Expert Insights on GCT Cold Chain Logistics

71. Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances 7/5/2021

    In the U.S., you're grappling with how to set up a fully interoperable electronic system for securing and tracing products across industry sectors per the Drug Supply Chain Security Act (DSCSA) by Nov. 2023. Here's how to navigate the key requirements, as well as the FDA's four new guidances on the subject released in June.

72. The Need For Digital Networks To Support Cell And Gene Therapies 12/30/2019

    Cell and gene therapies have a level of complexity from a supply chain perspective that needs new approaches, including a high level of information sharing and integration. This topic was covered from different perspectives at two recent conferences.

73. Does Blockchain Make Sense For The Cell & Gene Therapy Supply Chain? 9/12/2019

    Understanding the impact and requirements for a clearly defined supply chain strategy and implementing this into the complex environment of cell and gene therapies is not a simple task. It requires dedication and participation from all the stakeholders across the development-to-delivery life cycle. All the details need to be defined, simulation models developed, and risk assessed — and remediation plans put in place. 

74. Transforming Next-Gen Therapy Supply Chains Into Patient-Connected Value Chains 6/20/2019

    Cell, gene, and other emerging therapies are distinctly different from traditional biopharma products. Every lot is for a named patient or small population of patients, and that lot drives direct uplift on the bottom line. Traditional supply chain management does not necessarily create patient value in emerging therapy value chains. Operations should be the backbone of a distribution model that delivers these products efficiently and effectively over the last few yards.

75. Refrigerated Transport For Gene Therapies: Exploring The Pros And Cons 4/5/2019

    In the first part of this two-part article, common cryogenic shipping methods for gene therapy products were presented, and pros and cons of each method were discussed. In this part, major refrigerated transport methods of gene therapy intermediates will be addressed.

76. 4 Strategies For Success In The CAR-T 2.0 Marketplace 3/27/2019

    As the second wave of CAR-T therapies begins coming to market in the next five years, their manufacturers will need to anticipate and prepare to address many of the same commercial challenges as their predecessors, as well as several additional ones.

77. Cryogenic Transport For Gene Therapy Products — The Pros And Cons 3/21/2019

    Temperature-controlled packages used for the transport of gene therapy products use a combination of thermal insulators or thermoregulators to decrease the heat transfer rate from outside of the shipper to the inside. In this two-part article, we will explore common methods of temperature-controlled transportation and delve into their pros and cons. In Part 1, we focus on passive cryogenic options.

78. Big Data And AI In Pharma Development And Manufacturing: An Inside Look 2/27/2019

    Artificial intelligence and Big Data have the potential to lower the cost and time of drug trials, to better determine patient outcomes with established drugs, and to better design new drugs.

79. Recalibrating The Supply Chain For Allogeneic Cell Therapies 2/25/2019

    In November 2018, I wrote an article about establishing a supply chain for autologous cell therapies — those formulated using a patient’s own cells. This partner piece highlights considerations that need to be taken into account when developing a commercialization and supply chain strategy for allogeneic cell therapies.

80. Critical Considerations For Packaging And Delivery Of Gene Therapy Products 12/20/2018

    The temperature-sensitivity of cell and gene therapies, their personalized nature, and their circular (“vein-to-vein”) supply chain make maintaining a seamless supply chain critical; however, it is not easily achieved.