On August 6, 2012, I attended the IBC Life Sciences’ Drug & Diagnostic Development Conference at the Westin San Francisco Market Street Hotel. The three-day conference consisted of four ‘summits’ that included the Future of Rx/Dx Summit, the Clinical Biomarkers and New Frontiers in Cancer Summit, the Next-Gen Sequencing Summit, and the Antibody-Drug Conjugates, Bispecfics and Empowered Antibodies Summit. I decided to focus on the Future of Rx/Dx Summit business track. A number of the presentations discussed the many challenges and success factors that go into developing companion diagnostics (CDx), which companies need to consider when developing a CDx.
Tips to Navigate Rx/Dx Co-Development
Patrick Goody, Divisional Vice President, R&D at Abbott Molecular brought up a number of important guidelines during his case study presentation, “Co-development of Diagnostics and Therapeutics: Abbott/Pfizer Crizotinib.” Crizotinib (Xalkori) is Pfizer’s personalized medicine that targets a type of late stage non-small cell lung cancer (NSCLC). Abbott Molecular developed the FDA required EML4-ALK fusion companion molecular test that enables physicians to select the sub-group of patients that would benefit from using crizotinib.
He said in order to be successful, the partners need to “capitalize on their collective strengths and establish good chemistry.” He believes that good “communication is key.” Other important factors include “coordination of drug/IVD submissions as well as commercial execution and worldwide distribution.” Goody emphasized that pharmas should get involved with a diagnostic partner early. This point was mentioned in other presentations as well. He also said that there must be business incentives for both partners.
Ron Mazumber, Global Head, Research and Product Development, at Janssen Diagnostics spoke of the “Challenges and Opportunities/Solutions of CDx in Pharma” during his presentation. Some of the main challenges include the “complex regulatory landscape, PMA process/expectations, and variability of testing.” He offered some solutions such as “repurposing an existing 510 (k) cleared product, bridging studies, use of CTCs (circulating tumor cells), and multiple partners/platforms.” Mazumber said the “ideal scenario is to start at Phase 3 with an IUO (investigational use only).”
Panel Discusses Rx/Dx Business Ideas
I also attended the panel discussion about “Emerging Commercialization, Collaboration and Business Models for Rx and Dx.” One of the major themes of the discussion was that diagnostic companies need to continue to drive the value of their product. Panelist Michael Pellini, President and CEO, at Foundation Medicine, said, “it’s all about education.” Another panelist, Ron Andrews, President, Medical Sciences, at Life Technologies said, “We are venturing into a more complex world.” He said “a lot more goes into a diagnostic nowadays than even five years ago.” To the question posed by moderator Alexis Borisy, Partner, at Third Rock Ventures, “Do Pharmas ever pay diagnostic companies big fat royalties?” “No, pharmas are not paying diagnostic companies big fat royalties,” said panelist Ron Mazumder at Janssen.” However he did say, “pharmas are starting to recognize value but it is still a sticky issue.” Andrews said “there are tons of therapeutics that have been shelved that might have value if the right diagnostic is developed.” Panelist Pellini said that he “dreams of a fat royalty if they enter into a relationship with a pharma company and salvage a drug with a diagnostic.” “They should share revenue downstream if they add enough value,” he added.