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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

    • OCT 10, 2019 | 7:30 AM
      Keynote Presentation: Cancer Prevention for the Practicing Oncologist - Recommendations for Cancer Patients and Their Families
      Keynote Presentation: Cancer Prevention for the Practicing Oncologist...
      The Keynote Address will highlight eight actions that individuals can take to reduce their cancer risk. These recommendations span lifestyle modifications, cancer screening and molecular prev...
      Speaker: Ernest Hawk, MD, MPH
      Presented at: Cancer Research & Oncology Week Virtual Event Series 2019
      1
      OCT 09, 2019 | 10:30 AM
      Newly Diagnosed Ovarian Cancer: Surgical Options
      Newly Diagnosed Ovarian Cancer: Surgical Options
      A subset of women with ovarian cancer will present with an apparently isolated adnexal mass. Many of these women will have early stage ovarian cancer with a relatively good prognosis. Unfortu...
      Speaker: Mitchel Hoffman, MD
      Presented at: Cancer Research & Oncology Week Virtual Event Series 2019
      2
      OCT 09, 2019 | 9:00 AM
      Start at the End: A Strategy for Developing and Delivering Advanced Diagnostic Tests to improve Prostate Cancer Patient Outcomes
      Start at the End: A Strategy for Developing and Delivering Advanced...
      Although about one in every seven men in the developed world will be diagnosed with prostate cancer in their lifetime, the mortality rate remains low with a 99% five-year survival rate for lo...
      Speaker: Stephen Pennington
      Presented at: Cancer Research & Oncology Week Virtual Event Series 2019
      Sponsored By: Agilent
      1
      OCT 09, 2019 | 6:00 AM
      Multilevel Interventions in Cancer Prevention and Control: A Community-Based Translational Research Framework to Address Prostate Cancer Disparities
      Multilevel Interventions in Cancer Prevention and Control: A Community-Based...
      Introduction: Despite the current declines in prostate cancer mortality, African Americans (AA) continue to experience a 60% higher incidence and are twice as likely to die in comparison to m...
      Speaker: Brian Rivers, PhD, MPH
      Presented at: Cancer Research & Oncology Week Virtual Event Series 2019
      2
      SEP 24, 2019 | 8:00 AM
      Interrogating 3D spheroid versus 2D monolayer cell models in drug discovery using cell health microplate assays
      Interrogating 3D spheroid versus 2D monolayer cell models in drug...
      DATE: September 24, 2019TIME: 7:00am PDTHigh throughput screening (HTS) is an effective method for identifying putative active compounds for therapeutics. Assays that evaluate changes i...
      Speaker: Dr. Adyary Fallarero, Ph.D. Adjunct Professor/Docent in Pharmaceutical Biology , Dr. Leticia Montoya, Ph.D., Chemistry and Biochemistry
      Sponsored By: Thermo Fisher Scientific
      9
      SEP 19, 2019 | 8:00 AM
      Importance and Role of Biomarkers in the Management of Pediatric Inflammatory Disease
      Importance and Role of Biomarkers in the Management of Pediatric...
      Learning Objectives: Review basic immuno-pathobiology of IBD and the phenotypes of IBD or IBDs - Crohn’s, Ulcerative Colitis and Indeterminate Colitis Briefly describe the epide...
      Speaker: Benjamin Gold, MD, FACG, FAAP
      Sponsored By: Diasorin
      4
      SEP 18, 2019 | 9:00 AM
      Virus Hunters
      Virus Hunters
      DATE: September 18, 2019 TIME: 9:00am PDT, 12:00pm EDTDue to globalization, changes in the environment and climate, and the encroach- ment of humans into natural habitats, recent out...
      Speaker: Michael Berg, PhD
      Sponsored By: Abbott Molecular Diagnostic
      10
      AUG 29, 2019 | 8:00 AM
      Implementation of Helicobacter Pylori Stool Antigen Testing in a Large Metropolitan Center:  A Prospective Comparative Diagnostic Trial
      Implementation of Helicobacter Pylori Stool Antigen Testing in...
      Date: August 27, 2019Time: 11:00am PDT, 2:00pm EDTBackground: Clinical guidelines for H. pylori screening and post-treatment testing endorse the use of urea breath test (UBT), H. py...
