Overview​ FIRM History​

2011 June Established “The Forum for Innovative Regenerative Medicine (FIRM)” with 14 companies
2015 March Opened the FIRM subsidiary office in Kansai area
Entered into Memorandum of Understanding (MOU) with The Alliance for Regenerative
Medicine (ARM) in the US
2016 May Entered into MOU with Centre for Commercialization of Regenerative Medicine (CCRM) in Canada
for accelerating Regenerative Medicine
July Hosted the 1st “Regenerative Medicine Crossroad in Tokyo”
October Entered into MOU with The Council for Advanced Regenerative Medicine (CARM) in Korea for
accelerating Regenerative Medicine in both countries
Introduced the environments surrounding Regenerative Medicine in Japan at the workshop in
Cell & Gene Meeting on the MESA 2016
Hosted the 2nd “Regenerative Medicine Crossroad in Tokyo”
Cosponsored “Regenerative Medicine Japan” session in BioJapan 2016 with Japan
Bioindustry Association (JBA) and conducted four sponsored seminars
Cosponsored the 1st “Industry-Academia-Government Regenerative Medicine Symposium
November Cosponsored the “2016 World Alliance Forum in San Francisco”
Entered into MOU with China Medical Biotech Association (CMBA) in China
Hosted the 1st “Regenerative medicine venture supporting seminar”
December Received approval of ISO New Work Item Proposal on design process to establish
specification of cell transportation
2017 February Hosted the 3rd “Regenerative Medicine Crossroad in Tokyo”
Hosted the 2nd “Regenerative medicine venture supporting seminar”
August Entered into MOU with Association of Biotechnology Led Enterprises (ABLE) in India
October Entered into MOU with AusBiotech in Australia
Cosponsored “Australia – Japan Regenerative Medicine Round Table”
Entered into MOU with Cell and Gene Therapy Catapult (CGT Catapult) in UK
Entered into MOU with International Society for Cell & Gene Therapy (ISCT)
2018 February Entered into MOU with Israel Stem Cell Society (ISCS) in Israel
April Hosted “The 1st Asia Partnership Conference of Regenerative Medicine Associations (APACRM)”
Entered into MOU with Biotechnology and Pharmaceutical Industries Promotion Office (BPIPO) in Taiwan
September Hosted the 8th “Regenerative Medicine Crossroad in Tokyo”
Hosted the 6th “Regenerative medicine venture supporting seminar”
October Hosted 2018 APACRM – Working Level Meeting (WLM) in Yokohama.
The chairperson of FIRM Standardization Committee was elected as a director of Standards Coordinating Body, US.
December Issued Material Standard (ISO/TS 20399 series) which is ISO standard.
Released the second edition of FIRM guidelines on the points to note when selecting plastic equipment which are used in the process of cell processing such as regenerative medicine and preservation and storage of cells.
Worked together with the Japanese Society for Regenerative Medicine to build FIRM education system whose name was “Clinical embryologist training system. “
Issued International Standard (Technical Specification) on request for Ancillary materials for manufacturing regenerative medicine products from ISO.
2019 March Hosted symposium “International Standardization by unification of industry, government, academia and people: Impact on Regenerative Medicine” at the 18th General Meeting of the Japanese Society for Regenerative Medicine.
April Hosted the second APACRM at Nihonbashi.
Officially launched FIRM educational system, “Clinical embryologist training system. “
Entrusted International Standardization Project of on cell evaluation and applications to product manufacturing by METI and MRI.
June Hosted the 7th General Meeting and Joint Working Group Meeting of ISO/TC276 at Life Science Hub Nihonbashi.
July Hosted ISO/TC276 information session at Nihonbashi Life Science Building.
August Released “Guidance on applications for approval and renewal of product and specified cell-processing products based on the Pharmaceutical and Regenerative Medicine Law: for domestic and foreign companies and medical institutions involved in regenerative medicine” from Seibundo Shinkosha, which was the firstly published book from FIRM.
Hosted the 8th gathering of Start-up supporting forum. The 9th forum in December 2019, the 10th forum in February 2020.
September Hosted the 10th meeting of Regenerative Medicine Crossroad. Hosted the 11th, in February 2020.
October Hosted 2019 APACRM liaison meeting of practical business (APACRM- WLM) in Yokohama.
Hosted Japan Session at Cell & Gene Meeting on the MESA 2019.
Supporting Industries Committee planed FIRM booth exhibit in Regenerative Medicine Japan, and actively explained activities of each committee, each WG and member companies.
2020 April Entrusted International Standardization Project for industrialization of cell applied regenerative medicines and their technology by METI and MRI.
June Released “Checklist on items from development to approval of Regenerative Medicine products “only to the FIRM members.

In addition to the above, FIRM has made a number of proposals and public comments, hosted roundtable discussions and seminars with government offices and affiliates, and through these activities, FIRM is strengthening the cooperation between Regenerative Medicine organizations both in and out of Japan.
(As of July, 2020.)