INSIGHTS ON CELL & GENE COMMERCIALIZATION ISSUES

• How AI Could Clear Logistics Roadblocks Limiting Patient Access To CGT

  Patient access often gets mischaracterized solely as a cost and pricing issue. A discussion among industry leaders reaches a deeper, more complex conclusion.

• Mapping Candel Therapeutics' Sprint To The BLA Finish Line

  Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.

• U.S. Pharma Tariffs And MFN Become Law After April 2 Update

  Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.

• Overcome Patient-Level Access Barriers For New Medicine

  Explore market access from the patient’s perspective and identify five aspects of how people get hold of medicine that should inform commercialization.

• Industry Innovators: APAC's Sharp Advanced Therapeutics Edge

  APAC is rapidly advancing its role in the global therapeutics landscape, fueled by faster development models. Learn how this momentum is reshaping expectations for innovation and commercialization.

• Accelerating Technology Diffusion In Cell And Gene Therapy

  Unlike most other drugs, advanced therapies require complex, purpose-built supply chain networks. Making them requires cross-sector collaboration.

• Inside Mesoblast's Playbook For Making Allogeneic Cell Therapy Real

  Mesoblast's Silviu Itescu shares how two decades of rigorous science and manufacturing turned allogeneic MSCs into the first FDA-approved cell therapy while building a scalable platform for inflammatory diseases such as GvHD, back pain, and heart failure.

• The Value Of Real-World Evidence In Canadian Drug Commercialization

  Leveraging real-world evidence (RWE) across the product lifecycle enables manufacturers to fill the evidence gap beyond RCTs to help guide local commercial strategic planning and market access strategy.

• A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?

  In 2026, advanced therapies diverge: winners pair proven biology with scalable manufacturing, delivery, and workflow fit, while others advance more slowly under operational and economic limits.

• Advancing Off-The-Shelf CRISPR CAR-T Therapies Into The Community Setting With Caribou Biosciences' Rachel Haurwitz

  On episode 120 of Cell & Gene: The Podcast, Host Erin Harris is joined by Rachel Haurwitz, CEO of Caribou Biosciences, to discuss the company’s progress in developing CRISPR-edited, off-the-shelf CAR-T therapies for hematologic malignancies.