Harriet Edwards

Harriet Edwards

Harriet Edwards is Associate Director, Regulatory Affairs, at Alan Boyd Consultants Ltd., UK.

  • Advanced therapy medicinal products (ATMPs)

    Unlocking a new paradigm of healthcare through advanced therapies


    It seems like a recurring theme to start our advanced therapy medicinal products (ATMPs) issue with a familiar message: we are undoubtedly entering a new paradigm of healthcare thanks to these novel and innovative technologies. It is something that was as true in last year’s editorial for the ATMP-focused issue ...

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    Dr Peter Marks on reflecting innovation through FDA regulation


    Harriet Edwards and Dr Katherine Bowen spoke to Dr Peter Marks, Director of Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA), about his career and the continued evolvement of regulation to support innovative medicines development

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    Diverse and dynamic regulation in the Asia Pacific region


    Starting in Australia, authors David Batka and Kate Burke look at the trends within its market for 2024. Two years ago, the Australian government and its regulatory agency, the Therapeutic Goods Administration (TGA), initiated an expert review of medicine and device regulations to bring about reforms for patient access, flexible ...

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    G-E-T-ting there – how gene editing technologies could change more than genes


    The field of genome editing technologies (GETs) is rapidly advancing, marking a new and exciting era of curative medicines. These products can alter genetic material in patients, highlighting the crucial need to introduce dedicated legislation to ensure that GETs are developed and maintained in a safe and effective manner.

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    Mind the gap:
    Innovation vs
    regulation of ATMPs


    Technology has always developed faster than regulation – but the pace at which science is advancing is not being matched by progress of the current regulatory framework which, in stark contrast, is consultative, slow, and regional.

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    Navigating the regulatory landscape for regenerative medicines in Japan


    This is the final article in a series of three that critically analyse the differences and similarities between the regulation of advanced therapy medicinal products (ATMPs), also known as regenerative medicines…[1],[2]