Michael Vorwerk

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• Michael Vorwerk
• LifeConEx, LLC
• November 7th

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Did you know?

• That every fifth Drug is temperature-sensitive
• That 20 of the worlds best selling
  pharmaceuticals are temperature sensitive
• That 130 billion of the total pharmaceutical
  market ( about 650 billion ) is represented by
  temperature sensitive products.
• That the share of temperature-sensitive products
  will rise the next yearsBiologicals 15
  Chemical based 10
• That nearly 100 of all vaccines and 68 of all
  products sold by biotech companies need to be
  stored and transported between 2 to 8 ºC
• That 43 of all diagnostics and about 11 of
  all products from large pharmaceutical companies
  have to be handled with the same precautions.
• That there is a correlation between product price
  and temperature-sensitivityand that some
  biologicals, vaccines and hormones can reach a
  package price of up to 6000.- or you can fill a
  LD3 Container with up to 20 million of product
  value.

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Current Shortcomings

• Lack of integrated D to D management to all key
  partners
• Inconsistent standards infrastructure across
  climate zones and packaging validation to
  accommodate globalization
• Uncertain transfer of accountability at each key
  milestone
• Lack of temperature monitoring and documented
  temperature excursions
• Inconsistent documentation of cargo handling
  through transportation
• Insufficient tracking tracing for transport of
  temperature sensitive cargo

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How the industry is challenging the shortcomings

• Suppliers to develop and create a comprehensive
  integrated process with all parties
• Experts to develop standards for transport of
  perishables
• Suppliers to develop transfer of accountability
• Technology to enhance transparency throughout
  transport, proactively
• PDA Technical Report 39 / IATA Perishable Cargo
  Regulations (PCR)
• World Health Organisation (WHO), European Union
  (EU), UKs Medicines and Health Care, Products
  Regulatory Agency (MHRA), Food Drug
  Administration (FDA), United States Department
  of Agriculture (USDA)

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Recommendations

• Develop comprehensive quality agreements
• Utilize technological advances to further enhance
  the need for full transparency
• Develop experts in creating supply chain
  excellence
• Overhaul the current standards to address gaps
  and shortcomings
• Develop common jurisdiction which regulates
  global air transport
• Collaborate with associations agencies to
  further challenge industry standards and norms
• Introduce relevant training in Temperature
  Controlled Airfreight Handling

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Thank you for your attention !
leading industry-specific provider of
integrated end-to-end temperature-controlled
transportation solutions to the life sciences
industry providing customized information,
processes and services to create new standards
for the movement of temperature- controlled
products globally.