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“In April 2008 the pharmaceutical affairs law was revised to allow third party vendors to perform direct-to-site distribution. Prior to this, pharmaceutical companies were required to hand-carry all clinical samples to clinical sites.  Fisher Clinical Services opened its state-of-the-art GMP facility in 2010 to serve multinational pharmaceutical companies wishing to include Japan in their global clinical trial strategies.

Located in Central Tokyo, we invite you to find out more about the services we provide to our well established client base – GMP storage, distribution and returns management, ancillaries, comparator purchasing, blinded labelling and packaging in many variants of temperature specifications. Our team consists of highly motivated, skilled professionals with bilingual (English and Japanese) proficiency, fully trained to offer a truly global solution for your clinical trial programs.” 

Yu Kushimoto, General Manager, Fisher Clinical Services, Japan

Fast Facts on the Healthcare Industry

  • Japan is the 2nd largest pharmaceutical market in the world
  • It is home to 127 million people and currently has the 3rd largest economy in the world
  • People in Japan have the longest life expectancy at birth of those in any country in the world
  • In recent years industry, government, and academia bodies in Japan have helped to raise awareness of the importance of clinical trial research
  • Clinical trials conducted in Japan adhere to jGCP standards and often to global standards as well
  • Data from clinical trials in Japan must be up to FDA standards if a Sponsor wants to pursue marketing approval in the US
  • Japan has 3 registries that work as a network known as the Japan Primary Registries Network
  • The submission of the Clinical Trial Notification (CTN) needs to be submitted by a Japanese entity
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First fully dedicated cGMP clinical supplies facility in Japan

Tokyo Fast Facts:
Location: Located in the Tokyo Bay area.
Population: 12.8 million
Nearest Airport: Haneda, but Narita International is main gateway for pharmaceuticals
Distance from Airport to Facility: 57.6kms to Narita, 18.9kms to Haneda
Fun Fact: Tokyo is home to the busiest train station in the world, Shinjuku with, 3.6 million visitors on an average day.

City:
Tokyo
Country:
Japan
Opened:
2009
Expansion:
2015
Total Capacity:
4,040 m3
Secondary Rooms:
3
Warehouse Capacity:
1,009 m3
Refrigerated Storage Capacity:
124 m3
Frozen Storage Capacity:
25 m3
SSS Drug Storage Capacity:
8 m3
Environmental Technologies:
Yes
Comparator Sourcing:
Yes
Labeling:
Yes
Cell Therapy:
Yes

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Key Benefits for Sponsors:

  • Strategically located in Central Tokyo
  • Multi-lingual team (Japanese & English) with a true appreciation of cultural nuances
  • Harmonized quality systems and standard operating processes at local jGMP and international cGMP levels
  • Expertise in blinding of IMP to GMP standard
  • Ability to import bulk shipments and to store inventory in secure, temperature controlled environment
  • Facilitates fast customs clearance via local customs agents
  • Facilitates import tax payments on behalf of clients
  • Storage capacity for controlled ambient and cold chain IMP
  • Distribution & logistics models to realize cost and performance efficiencies
  • Full regulatory support and guidance for local and global trials
  • Established relationships with investigator sites – ability to schedule shipments to accommodate patient schedules

Local contact removes language, cultural and time zone barriers

Our client, a Japanese pharmaceutical company, having selected a new compound for clinical development, wanted to streamline clinical trial deployment, maximize efficiencies and mitigate risk, with a view to accelerating time to market in this highly competitive environment.

Regulatory Changes

Traditionally only clinical trial data from Japan was accepted by Japanese Authorities (PMDA) for clinical trials for Japanese registration.  This regulation has changed. The PMDA now accepts clinical trial data from other Asian countries – Korea, Taiwan & China – in addition to Japan. Our client made the decision to conduct its Phase II study in the wider Asia Pacific region.

