Paul J. Harber
`
`Paul Harber is Principal 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. Paul continues to serve on the
`PCCIG steering committee and regularly presents at the annual PDA meetings. Paul has contributed numerous articles on a variety of subjects related
`to cold chain including MKT and Stability Studies for Transportation. With a specific interest in standards, Paul assisted in the writing and execution
`of the ISTA 7E project.
`
`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.
`
`Indianapolis, IN
`League City, TX
`Indianapolis, IN
`West Lafayette, IN
`
`Purdue University
`Purdue University
`
`Work Experience
`Parenteral Supply Chain, LLC
`Modality Solutions, LLC
`Eli Lilly and Company
`Purdue University
`Education
`Bachelor of Science, Agricultural and Biological Engineering
`Master of Science, Engineering
`Past Affiliations
`PDA Member, PCCIG Steering Committee
`Past Technical Advisory Board Member, Envirotainer, AB
`ISTA; Director Thermal Testing Council
`ISPE; Member
`Publications
`PDA Technical Reports (TR), co-author
`TR 39 - Guidance for Industry: Cold Chain Guidance for Medicinal Products: Maintaining the Quality of Temperature-Sensitive
`Medicinal Products through the Transportation Environment
`TR 52 –Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain
`TR 53 – Guidance for Industry: Stability Testing to Support Distribution of New Drug Products
`ISPE Good Practice Guides, co-author
`-Cold Chain Management
`-Controlled Temperature Chambers Mapping and Monitoring
`-Specialty Pharmacy Standard Pharm-OP-07 Distribution
`URAC
`Book Chapter
`Quality by Design for Biopharmaceutical Drug Product Development
`Chapter 16- Quality by Design for Distribution of Environmentally Sensitive Pharmaceutical Products
`Articles, co-author
`“A new way to look at the performance of passive cold-chain shipping containers”, Pharmaceutical Commerce Jan—Feb 2016
`“Designing Stability Studies for Time/Temperature Exposure”, American Pharmaceutical Outsourcing Aug 2005
`
`Bethesda, MD
`Lagga Marma, Sweden
`East Lansing, MI
`Tampa, FL
`
`Patent
`
`USPTO S US10618687B2 “Shock And Vibration Absorbing Pallets And Panels”
`Compensation Structure
`Hearings, Study, Conference Calls
`Travel
`
`$250/Hr.
`$125/Hr.
`
`IPR2021-00085
`Pelican EX1010 Page 1
`
`