Thermo Fisher announced this week a collaboration with researchers at the Tokyo Medical University Hospital to establish a new Biomarker Research Center in Tokyo.
The center, which will be led by Tokyo Medical professor Toshihide Nishimura and Gyorgy Marko-Varga, professor at Tokyo Medical and Sweden's Lund University, will focus on developing biomarker panels for measuring patient response to drug treatments and the study of the modes of drug action, Marko-Varga told ProteoMonitor.
An obvious model for the Tokyo center is Thermo Fisher's Biomarker Research Initiatives in Mass Spectrometry, or BRIMS, Center in Cambridge, Mass., which the company established in 2005 for the purpose of developing turnkey mass-spec-based workflows for high-throughput biomarker discovery. According to Murray Wigmore, senior director of commercial operations for Thermo Fisher in Japan, BRIMS Center director Mary Lopez has been working with Marko-Varga and is "involved in collaborations and strategic planning" regarding the new center.
In addition, Thermo Fisher will be providing the center with "technical support and strategic direction," as well as instrumentation, software, and reagents for mass spectrometry workflows; bio-banking and sample prep equipment; and other technology, Wigmore told ProteoMonitor.
Prior to joining Tokyo Medical University Hospital, Marko-Varga was a senior drug discovery-development scientist at AstraZeneca where he was involved with a protein biomarker study of roughly 4,000 patients investigating the efficacy and safety of treating various cohorts with the lung cancer drug Iressa. Ultimately, the Iressa studies involved 52 lung cancer clinical centers throughout Japan and more than 6,000 patients – one of the largest biomarker initiatives in the pharmaceutical industry's history.
"In all of this I got to know a number of leading clinicians in Japan. And after leaving AstraZeneca, I wanted to do more of this biomarker research," he said. "That's how I got to meet with Murray and Mary and [established] the link to Thermo."
The center will focus particularly on biomarker tools to stratify cohorts of patients with lung cancer, chronic obstructive pulmonary disease, and cardiovascular disease. These illnesses, Marko-Varga said, will likely present the greatest challenges to Japan's medical establishment as the country's ranks of elderly citizens – currently 18 percent of the population – grows to an estimated 40 percent of the population by 2050. He has co-authored a soon-to-be-released white paper with several pharmaceutical companies and a number of Japanese clinicians identifying these diseases as being of key concern.
"The elderly group of society, this is a ticking bomb, and nobody really knows how to handle it," he said. "The big challenge here is how will Japan solve this problem, and that will be one major objective of the center."
"The healthcare area is under enormous pressure. So there need to be new solutions," he said. "And if you look at how you do diagnosis for a patient when they come in today, that is not satisfactory. After discussions with healthcare [providers] and researchers around the world, we made the analysis that it will be within the clinical area of diagnosis that most of the changes are going to happen."
"I know the challenges and the criticisms of the biomarker field," he said. "But if we are able to find drug effects on the molecular level, that's very important."
Marko-Varga cited recent studies led by Cristobal Belda-Iniesta at University Hospital La Paz in Madrid that he said suggested roughly 70 percent of cancer drug treatment has "no real use for the patient."
"It doesn't matter if you go to China or Japan or any country, you hear the same thing – too many patients, not efficient treatment," he said. "There are many drugs but the physician doesn't know which one to select. And this is where the Japanese authorities have said, 'We want to see a change.'"
In July 2009, the Japanese Ministry of Health, Labor, and Welfare announced new guidelines for drug reimbursement that tie pricing to whether or not a drug manufacturer can stratify potential patient cohorts by efficacy. Drug companies who "want the highest [reimbursement] pricing for a drug need some sort of assay that can stratify the patient group," Marko-Varga said — a development that will likely increase interest in the sort of biomarker work the center plans to focus on.
Discussions regarding funding for the center are ongoing, Marko-Varga said, citing talks with several Swedish and European funding sources and a number of healthcare companies.
"We know we can make [the funding goals], but it's still being put in place right now," he said.
The status of intellectual property developed within the center is also being worked out, he said, noting that the center's researchers have filed for four patents thus far. He suggested the organization might follow the Swedish university model where researchers own whatever IP is developed in their labs. Any licensing opportunities, he said, would be offered first to Thermo Fisher.
The researchers will maintain a laboratory at Tokyo Medical for housing comprehensive tissue and blood sample collections from drug responders and non-responders as well as complementary clinical and demographic data and materials from clinical studies conducted in Europe.
The center itself will be fully operational within the year, Marko-Varga said, noting that he and his colleagues are evaluating several potential hospital sites in Tokyo as headquarters. He said he expects it to comprise roughly 10 researchers.