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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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        Kurt Preugschat

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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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        Kurt Preugschat

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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={}})
      • Deborah P. avatar

        Deborah P.

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        Travis H.

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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

        Deborah P.

      • Maham A. avatar

        Maham A.

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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={}})
      • Kennon D. avatar

        Kennon D.

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All articles

  • Read: How To Calculate Viral Vector Yields - A Critical Component Of The 'Make vs Buy' Analysis How To Calculate Viral Vector Yields - A Critical Component Of The 'Make vs Buy' Analysis

    Manufacturing - Cell Therapies - Gene Therapies

    How To Calculate Viral Vector Yields - A Critical Component Of The 'Make vs Buy' Analysis

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546553, hs_child_table_id=0, hs_updated_at=1716454239819, hs_published_at=1748379090824, description=Life sciences leader who helped pioneer the industrialization of biologics and advanced therapies. Deep expertise in small and large molecules, honed through work with a range of life science organizations, from start-ups and academic centers to financial institutions and CMOs/CROs. Spearheaded significant global turnkey facility builds, automation, validation, engineering, and serialization track and trace, deploying billions in capital across the life sciences sector. Led the creation of the Advanced Therapy Manufacturing Playbook which has helped develop the world’s largest advanced therapy manufacturing footprint. Actively serves on multiple boards including academic, philanthropic, biotech, and financial investment institutions., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Tony%20Khoury.webp',altText='Tony Khoury',fileId=165893018152}, linkedin=https://www.linkedin.com/in/tony-khoury-7470755/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Khoury, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713169549303, hs_is_edited=false, hs_deleted_at=0, name=Tony, job=Executive Vice President, Manufacturing Solutions, slug=tony-khoury, hs_updated_by_user_id=51739740}, second={hs_id=165403836680, hs_child_table_id=0, hs_updated_at=1716326428569, hs_published_at=1748379090824, avatar=Image{width=572,height=680,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Christian-Hermanas.png',altText='Christian-Hermanas',fileId=167581705333}, linkedin=https://www.linkedin.com/in/christianhermanas/, lastname=Hermanas, hs_initial_published_at=1713967130374, hs_created_by_user_id=62155952, hs_created_at=1713965852214, hs_is_edited=false, hs_deleted_at=0, name=Christian, job=Sr. Manager, Precision for Medicine Manufacturing Solutions, slug=christian-hermanas, hs_updated_by_user_id=51739740}, third={}})
    • Tony K. avatar

      Tony K.

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      Christian H.

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  • Read: Dos And Don'ts Of Virtual Factory Acceptance Testing In Life Sciences Dos And Don'ts Of Virtual Factory Acceptance Testing In Life Sciences

    Manufacturing - Cell Therapies - Gene Therapies

    Dos And Don'ts Of Virtual Factory Acceptance Testing In Life Sciences

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      has third author: false, (SizeLimitingPyMap: {main={hs_id=164426546553, hs_child_table_id=0, hs_updated_at=1716454239819, hs_published_at=1748379090824, description=Life sciences leader who helped pioneer the industrialization of biologics and advanced therapies. Deep expertise in small and large molecules, honed through work with a range of life science organizations, from start-ups and academic centers to financial institutions and CMOs/CROs. Spearheaded significant global turnkey facility builds, automation, validation, engineering, and serialization track and trace, deploying billions in capital across the life sciences sector. Led the creation of the Advanced Therapy Manufacturing Playbook which has helped develop the world’s largest advanced therapy manufacturing footprint. Actively serves on multiple boards including academic, philanthropic, biotech, and financial investment institutions., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Tony%20Khoury.webp',altText='Tony Khoury',fileId=165893018152}, linkedin=https://www.linkedin.com/in/tony-khoury-7470755/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Khoury, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713169549303, hs_is_edited=false, hs_deleted_at=0, name=Tony, job=Executive Vice President, Manufacturing Solutions, slug=tony-khoury, hs_updated_by_user_id=51739740}, second={hs_id=164426546589, hs_child_table_id=0, hs_updated_at=1716326136263, hs_published_at=1748379090824, description=Respected technical and quality advisor to both start-ups and established pharmaceutical companies for CMO/CDMO operational readiness capabilities. Subject matter expert in designing, implementing, and maintaining cGMP facilities. Has led multiple capital projects for partners in the advanced therapies and biologics spaces., avatar=Image{width=720,height=812,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Daniel-Foody.png',altText='Daniel-Foody',fileId=167370294648}, linkedin=https://www.linkedin.com/in/danny-foody/, team=[{id=163080551774, name='Manufacturing Solutions Leadership'}], lastname=Foody, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713170108117, hs_is_edited=false, hs_deleted_at=0, name=Danny, job=Director, slug=danny-foody, hs_updated_by_user_id=51739740}, third={hs_id=164426546583, hs_child_table_id=0, hs_updated_at=1734630588121, hs_published_at=1748379090824, description=Trusted life sciences authority leading integrated teams in biologics, blood therapies and next generation medicines. Spearheads task forces focused on technical strategy and execution related to compliant pre-clinical, clinical, and commercial manufacturing. Directs agile teams across a range of functional areas spanning project management, facilities, infrastructure, process equipment, manufacturing operations, and quality projects., avatar=Image{width=668,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Phillip-Massey1.png',altText='Phillip-Massey1',fileId=167374597237}, linkedin=https://www.linkedin.com/in/phillip-massey-22baa257/, team=[{id=163080551774, name='Manufacturing Solutions Leadership'}], lastname=Massey, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713169955307, hs_is_edited=false, hs_deleted_at=0, name=Phil, job=Vice President, slug=phil-massey, hs_updated_by_user_id=51739740}})
    • Tony K. avatar Danny F. avatar Phil M. avatar
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  • Read: Best Practices for CDMO Evaluation, Selection, and Management Best Practices for CDMO Evaluation, Selection, and Management

    Manufacturing - Cell Therapies - Gene Therapies

    Best Practices for CDMO Evaluation, Selection, and Management

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546553, hs_child_table_id=0, hs_updated_at=1716454239819, hs_published_at=1748379090824, description=Life sciences leader who helped pioneer the industrialization of biologics and advanced therapies. Deep expertise in small and large molecules, honed through work with a range of life science organizations, from start-ups and academic centers to financial institutions and CMOs/CROs. Spearheaded significant global turnkey facility builds, automation, validation, engineering, and serialization track and trace, deploying billions in capital across the life sciences sector. Led the creation of the Advanced Therapy Manufacturing Playbook which has helped develop the world’s largest advanced therapy manufacturing footprint. Actively serves on multiple boards including academic, philanthropic, biotech, and financial investment institutions., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Tony%20Khoury.webp',altText='Tony Khoury',fileId=165893018152}, linkedin=https://www.linkedin.com/in/tony-khoury-7470755/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Khoury, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713169549303, hs_is_edited=false, hs_deleted_at=0, name=Tony, job=Executive Vice President, Manufacturing Solutions, slug=tony-khoury, hs_updated_by_user_id=51739740}, second={}, third={}})
    • Tony Khoury avatar

      Tony Khoury

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