Newsletter | January 24, 2025

01.24.25 -- A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies

FOCUS ON CLINICAL TRIALS

A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies

This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities. 

Daring To Learn From Failure: Insights On The Future Of Stem Cell Therapy

Stem cell therapy has already revolutionized the field of oncology. But where do we go from here? Dr. Robert S. Negrin addresses three key areas of CAR T-cell therapy on the brink of innovation.

Navigating The Complexities Of Ophthalmic Clinical Trials

By embracing decentralized models, leveraging mobile technology, and fostering strategic partnerships, sponsors and CROs can streamline ophthalmic clinical trials.

Diverse Mentorship Models Create Multiple Paths To Employee Success

Since life science professionals hail from diverse backgrounds, educations, and work experiences, different mentorship models serve their varied development needs and learning styles.

How To Realize The Value Of Patient-Centric Solutions

To realize the full value of patient-centric solutions sponsors, sites and patients all need to be continually integrated from concept to trial completion.

CLINICAL TRIALS SOLUTIONS

Muscular Dystrophy: Multi-National And Multi-Site Trials - Novotech

Personalized Cell & Gene Therapy Clinical Development - Worldwide Clinical Trials

Bridging The Gap Between CGT Innovation And Reality - InspiroGene

FOCUS ON SUPPLY CHAIN

Cell & Gene Therapies: Avoid This Common Pitfall In Supply Chain Planning

BioPhorum members propose a Design for Supply model for cell and gene therapy supply chain planning. Don't let it take a backseat until the later stages of the product life cycle.

What You Need To Know About Fluoropolymer Bag Cold Chain Durability

Drug manufacturers seek packaging that maintains integrity during processing and freezing, scales up to larger volumes easily, and remains robust throughout the temperature-controlled supply chain.

SUPPLY CHAIN SOLUTIONS

Bioprocess Powder Bags - Entegris, Inc.

DEHP-Free Fluid Transfer Bags - Charter Medical

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