4/10/2017. Agenda. Overview: Biomarker Industry. + Industry Overview + Biomarker Labs Overview + Biomarker Intended Use and Challenges
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1 Agenda Placement of Biomarker Analysis in a CLIA or Laboratory + Industry Overview + Biomarker Labs Overview + Biomarker Intended Use and Challenges Patrick Bennett, PPD Panel Discussion 29 March 2017 Overview: Biomarker Industry 1
2 Biomarker Analytical Laboratories Pharma Decision Making for Biomarker Project Pharma Decision Making for Biomarker Project Early Development Clinical Development Post-Approval Preclinical Development Phase I Phase II Phase III Regulatory Filing/ Approval Safety and Surveillance Qualified Vendor Lab Geographical Constraints Lab Selection Specialty Testing Lab Biomarkers Lab Capacity & Timing Capability, Platform & Experience Restart at Step 4? Academic/Research Institute Lab Type of Laboratory Pricing Commercial Clinical Lab/Hospital Central Lab Compliance Intended Use Qualified Vendor 4 2
3 Internal CRO Decision Making for Biomarker Project Industry Structure Comparison Biomarker Intended Use Laboratory Type Compliance Lab Selection Geographical constraints Capacity Capability Biomarker Labs Overview + Pharma/Biopharma: + Discovery + DMPK/ + Outsourcing & Procurement + CRO: + group + LC/MS + LBA + University: + Research + Clinical + Pharma/Biopharma + Translational, Biomarker + DMPK/ + CRO + + Central Labs + Specialty Labs + University/Medical + Commercial + Clinical Diagnostics + Companion Diagnostics + Other Vendors 9 3
4 Industry Challenges for Biomarkers Industry Challenges for Biomarkers Biomarker Lab Perspectives Pharma/Biopharma + +Translational Sciences + Biomarker + Clinical + Outsourcing & Procurement CRO + Preclinical/Toxicology based + Clinical based + group + LC/MS + Ligand Binding Assay + Central Lab + LC/MS + Ligand Binding Assay + Flow Cytometry + Clinical Chemistry + Immunohistochemistry + Anatomical Pathology + Clinical Diagnostic & Hospital + Medical + University + Research + Medical +Specialty Lab + Anatomical Pathology + ICH + Molecular genomics + Proteomics + Metabolomics + Other omics Academia & Research Institute Preclinical & Toxicology CRO Full Service Clinical CRO CRO Diagnostic & Medical Lab Compliance Perspectives Study Logistics Perspectives Reporting Perspectives Various Various Various Strong GLP focus Short Term Study/Protocol Based Strong Compliance, CLIA & CAP, GCLP, GLP CLIA & CAP, IVD, RUO Short and Long Term Immediate Vendors 510K, IVD, RUO Immediate & Future Central Labs: Patient based Labs: Study/protocol based Patient based NA
5 Biomarker Intended Use & Challenges Comparing Characteristics & Intended Use + Dosed + Quantitative, Qualitative or both + Determine drug concentration in biological matrix + ADME + Toxicology + Safety & Efficacy + Pharmacokinetics + Drug-Drug Interactions + Drug metabolites + Immunogenicity Biomarker + Endogenous analyte + Quantitative, Qualitative or both + Measurement or characterization in a biological matrix related to intended use + Up/down-regulated + Activity + Predictive, diagnostic, prognostic, theranostic, pharmacodynamic + Patient selection or stratification + Exposure + Safety/efficacy + Mechanism of action + Specific vs. pathway + Actual or surrogate endpoint Use of Biomarker Data +Decision Making CLIA/CAP Exploratory Fit for Purpose GCLP/GLP Medical/Diagnostic Related Inclusion: Analyte 1 Medical Monitoring: Analyte 2 Efficacy Primary Endpoint Analyte 3 Secondary Endpoint Analyte 4 Drug Development Related Analyte 5 Analyte 6 Analyte
6 Use of Biomarker Data & Challenges Assay Challenges Comparison Biomarker Assay Challenges: Study Design +Medical/Diagnostic Based: + Patient selection: rapid turnaround time, global implementation + Safety: rapid turnaround time, global implementation + Per Time point or Patient reporting + Informed Consent Process +Drug Development Based + Method validation/compliance/sample analysis and reporting varies based on use of the data + Retrospective analysis + Quality of standardization of sample collection, processing or curation. + Informed Consent Process +Pre-analytical Factors + Study Design + Compliance +Analytical Factors + Compliance + Method Development & Validation + Data Processing & Reporting + Study based Biomarker + Pre-analytical Factors + Study Design + Compliance + Test selections + Laboratory selections + Geography + Analytical Factors + Compliance decisions per analyte + Method Development & Qualification/Validation + Data Processing & Reporting + Study & sample/patient based +Range of samples/time point possible for each study +Shared samples for many biomarkers +Healthy Vs Diseased performance differences +Potentially different locations, labs, companies, instrumentation, methodology and SOPs +Potential different Normal Values +Sample collection, processing and shipping timing and issues +Matrix selection & volumes +Geographic Locations
7 Thank You! 7
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