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  • Clinical Research Insights

    All Clinical Research Articles
    • Read: Phase 1 Clinical Trial Designs Explained: BOIN, CRM, BLRM & Modern Adaptive Strategies Phase 1 Clinical Trial Designs Explained: BOIN, CRM, BLRM & Modern Adaptive Strategies

      Clinical Trials

      Phase 1 Clinical Trial Designs Explained: BOIN, CRM, BLRM & Modern Adaptive Strategies

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1709645745122, hs_published_at=1748379090824, description=Kurt Preugschat has over 11 years of statistical experience from Phase I to Phase IV clinical trials. He is a lead statistician, providing statistical support and oversight for numerous clinical trials associated with new drug applications (NDA), supplemental new drug applications (sNDA), and medical devices. His expertise includes the development of study designs to meet complex clinical questions and the measurement of desired outcomes. In addition, Kurt has extensive experience generating statistical analyses and creating complex SAS programs and macros used by study team., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/kurt-preugschat.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/kurt-preugschat-97298923a, hs_name=, hs_path=, lastname=Preugschat, hs_initial_published_at=1716136551646, hs_created_at=1709645745122, hs_is_edited=false, hs_deleted_at=0, name=Kurt, job=, slug=kurt-preugschat, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
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    • Read: Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM) Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM)

      Clinical Trials

      Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM)

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1709645745122, hs_published_at=1748379090824, description=Kurt Preugschat has over 11 years of statistical experience from Phase I to Phase IV clinical trials. He is a lead statistician, providing statistical support and oversight for numerous clinical trials associated with new drug applications (NDA), supplemental new drug applications (sNDA), and medical devices. His expertise includes the development of study designs to meet complex clinical questions and the measurement of desired outcomes. In addition, Kurt has extensive experience generating statistical analyses and creating complex SAS programs and macros used by study team., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/kurt-preugschat.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/kurt-preugschat-97298923a, hs_name=, hs_path=, lastname=Preugschat, hs_initial_published_at=1716136551646, hs_created_at=1709645745122, hs_is_edited=false, hs_deleted_at=0, name=Kurt, job=, slug=kurt-preugschat, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
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    • Read: Phase I Clinical Trial Designs: Bayesian Logistic Regression Model (BLRM) Phase I Clinical Trial Designs: Bayesian Logistic Regression Model (BLRM)

      Clinical Trials

      Phase I Clinical Trial Designs: Bayesian Logistic Regression Model (BLRM)

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1709645745122, hs_published_at=1748379090824, description=Kurt Preugschat has over 11 years of statistical experience from Phase I to Phase IV clinical trials. He is a lead statistician, providing statistical support and oversight for numerous clinical trials associated with new drug applications (NDA), supplemental new drug applications (sNDA), and medical devices. His expertise includes the development of study designs to meet complex clinical questions and the measurement of desired outcomes. In addition, Kurt has extensive experience generating statistical analyses and creating complex SAS programs and macros used by study team., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/kurt-preugschat.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/kurt-preugschat-97298923a, hs_name=, hs_path=, lastname=Preugschat, hs_initial_published_at=1716136551646, hs_created_at=1709645745122, hs_is_edited=false, hs_deleted_at=0, name=Kurt, job=, slug=kurt-preugschat, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
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  • Translational Research Insights

    All Translational Research Articles
    • Read: Key Strategies for Future-Proofing Gene Therapy Assays Key Strategies for Future-Proofing Gene Therapy Assays

      Translational Research - Regulatory - Assays - Gene Therapies

      Key Strategies for Future-Proofing Gene Therapy Assays

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1748379090824, description=Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Deb%20Phippard.webp',altText='Deb Phippard',fileId=165892372605}, linkedin=https://www.linkedin.com/in/deb-phippard-103b54, team=[{id=163072475007, name='Precision for Medicine Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716212769184, hs_created_at=1709645745106, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job= Chief Scientific Officer, slug=deborah-phippard, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778889, hs_child_table_id=0, hs_updated_at=1714461111815, hs_published_at=1748379090824, description=Travis Harrison, PhD, is Vice President of Diagnostic Development at Precision for Medicine. He brings more than 20 years of bioanalytical assay experience to the Precision team with expertise in ligand-binding and cell-based assays.  Travis has experience supporting clinical and nonclinical studies for a broad range of indications, with an emphasis on diagnostic assays to evaluate immune responses to gene therapies., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Travis%20Harrison.webp',altText='Travis Harrison',fileId=165893006481}, linkedin=https://www.linkedin.com/in/travis-harrison-phd-6108852/, hs_name=, hs_path=, lastname=Harrison, hs_initial_published_at=1716212769184, hs_created_at=1709645745120, hs_is_edited=false, hs_deleted_at=0, name=Travis, job=, slug=travis-harrison, email=, hs_updated_by_user_id=51739740}, third={}})
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    • Read: Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

