Agenda
The 2026 agenda will be posted as we confirm more speakers; below, please find the 2025 agenda.
(Because of the 2025 US government shutdown, the agenda did not include previously scheduled speakers from the US FDA, ASPR, and State Dept.)
| Oct. 9, 2025 | ||
| 9:00-10:00am | Registration & badge pick-up | |
| 10:00-10:05 | Introductory remarks | Gil Roth • PBOA |
| 10:05-10:35 | Legislative Update | Brent Del Monte • BGR Government Affairs |
| 10:35-11:25 | The New Normal: Serving Pharma in a Rapidly Changing Ecosystem | Ian Tzeng and Adam Siebert • L.E.K. Consultants |
| 11:25-noon | State of Tariffs: IEEPA, 232, and CDMOs | John Stone • BGR Government Affairs |
| noon-1:00 | LUNCH | |
| 1:00-1:35 | Industrializing GMP AI: Scaling Beyond One-Off Experiments | Kevin Baughman • AIZON AI |
| 1:35-2:10 | Integrating Quality Risk Management and AI | Patrick Day • Lachman Consultants |
| 2:10-2:45 | Computer Software Assurance: Final Guidance and Quality Considerations | Patrick Day • Lachman Consultants |
| 2:40-3:10 | COFFEE BREAK | |
| 3:10-3:45 | Adoption of Continuous Bioprocessing: CDMOs Lead the Way | Renaud Jacquemart • BioPlan Associates |
| 3:45-4:25 | Healthcare Cost Conundrum: Innovation, Onshoring, Tariffs, and MFN | David Windley • Jefferies |
| 4:25-5:00 | Fireside Chat: Lessons Learned from 40 Years at FDA | Alonza Cruse • FDA/ORA (Ret'd.) |
| 5:00 | Closing remarks | Gil Roth • PBOA |
| 5:00-6:00 | COCKTAIL RECEPTION | |
| 6:30-10:00 | OFF-SITE NETWORKING DINNER | |
| Oct. 10, 2025 | ||
| 7:00-8:00 | BREAKFAST | |
| 8:00-8:05 | Introductory remarks | Gil Roth • PBOA |
| 8:05-8:35 | CDMO Sector State Of The Union: Wall Street Perspective | Daniel Cohen • Morgan Stanley |
| 8:35-9:05 | Trends in Bio-Outsourcing | Eric Langer • BioPlan Associates |
| 9:05-9:35 | Fireside Chat: Supply Chains and Reshoring | Marta Wosinska • Brookings Institution |
| 9:35-10:05 | Beyond the Deal: Winning with Talent Before and After Acquisition | Neil Kelly • Vector Talent |
| 10:05-10:35 | Insights into Today’s FDA and Beyond | Alec Gaffney • AgencyIQ |
| 10:35-11:05 | COFFEE BREAK | |
| 11:05-11:40 | 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