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=1739807653319, 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=51739740}, second={hs_id=159488778840, hs_child_table_id=0, hs_updated_at=1716132440837, hs_published_at=1739807653319, 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=51739740}, third={}})
Optimizing Immunohistochemistry Validation and Regulatory Strategies
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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=1739807653319, 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=1716212769184, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=51739740}, second={hs_id=182710436924, hs_child_table_id=0, hs_updated_at=1731419754428, hs_published_at=1739807653319, 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=51739740}, 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=1739807653319, 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=51739740}, second={hs_id=163118037132, hs_child_table_id=0, hs_updated_at=1716310426403, hs_published_at=1739807653319, 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={}})
Choosing the Optimal Sample Type for Flow Cytometry: Key Considerations and Case Studies
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778846, hs_child_table_id=0, hs_updated_at=1713168962876, hs_published_at=1739807653319, description=Angelina Bisconte is an authority in utilizing human primary biological tissue and cells in research and drug discovery. She is a developer of translational biomarkers for Phase I/II clinical programs in autoimmunity, inflammation and cancer, and is an expert in phenotypic cell-based assays using multiple primary cell systems such as T/Th17/T-regs, NK-T, B/Plasma/Plasmablasts, Myeloid cells, Dendritic cells (pDCc/mDCs), and MDSCs. She serves as a strategist in multi-parametric single-cell flow cytometry and analysis of flow cytometry data. Additionally, Angelina maintains a broad network of contacts at clinical sites and research hospitals, experienced with IRB submissions and clinical protocols. She is a scientific leader for Precision’s Biomaterials commercial sourcing., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Angelina%20Bisconte.webp',altText='Angelina Bisconte',fileId=164430032419}, linkedin=https://www.linkedin.com/in/angelinabisconte, hs_name=, hs_path=, lastname=Bisconte, hs_initial_published_at=1716136551646, hs_created_at=1709645745077, hs_is_edited=false, hs_deleted_at=0, name=Angelina, job=, slug=angelina-bisconte, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Moving from Exploratory to Clinical Flow Cytometry Assays: 3 Critical Considerations
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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=1739807653319, 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=51739740}, second={}, third={}})
Harnessing the Power of Flow Cytometry in Biomarker-Driven Clinical Trials
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778877, hs_child_table_id=0, hs_updated_at=1714461706779, hs_published_at=1739807653319, description=Dr. Laura Lozza is Senior Director for Cell Biology at Precision for Medicine. She has long-standing expertise in immune monitoring and immune assay development with a particular focus on flow cytometry assays. Her focused on human immunology, including characterizing the regulatory activities of CD4 T cells, as well as analyzing the response of human dendritic cells in tuberculosis disease and BCG vaccination. She was a leader in establishing Precision’s Cell Biology Lab in Berlin which supports assay development and validation utilizing flow cytometry as well as other cell biology technologies., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Laura%20Lozza.webp',altText='Laura Lozza',fileId=165892782092}, linkedin=https://www.linkedin.com/in/laura-lozza, hs_name=, hs_path=, lastname=Lozza, hs_initial_published_at=1716212769184, hs_created_at=1709645745108, hs_is_edited=false, hs_deleted_at=0, name=Laura, job=, slug=laura-lozza, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
