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Beyond Geography: A Former Regulator’s Perspective on Multiregional Oncology Trials

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  • Clinical Research Insights

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    • Read: How a Biometrics Partnership Scaled: Stats-Only to Integrated Delivery How a Biometrics Partnership Scaled: Stats-Only to Integrated Delivery

      Clinical Trials

      How a Biometrics Partnership Scaled: Stats-Only to Integrated Delivery

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=181884577650, hs_child_table_id=0, hs_updated_at=1754641339342, hs_published_at=1768210872876, description=Niveda Ramkumar is a seasoned growth strategist with over 15 years of experience in marketing, business development, and account management at leading CROs and life science research firms. She has successfully spearheaded the launch of new services and technologies in clinical development, genomics and biomarkers, regulatory affairs, safety, and commercialization., avatar=Image{width=753,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/niveda-ramkumar-Photoroom.png',altText='niveda-ramkumar-Photoroom',fileId=194126091397}, lastname=Ramkumar, hs_initial_published_at=1729782775265, hs_created_by_user_id=26433386, hs_created_at=1729782662277, hs_is_edited=false, hs_deleted_at=0, name=Niveda, job=Director, Marketing, slug=niveda-ramkumar, hs_updated_by_user_id=65160865}, second={hs_id=164680191818, hs_child_table_id=0, hs_updated_at=1716326381066, hs_published_at=1768210872876, description=Visionary executive with a distinguished track-record fostering an environment of continuous innovation and growth through people-centric strategies. Data sciences leader focused on data analysis, visualization, and solutions to solve key issues in clinical trials. On a personal level, deeply committed to supporting educational excellence, particularly for underprivileged children., avatar=Image{width=661,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Nithiyanandhan-Ananthakrishnan-1.png',altText='Nithiyanandhan-Ananthakrishnan-1',fileId=167393416229}, linkedin=https://www.linkedin.com/in/nithiyanandhan/, team=[{id=163080551773, name='Clinical Solutions Leadership'}], lastname=Ananthakrishnan, hs_initial_published_at=1713346931329, hs_created_by_user_id=62155952, hs_created_at=1713346306368, hs_is_edited=false, hs_deleted_at=0, name=Nithiya, position=Senior Vice President, job=Biometrics, slug=nithiya-ananthakrishnan, hs_updated_by_user_id=65160865}, third={}})
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        Niveda R.

      • Nithiya A. avatar

        Nithiya A.

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    • Read: Case Study: Delivering Pivotal Data in Phase 3 R/R Multiple Myeloma Case Study: Delivering Pivotal Data in Phase 3 R/R Multiple Myeloma

      Clinical Trials - Oncology

      Case Study: Delivering Pivotal Data in Phase 3 R/R Multiple Myeloma

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=164725548848, hs_child_table_id=0, hs_updated_at=1754641451547, hs_published_at=1768210872876, 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=65160865}, second={}, third={}})
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        Alexis Hobbins-White

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    • Read: Case Study: Precise Data Management in Rare Liver Disease RNAi Trial Case Study: Precise Data Management in Rare Liver Disease RNAi Trial

      Clinical Trials - Autoimmune

      Case Study: Precise Data Management in Rare Liver Disease RNAi Trial

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=164725548848, hs_child_table_id=0, hs_updated_at=1754641451547, hs_published_at=1768210872876, 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=65160865}, second={}, third={}})
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        Alexis Hobbins-White

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  • Translational Research Insights

    All Translational Research Articles
    • 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

      Translational Research - Biospecimens - Oncology

      Back to the Source: A Translational Leader on Extending the Living Legacy of Genomic Data

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778886, hs_child_table_id=0, hs_updated_at=1763657611624, hs_published_at=1768210872876, 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=1767768596569, 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={hs_id=164691024166, hs_child_table_id=0, hs_updated_at=1716326265678, hs_published_at=1768210872876, description=Respected veteran of the biospecimen and biomarker laboratory services industry. Honed his expertise through leadership roles in organizations including Roche, Cancer Genetics, and BioServe. Holds a Master of Public Health and a Masters of Business Administration from the Johns Hopkins University., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Rob%20Fannon%20Headshot.webp',altText='Rob Fannon Headshot',fileId=165893006477}, linkedin=https://www.linkedin.com/in/rob-fannon-901378/, team=[{id=163072475009, name='Translational Sciences Leadership'}], lastname=Fannon, MPH, MBA, hs_initial_published_at=1713346931329, hs_created_by_user_id=62155952, hs_created_at=1713345787919, hs_is_edited=false, hs_deleted_at=0, name=Rob, job=General Manager, Biospecimen Solutions, slug=rob-fannon, hs_updated_by_user_id=65160865}, third={}})
      • Robert S. avatar

        Robert S.