      Speaker: Dylan Pillai, MD, PhD, FRCPC (C)
      Presented at: Discover More; Your Virtual Resource
      Sponsored By: Diasorin
      11
      JUN 26, 2019 | 10:00 AM
      Factors to Consider During Adaptation of a Manual Cell Line Development Workflow to Automation
      Factors to Consider During Adaptation of a Manual Cell Line Development...
      DATE: June 26, 2019TIME: 10:00am PDTMammalian cell line generation is a rate-limiting step in early CMC development and there is a constant desire to increase throughput. The implem...
      Speaker: Rob Ballinger
      Sponsored By: Beckman Coulter Life Sciences
      4
      JUN 20, 2019 | 1:30 PM
      Rapid Variant Modeling in a Hospital Setting
      Rapid Variant Modeling in a Hospital Setting
      Implementing precision genomic medicine in the pediatric acute care setting has several challenges. First, the diagnosis must be made quickly. Second, the determination of pathogenicity mus...
      Speaker: Matthew Bainbridge, PhD
      Presented at: Precision Medicine Virtual Event Series 2019
      1
      JUN 20, 2019 | 1:30 PM
      Introducing the therascreen FGFR RGQ RT-PCR Kit and Day-One Readiness at Insight Molecular Labs
      Introducing the therascreen FGFR RGQ RT-PCR Kit and Day-One Readiness...
      The practice of precision medicine utilizes advanced diagnostic tools to identify specific groups of patients on the basis of particular molecular characteristics, and guide their treatment w...
      Speaker: David Hout, PhD , Benjamin Chaffey, PhD
      Presented at: Precision Medicine Virtual Event Series 2019
      Sponsored By: QIAGEN
      1
      JUN 20, 2019 | 1:30 PM
      Single Cell CNV End-to-End Workflow to Dissect Tumor Heterogeneity
      Single Cell CNV End-to-End Workflow to Dissect Tumor Heterogeneity
      Tumor heterogeneity is a hallmark of cancer and can have significant impact on identifying drivers, including those that may be therapeutically relevant. Although, the traditional sequencing...
      Speaker: Lee Gibbs, PhD
      Presented at: Precision Medicine Virtual Event Series 2019
      1
      JUN 20, 2019 | 12:00 PM
      NGS Target Enrichment Solutions to Drive Discovery in Precision Medicine Research
      NGS Target Enrichment Solutions to Drive Discovery in Precision...
      The long term goal of our collaborative effort is to bring precision medicine to the practice of veterinary oncology, using the wealth of genomic data gathered in human cancers as a roadmap....
      Speaker: Duane Hassane, PhD , Guannan Wang, PhD
      Presented at: Precision Medicine Virtual Event Series 2019
      Sponsored By: Twist Bioscience
      2
      JUN 20, 2019 | 12:00 PM
      Antiplatelet Agents for Secondary Stroke Prevention - Can We Be More Precise?
      Antiplatelet Agents for Secondary Stroke Prevention - Can We Be...
      Clopidogrel, an antiplatelet agent frequently used for secondary stroke prevention, is a prodrug that requires both sufficient intestinal absorption and hepatic modification to produce its ac...
      Speaker: Karen Albright, DO, PhD, MPH
      Presented at: Precision Medicine Virtual Event Series 2019
      2
      JUN 20, 2019 | 12:00 PM
      Tissue and cfDNA Rare Alleles: How Low Can We Go?
      Tissue and cfDNA Rare Alleles: How Low Can We Go?
      This talk will review successful efforts at Washington University to employ novel reagents and informatics to the problem of rare allele detection. I will discuss a published bakeoff of in si...
      Speaker: Seth Crosby, MD
      Presented at: Precision Medicine Virtual Event Series 2019
      1
      JUN 20, 2019 | 10:30 AM
      Outlier Kinases as Targets for Precision Therapy
      Outlier Kinases as Targets for Precision Therapy
      In this presentation, Dr. Kothari will provide an overview of the Precision Medicine Initiative from NIH and how NGS technologies have helped the researchers to look deep inside the human tra...
