Globalizing Drug Development Programs for FDA Approval
Global drug development programs benefit greatly from partnerships with contact research organisations (CROs) in the Asia-Pacific region.
Across the big players in the industry, there has been a shift towards global partnerships in drug development, partially due to the speed of access to the clinic that CROs can provide biotech companies.
In the United States, the FDA has recently experienced significant delays in the review, approval, and early-stage processes.
To secure healthy volunteers quickly, many companies across the biotech industry are opting to implement global drug development programs.
Pharmaceutical companies are increasingly interested in devising efficient strategies to bring drugs to the US market based on a global development approach.
While this approach is favoured by the big hitters, interest hasn’t been limited to established multinational corporations.
An increasing number of emerging biopharmaceutical companies are seeking a global presence to better address unmet clinical needs and maximise their commercial opportunity.
From an FDA regulatory standpoint, at least 20% of supporting clinical data should come from patients in the US.
To address this requirement, clinical trial strategies for new drugs and therapeutics developed for the US market must include the United States as a key country, potentially facing restrictions on enrollment.
This can have significant implications in terms of higher trial costs, longer study timelines, delays for achieving approval, and may ultimately impact on the probability of success for the drug development program.
A Globalized Approach to Drug Development
Recent amendments to FDA legislation have allowed foreign clinical trials not conducted under an investigational new drug application to be accepted in validation pipelines.
Consequently, pharmaceutical companies seeking regulatory approval in the US are faced with the question: "What proportion of my study should involve participants from the US?"
For the five-year period of 2013-2017, the 176 pivotal clinical studies which supported approval by the FDA had, on average, 41% of study participants from the US.
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While this percentage is significantly higher than the 20% threshold, in each year there was significant variation from the mean.
Certain products received approval based on pivotal studies with 100% US participants, while others were approved based on studies with less than 10% US participants.
Broadly speaking, the push towards a greater diversity in ethnic backgrounds associated with global drug development programs is integral to the safe development of future therapeutics.
Studies which are more representative will indicate particular patient populations that may show better responsiveness to treatment, or which may be vulnerable to adverse effects not apparent in a study on a narrower patient population.
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