Agenda
The 2025 agenda is live! Because of the 2025 US government shutdown, the agenda below does not include the speakers we had previously scheduled from the US FDA, ASPR, and State Dept. If the shutdown ends in time, those speakers will be restored to the lineup.
| 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