      Speaker: Vishal Kothari, PhD
      Presented at: Precision Medicine Virtual Event Series 2019
      1
      JUN 20, 2019 | 10:30 AM
      Beyond the Score: Tools for Pan-Biomarker Analysis and TMB Estimation Enabling Deeper Understanding of Somatic Alterations that Contribute to Cancer Initiation, Progression and Recurrence
      Beyond the Score: Tools for Pan-Biomarker Analysis and TMB Estimation...
      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: Beate Litzenburger, Ph.D. , Raed Samara, PhD
      Presented at: Precision Medicine Virtual Event Series 2019
      Sponsored By: QIAGEN
      1
      JUN 20, 2019 | 10:30 AM
      The Massively Parallel Sequencing (MPS) Revolution
      The Massively Parallel Sequencing (MPS) Revolution
      The development of automated DNA sequencers utilizing Sanger sequencing and capillary electrophoresis made it possible to develop the first draft sequences of the human genome. The cost of do...
      Speaker: David Smith, PhD
      Presented at: Precision Medicine Virtual Event Series 2019
      1
      JUN 20, 2019 | 9:00 AM
      Keynote Presentation: Transforming Drug Discovery with Precision Medicine
      Keynote Presentation: Transforming Drug Discovery with Precision...
      Recent advances in genomic technologies have revealed enormous complexities and uniqueness of human physiology. Although enormous efforts are being made to apply this knowledge to enhance the...
      Speaker: Khyati Shah, PhD
      Presented at: Precision Medicine Virtual Event Series 2019
      1
      JUN 20, 2019 | 9:00 AM
      Precision Medicine & Health in Action: Practicing an N-of-1 Approach in the Clinic
      Precision Medicine & Health in Action: Practicing an N-of-1 Approach...
      The NIH put Precision Medicine on the map as a revolutionary way to manage disease, delivering the right treatment, to the right patient, at the right time. But what does Precision Medicine r...
      Speaker: Florence Comite, MD
      Presented at: Precision Medicine Virtual Event Series 2019
      1
      JUN 20, 2019 | 6:00 AM
      See Further: Expanded Carrier Screening Tools That Take You From Sample to Insight
      See Further: Expanded Carrier Screening Tools That Take You From...
      Inherited disorders affect millions of people globally. These diseases significantly impact lives of patients and their families, and in addition, also results in substantial socio-economic i...
      Speaker: Raed Samara, PhD , Rupert Yip, PhD
      Presented at: Precision Medicine Virtual Event Series 2019
      Sponsored By: QIAGEN
      1
      JUN 20, 2019 | 6:00 AM
      Connecting Genetic and Transcriptional Variation in Acute Myeloid Leukemia at Single-Cell Resolution
      Connecting Genetic and Transcriptional Variation in Acute Myeloid...
      Virtually all tumors are genetically heterogeneous, containing subclonal populations of cells that are defined by distinct mutations. Subclones can have unique phenotypes that influence disea...
      Speaker: Stephen Williams, PhD
      Presented at: Precision Medicine Virtual Event Series 2019
      2
      JUN 19, 2019 | 8:00 AM
      Exploring the genetic landscape of solid tumors using whole-genome copy number analysis
      Exploring the genetic landscape of solid tumors using whole-genome...
      DATE: June 19, 2019TIME: 8:00am PDT, 11:00am EDT Approximately 80% of all cancers are known to be affected by both somatic mutations and copy number changes. Furthermore, r...
      Speaker: Ravindra Kolhe, MD, PhD , Joanna Przybyl, PhD
      Sponsored By: Thermo Fisher Scientific - Applied Biosystems
      4
      MAY 16, 2019 | 4:00 PM
      Towards Standardized Workflows - A focus on microbiome insights
      Towards Standardized Workflows - A focus on microbiome insights
      DATE: May 16, 2019TIME: 7:00am PDT, 10:00am EDT, 4:00pm CEST The emergence of NGS is revolutionizing the microbiological sciences and transforming medicine. Deep sequencing has...
