INSIGHTS ON CELL & GENE COMMERCIALIZATION ISSUES

• Understanding The CMC Regulatory Landscape For Cell And Gene Therapy Products

  The curing potential of cell and gene therapies is driving the industry’s passion and motivation to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.

• How Skyland PIMS Is Helping Novavax Accelerate Vaccine Production

  Driven by its COVID-19 vaccine development and manufacturing data management complexities, this late-stage biotechnology company wanted to harden its data infrastructure, discontinue wide scale use of Excel for batch/process/product data management, and accelerate data sharing among a large external network. A data collaboration platform was their solution.

• Navigating The Road To Gene Therapy Commercialization

  With increases in development and investments in the gene therapy field, companies will increasingly be looking at manufacturing and commercialization of their therapies. Road to commercialization goes through a series of process validation phases. In this webinar, we take a closer look at the road to commercialization and focus on addressing primary questions.

• Overcoming Commercialization Challenges For Cell & Gene Therapies

  The early promise offered by cell therapies and gene therapies is tempered by the challenges associated with developing, manufacturing, and delivering the drug product to patients. This panel discussion highlights technical and regulatory hurdles associated with development and manufacturing steps, and strategies and solutions to facilitate development through commercialization.

• Reducing Cost Of Goods For Gene Therapy

  Frost & Sullivan recently invited industry leaders with gene therapy experience to participate in a new thought leadership forum, our Virtual Think Tank. This forum brought together leading minds in this emerging field to discuss key challenges and other insights related to reducing the cost of goods (COGs) for gene therapy.

• Regulatory Challenges For Viral Vectors For Cell And Gene Therapy

  Frost & Sullivan's Virtual Think Tank series brought together leading minds in the cell & gene space to discuss current regulatory issues and key challenges in viral vector manufacturing.

• Strategies To Address The Viral Vector Manufacturing Shortage

  Accelerating the production of your viral-vector based therapy requires understanding the strategies and cost-efficiencies available to address the viral vector manufacturing shortage.

• Cell & Gene Therapy Deals: Emerging Trends To Watch

  The pace of deal-making in cell and gene therapy is faster and occurring much earlier in the drug development process compared to what has historically been seen for other innovative therapies. To understand how the landscape is evolving, we reviewed more than 30 deals in the sector and compared them to deals that were executed for mAbs between 1999 and 2013.

• Non-Hodgkin’s Lymphoma CAR T-Cell Therapy: Where Do We Go From Here?

  Following the success of Kite/Gilead’s Yescarta and Novartis’ Kymriah in treating relapsed or refractory diffuse large B-cell lymphoma, key players are pursuing therapies in earlier treatment settings and in mantle cell lymphoma, chronic lymphocytic leukemia, and follicular lymphoma.

• Planning For Commercial Success – Best Practices For Designing Cell & Gene Therapy Clinical Trials

  Cell and gene therapy applications have, in the last three years, made the jump from pure research products to commercialized products with high clinical efficacy, particularly for hematologic malignancies. This webinar elaborates on how to design early development programs and clinical trials for CGTs to ensure that the product can be commercialized successfully in all target markets i.e. can be reimbursed and adopted successfully despite small patient numbers, rare diseases, complex administration etc.