@example.com.