FUTURE IN SOUTH FLORIDA FEBRUARY 3, 2016 Thank you to our Sponsors - - PowerPoint PPT Presentation

THE STATE OF PHARMA AND ITS FUTURE IN SOUTH FLORIDA

FEBRUARY 3, 2016

Thank you to our Sponsors

MIA PHARMA HUB

Economic Powerhouse ∙ Industry Leader ∙ International Brand

Jimmy Nares Section Chief, Marketing Division, MDAD February 3, 2016

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 Section Chief, Marketing Division, MDAD February 3, 2016

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IMPORTANCE OF GOOD PRACTICES FOR TRANSPORTING TEMPERATURE CONTROLLED PHARMA PRODUCTS

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Importance of Pharma Products

A collaborative approach is vital

…PATIENT SAFETY… it is collaborative responsibility! Immunization prevents 2.5 million deaths each year…

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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  Annual product losses between US$2.5-12.5 billion due to various reasons including temperature excursions during transport and shipping. Due to a lack of compliance, standardization, accountability and transparency across the air transport supply chain The use of air-mode transportation is re-considered unless industry partners ensure quality services

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Center of Excellence for Independent Validators

Improve together to protect and grow our industry

The solution  Develop standards with regulators  Train industry stakeholders on standards and regulation  Assess operations against standard check list  Train independent validators on standards and regulations  Certify and then register best players on a publicly website  Get States recognition to ensure audits are valid for all The Need  … for more safety, security and efficiency  … to raise the bar to (re)gain confidence  … to improve compliance to standards/regulations  … for independent assessments vs. self-assessments  … to identify and recognize the best players  … to harmonize and reduce the number

• f audits

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CEIV Pharma

Certified Pharmaceutical Trade Lanes Development

03 FEB 2016

Certification in Progress Certification Completed

Locations

1 8 1 1

61 19

2

+99

Certification in Discussion *

1 1 3 12 1 1 7 1 1 1 1 1 1 3

* Estimate

1 2 11 4 1 6 1 1 1 1 1 2

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

• 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

Changing Expectations

• American’s approach to world-class cold-chain focused on features that pharma

shippers want for proper handling of their delicate products:

ExpediteTC°

• Active / Passive + Network
• Operational Integrity
• High Visibility
• Proactive Communication
• Infrastructure
• Operational Ownership
• Quality Management (QMS)

Customer Needs

• 157 cities across 45 countries
• Highest Boarding Priority
• Integrated Monitoring Systems
• CRT: +15°C to +25°C
• COL: +2°C to +8°C
• Active Container Management
• Global Training Program

TC° Benefits

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

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CRT (Controlled Room Temperature): +15°C to +25°C

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Active Container Management (ACM)

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

Destination Passive Active GRU

 

VCP



EZE

 

SCL

 

BSB



PTY



BOG

 Coverage out of MIA: 82,000 sq ft temperature controlled capacity for:

2ºC - 8ºC 15ºC - 25ºC

Miami Facts

CEIV certification planned for 2016

2ºC - 25ºC

50% growth after implementation

ZERO excursions

1H 2014 2H 2014 1H 2015 2H 2015

THANK YOU!

Thank you to our Sponsors