Packaging Efficiencies
The Sponsor selected India as the country of choice for the packaging of its Phase II trial. Fisher Clinical Services Ahmedabad was the partner of choice for this Sponsor due to its Free Trade Zone location and its compliance with jGMP, Japanese standards, including 100% inspection. Fisher Clinical Services, Ahmedabad, was identified as the only facility in the Asia Pacific region fully audited and approved by the MHRA for clinical trial packaging.

Once official approval was granted to the Sponsor, the Fisher Clinical Services team was primed to initiate packaging immediately. Furthermore, smaller batch sizes were accommodated, whether automated or non-automated, allowing the Sponsor to speed up delivery of clinical supplies to the target patient base.

Maintaining standards
It was important for the Sponsor to ensure Japanese standards were being upheld in Ahmedabad.  By using “Virtual Man in Plant” Technology, Fisher Clinical Services allowed the Sponsor to view live packaging activities in Ahmedabad via a secure video link. This enabled the Sponsor to ensure expected standards were being maintained at all times

Tax savings
The Free Trade Zone in India, a duty free enclave, deemed to be a foreign territory for the purposes of trade operations, duties and tariffs offered additional benefits:

  • No license required for import/export
  • No direct or indirect taxation (VAT, excise/customs duty & import/export tax)
  • No routine examination by customs officials of export or import cargo

Communication
The benefit of outsourcing to a global player was further evident to the Sponsor as the project progressed. The Sponsor was able to communicate with just one key contact person in Japan. The ability to work in the same time zone and the same language made it easy to conduct business with Fisher Clinical Services. This contact then managed all communication within the
extended Fisher Clinical Services network.

Global Distribution via Singapore
The distribution of supplies was seamless to the Sponsor. Fisher Clinical Services expertise in shipping large volumes of supplies globally, and in choosing the best courier, lane and route for all supplies allowed the Sponsor to realize cost and performance efficiencies across the supply chain, delivering supplies On-Time and In-Full to the patient, whilst mitigating risk.

Fisher Clinical Services Ahmedabad worked with colleagues in Japan and Singapore to streamline distribution of supplies in small batch sizes. In addition, this primary contact person in Japan had the regulatory expertise that was needed to facilitate importation of supplies back into Japan and into Singapore.

New studies

This Japanese Sponsor is planning to follow this seamless, proven approach for future trials – packaging in India and distribution across the Fisher Clinical Services global network, supported by its local Fisher Clinical Services Japan team, removing language, cultural and time zone barriers.

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Thermo Fisher Scientific Expands Global Footprint to Support Cell and Gene Therapy Clinical Trials in Japan

New regional BioPharma Services’ dedicated solution enables seamless support for global cell and gene therapy clinical trials across multiple geographies for biopharmaceutical customers

TOKYO, 3 October 2016 – To help meet increasing demand for cell and gene therapy clinical trial support around the globe, Thermo Fisher Scientific, the world leader in serving science, today announced the expansion of its Fisher BioServices cryogenic service capabilities in Japan. This expansion enables its customers to seamlessly conduct clinical trials across multiple geographies and provides patients around the world with access to life changing therapies. As a leading service provider to the cell and gene therapy community, Fisher BioServices is uniquely positioned with the experience, resources, and global expertise to support its customers on their path towards commercialization.

The facility in Tokyo was expanded to include cryogenic storage and logistics by utilizing a combination of proven components and validated procedures developed with years of experience in the cell and gene therapy business. The new modules within this facility allow Fisher BioServices to configure and replicate each site to meet the specific requirements of individual clinical trials with minimal variation, regardless of volume or geographic location. The facility is also supported by a global comprehensive and integrated Quality System based on regulatory requirements, industry best practices and trained personnel.

“Japan is an increasingly important market for cell and gene therapy companies conducting clinical trials,” said Dennis Barger, Fisher BioServices vice president and general manager. “The addition of cryogenic services to this facility in Japan, combined with our existing capabilities in Europe and the US, enables us to seamlessly support our customers’ global trials as they develop and commercialize their therapies.”

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