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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

    • FEB 22, 2017 | 6:00 AM
      Mate-pair next generation sequencing as a powerful clinical tool for the characterization of cancer
      Mate-pair next generation sequencing as a powerful clinical tool...
      Recent advances in DNA sequencing have now made it possible to characterize genomes, transcriptomes and even methylomes which is transforming both basic research and clinical practice. Whole...
      Speaker: David Smith, PhD
      Presented at: Precision Medicine Virtual Event Series 2017
      4
      FEB 15, 2017 | 9:00 AM
      Advances in Parathyroid Hormone Testing
      Advances in Parathyroid Hormone Testing
      DATE:  February 15, 2017TIME:  9:00am PT, noon ETParathyroid hormone (PTH) is an 84 amino acid that plays a key role in phosphocalcic metabolism. Its measurement is essential...
      Speaker: Etienne Cavalier, PhD
      Presented at: Discover More; Your Virtual Resource
      Sponsored By: Diasorin
      18 3
      FEB 09, 2017 | 6:00 AM
      Continuous Professional Development (CPD) in Laboratory Animal Science, a continuous improvement in animal welfare and science
      Continuous Professional Development (CPD) in Laboratory Animal...
      DATE: February 9, 2017TIME: 6:00am PT, 9:00am ETThere is no professional area in which CPD is more necessary than in the field of laboratory animals. The continuous advancement of scien...
      Speaker: Patri Vergara, DVM, PhD, DipECLAM
      Presented at: Laboratory Animal Sciences Virtual Event Series 2017
      3
      FEB 08, 2017 | 12:00 PM
      Creating and Maintaining an Effective and Efficient In-Vivo Surgical Training Program
      Creating and Maintaining an Effective and Efficient In-Vivo Surgical...
      DATE: February 8, 2017TIME: 12:00pm PT, 3:00pm ETIn-vivo surgical models are becoming more prevalent and more critical to the drug development process.  As the vast majority of ind...
      Speaker: Matthew Flegal, BS, SRS
      Presented at: Laboratory Animal Sciences Virtual Event Series 2017
      5
      FEB 08, 2017 | 9:00 AM
      Rabbit Breeding: Standards and Practices
      Rabbit Breeding: Standards and Practices
      DATE: February 8, 2017TIME: 9:00am PT, 12:00pm ETThere are many factors involved in rabbit breeding that impact performance.  In this evaluation of a Dutch Belted rabbit breeding c...
      Speaker: Kathryn Cavanaugh
      Presented at: Laboratory Animal Sciences Virtual Event Series 2017
      1
      FEB 08, 2017 | 9:00 AM
      Evaluating the Effectiveness of Training  for Animal Care and Use Personnel
      Evaluating the Effectiveness of Training for Animal Care and...
      DATE: February 8, 2017TIME: 9:00am PT, Noon ETTraining programs for animal care and use personnel are integral to both animal welfare and quality research outcomes. There are a variety...
      Speaker: Melissa Dyson MS, DVM, DACLAM
      Presented at: Laboratory Animal Sciences Virtual Event Series 2017
      2
      FEB 08, 2017 | 6:00 AM
      Impact of Two Formulations of Buprenorphine on Postsurgical Condition in Mice
      Impact of Two Formulations of Buprenorphine on Postsurgical Condition...
      DATE: February 8, 2017TIME: 6:00am PT, 9:00 ETSeveral regulatory bodies require that animals used in biomedical and behavioral research exposed to procedures that may cause more th...
      Speaker: Nicole Herndon, DVM
      Presented at: Laboratory Animal Sciences Virtual Event Series 2017
      7
      JAN 31, 2017 | 9:00 AM
      WEBINAR: Networks of exchanging antibiotic resistance across human commensal, environmental, and pathogenic bacteria
      WEBINAR: Networks of exchanging antibiotic resistance across human...
      DATE: January 31, 2017TIME: 9:00AM PT, 12:00PM ET Gautam Dantas - While the most acute effects of increasing antibiotic resistance in pathogens are observed in clinical se...
      Speaker: Gautam Dantas, PhD , Shuiquan Tang, PhD
      Sponsored By: Zymo Research, Zymo Research
      18 14
      NOV 17, 2016 | 9:00 AM
      From bench to BLA - a review of common regulatory questions
      From bench to BLA - a review of common regulatory questions
      This panel will discuss quality requirements of ancillary materials used in cell therapy manufacturing, relevant standards and how requirements vary by phase.  Participants will learn wh...
