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The Precision Blog
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Read Why Global Oncology Evidence May Not Support U.S. Regulatory Approval
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Read Receptor Occupancy in the Era of Multispecific Therapeutics Receptor Occupancy in the Era of Multispecific Therapeutics
Read Early-Phase Oncology Trials in Ireland: Why START Dublin Is a High-Performing Site for Sponsors Early-Phase Oncology Trials in Ireland: Why START Dublin Is a High-Performing Site for Sponsors
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Read: Why Global Oncology Evidence May Not Support U.S. Regulatory Approval 
Why Global Oncology Evidence May Not Support U.S. Regulatory Approval
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Read: Early-Phase Oncology Trials in Ireland: Why START Dublin Is a High-Performing Site for Sponsors 
Early-Phase Oncology Trials in Ireland: Why START Dublin Is a High-Performing Site for Sponsors
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164713188870, hs_child_table_id=0, hs_updated_at=1754641424769, hs_published_at=1785476963368, description=Deana Demjen is Director of the Precision Site Network, bringing nearly 20 years of clinical research to the role. Most of her previous experience has been in feasibility and site-identification. She has been covering a wide range of therapeutic areas, but her main focus are rare diseases where she is an acting subject matter expert. She is responsible for relationships with PSN sites as well as the maintenance and expansion of the network., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Deana-Demjen-1.png',altText='Deana-Demjen-1',fileId=194123711869}, lastname=Demjen, hs_initial_published_at=1713363230550, hs_created_by_user_id=5166971, hs_created_at=1713363112834, hs_is_edited=false, hs_deleted_at=0, name=Deana, job=Director of PSN, slug=deana-demjen, hs_updated_by_user_id=65160865}, second={}, third={}}) -
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Read: Why APAC Is Becoming a Design Decision 
Why APAC Is Becoming a Design Decision
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Read: Receptor Occupancy in the Era of Multispecific Therapeutics 
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
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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=1785476963368, 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=65160865}, second={}, third={}}) -
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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=1785476963368, 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={hs_id=195821592097, hs_child_table_id=0, hs_updated_at=1757598947835, hs_published_at=1785476963368, 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=65160865}, third={hs_id=178046423372, hs_child_table_id=0, hs_updated_at=1754641388766, hs_published_at=1785476963368, 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=65160865}}) -
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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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