THE STATE OF PHARMA AND ITS FUTURE IN SOUTH FLORIDA FEBRUARY 3, 2016
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MIA PHARMA HUB Economic Powerhouse ∙ Industry Leader ∙ International Brand Jimmy Nares February 3, 2016 Section Chief, Marketing Division, MDAD
MIA PHARMA HUB Economic Powerhouse ∙ Industry Leader ∙ International Brand “In this world nothing can be said to be certain, except death, taxes, and pharmaceuticals." February 3, 2016 - Jimmy Nares
MIA PHARMA HUB Economic Powerhouse ∙ Industry Leader ∙ International Brand Building Capacity for Pharma at MIA • IATA Pharma Hub Airport Designation • CEIV Certified Logistics Companies • Air Route Network and Infrastructure for Handling Cold Chain Pharma • Foreign Trade Zone Magnet Site • Marketing Campaign
MIA PHARMA HUB Economic Powerhouse ∙ Industry Leader ∙ International Brand
MIA PHARMA HUB Economic Powerhouse ∙ Industry Leader ∙ International Brand Building Capacity for Pharma at MIA • IATA Pharma Hub Airport Designation • CEIV Certified Logistics Companies • Air Route Network and Infrastructure for Handling Cold Chain Pharma • Foreign Trade Zone Magnet Site • Marketing Campaign Jimmy Nares February 3, 2016 Section Chief, Marketing Division, MDAD
IMPORTANCE OF GOOD PRACTICES FOR TRANSPORTING TEMPERATURE CONTROLLED PHARMA PRODUCTS 03 FEB 2016 8 03 FEB 2016
Importance of Pharma Products A collaborative approach is vital Immunization prevents 2.5 million deaths each year… …PATIENT SAFETY… it is collaborative responsibility! 9 03 FEB 2016
Critical Issues During Transport There is a problem More than 50% of all temperature excursions occur while the package is in the hands of airlines/airports Temperature deviation denature the product, render it worthless and be harmful to the health of the patient Products can be lost, scrapped, returned leading to significant costs Due to a lack of compliance, standardization, accountability and Annual product losses between transparency across the air transport US$2.5-12.5 billion due to various supply chain reasons including temperature The use of air-mode transportation is excursions during transport and re-considered unless industry partners shipping. ensure quality services 10 03 FEB 2016
Center of Excellence for Independent Validators Improve together to protect and grow our industry The Need The solution Develop standards with regulators … for more safety, security and efficiency Train industry stakeholders on … to raise the bar to (re)gain confidence standards and regulation Assess operations against standard … to improve compliance to check list standards/regulations Train independent validators on … for independent assessments vs. standards and regulations self-assessments Certify and then register best … to identify and recognize the best players on a publicly website players Get States recognition to ensure … to harmonize and reduce the number audits are valid for all of audits 11 03 FEB 2016
CEIV Pharma Certified Pharmaceutical Trade Lanes Development 1 1 1 2 2 8 12 4 1 1 1 3 2 1 1 1 1 1 6 3 11 1 1 1 7 1 Locations 19 Certification Completed 1 1 1 61 Certification in Progress 1 +99 1 Certification in Discussion * * Estimate 12 03 FEB 2016
THANK YOU For further information, contact: Ricardo AITKEN Project Manager Miami, FL Email: AitkenR@iata.org Tel: + 1 786 427 8471 Mob: + 1 305 988 8417
Tom Grubb Manager, Cold Chain Strategy February 3, 2016
Global Regulatory Oversight • Objective: Product quality and integrity all the way to the patient • Both regulatory and shipper requirements continue to accelerate • Temperature-controlled logistics are growing: • Types of services offered • Information about the shipment status during transit • Quality of handling provided • Enhanced control and communication • Regulations are becoming increasingly stringent
Changing Expectations • Medicinal complexity will require enhanced transport options • Higher-end biologics necessitate close control & monitoring • Complex supply chains due to multi-step manufacturing • Growth in biologics and clinical trials = increased payload values • A further diversification of logistic product offerings
ExpediteTC° • American’s approach to world-class cold-chain focused on features that pharma shippers want for proper handling of their delicate products: Customer Needs TC° Benefits 157 cities across 45 countries Active / Passive + Network Highest Boarding Priority Operational Integrity Integrated Monitoring Systems High Visibility CRT: +15°C to +25°C Proactive Communication COL: +2°C to +8°C Infrastructure Active Container Management Operational Ownership Global Training Program Quality Management (QMS)
Infrastructure Enhancements PHL Pharma Facility Key features of the facility include: 6,000 ft² of Controlled Room Temperature (CRT) for passive shipments at +15°C and +25°C 3,000 ft² Refrigerated area (COL) for Passive shipments that need to be maintained in +2°C to +8°C A deep frozen capability (FRO) which caters to shipments requiring -10°C to -20°C Active Container Management (ACM) includes capacity for simultaneous charging of up to 30 RKNs Advanced monitoring technology with proactive alarming, validated to 0.25°C Full back up power generation ensures product protection in the event of a power failure
CRT (Controlled Room Temperature): +15°C to +25°C 19
Active Container Management (ACM) 20
PHARMA PASSIVE & ACTIVE PRODUCTS The State of Pharma and its Future Impact in South Florida, Miami February 3, 2016
Pharma Passive Features
Pharma Active Features
Miami Facts 82,000 sq ft temperature controlled Coverage out of MIA: capacity for: Destination Passive Active GRU 2ºC - 8ºC VCP 15ºC - 25ºC EZE SCL 2ºC - 25ºC BSB ZERO excursions PTY BOG CEIV certification planned for 2016 50% growth after implementation 1H 2014 2H 2014 1H 2015 2H 2015
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