Integrated cold chain management solutions provider Modality Solutions has announced its sponsorship and presentation at this year’s Global Cold Chain Exchange.
The three-day IQPC Exchange event will be held from 7 December to 9 December 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.
Hutchinson said: "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 programme is specifically designed for supply chain, packaging, and logistics executives in the pharmaceutical and biotechnology industries. Attendance is exclusive and participation is strictly limited to senior executives from leading corporations to facilitate true peer-level networking for delegation and speakers.
This year’s Exchange programme covers procedural, substantive, and legislative issues impacting cold chain logistics, including: increased globalisation and international regulations; standardised 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.
Hutchinson added: "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.
"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 customised itinerary, which reflects their current initiatives, priorities, and future strategic objectives. These opportunities include: conference sessions, one-on-one meetings, master classes, and BrainWeave® discussions.