Newsletter | April 2, 2024

04.02.24 -- CRISPR Therapies And The Regulatory Landscape

CRISPR Clinical Trials To Follow In 2024 And Beyond

CRISPR technology is being increasingly used in clinical trials for a variety of genomic medicines. This article discusses a variety of current and upcoming CRISPR clinical trials, from genetic disorders to infectious diseases and cancer.

 

Groundbreaking Casgevy Approval Retrospective

How is the approval of the U.S.' first CRISPR therapy reshaping the landscape of CRISPR regulations and ongoing clinical trials? One of the first patients in the Casgevy clinical trial shares his perspectives on the impact of this landmark CRISPR therapy.

 

Casgevy Approval Retrospective With Lina Jamis

After the groundbreaking approval of the U.S.' first CRISPR therapy, the Associate Director of Regulatory Affairs at Synthego shares some of the key learnings and valuable perspectives on the latest developments in the field of CRISPR therapeutics.

 

CMC And Regulatory Considerations For CRISPR Therapies

Explore the intricacies of Chemistry, Manufacturing, and Controls (CMC) requirements and Critical Quality Attributes (CQA), for CRISPR-based therapeutic development including how they differ from traditional drug and therapy development.

 

Regulatory Experts Discuss Development Of Cell And Gene Therapies

Moving your CRISPR therapies from bench to clinic can be a challenge. A regulatory expert has provided her insight on several questions including what regulatory experts do and what help you could receive to accelerate the clinical development process.

 

SOLUTIONS

CRISPR Therapeutic Regulatory Expertise And Support

Explore regulatory support services that can help you successfully to navigate CRISPR-based therapeutic development and prepare you for a successful IND submission.

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GMP sgRNA Manufacturing

Transition from early-phase research through process development into the clinic with these continuum sgRNA available in different grades.

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