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CAT: EMA must support gene and cell therapy developers

Report says regulator should help academic institutions, charities and small companies that lack necessary resources

The European Medicines Agency should improve its support of organisations developing advanced-therapy medicines (ATM), as they often lack resources to bring new therapies through the regulatory process.

Most sponsors of ATM trials are academic institutions, charities and small companies, according to a paper written by members of the EMA's Committee for Advanced Therapies (CAT) and published in the journal Molecular Therapies.

There has been a wealth of research on ATMs such as gene therapies, cell therapies and tissue-engineered products in animals, say the authors, but they note that "few have reached more advanced regulatory milestones in Europe".

The study provides additional evidence of a problem already laid out in the CAT's work programme for 2010-2015, which in addition to pointing out the obstacles to ATM development also notes that 2011-2012 will see the end of the transitional period allowing these products to be marketed without a centralised approval, potentially leading to some market withdrawals.

The aim of the study was to identify the major stakeholders in the development of ATMs and investigate why they have been unable to move these products further down the development pipeline.

Their analysis reveals that sponsors of clinical trials of ATMs between 2004 and 2010 generally have limited financial resources, as well as limited capacity to navigate regulatory procedures.

"This causes a translational gap between development of these medicines and reaching later regulatory milestones", the write. The EMA should try to close this gap by providing scientific advice, getting sponsors to meet with its Innovation Task Force, and running scientific workshops.

Assistance should also be given by the CAT to help sponsors get their candidates certified as ATM with regard to quality and non-clinical data.

The study found that over three-quarters of the ATMs under development were cell-based medicines, mostly being studied for cancer and conditions affecting the heart, blood vessels and blood.

16th March 2012

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