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Read Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions
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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
Read Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies
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Read: Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions 
Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions
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Read: Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies 
Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies
has not third author: true, (SizeLimitingPyMap: {main={hs_id=213698206365, hs_child_table_id=0, hs_updated_at=1780680681226, hs_published_at=1781285742914, 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, Crohn's disease 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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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
has not third author: true, (SizeLimitingPyMap: {main={hs_id=209983237513, hs_child_table_id=0, hs_updated_at=1774533604788, hs_published_at=1781285742914, 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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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
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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
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778886, hs_child_table_id=0, hs_updated_at=1763657611624, hs_published_at=1781285742914, 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=1781285742914, 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={}}) -
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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
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All articles
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Read: From Bench to Breakthrough: How Custom Kitting Fuels Precision Trials 
From Bench to Breakthrough: How Custom Kitting Fuels Precision Trials
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1781285742914, 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=1775839468505, 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=26433386}, second={hs_id=182710436924, hs_child_table_id=0, hs_updated_at=1754641257915, hs_published_at=1781285742914, 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=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Christie-Bongel_Square_260px-1.png',altText='Christie-Bongel_Square_260px-1',fileId=194123799456}, 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=26433386}, third={}}) -
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Read: Key Strategies for Future-Proofing Gene Therapy Assays 
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=1781285742914, 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=1775839468505, 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=26433386}, second={hs_id=159488778889, hs_child_table_id=0, hs_updated_at=1714461111815, hs_published_at=1781285742914, 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=1775839468505, hs_created_at=1709645745120, hs_is_edited=false, hs_deleted_at=0, name=Travis, job=, slug=travis-harrison, email=, hs_updated_by_user_id=26433386}, third={}}) -
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Read: Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity 
Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1781285742914, 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=1775839468505, 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=26433386}, second={hs_id=159488778840, hs_child_table_id=0, hs_updated_at=1771396592012, hs_published_at=1781285742914, 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., 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=1775839468505, hs_created_at=1709645745071, hs_is_edited=false, hs_deleted_at=0, name=Maham, position=Senior Director, IVD Regulatory Affairs, Gene Therapy CDx, job=, slug=maham-ansari, email=, hs_updated_by_user_id=26433386}, third={}}) -
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Read: 8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy 
8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy
has third author: false, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1781285742914, 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=1775839468505, 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=26433386}, second={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1781285742914, 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, PhD, hs_initial_published_at=1775839468505, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, position=Vice President, IVD Regulatory Consulting, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=26433386}, third={hs_id=159488778889, hs_child_table_id=0, hs_updated_at=1714461111815, hs_published_at=1781285742914, 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=1775839468505, hs_created_at=1709645745120, hs_is_edited=false, hs_deleted_at=0, name=Travis, job=, slug=travis-harrison, email=, hs_updated_by_user_id=26433386}}) -
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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
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1781285742914, 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=1775839468505, 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=26433386}, second={hs_id=159488778877, hs_child_table_id=0, hs_updated_at=1714461706779, hs_published_at=1781285742914, 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=1775839468505, hs_created_at=1709645745108, hs_is_edited=false, hs_deleted_at=0, name=Laura, job=, slug=laura-lozza, email=, hs_updated_by_user_id=26433386}, third={}}) -
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