Radiopharmaceutical Clinical Trials: What Sponsors Need to Know About Selecting a CRO
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778843, hs_child_table_id=0, hs_updated_at=1774960706353, hs_published_at=1775839468505, description=Robert Bauer is an Executive Director of Operational Strategy at Precision with over 20 years of clinical trial operations experience from both the sponsor and CRO perspectives. He has led teams in the conduct of trials from Phase I through IV and has experience across a wide variety of trial designs. Bob has experience across many therapeutic areas some of which include rare diseases, oncology, depression, schizophrenia, and substance use disorders., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Robert%20Bauer%20Square.webp',altText='Robert Bauer Square',fileId=165892429961}, linkedin=https://www.linkedin.com/in/robert-bauer-a78b704b, hs_name=, hs_path=, lastname=Bauer, hs_initial_published_at=1775839468505, hs_created_at=1709645745074, hs_is_edited=false, hs_deleted_at=0, name=Robert, position=Vice President, Operational Strategy, job=, slug=robert-bauer, email=, hs_updated_by_user_id=51739740}, second={hs_id=185416008260, hs_child_table_id=0, hs_updated_at=1754641208207, hs_published_at=1775839468505, description=Sarika is a Senior Clinical Trial Manager with 14+ years of experience in clinical research, specializing in oncology, rare diseases, and cardiology. With a robust focus on Phase I-IV clinical trials, she has successfully led projects from start-up to close-out and has experience in cohort management and solid tumor studies. She is a strong advocate for cross-functional teamwork, streamlining processes, and optimizing project efficiency., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Sarika-David-Armogan-1-1.png',altText='Sarika-David-Armogan-1-1',fileId=194123711873}, lastname=David-Armogan, hs_initial_published_at=1737992355064, hs_created_by_user_id=26433386, hs_created_at=1737992180108, hs_is_edited=false, hs_deleted_at=0, name=Sarika, slug=sarika-david-armogan, hs_updated_by_user_id=51739740}, third={}})
Cancer Is the Enemy: How Phase I Oncology Teams Accelerate Drug Development
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1754641583843, hs_published_at=1775839468505, description=Rob Maiale is a marketing strategist and creative technologist with 17 years of experience turning complex ideas into growth. He currently leads content strategy, where he transforms insights from Precision experts into market-shaping narratives that drive the advancement of next-generation therapies. Rob’s career spans journalism, advertising, and brand storytelling, with a through-line of making the meaningful memorable. His work blends creative strategy with emerging AI tools to help Precision stay ahead of the curve—and above the noise., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/rob.png',altText='rob',fileId=194099000843}, linkedin=https://www.linkedin.com/in/rob-maiale/, hs_name=, hs_path=, lastname=Maiale, hs_initial_published_at=1775839468505, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, position=Associate Director, Digital Content & Inbound Marketing, job=, slug=rob-maiale, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Expanding Clinical Trial Execution in Greater China: Beijing, Shanghai, Hong Kong & Taiwan
|
has third author: false, (SizeLimitingPyMap: {main={hs_id=199521241215, hs_child_table_id=0, hs_updated_at=1774887081250, hs_published_at=1775839468505, 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=51739740}, second={hs_id=199519203221, hs_child_table_id=0, hs_updated_at=1770145994248, hs_published_at=1775839468505, 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=51739740}, third={hs_id=199528025104, hs_child_table_id=0, hs_updated_at=1774885968488, hs_published_at=1775839468505, 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=51739740}})
Strategic Management of Radiopharmaceutical Trial Complexity
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778843, hs_child_table_id=0, hs_updated_at=1774960706353, hs_published_at=1775839468505, description=Robert Bauer is an Executive Director of Operational Strategy at Precision with over 20 years of clinical trial operations experience from both the sponsor and CRO perspectives. He has led teams in the conduct of trials from Phase I through IV and has experience across a wide variety of trial designs. Bob has experience across many therapeutic areas some of which include rare diseases, oncology, depression, schizophrenia, and substance use disorders., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Robert%20Bauer%20Square.webp',altText='Robert Bauer Square',fileId=165892429961}, linkedin=https://www.linkedin.com/in/robert-bauer-a78b704b, hs_name=, hs_path=, lastname=Bauer, hs_initial_published_at=1775839468505, hs_created_at=1709645745074, hs_is_edited=false, hs_deleted_at=0, name=Robert, position=Vice President, Operational Strategy, job=, slug=robert-bauer, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
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=1775839468505, 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=1775839468505, 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=1775839468505, 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}})
The Collaborative CRO Partnership Model: Amplifying Your Team
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164725548848, hs_child_table_id=0, hs_updated_at=1754641451547, hs_published_at=1775839468505, 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=51739740}, second={}, third={}})
EMA PRIME Scheme Explained: Eligibility, Benefits, Risks, and When to Apply
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1775839468505, 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=159488778852, hs_child_table_id=0, hs_updated_at=1765558855468, hs_published_at=1775839468505, description=Chris Ingram, BSc (Hons) is Head of Regulatory Consultancy (Europe) for Precision for Medicine. Chris received his BSc(Hons) in immunology and pharmacology from the University of Strathclyde and has since spent over 21 years working in regulatory affairs with a focus on clinical development. Chris’ regulatory expertise covers clinical development across all phases, regulatory strategy, marketing authorisations, scientific advice, orphan drug designation and paediatric investigation plans across a wide variety of therapeutic areas, including but not limited to, oncology, CNS, metabolic, endocrinology, analgesia and cardiovascular., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Chris-Ingram.png',altText='Chris-Ingram',fileId=202456722303}, linkedin=https://www.linkedin.com/in/chris-ingram-0255b216, hs_name=, hs_path=, lastname=Ingram, hs_initial_published_at=1775839468505, hs_created_at=1709645745083, hs_is_edited=false, hs_deleted_at=0, name=Chris, job=Executive Director, Regulatory Affairs, Europe, slug=chris-ingram, email=, hs_updated_by_user_id=51739740}, third={}})
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=1775839468505, 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=51739740}, second={hs_id=205683637278, hs_child_table_id=0, hs_updated_at=1769114711193, hs_published_at=1775839468505, 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=51739740}, third={}})
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=1775839468505, 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={}, third={}})