      Translational Research - Regulatory - Assays - Gene Therapies

      Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1748379090824, description=Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Deb%20Phippard.webp',altText='Deb Phippard',fileId=165892372605}, linkedin=https://www.linkedin.com/in/deb-phippard-103b54, team=[{id=163072475007, name='Precision for Medicine Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716212769184, hs_created_at=1709645745106, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job= Chief Scientific Officer, slug=deborah-phippard, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778840, hs_child_table_id=0, hs_updated_at=1716132440837, hs_published_at=1748379090824, description=Maham Ansari, MS, RAC is a Senior Director, IVD Regulatory Affairs. Her focus is on companion diagnostic co-development programs, where she leverages her regulatory expertise to secure approvals in the US, Europe and beyond for companion diagnostics with a specific focus on gene therapy. She brings more than 16 years of global regulatory leadership experience in the medical device and in vitro diagnostics industry, spanning major multinationals to small start-ups, including full life cycle management across all stages of product development, execution of global regulatory strategies, and post-market surveillance.sh, avatar=Image{width=710,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Maham_Ansari.png',altText='Maham_Ansari',fileId=167373022876}, linkedin=https://www.linkedin.com/in/maham-ansari-ms-rac-6a735739, hs_name=, hs_path=, lastname=Ansari, hs_initial_published_at=1716212769184, hs_created_at=1709645745071, hs_is_edited=false, hs_deleted_at=0, name=Maham, job=, slug=maham-ansari, email=, hs_updated_by_user_id=51739740}, third={}})
      • Deborah P. avatar

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    • Read: Optimizing Immunohistochemistry Validation and Regulatory Strategies Optimizing Immunohistochemistry Validation and Regulatory Strategies

      Translational Research - Biomarkers - Assays

      Optimizing Immunohistochemistry Validation and Regulatory Strategies

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1714461729999, hs_published_at=1748379090824, description=Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Kennon%20Daniels.webp',altText='Kennon Daniels',fileId=165893120790}, linkedin=https://www.linkedin.com/in/kennon-daniels-ph-d-84a90b6, hs_name=, hs_path=, lastname=Daniels, hs_initial_published_at=1716212769184, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=51739740}, second={hs_id=182710436924, hs_child_table_id=0, hs_updated_at=1731419754428, hs_published_at=1748379090824, description=Christie Bongel, MS, CT(ASCP), brings nearly two decades of experience in both research and clinical medicine. As the site director for Precision for Medicine’s IHC Center of Excellence in North Carolina, she excels in managing scientific operations and collaborating with clients. Christie is skilled in cytology, laboratory medicine, and molecular diagnostics. Her role focuses on building an energized team dedicated to delivering life-changing outcomes for patients. Christie earned her MS in Applied Biotechnology and is an ASCP certified cytotechnologist., avatar=Image{width=260,height=260,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Christie%20Bongel_Square_260px.jpg',altText='Christie Bongel_Square_260px',fileId=178044303113}, lastname= Bongel, hs_initial_published_at=1731517828480, hs_created_by_user_id=28386183, hs_created_at=1731419696820, hs_is_edited=false, hs_deleted_at=0, name=Christie, job=Site Director - Histology, slug=christie-bongel, hs_updated_by_user_id=51739740}, third={}})
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All articles

  • Read: Key Strategies for Future-Proofing Gene Therapy Assays Key Strategies for Future-Proofing Gene Therapy Assays

    Translational Research - Regulatory - Assays - Gene Therapies

    Key Strategies for Future-Proofing Gene Therapy Assays

    |
      has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1748379090824, description=Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Deb%20Phippard.webp',altText='Deb Phippard',fileId=165892372605}, linkedin=https://www.linkedin.com/in/deb-phippard-103b54, team=[{id=163072475007, name='Precision for Medicine Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716212769184, hs_created_at=1709645745106, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job= Chief Scientific Officer, slug=deborah-phippard, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778889, hs_child_table_id=0, hs_updated_at=1714461111815, hs_published_at=1748379090824, description=Travis Harrison, PhD, is Vice President of Diagnostic Development at Precision for Medicine. He brings more than 20 years of bioanalytical assay experience to the Precision team with expertise in ligand-binding and cell-based assays.  Travis has experience supporting clinical and nonclinical studies for a broad range of indications, with an emphasis on diagnostic assays to evaluate immune responses to gene therapies., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Travis%20Harrison.webp',altText='Travis Harrison',fileId=165893006481}, linkedin=https://www.linkedin.com/in/travis-harrison-phd-6108852/, hs_name=, hs_path=, lastname=Harrison, hs_initial_published_at=1716212769184, hs_created_at=1709645745120, hs_is_edited=false, hs_deleted_at=0, name=Travis, job=, slug=travis-harrison, email=, hs_updated_by_user_id=51739740}, third={}})
    • Deborah P. avatar

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  • Read: Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

