Due to their complexity and cost, developers of cell and gene therapies face unique manufacturing hurdles. Determining the right approach to manufacturing is crucial when bringing these advanced therapeutics from clinical to commercialization.

This white paper, based on a recent webinar co-sponsored by Precision for Medicine and Informa Pharma Intelligence, features the unique expertise of Erin Harris (Editor In Chief of Cell & Gene), David Carr (Director, PRECISIONadvisors), Tony Khoury (Executive Vice President, Project Farma), Janet Lambert (CEO, Alliance for Regenerative Medicine), and Alex Karnal (Partner and Managing Director, Deerfield Management).

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Calculating viral vector yields is essential to determine how much drug product is needed for a specific gene therapy. It’s a critical analysis for any gene therapy organization looking to scale from preclinical to clinical to commercial. Project Farma’s Tony Khoury, Christian Hermanas and Salome Philip provide an in depth review of a valuable yield calculation tool that can serve as a vital prerequisite of the “make vs buy” analysis.

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Although clinical trials in the cell and gene therapy space have skyrocketed, there’s a significant shortfall in the skilled talent required to execute on the exponential potential of cell and gene therapies. Project Farma and Precision ADVANCE leaders Anshul Mangal and John Khoury discuss the biotherapeutic process and manufacturing talent gap, and propose a multipronged approach to addressing the problem through internal innovation and the external influence of academia and industry associations.

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The cell and gene therapy manufacturing skills shortage is slowing the abilities of innovative therapies to reach patients, delaying manufacturing scaleup and increasing learning and development costs. Project Farma’s Anshul Mangal discusses the impact of the cell and gene therapy manufacturing skills shortage, and reviews ways to scale up and bring more therapies to commercialization despite the skills gap.

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A big bottleneck in the evolving field of cell and gene therapy is identifying sites with the capability and capacity to conduct these resource-intensive studies. Gene and cell therapy developers need to create clinical interest to find champions at investigative sites and differentiate their products and clinical trials to keep development moving forward. Precision’s Megan Liles explores strategies for building clinical enthusiasm and selecting the right sites for gene and cell therapy trials.

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Do you know the most important market dynamics to ensure the success of your gene therapy?

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Access challenges to cell and gene therapy are well documented. Precision’s Christina Poschen and David Carr discuss how some innovative manufacturers are moving away from the role of being purely a researcher and manufacturer and toward involvement at the point of diagnosis through manufacturing and delivery to patient access support in order to address those challenges head on.

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