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Gene Therapies

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  • Read: Clinical Trial Trends: Gene Therapy Clinical Trial Trends: Gene Therapy

    Clinical Trials - Gene Therapies

    Clinical Trial Trends: Gene Therapy

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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=1761062733198, 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=26433386}, second={}, third={}})
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      Alexis Hobbins-White

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  • Read: Case Study: Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy Case Study: Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy

    Early Phase Research - Gene Therapies

    Case Study: Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy

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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=1761062733198, 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=26433386}, second={}, third={}})
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      Alexis Hobbins-White

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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=1761062733198, 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=1758208027822, 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=1761062733198, 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=1758208027822, 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.

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      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=1761062733198, 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=1758208027822, 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=1761062733198, 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=1758208027822, 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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  • Read: Therapeutic Genome Editing – Reshaping the Landscape of Advanced Therapies Therapeutic Genome Editing

    Regulatory - Gene Therapies

    Therapeutic Genome Editing – Reshaping the Landscape of Advanced Therapies

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=169567234066, hs_child_table_id=0, hs_updated_at=1723217613021, hs_published_at=1761062733198, description=Precision Experts are among the most experienced specialists in clinical research. We focus our hiring strategy on select indications to deliver excellence across each role. , avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Precision%20Expert.png',altText='Precision Expert',fileId=164175466823}, lastname=Experts, hs_initial_published_at=1718988967067, hs_created_by_user_id=26433386, hs_created_at=1717603871601, hs_is_edited=false, hs_deleted_at=0, name=Precision, slug=precision-experts, hs_updated_by_user_id=26433386}, second={}, third={}})
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  • Read: Navigating Cell and Gene Therapy Acquisitions: A Strategic Blueprint Navigating Cell and Gene Therapy Acquisitions: A Strategic Blueprint

    Manufacturing - Cell Therapies - Gene Therapies

    Navigating Cell and Gene Therapy Acquisitions: A Strategic Blueprint

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1761062733198, description=Groundbreaking biotech entrepreneur, executive, and investor, dedicated to delivering transformative treatments to the patients who need them. Pioneered the industrialization of advanced therapeutics, including some of the earliest commercially approved cell and gene therapies, radioligand treatments, RNA-based therapies, and cutting-edge biologics. Created the leading global biologics and advanced therapy engineering consulting firm and developed the largest cell and gene therapy manufacturing footprint in the world. Deeply committed to advancing next-generation medicines, serves on multiple boards, philanthropic organizations, and patient-advocacy groups, including IQHQ, Alliance for Regenerative Medicines, and Alliance for mRNA Medicines., avatar=Image{width=720,height=812,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Anshul-Mangal.png',altText='Anshul-Mangal',fileId=167370347684}, linkedin=https://www.linkedin.com/in/amangal/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Mangal, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713169484118, hs_is_edited=false, hs_deleted_at=0, name=Anshul, job=President, Manufacturing Solutions, slug=anshul-mangal, hs_updated_by_user_id=26433386}, second={hs_id=164426546553, hs_child_table_id=0, hs_updated_at=1716454239819, hs_published_at=1761062733198, description=Life sciences leader who helped pioneer the industrialization of biologics and advanced therapies. Deep expertise in small and large molecules, honed through work with a range of life science organizations, from start-ups and academic centers to financial institutions and CMOs/CROs. Spearheaded significant global turnkey facility builds, automation, validation, engineering, and serialization track and trace, deploying billions in capital across the life sciences sector. Led the creation of the Advanced Therapy Manufacturing Playbook which has helped develop the world’s largest advanced therapy manufacturing footprint. Actively serves on multiple boards including academic, philanthropic, biotech, and financial investment institutions., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Tony%20Khoury.webp',altText='Tony Khoury',fileId=165893018152}, linkedin=https://www.linkedin.com/in/tony-khoury-7470755/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Khoury, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713169549303, hs_is_edited=false, hs_deleted_at=0, name=Tony, job=Executive Vice President, Manufacturing Solutions, slug=tony-khoury, hs_updated_by_user_id=26433386}, third={}})
    • Anshul M. avatar

      Anshul M.