      • Rob F. avatar

        Rob F.

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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

      Translational Research - Biospecimens

      Reflect on 20 Years of Cancer Research with MIRROR Biospecimens

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=199448088864, hs_child_table_id=0, hs_updated_at=1762810484868, hs_published_at=1768210872876, 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=65160865}, second={}, third={}})
      • Kaylee Mueller avatar

        Kaylee Mueller

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    • Read: Lost in Translation: Turning Multi-omic Chaos into Clinical Clarity Lost in Translation: Turning Multi-omic Chaos into Clinical Clarity

      Translational Research - Lab Services

      Lost in Translation: Turning Multi-omic Chaos into Clinical Clarity

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        has third author: false, (SizeLimitingPyMap: {main={hs_id=159488778872, hs_child_table_id=0, hs_updated_at=1744653337128, hs_published_at=1768210872876, description=Visionary leader with decades of distinguished biotechnology and clinical translational research experience. Founded ApoCell in 2004 and later was instrumental in developing and commercializing the ApoStream® rare-cell liquid biopsy technology. Globally recognized cancer researcher and the author of more than 100 peer-reviewed publications. Dedicated and committed to improving the lives of patients with debilitating diseases., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Darren%20Davis.webp',altText='Darren Davis',fileId=165891429693}, linkedin=https://www.linkedin.com/in/drdarrendavis, team=[{id=163072475009, name='Translational Sciences Leadership'}], hs_name=, hs_path=, lastname=Davis, PhD, hs_initial_published_at=1767768596569, hs_created_at=1709645745103, hs_is_edited=false, hs_deleted_at=0, name=Darren, job=Senior Vice President, Translational Sciences, slug=darren-davis, email=, hs_updated_by_user_id=65160865}, second={hs_id=167888548278, hs_child_table_id=0, hs_updated_at=1722451546286, hs_published_at=1768210872876, 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=163072475009, name='Translational Sciences Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716194887110, hs_created_by_user_id=2737751, hs_created_at=1716194842710, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job=Chief Scientific Officer, slug=deborah-phippard-translational-sciences, email=, hs_updated_by_user_id=65160865}, third={hs_id=159488778886, hs_child_table_id=0, hs_updated_at=1763657611624, hs_published_at=1768210872876, 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=1767768596569, 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}})
      • Darren D. avatar Deborah P. avatar Robert S. avatar
      • Darren D.

        Deborah P.

        Robert S.

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All articles

  • Read: Rare Disease Clinical Trials in Pediatric Populations: Lessons Learned Rare Disease Clinical Trials in Pediatric Populations: Lessons Learned

    Clinical Trials - Rare Diseases

    Rare Disease Clinical Trials in Pediatric Populations: Lessons Learned

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778849, hs_child_table_id=0, hs_updated_at=1714461239390, hs_published_at=1768210872876, description=Traci Fulton is Vice President of Project Management at Precision for Medicine, providing senior level oversight and support for clinical trials spanning rare disease, oncology and CNS indications. Ms. Fulton brings over 21 years’ experience with CRO teams, supporting the conduct of clinical trials across all phases, with over 18 years of her career focused on execution and delivery for complex clinical trials in oncology and rare diseases. She is passionate in her approach to support trials and her drive to support advancements in the treatment for underserved patient populations., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Traci%20Fulton.webp',altText='Traci Fulton',fileId=165892782093}, linkedin=https://www.linkedin.com/in/traci-kruckemyer-fulton-70ab42a, hs_name=, hs_path=, lastname=Fulton, hs_initial_published_at=1767768596569, hs_created_at=1709645745080, hs_is_edited=false, hs_deleted_at=0, name=Traci, job=, slug=traci-fulton, email=, hs_updated_by_user_id=65160865}, second={}, third={}})
    • Traci Fulton avatar

      Traci Fulton

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