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International Clinical Trials

The Landscape of Clinical Approval





Cell and gene therapies, and other advanced medicinal products, have generated substantial public health interest, and deservedly so. These living drugs have shown remarkable effectiveness against cancer and other life-threatening illnesses, including rare diseases with previously no treatment available. Recent approvals of cell- and gene-based therapies underscore the industry’s conviction that these drugs will have a strong, positive impact on patient health (1-2). At the same time, accelerated approval pathways are placing a heavy onus on drug developers to assure a consistently pure and efficacious product. Sourcing donor material and assuring efficacy are a lot more complicated when a drug comprises living cells and tissues rather than synthetic products. Accelerated approval also puts significant strain on starting material suppliers, especially in the cell therapy space.

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About the authors


Dominic Clarke PhD has 15-plus years of experience developing enabling solutions for cell therapy and bioprocessing applications. Dominic is the Global Head of Cell Therapy at HemaCare, the leading provider of donor starting material for development and commercial cell and gene therapies, where he is actively engaged with industry experts to ensure the highest quality materials are delivered. Previously, he has held roles as the Global Product Manager for Charter Medical's cell therapy and bioprocessing disposables portfolio, focused on creating flexible closedsystem solutions for early- and late-stage production, and as the Director of Research and Development at BioLife Solutions, developing novel biopreservation media and methods to support extended stability of cells and tissues.



Brad N Taylor PhD is the Global Marketing Director at HemaCare. Brad has 13- plus years of experience in the biotech industry, addressing multiple aspects of drug discovery and preclinical development. Previously, he has held roles as Application Scientist and Product Manager in the In Vivo Imaging division of PerkinElmer, where he worked to bring innovative solutions to market to assist the research community in expediting and streamlining the process of preclinical drug discovery for cancer and other clinical applications in animal models of disease.


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