安徽医科大学国际教育学院教案 serum creatinine and blood chemistries:CXR.ECG Pharmacodynamic(efficacy)biomarkers: blood glucose;urine,sputum,etc.cultures;pulmonary function tests JUSE OF SURROGATE ENDPOINTS IN LATE DRUG DEVELOPMENT] 2min 1.Use to assess whether drug has clinically significant efficacy:this is often faster than using clinical endpoint 2.Surrogate endpoints may be used to support-accelerated approval of a drug if the surrogate is deemed reasonably likely to predict a clinical endpoint of interest JUSE OF BIOMARKERS IN CLINICAL PRACTICE] 3min Disease and disease subtype diagnosis Prognostic determination Selection of appropriate therapy Maximize efficacy Minimize toxicity Selection of correct dose Monitoring outcomes(good and bad) FUTURE DEVELOPMENT OF BIOMARKERS] 3min As a consequence of scientific,economic and regulatory factors,biomarker development has lagged significantly behind therapeutic development. PROBLEM: 1.Classic thinking about biomarkers inhibits new biomarker development 2.Development of biomarkers-confounded with the surrogate endpoint issue 3.Near impossibility of-validating new surrogates has created a significant barrier 4安徽医科大学国际教育学院教案 4 serum creatinine and blood chemistries; CXR, ECG Pharmacodynamic (efficacy) biomarkers: blood glucose; urine, sputum, etc. cultures; pulmonary function tests [USE OF SURROGATE ENDPOINTS IN LATE DRUG DEVELOPMENT] 2min 1. Use to assess whether drug has clinically significant efficacy: this is often faster than using clinical endpoint 2. Surrogate endpoints may be used to support ―accelerated approval of a drug if the surrogate is deemed reasonably likely to predict a clinical endpoint of interest [USE OF BIOMARKERS IN CLINICAL PRACTICE] 3min Disease and disease subtype diagnosis Prognostic determination Selection of appropriate therapy Maximize efficacy Minimize toxicity Selection of correct dose Monitoring outcomes (good and bad) [FUTURE DEVELOPMENT OF BIOMARKERS] 3min As a consequence of scientific, economic and regulatory factors, biomarker development has lagged significantly behind therapeutic development. PROBLEM: 1. Classic thinking about biomarkers inhibits new biomarker development 2. Development of biomarkers―confounded with the surrogate endpoint issue 3. Near impossibility of―validating new surrogates has created a significant barrier