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Brent Del Monte of BGR Government Affairs, giving the Legislative Update
Attendees in the amphitheater
The Quality Technical Group panel
Tara Gooen-Bizjak of FDA discusses Quality Metrics
Ian Tzeng of L.E.K. Consulting on End-User Trends & CDMO implications
Cell & Gene Therapy panel, including Advanced Therapeutics, Catalent Gene Therapy, and FDA/CBER
Jim Miller closes out day 1 with Parting Thoughts on the CDMO sector
Informal networking dinner at JALEO in Bethesda!
The PBOA Rat Pack
Jim Miller receiving the inaugural PBOA Founders’ Award from Catalent’s Cornell Stamoran
Don’t break it!
Alonza Cruse of FDA on FDA/EMA mutual recognition of inspections
Adam Sybowsky of MasterControl on bridging quality in a paperless environment
Boyd Spencer of McKinsey on AI and Big Data in Pharma Manufacturing
Sulay Sandy of McKinsey/QuantumBlack on AI and Big Data in Pharma Manufacturing
Sue Schniepp of RCA Inc. on Data Integrity & CDMOs
Dave Windley of Jeffries LLC on M&A Trends in the pharma services sector
Eric Marshall of PDSA/Leavitt Partners on DSCSA issues and next steps
Bob DiScipio of Skyland Analytics on business and legal risks in outsourcing
Teresa Sankner of Novartis closed out the conference with “Talent & Diversity: Gaining a Competitive Advantage to Attract and Retain Top Talent”