| The discovery of peptide biomarkers is happening in | | | | - Peptide Biomarker Discovery: 14 months |
| the midst of many other exciting medical advances | | | | - Prototype Assay Development: 5 months |
| including emerging discoveries in proteomics, | | | | - Pre-Validation of Assay: 5 months |
| personalized medicine, combination products, delivery | | | | - Assay Development: 7 months |
| systems and translational medicine. Peptide biomarker | | | | - Clinical Validation: 17 months |
| discovery is a dynamic area of R&D which is born | | | | Clinical Validation includes: preclinical, phase 1, phase 2, |
| from natural, native physiological and pathological | | | | phase 3 and phase 4. The number of samples that |
| processes in biological systems. The field of | | | | must be collected and tested increase in number and |
| biomarker discovery and development - identification, | | | | size in late phase development. Preclinical POC (Proof |
| classification, R&D, clinical development phase, | | | | of Concept) samples collected and tested are usually |
| transition and validation is currently under debate. A | | | | small in number in discovery with around ten samples |
| number of groups such as NIH (National Institute of | | | | common, reaching hundreds of samples in the |
| Health Biomarker Definitions Working Group, Divisions | | | | validation stage, transitioning to thousands of samples |
| at FDA and other regulatory agencies worldwide are | | | | by the time of application to FDA and during |
| in the process of establishing set criteria for | | | | implementation. |
| proteomic biomarker development. | | | | Regardless of the type, a biomarker must |
| There are 3 types of Biomarkers: | | | | demonstrate, under routine implementation |
| | | | methodologies and conditions of use, how the |
| 1. Prognostic Biomarkers: capable of providing | | | | marker impacts clinical management of a patient with |
| information on clinical outcome at the time of | | | | life-threatening or terminal disease, either by |
| diagnosis, independent of therapy | | | | improving patient outcome or QoL (Quality of Life) or |
| 2. Predictive Biomarkers: capable of providing | | | | by lowering cost and time of patient care. |
| information on the likelihood of response to a given | | | | The quality, accuracy, reproducibility, consistency and |
| therapeutic modality | | | | integrity of data must be of high level and must be |
| 3. Screening Biomarkers: capable of providing | | | | quality controlled, processed and assured. Quality |
| information on clinical diagnosis in the general | | | | management plans, SOPs, WIs, GCP, GLP, GMP and |
| population. | | | | otherwise must be developed and meet compliance |
| The peptide biomarker developmental phases are | | | | quality standards. All plans, procedures and processes |
| commonly categorized as Discovery, Transition and | | | | must be developed in accordance with FDA |
| Validation. Estimated time lines for the development | | | | regulatory requirements, guidance and guidelines for |
| of a proteomic biomarker (total duration = 48 | | | | the year of the application and/or implementation. |
| months) is provided in months: | | | | |