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  • Clinical Research Insights

    All Clinical Research Articles
    • Read: Case Study: Early Genotype Confirmation Rescued a Phase 1-2 SCID Trial Case Study: Early Genotype Confirmation Rescued a Phase 1-2 SCID Trial

      Clinical Trials - Rare Diseases

      Case Study: Early Genotype Confirmation Rescued a Phase 1-2 SCID Trial

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=164725548848, hs_child_table_id=0, hs_updated_at=1716454310949, hs_published_at=1753470181038, 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=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Alexis-Hobbins-White-150x150.jpeg',altText='Alexis-Hobbins-White-150x150',fileId=164710912635}, 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=9297597}, second={}, third={}})
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        Alexis Hobbins-White

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    • Read: Phase 3 Prostate Cancer Case Study: Radiopharm Imaging at Scale Phase 3 Prostate Cancer Case Study: Radiopharm Imaging at Scale

      Clinical Trials

      Phase 3 Prostate Cancer Case Study: Radiopharm Imaging at Scale

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778843, hs_child_table_id=0, hs_updated_at=1714461297945, hs_published_at=1753470181038, 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=1716212769184, hs_created_at=1709645745074, hs_is_edited=false, hs_deleted_at=0, name=Robert, job=, slug=robert-bauer, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
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        Robert Bauer

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    • Read: Taiwan’s Clinical Trial Landscape: Fast, Efficient, and High-Quality Research Taiwan’s Clinical Trial Landscape: Fast, Efficient, and High-Quality Research

      Clinical Trials

      Taiwan’s Clinical Trial Landscape: Fast, Efficient, and High-Quality Research

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        has third author: false, (SizeLimitingPyMap: {main={hs_id=167906611101, hs_child_table_id=0, hs_updated_at=1743507158804, hs_published_at=1753470181038, description=Helen brings over 30 years of experience in multinational healthcare, biotech, and pharmaceutical industries, including work with Medical Research Institutes and CROs. She specializes in leading clinical research, drug and device development, and fostering innovative research collaborations. Based in Sydney, Australia, Helen has a strong track record of delivering clinical trials across the APAC region., avatar=Image{width=600,height=700,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Helene-Ormandy.png',altText='Helene-Ormandy',fileId=168387434767}, lastname=Ormandy, PhD, hs_initial_published_at=1716212950394, hs_created_by_user_id=2737751, hs_created_at=1716212897654, hs_is_edited=false, hs_deleted_at=0, name=Helen, job=Senior Director, Clinical Operations, slug=helen-ormandy, hs_updated_by_user_id=26433386}, second={hs_id=192644417560, hs_child_table_id=0, hs_updated_at=1752501506910, hs_published_at=1753470181038, description=Gavin Phan is a pharmacist based in Melbourne, Australia, who leads Precision’s APAC CRA team. Gavin has over a decade of experience in diverse clinical operations and leading teams throughout AsiaPac, including Taiwan., avatar=Image{width=622,height=624,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Gavin%20Phan.jpg',altText='Gavin Phan',fileId=192648011133}, lastname=Phan, hs_initial_published_at=1752501514571, hs_created_by_user_id=26433386, hs_created_at=1752501444306, hs_is_edited=false, hs_deleted_at=0, name=Gavin, job=Manager, Global Clinical Monitoring, slug=gavin-phan, hs_updated_by_user_id=26433386}, third={hs_id=192645526119, hs_child_table_id=0, hs_updated_at=1752501710597, hs_published_at=1753470181038, description=Kelly Lin is a Senior Clinical Research Associate supporting Precision clinical trials in the AsiaPac region., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Precision%20Expert.png',altText='Precision Expert',fileId=164175466823}, lastname=Lin, hs_initial_published_at=1752501630185, hs_created_by_user_id=26433386, hs_created_at=1752501557958, hs_is_edited=false, hs_deleted_at=0, name=Kelly, job=Senior Clinical Research Associate, slug=kelly-lin, hs_updated_by_user_id=26433386}})
      • Helen O. avatar Gavin P. avatar Kelly L. avatar
      • Helen O.

        Gavin P.

        Kelly L.

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  • Translational Research Insights

    All Translational Research Articles
    • Read: From Bench to Breakthrough: How Custom Kitting Fuels Precision Trials From Bench to Breakthrough: How Custom Kitting Fuels Precision Trials

      Translational Research - Biomarkers

      From Bench to Breakthrough: How Custom Kitting Fuels Precision Trials

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1753470181038, 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=163072475007, name='Precision for Medicine Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716212769184, hs_created_at=1709645745106, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job= Chief Scientific Officer, slug=deborah-phippard, email=, hs_updated_by_user_id=26433386}, second={hs_id=182710436924, hs_child_table_id=0, hs_updated_at=1731419754428, hs_published_at=1753470181038, description=Christie Bongel, MS, CT(ASCP), brings nearly two decades of experience in both research and clinical medicine. As the site director for Precision for Medicine’s IHC Center of Excellence in North Carolina, she excels in managing scientific operations and collaborating with clients. Christie is skilled in cytology, laboratory medicine, and molecular diagnostics. Her role focuses on building an energized team dedicated to delivering life-changing outcomes for patients. Christie earned her MS in Applied Biotechnology and is an ASCP certified cytotechnologist., avatar=Image{width=260,height=260,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Christie%20Bongel_Square_260px.jpg',altText='Christie Bongel_Square_260px',fileId=178044303113}, lastname= Bongel, hs_initial_published_at=1731517828480, hs_created_by_user_id=28386183, hs_created_at=1731419696820, hs_is_edited=false, hs_deleted_at=0, name=Christie, job=Site Director - Histology, slug=christie-bongel, hs_updated_by_user_id=26433386}, third={}})
      • Deborah P. avatar

        Deborah P.

