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