Solving the Cold Chain Puzzle for BRICS - Business Review Webinars

Solving the Cold Chain Puzzle for BRICS

PresentersDan Bell – Director Commercial Operations & Regulatory CompliancePaddy Hanlon – Senior Director, Business Development

Scope• Today, drugs have more very specifictemperature guidelines• How to achieve optimal results – no excursions• Key factors for successful temperaturecontrolled shipments with BRICS• Regulatory Challenges and solutionsPackaging is only part of the overall solution

Logisticspuzzle oneConnect the nine Marken pins with fourstraight lines without lifting your pen.

Four steps toconnecting the dotsThink inside the boxThink about the boxThink outside the boxSolve the puzzle

Think inside the boxConnect the nine Marken pins with fourstraight lines without lifting your pen.

Think inside the box• What is it we are shipping?• What are the boundaries of success?– Time– Temperature– System Selection– Conditioning & Handling• Regulatory Challenges

Think inside the box

Think inside the box

Relative cost vs. logistics complexityof clinical trials compared to the 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 trialsBRICSClinical Trials bydrug type and country*Number of Clinical Trials Starting*** Includes only industry-funded trials for drugs or biologics; does not include device, behavior, etc. studies. **Clinical trials with a starting date in the given time frame. Source: http://www.clinicaltrials.gov

Regulatory

Documentation ChallengeInvoice description of Goods MUST tally with what is shownon the label of the product

Documentation ChallengeActual label on the product shows “Ligand Assay SpecialSurvey Specimen Y-03”.

Infrastructure

Weather

Think about the boxConnect the nine Marken pins with fourstraight lines without lifting your pen.

Think about the boxHow to protect the product?• Envirotainers / UniCoolers(Active Solutions)• KryoTrans / Credo(Passive Solutions)• Temperature ControlledVehicles

Think about the boxEase of Conditioning and Configuration

Think about the boxIn-house TestingConditioning times for gel packs & phase change platesConditioning perfactory specs: 15 mins.Conditioning forreal-world specs: 60 mins.

Think outside the boxConnect the nine Marken pins with fourstraight lines without lifting your pen.

Think outside the boxHow do weget it there successfully?• Environmental conditions• Monitoring progress• Mitigating risks

ChallengeShipping from OneExtreme Temperature to AnotherExample:Shipping from Russia in winter to southern hemisphere countries•Originating temperature -25º to -30ºC to destination of 25ºC•Which pack-out configuration to use? Winter or Summer?

Overcomingthe ChallengeShipping from OneExtreme Temperatureto AnotherThe first 24 to 48 hours are the most critical.Our experience:•Use the “winter” configuration to prevent freezing and reduce thevalidation lifespan by 24 or 48 hours and have the shipment placedinto a 2º to 8ºC fridge or 15º-25ºC ambient room 1 or 2 days earlierthan the validation suggests•If you use the “summer” configuration (which has many more frozengel packs) thinking of the destination temperature it will freeze beforeit leaves the originating country

ChallengeExtreme Temperatures• Coping with extreme temperature which validated shippershave not been tested against• December 2010, the UK had temperatures -10º to -14ºwhich is normally 1º to 5ºC• Normal winter configuration would have failed

Overcomingthe ChallengeExtreme TemperaturesTemperatureVarianceLegendExternalInternalThe external temperature fluctuates as much as 20ºC but theinternal temperature remains within the client specified range.

Overcomingthe ChallengeExtreme TemperaturesMonitoring Temperature Worldwide• Temperature monitors on outside of shipping cartons to maptemperature data at various times of the year on particular shippingroutes• Careful monitoring of shipments in transit: TCV GPS based websitesystem• UniCooler, Envirotainer, AcuTemp - liaise with the airlines to getregular checks & temp readings en route, at each station and eachday at the airport

Overcomingthe 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 the PuzzleInside the Box –What are you shipping – who’s interested in it?About the Box –“Different horse for every course”Outside the Box –What environmental conditions will you be faced with?Solve the puzzle:Think outside the box - No one size fits all

Solve the PuzzleConnect the nine Marken pins with fourstraight lines without lifting your pen.

Q&AFor further Discussion or Work-shops• Dan Bell – dan.bell@marken.com• Paddy Hanlon – paddy.hanlon@marken.com