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European Biopharmaceutical Review

Drug Development Decisions




There has been great progress in the development of cellular, tissue, and gene therapy products/advanced therapy medicinal products (ATMPs) in the last decade. To date, 14 ATMPs have been approved in Europe (though four have been withdrawn now) and 10 cellular and gene therapy products are approved in the US. A summary of the approvals to date is presented in Table 1 and 2. Given the potential of these products, improved understanding of the regulatory hurdles, and potential to reduce costs in next-generation versions, the number of such products in development is increasing rapidly.

Many developers of cellular, tissue, and gene therapy medicinal products have orphan drug designation and/ or a form of priority/accelerated review status. This allows the developers to speed up various aspects of the development programme. However, this fast development has a significant impact on the area of chemistry manufacturing and controls (CMC), where some activities can be accelerated, but many of the critical activities cannot. This results in the requirement to complete complex CMC development activities in a tighter timeframe and often in parallel to nonclinical and clinical development.

From a CMC perspective, it has become apparent that, although the types of products are diverse with varying degrees of complexity and inputs, certain challenges are more common than others. These have been summarised in the following as key points for consideration.

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Zeb Younes has around 20 years of experience in biological products, including a range of cell, tissue, and gene therapy products, from proof of concept through and beyond commercialisation. She has prepared numerous regulatory documents and scientific advice procedures in Europe, the US, Brazil, and Canada. Zeb set up and managed research teams and GMP laboratories, developed and implemented risk-based approaches, and has led EU national/FDA GMP audits. She holds a first-in-class BSc (Honours) in Medical Biochemistry.

Zaklina Buljovcic is a regulatory specialist with more than 10 years’ experience in tissue, cell, and gene therapies and 15 years in regulatory. Her main focus is in regulatory strategy, programme management, and pharmaceutical quality. Zaklina manages projects within interdisciplinary teams on expedited programmes, scientific advice, and preparation for central marketing authorisations. Her experience includes biotech, blood, microbiota, and veterinary products. Zaklina is a biologist and holds a PhD from the University of Stuttgart-Hohenheim, Germany.
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Zeb Younes
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Zaklina Buljovcic
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