Cold Chain Strategies and Applications for Successful Clini - PowerPoint Presentation

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Cold Chain Strategies and Applications for Successful Clinical Research & Development in China

“Leng Lian” 冷鏈

Alex Guillen

Director, Global Cold Chain, Fisher Clinical Services

Thermo Fisher ScientificSlide2

The World Leader in Serving ScienceProprietary and Confidential

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

Unmatched Depth

Innovative technologies

Applications expertise

Lab productivity partnerSlide3

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We enable our customers to make the worldhealthier, cleaner and saferSlide4

BioPharma Services DivisionProprietary and Confidential

Critical

Biological

Material

Management

Clinical

Labeling

Specialists

Clinical Trial

Drug Packaging

And Distribution

Time Sensitive

Cold Chain

LogisticsSlide5

Comprehensive Supply Chain ServicesProprietary and Confidential

Project

Consultation

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 DivisionSlide6

Industry Trends - Changes in clinical trial design

Trial complexity, duration and cost is on the riseHigh prevalence of biologics1989, only 13 biotechnology products were commercially available.  By 2012, that number had grown to 210Today, 6 out of 10 drugs in clinical development are now biologicsEvidence 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

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Complexity puts at risk Cold Chain ManagementSlide7

Industry Trends - New Drug Delivery MethodsInhalersPatchesSyringesOthers

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New Delivery methods forces to re-think the way we secure product integritySlide8

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 complexityOrder of complexity

Important to keep in mind of global relationship and complexitySlide10

China - A Land of OpportunitiesAging Population

Aging populationWestern patterns of illness – infectious diseases & chronic diseasesA densely populated pool of patientsTrack record of fast patient recruitment & excellent retentionA 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 ChallengesCultural & language barriers

– 292 living languages A changing regulatory landscape Often protracted timelines for clinical trial approvalsOngoing healthcare reformsImport/export requirementsCultural differences in application of GCP and GMPSeveral site specific requirementsBudget control

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Transportation Challenges - in China Transportation Challenges in China

China – landscape is vast & diverseWorlds’ most populous country; population 1.35b+22 provincesThe world’s 2nd largest country by land area = 9.6m sq kilometersBorders 14 nationsExtends across much of East AsiaLongest 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 RequirementsProprietary and Confidential

Protracted regulatory approval process in ChinaHeightened awareness of FCPS (Foreign Corrupt Practices Act)Top Tip: Ensure to meet all information requirements:Expiry date for importationValuation of the productUnit value of the drug on the Pro-forma InvoiceDifferent requirements for different ports of entry First leg airway bill Controlled drugs – work with approved brokersDangerous goods – understand internal distribution requirements

Cold Chain Tip:

Domestic shipments subject to extreme variationsSlide14

2. Appreciate Clinical Trial Approval TimelinesCFDA Agency responsible for the technical review of the application

CTA approval can take more than 10 months, longer for biologicsExpect a long planning horizonTop Tip: Prepare all supplies in advance of CTAFree Trade Zone, e.g. FCS: Suzhou Source comparator in advancePack, label and prepare all kits Plan distribution models to accommodate patient recruitment predictionsEnsure 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.Slide15

3. Ensure Smooth Importation of SuppliesChoose the right IoR, Inco terms, and cash transfer to avoid delays

Have “valuation evidence” on hand to defend level for tax/duty paymentsMinimize handoffsEnsure all parties appreciate the temperature sensitivity of cold chain suppliesUnderstand the import process & timelinesEnsure documents are in order before shippingSchedule shipments for working week, not on weekendsHave a local presence to help resolve issues - local time, local language, local customs

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Cold Chain Tip

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Invest time with customs to understand the consequences of temperature excursions.Slide16

4. Apply Best PracticeAdvantages 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 chainEnsure anti-corruption policies are upheldIf risks are identified, enhance due diligenceTake a “continuous improvement” approachMulti-lingual capability imperativeProprietary and Confidential

Cold Chain Tip:

Demand records of thermo mapping and traceability of TORSlide17

Total Control of TOR*Facility audited to Global

GMP standards

FCS Suzhou*

Bulk tablets/capsules

FCS Suzhou

FCS Suzhou

FCS Suzhou

Distribution in China

Shipped from manufacturing site

Primary

Packaging

Secondary Packaging

Distribution ex – China

Monitor Controlled shippers

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5. Manage the Entire Supply ChainApply a holistic approach – view the supply chain from end to end

Use tools & technology to ensure a complete chain of custodyData driven courier analysis to define best distribution modelEstablish trusted relationship with customs officialsMeet requirements to facilitate smooth importationReduce handoffs to mitigate riskPlan shipments to meet with site expectationsClearly define roles & responsibilities for all partiesPredict timelines, plan for delays, be flexibleProprietary and Confidential

Cold Chain Tip:

Choose carefully your couriers and be on top of GDP and GCP.Slide19

APAC Strategic Facilities

Infrastructure & Capabilities

Strategic locations to support customers expanding into APAC

:

- Beijing, China in 2007.

- Suzhou, China Q3 2014: GMP, 50,000 ft

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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 & TransportationCourier SelectionChoose a Distribution and Transportation partner that can collect and analyze data across multiple couriersSet acceptable criteria for door to door delivery in elapsed hoursAnalyze data to evaluate On Time performanceIntegrators 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 ChainOptimized total transport costAchieved by selecting optimal carrier/route for each shipment Supported with proof points

De-risked supply chainExtensive global distribution network supports & guarantees shipment to any location in the worldReal-time supply chain visibility to shipments & in-transit drugUp-to-date regulatory knowledge & advice shipping IMP internationallyA team of dedicated Project Managers to provide multiple study oversightUp-to-date regulatory knowledge & adviceCommitted to investigator site satisfaction24/5 Help DeskComplimentary investigator training on shipment (temp tales, packaging, labeling, etc)Pre-alert to pending shipment arrivalsProprietary and ConfidentialSlide22

Monitoring and ReportingAll shipments monitored through the Global Logistics helpdesk irrespective of collection point anywhere on the globePre-alerts sent to consignee and Project Managers

Check point data sent to Global Logistics Helpdesk electronically where available, otherwise manual monitoringProactive intervention where requiredEscalation procedures agreed on a client by client basisReporting from Global Logistics Helpdesk of:Calls received and level of urgency reportedEscalations and resultsFailures, reasons and corrective actionsCourier performance across all shipmentsCourier performance by clientCourier performance by studyProprietary and ConfidentialSlide23

At FCS we call it: Total Transportation ManagementTotal 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 managementCustoms and regulatory guidanceStorage and distribution facilitiesOversight of third party depot shipmentsGlobal quality assurance supportProactive 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 $9,800,000980 visits impacted

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Case: Biobanking for Centralized Ultra Cold ChainProprietary and Confidential

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 projectsSlide26

Case: Biobanking for Centralized Ultra Cold ChainProprietary and Confidential

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 portalSlide27

In SummaryChina is a land of opportunitiesChallenges are inevitable, but manageableUnderstand regulatory requirements & timelines

Prepare well, plan in advance, agree on responsibilities Establish best practices across the supply chainPartner with specialists in-country Multi-lingual teams ease communication.Select well your couriers as mismanagement can be highly expensive.

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Contact InformationAlex GuillenAlex.Guillen@thermofisher.com

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Email:

Alex.Guillen@thermofisher.com

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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