Cell and Gene Commercialization

  1. The Need For Adaptive Distribution Partners For Cell And Gene Therapies 1/6/2026

    Optimize your commercial strategy by exploring how adaptive distribution models navigate reimbursement challenges and improve patient access. Partner early to align workflows and ensure operational success.

  2. Developing Itvisma for Broad-Range Treatment of SMA with Novartis' Dr. Norman Putzki 12/22/2025

    In episode 119 of Cell & Gene The Podcast, Host Erin Harris talks to Dr. Norman Putzki, Global Head Clinical Development, Novartis, about the FDA approval of Itvisma, now the only gene replacement therapy approved for children, adolescents, and adults with spinal muscular atrophy (SMA).

  3. CSL's HEMGENIX Shows Durable Benefit, A New Future For Gene Therapy in Hemophilia B 12/12/2025

    CSL's Dr. Deborah Long and Diego Sacristan highlight HEMGENIX's five-year Phase 3 data as a watershed for hemophilia B gene therapy.

  4. End-To-End Services: Discovery To Commercialization 12/11/2025

    Comprehensive global services accelerate biologics and cell therapy development, offering discovery, GMP manufacturing, and advanced platforms for efficient preclinical, clinical, and commercial stages.

  5. MHRA International Recognition: Fast-Track UK Market Access 12/10/2025

    MHRA’s IRP accelerates UK approvals via trusted regulators, but faster authorization only translates to access when aligned with NICE evidence needs, pricing policy, and coordinated launch strategy.

  6. Cell 2025, Advanced Therapies USA Taught Me Why Platformization Is No Longer Optional 12/10/2025

    True scalability and global-ready CGT manufacturing depends on platformization that tightly integrates MES, ERP, LIMS, and related systems into a harmonized, leadership-driven digital backbone that treats data as a strategic asset.

  7. Enhancing Preclinical Analytics to Drive Clinical Success 12/9/2025

    Bioanalysis is crucial for biopharma success. Here, Dash Bio’s Ander Tallett discusses selecting a bioanalysis CRO and collaborating effectively for assay results that accelerate drug development.

  8. 5 Questions That Put Sponsors Back in Control of Bioanalysis Projects 12/9/2025

    Bioanalysis service quality significantly impacts project success. Don't settle for typical CRO claims; demand better technology, pricing transparency, and dedicated partnership.

  9. Partnering With Health Systems: Essential Tips For CGT Commercialization 12/5/2025

    Successful cell and gene therapy commercialization requires early, detailed manufacturer collaboration with health systems to ensure scalable operations and seamless patient access beyond the clinical trial.

  10. Building Patient-Driven Culture and Leadership Resilience in CGT with Paul Perreault 12/2/2025

    On episode 117, Host Erin Harris welcomes Paul Perreault, Strategic Advisor, Board Member and former CEO of CSL, who shares insights from his decade leading the company through global expansion and the COVID-19 pandemic.