{"id":54,"date":"2017-08-21T21:31:23","date_gmt":"2017-08-21T21:31:23","guid":{"rendered":"https:\/\/pharma-bio.org\/conference\/?page_id=54"},"modified":"2025-10-06T14:39:45","modified_gmt":"2025-10-06T14:39:45","slug":"agenda","status":"publish","type":"page","link":"https:\/\/pharma-bio.org\/conference\/agenda\/","title":{"rendered":"Agenda"},"content":{"rendered":"

Agenda<\/h1>\n

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.<\/p>\n\n\n\n\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t
Oct. 9, 2025<\/strong><\/td><\/td><\/td>\n<\/tr>\n
9:00-10:00am<\/td>Registration & badge pick-up<\/td><\/td>\n<\/tr>\n
10:00-10:05<\/td>Introductory remarks<\/td>Gil Roth \u2022 PBOA<\/td>\n<\/tr>\n
10:05-10:35<\/td>Legislative Update<\/td>Brent Del Monte \u2022\u00a0BGR Government Affairs<\/td>\n<\/tr>\n
10:35-11:25<\/td>The New Normal: Serving Pharma in a Rapidly Changing Ecosystem<\/td>Ian Tzeng and Adam Siebert \u2022 L.E.K. Consultants<\/td>\n<\/tr>\n
11:25-noon<\/td>State of Tariffs: IEEPA, 232, and CDMOs<\/td>John Stone \u2022\u00a0BGR Government Affairs<\/td>\n<\/tr>\n
noon-1:00<\/td>LUNCH<\/em><\/td><\/td>\n<\/tr>\n
1:00-1:35<\/td>Industrializing GMP AI: Scaling Beyond One-Off Experiments<\/td>Kevin Baughman \u2022 AIZON AI<\/td>\n<\/tr>\n
1:35-2:10<\/td>Integrating Quality Risk Management and AI<\/td>Patrick Day \u2022 Lachman Consultants<\/td>\n<\/tr>\n
2:10-2:45<\/td>Computer Software Assurance: Final Guidance and Quality Considerations<\/td>Patrick Day \u2022 Lachman Consultants<\/td>\n<\/tr>\n
2:40-3:10<\/td>COFFEE BREAK<\/em><\/td><\/td>\n<\/tr>\n
3:10-3:45<\/td>Adoption of Continuous Bioprocessing: CDMOs Lead the Way<\/td>Renaud Jacquemart \u2022 BioPlan Associates<\/td>\n<\/tr>\n
3:45-4:25<\/td>Healthcare Cost Conundrum: Innovation, Onshoring, Tariffs, and MFN<\/td>David Windley \u2022 Jefferies<\/td>\n<\/tr>\n
4:25-5:00<\/td>Fireside Chat<\/strong>: Lessons Learned from 40 Years at FDA<\/td>Alonza Cruse \u2022 FDA\/ORA (Ret'd.)<\/strong><\/td>\n<\/tr>\n
5:00<\/td>Closing remarks<\/td>Gil Roth \u2022 PBOA<\/td>\n<\/tr>\n
5:00-6:00<\/td>COCKTAIL RECEPTION<\/em><\/td><\/td>\n<\/tr>\n
6:30-10:00<\/td>OFF-SITE NETWORKING DINNER<\/em><\/td><\/td>\n<\/tr>\n
Oct. 10, 2025<\/strong><\/td><\/td><\/td>\n<\/tr>\n
7:00-8:00<\/td>BREAKFAST<\/em><\/td><\/td>\n<\/tr>\n
8:00-8:05<\/td>Introductory remarks<\/td>Gil Roth \u2022 PBOA<\/td>\n<\/tr>\n
8:05-8:35<\/td>CDMO Sector State Of The Union: Wall Street Perspective<\/td>Daniel Cohen \u2022 Morgan Stanley<\/td>\n<\/tr>\n
8:35-9:05<\/td>Trends in Bio-Outsourcing<\/td>Eric Langer \u2022 BioPlan Associates<\/td>\n<\/tr>\n
9:05-9:35<\/td>Fireside Chat: Supply Chains and Reshoring<\/td>Marta Wosinska \u2022 Brookings Institution<\/td>\n<\/tr>\n
9:35-10:05<\/td>Beyond the Deal: Winning with Talent Before and After Acquisition <\/td>Neil Kelly \u2022 Vector Talent<\/td>\n<\/tr>\n
10:05-10:35<\/td>Insights into Today\u2019s FDA and Beyond<\/td>Alec Gaffney \u2022 AgencyIQ<\/td>\n<\/tr>\n
10:35-11:05<\/td>COFFEE BREAK<\/em><\/td><\/td>\n<\/tr>\n
11:05-11:40<\/td>PBOA Priorities: Setting the Agenda<\/td>Gil Roth \u2022 PBOA<\/td>\n<\/tr>\n
11:40-11:45<\/td>Closing remarks<\/td>Gil Roth \u2022 PBOA<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n

Visit our Speakers page<\/a> for bios of our speakers and panelists.<\/p>\n

Agenda subject to change<\/em><\/p>\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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. Visit our Speakers page for bios of our … <\/p>\n

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