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![Page 1: 1 The world leader in serving science Alex Guillen Director, Global Cold Chain, Fisher Clinical Services Thermo Fisher Scientific “Leng Lian” 冷鏈 Cold Chain.](https://reader038.fdocuments.us/reader038/viewer/2022110100/56649e155503460f94affbe7/html5/thumbnails/1.jpg)
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The world leader in serving science
Alex Guillen
Director, Global Cold Chain, Fisher Clinical Services
Thermo Fisher Scientific
“Leng Lian” 冷鏈Cold Chain Strategies and Applications for Successful Clinical Research & Development in China
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Premier Brands
Global Scale
• 50,000 employees in 50 countries
• $17 billion in annual revenues
• Unparalleled commercial reach
• 10,000 employees working with
customers every day
The World Leader in Serving Science
Unmatched Depth
• Innovative technologies
• Applications expertise
• Lab productivity partner
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We enable our customers to make the worldhealthier, cleaner and safer
A Mission We’re Proud Of
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BioPharma Services Division
Critical Biological Material Management
Clinical Labeling Specialists
Clinical TrialDrug PackagingAnd Distribution
Time SensitiveCold ChainLogistics
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Comprehensive Supply Chain Services
ProjectConsultation Phase I Phase II Phase III Commercial
Fisher BioServices
Fisher Clinical Services, Clintrak & Specialty Logistics
• Study Planning & Setup• Regulatory Consultation• End to End Supply Chain
& Inventory Management
• Over-encapsulation• Packaging & Labeling• Comparator Sourcing• Global Biobanking• Laboratory Services
• Global Distribution• Cold Chain Network• Worldwide Customs• Time & Temperature
Sensitive Material
Global Distribution
BioPharma Services Division
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Industry Trends - Changes in clinical trial design
Trial complexity, duration and cost is on the rise
• High prevalence of biologics• 1989, only 13 biotechnology products were commercially available. By 2012, that number had
grown to 210• Today, 6 out of 10 drugs in clinical development are now biologics• Evidence to suggest that a greater number of large molecule drugs reach market than small
molecule drugs
• Increase in the use of comparators • Enrolment periods have doubled.• Targeting patients in multiple countries, emerging regions, often remote locations• Importation/Exportation challenges • Regulatory hurdles, e.g. CTA processes differ from country to country
Source: KMR Group Study
Proprietary and Confidential
Complexity puts at risk Cold Chain Management
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Industry Trends - New Drug Delivery Methods
• Inhalers
• Patches
• Syringes
• Others
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New Delivery methods forces to re-think the way
we secure product integrity
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Industry Trends
“Typical international transportation can easily consist of 3 airports, 3 ground handlers, 2 different airlines, 2 truckers, 1 freight forwarder and 1
customs broker with two different country regulations in 3 different climate zones”*
• www.futurepharmaus.comProprietary and Confidential
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Order of complexity
• Order of complexityImportant to keep in mind of global relationship and complexity
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China - A Land of Opportunities
Aging Population • Aging population
• Western patterns of illness – infectious diseases & chronic diseases
• A densely populated pool of patients
• Track record of fast patient recruitment & excellent retention
• A talent pool of highly trained healthcare professionals
• Improved infrastructure
• Potential for cost savings
Within Asia, China remains the key emerging market for multinational pharmaceutical companies, and is now the world’s third largest market
Proprietary and Confidential
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China - A land of challenges
• Cultural & language barriers – 292 living languages
• A changing regulatory landscape
• Often protracted timelines for clinical trial approvals
• Ongoing healthcare reforms• Import/export requirements• Cultural differences in
