Grand Opening Singapore, November 2015

Thermo Fisher Scientific Opens New State-of-the Art GMP Clinical Services Facility in Singapore

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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.

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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 –

 

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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:

  • The fastest growing region for the number of registered trials is Asia. This trend will continue throughout the coming 10 years, (clinicaltrials.gov)
  • The proportion of clinical trial studies conducted in emerging Asian markets has grown in the past decade due to lower study costs & large patient populations
  • APAC Healthcare is predicted to have a CAGR of 12.8% between 2013-2018 vs. global growth rates of less than 6%
  • Governments in APAC are streamlining healthcare regulations & applying reforms to give more people access to healthcare
  • APAC is one of the largest marketplaces for speciality hospitals due to the increase in lifestyle and chronic diseases – diabetes, coronary heart disease & cancer
  • Changing demographic trends with increased urbanisation of the population is calling for new healthcare infrastructure in newly developed satellite cities
  • Increased life expectancy of the Asian population is resulting in more elderly people requiring long term care. In 2018 11.3% of the population will be 65+ years of age
  • Asian pharmaceutical companies are making their mark, running global trials for new drugs manufactured in Asia
about-singapore
The industry’s most established clinical supplies provider in the 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.

City:
Singapore
First Opening:
2001
New Facility:
2015
Total Capacity:
5,250 m2
Secondary Rooms:
4
Cold Production Rooms:
2
Warehouse Capacity (Controlled Ambient):
11,600 m3
Warehouse Capacity (Ambient – Non Aircon Warehouse):
3,500 m3
Refrigerated Storage Capacity:
4,500 m3
Frozen Storage Capacity (-20):
800 m3
Controlled Drug Ambient Storage Capacity:
400 m3
Controlled Drug Refrigerated Storage Capacity:
40 m3
Environmental Technologies:
Yes
Audited:
HSA Singapore
Comparator Sourcing:
Yes
Returns & Destruction:
Yes
Labeling:
Yes
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Key Benefits for Sponsors:

  • Singapore is a pro-clinical trial and pro-business country. The government grants relief of tax for all Clinical Trial medicinal imported into Singapore for local & overseas distribution. This supports the growth of clinical trials and eases the tax compliance burden for businesses engaged in clinical trials. Companies avoid paying 7% GST (Goods and Services Tax) on all Clinical Trial medicinal supplies imported into Singapore.
  • Fisher Clinical Services, Singapore, is a pioneer and the industry’s most established clinical supplies provider in the Asia Pacific region
  • Multi-lingual team with a true appreciation of cultural nuances, professionally proficient in managing all aspects of global trials
  • Harmonized quality systems and standard operating processes at cGMP levels, with certifications from the Health Sciences Authority
  • High capacity for ambient and cold chain IMP storage, handling and distribution of supplies
  • Ability to import bulk shipments and to store inventory in secure, temperature controlled environment
  • Just in time labelling of supplies giving Sponsors’ flexibility to accommodate specific trial timelines
  • Facilitates fast customs clearance via appointed customs agents
  • Distribution & logistics models to realize cost and performance efficiencies across the Asia Pacific region
  • Full, pro-active regulatory support and guidance for Asia Pacific trials speeding up study timelines
  • Proven track record having managed > 800 studies to date, >20,000 shipments annually, 280+ cities covered in the region
  • Solid client base, facilitating multinational trials across all therapeutic areas, in partnership with top 20 pharmaceuticals and smaller biotech companies

Accessing patient populations in remote locations presents challenges for ambitious new trial

Singapore team expertise paramount in trial success

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:

  • Select the best courier companies with whom to partner across the region. To base this decision on its data driven objectivity and extensive statistics gathered on each distribution lane with multiple courier companies.
  • Understand the customs clearance challenges across all countries in the APAC region. To mitigate risk of delays by choosing courier companies who had a history of effective customs clearance over time.
  • Set up and perform late stage labelling to meet changing requirements and timelines of the trial.
  • Suggest the best distribution plan to meet stipulated timelines and to get temperature sensitive supplies to remote areas.
  • Give consultative advice on the possible risks and implications related to distribution into remote locations.

 

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:

  • Carefully selected the most appropriate shipper box for the designated distribution channels, e.g. Summer versus Winter configuration, and/or specific technology enabled shipper boxes during seasonal change.
  • Monitored and tracked shipments and gave guidance to appointed courier companies on how to maintain supplies within the correct temperature specification during transit.
  • Pro-actively communicated with customs officers so as to limit delays in customs clearance.

 

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:

  • Longer timelines would be required to reach the more remote areas of Thailand, Vietnam, Malaysia, Indonesia and Philippines. In many cases an additional day was needed to reach sites located away from the main cities.
  • An established understanding was needed with the Sponsor/CRO prior to study kick off – to allow longer lead time for the IP to reach patient and to highlight in advance if a stressed timeline is required. Special arrangements were put in place in anticipation of urgent orders, e.g. sprinter services or dedicated truck services.
  • All import documentation (e.g. import license) and paperwork had to be completed in advance of shipments across the region. Advance notification of impending shipments to multiple parties involved (Sponsor, importer, appointed clearance agent etc) would enable smooth customs clearance.
  • Close communication with all parties was paramount. A proactive attitude in responding to any requests for further information, e.g. ad-hoc documents needed by the customs officials, would help to mitigate delays and maintains product integrity during transit.
  • Up-to-date information on customs requirements and regulatory changes was essential.

 

In Summary
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:

  • Performance reviews with courier companies helped achieve above satisfactory service during the trial
  • Reduction in deviations and complaints through trending of incidences which then helped to prevent re-occurrence
  • Overcoming cultural differences and language barriers ensured smooth distribution of supplies across 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.

An alternative logistics approach realizes cost and performance efficiencies in Asia Pacific

Regional Hub Model delivers control, compliance & visibility

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:

  • High inventory overage & poor inventory visibility
  • IMP wastage
  • Non-refundable tax & duty payments upfront
  • Additional fragmented costs, e.g. emergency deliveries
  • Exposure to risk of pilferage, order delivery accuracy and timeliness of shipments
  • Varying destruction costs & processes for each country

 

Analysis
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.

Benefits:

  • Confidence in consistent and high quality standards of a cGMP facility
  • Centralized inventory management
  • Validated storage conditions for ambient and cold chain supplies
  • Quick response to special trial requirements – late stage customization, Just In Time labelling
  • High level of control over distribution of supplies maximizing cost and performance efficiencies
  • Proactive regulatory support and guidance speeds up study timelines in the region
  • Simplified contract and invoice demands on the Sponsor
  • Dedicated staff ensures high level of attention to detail on all studies

 

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.