Upload
beverly-weaver
View
217
Download
2
Tags:
Embed Size (px)
Citation preview
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 Strategies and Applications for Successful Clinical Research & Development in China
2
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
3
We enable our customers to make the worldhealthier, cleaner and safer
A Mission We’re Proud Of
4
BioPharma Services Division
Critical Biological Material Management
Clinical Labeling Specialists
Clinical TrialDrug PackagingAnd Distribution
Time SensitiveCold ChainLogistics
5
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
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
Industry Trends - New Drug Delivery Methods
• Inhalers
• Patches
• Syringes
• Others
Proprietary and Confidential
New Delivery methods forces to re-think the way
we secure product integrity
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
Order of complexity
• Order of complexityImportant to keep in mind of global relationship and 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
Proprietary and Confidential
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
Proprietary and Confidential
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
1. Regulatory Requirements
Proprietary and Confidential
• 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
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
Proprietary and Confidential
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• 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
Proprietary and Confidential
Cold Chain Tip:
Invest time with customs to understand
the consequences of temperature
excursions.
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
Proprietary and Confidential
Cold Chain Tip:
Demand records of
thermo mapping and traceability of
TOR
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
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
Proprietary and Confidential
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
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
Proprietary and Confidential
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
Proprietary and Confidential
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
Proprietary and Confidential
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
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
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
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
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
Contact Information
Alex Guillen
Proprietary and Confidential
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