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, said Gary Hutchinson
Houston, Texas (PRWEB) January 24, 2012
With more than 100 combined years of career experience in the biotechnology and life science arena, five cold chain subject-matter experts have partnered to launch Modality Solutions, LLC. Paul J. Harber, Gary M. Hutchinson, Daniel J. Littlefield, Brian Wallin, and Donald Wilson identified a demand for their expertise in highly regulated industries, such as the biopharmaceutical, health, nutrition and wellness business sectors. The privately-held company delivers integrated cold chain management solutions that define, minimize or possibly eliminate transportation environmental hazards in the supply chain. Modality Solutions provides engineering / logistics consulting, systems integration, and simulation laboratory services from discovery through distribution.
As a comprehensive team of cold chain logistics experts, Modality Solutions is positioned to:
- Ensure regulatory compliance in highly regulated industries.
- Deliver cold chain management / thermal packaging design / qualification and controlled-environment logistics solutions.
- Conduct transport simulation testing with five environmental hazards – temperature, humidity, shock, vibration and pressure.
- Decrease development cycle times for a faster route-to-market.
- Develop transport validation strategies to support global regulatory applications.
Modality Solutions’ founders utilize their business and engineering experience to focus on solutions that work for their clients. They play a leadership role in several industry-recognized associations (PDA and IQPC) and standards-based organizations (ISTA and ASTM). Their body of work demonstrates an ability to solve complex controlled-environment logistics problems. The challenges they tackle require a diverse mix of compliance savvy, engineering expertise, along with process knowledge and innovative validation approaches.
Paul J. Harber is a founding member of the Parenteral Drug Association (PDA) / Pharmaceutical Cold Chain Interest Group (PCCIG). Harber co-authored the PDA Journal of Pharmaceutical Science and Technology Technical Report No. 39 (PDA TR#39). PDA TR#39 is the definitive reference source for best-demonstrated practices in transport validation. 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. As a member of the Parenteral Drug Association (PDA) / Pharmaceutical Cold Chain Interest Group (PCCIG), Hutchinson has been a featured speaker at three of the organization’s annual conferences.
“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.”
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. Littlefield 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). Wallin received Amgen’s Excellence in Science and Engineering Award for his work in shipper development.
Donald Wilson focuses his considerable engineering skills on primary packaging. He designed, tested, and implemented a nitrogen overlay process, automated vial washing systems, needle-free syringe technologies, and container closure integrity testing. Wilson received Amgen’s Excellence in Science and Engineering Award for his work in shipper development.
In addition, Rafik H. Bishara, Ph.D. serves as a Technical Advisor to Modality Solutions, he is the current Chair of the Pharmaceutical Cold Chain Interest Group (PCCIG), Parenteral Drug Association (PDA).
To learn more about Modality Solutions visit http://www.modality-solutions.com.
About Modality Solutions, LLC
Modality Solutions, LLC delivers cold chain management solutions for highly regulated industries, such as biopharmaceutical, health, nutrition and wellness. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing with five environmental hazards – temperature, humidity, shock, vibration and pressure; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. For more information, visit http://www.modality-solutions.com.