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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


The 2020 bioXchange Workshop is this week! The workshops will take place via Zoom. For your convenience, we've provided the meeting access information below:  

Wednesday, Sept. 23 | 12:00 - 2:00 EDT
Click Here For Meeting Link!
Meeting ID: 850 1459 7112
Passcode: 948631
Thursday, Sept. 24 | 12:00 - 2:00 EDT
Click Here For Meeting Link!
Meeting ID: 862 3762 2413
Passcode: 719755