Thermo Fisher Scientific Opens New State-of-the Art GMP Clinical Services Facility in Singapore
Pictured above (from left to right): US Deputy Chief of Mission Blair Hall, Leon Wyszkowski and Minister Counselor for Commercial Affairs, Regional Senior Commercial Officer – ASEAN, Margaret Hanson-Muse cut the ribbon during the official ribbon cutting ceremony.
New regional BioPharma Services hub offers larger operational space and advanced equipment to meet increasing clinical supply needs for pharma and biotech customers
SINGAPORE, 18 November 2016 – To address the growing global demand for clinical services, Thermo Fisher Scientific, the world leader in serving science, today announced the official opening of its new state-of-the-art GMP facility. Having established its first clinical services facility in Singapore in 2001, the move to this newly built facility will meet the growing demand for clinical supply services in the region. The new site will provide both regional and global pharmaceutical and biotech companies with a one-stop service for clinical supplies − from GMP storage, local labeling, secondary packaging, comparator sourcing, handling and distribution of ambient and cold chain supplies to returns management.
Located in Toh Guan Road, Jurong East − the hub for Singapore’s biomedical and pharmaceutical companies − the new facility is nearly 70,000 square feet (6,500sqm), more than 60 percent larger than the previous site and double the cold chain capacity.
The clinical services facility is also well-equipped with improved technologies and operational tools to serve a growing need for clinical supplies and trials in the region. This includes a larger storage system for its clinical supplies, a new climatic control energy consumption system that reduces the facility’s carbon footprint, and an overall building monitoring system that provides staff with timely updates on the facility’s conditions.
“Asia Pacific continues to be our fastest-growing market and a central contributor to our growth,” said Leon Wyszkowski, Thermo Fisher’s vice president of clinical services for North America and facility network. “For nearly 15 years, Singapore has been the central hub for our Asia-Pacific operations, due to its strategic location. With the opening of our larger and well-equipped facility, we aim to continue to build on our Singapore facility further and on the expertise of our local team, to strengthen our regional and global presence in the clinical supplies industry.”
Listen below to the Radio 938 Live Grand Opening Announcement –
At Fisher Clinical Services Singapore we are proud to be the industry’s most established clinical supplies provider in the Asia Pacific Region. Singapore, although one of the smallest countries in the world, is strategically located to distribute clinical trial supplies to surrounding Asia Pacific countries. Our Singapore team facilitates trials in Indonesia, Bangladesh, India, Pakistan, Thailand, Vietnam, South Korea, China, Japan, Hong Kong, Taiwan, the Philippines, Malaysia, South Africa, Australia and New Zealand.
We are proud to serve global pharmaceutical and biotech companies to meet their clinical supply needs – GMP storage, local labelling, secondary packaging, comparator sourcing, handling and distribution of ambient and cold chain supplies through to returns management. Our highly motivated, skilled professionals are fully trained to address the unique nuances of clinical trials in the Asia Pacific Region. Our customer service teams and professional project managers maintain the highest quality standards whether current Good Manufacturing Practices (cGMP) or strict international regulatory compliance.
We invite you to visit us in Singapore.
Chow Wengyin, General Manager, Fisher Clinical Services, Singapore
Fast Facts on the Healthcare Industry in Asia Pacific region:
Location: Southeast Asia
Population: 5.47 million
Nearest Airport: Singapore Changi (SIN)
Distance from Airport to Facility: 32 Km
Fun Fact: Singapore is a hub to the Asia Pacific region due to its strategic location at the crossroads of international trade and shipping routes and its free trade policy.
Our client, one of the top major pharmaceutical companies approached us for guidance on how to run an ambitious clinical trial in the Asia Pacific region; a trial involving 10+ countries, 74+ sites with 400+ shipments across the region.
This trial presented many challenges – cold chain IMP that needed to be kept at specified temperatures from point of origin to site delivery; late stage labelling of supplies to accommodate adaptive trial timelines; the need to access patient populations across many different countries in the Asia Pacific region and in many remote locations; multiple latent changes in client requirements; shortened timelines for fast drug approval. It became apparent that this Sponsor was going to totally rely on the Fisher Clinical Services team to manage this trial from start to finish.
