RESUMO
At the 5th FDA-Drug Industry Association (DIA) Workshop on 'Pharmacogenomics in Drug Development and Regulatory Decision Making', track four focused on the current thinking and issues in the co-development of therapeutic drugs or biologics, and their companion diagnostic products. Identification and validation of genomic and other biomarkers are becoming important components of drug-development strategies, and recent successes show the power of personalized approaches to change the benefit-risk paradigm for new drugs.
Assuntos
Biomarcadores Farmacológicos , Técnicas e Procedimentos Diagnósticos , Desenho de Fármacos , Indústria Farmacêutica , Regulamentação Governamental , Farmacogenética/métodos , Biomarcadores Farmacológicos/análise , Técnicas e Procedimentos Diagnósticos/normas , Indústria Farmacêutica/normas , Farmacogenética/legislação & jurisprudência , Estados Unidos , United States Food and Drug AdministrationRESUMO
Advances in therapeutic strategies for Alzheimer's disease that lead to even small delays in onset and progression of the condition would significantly reduce the global burden of the disease. To effectively test compounds for Alzheimer's disease and bring therapy to individuals as early as possible there is an urgent need for collaboration between academic institutions, industry and regulatory organizations for the establishment of standards and networks for the identification and qualification of biological marker candidates. Biomarkers are needed to monitor drug safety, to identify individuals who are most likely to respond to specific treatments, to stratify presymptomatic patients and to quantify the benefits of treatments. Biomarkers that achieve these characteristics should enable objective business decisions in portfolio management and facilitate regulatory approval of new therapies.