Cell and Gene Regulatory

1. 7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies 7/3/2025

   The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.

2. CMC Strategies For Cell And Gene Therapy Development 7/2/2025

   The regulatory environment for cell and gene therapies (CGTs) is evolving rapidly, requiring sponsors to adopt a more strategic, integrated development approach.

3. Planning Your IND: When And Why To Engage The FDA 7/2/2025

   This presentation explores how and when to initiate IND activities, highlighting that sponsors can strategically open an IND to access FDA guidance and enable U.S. clinical trials.

4. Project Optimus Explained: Shifting Away From Maximum Tolerated Dose 7/2/2025

   Project Optimus represents a transformative shift in oncology, advocating for a more nuanced, evidence-based approach to dose selection, prioritizing patient safety alongside treatment effectiveness.

5. Inside AviadoBio And Astellas's Shared Mission To Bring Gene Therapy To Patients With FTD-GRN 7/2/2025

   AviadoBio and Astellas have joined forces to advance an investigational gene therapy designed to treat frontotemporal dementia with progranulin mutations (FTD-GRN), aiming to address a critical unmet need in neurodegenerative disease.

6. The Power Of Collaboration In Uncertain Times 7/1/2025

   In times of uncertainty, collaboration becomes a strategic advantage. Explore how leading organizations can leverage collective expertise to navigate complexity, drive innovation, and build resilience.

7. How CGT Leaders Are Reducing Failures, Scaling Processes, And Overcoming Regulatory Friction 6/30/2025

    Industry leaders share their philosophy on reducing product failure, embracing AI, and building dynamic teams to stay ahead of the curve to bring curative CGT therapies to patients.

8. Viral Clearance Services 6/27/2025

   Ensure safety with expert-led viral clearance studies. Our global team delivers regulatory-compliant, scientifically robust solutions to eliminate viral risks and support your product’s success.

9. Expert Guidance For EU Gene Therapy And Companion Diagnostic Trial Regulations 6/27/2025

   This playbook provides a concise yet comprehensive roadmap for navigating Europe’s multifaceted regulatory environment when conducting gene therapy trials involving GMOs and CDx.

10. Ethical, Considerations As Gene Editing Technologies Advance 6/26/2025

    Observe as experts highlight innovative tools and strategies advancing the safety of gene editing therapies while addressing off-target effects, regulatory demands, and manufacturing efficiency.