Gary M. Hutchinson
Modality Solutions LLC
Gary Hutchinson is a controlled-environment logistics subject-matter expert. His time-definite delivery networks deliver product around the world in a regulatory compliant and cost-effective way. He accomplishes this highly complex process by understanding environment and infrastructure challenges, designing controls, and creating monitoring systems that work.
Gary is president of Modality Solutions. He was recently recognized by his peers as a 2012 Temperature Controlled Logistic Leader by the international pharmaceutical cold chain community, as compiled and reported by Cold Chain IQ.
Daniel J. Littlefield
Daniel Littlefield is an expert in process improvement, safety, and security with experience in a wide variety of industries. During his 18 year career with DuPont, he held a variety of technical and supervisory assignments in research and operations starting in Teflon® research. In 2000, Dan was part of the first group of Six Sigma Black Belts. After four years, he was assigned as a Master Black Belt (MBB) and as an expert LEAN Practitioner. During the six years of his Six Sigma work with DuPont, Dan led successful projects in safety performance, e-business, sales and marketing, product packaging, logistics, yield improvement, strategic business planning, supply chain design, maintenance cost improvement, and waste treatment. Dan is a two-time recipient of Dupont’s Engineering Excellence Award.
Paul J. Harber
Paul Harber is a founding member of the Parenteral Drug Association (PDA) / Pharmaceutical Cold Chain Interest Group (PCCIG). Paul coauthored the PDA Journal of Pharmaceutical Science and Technology Technical Report No. 39 (PDA TR#39). PDA TR#39 is widely used by both industry professionals and regulators as the definitive reference source for best-demonstrated practices in transport validation. Paul continues to serve on the PCCIG steering committee and regularly presents at annual PDA meetings. Paul has authored numerous articles on a variety of subjects related to cold chain logistics, including the Use of Mean Kinetic Temperature (MKT) and Stability Studies for Transportation. With a specific interest in standards, Paul assisted in the writing and...
Technical Consulting Engineer
In her position as a Modality Solutions’ technical consulting engineer, Hannah Anderson serves as one of the specialized project consultants for the cold chain management firm. Hannah assisting a Modality Solutions’ pharmaceutical client with onsite program management of its thermal package engineering services. In her position, she forecasts and determines personnel project resource requirements and manages resource allocations. She writes up procedures, specifications and reports. Hannah conducts project update meetings, manages schedules, and ensures all deliverable are being completed on time...
In his position as a Modality Solutions’ consulting engineer, Brian Brazill serves as one of the cold chain management firm’s dedicated project engineers.
Brian programs and runs Modality Solutions’ Advantage Transport Simulation Laboratory™. The simulation lab’s capabilities provide valuable data on the impact of five environmental hazards (temperature, humidity, pressure, shock and vibration) on the critical-to-quality attributes of products. Brian brings his study and passion in chemical engineering to the study of environmental stresses on biologics and vaccines, diagnostics, solid oral formulations, and combination medical devices during transport...
Andrew Larrigan serves as a Modality Solutions Consulting Engineer as he works with other dedicated project engineers.
As a component of his position, Andrew works in part at the Advantage Transportation Simulation Laboratory™, which provides valuable data on the impact of five environmental hazards (temperature, humidity, pressure, shock and vibration) on the critical-to-quality attributes of products. He helps with writing protocols and reports for a variety of distribution and thermal testing...
Gabrielle Mosiniak is a consulting engineer with Modality Solutions. At the Advantage Transport Simulation Lab, Gabrielle assists with laboratory testing and completes protocols and reports for distribution and thermal testing. She also writes and updates standard operating procedures, and she assembles data packages for reporting. Through these responsibilities, Gabrielle consistently works with her clients to listen to their needs so that she can design and develop packaging based on their parameters and objectives.
Robert Battista is a consulting engineer at Modality Solutions. With the engineering teams, he works with clients to ensure proper design and use of cold chain systems, writes standard operating procedures for cold chain related processes that meet regulatory requirements, drafts protocols and reports for the qualification of equipment and the validation of processes, reviews data packages for reports, and conducts in-person training for cold chain systems.