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  • Clinical Research Insights

    All Clinical Research Articles
    • Read: Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies

      Clinical Trials

      Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=213698206365, hs_child_table_id=0, hs_updated_at=1780425957872, hs_published_at=1780425963343, description=Rui F. Duarte‑Lopes is a senior biostatistics leader with over 31 years of international experience across biopharmaceutical, biotechnology, and CRO sectors. He provides strategic statistical oversight, ensuring rigorous, high‑quality, and decision‑focused delivery aligned with sponsor and regulatory expectations. He has more than 12 years of CRO experience supporting Phase I–IV clinical trials and has held roles including Lead Statistician, Project Lead, and Senior Manager. His therapeutic experience includes oncology and autoimmune diseases, notably lupus erythematosus and rheumatoid arthritis. Specializing in oncology over the past six years, Rui focuses on advanced solid tumors and early‑phase studies, contributing to study design, interim analyses, and data‑driven decision frameworks., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Rui%20F%20Duarte-Lopes.jpg',altText='Rui F Duarte-Lopes',fileId=213695319705}, lastname=Duarte-Lopes, hs_initial_published_at=1779886328878, hs_created_by_user_id=26433386, hs_created_at=1779886165792, hs_is_edited=false, hs_deleted_at=0, name=Rui F, job=Senior Manager, Biostatistics, slug=rui-f-duarte-lopes, hs_updated_by_user_id=26433386}, second={}, third={}})
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        Rui F Duarte-Lopes

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    • Read: China’s New Drug Regulatory Framework Positions the Country as a Global Hub for Innovative Medicine Launches China’s New Drug Regulatory Framework Positions the Country as a Global Hub for Innovative Medicine Launches

      Clinical Trials

      China’s New Drug Regulatory Framework Positions the Country as a Global Hub for Innovative Medicine Launches

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=209983237513, hs_child_table_id=0, hs_updated_at=1774533604788, hs_published_at=1780425963343, description=Calvin Niu received his BD in pharmaceuticals from Lanzhou University. He has brought over 22 years of drug development and regulatory experience in pharmaceutical companies and CROs. Calvin’s regulatory expertise covers regulatory agency engagements and all types of regulatory submissions throughout product development and post market life cycles in oncology, immunology, ophthalmology, clinical nutrition, cardiovascular, gastroenterology, women’s health, CNS, rare disease, etc. , avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Calvin%20Niu.png',altText='Calvin Niu',fileId=209991702802}, lastname=Niu, hs_initial_published_at=1774533614867, hs_created_by_user_id=51739740, hs_created_at=1774531720533, hs_is_edited=false, hs_deleted_at=0, name=Calvin, job=Director, Regulatory Affairs, China, slug=calvin-niu, hs_updated_by_user_id=26433386}, second={}, third={}})
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        Calvin Niu

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    • Read: Bringing Early Phase Oncology Closer to Patients in Los Angeles Bringing Early Phase Oncology Closer to Patients in Los Angeles

      Clinical Trials - Oncology

      Bringing Early Phase Oncology Closer to Patients in Los Angeles

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1754641583843, hs_published_at=1780425963343, description=Rob Maiale is a marketing strategist and creative technologist with 17 years of experience turning complex ideas into growth. He currently leads content strategy, where he transforms insights from Precision experts into market-shaping narratives that drive the advancement of next-generation therapies.  Rob’s career spans journalism, advertising, and brand storytelling, with a through-line of making the meaningful memorable. His work blends creative strategy with emerging AI tools to help Precision stay ahead of the curve—and above the noise., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/rob.png',altText='rob',fileId=194099000843}, linkedin=https://www.linkedin.com/in/rob-maiale/, hs_name=, hs_path=, lastname=Maiale, hs_initial_published_at=1775839468505, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, position=Associate Director, Digital Content & Inbound Marketing, job=, slug=rob-maiale, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
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        Rob Maiale

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  • Translational Research Insights

    All Translational Research Articles
    • Read: Developing a Comprehensive Strategy for Implementing AI & Multi-Omics for Translational Research Developing a Comprehensive Strategy for Implementing AI & Multi-Omics for Translational Research

