Newsletter | November 15, 2024

11.15.24 -- Regeneron's Strategy To Address Congenital Deafness

FOCUS ON CLINICAL TRIALS

Regeneron's Strategy To Address Congenital Deafness

Regeneron's Jonathon Whitton, Au.D., Ph.D., and Christos Kyratsous, Ph.D., discuss the company's clinical and developmental strategy for DB-OTO, a gene therapy to treat congenital deafness.

How The Australian Advantage Maximizes Benefits For U.S. Biotechs

The "Australian Advantage" approach offers U.S. biotech firms numerous benefits, including a cash rebate of almost 50%, faster timelines, no IND requirement, and globally accepted data.

Building Successful Studies: A Proven Framework

To provide a deeper understanding of successful study design, this author guides readers through study personas, core design, a seven-step process for post-go-live (PGL) changes, and more.

Key Checkpoints In Autoimmune Disease Onset And Flare

What causes otherwise normal, healthy immune cell populations to go bad? Isaac Stoner, CEO and Co-Founder at Octagon Therapeutics explains the strategy behind maintaining chronic immune health.

How To Build A Hybrid Visit Strategy That Delivers High-Quality Results

In-home clinical trial visits yield major benefits for patients, including increased access and convenience. As a result, hybrid trials are helping developers increase enrollment, engagement, and retention.

Successful Procedure Execution: CSF, Concurrent Muscle Biopsy

While exploring a novel therapeutic protein (TP) in 48 healthy volunteers, several technical calls were required so the study could begin running promptly.

CLINICAL TRIALS SOLUTIONS

Unlocking Healthier Futures With Cell And Gene Therapy - Cencora

A Better Outcome For Your Clinical Trials - Revvity Signals Software, Inc.

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.

Top Bottlenecks Facing mRNA Supply Chain

In this first segment from Cell & Gene Live, we explore the state of the mRNA therapeutics supply chain and the major bottlenecks that exist today, including non-GMP grade reagents for sourcing DNA.

Automated Cryopreservation For Leukapheresis Supports CGT Supply Chain

Uncover how this optimized process ensures consistency in cell viability and recovery while preserving immune cell populations across multiple donor samples.

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