false
The Precision Blog
100% sourced from leading minds on the front lines of research
Recent and Featured Posts
View all articles-
Read Case Study: Swift Stabilization in Phase 1 Solid Tumor Rescue
-
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
Read The EU Biotech Act: What Sponsors Need to Know About Europe's Biotechnology Transformation The EU Biotech Act: What Sponsors Need to Know About Europe's Biotechnology Transformation
Read Empowering Clinical Operations with Enhanced Biospecimen Lifecycle Management Empowering Clinical Operations with Enhanced Biospecimen Lifecycle Management
-
-
Read: Case Study: Swift Stabilization in Phase 1 Solid Tumor Rescue 
Case Study: Swift Stabilization in Phase 1 Solid Tumor Rescue
has not third author: true, (SizeLimitingPyMap: {main={hs_id=205683637283, hs_child_table_id=0, hs_updated_at=1769114822287, hs_published_at=1770040586344, description=Karen Stokes is a dedicated, collaborative and solution-oriented drug development professional with over 25 years of experience in Data Management, Clinical Operations and Project Management on Phase I-IV studies in Academic and Contract Research Organization (CRO) environments. She has expertise in CNS, Rare and Oncology indications and have successfully led cross functional teams to deliver quality on time. , avatar=Image{width=208,height=246,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Karen%20Stokes.png',altText='Karen Stokes',fileId=205695655336}, lastname=Stokes, hs_initial_published_at=1769114824037, hs_created_by_user_id=26433386, hs_created_at=1769114779691, hs_is_edited=false, hs_deleted_at=0, name=Karen, job=Project Director, slug=karen-stokes, hs_updated_by_user_id=65160865}, second={hs_id=205683637278, hs_child_table_id=0, hs_updated_at=1769114711193, hs_published_at=1770040586344, description=Annie Raymond-Desgagné is a Principal Clinical Trial Manager specializing in oncology, known for her strong leadership, structured planning, and proactive mindset. She excels at building high‑performing teams, with a passion for mentoring and helping colleagues bring out the best in themselves. Skilled at implementing tools that improve forecasting and operational readiness, Annie consistently keeps teams two steps ahead in fast‑moving clinical environments. She has a particular affinity for first‑in‑human (FIH) studies, where the science unfolds in real time—an area that fuels her love of challenge and innovation. Collaborative, committed, and science‑driven, she brings clarity, foresight, and positive energy to every project she leads., avatar=Image{width=226,height=226,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/A%20person%20with%20short%20brown%20hair%20wearing%20glasses%20Description%20automatically%20generated.png',altText='A person with short brown hair wearing glasses Description automatically generated',fileId=205695412385}, lastname=Raymond-Desgagné, hs_initial_published_at=1769114715920, hs_created_by_user_id=26433386, hs_created_at=1769114644600, hs_is_edited=false, hs_deleted_at=0, name=Annie, job=Principal Clinical Trial Manager, slug=annie-raymond-desgagne, hs_updated_by_user_id=65160865}, third={}}) -
-
Read: The EU Biotech Act: What Sponsors Need to Know About Europe's Biotechnology Transformation 
The EU Biotech Act: What Sponsors Need to Know About Europe's Biotechnology Transformation
has not third author: true, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1770040586344, description=John is an experienced regulatory affairs consultant with more than 15 years of professional experience in drug development. He brings a proven track record in providing regulatory strategy, regulatory document development and review, and liaising with regulatory authorities., avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/John%20McIntyre.png',altText='John McIntyre',fileId=201584594055}, lastname=McIntyre, PhD, hs_initial_published_at=1757516163742, hs_created_by_user_id=26433386, hs_created_at=1757515873736, hs_is_edited=false, hs_deleted_at=0, name=John, job=Senior Director, Regulatory Strategy, slug=john-mcintyre, hs_updated_by_user_id=65160865}, second={}, third={}}) -
-
Read: Navigating Complexity: Rescuing a Biomarker-Driven Breast Cancer Trial 
Navigating Complexity: Rescuing a Biomarker-Driven Breast Cancer Trial
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164725548848, hs_child_table_id=0, hs_updated_at=1754641451547, hs_published_at=1770040586344, description=Alexis Hobbins-White is an accomplished leader who plays a pivotal role in navigating the complex landscape of global oncology and rare disease-focused clinical trials. With a career spanning over 15 years in the clinical trials industry, Alexis brings a wealth of experience across multiple therapeutic areas, showcasing her proficiency in diverse aspects of operational strategy. She specializes in early phase adaptive studies, particularly in immuno-oncology and advanced therapeutics. She has an MSc in Neuroscience and an MA in Biotechnology Law and Ethics., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Alexis-Hobbins.png',altText='Alexis-Hobbins',fileId=194096322982}, linkedin=https://www.linkedin.com/in/alexis-hobbins-white-400a1720/, lastname=Hobbins-White, hs_initial_published_at=1713362276020, hs_created_by_user_id=5166971, hs_created_at=1713361952861, hs_is_edited=false, hs_deleted_at=0, name=Alexis, job=Senior Director, Operational Strategy , slug=alexis-hobbins-white, hs_updated_by_user_id=65160865}, second={}, third={}}) -
-
-
-
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=1770040586344, 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_created_at=1709645745117, hs_is_edited=false, hs_deleted_at=0, name=Robert, job=, slug=robert-snyder, email=, hs_updated_by_user_id=65160865}, second={hs_id=164691024166, hs_child_table_id=0, hs_updated_at=1716326265678, hs_published_at=1770040586344, 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=65160865}, third={}}) -
-