application of GCP and GMP• Several site specific
requirements• Budget control
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Transportation Challenges - in China
Transportation Challenges in China
China – landscape is vast & diverse
• Worlds’ most populous country; population 1.35b+
• 22 provinces
• The world’s 2nd largest country by land area = 9.6m sq kilometers
• Borders 14 nations
• Extends across much of East Asia
• Longest highway system in the world
• The world’s largest market for automobiles
• Railways are amongst the busiest in the world
• 180+ commercial airports
• 2000+ river & seaportsProprietary and Confidential
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1. Regulatory Requirements
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• Protracted regulatory approval process in China
• Heightened awareness of FCPS (Foreign Corrupt Practices Act)
• Top Tip: Ensure to meet all information requirements:
• Expiry date for importation• Valuation of the product• Unit value of the drug on the Pro-forma Invoice• Different requirements for different ports of entry • First leg airway bill • Controlled drugs – work with approved brokers• Dangerous goods – understand internal distribution
requirements
Cold Chain Tip:
Domestic shipments subject to extreme
variations
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2. Appreciate Clinical Trial Approval Timelines
• CFDA Agency responsible for the technical review of the application
• CTA approval can take more than 10 months, longer for biologics
• Expect a long planning horizon• Top Tip: Prepare all supplies in advance of
CTA• Free Trade Zone, e.g. FCS: Suzhou • Source comparator in advance• Pack, label and prepare all kits • Plan distribution models to accommodate patient
recruitment predictions• Ensure all supplies are ready for immediate trial
start
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Cold Chain Tip:
Make sure providers of temporary
solution are duly audited
for compliance.
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3. Ensure smooth importation of supplies
• Choose the right IoR, Inco terms, and cash transfer to avoid delays
• Have “valuation evidence” on hand to defend level for tax/duty payments
• Minimize handoffs• Ensure all parties appreciate the temperature
sensitivity of cold chain supplies• Understand the import process & timelines• Ensure documents are in order before shipping• Schedule shipments for working week, not on
weekends• Have a local presence to help resolve issues - local time, local language, local customs
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Cold Chain Tip:
Invest time with customs to understand
the consequences of temperature
excursions.
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4. Apply best practice
• Advantages of working in a EU GMP environment
• Partner with organizations that have a track record of working to similar global standards
• Contract approved organizations to monitor & audit all parties to the supply chain
• Ensure anti-corruption policies are upheld
• If risks are identified, enhance due diligence
• Take a “continuous improvement” approach
• Multi-lingual capability imperative
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Cold Chain Tip:
Demand records of
thermo mapping and traceability of
TOR
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Total Control of TOR
FCS Suzhou*
Bulk tablets/capsules
FCS Suzhou FCS Suzhou FCS Suzhou
Distribution in China
Shipped from manufacturing site
Primary Packaging Secondary Packaging
*Facility audited to Global GMP standards
Distribution ex – China
Monitor Controlled shippers
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5. Manage the entire supply chain
• Apply a holistic approach – view the supply chain from end to end
• Use tools & technology to ensure a complete chain of custody
• Data driven courier analysis to define best distribution model
• Establish trusted relationship with customs officials
• Meet requirements to facilitate smooth importation
• Reduce handoffs to mitigate risk
• Plan shipments to meet with site expectations
• Clearly define roles & responsibilities for all parties
• Predict timelines, plan for delays, be flexible
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Cold Chain Tip:
Choose carefully your couriers and be on top of
GDP and GCP.
