Agenda

Agenda

The 2021 edition of the PBOA Meeting & Conference will be held virtually from December 13 to December 17. More speakers and sessions will be added in the days ahead, so please check back.

Monday, Dec. 13
1:00 p.m.Introductory remarksPeter Bigelow • PBOA
1:05 p.m.The State of the Biopharma & Vaccine Manufacturing SectorEric Langer • BioPlan Associates
3:00 p.m.How To Improve CDMO Effectiveness on Capitol HillRemy Brim and Brent Del Monte • BGR Government Affairs
Tuesday, Dec. 14
noonSimplify Quality: Unifying QA and QCJason Boyd • Senior Director, Veeva, LIMS
1:00 p.m.CMO/CDMO State Compliance RequirementsSumeet Singh, Kelly DiBattista, Esq., and Sue Winter, CQA • Pharma Solutions
Wednesday, Dec. 15
noonTrends & Innovation in Lab Automation for CDMOsDr. Ian John Edwards • Global Pharmaceutical Leader, Waters Corp.
2:00 p.m.FDA Keynote - Inspectional Oversight & Remote AssessmentsAlonza Cruse • Director • Office of Pharmaceutical Quality Operations, FDA/Office of Regulatory Affairs
Thursday, Dec. 16
10:00 a.m.FDA Keynote - CARES Act: Drug Amount Reporting using FDA NextGen PortalObinna Ugwu-Oju • Director, FDA/CDER/OPQ/OQS/Division of Quality Data Science
noonCSR/ESG & Sustainability Issues for CDMOsShannon Trilli Kempner • Vice President, Corporate Responsibility and Diversity & Inclusion, Catalent Pharma Solutions
Nandini Piramal • Executive Director, Piramal Enterprises, Piramal Pharma Solutions
Meron Mathias • Senior Director, Head of Global CSR & Sustainability, Thermo Fisher
3:00 p.m.CDMO Industry Outlook Panel: M&A and Investment Trends for CDMOs & Other Pharma ServicesIan Tzeng • L.E.K. Consulting
John Kreger • Wm. Blair
Daniel Cohen • RBC
Jim Miller • PharmSource (ret'd.)
Friday, Dec. 17
noonState of the PBOA • 2022 Agenda / AMAGil Roth • PBOA

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

Agenda subject to change


For reference, here is the agenda from our 2020 virtual meeting:

Monday, Dec. 7
Introductory remarksPeter Bigelow • PBOA
noonVirtual Inspections & CDMOsCynthia Schnedar and Kalah Auchincloss • GreenLeaf Health
Tuesday, Dec. 8
11:00 a.m.Financing Projects with DFCDavid Vidal and Thuan Nguyen • US International Development Finance Corp. (DFC)
1:00 p.m.State and Local Distribution RegulationsSumeet Singh • Five Rivers Rx
Wednesday, Dec. 9
11:00 a.m.Annex 1: European GMPs for Sterile ProductsPanel led by Jörg Zimmermann • Vetter Pharma
Christa Meyers • CRB
Vince Cebular •IPS
Alice Redmond • CAI
Walid El Azab • Steris Solutions
1:00 p.m.State of the CDMO SectorIan Tzeng • L.E.K. Consulting
David Windley • Jefferies LLC
Jim Miller • PharmSource (ret'd.)
Daniel Cohen • RBC
Monday, Dec. 14
11:00 a.m.FDA's Quality Management Maturity MetricsLyle Canida • FDA
1:00 p.m.State of Biologics Outsourcing & Contract ManufacturingEric Langer • BioPlan Associates
Tuesday, Dec. 15
11:00 a.m.FDA Inspectional UpdateAlonza Cruse • FDA
1:00 p.m.Accelerating the Transition from Paper to Digital in High Volume ManufacturingAdam Sybrowsky • MasterControl
3:00 p.m.Post-Approval Changes and One Quality VoiceAnders Vinther • Intarcia Therapeutics
Wednesday, Dec. 16
11:00 a.m.CDMOs and Virtual Customer Audits PanelPatrick Butler • Lifecore Biomedical
Darwin Richardson • Aji Biopharma Services
Dawn Wofford • Cytovance Biologics
Audrey Butler • Adare Pharma Solutions
Monica Commerford • Thermo Fisher Scientific
1:00 p.m.State of the PBOA • Strategic Plan RolloutGil Roth • PBOA