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European Biopharmaceutical Review

Teething Problems

One of the most significant developments in the progress of new therapies is when the asset comes out of the laboratory and into the clinic. While the final goal – to market a new therapy with proven effect – is someway off from this event, progression or lack thereof has many more consequences than are seen prior to this milestone, including a significant increase in costs, which is coupled with amplified potential for attracting investment. The visibility of the asset is heightened, as are the risks. The scientific endeavour becomes more complex both operationally and technically.

This requires that the assessment, management and mitigation of the risks is more critical than previously, partly due to the developing trend in the type of organisations embarking on clinical trials with new potential therapies. More and more biotechnology companies, some of which are almost virtual in size, are involved in drug discovery and development. A common trend is that it is only the Phase 1 and possibly 2a studies being completed by the biotech firms alone. The expectation is that these assets are then subsequently co-developed or sold on to the large pharma organisations to take through full development and to market.

The attrition rate in clinical development is that less than 10% of compounds entering trials achieve approval. Overall, the attrition rate also appears to be increasing at each key stage, but the biggest impacts remain in late stage failure. Thus, the ‘biotech model’ is changing, sometimes quite subtly, regarding how this early phase development is run, resourced and funded.

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Richard Hucker is Director for Regulatory Bioanalysis for A4P Consulting and was one of the four co-founders of the company in 2011. Originally trained as a biochemist, he began his career in bioanalysis over 30 years ago and has worked in organisations in both the public and private sectors. Richard has published and presented on numerous bioanalytical topics and is currently interested in the interface between regulatory demands and the practice of bioanalysis.

Ian James is the Director, Chief Executive Officer and co-founder of A4P Consulting and holds a PhD on the study of novel bone biomarkers. Originally a Pharmacodynamic Assay Advisor at Pfizer, Ian moved into the support of global companion diagnostics working in HIV tropism diagnostic development for Maraviroc and supporting additional HIV/hepatitis C virus, oncology and various near patient platform developments.

Scott Vincent is Logistics Director and co-founder of A4P Consulting. He graduated in management science from the University of Manchester Institute of Science and Technology, UK, and is a member of the Chartered Institute of Logistics and Transport. Scott is an industry acknowledged expert in providing inventive logistical solutions for time and condition critical shipments, bespoke packaging solutions and best value approaches for provider management and selection.

Carl Watson is a Director and co-founder of A4P Consulting. He has held various roles in the field of biomarker analysis in CROs and is a subject matter expert in various bioanalytical technologies, including flow cytometry and ligand binding analysis.
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Richard Hucker
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Ian James
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Scott Vincent
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Carl Watson
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