By Koh Furuta
Director, Division of Clinical Laboratory, Kanagawa Cancer Center
East met West at the second symposium held by the Japan Human Biospecimen Science Society (JHUBSS). The topic for the conference, which met December 6 at the Tokyo International Exchange Center on the National Cancer Center Tsukiji Campus, was International Standardization and Specimen and Data Distribution in the Field of Biobanking. The meeting was highlighted by presentations from Dr. Jan-Eric Litton, Director General of the European based BBMRI-ERIC, as well as by Dr. Tohru Masui, Professor at the Center for Medical Genetics at Keio University School of Medicine, and Dr. Yohei Miyagi, Director of the Kanagawa Cancer Center Research Institute.
Masui presented “Current Status and Progress of Standardization by the ISO in the Field of Biobanking.” Miyagi’s presentation focused on “Distribution Experience of the Kanagawa Cancer Center.” Both topics flowed well with Litton’s overview of the BBMRI-ERIC experience and how it may relate to both the Japanese biobanking experience as well as the global perspective.
The BBMRI-ERIC “hub and spoke” biobank blueprint: “A new governance tool for the international standardization for biobanking.”
Using the development of the Research Infrastructure for Biobanking and BioMolecular Resources (BBMRI) and the European Research Infrastructure Consortium (ERIC) as a backdrop, Dr. Litton highlighted how the evolving scientific landscape brought biobanking into sharp relief for the critical role it will play in elucidating causes of disease, translating findings, and advancing public health.
To help meet these challenges, Dr. Litton explained, many countries are investing in biobanking infrastructures and substantial efforts are targeted towards developing an internationally harmonized network of biobanks to support large-scale bioscience. To strengthen biological and medical research and to overcome the fragmentation of European biobanks, BBMRI was initiated in 2008. Within three years, it grew into one of the largest health consortiums in Europe. These efforts culminated in the European Member States’ decision to apply for the European Research Infrastructure Consortium (ERIC) legal framework. BBMRI-ERIC was founded on 3 December 2013, three days after the Statutes were published in the Official Journal of the European Union.
Because the existing biobanks have a strong national character and background, Dr. Litton explained that a distributed hub-and-spoke structure was implemented for BBMRI-ERIC. This structure, Dr. Litton said, is now expanding to a global level. To serve as a hub to connect researchers with biobank services, the consortium launched the BBMRI-ERIC Directory in 2015, making about 45 million samples available to researchers over the internet. The Directory is closely coupled with the development of the MIABIS (Minimum Information About Biobank data Sharing) 2.0 standard.
International quality standards was also a major topic, as Dr. Tohru Masui’s presentation served as an introduction to the International Standards Organisation (ISO) and the history of Technical Committee 276 (TC276), in particular TC276/Working Group 2 (WG2) – the working group focused on biobanking per se. Dr. Masui provided a summary of the Tokyo meeting of TC276 at the end of October 2015. Incidentally, the TC276 meeting was held at the same venue of this JHUBSS seminar.
Dr. Litton also commented on ISO and Europe noting that since April 2015 BBMRI-ERIC has been an Observer Liaison of ISO/TC 276 “Biotechnology” as well as ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems”. The consortium, Dr. Litton explained, actively contributes to the process of international standard developments in addressing comments and references as well by sharing developments of the ISO Working Groups with the BBMRI community.
Dr. Yohei Miyagi’s presentation focused on the “Distribution Experience of the Kanagawa Cancer Center.” The center collects cancer-related specimens, and offers them without charge to researchers and treatment drug and method developers engaged in oncology. In this role, the center also created systems to appropriately distribute specimens by obtaining comprehensive consent before collecting cancer-related specimens, storing/managing them using the linkable anonymization method, and recruiting members of the Kanagawa Cancer Research and Information Association. The Center established the association in 2006 through cooperation with the former Kanagawa Prefectural Hospital Services Agency (currently the Kanagawa Prefectural Hospital Organization).
With its internal research and ethics examination systems, the Kanagawa Cancer Research and Information Association has independently examined members’ research projects. Being launched without experience, the distribution business had been improved through minor modifications, and continued until May 2013 when the association was dissolved.
At present, specimen distribution services are suspended to implement preparatory procedures designed to ensure appropriate ELSI management in consideration of differences from that needed since 2006 when the association was first formed. The Center appreciated sharing its experiences with members of the Japanese biobanking community, and receiving input from both providers and users.
81 biobankers and professionals with an interest in biobanking participated in the symposium.. According to a questionnaire distributed afterwards, 99% of participants were satisfied with this symposium and was looking forward to future meetings like this.