Newsletter | August 1, 2024

08.01.24 -- Breaking Down The Recent FDA Draft Guidance On Rare Diseases

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FROM THE EDITOR

Breaking Down The Recent FDA Draft Guidance On Rare Diseases

Raj Bandaru, Associate Director in Regulatory Affairs and U.S. Regulatory Affairs Lead at Accenture provides rich context on parts of the recent FDA Draft Guidance, Rare Diseases: Considerations For The Development Of Drugs And Biological Products.

FEATURED EDITORIAL

Inside Enhanced Delivery Systems For Genome Editing

Improvements in delivery systems can help ensure that the editing machinery reaches the target cells efficiently, reducing the likelihood of off-target effects in non-target cells.

INDUSTRY INSIGHTS

Insights into Global Non-Small Cell Lung Cancer Research

This FAQ section delves into non-small cell lung cancer (NSCLC) incidence, current trials, innovative drugs, and their effects on patient outcomes.

The Sponsor's Clinical Development Handbook For Gene Therapy Trials

Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.

Delving Into Modular Cleanroom Designs For Drug Manufacturing

Explore the reasoning behind the increasing demand for cleanroom technology as well as the advantages modular cleanroom design brings to the sterile processing of complex therapies.

Cell Culture Solutions To Unlock Your Cell Performance

Gain insight into an innovative approach to cell culture media development, and learn about the journey a cell therapy company underwent to accelerate the development of their cell-based therapeutic.

Transforming T Cell Manufacturing Via Elutriation

This study demonstrates the Korus platform's ability to reduce manufacturing variability by elutriating lymphocytes from apheresis, providing a more consistent cell product for downstream manufacturing.

Facilitating Good Clinical Data Review In Your Clinical Trial

Learn how to create a system based on connectivity and automation, aggregated and usable data, flexible analysis, and methods of collaborative data review by centralizing analysis and communications.

Optimizing DNA Digestion In Viral Vector Production For Gene Therapy

This application note highlights optimizing DNA digestion with Benzonase® endonuclease to enhance viral vector purification and process economics.

Achieve Manufacturing Scale For Your Viral Vector Production

Elevate your viral vector production to commercial scale by choosing the optimal production system paired with the right single-use bioreactor combination.

Why Leading Cancer Research Centers Trust OpenClinica For Oncology Trials

See eight key reasons why leading cancer research centers rely on OpenClinica to navigate the intricacies of oncology trials and advance the field of cancer research.

SOLUTIONS

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