      Speaker: Rita Colwell, PhD , Christiane Honisch, PhD
      Sponsored By: Eppendorf
      10 2
    OCT 10, 2019 | 7:30 AM
    Keynote Presentation: Cancer Prevention for the Practicing Oncologist - Recommendations for Cancer Patients and Their Families
    Keynote Presentation: Cancer Prevention for the Practicing Oncologist...
    The Keynote Address will highlight eight actions that individuals can take to reduce their cancer risk. These recommendations span lifestyle modifications, cancer screening and molecular prev...
    Speaker: Ernest Hawk, MD, MPH
    Presented at: Cancer Research & Oncology Week Virtual Event Series 2019
    1
    OCT 09, 2019 | 10:30 AM
    Newly Diagnosed Ovarian Cancer: Surgical Options
    Newly Diagnosed Ovarian Cancer: Surgical Options
    A subset of women with ovarian cancer will present with an apparently isolated adnexal mass. Many of these women will have early stage ovarian cancer with a relatively good prognosis. Unfortu...
    Speaker: Mitchel Hoffman, MD
    Presented at: Cancer Research & Oncology Week Virtual Event Series 2019
    2
    OCT 09, 2019 | 9:00 AM
    Start at the End: A Strategy for Developing and Delivering Advanced Diagnostic Tests to improve Prostate Cancer Patient Outcomes
    Start at the End: A Strategy for Developing and Delivering Advanced...
    Although about one in every seven men in the developed world will be diagnosed with prostate cancer in their lifetime, the mortality rate remains low with a 99% five-year survival rate for lo...
    Speaker: Stephen Pennington
    Presented at: Cancer Research & Oncology Week Virtual Event Series 2019
    Sponsored By: Agilent
    1
    OCT 09, 2019 | 6:00 AM
    Multilevel Interventions in Cancer Prevention and Control: A Community-Based Translational Research Framework to Address Prostate Cancer Disparities
    Multilevel Interventions in Cancer Prevention and Control: A Community-Based...
    Introduction: Despite the current declines in prostate cancer mortality, African Americans (AA) continue to experience a 60% higher incidence and are twice as likely to die in comparison to m...
    Speaker: Brian Rivers, PhD, MPH
    Presented at: Cancer Research & Oncology Week Virtual Event Series 2019
    2
    SEP 24, 2019 | 8:00 AM
    Interrogating 3D spheroid versus 2D monolayer cell models in drug discovery using cell health microplate assays
    Interrogating 3D spheroid versus 2D monolayer cell models in drug...
    DATE: September 24, 2019TIME: 7:00am PDTHigh throughput screening (HTS) is an effective method for identifying putative active compounds for therapeutics. Assays that evaluate changes i...
    Speaker: Dr. Adyary Fallarero, Ph.D. Adjunct Professor/Docent in Pharmaceutical Biology , Dr. Leticia Montoya, Ph.D., Chemistry and Biochemistry
    Sponsored By: Thermo Fisher Scientific
    9
     
     
  • SEP 19, 2019 | 8:00 AM
    Importance and Role of Biomarkers in the Management of Pediatric Inflammatory Disease
    Importance and Role of Biomarkers in the Management of Pediatric...
    Learning Objectives: Review basic immuno-pathobiology of IBD and the phenotypes of IBD or IBDs - Crohn’s, Ulcerative Colitis and Indeterminate Colitis Briefly describe the epide...
    Speaker: Benjamin Gold, MD, FACG, FAAP
    Sponsored By: Diasorin
    4
    SEP 18, 2019 | 9:00 AM
    Virus Hunters
    Virus Hunters
    DATE: September 18, 2019 TIME: 9:00am PDT, 12:00pm EDTDue to globalization, changes in the environment and climate, and the encroach- ment of humans into natural habitats, recent out...
    Speaker: Michael Berg, PhD
    Sponsored By: Abbott Molecular Diagnostic
    10
    AUG 29, 2019 | 8:00 AM
    Implementation of Helicobacter Pylori Stool Antigen Testing in a Large Metropolitan Center:  A Prospective Comparative Diagnostic Trial
    Implementation of Helicobacter Pylori Stool Antigen Testing in...
    Date: August 27, 2019Time: 11:00am PDT, 2:00pm EDTBackground: Clinical guidelines for H. pylori screening and post-treatment testing endorse the use of urea breath test (UBT), H. py...
