Newsletter | January 15, 2025

01.15.25 -- 4 Considerations For Overcoming Challenges In Gene Therapy Testing

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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.

FOCUS ON REGULATORY & COMPLIANCE

2025 Outlook: Focus On Non-Oncology Indications, And In Vivo Gene Editing

Leaders from Kiji Therapeutics, Precision Biosciences, and Orgenesis weigh in on what will likely accelerate the development of novel treatments, potentially revolutionizing patient care across a wider range of diseases and bringing the promise of personalized medicine closer to reality in 2025 and beyond.

4 Considerations For Overcoming Challenges In Gene Therapy Testing

With continuously evolving gene therapy regulations and guidance and limited time during development for testing, explore points to consider when planning product-release testing.

Beyond Definitions: The Intricacies Of Cell Therapy Categorization

Understanding the intricacies of cell and gene therapy naming conventions can be confusing but necessary for effectively navigating the pathway to bring these advanced therapies to market.

Three Vital Steps To QMS Implementation

When selecting a QMS, it may feel like the most challenging step is making the purchase. This is not necessarily the case. Read more about the challenges of implementing an effective QMS.

Navigating Regulatory Challenges In Oligonucleotide Therapeutics

Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.

Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology

Learn about the rising demand for cleanrooms in the biopharmaceutical industry, factors driving cleanroom design, building in flexibility, the role of critical path assessments, and more.

REGULATORY & COMPLIANCE SOLUTIONS

Why Use A Modern Laboratory Information Management System? - Veeva

Global Scientific And Regulatory Affairs - Avance Clinical

Contamination Control Products For Annex I Compliant Facilities - Contec, Inc.

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