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| With over 450 unique products in clinical development and 50 anticipated approvals by 2030, the evolving regulatory landscape for cell and gene therapies is more critical than ever. Don't miss your chance to gain expert insights! Join the next Cell & Gene Live for an exclusive digital panel discussion exploring forward-looking perspectives on this transformative field. Registration is free—thanks to the support of Thermo Fisher Scientific. |
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By Steve Kornher, Halloran Consulting Group, a PLG company | For preclinical or early-stage cell or gene therapy companies, proper evaluation of each CDMO candidate should include the raw materials program, QC testing, and more. |
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| A Digital Thread Centric Integrated IT/OT Foundation | Article | By Shanti Chari, Landmark Bio | By adopting unified digital platforms, implementing standardized data models, and enabling seamless system integrations, see how organizations can establish continuous digital threads. |
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| Quality Agreements: Defining Governance In CDMO Partnerships | Webinar | Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises | Quality agreements serve a critical role within a CDMO-Sponsor partnership. Review the importance of aligning objectives, quality standards, and compliance frameworks to establish a robust foundation. |
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| Streamlined Cell Therapy Development: Part I | Article | By Dr. Bruce Thompson, Kincell Bio | The first in a two-part series, this article focuses on how to move from candidate selection to a Phase 1 Investigational New Drug (IND) application. |
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