At the 2019 edition of the Biomanufacturing World Summit series last November in San Diego we spoke with Dan Littlefield of Modality Solutions. Dan recently worked with the National Institute of Health to support clinical trials to help fight Ebola in the Democratic Republic of Congo. In this interview, Dan talks about some of the challenges of working in an unusual environment, and how Modality Solutions’ experience designing and implementing bespoke cold chain solutions contributed to an important project.
Daniel J. Littlefield is a founder of Modality Solutions. He has helped establish Modality Solutions as an innovator in the cold chain logistics industry. Dan recently headed up Modality Solutions’ CDC-sponsored Ebola clinical trial operations project in Sierra Leone and NIH-sponsored clinical trial operations project in Liberia in 2015 and 2016. He was a presenter at the 2017 17th Annual World Vaccine Congress and the 2016 PRA Vaccine Summit. Dan is an expert in heat transfer, mathematical modeling, process improvement, safety, and security for varied industry sectors, including health care, pharmaceutical, packaging, medical device, law enforcement, and defense industries.
Modality Solutions is the leading biopharmaceutical cold chain engineering firm in the world. We combine three types of firms into a single source of expertise for your cold chain management integration: a cold chain regulatory filing authority, a logistics network operations team, and an integrated experienced staffing firm. Services include ensuring compliance with cold chain regulations, delivering cold chain thermal packaging design/qualification and controlled-environment logistics solutions, conducting transport simulation testing, providing staffing augmentation, decreasing development cycle times for faster route-to-market, developing transport validation strategies to support global regulatory applications and supporting clinical trial operations. Modality Solution’s Advantage Transport Simulation Laboratory™ concurrently exposes product and packaging to all five environmental hazards – temperature, shock, vibration, humidity, and pressure as they occur during real-world distribution.