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The Precision Blog
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Read Receptor Occupancy in the Era of Multispecific Therapeutics
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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 Why APAC Is Becoming a Design Decision Why APAC Is Becoming a Design Decision
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Read: Why APAC Is Becoming a Design Decision 
Why APAC Is Becoming a Design Decision
has third author: false, (SizeLimitingPyMap: {main={hs_id=199521241215, hs_child_table_id=0, hs_updated_at=1774887081250, hs_published_at=1785358329759, description=An industry veteran with nearly three decades of experience in the clinical research industry and deep expertise in clinical operations and strategic leadership across both pharmaceutical and CRO environments. Held pivotal roles as Head of Clinical Operations for Greater China at Boehringer Ingelheim, leading trials in oncology, respiratory, stroke, and cardio-metabolic diseases and CEO of George Clinical, a global CRO with strong scientific capabilities in renal and oncology therapeutic areas. At Precision for Medicine, a leader for business strategy across the Asia Pacific region. Focused on driving regional growth, building strategic partnerships, and supporting excellence in portfolio delivery and client satisfaction. An acknowledged driver of precision-driven solutions that improve patient outcomes., avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/James%20Cheong.png',altText='James Cheong',fileId=199519079710}, linkedin=https://www.linkedin.com/in/james-cheong-36a543a/, lastname=Cheong, hs_initial_published_at=1762885727645, hs_created_by_user_id=78347666, hs_created_at=1762885637470, hs_is_edited=false, hs_deleted_at=0, name=James, job=Senior Vice President, Asia Pacific, Clinical Solutions, slug=james-cheong, hs_updated_by_user_id=65712240}, second={hs_id=199519203221, hs_child_table_id=0, hs_updated_at=1770145994248, hs_published_at=1785358329759, description=Highly accomplished global clinical operations executive with nearly three decades of experience providing strategic leadership, regional expansion, and operational excellence across Asia Pacific. Brings deep expertise across clinical development, project and portfolio operations, biometrics, regulatory affairs, safety and pharmacovigilance, quality management, and financial governance. Proven builder and scaler of high‑performing teams and start‑up operations in both regional and global environments. Recognized industry leader who actively contributes to advancing clinical research standards through advisory and governance roles across Asia., avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Jing%20Ping%20Yeo.png',altText='Jing Ping Yeo',fileId=199530854290}, linkedin=https://www.linkedin.com/in/jing-ping-yeo/, lastname=Yeo, PhD , hs_initial_published_at=1762893310168, hs_created_by_user_id=78347666, hs_created_at=1762893091367, hs_is_edited=false, hs_deleted_at=0, name=Jing Ping, job=Vice President, Clinical Operations, Head of Asia Pacific, slug=JingPing-Yeo, hs_updated_by_user_id=65712240}, third={hs_id=199528025104, hs_child_table_id=0, hs_updated_at=1774885968488, hs_published_at=1785358329759, description=With 20+ years of experience in the clinical trial industry, he has led project management, clinical operations, and business development teams. Prior to joining Precision, he served as the General Manager of Emerald (formerly George Clinical) China, and held project management and business development leadership roles at ICON, WuXi CDS, IQVIA, and KUNTUO. He has successfully led teams to complete more than 120 Phase I–IV clinical trials, many of which were MRCT studies across Asia‑Pacific, Australia, and the United States. He holds a Master’s degree in Urology from Peking University First Hospital., avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Zhenfei%20Yin.png',altText='Zhenfei Yin',fileId=199530854553}, lastname=Yin, hs_initial_published_at=1762893310168, hs_created_by_user_id=78347666, hs_created_at=1762893190542, hs_is_edited=false, hs_deleted_at=0, name=Zhenfei, job=China Country Head, Senior Director, Project Management, slug=Zhenfei Yin, hs_updated_by_user_id=65712240}}) -
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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=1785358329759, 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=65712240}, second={}, third={}}) -
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Read: Receptor Occupancy in the Era of Multispecific Therapeutics 
Receptor Occupancy in the Era of Multispecific Therapeutics
