Agenda

Agenda

The 2019 edition of the PBOA Meeting & Conference is complete! The conference programming was fantastic, and our speakers and panelists provided plenty of great material for our members to take back to their companies. Here is the conference 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
2:35-2:50Mid-day break
2:50-3:25End-User Trends & CDMO ImplicationsIan Tzeng • L.E.K. Consultants
3:25-4:00Large Molecule Outsourcing TrendsEric Langer • BioPlan Associates
4:00-4:35PANEL: Personalized Medicine, Cell & Gene Therapies, and CDMOsJulia Tierney • FDA/CBER
Alan Moore • Advanced Therapeutics
George Buchman • Catalent Gene Therapy
moderated by Eric Langer • BioPlan Associates
4:35-5:10Jim Miller: Parting ThoughtsJim Miller
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/ORA
8:45-9:20Bridging Manufacturing & Quality in a Paperless EnvironmentAdam Sybrowsky • MasterControl
9:20-9:55AI and Data in Pharma ManufacturingSulay Sandy • McKinsey / QuantumBlack Analytics
Boyd Spencer • McKinsey
9:55-10:30Data Integrity and CDMO PerspectivesSue Schniepp • Regulatory Compliance Associates (RCA)
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
1:00-1:35Business and Legal Risks in OutsourcingRobert Di Scipio • Skyland Analytics
1:35-2:10Talent & Diversity: Gaining a Competitive Advantage to Attract and Retain Top TalentTeresa Laggini Sankner • Novartis
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.