Clinical Sample Logistics and Biostorage

Read: Why Most Early Autoimmune Trials Fail to Yield Decision-ready Evidence

Early Phase Research - Autoimmune

Why Most Early Autoimmune Trials Fail to Yield Decision-ready Evidence

Aug 10, ‘26 | 6 min read

has not third author: true, (SizeLimitingPyMap: {main={hs_id=213698206365, hs_child_table_id=0, hs_updated_at=1780680681226, hs_published_at=1786473638412, 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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  Rui F Duarte-Lopes

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Read: Why Global Oncology Evidence May Not Support U.S. Regulatory Approval

Clinical Trials - Regulatory

Why Global Oncology Evidence May Not Support U.S. Regulatory Approval

Aug 03, ‘26 | 9 min read

has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1786473638412, description=Industry-leading oncologist and demonstrated medical leader in precision medicine, novel trial design and innovative regulatory initiatives designed to expedite drug approvals. Draws on nearly a decade leading oncology and rare disease programs at the FDA. Former fellow at the National Cancer Institute and frequent featured speaker at ASCO and AACR. CDER technical authority on oncologic drug and biological products for thoracic and head and neck malignancies, neurologic tumors, pediatric solid tumors and rare tumors., avatar=Image{width=553,height=580,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Harpreet-Singh2.png',altText='Harpreet-Singh2',fileId=171747124346}, linkedin=https://www.linkedin.com/in/harpreetsinghmd/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Singh, MD, hs_initial_published_at=1715692570942, hs_created_by_user_id=2737751, hs_created_at=1715692477118, hs_is_edited=false, hs_deleted_at=0, name=Harpreet, job=Chief Medical Officer, slug=harpreet-singh, hs_updated_by_user_id=65712240}, second={}, third={}})
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  Harpreet Singh, MD

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Read: Early-Phase Oncology Trials in Ireland: Why START Dublin Is a High-Performing Site for Sponsors

Clinical Trials

Early-Phase Oncology Trials in Ireland: Why START Dublin Is a High-Performing Site for Sponsors

Aug 03, ‘26 | 10 min read

has not third author: true, (SizeLimitingPyMap: {main={hs_id=164713188870, hs_child_table_id=0, hs_updated_at=1754641424769, hs_published_at=1786473638412, 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=65712240}, second={}, third={}})
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  Deana Demjen

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