Agenda

Agenda

Here’s the tentative agenda for PBOA’s 2nd Annual Meeting & Conference:

Sept. 17
1:00-1:05Introductory remarksPeter Bigelow • PBOA
1:05-1:30PBOA Working Group Reports: Quality, Serialization, Shortages & moreGil Roth, Chris Verbicky • PBOA
1:30-2:05FDA Inspectional TrendsTom Cosgrove & Paula Katz • Covington & Burling
2:05-2:35Legislative Overview
Brent Del Monte • BGR Government Affairs
2:35-2:50Mid-day break
2:50-3:25M&A and Investment Trends in CDMO & Pharma Services Daniel Cohen • RBC
3:25-4:00End-Market Trends & CDMO ImplicationsGerti Pellumbi • McKinsey & Co.
4:00-4:35Trends in Large molecule CMC activity: Outsourcing for Novel ModalitiesPatricia Seymour • BioProcess Technology Consultants (BPTC)
4:35-5:10FDA: Quality Metrics and CDMOsTara Gooen-Bizjak • FDA (CONFIRMED)
5:10-5:15Closing remarksGil Roth • PBOA
5:15-6:30COCKTAIL RECEPTIONSponsored by INTERPHEX
7:00-10:30OFF-SITE NETWORKING DINNERJALEO in Bethesda, MD
Sept. 18
7:00-8:00BREAKFAST
8:00-8:10Introductory remarksGil Roth • PBOA
TRACK 1QUALITY & REGULATORY
8:10-8:45EHS Audits & the Quality ConnectionDaniel O. Chute • BSI EHS Services and Solutions
8:45-9:20FDA: Data Integrity and CDMO InspectionsSarah Barkow • FDA (CONFIRMED)
9:20-9:55FDA: Quality Assessments & InspectionsYing Zhang • FDA (CONFIRMED)
TRACK 2BUSINESS & OPERATIONS
8:10-8:45Advanced Manufacturing TechnologiesKe Hong • Pfizer
8:45-9:20CDMO Concerns with Safe Handling of Potent APIsRobert Sussman • SafeBridge Consultants
9:20-9:55Analytics: Delivering Real Business ValueBrian Vogel • Rockwell Automation
10:00-10:40COFFEE BREAK
10:40-11:20Serialization Issues for CDMOsEric Marshall • Pharma Distribution Security Alliance
11:20-noonWorking with ANDA Holders Under GDUFA IIJoyce Anne DelGaudio • Teva
noon-12:45LUNCH
12:45-1:25Brexit: Are CDMOs Ready?Johnathon Marshall • PWC
1:25-2:00State Distribution RegulationsEmily Leongini • Arent Fox
2:00-2:30PBOA 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)

Topics, speakers and times subject to change