Cell and Gene Regulatory

  1. Inside a Breakthrough HER2 Immunotherapy for PMO with OS Therapies' Paul Romness 2/10/2026

    In episode 122 of Cell & Gene: The Podcast, Host Erin Harris talks to Paul Romness, CEO of OS Therapies, to learn the company’s mission to address the severe unmet need in pulmonary metastatic osteosarcoma (PMO), a rare pediatric cancer with no established standard of care once it metastasizes.

  2. Accelerated CGT Pathways Favor Programs Built On Strong Science 2/10/2026

    In this final segment of Cell & Gene Live, “2026 Regulatory Roadmap,” Cell & Gene's Chief Editor, Erin Harris, Wilson Bryan, M.D., former director of FDA’s Office of Tissues and Advanced Therapies (OTAT), and Daniela Drago, Ph.D., RAC, Partner at NDA Partners shared that accelerated regulatory designations can meaningfully speed development only when backed by strong biology, compelling early data, and thoughtful use of increased FDA engagement.

  3. Regulators Remain Consistent On Endpoints While Raising The Bar On Evidence Quality 2/10/2026

    In this segment of Cell & Gene Live, “2026 Regulatory Roadmap,” Cell & Gene's Chief Editor, Erin Harris, Wilson Bryan, M.D., former director of FDA’s Office of Tissues and Advanced Therapies (OTAT) and Daniela Drago, Ph.D., RAC, Partner at NDA Partners emphasized that regulatory expectations for functional endpoints, biomarkers, and real-world evidence have remained largely consistent over time, with the greatest weight still placed on rigorously designed trials using bias-resistant functional endpoints and well-validated biomarkers tied to clinical benefit.

  4. Disciplined CMC And Rigorous Trial Design Define Credibility In Accelerated CGT Development 2/10/2026

    In this segment of Cell & Gene Live, “2026 Regulatory Roadmap,” Cell & Gene’s Chief Editor, Erin Harris, Wilson Bryan, M.D., former director of FDA’s Office of Tissues and Advanced Therapies (OTAT) and Daniela Drago, Ph.D., RAC, Partner at NDA Partners emphasized that credible cell and gene therapy programs succeed by integrating CMC as a core, well-controlled part of development, with early but flexible frameworks, strong analytics, clear comparability plans, and potency strategies tied directly to clinical outcomes.

  5. CGT Regulation In 2026 Moves Toward Disciplined Flexibility And Higher Standards 2/10/2026

    This first segment of Cell & Gene Live, “2026 Regulatory Roadmap,” Cell & Gene's Chief Editor and Wilson Bryan, M.D., former director of FDA’s Office of Tissues and Advanced Therapies (OTAT) and Daniela Drago, Ph.D., RAC, Partner at NDA Partners highlighted that CGT regulation in 2026 has entered a more mature phase, with increased approvals, higher regulatory scrutiny, and a shift from broad flexibility toward “disciplined flexibility” that depends on strong CMC, clinical, and risk-based foundations.

  6. Charting The Path To First-In-Human: Strategic Readiness For Early Clinical Success 2/10/2026

    Gain a comprehensive, end-to-end perspective on the journey to first-in-human and understand how early decisions influence downstream success.

  7. mRNA Portfolio Products 2/10/2026

    High-purity enzymes and ribonucleotides are essential for scaling therapeutic synthesis. Ensure consistency and safety by choosing GMP-grade materials designed for rigorous clinical standards.

  8. Why Early CRO Choice Is Critical To Accelerating Delivery Of Your Clinical Program 2/9/2026

    Regulatory readiness for global expansion begins in Phase I. A development partner should design your trial and data collection to anticipate downstream regulatory requirements in your target regions.

  9. Bringing Curative Cell Therapies To Market with Kite Pharma's Cindy Perettie 2/6/2026

    On this week's episode of the Business of Biotech, we're speaking with Cindy Perettie, Executive Vice President and Global Head at Kite Pharma, a Gilead-owned company focused on curing cancer with cell therapies.

  10. Safeguarding Biologic Integrity Through Enhanced Component Compatibility 2/4/2026

    For sensitive biologics and viral vectors, risk extends beyond simple contamination. Utilizing inert barrier films on contact surfaces reduces compound migration and adsorption, maintaining dosage accuracy.