INSIGHTS ON CELL & GENE REGULATORY ISSUES

• Transforming Patient Access To CGT

  Chief Commercial Officer Aruna Mor recently delivered a powerful keynote at the Advanced Therapies Congress in London, highlighting the challenges of patient access to advanced therapies.

• Enabling The Outcome Through Enhancing Patient Accessibility

  To ensure that the transformative potential of cell and gene therapy reaches every patient in need, we must prioritize equitable access and overcome the remaining barriers to widespread delivery.

• FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating

  Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

• PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand

  Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.

• ICH Revises Q1 Guideline, Advancing Stability Testing Standards

  In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

• CRI's Response to NIH Cuts with Alicia Zhou, Ph.D.

  In this episode of the Cell & Gene podcast, Host Erin Harris speaks with Alicia Zhou, Ph.D., CEO of the Cancer Research Institute (CRI), about CRI’s mission to advance cancer immunotherapy and the critical role of federal funding, particularly from the NIH, in supporting basic and translational cancer research.

• The Future Of GxP Manufacturing With AI

  Discover how to digitize batch records in just 180 days with Christian Gay Porcel by leveraging AI for automated compliance and scalable validation.

• Accelerate Development With Excipient GMP Quality Cell Culture Solutions

  Reduce risk and speed up timelines as you move towards commercialization. Learn about end-to-end services offering Excipient GMP cell culture solutions for streamlined development and regulatory success.

• Revolutionizing Aseptic Fill-Finish With Innovation

  Experience an innovative aseptic fill-finish technology designed for ATMP production in this live demo, which is a cutting-edge solution that ensures optimal efficiency and product quality.

• Mitigate Clinical Risk In Cell Therapy Development With A GMP Compliant Process

  Help shape the future of medicine by building better, safer cell therapies. See how expertise in scalable, GMP-compliant cell engineering can effectively mitigate clinical development risks.