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OUTSOURCING


Data-driven sourcing strategies for clinical trial supplies


Clinical Services International (CSI) is a world leader in the sourcing and management of quality-certified, commercially available medicines for clinical trials. Dr Vanessa Dekou, managing director at CSI, discusses the best approach for clinical trial supply strategies.


M


arket analysis and data collection are two of the most important tools when putting together a sourcing


solution to effectively safeguard clinical trial supplies. For a study running over several years, it is important to have an accurate forecast of drug requirements, and how the market might develop and change during the study. This is done by closely monitoring market trends to develop a sustainable sourcing strategy – as trials can be jeopardised if a submission is made with a certain drug that is later on shortage, more expensive or even withdrawn from the market. Keeping track of price changes, alternative suppliers and manufacturers can be the best position to negotiate from. Even the ability to walk away from an offer that, on reflection, is not as promising as it first seemed is a good position to be in.


Biologics and biosimilars Small molecule drug development involves chemical synthesis following a reproducible, ‘recipe-book’ approach. Biologics, however, are produced by a living-host organism – one that is genetically engineered to produce large, protein-based molecules, such as vaccines and monoclonal antibodies. Their larger structures


The first biologic Development cost


Development time Reference drug exclusivity 28 | Outsourcing in Clinical Trials Handbook


and biological production make them harder to characterise, requiring advanced spectroscopic and biophysical analytical techniques, while also making the manufacture of generics – called biosimilars (see the table below) – complex. Manufacture cost in drug development is


normally between $95–225/g, whereas a small molecule drug may cost as little as $0.58/g. In 2019, 22 biological licence applications were approved by the FDA. In Europe, the first biosimilar was approved in 2006, while in the US, the first biosimilar was approved in 2015. Over 30% of the drug spend in Europe is biologics, 1.5% of which is biosimilars.


Magic bullets with a price tag to match Biologics are the so-called ‘magic bullets’ in the drug industry and are likely to shape medicine in the future. However, bringing a biologic to the market is expensive, and estimates suggest that the average daily cost of a biologic in the US is $45, compared with $2 for a small molecule drug. How this develops in a world of increasing healthcare costs and demand for personalised treatment is a matter for governments, hospitals, pharmaceutical companies and, sometimes, insurance providers to debate.


Biosimilar > $100m


5–9 years >10 years


Generic $1–2m


~2 years 58 years


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