Manufacturing & Supply
15 videos · last 6 months shuffled daily, then older videos newest first
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10:12 How to Match CGT Manufacturing Models to Pipeline Needs
Omkar Kawalekar of Deloitte and Zoe Zheng of Legend Biotech on how early manufacturing decisions shape scalability, and the pitfall of treating manufacturing as a question about a facility.
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6:28 Revisiting CGT Manufacturing Strategy and De-Risking Tech Transfer
Omkar Kawalekar of Deloitte and Zoe Zheng of Legend Biotech on when cell and gene therapy developers should stress-test manufacturing strategy, arguing it starts in Phase 1 and is revisited as clinical data arrives.
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5:17 Kim Brown, CEO, Compass Biomedical
Kim Brown, CEO of Compass Biomedical, argues that the culture material cells are grown in quietly shapes the quality and consistency of the finished cell therapy product.
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40:08 Stevie Ringel of Nome on AI in Ultra-Rare Drug Development
Stevie Ringel, co-founder of Nome and founder of the Kizuna Foundation, tells The Genetics Podcast how AI agents handle the operational work of small-batch ultra-rare drug development, and discusses FDA signals and funding models.
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20:04 Pharma Commerce on Domestic Manufacturing and the German Pricing Standoff
The FDA has named the first seven manufacturers in its PreCheck pilot, from more than eighty applicants. The programme moves FDA scrutiny of facility readiness earlier, before problems become approval-blocking deficiencies.
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1:27:12 OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs
The FDA's Office of Therapeutic Products answers questions on chemistry, manufacturing and controls readiness for late-stage cell therapy INDs, in a September 2024 town hall.
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7:47 Supply Chain Orchestration, Priorities for Smaller CGT Biotechs
Omkar Kawalekar of Deloitte and Zoe Zheng of Legend Biotech on cell and gene therapy supply chains, and why the worst vulnerabilities show up in patient scheduling, data fragmentation and QC release.
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10:34 CGT Biotech/CDMO Transparency & Core Capabilities
Omkar Kawalekar of Deloitte and Zoe Zheng of Legend Biotech on what cell and gene therapy developers should look for in a CDMO partner: transparency, data visibility and capability rather than capacity.
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6:11 CGT Modality, Hybrid Models, And What To Keep In-House
Omkar Kawalekar of Deloitte and Zoe Zheng of Legend Biotech on how modality changes cell and gene therapy manufacturing, from patient-specific autologous programs to allogeneic and in vivo approaches.
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4:23 End-to-End Planning for Clinical Trial Execution
Jeremy Liska, Integrated Project Delivery Lead at Thermo Fisher Scientific, explains how planning feasibility, site selection, regulatory and supply activities from day one avoids fragmented vendor handoffs.
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7:25 Cell Therapy and Personalized Medicine From Cellares and AT&T
Start up Cellares develops modular factories to assist in the manufacture of cell therapies that can be used for personalized medicine.
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52:41 Clinical Trial Supply Chains: Fragmented vs Centralized
Signant Health's clinical supply chain experts discuss the risks of managing trial supplies across spreadsheets, emails and paper records, and how a centralised cloud-based system supports forecasting, inventory management and study-wide visibility.
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6:15 The mRNA Boom Is Upon Us and the University of Queensland Working on mRNA Vaccines
Video from ABC looks at how mRNA delivers genetic instructions and how these mRNA technologies started to gain traction with COVID so that now Australia has its own mRNA manufacturing plant and several pre-clinical advancements in mRNA delivery.
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2:32 Agile Quality by Design: A Smarter Way to Develop Medicines
Thierry Bastogne explains why traditional Quality by Design often comes too late in preclinical development, and how Agile QbD combines QbD with Agile methods to allow earlier decision-making.
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10:31 Drug Law Earthquake: Will BioSecure Act Shift $$$ From China to India?
ibaji Biswas, ED & CFO, Syngene International, as US considers the Biosecure Act that aims to reduce reliance on Chinese contract drug manufacturers & research organizations.