This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Delivered as a Hybrid Event from September 20-30, 2021
Live In-Person Experience Delivered September 20-23; On-demand experience Delivered September 28-30Boston Convention and Exhibition Center

James Hathcock, Ph.D.
Senior Director, Regulatory and Validation Strategy, Pall Biotech at Pall Life Sciences


James Hathcock, PhD is Senior Director of Regulatory and Validation Strategy at Pall Biotech, which includes responsibility for the characterization strategy to support the safe and successful end-user implementation of technologies enabling pharmaceutical manufacturing.   He leads the BPSA imitative on X-ray qualification for single-use disposables, the BioPhorum Community of Practice for Extractables and leachables,and is an expert manel member for USP <665> & <1665>.  He is also  an active member of ASTM, ASME-BPE, PDA, ISPE, BPSA. Since joining Pall in 2008, James has led chemical and performance characterization of medical and biotech components, as well as relevant technical packages supporting regulatory filings.  Prior to joining Pall, James served as professor of hematology at the Mt. Sinai School of Medicine in New York City, where he directed the protein purification laboratory related to drug characterization and discovery.  James enjoys coaching his daughters’ Lego Robotics team (NYC champions), reef tanking, and biking.

Agenda Sessions

  • ROOM 258AB: A Town Hall Forum: BioProcess and Single-Use Standardization: What are the Next Steps for the Industry?