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2020 Virtual bioXchange Workshop | Agenda

Sept. 23 & 24, 2020 | 12:00 - 2:00 PM EDT


Day 1 - Sept. 23


Risk-Based Approaches to ATMP Manufacturing

Moderator: Radhakrishna S. Tirumalai, PhD; Principal Scientific Liaison - United States Pharmacopeia

  12:00 - 1:20 PM

Risked-Based Approaches to ATMP Manufacturing
Tony Cundell, PhD; Principal Consultant
Microbiological Consulting, LLC


Chain of Identity Risk Assessment in Cell Therapy
César Tapia; Sr. Manager CAR-T Operational Excellence & Lean Six Sigma Black Belt
Bristol Myers Squibb


Regulatory Considerations for Risk Assessments Conducted for ATMPs
Steve Langille, PhD; Senior Microbiology Consultant
Valsource, Inc.

  1:20 - 2:00 PM

Panel Discussion – Ask the Experts
Session presenters joined by:
John Duguid; Senior Director, Research & Development
Vericel Corporation 



Day 2 - Sept. 24

Innovating Smarter Quality Monitoring in Biologics

Moderator: Lori Daane, PhD; Scientific Director, Healthcare - bioMérieux, Inc.

12:00 - 1:20 PM

Creating a Global End-to-End Quality Control Strategy in the Digital Age
Mousumi Paul; Director Quality, Product Strategy & Business Process
Merck and Co., Inc.


Advanced Pyrogen Testing: MAT and rFC
Ingo Spreitzer, PhD; Deputy Head Section 1/3 Microbiological Safety


Evaluation of a One-hour, At-line Mycoplasma Test
Sylvanie Cassard-Guilloux, PhD; Global Solution Manager
bioMérieux, SA

1:20 - 2:00 PM
Panel Discussion – Ask the Experts
Panel presenters joined by:
Anna Lau, PhD, D (ABMM); Chief, Sterility Testing Service
Clinical Center, National Institutes of Health