Transcript 53255x - International Security Cooperation Summit

“Leng Lian” 冷鏈
Cold Chain Strategies and Applications for Successful Clinical Research &
Development in China
Alex Guillen
Director, Global Cold Chain, Fisher Clinical
Services
Thermo Fisher Scientific
The World Leader in Serving Science
Global Scale
• 50,000 employees in 50 countries
• $17 billion in annual revenues
• Unparalleled commercial reach
• 10,000 employees working with
customers every day
Unmatched Depth
• Innovative technologies
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• Applications expertise
• Lab productivity partner
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A Mission We’re Proud Of
We enable our customers to make the world
healthier, cleaner and safer
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BioPharma Services Division
Clinical Trial
Drug Packaging
And Distribution
Critical
Biological
Material
Management
Clinical
Labeling
Specialists
Time Sensitive
Cold Chain
Logistics
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Comprehensive Supply Chain Services
Project
Consultation
Phase I
Phase II
Phase III
Commercial
Global
Distribution
Fisher BioServices
Fisher Clinical Services, Clintrak & Specialty Logistics
BioPharma Services Division
• Study Planning & Setup
• Regulatory Consultation
• End to End Supply Chain
& Inventory Management
• Over-encapsulation
• Packaging & Labeling
• Comparator Sourcing
• Global Biobanking
• Laboratory Services
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• Global Distribution
• Cold Chain Network
• Worldwide Customs
• Time & Temperature
Sensitive Material
Industry Trends - Changes in clinical trial design
• 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
Source: KMR Group Study
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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
Trial complexity, duration and cost is on the rise
Complexity puts at risk Cold Chain Management
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Industry Trends - New Drug Delivery Methods
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Inhalers
Patches
Syringes
Others
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.com
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Order of complexity
Important to keep in mind of
global relationship and
• Order of complexity
complexity
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
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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 & seaports
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1. Regulatory Requirements
• Protracted regulatory approval process in
China
• Heightened awareness of FCPS (Foreign
Corrupt Practices Act)
• Top Tip: Ensure to meet all information
requirements:
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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
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Cold Chain
Tip:
Domestic
shipments
subject to
extreme
variations
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
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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.
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
Cold Chain
• Understand the import process & timelines
Tip:
• Ensure documents are in order before shipping
Invest time
• Schedule shipments for working week, not on
with customs
weekends
to understand
• Have a local presence to help resolve issues
the
- local time, local language, local customs
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
Total Control of TOR
Bulk tablets/capsules
Shipped from
manufacturing
site
Primary Packaging
FCS Suzhou*
Secondary Packaging
FCS Suzhou
FCS Suzhou
FCS Suzhou
Monitor Controlled shippers
Distribution ex – China
*Facility audited to Global GMP standards
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Distribution in China
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.
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:
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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:
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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
980 visits impacted
Financial impact between
$1,000 per visit
$10,000 per patient
$980,000
$9,800,000
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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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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
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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.
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Contact Information
Alex Guillen
[email protected]
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
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