Patients Organisations Working Party Why biomarkers in clinical - - PowerPoint PPT Presentation
Patients Organisations Working Party Why biomarkers in clinical drug development and use Marisa Papaluca, MD Senior Science Advisor Scientific Committees Regulatory Science Strategy Marisa Papaluca, MD P C WP meeting 30 November 2016
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Marisa Papaluca, MD – PCWP meeting – 30 November 2016
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Marisa Papaluca, MD – PCWP meeting – 30 November 2016
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Marisa Papaluca, MD – PCWP meeting – 30 November 2016
Biom arkers ( BM) augm ent understanding and precision for m edicines developm ent and use
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Marisa Papaluca, MD – PCWP meeting – 30 November 2016
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Nature Review s Drug Discovery 1 2 , 1 0 3 -1 1 5 ( February 2 0 1 3 ) | doi:1 0 .1 0 3 8/ nrd3 931 Opinion: Pharm acogenetics in the evaluation of new drugs: a m ultiregional regulatory perspective
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Marisa Papaluca, MD – PCWP meeting – 30 November 2016
SCRIP 11 May 2015
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Figure 2 : Num ber of m edicinal products and ratio of m edicinal products containing a genom ic biom arker ( gene) in their product label under “Therapeutic I ndication” per year. The num ber of pharm acogenom ic biom arker in EU product label have been steady betw een 1 9 9 9 and 2 0 1 0 and since then gradually increasing in recent years. I nitially, they have been intended for inform ation only, progressing into becom ing one of the im portant determ inant for selection of patients likely to benefit from treatm ent and “m ore” individualised dose selection. Biom arker inform ation m ay also be included in the labelling in case of negative selection ( i.e., if the biom arker is used to select a population unlikely to respond) or in case of uncertainty about the value of the biom arker but w here a negative selection is suspected, e.g. vandetanib.
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Pharmacogenomic information in drug labels: European Medicines Agency perspective The Pharmacogenomics Journal (2015), 1 – 10
Marisa Papaluca, MD – PCWP meeting – 30 November 2016
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Marisa Papaluca, MD – PCWP meeting – 30 November 2016
– during clinical trials and – up on the occurrence of serious ADRs, lack of effectiveness post authorisation or unexpected worsening of the condition
Marisa Papaluca, MD – PCWP meeting – 30 November 2016
Marisa Papaluca, MD – PCWP meeting – 30 November 2016
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Source: “Personalized Medicine: Current and Future Perspectives,” Patricia Deverka, MD, Duke University, Institute for Genome Sciences and Policy; and Rick J. Carlson, JD, University of Washington
Typical current intervention Earliest clinical detection Earliest molecular detection Initiating events Baseline risk
Decision support tools: Baseline risk Preclinical progression Disease initiation and progression Assess risk Refine assessm ent Predict diagnose Track progression Predict events I nform Therapeutics Sources of new biom arkers:
Stable genom ics: Single nucleotide Polym orphism s Haplotype m apping Gene sequencing Dynam ic genom ics: Gene expression Proteom ics Metabolom ics Molecular im aging
Therapeutic decision support
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medicines and personalise care adding precision to the clinical judgment about which medicines an individual may either benefit from and how (e.g. dose) or should avoid
medicines in clinical development and use
participatory, preventive, predictive and patient centred health care
document with statements on the reason for taking samples/ measurements, the planned and future use of the samples and data, the measure for data privacy protection, the description of interactions and communication on both expected and unexpected findings
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