Following the announcement of a plan to speed up clinical trials in the face of competition from China, the sector is calling for an end to the uncertainty and for the evaluation of new drugs to be standardised

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The Biotechnology Innovation Organisation (BIO), the leading advocacy group for the biotechnology industry in the US, has collaborated with the FDA on the plans announced on Monday to streamline clinical trials, and is confident that the next initiative will focus on standardising the assessment of drug approval applications. This was explained by its chief executive, John Crowley, who, during the organisation’s annual meeting in San Diego, emphasised – according to Reuters – the need for greater consistency in the regulatory agency’s processes.

The meeting highlighted the growing competitive pressure from both China and the advance of artificial intelligence in the biotechnology sector. Crowley stated that BIO is aligned with Congress and the Administration, adding that these are “bipartisan issues”. He also reiterated that biotechnology is a “strategic national asset”.

PROGRAMME TO RESTORE LEADERSHIP

Specifically, the US health authorities announced this week a programme aimed at “restoring the country’s leadership in clinical trials”, based on a series of measures designed to speed up research into new drugs. For Crowley, the priority now is to establish standardised review criteria by the FDA, as these can currently vary significantly depending on the disease or the type of drug molecule. “There is uncertainty in the regulatory review process for many medicines, particularly in the case of rare diseases,” says the CEO of BIO.

He also points out that clearer standards are needed to determine whether a medicine qualifies as an innovative therapy or is subject to another form of special review. With all this in mind, he insists: “The US FDA must remain the global benchmark.”