      • Christie  . avatar

        Christie .

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    • Read: Key Strategies for Future-Proofing Gene Therapy Assays Key Strategies for Future-Proofing Gene Therapy Assays

      Translational Research - Regulatory - Assays - Gene Therapies

      Key Strategies for Future-Proofing Gene Therapy Assays

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1753470181038, 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=163072475007, name='Precision for Medicine Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716212769184, hs_created_at=1709645745106, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job= Chief Scientific Officer, slug=deborah-phippard, email=, hs_updated_by_user_id=26433386}, second={hs_id=159488778889, hs_child_table_id=0, hs_updated_at=1714461111815, hs_published_at=1753470181038, description=Travis Harrison, PhD, is Vice President of Diagnostic Development at Precision for Medicine. He brings more than 20 years of bioanalytical assay experience to the Precision team with expertise in ligand-binding and cell-based assays.  Travis has experience supporting clinical and nonclinical studies for a broad range of indications, with an emphasis on diagnostic assays to evaluate immune responses to gene therapies., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Travis%20Harrison.webp',altText='Travis Harrison',fileId=165893006481}, linkedin=https://www.linkedin.com/in/travis-harrison-phd-6108852/, hs_name=, hs_path=, lastname=Harrison, hs_initial_published_at=1716212769184, hs_created_at=1709645745120, hs_is_edited=false, hs_deleted_at=0, name=Travis, job=, slug=travis-harrison, email=, hs_updated_by_user_id=26433386}, third={}})
      • Deborah P. avatar

        Deborah P.

      • Travis H. avatar

        Travis H.

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    • Read: Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

      Translational Research - Regulatory - Assays - Gene Therapies

      Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1753470181038, 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=163072475007, name='Precision for Medicine Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716212769184, hs_created_at=1709645745106, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job= Chief Scientific Officer, slug=deborah-phippard, email=, hs_updated_by_user_id=26433386}, second={hs_id=159488778840, hs_child_table_id=0, hs_updated_at=1716132440837, hs_published_at=1753470181038, description=Maham Ansari, MS, RAC is a Senior Director, IVD Regulatory Affairs. Her focus is on companion diagnostic co-development programs, where she leverages her regulatory expertise to secure approvals in the US, Europe and beyond for companion diagnostics with a specific focus on gene therapy. She brings more than 16 years of global regulatory leadership experience in the medical device and in vitro diagnostics industry, spanning major multinationals to small start-ups, including full life cycle management across all stages of product development, execution of global regulatory strategies, and post-market surveillance.sh, avatar=Image{width=710,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Maham_Ansari.png',altText='Maham_Ansari',fileId=167373022876}, linkedin=https://www.linkedin.com/in/maham-ansari-ms-rac-6a735739, hs_name=, hs_path=, lastname=Ansari, hs_initial_published_at=1716212769184, hs_created_at=1709645745071, hs_is_edited=false, hs_deleted_at=0, name=Maham, job=, slug=maham-ansari, email=, hs_updated_by_user_id=26433386}, third={}})
      • Deborah P. avatar

        Deborah P.

      • Maham A. avatar

        Maham A.

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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

    Rescuing a Complex Hematology Oncology Trial: Case Study in Precision

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      has third author: false, (SizeLimitingPyMap: {main={hs_id=164713188766, hs_child_table_id=0, hs_updated_at=1714747844927, hs_published_at=1753470181038, 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=300,height=300,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Anne-Kopko-300x300.jpeg',altText='Anne-Kopko-300x300',fileId=164721973774}, 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=26433386}, second={hs_id=182260357962, hs_child_table_id=0, hs_updated_at=1730486118009, hs_published_at=1753470181038, 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=250,height=248,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Andrea%20Chavlovich%E2%80%8B.jpg',altText='Andrea Chavlovich​',fileId=182263330445}, 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=26433386}, third={hs_id=164713188782, hs_child_table_id=0, hs_updated_at=1714747852941, hs_published_at=1753470181038, 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=300,height=300,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Hasni-Mhidi-300x300.jpeg',altText='Hasni-Mhidi-300x300',fileId=164721971514}, 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=26433386}})
    • Anne K. avatar Andrea​ C. avatar Hasni M. avatar
    • Anne K.

      Andrea​ C.

      Hasni M.

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  • 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

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=164713188766, hs_child_table_id=0, hs_updated_at=1714747844927, hs_published_at=1753470181038, 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=300,height=300,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Anne-Kopko-300x300.jpeg',altText='Anne-Kopko-300x300',fileId=164721973774}, 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=26433386}, second={hs_id=164713188782, hs_child_table_id=0, hs_updated_at=1714747852941, hs_published_at=1753470181038, 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=300,height=300,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Hasni-Mhidi-300x300.jpeg',altText='Hasni-Mhidi-300x300',fileId=164721971514}, 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=26433386}, third={}})
    • Anne K. avatar

      Anne K.

    • Hasni M. avatar

      Hasni M.

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