Practical Aspects of Shipping Cell and Gene Therapies

Published: Mar 2, 2017

Cell and Gene Therapies demonstrate real promise as they move into the clinical trial phase for a variety of life changing and deadly diseases. The results of these studies and their potential impact to patients, their loved ones and the industry as a whole are almost incalculable, which makes securing the supply chain mission critical — though not easily accomplished.

The challenges the industry face include ensuring the integrity of the product, with chain-of-condition documentation and custody validation,  utilising the right advanced refrigeration and cryo-shipping technologies and ensuring airline buy-in and understanding.  Precision global logistics planning and flawless execution are vital for these precious shipments

In this webinar World Courier’s Cell and Gene Therapy specialists share their knowledge with you, and discuss how our practical experience of Cell and Gene shipments is evolving logistics. 

1. Explore the special requirements for shipping these vital consignments
2. Understand the vital importance of pre-planning for every patient sample and therapeutic agent
3. How to identify and comply with airline and customs requirements and gathering all the necessary documentation

Author
James Klingelhoefer
James Klingelhoefer
Regional Sales Director USA
World Courier
jklingelhoefer@worldcourier.com

James Klingelhoefer, a Regional Business Development Director for World Courier, works with customers in the pharmaceutical industry to leverage supply chain efficiencies. He has extensive knowledge and experience in Temperature Control Management and Drug Distribution.

For over 9 years, James has helped sponsors, CMOs, and packaging companies to shorten timelines, reduce costs, and meet the demanding industry and regulatory requirements in the area of global distribution of temperature controlled clinical and commercial product. He works with clients on clinical and commercial projects providing guidance in the areas of; packaging, import/export regulations, route analysis, and distribution strategy. James has spoken at several industry conferences including Global Clinical Supply, Biologistcs Summit, and Clinical Supply East.

Author
Martin Pohle
Martin Pohle
Branch Manager
World Courier
mpohle@worldcourier.de

Martin Pohle is a in industry expert and manager in specialty logistics for Pharmaceutics, Semiconductor, Automotive and the Life Sciences. Since 2012 he serves as Branch Manager and leads the Leipzig and Berlin branches of WorldCourier. At World Courier, he is active in global CRO logistics business and is actively involved shaping World Couriers Cell & Gene Therapy service offerings. Martin is also an active speaker for topics such as Innovative Clinical Trial Design and Good Distribution Practices. Before joining WorldCourier, Martin served at medways, a medical technology and Life Science consulting firm. After acquiring a 3-year follow-on funding from the State of Thuringia in early 2009, Martin Pohle became Head of the Biotechnology conultancy practice at medways. He was active in generating, developing and funding technology transfer opportunities in Biopharma and medical instrumentation across Germany.  In 2009, Martin Pohle co-founded a global innovation management consultancy located in Berlin, San Francisco, Washington, D.C. and Dubai (VAE). Serving as Chief Operating Officer, he oversaw project management and corporate finance projects across various industries such as Life Sciences, Renewable Energies and Information Technology.

Author
Arnold Bernard
Arnold Bernard
Senior Manager, Specialty Group, USA
World Courier
abernard@worldcourier.com

Arnold Bernard is a Senior Leader within World Courier’s Customer Service Organization. With over 23 years experience in various management roles, Arnold has lead with a customer focused approach that has benefited many facets of the organization from Customer Service to Vendor Management, Compliance, and IT development. Under his leadership, Arnold’s Specialty Group brings industry leading innovation to such areas as active and passive pharmaceutical logistics and clinical trials execution. Most recently, Arnold has lead World Couriers efforts to develop logistics planning for what World Courier has branded as Personalized Solutions to include Direct to Patient and Cell and Gene Therapy service offerings. These have been identified as key growth areas in drug delivery that require a highly detailed level of planning and execution. Arnold has always lead a client centric approach that identifies challenges in what can be complex business models, while providing solutions that directly benefit the patient.