      Translational Research

      Developing a Comprehensive Strategy for Implementing AI & Multi-Omics for Translational Research

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=199448088864, hs_child_table_id=0, hs_updated_at=1762810484868, hs_published_at=1780425963343, avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Kaylee%20Mueller.png',altText='Kaylee Mueller',fileId=199456336149}, lastname=Mueller, hs_initial_published_at=1762810487482, hs_created_by_user_id=26433386, hs_created_at=1762810467146, hs_is_edited=false, hs_deleted_at=0, name=Kaylee, slug=kaylee-mueller, hs_updated_by_user_id=26433386}, second={}, third={}})
      • Kaylee Mueller avatar

        Kaylee Mueller

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    • Read: Back to the Source: A Translational Leader on Extending the Living Legacy of Genomic Data Back to the Source: A Translational Leader on Extending the Living Legacy of Genomic Data

      Translational Research - Biospecimens - Oncology

      Back to the Source: A Translational Leader on Extending the Living Legacy of Genomic Data

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778886, hs_child_table_id=0, hs_updated_at=1763657611624, hs_published_at=1780425963343, description=Robert Snyder, PhD, is a seasoned expert with a 20-year track record in genomics, specializing in in vitro diagnostic assay development and bioinformatics. Committed to advancing medical science, he is proficient in regulatory V&V study designs and understands the nuances of orthogonal methods. A collaborative partner in biomedical development, Dr. Snyder champions the critical transition of biospecimens from benchtop to bedside., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Robert%20Snyder.webp',altText='Robert Snyder',fileId=165892444501}, linkedin=https://www.linkedin.com/in/robert-snyder-ph-d-9b67b035, hs_name=, hs_path=, lastname=Snyder, PhD, hs_initial_published_at=1775839468505, hs_created_at=1709645745117, hs_is_edited=false, hs_deleted_at=0, name=Robert, job=, slug=robert-snyder, email=, hs_updated_by_user_id=26433386}, second={hs_id=164691024166, hs_child_table_id=0, hs_updated_at=1716326265678, hs_published_at=1780425963343, description=Respected veteran of the biospecimen and biomarker laboratory services industry. Honed his expertise through leadership roles in organizations including Roche, Cancer Genetics, and BioServe. Holds a Master of Public Health and a Masters of Business Administration from the Johns Hopkins University., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Rob%20Fannon%20Headshot.webp',altText='Rob Fannon Headshot',fileId=165893006477}, linkedin=https://www.linkedin.com/in/rob-fannon-901378/, team=[{id=163072475009, name='Translational Sciences Leadership'}], lastname=Fannon, MPH, MBA, hs_initial_published_at=1713346931329, hs_created_by_user_id=62155952, hs_created_at=1713345787919, hs_is_edited=false, hs_deleted_at=0, name=Rob, job=General Manager, Biospecimen Solutions, slug=rob-fannon, hs_updated_by_user_id=26433386}, third={}})
      • Robert S. avatar

        Robert S.

      • Rob F. avatar

        Rob F.

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    • Read: Reflect on 20 Years of Cancer Research with MIRROR Biospecimens Reflect on 20 Years of Cancer Research with MIRROR Biospecimens

      Translational Research - Biospecimens

      Reflect on 20 Years of Cancer Research with MIRROR Biospecimens

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=199448088864, hs_child_table_id=0, hs_updated_at=1762810484868, hs_published_at=1780425963343, avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Kaylee%20Mueller.png',altText='Kaylee Mueller',fileId=199456336149}, lastname=Mueller, hs_initial_published_at=1762810487482, hs_created_by_user_id=26433386, hs_created_at=1762810467146, hs_is_edited=false, hs_deleted_at=0, name=Kaylee, slug=kaylee-mueller, hs_updated_by_user_id=26433386}, second={}, third={}})
      • Kaylee Mueller avatar

        Kaylee Mueller

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All articles

  • Read: Why 100% SDV Is No Longer Feasible — and How Risk-Based Monitoring Saves Time, Money, and Your Trial Why 100% SDV Is No Longer Feasible — and How Risk-Based Monitoring Saves Time, Money, and Your Trial