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      Tony K.

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  • Read: Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies

    Translational Research - Gene Therapies

    Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1714461729999, hs_published_at=1761062733198, description=Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Kennon%20Daniels.webp',altText='Kennon Daniels',fileId=165893120790}, linkedin=https://www.linkedin.com/in/kennon-daniels-ph-d-84a90b6, hs_name=, hs_path=, lastname=Daniels, hs_initial_published_at=1758208027822, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=26433386}, second={hs_id=159488778882, hs_child_table_id=0, hs_updated_at=1714461102447, hs_published_at=1761062733198, description=Dr. Curnutte has more than ten years of research and regulatory affairs experience focused on in vitro diagnostics (IVDs). She has held regulatory positions at both device and pharmaceutical companies, during which she led seven U.S. and ex-U.S. companion diagnostic registrations. She has extensive expertise in CDx development and clinical trial integration, IVD product development, next-generation sequencing technologies, and translation of U.S. regulatory strategy to major markets., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Margaret%20Curnutte.webp',altText='Margaret Curnutte',fileId=165892782094}, linkedin=https://www.linkedin.com/in/margaret-curnutte-93558913, hs_name=, hs_path=, lastname=Curnutte, hs_initial_published_at=1758208027822, hs_created_at=1709645745113, hs_is_edited=false, hs_deleted_at=0, name=Margaret, job=, slug=margaret-curnutte, email=, hs_updated_by_user_id=26433386}, third={}})
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      Kennon D.

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      Margaret C.

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  • Read: 8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy

    Translational Research - Gene Therapies

    8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy

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      has third author: false, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1761062733198, 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=1758208027822, 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=159488778874, hs_child_table_id=0, hs_updated_at=1714461729999, hs_published_at=1761062733198, description=Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Kennon%20Daniels.webp',altText='Kennon Daniels',fileId=165893120790}, linkedin=https://www.linkedin.com/in/kennon-daniels-ph-d-84a90b6, hs_name=, hs_path=, lastname=Daniels, hs_initial_published_at=1758208027822, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=26433386}, third={hs_id=159488778889, hs_child_table_id=0, hs_updated_at=1714461111815, hs_published_at=1761062733198, 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=1758208027822, 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}})
    • Deborah P. avatar Kennon D. avatar Travis H. avatar
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  • Read: Scaling Hope: The Growth of Allogeneic Cell Therapy Sector Scaling Hope: The Growth of Allogeneic Cell Therapy Sector

    Manufacturing - Cell Therapies - Gene Therapies

    Scaling Hope: The Growth of Allogeneic Cell Therapy Sector

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1761062733198, description=Groundbreaking biotech entrepreneur, executive, and investor, dedicated to delivering transformative treatments to the patients who need them. Pioneered the industrialization of advanced therapeutics, including some of the earliest commercially approved cell and gene therapies, radioligand treatments, RNA-based therapies, and cutting-edge biologics. Created the leading global biologics and advanced therapy engineering consulting firm and developed the largest cell and gene therapy manufacturing footprint in the world. Deeply committed to advancing next-generation medicines, serves on multiple boards, philanthropic organizations, and patient-advocacy groups, including IQHQ, Alliance for Regenerative Medicines, and Alliance for mRNA Medicines., avatar=Image{width=720,height=812,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Anshul-Mangal.png',altText='Anshul-Mangal',fileId=167370347684}, linkedin=https://www.linkedin.com/in/amangal/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Mangal, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713169484118, hs_is_edited=false, hs_deleted_at=0, name=Anshul, job=President, Manufacturing Solutions, slug=anshul-mangal, hs_updated_by_user_id=26433386}, second={}, third={}})
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      Anshul Mangal

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