Paul Harber Parenteral Supply Chain, LLC

Paul Harber is founder of Parenteral Supply Chain, LLC. PSC, as it is known, collaborates with clients devoted to all facets of the distribution of parenteral products.

Paul Harber was a Principal with Modality Solutions, LLC. He completed work with a variety of companies in the Life Science areas. The scope of work has ranged from validation of active and passive shippers for numerous pharmaceutical clients as well as the installation and qualification of the Transport Simulation Lab located at BioConvergence. In 2014, project work with NGOs in the evaluation of cold chain operations at Ebola vaccine clinical trial sites in Zone 4 countries was a personally rewarding addition to scope of work.

Paul Harber was a founding member of the PDA Pharmaceutical Cold Chain Interest Group. Paul co-authored for the Parenteral Drug Association (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. For 16 years, the scope of Paul’s work at Eli Lilly and Company focused on the qualification of both active and passive shippers in support of clinical and commercial transportation of temperature labile products. He had major roles in defining and specifying the cold chain components and practices necessary to support the commercialization of four Lilly products worth over one billion in annual sales. Paul was the interface to all regulatory agencies on issues of transport package qualification. Paul has provided tech transfer support to implement numerous changes and improvements across the supply chain in support of the Lilly API supply strategy. As a team member on the internal Lilly CM&C teams, Paul made major contributions in the selection and justification of primary packaging as well.

Paul is the 2008 recipient of Eli Lilly Engineering Excellence Award, a peer selected award acknowledging lifetime engineering achievements at Eli Lilly and Company.