Agenda

Agenda

Oct. 15
1:00-1:05Introductory remarksPeter Bigelow • PBOA
1:05-1:30Legislative OverviewBrent Del Monte • BGR Government Affairs
1:30-2:00PBOA Quality Technical Group ReportChris Verbicky and QTG panel • PBOA
2:00-2:35FDA: Quality Metrics - Next StepsTara Gooen-Bizjak • FDA (CONFIRMED)
2:35-2:50Mid-day break
2:50-3:25End-User Trends & CDMO ImplicationsIan Tzeng • LEK Consultants
3:25-4:00Large Molecule Outsourcing TrendsEric Langer • BioPlan Associates
4:00-4:35Personalized Medicine, Cell & Gene Therapies, and CDMOsPANEL, moderated by Eric Langer
4:35-5:10Jim Miller: A TributeJim Miller • PharmSource (ret'd.)
5:10-5:15Closing remarksGil Roth • PBOA
5:15-6:30COCKTAIL RECEPTION
7:00-10:30OFF-SITE NETWORKING DINNERJALEO in Bethesda, MD
Oct. 16
7:00-8:00BREAKFAST
8:00-8:05Introductory remarksGil Roth • PBOA
8:05-8:45FDA: Mutual Recognition of Inspections: EMA-FDA ProgressAlonza Cruse • FDA/CDER (invited)
8:45-9:20Bridging Manufacturing & Quality in a Paperless EnvironmentAdam Sybrowsky • MasterControl
9:20-9:55AI and Data in Pharma ManufacturingDaniele Iacovelli, Boyd Specer • McKinsey
9:55-10:30Data Integrity and CDMO PerspectivesKir Henrici • hg group
Paula Katz • Covington & Burling
10:30-11:00COFFEE BREAKSponsored by INTERPHEX
11:00-11:40M&A TrendsDavid H. Windley • Jeffries LLC
11:40-12:15Serialization & Returns Verification for CDMOs & PartnersEric Marshall • Pharma Distribution Security Alliance
12:15-1:00LUNCH
1:00-1:35Diversity and Recruitment, Training and RetentionTBD
1:35-2:10Business and Legal Risks in OutsourcingRobert Di Scipio • Skyland Analytics
2:10-2:30PBOA Priorities: Setting the AgendaGil Roth • PBOA
2:30-2:35Closing remarksPeter Bigelow • PBOA
3:00-5:00Quarterly Meeting of PBOA Board of Trustees(closed to non-board members)

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

Topics, speakers and times subject to change