Agenda

Agenda

We’re in the process of confirming topics, speakers and panelists, and will update this page in the weeks ahead. Meanwhile, here’s the agenda for LAST YEAR’S VIRTUAL EVENT

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