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APAC Strategic Facilities
• Infrastructure & Capabilities• Strategic locations to support customers expanding into
APAC: - Beijing, China in 2007. - Suzhou, China Q3 2014: GMP, 50,000 ft2
• Materials and supplies management with high global interoperability to provide seamless environment for customers‘ biobanking projects
• Global Quality • Training and SOPs transferrable to
implement customer/project specific processes locally
• Designed to accelerate and deliver consistent results for globally oriented customer teams or projects
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Distribution Readiness – Post Approval
Post Approval. Risk Avoidance in Distribution & Transportation
Courier Selection• Choose a Distribution and Transportation partner that can collect and
analyze data across multiple couriers
• Set acceptable criteria for door to door delivery in elapsed hours
• Analyze data to evaluate On Time performance• Integrators may have better performance in some lanes• Can drill down to broker performance
• Use data to Monitor trends monitored over time and updated quarterly
• Where justified use most effective Premium Courier
Data Driven Decisions
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Delivering Results Across the Supply Chain
Optimized total transport cost• Achieved by selecting optimal carrier/route for each shipment • Supported with proof points
De-risked supply chain• Extensive global distribution network supports & guarantees shipment to any
location in the world• Real-time supply chain visibility to shipments & in-transit drug
Up-to-date regulatory knowledge & advice shipping IMP internationally• A team of dedicated Project Managers to provide multiple study oversight• Up-to-date regulatory knowledge & advice
Committed to investigator site satisfaction• 24/5 Help Desk• Complimentary investigator training on shipment (temp tales, packaging, labeling,
etc)• Pre-alert to pending shipment arrivals
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Monitoring and Reporting
• All shipments monitored through the Global Logistics helpdesk irrespective of collection point anywhere on the globe
• Pre-alerts sent to consignee and Project Managers
• Check point data sent to Global Logistics Helpdesk electronically where available, otherwise manual monitoring
• Proactive intervention where required
• Escalation procedures agreed on a client by client basis
• Reporting from Global Logistics Helpdesk of:• Calls received and level of urgency reported• Escalations and results• Failures, reasons and corrective actions• Courier performance across all shipments• Courier performance by client• Courier performance by study
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At FCS we call it: Total Transportation Management
Total Transportation Management Services include complete oversight of the supply chain processes required to move IMP shipments internationally and within the country of destination, including:
• Courier Selection and management• Customs and regulatory guidance• Storage and distribution facilities• Oversight of third party depot shipments• Global quality assurance support• Proactive track & trace
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Distribution Readiness – Post Approval
• Risk avoidance in distribution and transportation
• Data interpretation –why does % matter?
99.8%
On Time in Full
96.0%
On Time in Full
5,000 patients, 7 visit study
Financial impact between
$1,000 per visit $980,000
$10,000 per patient $9,800,000
980 visits impacted
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25Proprietary & Confidential
Case: Biobanking for Centralized Ultra Cold Chain
• Background• One of the largest cardiovascular clinical center
in China
• Partners with world’s leading research institutes, biotech/pharma, and government for clinical trials and public health studies
• Managing critical biological materials such as: heart tissue, stem cells, DNA/RNA, and biologics.
• Challenge• Lack of standardization, structure, size, control
and expertise to manage the rapid growth of projects within China and global partners
• Temperature at all points of process and logistics are critical to sample integrity
• Samples were at high risk, especially for those that were very precious and irreplaceable
• Needed a total ultra cold storage and transport solution to support existing and future projects
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26Proprietary & Confidential
Case: Biobanking for Centralized Ultra Cold Chain
• Solution• Contacted Thermo Fisher Scientific for its biobanking expertise
• Fisher BioServices supported in the design, setup, implementation, qualification/validation, and personnel training of a brand new biobank at the clinical center
• This provided the biobank with state-of-the art biobanking equipment , software, and also a total ultra cold chain infrastructure to manage the critical biological materials from point of collection to receipt through storage and distribution to partners.
• Benefits• Quickly scale up capacity and density: from 840 samples in 2013 to now
at ~4 Million Samples.
• Transported and distributed over 380,000 samples to various sites
• Sample inventory, temperature profile, tracking, and transport chain of custody reporting data available specific to each project through web portal
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In Summary
• China is a land of opportunities
• Challenges are inevitable, but manageable
• Understand regulatory requirements & timelines
• Prepare well, plan in advance, agree on responsibilities
• Establish best practices across the supply chain
• Partner with specialists in-country
• Multi-lingual teams ease communication.
• Select well your couriers as mismanagement can be highly expensive.
Proprietary and Confidential
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Contact Information
Alex Guillen
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Email: [email protected]
For eBooks, Insights, Whitepapers, Webinars and More – Visit:
Clinical Trial Supply Chain – blog.FisherClinicalServices.com
Ultra Cold Chain/Biobanking/Cell Therapy – blog.FisherBioServices.com
Global Premium Courier Network – www.prioritysolutions.com