      Speaker: Joyce Frey-Vasconcells, PhD , Michael Mendicino, PhD , Kelli Tanzella, PhD
      Presented at: 4th Annual 24 Hours of Stem Cellsâ„¢ virtual event
      3
      NOV 17, 2016 | 5:00 AM
      Partnering to advance regenerative medicine and cellular therapies
      Partnering to advance regenerative medicine and cellular therapies
      The Alliance for Regenerative Medicine (ARM) is the preeminent global advocate for regenerative and advanced therapies. ARM fosters research, development, investment and commercialization of ...
      Speaker: Michael Werner , Morrie Ruffin, PhD
      Presented at: 4th Annual 24 Hours of Stem Cellsâ„¢ virtual event
      4
      NOV 09, 2016 | 8:00 AM
      ProEnkephalin:(PENK).  New Biomarker and Novel Window to Kidney Function: Emerging new data of ProEnkephalin in Clinical Populations
      ProEnkephalin:(PENK). New Biomarker and Novel Window to Kidney...
      DATE:  November 9, 2016 TIME:  8:00am PT, 11:00am ET This talk will characterize the current clinical and laboratory standards for determining risk for chronic renal dysfunction...
      Speaker: Ravindra Mehta, MD , Alan Maisel, M.D. , Olle Melander, MD, PhD
      Sponsored By: Sphingotec LLC, Sphingotec LLC
      3
      NOV 01, 2016 | 8:00 AM
      Development of selection strategies for Homologous Recombination Deficient (HRD) patients utilizing a Liquid Biopsy
      Development of selection strategies for Homologous Recombination...
      DATE: November 1, 2016 TIME: 8:00AM PT, 11:00AM ET Metastatic cancer is an evolving, heterogeneous disease that becomes more complex over time through the selection of sub-clonal tumor po...
      Speaker: Mark Landers
      Sponsored By: Epic Sciences, Epic Sciences , Epic Sciences
      4
      SEP 13, 2016 | 12:30 PM
      Defining Best Practices for Urinalysis Diagnostics in a Value-Based Healthcare System
      Defining Best Practices for Urinalysis Diagnostics in a Value-Based...
      Urinalysis is one the oldest, most established, and most frequently ordered laboratory tests.  However, there is wide variation in the methods, processes, quality checks, specifications,...
      Speaker: Tim Skelton
      Presented at: A Virtual Destination for Laboratory Professionals
      Sponsored By: Cardinal Healthâ„¢ OptiFreight® Logistics, ARKRAY
      7
      SEP 08, 2016 | 7:30 AM
      The Molecular Pathology Perspective of the CDC's Infectious Diseases Pathology Branch
      The Molecular Pathology Perspective of the CDC's Infectious Diseases...
      The Infectious Diseases Pathology Branch of the Centers for Disease Control and Prevention (CDC) routinely receives autopsy and biopsy tissues for diagnostic evaluation. These tissues are typ...
      Speaker: Amy Denison, PhD
      Presented at: Microbiology & Immunology Virtual Event Series 2016
      4
      AUG 30, 2016 | 8:00 AM
      Challenge toward Clinical Trial for Spinal Cord Injury using iPS Cell
      Challenge toward Clinical Trial for Spinal Cord Injury using iPS...
      In our previous preclinical studies, when neural stem progenitor cells (NS/PCs)-derived from hiPSCs were transplanted into mouse or non-human primate spinal cord injury (SCI) models, long-ter...
      Speaker: Hideyuki Okano, MD, PhD
      Presented at: 4th Annual 24 Hours of Stem Cellsâ„¢ virtual event
      1
      AUG 11, 2016 | 11:00 AM
      RNA-ISH for Long non-coding RNAs - new game changers in pathology
      RNA-ISH for Long non-coding RNAs - new game changers in pathology
      DATE: August 11, 2016 TIME: 11:00AM PST, 2:00PM ET, 7:00PM GMT The central dogma that forms the backbone of molecular biology is that DNA codes for RNA (transcription) which then c...
      Speaker: Rohit Mehra, M.D.
