Skip to content
Precision for Medicine
Early Access to Whitepaper

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

false
Blog

The Precision Blog

100% sourced from leading minds on the front lines of research

Recent and Featured Posts

View all articles
  • Clinical Research Insights

    All Clinical Research Articles
    • Read: Hope Through Access: Inside the Partnership Bringing Novel Cancer Therapies to Patients Worldwide Hope Through Access: Inside the Partnership Bringing Novel Cancer Therapies to Patients Worldwide

      Clinical Trials - Oncology

      Hope Through Access: Inside the Partnership Bringing Novel Cancer Therapies to Patients Worldwide

      |
        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1754641583843, hs_published_at=1768210872876, 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=1767768596569, 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=65160865}, second={}, third={}})
      • Rob Maiale avatar

        Rob Maiale

      Discover
    • 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

      |
        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={}})
      • Niveda R. avatar

        Niveda R.

      • Nithiya A. avatar

        Nithiya A.

      Discover
    • 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

      |
        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={}})
      • Alexis Hobbins-White avatar

        Alexis Hobbins-White

      Discover
  • 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

      |
        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.

      Discover
    • 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

      |
        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

      Discover
    • 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

      |
        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.

      Discover

All articles

  • Read: Rescuing a Complex Hematology Oncology Trial: Case Study in Precision Rescuing a Complex Hematology Oncology Trial: Case Study in Precision

    Clinical Trials - Oncology

    Rescuing a Complex Hematology Oncology Trial: Case Study in Precision

    |
      has third author: false, (SizeLimitingPyMap: {main={hs_id=164713188766, hs_child_table_id=0, hs_updated_at=1754641439746, hs_published_at=1768210872876, description=Anne Kopko is a Clinical Science Analytics & Insights Principal Scientist with fifteen years of professional oncology clinical research experience supporting Phase 1-3 clinical trials across a variety of therapeutic areas, including first-in-human, Phase 1-2 combination trials, dose escalation and expansion hematology and solid tumor studies. She plays a pivotal role in navigating the complex landscape of clinical data quality and supporting the cross-functional data cleaning process. She is a knowledgeable and collaborative partner with a passion to deliver quality data to her clients through a holistic, clinical sense data review approach., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Anne-Kopko-300x300.png',altText='Anne-Kopko-300x300',fileId=194099000835}, linkedin=https://www.linkedin.com/in/anne-kopko-39b16888/, lastname=Kopko, hs_initial_published_at=1713363230550, hs_created_by_user_id=5166971, hs_created_at=1713362764236, hs_is_edited=false, hs_deleted_at=0, name=Anne, job=Manager, Clinical Oncology Solutions, slug=anne-kopko, hs_updated_by_user_id=65160865}, second={hs_id=182260357962, hs_child_table_id=0, hs_updated_at=1754641265490, hs_published_at=1768210872876, description=Andrea Chavlovich is Senior Clinical Scientist and contact for Clinical Science Analytics & Insights (CSAI). She is a hematology/oncology nurse (BSN, RN, BS) with over seven years of clinical research experience, both at the CRO and site levels. Andrea has worked on Phase 1-4 Oncology studies, including First-In-Human (FIH), Dose Escalation, and Dose Expansion. She has experience in hematology, cellular therapy, solid tumor, and rare disease studies, including but not limited to AML, breast cancer, and pancreatic malignancies. ​, avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/andrea-chavlovich-1.png',altText='andrea-chavlovich-1',fileId=194126030109}, lastname=Chavlovich​, hs_initial_published_at=1730486124094, hs_created_by_user_id=26433386, hs_created_at=1730485944077, hs_is_edited=false, hs_deleted_at=0, name=Andrea​, job=Senior Clinical Scientist, slug=andrea-chavlovich​, hs_updated_by_user_id=65160865}, third={hs_id=164713188782, hs_child_table_id=0, hs_updated_at=1754641432625, hs_published_at=1768210872876, description=Hasni M’hidi, PhD is a seasoned oncology clinical research professional, passionate about advancing medical science. As Global Project Manager, Hasni oversees operations in the US and EU. His expertise spans all phases of clinical trials, and his commitment to improving patient outcomes is unwavering., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Hasni-Mhidi-300x300.png',altText='Hasni-Mhidi-300x300',fileId=194097314083}, linkedin=https://www.linkedin.com/in/hasni-m-hidi-4902b086/, lastname=M’hidi, PhD, hs_initial_published_at=1713363230550, hs_created_by_user_id=5166971, hs_created_at=1713362890341, hs_is_edited=false, hs_deleted_at=0, name=Hasni, job=Project Manager, slug=hasni-mhidi, hs_updated_by_user_id=65160865}})
    • Anne K. avatar Andrea​ C. avatar Hasni M. avatar
    • Anne K.

      Andrea​ C.

      Hasni M.

    Discover
  • Read: Case Study: AML Phase 1-2 Trial Case Study: AML Phase 1-2 Trial

    Clinical Trials - Oncology

    Case Study: AML Phase 1-2 Trial

    |
      has not third author: true, (SizeLimitingPyMap: {main={hs_id=164713188766, hs_child_table_id=0, hs_updated_at=1754641439746, hs_published_at=1768210872876, description=Anne Kopko is a Clinical Science Analytics & Insights Principal Scientist with fifteen years of professional oncology clinical research experience supporting Phase 1-3 clinical trials across a variety of therapeutic areas, including first-in-human, Phase 1-2 combination trials, dose escalation and expansion hematology and solid tumor studies. She plays a pivotal role in navigating the complex landscape of clinical data quality and supporting the cross-functional data cleaning process. She is a knowledgeable and collaborative partner with a passion to deliver quality data to her clients through a holistic, clinical sense data review approach., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Anne-Kopko-300x300.png',altText='Anne-Kopko-300x300',fileId=194099000835}, linkedin=https://www.linkedin.com/in/anne-kopko-39b16888/, lastname=Kopko, hs_initial_published_at=1713363230550, hs_created_by_user_id=5166971, hs_created_at=1713362764236, hs_is_edited=false, hs_deleted_at=0, name=Anne, job=Manager, Clinical Oncology Solutions, slug=anne-kopko, hs_updated_by_user_id=65160865}, second={hs_id=164713188782, hs_child_table_id=0, hs_updated_at=1754641432625, hs_published_at=1768210872876, description=Hasni M’hidi, PhD is a seasoned oncology clinical research professional, passionate about advancing medical science. As Global Project Manager, Hasni oversees operations in the US and EU. His expertise spans all phases of clinical trials, and his commitment to improving patient outcomes is unwavering., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Hasni-Mhidi-300x300.png',altText='Hasni-Mhidi-300x300',fileId=194097314083}, linkedin=https://www.linkedin.com/in/hasni-m-hidi-4902b086/, lastname=M’hidi, PhD, hs_initial_published_at=1713363230550, hs_created_by_user_id=5166971, hs_created_at=1713362890341, hs_is_edited=false, hs_deleted_at=0, name=Hasni, job=Project Manager, slug=hasni-mhidi, hs_updated_by_user_id=65160865}, third={}})
    • Anne K. avatar

      Anne K.

    • Hasni M. avatar

      Hasni M.

    Discover
Loading...
You've reach the end