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European Biopharmaceutical Review

Anticipating Advancements

Currently, around 1,000 clinical trials are taking place, with over 350 in the gene therapy area and over 30 of the gene therapy products in late-phase studies. While only one licenced product (Spark Therapeutics, Luxturna) is available, the FDA are predicting that 40 products will be licenced by 2020, with an anticipated 10 products being licenced per year.

Many of these products have been given ‘fast-track’ designation by the FDA and PRIME status by the EMA, accelerating their development with the aim of giving patients early access to these therapies.

The ongoing clinical success has led to an increased focus on the manufacturing of these products to meet the continuing demands for clinical studies and how requirements for commercial in-market supplies will be met. This not only relates to the manufacturing of specific vectors, but, also, the supply chains involved in the production of these materials within the clinical and commercial space.

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Antony Hitchcock BSc is Technical Director at Cobra Biologics. He has over 30 years of experience in the large-scale manufacture of biopharmaceuticals. As a founding staff member of Cobra, Tony has been responsible for the development of much of Cobra’s manufacturing technologies in the field of DNA and virus production. He has held a number of senior roles, managing both manufacturing and development functions within the company, working on over 40 programmes for the development of novel therapeutic products including protein, recombinant virus, bacteriophage, and plasmid DNA products. His current role is based in the commercial group supporting external collaborations and outreach activities.
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Antony Hitchcock BSc
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