Biomarkers

Articles

• Biomarkers 101 1 hour CE which expires 2/13/22

• Biomarkers-A General Review PMID: 28306150

• Biomarker definitions and their applications PMID: 29405771

• Clinical biomarker validation PMID: 25458054

• FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource. [Internet]. FDA. Dec 2016

• How-to guide on Biomarkers: Biomarker Definitions, Validation and Applications with Examples from Cardiovascular Disease. Postgraduate Medical Journal 2009;85:538-545.Puntmann VO.

• More About Biomarkers & Qualification

• The Use of Biomarkers in Clinical Practice  

Cardiovascular

• American Heart Association Expert Panel on Subclinical Atherosclerotic Diseases and Emerging Risk Factors and the Stroke Council. Hlatky MA, Greenland P, Arnett DK, Ballantyne CM, Criqui  Smith SC Jr, Wilson PW.

• Cardiac biomarkers are associated with an increased risk of stroke and death in patients with atrial fibrillation: a Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) substudy. Circulation. 2012 Apr; 125(13):1605-16. Epub 2012 Feb 28.

• Circulation. 2009 May;119(17):2408-16. Epub 2009 Apr 13. 

• Use of Multiple Biomarkers to Improve the Prediction of Death From Cardiovascular Causes. N Engl J Med. 2008;358(20):2107-16. Zethelius B, et al. 

Infectious Disease

• Clinical review: The Role of Biomarkers in the Diagnosis and Management of Community-Acquired Pneumonia. Critical Care. 2010;14(1):203. Christ-Crain M, Opal SM.

• Effect of Procalcitonin-Based Guidelines vs Standard Guidelines on Antibiotic Use in Lower Respiratory Tract Infections: The ProHOSP Randomized Controlled Trial. JAMA. 2009;302(10). Schuetz P, et al.

• Effectiveness and Safety of Procalcitonin-Guided Antibiotic Therapy in Lower Respiratory Tract Infections in “Real Life” An International, Multicenter Poststudy Survey (ProREAL). Arch Intern Med. 2012;172(9):715–722. Albrich WC, et al.

• Procalcitonin-guided algorithm to reduce length of antibiotic therapy in patients with severe sepsis and septic shock. BMC Infect Dis. 2013;13:158. doi:10.1186/1471-2334-13- 158. Hohn A, et al.

Oncology

• Complementary versus companion diagnostics: apples and oranges? Biomark Med 2015;9:25-34. Milne CP, Bryan C, Garafalo S, et al.
• Considerations for Development and Launch. Clin Transl Sci 2017;10:84-92.
• Curr Opin Pharmacol 2015;23:32-8. Sunshine J, Taube JM. PD-1/PD-L1 inhibitors.
• Current Status of Companion and Complementary Diagnostics: Strategic. Scheerens H, Malong A, Bassett K, et al.
• Diagnostic assay harmonization for the selection of lung cancer immunotherapy. Journal of Thoracic Disease. 10.21037/jtd.2018.10.24.
• FDA Companion diagnostic definition
• Innovative Biomarkers for Prostate Cancer Early Diagnosis and Progression. Crit Rev Oncol Hematol. 2010;73(1):10-22. You J. et al.
• Prognostic value of MACC1 and proficient mismatch repair status for recurrence risk prediction in stage II colon cancer patients: the BIOGRID studies
• The importance of PD-L1. Hernandez-Martinez, Juan Manuel & Zatarain, Lucia & Cardona, Andrés & Arrieta, Oscar. (2018).

Pulmonary

• Change in Sweat Chloride as a Clinical End Point in Cystic Fibrosis Clinical Trials: The Ivacaftor Experience. Chest. 2013;143(1):14-18. Durmowicz A, et al.
• Plasma Fibrinogen Qualification as a Drug Development Tool in Chronic Obstructive Pulmonary Disease. Perspective of the Chronic Obstructive Pulmonary Disease Biomarker Qualification Consortium. Am J Respir Crit Care Med. 2016;193(6):607-13. Miller BE, at al.
• Plasma MMP2/TIMP4 Ratio at Follow-up Assessment Predicts Disease Progression of Idiopathic Pulmonary Arterial Hypertension. Lung. 2017. 195(4):489-496. Wetzel V, et al.

Inflammation

• Cytokine Signature Associated with Disease Severity in Chronic Fatigue Syndrome Patients. Proc Natl Acad Schl. 2017. Montoya J, et al.
• The role of biomarkers in the management of patients with rheumatoid arthritis. PMID. 19772833

Renal

• Crit Care 2013; 17:R25. Kashani K et al.
• Critical Care 2014; 189:932-9. Bihorac A et al Amer J Resp
• Drug Safety 2017; 40:1049. Kane-Gill et al.
• Kidney Int 2014, 85:513-21. Murray PT et al.
• Renal biomarkers presentation from MidYear 2020 --- "On Your Mark, Ready, Set....Should We Go: An Update on Acute Kidney Injury Biomerkeres" CE Credit and expiration date ???

Prognostic

• Current concepts and future prospects Blood 2018 (DOI: 10.1182/blood-2008-06-165845) Adam, SS et al D-dimer antigen
• D-dimer: Preanalytical, analytical, postanalytical variables, and clinical applications. Critical Reviews in Clinical Laboratory Sciences 2018; vol 55, no 8, 548-577 (https://doi.org/10.1080/10408363.2018.1529734). Favresse, J eet al.
• Widely used types and clinical applications of d-dimer assay Laboratory Medicine 47; 2:90-102. (DOI 10.1093/labmed/lmw001). Riley, RS et al.

Articles

• Biosimilars: Policy, clinical, and regulatory considerations, AJHP
• Implications of biosimilars for the future, AJHP
• Biosimilars: Illustration of scientific issues in two examples, AJHP
• Forum discusses biosimilars, better biologicals, AJHP
• The State of the Art in the Development of Biosimilars, Clin Pharmacol Ther
• NCCN Biosimilars White Paper: Regulatory, Scientific, and Patient Safety Perspectives, J Natl Compr Canc Netw

Guidelines

• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, [PDF] FDA
• Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, [PDF] FDA
• Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009, [PDF] FDA

Others

• FDA: Information on Biosimilars, FDA