      Sponsored By: Advanced Cell Diagnostics, Advanced Cell Diagnostics
      12
      JUL 29, 2016 | 8:00 AM
      NMR-based tools in Clinical Research and Biobanking
      NMR-based tools in Clinical Research and Biobanking
      DATE: July 29, 2016 TIME:  8 AM PST 11 AM ET 5 PM Berlin One of the major benefits of In-Vitro Diagnostic Research (IVDr) by NMR is its reproducibility and transferability, which ena...
      Speaker: Professor Dr. Friedrich Trefz , Dr. Manfred Spraul
      Sponsored By: Bruker Microbiology & Diagnostics, Bruker Microbiology & Diagnostics
      1 2
      JUL 29, 2016 | 1:00 AM
      NMR-based tools in Clinical Research and Biobanking
      NMR-based tools in Clinical Research and Biobanking
      DATE:  July 29th, 2016 TIME:  10am Berlin time, 4pm Beijing time   One of the major benefits of In-Vitro Diagnostic Research (IVDr) by NMR is its reproducibility and trans...
      Speaker: Professor Dr. Friedrich Trefz , Dr. Manfred Spraul
      Sponsored By: Bruker Microbiology & Diagnostics, Bruker Microbiology & Diagnostics
      2
      JUN 10, 2016 | 8:00 AM
      C.E. CREDITS
      Lupus Anticoagulant (LA): Choosing the Right Testing Strategy for Your Laboratory
      Lupus Anticoagulant (LA): Choosing the Right Testing Strategy...
      Update on lupus anticoagulant testing: guidelines, assay selection, drug interference, and clinical cases in antiphospholipid syndrome....
      Speaker: Oksana Volod, MD
      Presented at: Stago EdVantage Virtual University
      Sponsored By: Diagnostica Stago, Inc.
      2
      MAY 17, 2016 | 10:00 AM
      Epstein-Barr Virus Infections: Pay Me Now or Pay Me Later
      Epstein-Barr Virus Infections: Pay Me Now or Pay Me Later
      10:00AM PT – 12:00PM CT – 1:00PM ETInfectious mononucleosis has been recognized as a unique disease for more than 100 years and its cause, Epstein-Barr virus (EBV), was discov...
      Speaker: Henry Balfour, Jr, MD
      Presented at: Discover More; Your Virtual Resource
      Sponsored By: Diasorin
      23 8
      MAY 12, 2016 | 6:00 AM
      The sequencing of 10,000 Human Genomes
      The sequencing of 10,000 Human Genomes
      Technological advances allow for the large scale sequencing of the whole human genome. Most studies have generated population-based information on human diversity using low to intermediate co...
      Speaker: Amalio Telenti MD, PhD
      Presented at: Genetics and Genomics Virtual Event Series 2016
      2
      MAY 11, 2016 | 3:00 PM
      Genomics in the Clinic - Medical Ethics and Policy
      Genomics in the Clinic - Medical Ethics and Policy
      It is estimated that by the end of this year more than 1 million people worldwide will have had their genome sequenced. Genomic sequencing is increasingly being integrated into clinical care,...
      Speaker: Amy McGuire, JD, PhD
      Presented at: Genetics and Genomics Virtual Event Series 2016
      4
      MAY 11, 2016 | 1:30 PM
      C.E. CREDITS
      Microfluidic Single Cell Exome-seq and RNA-seq analysis of Tumor Composition
      Microfluidic Single Cell Exome-seq and RNA-seq analysis of Tumor...
      Human breast tumors have been shown to exhibit extensive inter- and intra-tumor heterogeneity. While recent advances in genomic technologies have allowed us to deconvolute this heterogeneity,...
      Speaker: Ioannis (Jiannis) Ragoussis, PhD
      Presented at: Genetics and Genomics Virtual Event Series 2016
      3
      MAY 11, 2016 | 12:00 PM
      C.E. CREDITS
      The FDA's experience with emerging genomics technologies - past, present and future
      The FDA's experience with emerging genomics technologies - past,...
      Emerging technologies facilitate basic science research, but their value in regulatory applications requires rigorous assessment and consensus within the research community. Next-generation s...
