INSIGHTS ON CELL & GENE REGULATORY ISSUES

• How Is RIM Software Transforming Regulatory Compliance?

  Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.

• EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence?

  On July 1, 2025, the EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials is slated to come into effect. 

• Closed-Loop Manufacturing Is The Cell Therapy Revolution We Need

  In cell therapy manufacturing, automated closed systems with integrated software controls offer numerous benefits over traditional open systems.

• Exploring The Market For Closed-Loop Cell Therapy Production

  The second part of a discussion on closed-loop systems explores the CDMO and equipment landscape for scaling automated closed loop cell therapy manufacturing systems.

• Extracellular Vesicle Breakthroughs with Aegle Therapeutics' Dr. Gloria Matthews

  In this episode of Cell & Gene: The Podcast, Host Erin Harris interviews Dr. Gloria Matthews, Chief Medical Officer of Aegle Therapeutics, a clinical-stage regenerative medicine company focused on developing therapies for rare and severe dermatologic and immunologic disorders.

• What Global Survey Says About Scant Patient Access To CAR-T Therapy

  The Worldwide Network for Blood and Marrow Transplantation initiated a survey to understand cost, infrastructure, and regulatory differences affecting access.

• Navigating Special Regulatory Pathways For Advanced Therapy Development Success

  Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.

• A Look At Elsa, The FDA's New AI Digital Assistant

  The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.

• Mastering GMO & Companion CDx Trials: The EU Regulatory Playbook

  This presentation offers strategic and operational guidance for navigating the regulatory challenges of conducting gene-modified organism (GMO) trials in Europe.

• Navigating Allogeneic Cell Therapy Supply Chain Management

  In 2024, allogeneic cell therapies gained clinical momentum and regulatory attention, prompting increased collaboration between developers and the FDA to address safety, manufacturing, and access challenges critical to broader adoption and commercialization.