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Mastering clinical drug distribution in an era of advanced therapies and global trials
Originally published on Outsourcing-Pharma.com.
The composition of clinical trial pipelines is changing quickly as the rise of advanced therapies adds another layer to the multi-decade shift from small molecules to biologics. This change is fueling once-unimaginable advances in the treatment of cancers, rare diseases and other conditions, but it is also placing strains on infrastructure and processes originally created to handle more robust small molecules. In this new environment, clinical drug distribution is a key enabler of success.
The significance of distribution has risen in line with the complexity of therapeutics and clinical trial designs. Whereas once clinical supply chains took robust small molecules to centers in North America and Western Europe, today they ferry expensive, highly-sensitive biologics to sites around the world.
Antibodies and other temperature-sensitive biologics account for almost two-fifths of the biopharma industry pipeline, up from around one-fifth 20 years ago.1 A fast-growing and vitally important part of the pipeline is made up of gene, cell and other advanced therapies that are even more sensitive and challenging to ship than antibodies.
As of the end of 2018, there were more than 1,000 active clinical trials of regenerative medicines, such as cell and gene-based therapies, according to the Alliance for Regenerative Medicine.2 That represents an increase of 63% over the past three years.13 The rise is underpinned by a 132% surge in the number of regenerative medicine trials targeting cancers.
There are reasons to think the growth will continue. Growth in Phase I trials has outstripped other stages of human testing, meaning the sector has a big pool of programs to move deeper into clinical development in the coming years. And money has flooded into the industry to fund these programs.
Understanding why we must adapt, continuously asking ourselves how we can change what matters is how we keep on delivering it.
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