PPT-Biomarker Development and Validation

Practices amp Experiences Shawn Li MD PhD October 1 2012 Introduction Frontage Capabilities and Approaches Case Studies Challenges and Solutions Measurement of Analyte in Presence of Endogenous Protein. Biomarker Potential and . Limitations of . Circulating miRNA. Performed by the . Data Management . a. nd Resource Repository (DMRR). ERCC . D. ata Analysis. 1. Williams Z., et al. . (. 2013. ) Comprehensive profiling of circulating microRNA via small RNA sequencing of cDNA libraries reveals biomarker potential and limitations. MBBS (Hons), . MMedSci. (. Clin. . Epid. ), . MBiostat. , PhD, FRACP. Biomarker-Based Clinical Trials: Practical and Design Considerations. Biomarker. “Any characteristic that can be objectively measured as an indicator of normal or pathological biological processes or the response to a therapy”. Biomarker Potential and . Limitations of . Circulating miRNA. Performed by the . Data Management . a. nd Resource Repository (DMRR). ERCC . D. ata Analysis. 1. Williams Z., et al. . (. 2013. ) Comprehensive profiling of circulating microRNA via small RNA sequencing of cDNA libraries reveals biomarker potential and limitations. Neil P. Shull, Ph.D., J.D.. Sterne, Kessler, Goldstein & Fox P.L.L.C.. F.I.R.E. Series LXIX. March 8, 2012. Overview of issues. . What can be patented?. Is it useful?. How much data is needed?. Potential prior art issues. Not Quite Ready . for Prime Time. Scott Kopetz, MD, PhD. . Department of GI Medical Oncology. MD Anderson Cancer Center. NOT YET. YES. Individual Biomarkers versus . Molecular Subtypes. Individual biomarkers:. The Development of Essential Practice. Richard B. Rood. University of Michigan. Wunderground.com. NOAA, ESRL, 29 February 2012. Deep Background. As a manager at NASA . I felt a responsibility to deliver a series of model products addressing a specific set of scientific capabilities, on time, on budget.. CRF Completion guidelines. Overview. General CRF . completion. Patient details header. Registration CRF. After registration. Almac. Test Request Form. Blood CRF. Color Sample Requisition Form. Screening and . 2018 . AACR Annual Meeting. April 15, 2018 . Edward Chu, MD. UPMC Hillman Cancer Center. University of Pittsburgh School of Medicine. Drug . “. A. ”. Time (years) . Percent . One Size Fits All Approach. a measurable indicator . that . can . tell . us something about a person’s health or disease . state, for example, . disease (pathological) processes in the body, for example, disease stage. , . biological processes in the body (heart rate, blood pressure, temperature), . 9:00 – 9:05 Welcome and Introduction- . Vic Kadambi (MPI, MA). 9:05 – 9:35 Regulatory expectations concerning safety assessment . of genotoxic . impurities –. David De Antonis (Pfizer). 9:35 – 10:05 In Silico genotoxicity prediction – . cancer. Khanmi. . Kasomva. ,. Ph.D. . Research . Scholar,. Biotechnology & Molecular Biology Unit, . ERI, . Loyola . College. Chennai, . Inida. .. . . . What we will be discussing about. 2 Understanding the biomarker research activity, is critical as multiple stakeholders align themselves with the latest science. CONTENTSFOREWORDBy Edward Abrahams, President, Personalized Medicine Coa Rui. Tang (Vertex Pharmaceuticals), . Michael . Hale (Shire Plc. ), and . Jing Huang (. Veracyte. Inc. .). March 22, 2017. A Visualization Tool Measuring the Performance of Biomarkers for Guiding Treatment . Limitations of . Circulating miRNA. Performed by the . Data Management . a. nd Resource Repository (DMRR). ERCC . D. ata Analysis. 1. Williams Z., et al. . (. 2013. ) Comprehensive profiling of circulating microRNA via small RNA sequencing of cDNA libraries reveals biomarker potential and limitations.