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European Biopharmaceutical Review

Human Fresh Tissues vs Clinical Attrition

Despite the ever-increasing number of technologies available to drug developers, attrition rates remain stubbornly high. For novel compounds entering Phase II trials, the rate of success has historically remained around 10-15% (1). Even once Phase III is reached, the current rate of success is only around 55% (2). In addition, the bar for drug approval and commercial success has never been higher. Blockbuster drugs have achieved their success by addressing a large unmet medical need and by outperforming standard of care treatments. As these treatments improve, the quest to develop the next blockbuster becomes more difficult, the number of unmet medical needs becomes less, and the target patient populations becomes smaller.

The advent of precision medicine has provided an opportunity for drug developers to better target these non-responding patient groups (3). The challenge now is to streamline the drug development process to account for these more abundant, but smaller, target patient populations. Clinical phases of development are by far the highest contributors to the overall cost of drug development, therefore, improving translation to the clinic and understanding the target patient populations at the preclinical stage is critical (4). In practice, 100% translation to the clinic is clearly not realistic, but there is, as evidenced above, plenty of room for improvement.

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Graeme Macluskie is Director of Precision Medicine at REPROCELL. Since 2011, he has been designing and delivering preclinical projects globally. With more than 15 years’ research experience in the pharma and biotech industry, he leads a team responsible for developing tissue-based assays for inflammatory disease such as psoriasis, COPD, and IBD.

Zara Puckrin is Marketing Manager for REPROCELL. Since joining the company in 2017, she has been helping scientists understand the benefits of incorporating human data in their research. A molecular biologist by training, Zara’s mission is to make the world a better place through translational science and pharmacology.
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Graeme Macluskie
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Zara Puckrin
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