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.
- COVID-19/SARS-Cov-2 – Role of Cell-based Therapy | 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)
- COVID-19 Impacts on GMP Facilities: Preparing for Apocalypse 2.0 | Joseph Gold, PhD
(Senior Director of Manufacturing, Center for Biomedicine & Genetics, City of Hope)
Prior Web Seminars
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.
- Contracting: In and Out | Adrian Gee, PhD, MI Biol
- Contract Manufacturing at an Academic Medical Center | Allan Dietz, PhD
- HESI CT-TRACS: a Collaborative Effort to Address Collective Challenges & Needs | Bill Shingleton, BSc, PhD
- Tracking Cells after Administration: Imaging Modalities and Probes | Brooke Helfer, PhD
- The Need for Collaboration Across Stakeholders to Address the Challenges Facing the Translation of Cell Therapies into the Clinic | David Morrow, PhD, MBA
- Aligning Academic Cell Therapy Manufacturing Facility Capability with FDA Requirements: Can We Increase Output as Demand Ramps Up? | Linda Kelley, PhD
- Design, Construction and Commissioning of an Academic Cellular Manufacturing Facility | Amittha Wickrema, PhD