Study Planning and Set-Up
From the outset it was clear that the Sponsor was relying on Fisher Clinical Services to:
Temperature Control challenges
South East Asia, in certain periods of the year, can experience extreme high temperature conditions, 32+ ?C. In addition, Pacifica zone and South Korea have different temperature climates which can affect the shipping conditions of cold chain clinical supplies. To help mitigate risk of temperature excursions on supplies during transit, the Fisher Clinical Services team:
Distribution model including remote locations
Many of the target patient population were living away from the big cities, in newly developed satellite cities and/or in more remote locations. Having thoroughly analysed the patient reach and expected delivery schedule for the entire study, the Fisher Clinical Services team identified that:
The success of this trial was measured in metrics, important for the Sponsor when reviewing the trial and when planning new trials in the region:
A 99% On-Time delivery record to patients participating in this ambitious trial is a statistic to be proud of. However, we continue to work at achieving a 100% statistic. Let’s never forget in our pursuit of performance perfection that at the heart of all we do is a patient.
Our client, one of the top major pharmaceutical companies with research priorities aligned to significant global health needs – diabetes, heart disease, cancer and mental health – had a high number of studies already in progress in the Asia Pacific region. The Sponsor’s focus on particular therapeutic areas indicated that many more studies would be planned for this region. The Sponsor, having concerns with its current distribution approach, recognized the need to review its distribution model for existing and planned studies in an effort to realize efficiencies in cost and performance.
Country specific affiliates
Traditionally all packaging and labelling functions were carried out in the North American and/or European facility and then transported as complete supplies to the many “country specific affiliates” across the Asia Pacific region. One obvious concern pointed to the varying levels of quality standards from one affiliate to another, as many did not consistently adhere to global GMP/GDP standards. In addition, this traditional model presented other challenges:
Historically there were many parties involved in managing the Asia Pacific trials – the Sponsor and Fisher Clinical Services teams globally and in the Asia Pacific region. A plan was put in place for all parties to work together as one team to carry out a high level of analysis of all current and planned clinical trial studies, to evaluate all aspects of the trial from start to finish, including packaging, labelling, storage, distribution models, returns and destruction. The team was tasked with realizing cost and performance efficiencies across the entire clinical trial process while adhering to trial timelines. This thorough analysis resulted in an alternative approach from the outset.
Regional Hub Approach
The new logistics model dictated the set up of an “Asia Pacific Hub” for the labelling and distribution of clinical supplies to all Asia Pacific countries. This hub would be Fisher Clinical Services Singapore. All IMP were sent directly to this facility, which would then handle all label printing, secondary packaging, ancillary supplies and comparator sourcing functions for clinical trials conducted in the Asia Pacific region. All the above services had provided the Sponsor with much flexibility. In addition, the capability to import pooled stock to Singapore and to label it at a later stage further accommodated the Sponsor’s increase in adaptive clinical trials in the region. In addition, as Fisher Clinical Services is an approved member of the importer of Clinical Trial Medicinal, the Sponsor could be exempt from paying 7% GST (Goods & Services Tax) on all supplies imported into Singapore for Clinical trial purposes. This represented significant savings for the Sponsor.
On Going Monitoring
In order for this new Regional Hub Approach to work effectively it was important to clearly define roles and responsibilities of key functions – Account Management, Study Set-Up, Project Management, Warehouse Management and Transport Management. Dedicated Project Managers were solely designated to the Sponsor’s studies to oversee all aspects of its studies from start to finish. Logistics decisions are based on real-time and historical data on shipments and courier performance. This data-driven objectivity continues to drive optimized courier selection realizing cost and performance efficiencies.
Frequent monitoring of the defined Regional Hub Strategy ensures control, compliance and visibility of inventory at all times. The team continues to maximize On-Time In-Full delivery of supplies, reducing overall costs and mitigating risk across the supply chain.