INSIGHTS ON CELL & GENE COMMERCIALIZATION ISSUES

• The Moral Economics Of Precision Medicine

  The most complex and expensive drugs to develop often target terrible diseases that affect only a small number of people and will never reach blockbuster status.

• Understanding CLL And SLL Treatment Evolution

  Tevogen Bio's Dr. Neal Flomenberg and Dr. Dolores Grosso discuss the shift from chemotherapy to targeted therapies such as Jaypirca and highlight Tevogen’s antigen-specific T cell platform as a new frontier in cancer and infectious disease treatment.

• Know Your Product, Know Your Path: A Primer On Advanced Therapy Development

  To prevent path-to-market setbacks, it is critical to develop a Chemistry, Manufacturing, and Controls strategy that proactively identifies scientific and compliance gaps, as well as mitigates risk.

• How Strategic CMC Planning Drives Cell Therapy Success

  CMC is essential for cell therapy success, with FDA CRLs often due to CMC gaps; early strategic planning and robust controls reduce risks and accelerate market approvals.

• Scaling Allogeneic NK Cell Therapies

  In this segment of Cell & Gene Live, Building the Future of Cancer Immunotherapy Through Allogeneic NK Cell Innovation, Tracy Ryan, Co-Founder and Chief Communications Officer of NKore BioTherapeutics, highlighted the allogeneic, off-the-shelf nature of their NK cell therapy. Raphael Ognar, President, CEO, and Co-Founder of NKILT Therapeutics expressed strong confidence that NK cell therapies can be produced at a fraction of the cost of autologous treatments, making them widely accessible and commercially viable.

• Process And Analytical Development

  Applied StemCell’s development services help our clients design and develop robust processes and analytical methods providing the foundation for success in the clinic through commercialization.

• Driving Prostate Cancer Innovation Through Immunotherapy With OS Therapies' Dr. Robert Petit

  OS Therapies' Dr. Robert Petit discusses the evolving role of immunotherapy in prostate cancer.

• A Study In Optimizing Late-Stage Processes With QbD, DoE

  Nobody wants to redesign analytical process profiles when a market approval is within reach, but what about when a last-lap QbD exercise could bring real benefit?

• On The Ground At BPI: Industry Reflections With Carl Schoellhammer, Ph.D.

  DeciBio partner Carl Schoellhammer, Ph.D., speaks on the record with Bioprocess Online's chief editor Tyler Menichiello at the 2025 BioProcess International conference in Boston.

• Navigating Commercial Logistics For CGTs: A Roadmap To Scalable, Patient-Centered Success

  The commercialization of cell and gene therapies requires a precise and resilient logistics model that can adapt to rapid demand and global expansion while maintaining a patient-first approach.