Cell and Gene Commercialization

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Cell And Gene Therapy Commercialization Handbook 11/24/2025

    Bringing advanced therapeutics to market requires overcoming hurdles in regulation, logistics, and reimbursement. Learn how to coordinate supply chains and implement adaptive strategies for long-term commercial success.

  6. Unlock The Future Of Market Access In 2026: A Guide To Navigating A Shifting Healthcare Landscape 11/24/2025

    Navigating the future healthcare landscape requires early strategic planning and organizational agility to manage policy shifts. From AI implementation to global pricing dynamics, understanding these trends is essential for ensuring timely patient access.

  7. Notes From A VC: What It Takes To Be Impactful In Longevity Science 11/6/2025

    Impact in longevity science (particularly for cell and gene therapies) is not about chasing the next unicorn; it is about carrying transformative ideas across the threshold of scientific validation, regulatory trust, and societal acceptance.

  8. Advancing Hematology and Cell Therapy Innovation with AstraZeneca's Aliya Omer 11/4/2025

    On episode 115 of Cell & Gene: The Podcast, Host Erin Harris talks to Aliya Omer, Vice President and Global Head of Hematology and Cell Therapy at AstraZeneca, who shares valuable insights from her rich experience leading cell therapy development across multiple top companies.

  9. Tips For Partnering With Health Systems: A Critical Step For CGT Commercialization 11/3/2025

    Collaborating with health systems is key to CGT commercialization. Learn how to address operational and financial challenges to ensure processes are scalable and patient access is streamlined.

  10. Commercializing Your First CGT Product: Value Chain Planning 10/31/2025

    Effective value chain planning for cell and gene therapies requires early decisions on manufacturing, complex cold storage solutions, flexible reimbursement models, and scalable partnerships.