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White Paper

Navigating Key Complexities in the Development of Cell and Gene Therapies

Explore the uniquely complex regulatory guidelines and challenges cell and gene therapy presents in research.

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Blog

Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Learn why an institutional biosafety committee needs to complete a risk assessment for engineered genetic material in clinical research.

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4 min. read
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Blog

FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy

FDA recently released new guidance, potentially impacting early-phase cell and gene therapy trials.

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3 min. read
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Blog

Regulatory Trends in Cell and Gene Therapies

Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.

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6 min. read
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News

Advarra Achieves 1,000+ Site Milestone for its Gene Therapy Ready Network

Research involving gene therapy-based treatments can start more quickly with Advarra’s growing network of registered research sites.

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3 min. read
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Abstract

FDA Guidance on Shedding and Environmental Impact in Clinical Trials Involving Gene Therapy Products

Our IBC experts authored “FDA Guidance on Shedding and Environmental Impact in Clinical Trials Involving Gene Therapy Products” in Applied Biosafety.

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Webinar

A Guide for Successful Cell and Gene Therapy Research

Understand the unique regulatory, clinical, and manufacturing requirements for cell and gene therapy research.

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Blog

Reflections from Cell and Gene Meeting on the Mesa 2021

This blog recounts the 2021 Cell and Gene Meeting on the Mesa conference, including details on cell and gene therapy's growth and trajectory.

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4 min. read
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Blog

Why Institutions Should Consider an Externally Administered IBC

Gene therapy clinical trials require specialized oversight & expertise. Read how institutions can prep for the boom in gene therapy research.

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4 min. read
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White Paper

Understanding the Current and Future States of Cell and Gene Therapy Research

This white paper focuses on gene therapy uses in oncology and looks at a successful program at an NCI-designated comprehensive cancer center.

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Podcast

Daniel Eisenman, Paul Gulig, and Adam Soloff Explore The Exponential Rise of Gene Therapy and Unlocking Its Potential Promise

In this podcast, Daniel Eisenmann talks with Adam Soloff and Paul Gulig for a discussion on the growth and the promise of gene therapy.  

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Blog

Improving Study Activation Time for Gene Therapy Research

With the growing popularity of gene therapy research and genetically engineered vaccines, sites need to understand study activation impacts

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5 min. read
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