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    Clinical Evaluation

    Clinical Evaluation: is the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device.

    Webinars

    • APR 21, 2020 | 5:30 AM
      PRINCESS: A Framework for Comprehensive Detection and Haplotype Phasing of SNPs and Structural Variants
      PRINCESS: A Framework for Comprehensive Detection and Haplotype...
      Long-read DNA sequencing technologies such as the Pacific Biosciences (PacBio) and Oxford Nanopore (ONT) platforms, have demonstrated enhanced detection of genomic variation, including Singl...
      Speaker: Medhat Mahmoud, PhD
      Presented at: Genetics Week Virtual Event Series 2020
      1
      APR 20, 2020 | 9:00 AM
      Hematopoietic Cell Therapy Products: Determining Potency and Stability
      Hematopoietic Cell Therapy Products: Determining Potency and Stability
      DATE: April 20, 2020 TIME: 9:00am PT, 12:00pm ET...
      Speaker: Jackie Damen, PhD
      Sponsored By: STEMCELL Technologies
      13 1
      APR 20, 2020 | 8:00 AM
      C.E. CREDITS
      Emergency patient management using coagulation assays
      Emergency patient management using coagulation assays
      Explore emergency hemostasis testing approaches, from rapid lab assays to viscoelastic methods, for managing bleeding patients....
      Speaker: Wayne Chandler, MD
      Presented at: Stago EdVantage Virtual University
      Sponsored By: Diagnostica Stago, Inc.
      17 5
      APR 16, 2020 | 9:00 AM
      Visualize more biomarkers and extract more insights: Moving from single marker IHC to multiplex IF
      Visualize more biomarkers and extract more insights: Moving from...
      DATE: April 16, 2020 TIME: 9:00am PT, 12:00pm ET There is an increasing need to evaluate and understand unique phenotypes and mechanisms of action within the tumor microenvironment. Existing...
      Speaker: Scott Lawrence (M.S., HT(ASCP)) [C] , Katir Patel, PhD
      Sponsored By: Ultivue
      5
      APR 08, 2020 | 12:00 AM
      The NISTmAb and Related Biopharmaceutical Resources
      The NISTmAb and Related Biopharmaceutical Resources
      The NIST Biomanufacturing Program develops measurement science, standards, reference data and tools to support the development, manufacturing, and regulatory approval of biologic medicines....
      Speaker: John Schiel, PhD
      Presented at: BioProcessing Virtual Event Series 2020
      1
      APR 08, 2020 | 12:00 AM
      Droplet Digital PCR as a tool for gene therapy application
      Droplet Digital PCR as a tool for gene therapy application
      Digital PCR has become the emerging technique for the sequence-specific detection and quantification of nucleic acids for various applications. During the recent years, numerous articles of...
      Speaker: Nagarjun Kasaraneni, PhD
      Presented at: BioProcessing Virtual Event Series 2020
      1
      MAR 25, 2020 | 6:00 AM
      Challenges to Starting a New Cannabis Lab: from Sample Traceability to Method Development to Data Management
      Challenges to Starting a New Cannabis Lab: from Sample Traceability...
      Setting up an analytical laboratory requires a clear objective and analytical resources, both instrumentation and technical. The four main areas of focus exist during this process: 1) Instru...
      Speaker: Matthew Brittain, PhD
      Presented at: Cannabis Sciences Virtual Event Series 2020
      1
      MAR 24, 2020 | 11:00 AM
      3-D Organoid Models for Differentiation of PSC-Derived Dopaminergic Neurons
      3-D Organoid Models for Differentiation of PSC-Derived Dopaminergic...
      DATE: March 24, 2020 TIME: 11:00am PT, 2:00pm ET While in vitro cell culture has long been used to study neurological diseases, researchers have come to the realization that 2-D systems do n...
      Speaker: Richard Josephson, PhD
      Sponsored By: Thermo Fisher Scientific - Disease Modeling
      9
      MAR 24, 2020 | 10:00 AM
      Save your time on data analysis with new Batch Analysis feature in Axon pCLAMP 11 Software
      Save your time on data analysis with new Batch Analysis feature...
