A solid foundation for personalized medicine

CAMBRIDGE, Mass.—Foundation Medicine Inc., a personalizedcancer medicine company that aims to bring comprehensive cancer genome analysisto routine clinical care, will collaborate with Novartis to develop, enhanceand optimize Foundation's cancer genome panel test for Novartis' needs.

If the pilot phase is successful, Novartis and FoundationMedicine will evaluate opportunities to collaborate on the production andcommercialization of the test. Financial details of the agreement were notdisclosed.

In a joint statement, Novartis noted that it became aware ofFoundation's expertise in sequencing from existing Novartis Institutes forBiomedical Research (NIBR) collaborations, and as a result, decided toimplement the partnership.

Foundation was launched with the assistance of a team ofacademic advisors from the Broad Institute, the Dana Farber Cancer Institute,Harvard Medical School and the Massachusetts Institute of Technology, and isbacked by Third Rock Ventures, a life sciences venture capital firm. AlexBorisy, formerly an entrepreneur-in-residence at Third Rock, founded Foundationand was named CEO in 2010.

Foundation is focused on developing clinical laboratorytests—using next generation sequencing and other advanced technologies—thatwill broadly analyze the relevant tumor genomic and other molecular informationpresent in individual patients' cancers.

The results will be delivered tooncologists in an easily accessible, as yet unspecified, format, "within thecontext of a growing knowledge base of published clinical data to helponcologists personalize treatment," the company states.

As of now, Foundation'scancer genomics laboratory tests are in development and not yet available forclinical use.

According to the joint statement, "It is too early tospeculate on specific timing, but we anticipate being able to complete theevaluation of Foundation's current approach by the end of 2011. The value ofthe Foundation Medicine test is that it will be relevant to all cancer typesand the entire Novartis oncology portfolio."

Apparently, Foundation expects its technology and tests torequire changes in regulatory policies and approaches.

"The transformation toward personalized cancer medicine willnot be simple; many scientific and technical hurdles must be crossed before werealize our vision. The business, regulatory and public policy issues that mustbe addressed are challenging, too.

"For example, will the United States' patent system (andother national and multinational patent organizations) remove barriers thatimpede the equitable provision of new genomic and other molecular diagnostictests? Will the Food and Drug Administration (and its sister organizationsaround the world) modify or clarify regulations and policies to accommodate thenew world of personalized medicine? Will Medicare, Medicaid and privateinsurers reexamine evidentiary and other reimbursement preconditions, so thatpersonalized cancer care becomes available and accessible to all patients?Genomic medicine has the capacity to revolutionize cancer care, but if thesebusiness, regulatory and public policy issues are not adequately addressed, thetransformation in cancer care will be slowed," the company cautions.

"This pilot collaboration with Novartis represents our firstpharmaceutical partnership, and we are delighted to accomplish this importantmilestone with one of the world's leading cancer therapeutic companies," Borisysays. "As part of this agreement, Foundation will leverage the broad contentsand high quality of our cancer genome analysis platform. By delivering aclinical-grade analysis of molecular information, Foundation's dedicatedclinical research team will help our partners more rapidly translate novelfindings into therapeutically applicable results. This collaboration is animportant step forward for Foundation and could provide us with the basis forbuilding successful cancer genome analysis platforms for future collaborationsand partners."