    Translational Research - Regulatory - Assays - Gene Therapies

    Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1748379090824, description=Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Deb%20Phippard.webp',altText='Deb Phippard',fileId=165892372605}, linkedin=https://www.linkedin.com/in/deb-phippard-103b54, team=[{id=163072475007, name='Precision for Medicine Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716212769184, hs_created_at=1709645745106, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job= Chief Scientific Officer, slug=deborah-phippard, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778840, hs_child_table_id=0, hs_updated_at=1716132440837, hs_published_at=1748379090824, description=Maham Ansari, MS, RAC is a Senior Director, IVD Regulatory Affairs. Her focus is on companion diagnostic co-development programs, where she leverages her regulatory expertise to secure approvals in the US, Europe and beyond for companion diagnostics with a specific focus on gene therapy. She brings more than 16 years of global regulatory leadership experience in the medical device and in vitro diagnostics industry, spanning major multinationals to small start-ups, including full life cycle management across all stages of product development, execution of global regulatory strategies, and post-market surveillance.sh, avatar=Image{width=710,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Maham_Ansari.png',altText='Maham_Ansari',fileId=167373022876}, linkedin=https://www.linkedin.com/in/maham-ansari-ms-rac-6a735739, hs_name=, hs_path=, lastname=Ansari, hs_initial_published_at=1716212769184, hs_created_at=1709645745071, hs_is_edited=false, hs_deleted_at=0, name=Maham, job=, slug=maham-ansari, email=, hs_updated_by_user_id=51739740}, third={}})
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  • Read: 8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy

    Translational Research - Gene Therapies

    8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy

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      has third author: false, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1748379090824, description=Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Deb%20Phippard.webp',altText='Deb Phippard',fileId=165892372605}, linkedin=https://www.linkedin.com/in/deb-phippard-103b54, team=[{id=163072475007, name='Precision for Medicine Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716212769184, hs_created_at=1709645745106, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job= Chief Scientific Officer, slug=deborah-phippard, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1714461729999, hs_published_at=1748379090824, description=Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Kennon%20Daniels.webp',altText='Kennon Daniels',fileId=165893120790}, linkedin=https://www.linkedin.com/in/kennon-daniels-ph-d-84a90b6, hs_name=, hs_path=, lastname=Daniels, hs_initial_published_at=1716212769184, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=51739740}, third={hs_id=159488778889, hs_child_table_id=0, hs_updated_at=1714461111815, hs_published_at=1748379090824, description=Travis Harrison, PhD, is Vice President of Diagnostic Development at Precision for Medicine. He brings more than 20 years of bioanalytical assay experience to the Precision team with expertise in ligand-binding and cell-based assays.  Travis has experience supporting clinical and nonclinical studies for a broad range of indications, with an emphasis on diagnostic assays to evaluate immune responses to gene therapies., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Travis%20Harrison.webp',altText='Travis Harrison',fileId=165893006481}, linkedin=https://www.linkedin.com/in/travis-harrison-phd-6108852/, hs_name=, hs_path=, lastname=Harrison, hs_initial_published_at=1716212769184, hs_created_at=1709645745120, hs_is_edited=false, hs_deleted_at=0, name=Travis, job=, slug=travis-harrison, email=, hs_updated_by_user_id=51739740}})
    • Deborah P. avatar Kennon D. avatar Travis H. avatar
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  • Read: Advancing Clinical Development of Immuno-modulatory Therapies with Flow Cytometry-Based Receptor Occupancy Assays Advancing Clinical Development of Immuno-modulatory Therapies with Flow Cytometry-Based Receptor Occupancy Assays

    Translational Research

    Advancing Clinical Development of Immuno-modulatory Therapies with Flow Cytometry-Based Receptor Occupancy Assays

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1748379090824, description=Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Deb%20Phippard.webp',altText='Deb Phippard',fileId=165892372605}, linkedin=https://www.linkedin.com/in/deb-phippard-103b54, team=[{id=163072475007, name='Precision for Medicine Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716212769184, hs_created_at=1709645745106, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job= Chief Scientific Officer, slug=deborah-phippard, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778877, hs_child_table_id=0, hs_updated_at=1714461706779, hs_published_at=1748379090824, description=Dr. Laura Lozza is Senior Director for Cell Biology at Precision for Medicine. She has long-standing expertise in immune monitoring and immune assay development with a particular focus on flow cytometry assays. Her focused on human immunology, including characterizing the regulatory activities of CD4 T cells, as well as analyzing the response of human dendritic cells in tuberculosis disease and BCG vaccination. She was a leader in establishing Precision’s Cell Biology Lab in Berlin which supports assay development and validation utilizing flow cytometry as well as other cell biology technologies., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Laura%20Lozza.webp',altText='Laura Lozza',fileId=165892782092}, linkedin=https://www.linkedin.com/in/laura-lozza, hs_name=, hs_path=, lastname=Lozza, hs_initial_published_at=1716212769184, hs_created_at=1709645745108, hs_is_edited=false, hs_deleted_at=0, name=Laura, job=, slug=laura-lozza, email=, hs_updated_by_user_id=51739740}, third={}})
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