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ISCT CSO Global Showcase on COVID-19, Part II "A New Hope"

This second COVID-19 session will focus on novel cell-based and immunologic-based therapeutics. With the ongoing threat of emerging infectious disease, what role can cell therapies play therapeutically and how should studies be conducted and interpreted? Through translational and clinical...

1311518.mp4


Library Entry
ISCT GRP Workshop

ISCT Global Regulatory Perspectives Co-Chairs: Karen Nichols (US) and Dominic Wall (AU) Key Topics in Combination Products Interviewers: Karen Nichols (US) David DiGiusto (US) Panelists: Melanie Eacho (US) Colin White (US) Patrick Bedford (CA) Sterility Controls, Past...

1311346.mp4


Library Entry
Imaging Cellular Therapeutics

Speakers will present their experience with imaging cellular therapeutics to bring awareness to how noninvasive in-vivo cell tracking technologies and methods can provide unique opportunities to optimize efficacy of cell-based therapies and aid in the assessment and management of eventual...

1320323.mp4


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Safety Matters, Long-Term Follow-Up, Accreditation and Clinical Registries for Regenerative medicine Product

The field of regenerative medicine has shown tremendous growth in just a few short years, with advancements at all stages of translation for cell-based therapeutics. This session will highlight important considerations and recent steps taken to improve the safety and efficacy of regenerative...

1321961.mp4


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Qualification, Regulation of Gene Editing Tools in Cell & Gene Therapy

Recent advances in genome editing technologies have substantially improved our ability to make changes in the genomes of eukaryotic cells. Viral vectors and programmable nucleases are already revolutionizing our ability to interrogate the function of the genome. This session provides an overview...

1311411.mp4


Library Entry
Manufacturing Profess Validation - Consideration for Validation of Autologous Products

Process Validation – it has to happen! Join us to hear regulatory perspectives and real-world examples of considerations specific to autologous products, including both cells and tissues. Are normal donor cells ok to use? What risks are associated with validating your process using cells or...

1311424.mp4


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Innovating process development for sustainable manufacturing

Optimizing a product through process development is a natural step in translating the therapeutic to the clinic. While this is a critical milestone, many of the processes have not been optimized for larger-scale industrialization. This session will evaluate how industry innovators are...

1311406.mp4


Library Entry
Clinical Experience in regenerative medicine and tissue engineering, the next wave of advanced therapies

Chair: Julie Allickson (US) Speakers: Julie Allickson (US) – Clinical Translation of Tissue Engineering in an Academic Facility Petter Björquist (SE) – Personalized Tissue-Engineered Organs that Will Revolutionize Future Medicine Laura Niklason (US) – Will Engineered Tissues Transform...

1311410.mp4


Library Entry
Can we industrialize CAR T therapies? The Practice Challenges in achieving wide-spread patient access

Today the first two autologous CAR-T therapies are commercialized in multiple developed countries, through dozens of health care facilities, and many hundreds of patients are benefiting from treatment! Now “industrializing” CAR-T therapy to gain world-wide, broad patient access to this new...

1311408.mp4


Library Entry
State of the Art: Success and Failure of Cell Therapy Clinical Trials for Acute and Chronic Lung Diseases

Mesenchymal stem/stromal cell (MSC) therapy holds promise for the treatment of acute and chronic lung diseases. The benefits of MSC-based therapies appeared to be induced by complex, well-orchestrated signaling pathways rather than by any one (or few) mechanisms. Safety results from phase I and...

1311367.mp4