Solving the Cold Chain Puzzle for BRICS - Business Review Webinars
Solving the Cold Chain Puzzle for BRICS - Business Review Webinars
Solving the Cold Chain Puzzle for BRICS - Business Review Webinars
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
<strong>Solving</strong> <strong>the</strong> <strong>Cold</strong> <strong>Chain</strong> <strong>Puzzle</strong> <strong>for</strong> <strong>BRICS</strong>
PresentersDan Bell – Director Commercial Operations & Regulatory CompliancePaddy Hanlon – Senior Director, <strong>Business</strong> Development
Scope• Today, drugs have more very specifictemperature guidelines• How to achieve optimal results – no excursions• Key factors <strong>for</strong> successful temperaturecontrolled shipments with <strong>BRICS</strong>• Regulatory Challenges and solutionsPackaging is only part of <strong>the</strong> overall solution
Logisticspuzzle oneConnect <strong>the</strong> nine Marken pins with fourstraight lines without lifting your pen.
Four steps toconnecting <strong>the</strong> dotsThink inside <strong>the</strong> boxThink about <strong>the</strong> boxThink outside <strong>the</strong> boxSolve <strong>the</strong> puzzle
Think inside <strong>the</strong> boxConnect <strong>the</strong> nine Marken pins with fourstraight lines without lifting your pen.
Think inside <strong>the</strong> box• What is it we are shipping?• What are <strong>the</strong> boundaries of success?– Time– Temperature– System Selection– Conditioning & Handling• Regulatory Challenges
Think inside <strong>the</strong> box
Think inside <strong>the</strong> box
Relative cost vs. logistics complexityof clinical trials compared to <strong>the</strong> USSOURCE: ReSolution Latin America (2009), Marken (2010)
Quality of Infrastructure2011 Country RankingRanking Country Infrastructure Quality Score1 Switzerland 6.82 Korea 6.73 Singapore 6.613 Canada 6.023 United States 5.833 United Kingdom 5.356 South Africa 4.672 China 4.184 Brazil 3.891 India 3.694 Russia 3.6* Source: World Economic Forum
fast paced growth in biologicsPipeline by Product Type
increasing volume of clinical trials<strong>BRICS</strong>Clinical Trials bydrug type and country*Number of Clinical Trials Starting*** Includes only industry-funded trials <strong>for</strong> drugs or biologics; does not include device, behavior, etc. studies. **Clinical trials with a starting date in <strong>the</strong> given time frame. Source: http://www.clinicaltrials.gov
Regulatory
Documentation ChallengeInvoice description of Goods MUST tally with what is shownon <strong>the</strong> label of <strong>the</strong> product
Documentation ChallengeActual label on <strong>the</strong> product shows “Ligand Assay SpecialSurvey Specimen Y-03”.
Infrastructure
Wea<strong>the</strong>r
Think about <strong>the</strong> boxConnect <strong>the</strong> nine Marken pins with fourstraight lines without lifting your pen.
Think about <strong>the</strong> boxHow to protect <strong>the</strong> product?• Envirotainers / UniCoolers(Active Solutions)• KryoTrans / Credo(Passive Solutions)• Temperature ControlledVehicles
Think about <strong>the</strong> boxEase of Conditioning and Configuration
Think about <strong>the</strong> boxIn-house TestingConditioning times <strong>for</strong> gel packs & phase change platesConditioning perfactory specs: 15 mins.Conditioning <strong>for</strong>real-world specs: 60 mins.
Think outside <strong>the</strong> boxConnect <strong>the</strong> nine Marken pins with fourstraight lines without lifting your pen.
Think outside <strong>the</strong> boxHow do weget it <strong>the</strong>re successfully?• Environmental conditions• Monitoring progress• Mitigating risks
ChallengeShipping from OneExtreme Temperature to Ano<strong>the</strong>rExample:Shipping from Russia in winter to sou<strong>the</strong>rn hemisphere countries•Originating temperature -25º to -30ºC to destination of 25ºC•Which pack-out configuration to use? Winter or Summer?
Overcoming<strong>the</strong> ChallengeShipping from OneExtreme Temperatureto Ano<strong>the</strong>rThe first 24 to 48 hours are <strong>the</strong> most critical.Our experience:•Use <strong>the</strong> “winter” configuration to prevent freezing and reduce <strong>the</strong>validation lifespan by 24 or 48 hours and have <strong>the</strong> shipment placedinto a 2º to 8ºC fridge or 15º-25ºC ambient room 1 or 2 days earlierthan <strong>the</strong> validation suggests•If you use <strong>the</strong> “summer” configuration (which has many more frozengel packs) thinking of <strong>the</strong> destination temperature it will freeze be<strong>for</strong>eit leaves <strong>the</strong> originating country
ChallengeExtreme Temperatures• Coping with extreme temperature which validated shippershave not been tested against• December 2010, <strong>the</strong> UK had temperatures -10º to -14ºwhich is normally 1º to 5ºC• Normal winter configuration would have failed
Overcoming<strong>the</strong> ChallengeExtreme TemperaturesTemperatureVarianceLegendExternalInternalThe external temperature fluctuates as much as 20ºC but <strong>the</strong>internal temperature remains within <strong>the</strong> client specified range.
Overcoming<strong>the</strong> ChallengeExtreme TemperaturesMonitoring Temperature Worldwide• Temperature monitors on outside of shipping cartons to maptemperature data at various times of <strong>the</strong> year on particular shippingroutes• Careful monitoring of shipments in transit: TCV GPS based websitesystem• UniCooler, Envirotainer, AcuTemp - liaise with <strong>the</strong> airlines to getregular checks & temp readings en route, at each station and eachday at <strong>the</strong> airport
Overcoming<strong>the</strong> ChallengeRegional Depot ModelSupport clinical trials across Asiaand Australia from Singapore• Provides 24-72 hour delivery• Four distinct temperature control zones• GMP compliant• ISO 9001/2008 certified• Duty-free import and export
Solve <strong>the</strong> <strong>Puzzle</strong>Inside <strong>the</strong> Box –What are you shipping – who’s interested in it?About <strong>the</strong> Box –“Different horse <strong>for</strong> every course”Outside <strong>the</strong> Box –What environmental conditions will you be faced with?Solve <strong>the</strong> puzzle:Think outside <strong>the</strong> box - No one size fits all
Solve <strong>the</strong> <strong>Puzzle</strong>Connect <strong>the</strong> nine Marken pins with fourstraight lines without lifting your pen.
Q&AFor fur<strong>the</strong>r Discussion or Work-shops• Dan Bell – dan.bell@marken.com• Paddy Hanlon – paddy.hanlon@marken.com