      Speaker: Weida Tong, PhD
      Presented at: Genetics and Genomics Virtual Event Series 2016
      2
    FEB 22, 2017 | 6:00 AM
    Mate-pair next generation sequencing as a powerful clinical tool for the characterization of cancer
    Mate-pair next generation sequencing as a powerful clinical tool...
    Recent advances in DNA sequencing have now made it possible to characterize genomes, transcriptomes and even methylomes which is transforming both basic research and clinical practice. Whole...
    Speaker: David Smith, PhD
    Presented at: Precision Medicine Virtual Event Series 2017
    4
    FEB 15, 2017 | 9:00 AM
    Advances in Parathyroid Hormone Testing
    Advances in Parathyroid Hormone Testing
    DATE:  February 15, 2017TIME:  9:00am PT, noon ETParathyroid hormone (PTH) is an 84 amino acid that plays a key role in phosphocalcic metabolism. Its measurement is essential...
    Speaker: Etienne Cavalier, PhD
    Presented at: Discover More; Your Virtual Resource
    Sponsored By: Diasorin
    18 3
    FEB 09, 2017 | 6:00 AM
    Continuous Professional Development (CPD) in Laboratory Animal Science, a continuous improvement in animal welfare and science
    Continuous Professional Development (CPD) in Laboratory Animal...
    DATE: February 9, 2017TIME: 6:00am PT, 9:00am ETThere is no professional area in which CPD is more necessary than in the field of laboratory animals. The continuous advancement of scien...
    Speaker: Patri Vergara, DVM, PhD, DipECLAM
    Presented at: Laboratory Animal Sciences Virtual Event Series 2017
    3
    FEB 08, 2017 | 12:00 PM
    Creating and Maintaining an Effective and Efficient In-Vivo Surgical Training Program
    Creating and Maintaining an Effective and Efficient In-Vivo Surgical...
    DATE: February 8, 2017TIME: 12:00pm PT, 3:00pm ETIn-vivo surgical models are becoming more prevalent and more critical to the drug development process.  As the vast majority of ind...
    Speaker: Matthew Flegal, BS, SRS
    Presented at: Laboratory Animal Sciences Virtual Event Series 2017
    5
    FEB 08, 2017 | 9:00 AM
    Rabbit Breeding: Standards and Practices
    Rabbit Breeding: Standards and Practices
    DATE: February 8, 2017TIME: 9:00am PT, 12:00pm ETThere are many factors involved in rabbit breeding that impact performance.  In this evaluation of a Dutch Belted rabbit breeding c...
    Speaker: Kathryn Cavanaugh
    Presented at: Laboratory Animal Sciences Virtual Event Series 2017
    1
     
     
  • FEB 08, 2017 | 9:00 AM
    Evaluating the Effectiveness of Training  for Animal Care and Use Personnel
    Evaluating the Effectiveness of Training for Animal Care and...
    DATE: February 8, 2017TIME: 9:00am PT, Noon ETTraining programs for animal care and use personnel are integral to both animal welfare and quality research outcomes. There are a variety...
    Speaker: Melissa Dyson MS, DVM, DACLAM
    Presented at: Laboratory Animal Sciences Virtual Event Series 2017
    2
    FEB 08, 2017 | 6:00 AM
    Impact of Two Formulations of Buprenorphine on Postsurgical Condition in Mice
    Impact of Two Formulations of Buprenorphine on Postsurgical Condition...
    DATE: February 8, 2017TIME: 6:00am PT, 9:00 ETSeveral regulatory bodies require that animals used in biomedical and behavioral research exposed to procedures that may cause more th...
    Speaker: Nicole Herndon, DVM
    Presented at: Laboratory Animal Sciences Virtual Event Series 2017
    7
    JAN 31, 2017 | 9:00 AM
    WEBINAR: Networks of exchanging antibiotic resistance across human commensal, environmental, and pathogenic bacteria
    WEBINAR: Networks of exchanging antibiotic resistance across human...
    DATE: January 31, 2017TIME: 9:00AM PT, 12:00PM ET Gautam Dantas - While the most acute effects of increasing antibiotic resistance in pathogens are observed in clinical se...
    Speaker: Gautam Dantas, PhD , Shuiquan Tang, PhD
    Sponsored By: Zymo Research, Zymo Research
    18 14
    NOV 17, 2016 | 9:00 AM
    From bench to BLA - a review of common regulatory questions
    From bench to BLA - a review of common regulatory questions
    This panel will discuss quality requirements of ancillary materials used in cell therapy manufacturing, relevant standards and how requirements vary by phase.  Participants will learn wh...
