Cell and Gene Regulatory

  1. How Sanofi Navigates Regulatory CMC Across Global Markets 8/3/2026

    Sanofi's Manda Pasarkar shares 20+ years of regulatory CMC expertise, covering FDA, EMA, and PMDA differences, CDMO partnerships, ICH guidelines, and AI's emerging role in global drug approvals.

  2. Tariffs, FDA Chaos, And BioSecure: How CDMOs Should Operate 8/3/2026

    Tariffs, FDA workforce cuts, and a stalled BioSecure Act are reshaping CDMO strategy. Get the full policy breakdown to stress-test your supply chain planning now.

  3. Turn Future Therapies Into Product Realities 7/29/2026

    Balancing speed, quality, and cost is key in cell therapy manufacturing. Streamlined design and scalable platforms shorten timelines, sustain high yields, and lower costs.

  4. Everything You Need To Know About Vestigo®: Simplifying Investigational Drug Management 7/29/2026

    Streamline clinical trial pharmacy operations, slash manual documentation time, and maintain continuous audit readiness across complex studies.

  5. The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable 7/29/2026

    In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.

  6. Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts 7/29/2026

    Version-controlled quality target product profiles, authored by the drug sponsor, close any gaps between the CDMO's and sponsor's definitions of quality.

  7. Reshoring Pressure Meets Manufacturing Reality 7/27/2026

    U.S. pharma can't reshore what domestic capacity can't absorb. Senior leaders from Takeda, Biogen, Eli Lilly, and others reveal why tariff pressure is colliding with a sterile fill-finish shortage, workforce gaps, and ADC capacity bottlenecks.

  8. Drug Development Plan Explained: DPP Templates And Examples 7/27/2026

    Only 6.7% of Phase 1 drugs reach approval. A well-structured Drug Development Plan (DDP) can meaningfully improve your odds — learn exactly how to build one.

  9. CDMO Live Europe 2026: Partnerships For An Uncertain World 7/27/2026

    112 pages of executive insight from CDMO Live Europe 2026: tariffs, geopolitics, supply resilience, AI in manufacturing, and why strategic partnerships remain aspirational for most.

  10. Distributed Manufacturing May Open New Doors For Well-Prepared CGT Sponsors 7/27/2026

    Although cell and gene therapy developers have more manufacturing options than ever, choosing the right strategy remains complex. Aligning production models with both clinical and commercial goals is increasingly critical, particularly as proposed FDA distributed manufacturing guidelines could soon enable sponsors to streamline multi-site operations under one quality system.