Newsletter | May 30, 2025

05.30.25 -- Unlocking The Potential Of iPSC Therapies In Regenerative Medicine

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Clinical Research As A Delicate Ecosystem

Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors. Entrust that your program is in hands you can rely on, where integrity is paramount, and excellence is the standard.

FOCUS ON CLINICAL TRIALS

Unlocking The Potential Of iPSC Therapies In Regenerative Medicine

In a recent Cell & Gene Live webinar, leaders from Mayo Clinic and Astellas discussed the transformative potential of iPSC therapies in regenerative medicine, highlighting regulatory alignment and manufacturing innovation to realize their full impact.

Exploring The Power Of Gene Expression

Dan Oliver, CEO at Rejuvenate Bio, discusses parallel clinical trials designed to address chronic, age-related diseases in people and their pets.

Key Strategies For Future-Proofing Gene Therapy Assay Validation

Rigorous validation of immunogenicity assays is crucial for ensuring safety and efficacy, especially in the evolving regulatory landscape. Discover the importance of understanding regulatory standards.

The Power Of AI To Improve Clinical Trial Monitoring

By analyzing patient data sets, AI enhances predictive analytics, supports real-time patient alerts, and strengthens continuous monitoring — improving the effectiveness of clinical trial oversight.

Conflict Of Interest: Implications For Clinical Research Sites

Amid scrutiny of the financial conflicts of interest in biomedical research, new federal rules aim to improve transparency and preserve the integrity of publicly funded research.

6 Key Ways Real-World Data Is Advancing Colorectal Cancer Therapies

Real-world data (RWD) is transforming Colorectal cancer (CRC) research by complementing traditional clinical trials, accelerating drug development, and improving patient outcomes.

How The Cell And Gene Therapy Market Is Taking Shape

Targeting diseases at their genetic root, cell and gene therapies offer unprecedented hope. Yet, the industry grapples with balancing potential against the challenge of high-priced treatments.

How Home Trial Visits Support Sites And Patients

By reaching into the heart of communities, Home Trial Support plays an invaluable role in driving the development of lifesaving, representative, medicines and therapies.

FDA Guidance On The Use Of DMCs In Clinical Trials

Gain an overview of FDA guidance on the use of Data Monitoring Committees (DMCs) in clinical trials and their critical role in safeguarding patient safety and ensuring unbiased decision-making.

CLINICAL TRIALS SOLUTIONS

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

Your Ally For Bringing CGTs From Discovery To Delivery - InspiroGene

FOCUS ON SUPPLY CHAIN

Good Distribution Practice Is Evolving — Here's How

Managing a global supply chain for increasingly complex biologic drugs takes special attention and expertise. Explore the key drivers of a modern logistics management plan.

Reduce Contamination Risks When Storing Synthetic DNA

An alternative to traditional polyethylene bags is offering cell and gene therapy manufacturers a solution to contamination concerns regarding DNA or RNA fragments.

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