Cell and Gene Commercialization

  1. Pricing, Value, And Access of CGTs With The Dedham Group's Jennifer Klarer, M.Sc.Eng. 2/1/2024

    The Dedham Group's Jennifer Klarer, M.Sc.Eng., Partner and Head of Cell & Gene Therapy, joins Erin Harris on this episode of Cell & Gene: The Podcast for a deep dive into pricing and value for CGTs. Klarer shares a detailed breakdown of the most misunderstood aspects of cell and gene therapy pricing, value, and affordability. She details how manufacturers can get ahead of addressing time-to-treatment issues typically experienced at launch. They cover obtaining adequate investment dollars, and much more.

  2. An Exploration Of ICIs In Cancer Therapy 1/31/2024

    This collection of frequently asked questions highlights the remarkable efficacy of immune checkpoint inhibitors (ICIs) and the projected growth of the global ICI market.

  3. Pricing, Value, And Access of CGTs With The Dedham Group's Jennifer Klarer, M.Sc.Eng. 1/30/2024

    The Dedham Group's Jennifer Klarer, M.Sc.Eng., Partner and Head of Cell & Gene Therapy, joins Erin Harris on this episode of Cell & Gene: The Podcast for a deep dive into pricing and value for CGTs. Klarer shares a detailed breakdown of the most misunderstood aspects of cell and gene therapy pricing, value, and affordability. She details how manufacturers can get ahead of addressing time-to-treatment issues typically experienced at launch. They cover obtaining adequate investment dollars, and much more. 

  4. The Ins And Outs Of In-House Manufacturing: Building A Cell & Gene Production Facility 1/30/2024

    Deciding whether to bring manufacturing in-house or outsource it to a partner can be a daunting decision, particularly as market forces continue to put pressure on small biotechs.

  5. Collaborating with the FDA: Dr. Peter Marks and Dr. Nicole Verdun Share Advice For Small And Emerging Biotechs 1/30/2024

    In this segment, Dr. Peter Marks and Dr. Nicole Verdun share their advice and best practices for small and emerging biotechs when working with the FDA.

  6. How Past Gene Therapy Approvals Are Shaping the Future with Dr. Peter Marks 1/30/2024

    In this segment of Cell & Gene Live, Dr. Peter Marks shared what he and his team have learned from current gene therapy approvals to accelerate future approvals.

  7. Leveraging Tech, Regulatory Frameworks To Deliver Patient Access Today 1/29/2024

    Amidst the shift toward decentralized manufacturing models, consider an approach that allows for standardized processes, remote monitoring and control, and centralized quality oversight.

  8. 2024 Regulatory Outlook With FDA's Drs. Peter Marks And Nicole Verdun 1/25/2024

    Explore the evolving regulatory landscape for cell and gene therapies in 2024 including the increasing speed availability of cell and gene therapies by enabling manufacturing processes and standards development.

  9. Shaping A Digitally Enabled Commercialization Road Map For Your Cell/Gene Therapy Company 1/25/2024

    For cell and gene therapy companies, it is critical for commercial, marketing, and digital leaders to understand key business decisions that shape the digital backbone of your commercialization road map.

  10. Paving The Way For India's First Domestic CAR-T Approval 1/22/2024

    India recently saw the approval of its first domestic CAR-T cell therapy, NexCAR19. This not only marks a significant achievement for the country, but for the CGT industry as a whole. To learn more about this journey to approval, I met with ImmunoACT, the pioneer behind NexCAR19.