    Clinical Trials

    Why 100% SDV Is No Longer Feasible — and How Risk-Based Monitoring Saves Time, Money, and Your Trial

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=187570680222, hs_child_table_id=0, hs_updated_at=1754641181518, hs_published_at=1780425963343, description=Christine has been ensuring high performance delivery of clinical research projects for more than 23 years. During this time, she has successfully led diverse teams across various cancer indications including renal, pancreatic, melanoma, lung, head and neck, breast, multiple myeloma, extra-nodal NK/T lymphoma, non-Hodgkin’s lymphoma, and Hodgkin’s lymphoma. Within the CRO setting she also supported the strategic development of over 50 hematology/oncology programs including complex Phase 1 projects in immuno-oncology and autologous cell therapy. She also led the establishment of a novel oncology research infrastructure which accelerated study activations for Phase 1 solid tumor studies. Christine obtained her master’s degree in public health at the University of Texas where she also trained in the development and implementation of clinical and epidemiologic research at the Coordinating Center for Clinical Trials as well as the Center for Occupational and Environment Health., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Christine-Lusk-1.png',altText='Christine-Lusk-1',fileId=194126038306}, lastname=Lusk, hs_initial_published_at=1742410730688, hs_created_by_user_id=26433386, hs_created_at=1742410650472, hs_is_edited=false, hs_deleted_at=0, name=Christine, job=Director, Project Management, slug=christine-lusk, hs_updated_by_user_id=26433386}, second={hs_id=190691157084, hs_child_table_id=0, hs_updated_at=1754641163041, hs_published_at=1780425963343, description=Over the last 15 years, Megan has played a key role in advancing multiple oncology compounds through various stages of development, across numerous tumor types. Having worked at both biotech and CRO companies, Megan brings a comprehensive understanding of clinical operations and drug development. Megan maintains a focus on accelerating the development of innovative cancer therapies to improve patient outcomes worldwide., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Megan-Knoch-1.png',altText='Megan-Knoch-1',fileId=194123711870}, lastname=Knoch, hs_initial_published_at=1748379090824, hs_created_by_user_id=26433386, hs_created_at=1748379018316, hs_is_edited=false, hs_deleted_at=0, name=Megan, slug=megan-knoch, hs_updated_by_user_id=26433386}, third={}})
    • Christine L. avatar

      Christine L.

    • Megan K. avatar

      Megan K.

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  • Read: The Amendment Trap: Why 76% of Clinical Trials Face Six-Figure Protocol Changes The Amendment Trap: Why 76% of Clinical Trials Face Six-Figure Protocol Changes

    Clinical Trials

    The Amendment Trap: Why 76% of Clinical Trials Face Six-Figure Protocol Changes

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=187570680222, hs_child_table_id=0, hs_updated_at=1754641181518, hs_published_at=1780425963343, description=Christine has been ensuring high performance delivery of clinical research projects for more than 23 years. During this time, she has successfully led diverse teams across various cancer indications including renal, pancreatic, melanoma, lung, head and neck, breast, multiple myeloma, extra-nodal NK/T lymphoma, non-Hodgkin’s lymphoma, and Hodgkin’s lymphoma. Within the CRO setting she also supported the strategic development of over 50 hematology/oncology programs including complex Phase 1 projects in immuno-oncology and autologous cell therapy. She also led the establishment of a novel oncology research infrastructure which accelerated study activations for Phase 1 solid tumor studies. Christine obtained her master’s degree in public health at the University of Texas where she also trained in the development and implementation of clinical and epidemiologic research at the Coordinating Center for Clinical Trials as well as the Center for Occupational and Environment Health., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Christine-Lusk-1.png',altText='Christine-Lusk-1',fileId=194126038306}, lastname=Lusk, hs_initial_published_at=1742410730688, hs_created_by_user_id=26433386, hs_created_at=1742410650472, hs_is_edited=false, hs_deleted_at=0, name=Christine, job=Director, Project Management, slug=christine-lusk, hs_updated_by_user_id=26433386}, second={}, third={}})
    • Christine Lusk avatar

      Christine Lusk

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