    Speaker: Dylan Pillai, MD, PhD, FRCPC (C)
    Presented at: Discover More; Your Virtual Resource
    Sponsored By: Diasorin
    11
    JUN 26, 2019 | 10:00 AM
    Factors to Consider During Adaptation of a Manual Cell Line Development Workflow to Automation
    Factors to Consider During Adaptation of a Manual Cell Line Development...
    DATE: June 26, 2019TIME: 10:00am PDTMammalian cell line generation is a rate-limiting step in early CMC development and there is a constant desire to increase throughput. The implem...
    Speaker: Rob Ballinger
    Sponsored By: Beckman Coulter Life Sciences
    4
    JUN 20, 2019 | 1:30 PM
    Rapid Variant Modeling in a Hospital Setting
    Rapid Variant Modeling in a Hospital Setting
    Implementing precision genomic medicine in the pediatric acute care setting has several challenges. First, the diagnosis must be made quickly. Second, the determination of pathogenicity mus...
    Speaker: Matthew Bainbridge, PhD
    Presented at: Precision Medicine Virtual Event Series 2019
    1
     
     
  • JUN 20, 2019 | 1:30 PM
    Introducing the therascreen FGFR RGQ RT-PCR Kit and Day-One Readiness at Insight Molecular Labs
    Introducing the therascreen FGFR RGQ RT-PCR Kit and Day-One Readiness...
    The practice of precision medicine utilizes advanced diagnostic tools to identify specific groups of patients on the basis of particular molecular characteristics, and guide their treatment w...
    Speaker: David Hout, PhD , Benjamin Chaffey, PhD
    Presented at: Precision Medicine Virtual Event Series 2019
    Sponsored By: QIAGEN
    1
    JUN 20, 2019 | 1:30 PM
    Single Cell CNV End-to-End Workflow to Dissect Tumor Heterogeneity
    Single Cell CNV End-to-End Workflow to Dissect Tumor Heterogeneity
    Tumor heterogeneity is a hallmark of cancer and can have significant impact on identifying drivers, including those that may be therapeutically relevant. Although, the traditional sequencing...
    Speaker: Lee Gibbs, PhD
    Presented at: Precision Medicine Virtual Event Series 2019
    1
    JUN 20, 2019 | 12:00 PM
    NGS Target Enrichment Solutions to Drive Discovery in Precision Medicine Research
    NGS Target Enrichment Solutions to Drive Discovery in Precision...
    The long term goal of our collaborative effort is to bring precision medicine to the practice of veterinary oncology, using the wealth of genomic data gathered in human cancers as a roadmap....
    Speaker: Duane Hassane, PhD , Guannan Wang, PhD
    Presented at: Precision Medicine Virtual Event Series 2019
    Sponsored By: Twist Bioscience
    2
    JUN 20, 2019 | 12:00 PM
    Antiplatelet Agents for Secondary Stroke Prevention - Can We Be More Precise?
    Antiplatelet Agents for Secondary Stroke Prevention - Can We Be...
    Clopidogrel, an antiplatelet agent frequently used for secondary stroke prevention, is a prodrug that requires both sufficient intestinal absorption and hepatic modification to produce its ac...
    Speaker: Karen Albright, DO, PhD, MPH
    Presented at: Precision Medicine Virtual Event Series 2019
    2
    JUN 20, 2019 | 12:00 PM
    Tissue and cfDNA Rare Alleles: How Low Can We Go?
    Tissue and cfDNA Rare Alleles: How Low Can We Go?
    This talk will review successful efforts at Washington University to employ novel reagents and informatics to the problem of rare allele detection. I will discuss a published bakeoff of in si...
    Speaker: Seth Crosby, MD
    Presented at: Precision Medicine Virtual Event Series 2019
    1
     
     
  • JUN 20, 2019 | 10:30 AM
    Outlier Kinases as Targets for Precision Therapy
    Outlier Kinases as Targets for Precision Therapy
    In this presentation, Dr. Kothari will provide an overview of the Precision Medicine Initiative from NIH and how NGS technologies have helped the researchers to look deep inside the human tra...
