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The Precision Blog
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Read Phase 1 Clinical Trial Designs Explained: BOIN, CRM, BLRM & Modern Adaptive Strategies
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Read Key Strategies for Future-Proofing Gene Therapy Assays Key Strategies for Future-Proofing Gene Therapy Assays
Read Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM) Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM)
Read Empowering Clinical Operations with Enhanced Biospecimen Lifecycle Management Empowering Clinical Operations with Enhanced Biospecimen Lifecycle Management
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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
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Read: Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM) 
Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM)
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)
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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=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
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: Optimizing Immunohistochemistry Validation and Regulatory Strategies 
Optimizing Immunohistochemistry Validation and Regulatory Strategies
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
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Read: Precision Medicine in Pediatrics: Biomarkers and Assay Development 
Precision Medicine in Pediatrics: Biomarkers and Assay Development
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778880, hs_child_table_id=0, hs_updated_at=1714461214107, hs_published_at=1748379090824, description=Eva Raschke, PhD serves as a subject matter expert for immune monitoring solutions at Precision for Medicine with a focus on the epigenetic immune monitoring technology Epiontis ID. She has supported the development, validation and clinical use of this technology platform in different roles since 2008. Eva obtained a Ph.D. in Molecular Biology from the Ludwig-Maximilians-University Munich., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Eva%20Raschke.webp',altText='Eva Raschke',fileId=165892728972}, linkedin=https://www.linkedin.com/in/eva-raschke-678b439, hs_name=, hs_path=, lastname=Raschke, hs_initial_published_at=1716212769184, hs_created_at=1709645745111, hs_is_edited=false, hs_deleted_at=0, name=Eva, job=, slug=eva-raschke, email=, hs_updated_by_user_id=51739740}, second={}, third={}}) -
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Read: Conducting Pediatric Studies: Addressing Ethical and Clinical Challenges 
Conducting Pediatric Studies: Addressing Ethical and Clinical Challenges
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Read: Methods for a Comprehensive Characterization of the Tumor Microenvironment 
Methods for a Comprehensive Characterization of the Tumor Microenvironment
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Read: Characterizing a Central Switch of Immune Suppression: Monitoring Treg Cells in Clinical Studies 
Characterizing a Central Switch of Immune Suppression: Monitoring Treg Cells in Clinical Studies
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Read: Using Epigenetic Immunophenotyping to Explore Potential Biomarkers in Hepatocellular Carcinoma 
Using Epigenetic Immunophenotyping to Explore Potential Biomarkers in Hepatocellular Carcinoma
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778880, hs_child_table_id=0, hs_updated_at=1714461214107, hs_published_at=1748379090824, description=Eva Raschke, PhD serves as a subject matter expert for immune monitoring solutions at Precision for Medicine with a focus on the epigenetic immune monitoring technology Epiontis ID. She has supported the development, validation and clinical use of this technology platform in different roles since 2008. Eva obtained a Ph.D. in Molecular Biology from the Ludwig-Maximilians-University Munich., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Eva%20Raschke.webp',altText='Eva Raschke',fileId=165892728972}, linkedin=https://www.linkedin.com/in/eva-raschke-678b439, hs_name=, hs_path=, lastname=Raschke, hs_initial_published_at=1716212769184, hs_created_at=1709645745111, hs_is_edited=false, hs_deleted_at=0, name=Eva, job=, slug=eva-raschke, email=, hs_updated_by_user_id=51739740}, second={}, third={}}) -
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Read: Non-Invasive Immune Monitoring to Predict COVID-19 Disease Course and Assess SARS-CoV-2 Vaccine Response 
Non-Invasive Immune Monitoring to Predict COVID-19 Disease Course and Assess SARS-CoV-2 Vaccine Response
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778880, hs_child_table_id=0, hs_updated_at=1714461214107, hs_published_at=1748379090824, description=Eva Raschke, PhD serves as a subject matter expert for immune monitoring solutions at Precision for Medicine with a focus on the epigenetic immune monitoring technology Epiontis ID. She has supported the development, validation and clinical use of this technology platform in different roles since 2008. Eva obtained a Ph.D. in Molecular Biology from the Ludwig-Maximilians-University Munich., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Eva%20Raschke.webp',altText='Eva Raschke',fileId=165892728972}, linkedin=https://www.linkedin.com/in/eva-raschke-678b439, hs_name=, hs_path=, lastname=Raschke, hs_initial_published_at=1716212769184, hs_created_at=1709645745111, hs_is_edited=false, hs_deleted_at=0, name=Eva, job=, slug=eva-raschke, email=, hs_updated_by_user_id=51739740}, second={}, third={}}) -
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Read: Next-Generation Immune Monitoring in Immuno-oncology Trials 
Next-Generation Immune Monitoring in Immuno-oncology Trials
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778880, hs_child_table_id=0, hs_updated_at=1714461214107, hs_published_at=1748379090824, description=Eva Raschke, PhD serves as a subject matter expert for immune monitoring solutions at Precision for Medicine with a focus on the epigenetic immune monitoring technology Epiontis ID. She has supported the development, validation and clinical use of this technology platform in different roles since 2008. Eva obtained a Ph.D. in Molecular Biology from the Ludwig-Maximilians-University Munich., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Eva%20Raschke.webp',altText='Eva Raschke',fileId=165892728972}, linkedin=https://www.linkedin.com/in/eva-raschke-678b439, hs_name=, hs_path=, lastname=Raschke, hs_initial_published_at=1716212769184, hs_created_at=1709645745111, hs_is_edited=false, hs_deleted_at=0, name=Eva, job=, slug=eva-raschke, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778885, hs_child_table_id=0, hs_updated_at=1714461091541, hs_published_at=1748379090824, description=Dr. Hoffmueller is a veteran biochemist, industry expert, and cofounder of Epiontis. He holds a Master’s in Biochemistry from Humboldt University, a PhD from the Charité University Clinic, receiving the Charité Research Award, and an MBA from the Berlin School of Economics and Law, Berlin, Germany., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Ulrich%20Hoffmueller.webp',altText='Ulrich Hoffmueller',fileId=165891429692}, linkedin=https://www.linkedin.com/in/hoffmueller, hs_name=, hs_path=, lastname=Hoffmueller, hs_initial_published_at=1716212769184, hs_created_at=1709645745116, hs_is_edited=false, hs_deleted_at=0, name=Ulrich, job=, slug=ulrich-hoffmueller, email=, hs_updated_by_user_id=51739740}, third={}}) -
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