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European Biopharmaceutical Review

Driving Development

Suzanne M Sensabaugh at MDS Pharma Services recognises the advantages of expediting drug development through the use of biomarkers

Biological markers, or biomarkers, play a pivotal role in a successful biopharmaceutical development programme. Biomarkers enable each step of the process – from discovery and preclinical development, to the clinic and finally to market – and can assist in streamlining and expediting the drug development process.

Biomarkers are defined as a characteristic that is objectively measured and evaluated as an indicator of normal biological or pathogenic processes, or pharmacologic responses to a therapeutic intervention (1). Biomarkers are qualitative measures of biological effects that provide links between the mechanism of action and clinical effectiveness (2). This link can assist companies in evaluating the biological response to a biopharmaceutical in each stage of development. The drug development process is a methodical one in which the results of each step lead to the development of a hypothesis and testing of that hypothesis. Biomarkers can assist companies in the development and design of hypothesis testing. The results of each step require analysis and ‘go/no go’ decision-making prior to passing into the next phase of development.

Biomarkers are considered to be an additional variable in the design of preclinical and clinical trials, which may contribute to the rate of trial success. A successful outcome may result in faster time-to-market for the product and/or the avoidance of the inclusion of trial subjects who have a low probability of responding to the biopharmaceutical product. In fact, the European Medicines Agency (EMEA) cites biomarkers as key to “the right drug at the right dose in the right patient group” approach (3). Success may also be measured in halting a drug with no promise of reaching the market as early in the drug development process as possible. A new product entering Phase I testing is estimated to have only an eight per cent chance of reaching the market (4), and drug failures account for 75 per cent of cumulative research and development cost (5).

Therefore, the use of biomarkers can lead to capital resource savings and reduce the risk of late-phase attrition through the removal of a product from the development pipeline as early as possible prior to the product’s eventual failure.


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Suzanne M Sensabaugh is VP, Biopharmaceutical Development, MDS Pharma Services, where she is responsible for managing and directing the consulting group in Development and Regulatory Services and providing professional guidance to clients. Prior to this position, she was VP, Regulatory Affairs, and Senior Director for Global Biogenerics, Teva Pharmaceutical Industries Ltd. She has more than 10 years’ experience at the FDA/CBER as a researcher, product reviewer and inspector for biologics. She was also involved in the development and implementation of SOPs, guidance, regulations and laws. Suzanne serves on company boards, is the industry representative to numerous scientific committees and the ICH, and teaches Clinical Development at Johns Hopkins University, Maryland. She received her MBA from Duke University, North Carolina, an MSc in Biotechnology from Johns Hopkins University and a BSc in Zoology from the University of Maryland.
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