    Speaker: Joyce Frey-Vasconcells, PhD , Michael Mendicino, PhD , Kelli Tanzella, PhD
    Presented at: 4th Annual 24 Hours of Stem Cellsâ„¢ virtual event
    3
    NOV 17, 2016 | 5:00 AM
    Partnering to advance regenerative medicine and cellular therapies
    Partnering to advance regenerative medicine and cellular therapies
    The Alliance for Regenerative Medicine (ARM) is the preeminent global advocate for regenerative and advanced therapies. ARM fosters research, development, investment and commercialization of ...
    Speaker: Michael Werner , Morrie Ruffin, PhD
    Presented at: 4th Annual 24 Hours of Stem Cellsâ„¢ virtual event
    4
     
     
  • NOV 09, 2016 | 8:00 AM
    ProEnkephalin:(PENK).  New Biomarker and Novel Window to Kidney Function: Emerging new data of ProEnkephalin in Clinical Populations
    ProEnkephalin:(PENK). New Biomarker and Novel Window to Kidney...
    DATE:  November 9, 2016 TIME:  8:00am PT, 11:00am ET This talk will characterize the current clinical and laboratory standards for determining risk for chronic renal dysfunction...
    Speaker: Ravindra Mehta, MD , Alan Maisel, M.D. , Olle Melander, MD, PhD
    Sponsored By: Sphingotec LLC, Sphingotec LLC
    3
    NOV 01, 2016 | 8:00 AM
    Development of selection strategies for Homologous Recombination Deficient (HRD) patients utilizing a Liquid Biopsy
    Development of selection strategies for Homologous Recombination...
    DATE: November 1, 2016 TIME: 8:00AM PT, 11:00AM ET Metastatic cancer is an evolving, heterogeneous disease that becomes more complex over time through the selection of sub-clonal tumor po...
    Speaker: Mark Landers
    Sponsored By: Epic Sciences, Epic Sciences , Epic Sciences
    4
    SEP 13, 2016 | 12:30 PM
    Defining Best Practices for Urinalysis Diagnostics in a Value-Based Healthcare System
    Defining Best Practices for Urinalysis Diagnostics in a Value-Based...
    Urinalysis is one the oldest, most established, and most frequently ordered laboratory tests.  However, there is wide variation in the methods, processes, quality checks, specifications,...
    Speaker: Tim Skelton
    Presented at: A Virtual Destination for Laboratory Professionals
    Sponsored By: Cardinal Healthâ„¢ OptiFreight® Logistics, ARKRAY
    7
    SEP 08, 2016 | 7:30 AM
    The Molecular Pathology Perspective of the CDC's Infectious Diseases Pathology Branch
    The Molecular Pathology Perspective of the CDC's Infectious Diseases...
    The Infectious Diseases Pathology Branch of the Centers for Disease Control and Prevention (CDC) routinely receives autopsy and biopsy tissues for diagnostic evaluation. These tissues are typ...
    Speaker: Amy Denison, PhD
    Presented at: Microbiology & Immunology Virtual Event Series 2016
    4
    AUG 30, 2016 | 8:00 AM
    Challenge toward Clinical Trial for Spinal Cord Injury using iPS Cell
    Challenge toward Clinical Trial for Spinal Cord Injury using iPS...
    In our previous preclinical studies, when neural stem progenitor cells (NS/PCs)-derived from hiPSCs were transplanted into mouse or non-human primate spinal cord injury (SCI) models, long-ter...
    Speaker: Hideyuki Okano, MD, PhD
    Presented at: 4th Annual 24 Hours of Stem Cellsâ„¢ virtual event
    1
     
     
  • AUG 11, 2016 | 11:00 AM
    RNA-ISH for Long non-coding RNAs - new game changers in pathology
    RNA-ISH for Long non-coding RNAs - new game changers in pathology
    DATE: August 11, 2016 TIME: 11:00AM PST, 2:00PM ET, 7:00PM GMT The central dogma that forms the backbone of molecular biology is that DNA codes for RNA (transcription) which then c...
    Speaker: Rohit Mehra, M.D.
