09.30.24 -- The Evolution From Data Integrity To Data Quality

There are challenges in AAV empty-full separation in the gene therapy industry as well as some misconceptions. Experts are always looking for ways to find the best solution to these challenges. Through this article, you will discover the strategies of AAV capture and empty-full separation, as well as the trends driving innovation in this area. Read it here.

PwC's Medical Cost Trend: Behind The Numbers 2025 report offers details on the key 'inflators' and 'deflators' impacting medical spending next year. The key inflator? You guessed it, weight loss drugs.

Oral conversations with the FDA about trial design and protocol can lead to questions, and answers, which help drug developers avoid costly surprises and misunderstandings.

Consider these three factors when transitioning to a more robust and quality-driven data cleaning and central monitoring strategy.

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.

Explore some of the biggest obstacles companies are encountering and what is already being done to move the industry closer to significant sustainability progress and environmental achievements.

There is a significant opportunity for NK cell-based therapies to continue to make a significant impact in patient care. Discover three strategies for creating a cost-effective NK cell biopharma product.

The second quarter of 2024 saw no new gene therapy or cell therapy approvals. However two new RNA therapies were approved in the US during the quarter: Rytelo, an oligonucleotide telomerase inhibitor for myelodysplastic syndrome; and mRESVIA, an mRNA vaccine for respiratory syncytial virus (RSV) prevention.

Expedited development programs require adapting to accelerated development timelines. The challenge is to build a strategy that maintains the integrity, quality, and timeliness of the manufacturing process.

This Q&A with Srinivasan Shanmugam, Ph.D., Executive Director of Pharmaceutical Sciences at Adare, discusses pediatric patient compliance, regulations impacting pediatric trial access, excipients within pediatric formulations, and more.