Transport Simulation Testing for Your Therapy: A Better Approach Than “Real World” Shipping Tests

Sponsored by: Modality Solutions

Focused on:

  • Simulation Testing
  • Biopharmaceutical
  • Therapy

Date: 2 December


Time: 6PM London / 1PM New York / 10AM San Francisco

A Proven Approach to Ensure Success

Transport Simulation Testing for Your Therapy: A Better Approach Than “Real World” Shipping Tests

• Accelerated sequential testing alone (e.g., ASTM, ISTA) is no longer acceptable by the FDA for drug product testing
• Real-world testing cannot test the “worst-case” edges of your operating space
• Real-world testing in the post-COVID-19 world will be difficult, time-consuming and expensive

Validating your cold chain to meet and exceed increasingly stringent regulatory expectations in today’s global market is a challenge. With more than 35 international cold chain regulatory compliance guidance documents, global standards are becoming more comprehensive and increasingly complex. The testing strategies historically used to test packing only (i.e., ASTM, ISTA) is no longer considered a comprehensive test to confirm drug product integrity for regulators around the globe.

Real-world testing cannot test the “worst-case” edges of your operating space. No single (or multiple) real-world shipment can ever confirm testing for all the transportation hazards concurrently. The transport simulation methodology and validation master plan strategy outlined in the webinar have been used in over 90 successful regulatory interactions since 2017.

The goal of cold chain process validation is to create a robust operation that ensures qualified product packaging and validated handling, storage, transportation, and distribution operations that are executed according to well-defined, established and proper control and monitoring procedures. Testing for relevant environmental conditions concurrently such as temperature, relative humidity, light, shock, and vibration will assure product physical integrity, purity, efficacy, quality, and safety. Integrating your stability data on any drug product with your validation strategy and transport simulation methodology will provide assurance, especially if your drug product is highly-sensitive to the environmental hazards in the transportation network.

Join industry experts Gary Hutchinson and Dan Littlefield from Modality Solutions in this engaging and informative webinar on how to successfully integrate transport simulation into your biopharmaceutical filing. Modality Solutions has access to the latest regulatory agency requirements for emerging new therapies and will share how to successfully validate your biopharmaceutical cold chain with transport simulation. Register today for the webinar on a better approach to “real world” shipping tests using transport simulation technology.

Presented by

Gary Hutchinson,


As a co-founder and the President of Modality Solutions, Gary Hutchinson has developed logistics processes and managed biopharmaceutical cold chains throughout his career. Over the last two decades, he has devoted his career to life sciences, becoming a leading authority and expert practitioner of controlled-environment logistics management. He is a leading advocate and sought-after speaker across the industry on cold chain management, transport validation, carrier performance management, and the implementation of quality systems across the supply chain.

Dan Littlefield,

Co-Founder and Head of Technical Operations

Daniel Littlefield is a founder of Modality Solutions. He has helped establish Modality Solutions as an innovator in the cold chain logistics industry. Dan recently headed up Modality Solutions’ CDC-sponsored Ebola clinical trial operations project in Sierra Leone and NIH-sponsored clinical trial operations project in Liberia in 2015, 2016 and 2020. He was a presenter at the 2017 17th Annual World Vaccine Congress and the 2016 PRA Vaccine Summit. Dan is an expert in process improvement, safety, and security for varied industry sectors, including health care, pharmaceutical, packaging, medical device, law enforcement, and defence industries.

Key Learning Objectives

  • Integrate transport simulation testing for environmental hazards into your filing strategy
  • Understand why ASTM and ISTA package testing is not acceptable for drug product testing
  • Learn the challenges of “real world” testing and why it is less reliable than transport simulation
  • Discuss the challenges to “real world” shipment testing in a post-COVID-19 transportation network


  • Packaging
  • Packaging Development
  • Supply Chain
  • Program Manager
  • Quality
  • Managing Director
  • Site Head
  • Quality Assurance
  • Technical Manager
  • Technical Operations
  • Transportation
  • Cold Chain
  • Compliance
  • Regulatory Affairs
  • Process Development
  • Clinical Operations
  • Logistics
  • Pharmaceutical Operations
  • Commercial Supply
  • Clinical Supply
  • Scientist
  • Product Quality
  • Stability
  • CMC