11.17.25 -- Patients And Industry Need A New Model For Rare Disease Gene Therapy

As the U.S. FDA is impacted by layoffs that threaten its oversight capabilities, the importance of robust software and manufacturing process validation has never been more critical.

Review the different technologies that are being used to develop next-generation vaccines and the challenges and opportunities that these technologies present.

Industry experts share strategies to overcome key barriers in CGT development, from reproducibility to scale-up. Gain practical insights to help teams move faster and more reliably toward commercialization.

The updated ICH GCP guideline modernizes clinical trial standards, aligning with today’s technologies to enhance participant safety, data integrity, and risk-based trial design.

Viral vector-based gene therapies are expanding beyond rare diseases to treat larger populations. Discover how innovations in manufacturing are making these life-changing treatments more accessible.

A new biotech lab at Durham Tech, funded by Biogen’s $250K donation, will expand hands-on training and strengthen workforce development in North Carolina’s growing life sciences sector.

Inefficiencies in clinical trials not only drive emissions but also risk drug shortages and trial delays, and clinical technology solutions offer a pathway to more sustainable research.

TargTex CEO Dr. João Seixas and Nanoform CCO Christian Jones present highly promising in-vivo data, enabled by a nanoformed drug product for the treatment of glioblastoma multiforme (GBM).