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The Precision Blog
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Read Why APAC Is Becoming a Design Decision
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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 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: Why APAC Is Becoming a Design Decision 
Why APAC Is Becoming a Design Decision
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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=1784230314171, 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=51739740}, 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
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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: What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs 
What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs
has third author: false, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1784230314171, 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=51739740}, second={hs_id=195821592097, hs_child_table_id=0, hs_updated_at=1757598947835, hs_published_at=1784230314171, description=An expert in hematology and oncology and a veteran of the FDA with almost nine years of experience, culminating as a Deputy Director for the Division of Hematologic Malignancies 2. Possesses a profound understanding of regulatory strategy, particularly in the development of CAR-T cell therapies, bispecifics and T-cell engagers. Spearheaded initiatives to develop novel endpoints in blood cancer such as minimal residual disease (MRD) in lymphoma and chronic lymphocytic leukemia (CLL.), avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Nicholas%20Richardson.png',altText='Nicholas Richardson',fileId=195817841672}, linkedin=https://www.linkedin.com/in/nicholas-richardson-do-mph-049784113/, team=[{id=163080551773, name='Clinical Solutions Leadership'}], lastname=Richardson, DO, MPH, hs_initial_published_at=1757528527317, hs_created_by_user_id=51739740, hs_created_at=1757528274871, hs_is_edited=false, hs_deleted_at=0, name=Nicholas, job=Vice President, Clinical Development, slug=nicholas-richardson-clinical-solutions, hs_updated_by_user_id=51739740}, third={hs_id=178046423372, hs_child_table_id=0, hs_updated_at=1754641388766, hs_published_at=1784230314171, description=Rosamund (Roz) Round is a seasoned expert in patient engagement and innovation bringing over 20 years of experience. She is focused on listening to and learning from patients and care partners to understand how to better improve trial access and experience. Roz successfully built and led decentralized clinical trials service through the pandemic and is now addressing the implementation of AI across various aspects of clinical research. She has a strong focus on diversity, equity, and inclusion (DEI) to drive health equity in clinical research. Roz holds an MSc in Health Psychology, studied Psychology and Immunology at Harvard University, and is a recognized thought leader with an extensive portfolio of publications, conference presentations, webinars, and vlogs., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Round-Rosamund.png',altText='Round-Rosamund',fileId=194123714174}, lastname=Round, hs_initial_published_at=1725972637852, hs_created_by_user_id=51739740, hs_created_at=1725972446462, hs_is_edited=false, hs_deleted_at=0, name=Rosamund, job=Vice President, PAtient Engagement & Innovation, slug=rosamund-round, hs_updated_by_user_id=51739740}}) -
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Read: EMA PRIME Scheme Explained: Eligibility, Benefits, Risks, and When to Apply 
EMA PRIME Scheme Explained: Eligibility, Benefits, Risks, and When to Apply
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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
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Read: MHRA's International Recognition Procedure: Fast-Track Access to the UK Market 
MHRA's International Recognition Procedure: Fast-Track Access to the UK Market
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Read: FDA Draft Guidance on Overall Survival in Oncology Trials – What Sponsors Need to Know 
FDA Draft Guidance on Overall Survival in Oncology Trials – What Sponsors Need to Know
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