PACT Web Seminars

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2020 - 2021


May 24, 2021 - The COVID-19 Pandemic: Challenges and Opportunities for Cell Processing Facilities

In this extended web seminar (running 1.5 hours), we will focus on the impacts in the cell therapy community and specifically on cell processing facilities as they navigate the ‘new normal’. The pandemic’s impact includes the plethora of clinical trials and networks that have started rapidly in the field of cell therapy and regulatory pathways have also been fast-forwarded in previously unimaginable ways. Cell therapy facilities manufacturing these products have experienced unprecedented manufacturing and operations issues as a result of the pandemic. An overview of the change in the clinical cell therapy landscape, as well as how manufacturing facilities have managed and continue to troubleshoot operations in these conditions will be discussed.  The speakers are from two of the PACT Cell Processing Facilities and the the presentation will be followed by an extended Question and Answer Session which will include representatives from all five of the PACT Cell Processing Facilities.


  • Joshua Hare, MD, FACC, FAHA (Louis Lemberg Professor of Medicine and Founding Director, Interdisciplinary Stem Cell Institute, Miller School of Medicine at the University of Miami)
  • Joseph Gold, PhD (Senior Director of Manufacturing, Center for Biomedicine & Genetics, City of Hope)

Save the date flyer
Activity Accreditation Statement Sheet
Web Seminar Handouts (will be posted the day of the web seminar)
Web Seminar Audio File (will be posted after the web seminar)


Prior Web Seminars

December 15, 2020 - Contract Manufacturing By and For Academic Institutes

In this webinar we will review how academic institutions are operationalizing their resources to offer contract manufacturing. We will also cover outsourcing of manufacturing and testing by academic institutions. The personalized nature of cellular therapy products introduces a detailed and scientific development. Academic institutes are well-equipped to develop products with scientific oversight. Their involvement also helps to accelerate their institutional ideology in furthering the growth and evolution of the field of cell therapy.



September 3, 2020 - Methods for Cellular Therapies: Tracking Cells In Vivo and Assessing Biodistribution in Patients -- What are your cells doing? Where do they go?




July 17, 2020 - Cell Therapy GTP and GMP Facilities: Design and Operation to Optimize Space to Meet Manufacturing Needs



December 10, 2019 - Guidance for Submission of an Initial IND (Investigational New Drug) Application


September 10, 2019 - Vendor Qualification


February 11, 2019 - Accelerating Your Cell Therapy: A PACT Program Update


November 8, 2018 - Issues Involved in Starting CAR T Cell Manufacturing


June 19, 2018 - Development of GMP Cell Manufacturing of Cardiac Stem Cell


January 16, 2018 - Early Phase Cell Therapy Product Development: Potency Assays


September 26, 2017 - Early Phase Cell Therapy Product Development: Quality in the Lab


June 8, 2017 - Academic and Industry Partnerships - The Next Generation


March 14, 2017 - Accelerating Your Cell Therapy


September 25, 2014 - Challenges and Problem-Solving in Cell Therapy Product Development


May 8, 2014 - Scaling Up Cell Culture: Application of Closed Cell Culture Systems in Clinical Research


November 14, 2013 - Ask the Experts


February 20, 2013 - Cell Therapy for Lung Indications


September 27, 2012 - Protecting Patients from Harm: Ethical, Legal & Policy Responses to Domestic and International Marketing of Clinically Unproven Stem Cell Interventions


February 23, 2012 - Adverse Events and Reactions In Cellular Therapy


August 11, 2011 - Preparing for a FDA Inspection


May 4, 2010 - PACT Web Seminar

The NHLBI and EMMES (PACT Coordinating Center) presentations are available for viewing and printing using the link below. The 5 PACT facility speaker presentations are not available on our website. Please contact the speakers regarding their presentations. Speaker contact information can be found in the Webcast Overview Document embedded in the link below:

May 4, 2010 PACT Webcast Presentation Overview 


October 15, 2009 - Interpretation of the Final Rule: cGMP and Investigational New Drugs Intended for Use in Phase 1 Clinical Trials

July 16, 2009 - Deviation Management of Type 351 and 361 Cell Products


January 29, 2009 - Qualification: Vendor, Equipment and Supplies



November 6, 2008 - Delivering Effective and Result-based Training


July 31, 2008 - Validation Processes


June 25, 2008 - NHLBI Training and Funding Opportunities & Overview of Cell Therapy in Lung Biology and Disease


Februray 21, 2008 - Cryopreservation of Cell Therapy Products


October 11, 2007 - Preparing for an FDA Inspection


July 19, 2007 - Interpreting AABB & FACT Cell Therapy Standards


February 22, 2007 - Adverse Event Reporting (Reporting Issues & Requirements)


October 26, 2006 - Cell Therapy Data Management


July 20, 2006 - Facility Master Files, SOP Development, Deviation Management System


January 19, 2006 - Rapid Release Testing, Product Transportation, Workflow Analysis: Handling Multiple Specimens


July 14, 2005 - CMC Writing, Biological Product Deviation Reporting and Staff Training & Competency Testing


March 31, 2005 - Validation, equipment management and facility cleaning and disinfection

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