Newsletter | September 5, 2025

09.05.25 -- The Hidden Risk In Cell & Gene Therapy Commercialization

SPONSOR

Webinar: Advances in Pediatric Transplant: T-cell Depleted Haploidentical Experience

Join Miltenyi Biotec for an insightful live webinar on transforming pediatric transplant care with T cell–depleted haploidentical HSCT. Learn how this cutting-edge approach expands donor access while minimizing GVHD risk. Hear firsthand clinical experiences, explore immune recovery data, and discover how virus-specific T cells may shape the future of transplantation. Don’t miss this opportunity to deepen your expertise—register now! Click here to learn more.

FOCUS ON SUPPLY CHAIN

Rethinking CGT Biotech Growth & Investment With Audrey Greenberg

On the 100th episode of Cell & Gene: The Podcast, Host, Erin Harris, sits down with Audrey Greenberg, Founder and CEO of AG Capital Advisors. Audrey is the award-winning executive, board director, and strategic advisor with a proven track record of launching, scaling, and successfully exiting multi-billion-dollar ventures.

Navigating Cold Chain Challenges In Cell And Gene Therapy

Experts highlight critical concerns regarding insufficient cold chain infrastructure for cell and gene therapies, emphasizing an urgent need for robust, scalable solutions to meet future demand.

Preventing Gas Ingress In Single-Layer Fluoropolymer Bags

While barrier films in bags can be useful for cold chain applications, they do not fully protect against gas ingress and ignore other sources of permeability.

SUPPLY CHAIN SOLUTIONS

Secure Your Serum Supply - Corning Life Sciences

FOCUS ON CLINICAL TRIALS

The Hidden Risk In Cell & Gene Therapy Commercialization

Of the root causes of new product launch failure, insufficient relative advantage is by far the most important. Let's take a closer look at lessons we can learn from two key (approved) cell therapies.

New AI Assistant Aids In Clinical Settings

Discover a new AI Copilot that revolutionizes clinical data analysis and offers seamless deployment with intuitive question-answering, chart generation, and content integration.

Audit Trails And Transparency: Changes In Clinical Data

Audit trails are not only a regulatory necessity but a strategic tool to ensure data reliability and accelerate high-quality clinical research outcomes.

Rescue Studies

Clinical trials frequently encounter delays, and rescue studies have become vital to address this challenge, especially in complex therapeutic areas.

Site Networks And Hybrid Solutions

Learn how community- and patient-centric site networks that have DCT capabilities are able to work with a broad-range of site types.

How To Think About Valuation In Biotech

Frank David, Founder and Managing Director of Pharmagellan, discusses how mission, vision, and data analysis fit into today's biotech goals.

Initial IRB Submission: 7 Fundamentals Of Success

The initial IRB submission process can involve common challenges. To help you overcome these obstacles, discover seven fundamentals you should know about a successful initial IRB submission.

5 Essential Capabilities For Decentralized Clinical Trials

Learn how to develop and utilize a successful DCT framework, enabling your study to enhance patient access, improve data quality, and streamline study operations.

CLINICAL TRIALS SOLUTIONS

Enable Value-Based Evaluation Of Medicines - CHDR

Reducing The Travel Burden For Patients - The Benefits Of Mobile Vision Clinics - 20/20 Onsite

Accelerating Biologics Through Development Milestones - Veristat, Inc.

EVENTS

Advancing the Future of Cell & Gene Therapy

This 11-12 November, Cell 2025 unites 1,000+ leading experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development timelines.

 

Gain practical strategies across cell culture, therapy development, and CGT manufacturing, and hear from world-renowned leaders Bobby Gaspar (CEO, Orchard Therapeutics), Christof Von Kalle, (Director & BIH Chair, Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now

Connect With Cell & Gene: