Five cold chain experts have partnered to launch Modality Solutions, LLC, a privately-held company that will provide integrated cold chain management solutions for highly regulated biopharmaceutical, health, nutrition and wellness industries. Modality Solutions’ founders Paul J. Harber, Gary M. Hutchinson, Daniel J. Littlefield, Brian Wallin, and Donald Wilson, have more than 100 combined years of career experience in biotechnology and the life sciences.

The company offers engineering and logistics consulting, systems integration and simulation lab services from discovery through distribution. The company aims to deliver integrated cold chain management solutions that define, minimize or possibly eliminate transportation environmental hazards in the supply chain.

Paul J. Harber is a founding member of the PDA / Pharmaceutical Cold Chain Interest Group (PCCIG). He co-authored the PDA Journal of Pharmaceutical Science and Technology Technical Report No. 39 (PDA TR#39), the definitive reference source for best-demonstrated practices in transport validation. Mr. Harber is the 2008 recipient of the Eli Lilly Engineering Excellence Award.

Gary M. Hutchinson, former director of Global Transportation at Amgen, has designed logistics networks and solutions for biologics and solid oral dosages, including cold-chain logistics networks, import/export compliance, and transport validation. He is also a member of the PDA / PCCIG, and has been a featured speaker at the organization’s annual conferences.

Daniel J. Littlefield is an expert in process improvement, safety and security with experience in a wide variety of industries. During his tenure at DuPont, he was assigned as a Six Sigma Black Belt, Six Sigma Master Black Belt (MBB) and an expert LEAN Practitioner. He is a two-time recipient of DuPont’s Engineering Excellence Award.

Brian Wallin co-authored with ISTA the first global standards of insulated shipping container performance (Standard 7E) and testing methodology and lab certification (Standard 20). Mr. Wallin received Amgen’s Excellence in Science and Engineering Award for his work in shipper development.

Donald Wilson has considerable engineering skills in primary packaging. He designed, tested, and implemented a nitrogen overlay process, automated vial washing systems, needle-free syringe technologies, and container closure integrity testing. He received Amgen’s Excellence in Science and Engineering Award for his work in shipper development.

Also, Rafik H. Bishara, Ph.D. will serve as a technical advisor to Modality Solutions. He is the current chair of PCCIG, PDA.

“Until now, innovators needed to work with a variety of companies to deliver cold chain management solutions. Our clients leverage years of biotech subject-matter experience in three critical areas: regulatory compliance guidance, package engineering, and controlled-environment logistics execution,” said Gary Hutchinson. “We encourage a collaborative relationship with current and potential clients. They are free to call us at any time, during a current engagement or not, to discuss their issues, concerns and opportunities.”