    Speaker: Vishal Kothari, PhD
    Presented at: Precision Medicine Virtual Event Series 2019
    1
    JUN 20, 2019 | 10:30 AM
    Beyond the Score: Tools for Pan-Biomarker Analysis and TMB Estimation Enabling Deeper Understanding of Somatic Alterations that Contribute to Cancer Initiation, Progression and Recurrence
    Beyond the Score: Tools for Pan-Biomarker Analysis and TMB Estimation...
    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: Beate Litzenburger, Ph.D. , Raed Samara, PhD
    Presented at: Precision Medicine Virtual Event Series 2019
    Sponsored By: QIAGEN
    1
    JUN 20, 2019 | 10:30 AM
    The Massively Parallel Sequencing (MPS) Revolution
    The Massively Parallel Sequencing (MPS) Revolution
    The development of automated DNA sequencers utilizing Sanger sequencing and capillary electrophoresis made it possible to develop the first draft sequences of the human genome. The cost of do...
    Speaker: David Smith, PhD
    Presented at: Precision Medicine Virtual Event Series 2019
    1
    JUN 20, 2019 | 9:00 AM
    Keynote Presentation: Transforming Drug Discovery with Precision Medicine
    Keynote Presentation: Transforming Drug Discovery with Precision...
    Recent advances in genomic technologies have revealed enormous complexities and uniqueness of human physiology. Although enormous efforts are being made to apply this knowledge to enhance the...
    Speaker: Khyati Shah, PhD
    Presented at: Precision Medicine Virtual Event Series 2019
    1
    JUN 20, 2019 | 9:00 AM
    Precision Medicine & Health in Action: Practicing an N-of-1 Approach in the Clinic
    Precision Medicine & Health in Action: Practicing an N-of-1 Approach...
    The NIH put Precision Medicine on the map as a revolutionary way to manage disease, delivering the right treatment, to the right patient, at the right time. But what does Precision Medicine r...
    Speaker: Florence Comite, MD
    Presented at: Precision Medicine Virtual Event Series 2019
    1
     
     
  • JUN 20, 2019 | 6:00 AM
    See Further: Expanded Carrier Screening Tools That Take You From Sample to Insight
    See Further: Expanded Carrier Screening Tools That Take You From...
    Inherited disorders affect millions of people globally. These diseases significantly impact lives of patients and their families, and in addition, also results in substantial socio-economic i...
    Speaker: Raed Samara, PhD , Rupert Yip, PhD
    Presented at: Precision Medicine Virtual Event Series 2019
    Sponsored By: QIAGEN
    1
    JUN 20, 2019 | 6:00 AM
    Connecting Genetic and Transcriptional Variation in Acute Myeloid Leukemia at Single-Cell Resolution
    Connecting Genetic and Transcriptional Variation in Acute Myeloid...
    Virtually all tumors are genetically heterogeneous, containing subclonal populations of cells that are defined by distinct mutations. Subclones can have unique phenotypes that influence disea...
    Speaker: Stephen Williams, PhD
    Presented at: Precision Medicine Virtual Event Series 2019
    2
    JUN 19, 2019 | 8:00 AM
    Exploring the genetic landscape of solid tumors using whole-genome copy number analysis
    Exploring the genetic landscape of solid tumors using whole-genome...
    DATE: June 19, 2019TIME: 8:00am PDT, 11:00am EDT Approximately 80% of all cancers are known to be affected by both somatic mutations and copy number changes. Furthermore, r...
    Speaker: Ravindra Kolhe, MD, PhD , Joanna Przybyl, PhD
    Sponsored By: Thermo Fisher Scientific - Applied Biosystems
    4
    MAY 16, 2019 | 4:00 PM
    Towards Standardized Workflows - A focus on microbiome insights
    Towards Standardized Workflows - A focus on microbiome insights
    DATE: May 16, 2019TIME: 7:00am PDT, 10:00am EDT, 4:00pm CEST The emergence of NGS is revolutionizing the microbiological sciences and transforming medicine. Deep sequencing has...
    Speaker: Rita Colwell, PhD , Christiane Honisch, PhD
    Sponsored By: Eppendorf
    10 2
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