      DATE: March 24, 2020 TIME: 10:00 am PDT, 1:00pm EDT The Clampfit software module is a useful tool to manipulate and analyze electrophysiological data acquired by pCLAMP™ software. Rece...
      Speaker: Jeffrey Tang, Ph.D.
      Sponsored By: Molecular Devices
      10
      MAR 05, 2020 | 9:00 AM
      An Update on H. pylori testing with a focus on the Houston Consensus recommendations
      An Update on H. pylori testing with a focus on the Houston Consensus...
      Recommendations for key factors in testing and diagnosis of H. pylori infections to include information on appropriate patients for H.pylori testing, current testing options, post treatment...
      Speaker: David Graham, MD
      8
      FEB 25, 2020 | 9:00 AM
      CAR-T Generation for Identity, Purity and Potency Assay Testing
      CAR-T Generation for Identity, Purity and Potency Assay Testing
      Learn about how to generate a small scale CAR-T workflow using ThermoFisher products See detailed characterization tools that can be utilized and applied in a CAR-T workflow...
      Speaker: Tia Hexom, PhD
      Sponsored By: Thermo Fisher Scientific/Gibco
      10 1
      FEB 05, 2020 | 8:00 AM
      C.E. CREDITS
      Emerging Issues in the Coagulation Laboratory
      Emerging Issues in the Coagulation Laboratory
      Learn how new hemophilia and anticoagulant therapies impact coagulation assays and clinical decisions in our educational session....
      Speaker: Donna Castellone, MS, MASCP, MT(ASCP) SH
      Presented at: Stago EdVantage Virtual University
      Sponsored By: Diagnostica Stago, Inc.
      10 1
      JAN 14, 2020 | 9:00 AM
      Fecal Elastase-1 - a Biomarker for Pancreatic Exocrine Insufficiency
      Fecal Elastase-1 - a Biomarker for Pancreatic Exocrine Insufficiency
      Fecal elastase-1 – a biomarker for pancreatic exocrine insufficiency(EPI) continues to gain traction as an ideal biomarker for assessing EPI. This presentation will include a review of...
      Speaker: Roy Sherwood, BSc, MSC, DPhil
      Sponsored By: Diasorin S.p.A.
      5
      JAN 14, 2020 | 8:00 AM
      CiPA initiative and validation of high-throughput methods to characterize compound effects in human iPSC-derived cardiomyocytes
      CiPA initiative and validation of high-throughput methods to characterize...
      DATE: January 14, 2019 TIME: 8:00am PST Drug-induced QT interval prolongation and Torsades de Pointes (TdP) arrhythmias are the leading causes for drug withdrawals from market and compound a...
      Speaker: Muthukrishnan Renganathan, PhD , Panida Lertkiatmongkol, PhD , Oksana Sirenko, PhD , Carole Crittenden
      Sponsored By: Molecular Devices, Eurofins Discovery
      3
      JAN 01, 2020 | 6:00 AM
      Using 3D cell culture models and high content confocal imaging to evaluate efficacy and expose toxic liabilities in the drug development pipeline
      Using 3D cell culture models and high content confocal imaging...
      With an increasing push to improve safety, efficacy, and efficiency throughout the drug development pipeline, researchers are evermore looking to improve the predictive capacity of their in...
      Speaker: Erin Edwards, PhD
      Presented at: Drug Discovery & Development Virtual Event Series 2020
      1
      JAN 01, 2020 | 6:00 AM
      Organoids: A Revolutionary New Tool for Drug Screening
      Organoids: A Revolutionary New Tool for Drug Screening
      “The poor translatability of early-stage preclinical models is a major setback in oncology drug development. Immortalized cell lines, that are extensively used in drug screens, undergo...
      Speaker: Rekha Pal, PhD
      Presented at: Drug Discovery & Development Virtual Event Series 2020
      1
      JAN 01, 2020 | 6:00 AM
      Selective D4R Ligands Reveal Structure-Activity Relationships that Engender Agonist Efficacy
      Selective D4R Ligands Reveal Structure-Activity Relationships...
      The dopamine D4 receptor (D4R) is enriched in the prefrontal cortex where it plays important roles in cognition, attention, decision making and executive function. Novel D4R-selective ligand...
      Speaker: Comfort Boateng, PhD
      Presented at: Neuroscience Virtual Event Series 2020
      1
      DEC 11, 2019 | 7:00 AM
      A Sensitive and Robust Plasmid Analysis Method by Capillary Electrophoresis with Laser-Induced Fluorescence Detection
      A Sensitive and Robust Plasmid Analysis Method by Capillary Electrophoresis...
      DATE: December 11, 2019TIME: 7:00am PST, 10:00am EST An important part of the biopharma industry, Plasmid DNA is used as a gene-delivery vehicle for DNA vaccination and as a key...
      Speaker: Colleen Reed
      Sponsored By: SCIEX
      7
      NOV 14, 2019 | 9:00 AM
      Drug testing in Regulatory Monitoring
      Drug testing in Regulatory Monitoring
      Random drug testing is used as a preventive and detection tool for drug or alcohol use, and medication compliance in the monitoring of regulatory and treatment compliance monitoring. Urine sc...
      Speaker: John Furman, PhD, MSN, COHN-S
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2019
      5 1
      NOV 06, 2019 | 6:00 AM
      Understanding the Pathogenesis of Human Influenza Virus: A Systems Virology Approach
      Understanding the Pathogenesis of Human Influenza Virus: A Systems...
      Multiple factors can affect and impact infection dynamics and virulence produced by influenza virus (IV) infections. Susceptibility factors and host responses can also have major effects in d...
      Speaker: Rafael Medina Silva, PhD
      Presented at: Influenza Virtual Event Series 2019
      1
      OCT 29, 2019 | 8:00 AM
      Multi-omics Approach to Understanding PD-L1 Resistance in Cancer
      Multi-omics Approach to Understanding PD-L1 Resistance in Cancer
      DATE: October 29, 2019TIME: 8:00am PDTAlthough immune-based therapies targeting the inhibitory receptors (PD-L1, PD1, and CTLA4) are proven to be effective to treat cancer, some pati...
      Speaker: Moshe Sade Feldman (PhD) , Russell Jenkins MD, PhD
      Sponsored By: Sony Biotechnology
      8
      OCT 24, 2019 | 10:30 AM
      Supercritical fluid chromatography of polar biomolecules at the analytical and preparative scale: evaluation of global conformational changes in peptides and proteins
      Supercritical fluid chromatography of polar biomolecules at the...
      Supercritical fluid chromatography (SFC) has historically been very effective for exacting difficult chiral separations, with an unmatched power in terms of enabling highly efficient enantios...
      Speaker: Raffeal Bennett, PhD
      Presented at: Analytical Chemistry Virtual Event Series 2019
      2
      OCT 10, 2019 | 1:30 PM
      Precision oncology: Biomarkers for treatment selection in metastatic castration resistant prostate cancer
      Precision oncology: Biomarkers for treatment selection in metastatic...
      Metastatic castration resistant prostate cancer (mCRPC) refractory to secondary hormonal treatments such as enzalutamide or abiraterone acetate are the most lethal of prostate cancers. In thi...
      Speaker: Tian Zhang, MD, MHS
      Presented at: Cancer Research & Oncology Week Virtual Event Series 2019
      1
      OCT 10, 2019 | 12:00 PM
      Tumor Mutation Burden: Challenges and opportunities of measuring and interpreting tumor mutational burden for patient care
      Tumor Mutation Burden: Challenges and opportunities of measuring...
      Tumor mutational burden (TMB) is an emerging biomarker that correlates with response to immunotherapeutic agents, such as checkpoint inhibitors. Recent studies indicate that a high mutation l...
      Speaker: Ravindra Kolhe, MD, PhD
      Presented at: Cancer Research & Oncology Week Virtual Event Series 2019
      Sponsored By: QIAGEN
      1
    APR 21, 2020 | 5:30 AM
    PRINCESS: A Framework for Comprehensive Detection and Haplotype Phasing of SNPs and Structural Variants
    PRINCESS: A Framework for Comprehensive Detection and Haplotype...
    Long-read DNA sequencing technologies such as the Pacific Biosciences (PacBio) and Oxford Nanopore (ONT) platforms, have demonstrated enhanced detection of genomic variation, including Singl...
    Speaker: Medhat Mahmoud, PhD
    Presented at: Genetics Week Virtual Event Series 2020
    1
    APR 20, 2020 | 9:00 AM
    Hematopoietic Cell Therapy Products: Determining Potency and Stability
    Hematopoietic Cell Therapy Products: Determining Potency and Stability
    DATE: April 20, 2020 TIME: 9:00am PT, 12:00pm ET...
    Speaker: Jackie Damen, PhD
    Sponsored By: STEMCELL Technologies
    13 1
    APR 20, 2020 | 8:00 AM
    C.E. CREDITS
    Emergency patient management using coagulation assays
    Emergency patient management using coagulation assays
    Explore emergency hemostasis testing approaches, from rapid lab assays to viscoelastic methods, for managing bleeding patients....
    Speaker: Wayne Chandler, MD
    Presented at: Stago EdVantage Virtual University
    Sponsored By: Diagnostica Stago, Inc.
    17 5
    APR 16, 2020 | 9:00 AM
    Visualize more biomarkers and extract more insights: Moving from single marker IHC to multiplex IF
    Visualize more biomarkers and extract more insights: Moving from...
    DATE: April 16, 2020 TIME: 9:00am PT, 12:00pm ET There is an increasing need to evaluate and understand unique phenotypes and mechanisms of action within the tumor microenvironment. Existing...
    Speaker: Scott Lawrence (M.S., HT(ASCP)) [C] , Katir Patel, PhD
    Sponsored By: Ultivue
    5
    APR 08, 2020 | 12:00 AM
    The NISTmAb and Related Biopharmaceutical Resources
    The NISTmAb and Related Biopharmaceutical Resources
    The NIST Biomanufacturing Program develops measurement science, standards, reference data and tools to support the development, manufacturing, and regulatory approval of biologic medicines....
    Speaker: John Schiel, PhD
    Presented at: BioProcessing Virtual Event Series 2020
    1
     
     
  • APR 08, 2020 | 12:00 AM
    Droplet Digital PCR as a tool for gene therapy application
    Droplet Digital PCR as a tool for gene therapy application
    Digital PCR has become the emerging technique for the sequence-specific detection and quantification of nucleic acids for various applications. During the recent years, numerous articles of...
    Speaker: Nagarjun Kasaraneni, PhD
    Presented at: BioProcessing Virtual Event Series 2020
    1
    MAR 25, 2020 | 6:00 AM
    Challenges to Starting a New Cannabis Lab: from Sample Traceability to Method Development to Data Management
    Challenges to Starting a New Cannabis Lab: from Sample Traceability...
    Setting up an analytical laboratory requires a clear objective and analytical resources, both instrumentation and technical. The four main areas of focus exist during this process: 1) Instru...
    Speaker: Matthew Brittain, PhD
    Presented at: Cannabis Sciences Virtual Event Series 2020
    1
    MAR 24, 2020 | 11:00 AM
    3-D Organoid Models for Differentiation of PSC-Derived Dopaminergic Neurons
    3-D Organoid Models for Differentiation of PSC-Derived Dopaminergic...
    DATE: March 24, 2020 TIME: 11:00am PT, 2:00pm ET While in vitro cell culture has long been used to study neurological diseases, researchers have come to the realization that 2-D systems do n...
    Speaker: Richard Josephson, PhD
    Sponsored By: Thermo Fisher Scientific - Disease Modeling
    9
    MAR 24, 2020 | 10:00 AM
    Save your time on data analysis with new Batch Analysis feature in Axon pCLAMP 11 Software
    Save your time on data analysis with new Batch Analysis feature...
    DATE: March 24, 2020 TIME: 10:00 am PDT, 1:00pm EDT The Clampfit software module is a useful tool to manipulate and analyze electrophysiological data acquired by pCLAMP™ software. Rece...
    Speaker: Jeffrey Tang, Ph.D.
    Sponsored By: Molecular Devices
    10
    MAR 05, 2020 | 9:00 AM
    An Update on H. pylori testing with a focus on the Houston Consensus recommendations
    An Update on H. pylori testing with a focus on the Houston Consensus...
    Recommendations for key factors in testing and diagnosis of H. pylori infections to include information on appropriate patients for H.pylori testing, current testing options, post treatment...
    Speaker: David Graham, MD
    8
     
     
  • FEB 25, 2020 | 9:00 AM
    CAR-T Generation for Identity, Purity and Potency Assay Testing
    CAR-T Generation for Identity, Purity and Potency Assay Testing
    Learn about how to generate a small scale CAR-T workflow using ThermoFisher products See detailed characterization tools that can be utilized and applied in a CAR-T workflow...
    Speaker: Tia Hexom, PhD
    Sponsored By: Thermo Fisher Scientific/Gibco
    10 1
    FEB 05, 2020 | 8:00 AM
    C.E. CREDITS
    Emerging Issues in the Coagulation Laboratory
    Emerging Issues in the Coagulation Laboratory
    Learn how new hemophilia and anticoagulant therapies impact coagulation assays and clinical decisions in our educational session....
    Speaker: Donna Castellone, MS, MASCP, MT(ASCP) SH
    Presented at: Stago EdVantage Virtual University
    Sponsored By: Diagnostica Stago, Inc.
    10 1
    JAN 14, 2020 | 9:00 AM
    Fecal Elastase-1 - a Biomarker for Pancreatic Exocrine Insufficiency
    Fecal Elastase-1 - a Biomarker for Pancreatic Exocrine Insufficiency
    Fecal elastase-1 – a biomarker for pancreatic exocrine insufficiency(EPI) continues to gain traction as an ideal biomarker for assessing EPI. This presentation will include a review of...
    Speaker: Roy Sherwood, BSc, MSC, DPhil
    Sponsored By: Diasorin S.p.A.
    5
    JAN 14, 2020 | 8:00 AM
    CiPA initiative and validation of high-throughput methods to characterize compound effects in human iPSC-derived cardiomyocytes
    CiPA initiative and validation of high-throughput methods to characterize...
    DATE: January 14, 2019 TIME: 8:00am PST Drug-induced QT interval prolongation and Torsades de Pointes (TdP) arrhythmias are the leading causes for drug withdrawals from market and compound a...
    Speaker: Muthukrishnan Renganathan, PhD , Panida Lertkiatmongkol, PhD , Oksana Sirenko, PhD , Carole Crittenden
    Sponsored By: Molecular Devices, Eurofins Discovery
    3
    JAN 01, 2020 | 6:00 AM
    Using 3D cell culture models and high content confocal imaging to evaluate efficacy and expose toxic liabilities in the drug development pipeline
    Using 3D cell culture models and high content confocal imaging...
    With an increasing push to improve safety, efficacy, and efficiency throughout the drug development pipeline, researchers are evermore looking to improve the predictive capacity of their in...
    Speaker: Erin Edwards, PhD
    Presented at: Drug Discovery & Development Virtual Event Series 2020
    1
     
     
  • JAN 01, 2020 | 6:00 AM
    Organoids: A Revolutionary New Tool for Drug Screening
    Organoids: A Revolutionary New Tool for Drug Screening
    “The poor translatability of early-stage preclinical models is a major setback in oncology drug development. Immortalized cell lines, that are extensively used in drug screens, undergo...
    Speaker: Rekha Pal, PhD
    Presented at: Drug Discovery & Development Virtual Event Series 2020
    1
    JAN 01, 2020 | 6:00 AM
    Selective D4R Ligands Reveal Structure-Activity Relationships that Engender Agonist Efficacy
    Selective D4R Ligands Reveal Structure-Activity Relationships...
    The dopamine D4 receptor (D4R) is enriched in the prefrontal cortex where it plays important roles in cognition, attention, decision making and executive function. Novel D4R-selective ligand...
    Speaker: Comfort Boateng, PhD
    Presented at: Neuroscience Virtual Event Series 2020
    1
    DEC 11, 2019 | 7:00 AM
    A Sensitive and Robust Plasmid Analysis Method by Capillary Electrophoresis with Laser-Induced Fluorescence Detection
    A Sensitive and Robust Plasmid Analysis Method by Capillary Electrophoresis...
    DATE: December 11, 2019TIME: 7:00am PST, 10:00am EST An important part of the biopharma industry, Plasmid DNA is used as a gene-delivery vehicle for DNA vaccination and as a key...
    Speaker: Colleen Reed
    Sponsored By: SCIEX
    7
    NOV 14, 2019 | 9:00 AM
    Drug testing in Regulatory Monitoring
    Drug testing in Regulatory Monitoring
    Random drug testing is used as a preventive and detection tool for drug or alcohol use, and medication compliance in the monitoring of regulatory and treatment compliance monitoring. Urine sc...
    Speaker: John Furman, PhD, MSN, COHN-S
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2019
    5 1
    NOV 06, 2019 | 6:00 AM
    Understanding the Pathogenesis of Human Influenza Virus: A Systems Virology Approach
    Understanding the Pathogenesis of Human Influenza Virus: A Systems...
    Multiple factors can affect and impact infection dynamics and virulence produced by influenza virus (IV) infections. Susceptibility factors and host responses can also have major effects in d...
    Speaker: Rafael Medina Silva, PhD
    Presented at: Influenza Virtual Event Series 2019
    1
     
     
  • OCT 29, 2019 | 8:00 AM
    Multi-omics Approach to Understanding PD-L1 Resistance in Cancer
    Multi-omics Approach to Understanding PD-L1 Resistance in Cancer
    DATE: October 29, 2019TIME: 8:00am PDTAlthough immune-based therapies targeting the inhibitory receptors (PD-L1, PD1, and CTLA4) are proven to be effective to treat cancer, some pati...
    Speaker: Moshe Sade Feldman (PhD) , Russell Jenkins MD, PhD
    Sponsored By: Sony Biotechnology
    8
    OCT 24, 2019 | 10:30 AM
    Supercritical fluid chromatography of polar biomolecules at the analytical and preparative scale: evaluation of global conformational changes in peptides and proteins
    Supercritical fluid chromatography of polar biomolecules at the...
    Supercritical fluid chromatography (SFC) has historically been very effective for exacting difficult chiral separations, with an unmatched power in terms of enabling highly efficient enantios...
    Speaker: Raffeal Bennett, PhD
    Presented at: Analytical Chemistry Virtual Event Series 2019
    2
    OCT 10, 2019 | 1:30 PM
    Precision oncology: Biomarkers for treatment selection in metastatic castration resistant prostate cancer
    Precision oncology: Biomarkers for treatment selection in metastatic...
    Metastatic castration resistant prostate cancer (mCRPC) refractory to secondary hormonal treatments such as enzalutamide or abiraterone acetate are the most lethal of prostate cancers. In thi...
    Speaker: Tian Zhang, MD, MHS
    Presented at: Cancer Research & Oncology Week Virtual Event Series 2019
    1
    OCT 10, 2019 | 12:00 PM
    Tumor Mutation Burden: Challenges and opportunities of measuring and interpreting tumor mutational burden for patient care
    Tumor Mutation Burden: Challenges and opportunities of measuring...
    Tumor mutational burden (TMB) is an emerging biomarker that correlates with response to immunotherapeutic agents, such as checkpoint inhibitors. Recent studies indicate that a high mutation l...
    Speaker: Ravindra Kolhe, MD, PhD
    Presented at: Cancer Research & Oncology Week Virtual Event Series 2019
    Sponsored By: QIAGEN
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