Read: Reflect on 20 Years of Cancer Research with MIRROR Biospecimens 
Reflect on 20 Years of Cancer Research with MIRROR Biospecimens
has not third author: true, (SizeLimitingPyMap: {main={hs_id=199448088864, hs_child_table_id=0, hs_updated_at=1762810484868, hs_published_at=1770040586344, 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=65160865}, second={}, third={}}) -
-
Read: Lost in Translation: Turning Multi-omic Chaos into Clinical Clarity 
Lost in Translation: Turning Multi-omic Chaos into Clinical Clarity
has third author: false, (SizeLimitingPyMap: {main={hs_id=159488778872, hs_child_table_id=0, hs_updated_at=1744653337128, hs_published_at=1770040586344, description=Visionary leader with decades of distinguished biotechnology and clinical translational research experience. Founded ApoCell in 2004 and later was instrumental in developing and commercializing the ApoStream® rare-cell liquid biopsy technology. Globally recognized cancer researcher and the author of more than 100 peer-reviewed publications. Dedicated and committed to improving the lives of patients with debilitating diseases., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Darren%20Davis.webp',altText='Darren Davis',fileId=165891429693}, linkedin=https://www.linkedin.com/in/drdarrendavis, team=[{id=163072475009, name='Translational Sciences Leadership'}], hs_name=, hs_path=, lastname=Davis, PhD, hs_created_at=1709645745103, hs_is_edited=false, hs_deleted_at=0, name=Darren, job=Senior Vice President, Translational Sciences, slug=darren-davis, email=, hs_updated_by_user_id=65160865}, second={hs_id=167888548278, hs_child_table_id=0, hs_updated_at=1722451546286, hs_published_at=1770040586344, 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=163072475009, name='Translational Sciences Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716194887110, hs_created_by_user_id=2737751, hs_created_at=1716194842710, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job=Chief Scientific Officer, slug=deborah-phippard-translational-sciences, email=, hs_updated_by_user_id=65160865}, third={hs_id=159488778886, hs_child_table_id=0, hs_updated_at=1763657611624, hs_published_at=1770040586344, 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_created_at=1709645745117, hs_is_edited=false, hs_deleted_at=0, name=Robert, job=, slug=robert-snyder, email=, hs_updated_by_user_id=65160865}}) -
-
All articles
-
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=1765824406763, hs_published_at=1770040586344, 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_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=65160865}, second={hs_id=182710436924, hs_child_table_id=0, hs_updated_at=1754641257915, hs_published_at=1770040586344, 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=65160865}, third={}}) -
-
Read: Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics 
Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1770040586344, 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_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=65160865}, second={hs_id=159488778882, hs_child_table_id=0, hs_updated_at=1714461102447, hs_published_at=1770040586344, description=Dr. Curnutte has more than ten years of research and regulatory affairs experience focused on in vitro diagnostics (IVDs). She has held regulatory positions at both device and pharmaceutical companies, during which she led seven U.S. and ex-U.S. companion diagnostic registrations. She has extensive expertise in CDx development and clinical trial integration, IVD product development, next-generation sequencing technologies, and translation of U.S. regulatory strategy to major markets., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Margaret%20Curnutte.webp',altText='Margaret Curnutte',fileId=165892782094}, linkedin=https://www.linkedin.com/in/margaret-curnutte-93558913, hs_name=, hs_path=, lastname=Curnutte, hs_created_at=1709645745113, hs_is_edited=false, hs_deleted_at=0, name=Margaret, job=, slug=margaret-curnutte, email=, hs_updated_by_user_id=65160865}, third={}}) -
-
Read: Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies 
Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1770040586344, 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_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=65160865}, second={hs_id=159488778882, hs_child_table_id=0, hs_updated_at=1714461102447, hs_published_at=1770040586344, description=Dr. Curnutte has more than ten years of research and regulatory affairs experience focused on in vitro diagnostics (IVDs). She has held regulatory positions at both device and pharmaceutical companies, during which she led seven U.S. and ex-U.S. companion diagnostic registrations. She has extensive expertise in CDx development and clinical trial integration, IVD product development, next-generation sequencing technologies, and translation of U.S. regulatory strategy to major markets., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Margaret%20Curnutte.webp',altText='Margaret Curnutte',fileId=165892782094}, linkedin=https://www.linkedin.com/in/margaret-curnutte-93558913, hs_name=, hs_path=, lastname=Curnutte, hs_created_at=1709645745113, hs_is_edited=false, hs_deleted_at=0, name=Margaret, job=, slug=margaret-curnutte, email=, hs_updated_by_user_id=65160865}, third={}}) -
-
Read: Going Beyond Viral Detection: COVID-19 Diagnostics 
Going Beyond Viral Detection: COVID-19 Diagnostics
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1770040586344, 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_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=65160865}, second={}, third={}}) -
-
Read: Choosing the Right Partner: Special Sample Needs For In Vitro Diagnostics 
Choosing the Right Partner: Special Sample Needs For In Vitro Diagnostics
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1770040586344, 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_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=65160865}, second={}, third={}}) -
You've reach the end