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=1736962071401, 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=1736962071401, 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={}})
Optimizing Immunohistochemistry Validation and Regulatory Strategies
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Women Leaders Share Raw Truths About Leadership in Life Sciences
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1736540179119, hs_published_at=1736962071401, description=Rob Maiale is an innovative marketing leader and creative technologist who transforms complex healthcare challenges into meaningful, impactful stories. With over 15 years of experience across clinical and translational research, patient education, pharmaceuticals, and diagnostics, he merges cutting-edge technology with inspired storytelling to build award-winning brand narratives. At Precision, Rob collaborates with leading experts to translate deep scientific expertise into accessible, engaging, and culturally resonant content—connecting audiences to the future of life-changing research., avatar=Image{width=400,height=400,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Rob%20Maiale.jpg',altText='Rob Maiale',fileId=184765575245}, linkedin=https://www.linkedin.com/in/rob-maiale/, hs_name=, hs_path=, lastname=Maiale, hs_initial_published_at=1729783715853, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, job=, slug=rob-maiale, email=, hs_updated_by_user_id=26433386}, second={hs_id=181884577650, hs_child_table_id=0, hs_updated_at=1729782746463, hs_published_at=1736962071401, 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/niveda-ramkumar.jpg',altText='niveda-ramkumar',fileId=181890014492}, 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=26433386}, third={}})
Immunohistochemistry in Precision Medicine: From Biomarker to Clinical Trial Assay
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778881, hs_child_table_id=0, hs_updated_at=1716197119194, hs_published_at=1736962071401, description=Experienced leader of scientific operations for drug discovery in both the pharmaceutical and CRO industries. Driven to provide actionable data enabling biopharmaceutical research and development. Collaborative partner ensuring licensing and scientific support for corporate development initiatives., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Amanda%20Woodroofe.webp',altText='Amanda Woodroofe',fileId=164429420051}, linkedin=https://www.linkedin.com/in/amandawoodrooffe, team=[{id=163072475009, name='Translational Sciences Leadership'}], hs_name=, hs_path=, lastname=Woodrooffe, PhD, hs_initial_published_at=1716212769184, hs_created_at=1709645745112, hs_is_edited=false, hs_deleted_at=0, name=Amanda, job=Senior Vice President, General Manager UK Labs, slug=amanda-woodrooffe, email=, hs_updated_by_user_id=26433386}, second={hs_id=163118037132, hs_child_table_id=0, hs_updated_at=1716310426403, hs_published_at=1736962071401, description=Former Chief of Pathology at Greensboro Pathology Associates, part of Sonic Healthcare, Aurora Diagnostics, Inc. •Hematopathology and Anatomical and Clinical Pathology, American Board of Pathology, avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Dawn%20Butler.webp',altText='Dawn Butler',fileId=165893006480}, linkedin=https://www.linkedin.com/in/dawn-lain-butler-4a014b1a6/, lastname=Butler, hs_initial_published_at=1712160837127, hs_created_by_user_id=5166971, hs_created_at=1712160272387, hs_is_edited=false, hs_deleted_at=0, name=Dawn, job=M.D. Staff Pathologist, slug=dawn-butler, hs_updated_by_user_id=51739740}, third={}})
Protein Assays: Choosing the Most Effective Method for Biopharmaceutical Development
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778889, hs_child_table_id=0, hs_updated_at=1714461111815, hs_published_at=1736962071401, 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}, second={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1736962071401, 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}, third={}})
Precision Medicine in Pediatrics: Biomarkers and Assay Development
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778880, hs_child_table_id=0, hs_updated_at=1714461214107, hs_published_at=1736962071401, description=Eva Raschke, PhD serves as a subject matter expert for immune monitoring solutions at Precision for Medicine with a focus on the epigenetic immune monitoring technology Epiontis ID. She has supported the development, validation and clinical use of this technology platform in different roles since 2008. Eva obtained a Ph.D. in Molecular Biology from the Ludwig-Maximilians-University Munich., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Eva%20Raschke.webp',altText='Eva Raschke',fileId=165892728972}, linkedin=https://www.linkedin.com/in/eva-raschke-678b439, hs_name=, hs_path=, lastname=Raschke, hs_initial_published_at=1716212769184, hs_created_at=1709645745111, hs_is_edited=false, hs_deleted_at=0, name=Eva, job=, slug=eva-raschke, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics
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Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies
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8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy
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