Newsletter | September 12, 2025

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

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Discover how allogeneic NK cell therapies are reshaping cancer immunotherapy! Join Cell & Gene's Erin Harris as she hosts industry leaders for a dynamic discussion on their groundbreaking, complementary approaches. Don’t miss this inside look at the future of cell therapy—Register now for free! This event is supported by ThermoFisher Scientific.

FOCUS ON CLINICAL TRIALS

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

The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025

2025 Global Report For In-Vivo CAR Cell Therapy

Explore global trends shaping in-vivo CAR therapies—delivery innovations, clinical trial momentum, and regulatory strategies across oncology and autoimmune diseases.

Understanding Immunogenicity In AAV Gene Therapy

As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.

Don't Let Distribution Derail Your CGT Launch

Overcoming distribution challenges is critical for the success of cell and gene therapies. Learn how to build a flexible, robust strategy to optimize patient access.

Remote Patient Monitoring Using Mobile Health Technology

This study investigates the attitudes of cancer patients towards the adoption of mHealth technologies, including applications and wearable devices, for monitoring purposes during or after their treatment.

Productivity Hacks For An Effective RFP / Clinical Trial Vendor Selection

Starting a new clinical study requires careful vendor selection and these practical, actionable steps to enhance your selection process and ensure long-term partnership alignment.

6 Ways Lab Data Can Improve Clinical Trials

Explore six key ways laboratory data strengthens the clinical trial process, focusing on how RWD enhances patient recruitment, accelerates screening workflows, and improves overall study outcomes.

The Evolving Landscape Of Radiopharmaceuticals In Oncology Research

From selecting appropriate targeting molecules to optimizing dosing strategies and managing off-target effects, radiopharmaceutical development demands a tailored and strategic clinical approach.

Clinical Trial Support: Point Of Need vs. Traditional Solutions

Examine the limitations of traditional, fixed-location ophthalmic trial sites and how a mobile assessment model can significantly improve patient retention while ensuring high-quality data collection.

SPONSOR

The Advanced Therapies Congress is America's most exciting cell and gene therapy conference and exhibition. The event is for the leaders of pioneering ATMP companies and their most senior executives in charge of the latest tech and strategies that are driving the industry forward. The conference brings together over 1,200 global executives at Pennsylvania Convention Center, Philadelphia, to be inspired by 200 speakers and 50 start-ups over 2 days. Register nowUse discount code CELL20.

CLINICAL TRIALS SOLUTIONS

Get To Know Biorasi CRO Services - Biorasi

Recruiting & Retaining More Patients Per Site: - MRN - Medical Research Network

FOCUS ON SUPPLY CHAIN

Using Slot Management To Bridge The Gap Between Capacity And CGTs

Optimizing slot management is essential for cell and gene therapy manufacturers to overcome high costs, long turnaround times, and limited patient access by enabling real-time scheduling, better resource utilization, and advanced technology integration.

Leveraging Single-Use Solutions To Solve Working Cell Bank Challenges

Discover how custom manifolds enhance allogeneic therapy development from formulation to commercialization by improving process control, scalability, and efficiency.

Raw Materials Considerations When Manufacturing CGTs And Other Biologics

Explore key factors in qualifying GMP raw materials for cell and gene therapies: quality control, supplier selection, and compliance to ensure safety and efficacy.

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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

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