    Sponsored By: Advanced Cell Diagnostics, Advanced Cell Diagnostics
    12
    JUL 29, 2016 | 8:00 AM
    NMR-based tools in Clinical Research and Biobanking
    NMR-based tools in Clinical Research and Biobanking
    DATE: July 29, 2016 TIME:  8 AM PST 11 AM ET 5 PM Berlin One of the major benefits of In-Vitro Diagnostic Research (IVDr) by NMR is its reproducibility and transferability, which ena...
    Speaker: Professor Dr. Friedrich Trefz , Dr. Manfred Spraul
    Sponsored By: Bruker Microbiology & Diagnostics, Bruker Microbiology & Diagnostics
    1 2
    JUL 29, 2016 | 1:00 AM
    NMR-based tools in Clinical Research and Biobanking
    NMR-based tools in Clinical Research and Biobanking
    DATE:  July 29th, 2016 TIME:  10am Berlin time, 4pm Beijing time   One of the major benefits of In-Vitro Diagnostic Research (IVDr) by NMR is its reproducibility and trans...
    Speaker: Professor Dr. Friedrich Trefz , Dr. Manfred Spraul
    Sponsored By: Bruker Microbiology & Diagnostics, Bruker Microbiology & Diagnostics
    2
    JUN 10, 2016 | 8:00 AM
    C.E. CREDITS
    Lupus Anticoagulant (LA): Choosing the Right Testing Strategy for Your Laboratory
    Lupus Anticoagulant (LA): Choosing the Right Testing Strategy...
    Update on lupus anticoagulant testing: guidelines, assay selection, drug interference, and clinical cases in antiphospholipid syndrome....
    Speaker: Oksana Volod, MD
    Presented at: Stago EdVantage Virtual University
    Sponsored By: Diagnostica Stago, Inc.
    2
    MAY 17, 2016 | 10:00 AM
    Epstein-Barr Virus Infections: Pay Me Now or Pay Me Later
    Epstein-Barr Virus Infections: Pay Me Now or Pay Me Later
    10:00AM PT – 12:00PM CT – 1:00PM ETInfectious mononucleosis has been recognized as a unique disease for more than 100 years and its cause, Epstein-Barr virus (EBV), was discov...
    Speaker: Henry Balfour, Jr, MD
    Presented at: Discover More; Your Virtual Resource
    Sponsored By: Diasorin
    23 8
     
     
  • MAY 12, 2016 | 6:00 AM
    The sequencing of 10,000 Human Genomes
    The sequencing of 10,000 Human Genomes
    Technological advances allow for the large scale sequencing of the whole human genome. Most studies have generated population-based information on human diversity using low to intermediate co...
    Speaker: Amalio Telenti MD, PhD
    Presented at: Genetics and Genomics Virtual Event Series 2016
    2
    MAY 11, 2016 | 3:00 PM
    Genomics in the Clinic - Medical Ethics and Policy
    Genomics in the Clinic - Medical Ethics and Policy
    It is estimated that by the end of this year more than 1 million people worldwide will have had their genome sequenced. Genomic sequencing is increasingly being integrated into clinical care,...
    Speaker: Amy McGuire, JD, PhD
    Presented at: Genetics and Genomics Virtual Event Series 2016
    4
    MAY 11, 2016 | 1:30 PM
    C.E. CREDITS
    Microfluidic Single Cell Exome-seq and RNA-seq analysis of Tumor Composition
    Microfluidic Single Cell Exome-seq and RNA-seq analysis of Tumor...
    Human breast tumors have been shown to exhibit extensive inter- and intra-tumor heterogeneity. While recent advances in genomic technologies have allowed us to deconvolute this heterogeneity,...
    Speaker: Ioannis (Jiannis) Ragoussis, PhD
    Presented at: Genetics and Genomics Virtual Event Series 2016
    3
    MAY 11, 2016 | 12:00 PM
    C.E. CREDITS
    The FDA's experience with emerging genomics technologies - past, present and future
    The FDA's experience with emerging genomics technologies - past,...
    Emerging technologies facilitate basic science research, but their value in regulatory applications requires rigorous assessment and consensus within the research community. Next-generation s...
    Speaker: Weida Tong, PhD
    Presented at: Genetics and Genomics Virtual Event Series 2016
    2
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