Modality Solutions is a Presenter and Sponsor at the 2016 Global Cold Chain Exchange

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Modality Solutions’ President Gary Hutchinson will present a case study titled: Preparing for Your Biosimilar Cold Chain for a FDA Biologics Licensing Application (BLA) at the 2016 Global Cold Chain Exchange.

Global Cold Chain Exchange

The Global Cold Chain Exchange is a premier event on maintaining compliance, safety, and security throughout the cold chain. The program is specifically designed for supply chain executives.

The Global Cold Chain Exchange provides one of the most credible interactive forums for supply chain, logistics and distribution executives to share ideas and cold chain solutions,” said Gary Hutchinson.

Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for life science and food industries, is pleased to announce its sponsorship and presentation at the 2016 Global Cold Chain Exchange. The three-day IQPC Exchange event will be held December 7 – 9 at the JW Marriott Marquis in Miami, Florida.

On day one of the Exchange, Modality Solutions’ President Gary Hutchinson will present a case study titled: Preparing for Your Biosimilar Cold Chain for a FDA Biologics Licensing Application (BLA). During this interactive session, attendees will learn the necessary steps and the differences in approach required for filing a biosimilar cold chain.

Gary Hutchinson shared, “Regulatory expectations for filing a biosimilar BLA are significantly more challenging for biologics targeting an unmet clinical need. The qualification of the technology, the validation of cold chain processes, and even the stress testing of drug product formulations for suitability for use in a cold chain are under stricter scrutiny.”

The Global Cold Chain Exchange is a premier event on maintaining compliance, safety, and security throughout the cold chain. The program is specifically designed for supply chain, packaging and logistics executives in the pharmaceutical and biotechnology industries. Attendance is exclusive, participation is strictly limited to senior executives from leading corporations to facilitate true peer-level networking for delegation and speakers.

This year’s Exchange program covers procedural, substantive and legislative issues that impact cold chain logistics, including: increased globalization and International regulations; standardized data monitoring; supply chain efficiency; handover delays with product sensitivity and risk management; quality agreements with carriers and 3PL’s; the future direction of global cold chain matters, and other pharmaceutical and biotechnology industry cold chain challenges.

“We are excited to sponsor and present at this year’s Global Cold Chain Exchange. It provides one of the most credible interactive forums for supply chain, logistics and distribution executives to share ideas and cold chain solutions,” said Hutchinson. “At Modality Solutions, we are committed to helping life science companies explore cost-reduction strategies, understand changing industry standards, and initiate risk management processes to ensure compliance, quality and product integrity. Exchange participants take away actionable insights to stay ahead in the evolving cold chain environment."

In addition, the Exchange offers a variety of unique learning styles and sessions. Attendees can select and build a customized itinerary that reflects their current initiatives, priorities, and future strategic objectives. These opportunities include: conference sessions, one-on-one meetings, master classes and BrainWeave® discussions.

To learn more about Modality Solutions, visit http://www.modality-solutions.com.

About Modality Solutions, LLC
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. For more information visit http://www.modality-solutions.com.

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Susan Almon-Pesch
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