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1785358329759, 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=65712240}, second={hs_id=218178874459, hs_child_table_id=0, hs_updated_at=1785241362455, hs_published_at=1785358329759, description=Jenny Zilberberg has more than 20 years of combined experience across academia and biotechnology, with expertise in translational immunology, cancer immunotherapy, and biomarker strategy. Most recently, she served as Head of Research at Imvax, where she led preclinical development and biomarker activities for the company’s immunotherapy platform and lead glioblastoma program. At Precision, Jenny partners with sponsors to design and implement biomarker and bioanalytical solutions that support clinical development across oncology and autoimmune diseases., avatar=Image{width=480,height=480,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/JennyZilberberg.jpeg',altText='JennyZilberberg',fileId=218182303073}, lastname=Zilberberg, hs_initial_published_at=1785241367324, hs_created_by_user_id=65712240, hs_created_at=1785241302354, hs_is_edited=false, hs_deleted_at=0, name=Jenny, job=Vice President, Scientific Strategy, slug=Jenny-zilberberg, hs_updated_by_user_id=65712240}, 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
has not third author: true, (SizeLimitingPyMap: {main={hs_id=199448088864, hs_child_table_id=0, hs_updated_at=1762810484868, hs_published_at=1785358329759, 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=65712240}, second={}, third={}}) -
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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=1785358329759, 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=65712240}, second={}, third={}}) -
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All articles
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Read: Case Study: Advancing IHC Assays from RUO to Clinical Trials and CDx 
Case Study: Advancing IHC Assays from RUO to Clinical Trials and CDx
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1785358329759, 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=65712240}, second={hs_id=164426546714, hs_child_table_id=0, hs_updated_at=1778171432595, hs_published_at=1785358329759, description=Angélique Heckmann, PhD is a people‑driven leader who combines scientific expertise and business acumen with a strong foundation in human values. With a background in therapeutic drug development and an MBA‑shaped strategic mindset, she focuses on building meaningful, long‑term relationships with teams, partners, and clients. By bridging science and strategy, she supports informed decision‑making, fosters collaboration, and helps translate innovation into real‑world impact—always guided by a shared purpose: advancing solutions that ultimately improve patients’ lives, avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/angelique-1.png',altText='angelique-1',fileId=194126030110}, lastname=Heckmann, PhD, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713172107894, hs_is_edited=false, hs_deleted_at=0, name=Angelique, job=Regional Vice President, Translational Business Solutions, slug=angelique-heckmann, hs_updated_by_user_id=65712240}, 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=1765824406763, hs_published_at=1785358329759, 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=65712240}, second={hs_id=182710436924, hs_child_table_id=0, hs_updated_at=1754641257915, hs_published_at=1785358329759, 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=65712240}, third={}}) -
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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=1785358329759, 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=65712240}, second={hs_id=159488778882, hs_child_table_id=0, hs_updated_at=1714461102447, hs_published_at=1785358329759, 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_initial_published_at=1775839468505, hs_created_at=1709645745113, hs_is_edited=false, hs_deleted_at=0, name=Margaret, job=, slug=margaret-curnutte, email=, hs_updated_by_user_id=65712240}, third={}}) -
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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=1785358329759, 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=65712240}, second={hs_id=159488778882, hs_child_table_id=0, hs_updated_at=1714461102447, hs_published_at=1785358329759, 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_initial_published_at=1775839468505, hs_created_at=1709645745113, hs_is_edited=false, hs_deleted_at=0, name=Margaret, job=, slug=margaret-curnutte, email=, hs_updated_by_user_id=65712240}, third={}}) -
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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=1785358329759, 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=65712240}, second={}, third={}}) -
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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=1785358329759, 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=65712240}, second={}, third={}}) -
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