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The Precision Blog
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Read Case Study: Conducting Autologous Cell Therapy Research Across 3 Continents with Zero Sample Loss
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Read Key Strategies for Future-Proofing Gene Therapy Assays Key Strategies for Future-Proofing Gene Therapy Assays
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
Read Empowering Clinical Operations with Enhanced Biospecimen Lifecycle Management Empowering Clinical Operations with Enhanced Biospecimen Lifecycle Management
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Read: Case Study: Conducting Autologous Cell Therapy Research Across 3 Continents with Zero Sample Loss 
Case Study: Conducting Autologous Cell Therapy Research Across 3 Continents with Zero Sample Loss
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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
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)
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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
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Read: Optimizing Immunohistochemistry Validation and Regulatory Strategies 
Optimizing Immunohistochemistry Validation and Regulatory Strategies
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All articles
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Read: Best Practices to Streamline Development of Safety Update Reports (DSURs) 
Best Practices to Streamline Development of Safety Update Reports (DSURs)
has not third author: true, (SizeLimitingPyMap: {main={hs_id=182849803084, hs_child_table_id=0, hs_updated_at=1731697230236, hs_published_at=1748379090824, description=Lena Randhawa, PhD is a Principal Medical Writer at Precision for Medicine. She brings to Precision >23 years of written and oral communication experience and >12 years of regulatory medical writing experience, project management, and leadership roles. Lena has extensive experience across various regulatory documents including CSRs (interim CSRs, CSR amendments/addenda, and abbreviated/synoptic CSRs), CSR patient narratives, DSURs/IND annual reports, IBs and updates, clinical protocols and amendments, informed consent forms, IND/NDA components, and briefing packages., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Lena%20Randhawa-1.jpg',altText='Lena Randhawa-1',fileId=182849417502}, lastname=Randhawa, hs_initial_published_at=1731697233687, hs_created_by_user_id=26433386, hs_created_at=1731697009126, hs_is_edited=false, hs_deleted_at=0, name=Lena, job=Senior Manager, Medical Writing, slug=lena-randhawa, hs_updated_by_user_id=51739740}, second={}, third={}}) -
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