Agenda

Oct. 5
9:00-10:00am	Registration & badge pick-up
10:00-10:05	Introductory remarks	Gil Roth • PBOA
10:05-10:40	Legislative Advocacy	Brent Del Monte • BGR Government Affairs
10:40-11:20	Pharma Pressures and Implications for CDMOs	Ian Tzeng • L.E.K. Consultants
11:20-11:55	Data Integrity: Past Trends and Future Risks	Patrick Day • Lachman Consultants
noon-1:00	LUNCH
1:00-1:35	FDA: Drug Shortages & CDMOs	Jacqueline Corrigan-Curay J.D., M.D. • FDA/CDER
1:35-2:10	How to Empower and Operationalize CDMOs using AI	Laura Jacoby • Apprentice.io
2:10-2:40	Workforce on the Precipice	Neil Kelly & Jack Shute • Vector Partners
2:40-3:10	COFFEE BREAK
3:10-3:45	Application of AI in the Pharma Industry	Sumeet Singh • LighthouseAI
3:45-4:20	FDA's QMM Pilot Program: Lessons Learned	Bryant Headley • Pacific Force Consulting Group
4:20-4:55	FDA: Inspectional Update	Alonza Cruse • FDA/ORA
4:55-5:00	Closing remarks	Gil Roth • PBOA
5:00-6:00	COCKTAIL RECEPTION
6:30-10:00	OFF-SITE NETWORKING DINNER
Oct. 6
7:00-8:00	BREAKFAST
8:00-8:05	Introductory remarks	Gil Roth • PBOA
8:05-8:45	Inspection Trends and Sponsor Scoring Models for CDMOs	Michael De La Torre • Redica Systems
8:45-9:20	Large Molecule Outsourcing: Growth in Demand for Bioprocessing Services Continues	Eric Langer • BioPlan Associates
9:20-9:55	Recovering from Long COVID: The CDMO Landscape as it Returns to “Normal”	David Windley • Jefferies
9:55-10:30	FDA: Current Thinking on Quality Agreements and Contract Manufacturing	Elizabeth M. Kelley • FDA/CDER
10:30-11:00	COFFEE BREAK
11:00-11:40	PBOA Priorities: Setting the Agenda	Gil Roth • PBOA
11:40-11:45	Closing remarks	Gil Roth • PBOA

Visit our Speakers page for bios of our speakers and panelists.

Agenda subject to change; FDA participation may be affected by US government shutdown policies