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The Precision Blog
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Read 2025 Biotech Economics: CROs, Advanced Therapies & Trends in Funding
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Read Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity
Read FDA's Project Optimus: What Pharma and Biotech Need to Know FDA's Project Optimus: What Pharma and Biotech Need to Know
Read The BIOSECURE Act’s Impact May Outlive the Bill Itself The BIOSECURE Act’s Impact May Outlive the Bill Itself
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Read: 2025 Biotech Economics: CROs, Advanced Therapies & Trends in Funding 
2025 Biotech Economics: CROs, Advanced Therapies & Trends in Funding
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1741014116242, hs_published_at=1741014119284, description=Rob Maiale is a marketing strategist and creative technologist known for shaping content strategies that drive engagement, influence, and business impact. With more than 15 years of experience spanning clinical research, patient education, pharma, and diagnostics, he specializes in turning expert insights into market-shaping narratives. At Precision, Rob leads innovative storytelling initiatives that connect cutting-edge science with the right audiences—leveraging AI, emerging technologies, and deep industry expertise to keep content ahead of the curve., 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=1741014119343, 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={}, third={}}) -
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Read: FDA's Project Optimus: What Pharma and Biotech Need to Know 
FDA's Project Optimus: What Pharma and Biotech Need to Know
has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1741014119284, description=Industry-leading oncologist and demonstrated medical leader in precision medicine, novel trial design and innovative regulatory initiatives designed to expedite drug approvals. Draws on nearly a decade leading oncology and rare disease programs at the FDA. Former fellow at the National Cancer Institute and frequent featured speaker at ASCO and AACR. CDER technical authority on oncologic drug and biological products for thoracic and head and neck malignancies, neurologic tumors, pediatric solid tumors and rare tumors., avatar=Image{width=553,height=580,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Harpreet-Singh2.png',altText='Harpreet-Singh2',fileId=171747124346}, linkedin=https://www.linkedin.com/in/harpreetsinghmd/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Singh, MD, hs_initial_published_at=1715692570942, hs_created_by_user_id=2737751, hs_created_at=1715692477118, hs_is_edited=false, hs_deleted_at=0, name=Harpreet, job=Chief Medical Officer, slug=harpreet-singh, hs_updated_by_user_id=26433386}, second={}, third={}}) -
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Read: Case Study Phase 3 NSCLC: Site Relationships Streamline Feasibility 
Case Study Phase 3 NSCLC: Site Relationships Streamline Feasibility
has not third author: true, (SizeLimitingPyMap: {main={hs_id=185838258545, hs_child_table_id=0, hs_updated_at=1738849388884, hs_published_at=1741014119284, description=Anna Rodecki is a results driven leader with 24 years of experience in clinical research across the pharmaceutical, device, and biotech industries. She has played a pivotal role in shaping clinical development plans on both Sponsor and CRO, successfully supporting First- In-Human (FIH) – Phase IV trials successfully across various therapeutics areas. Anan thrives on building strong, collaborative teams fostering innovation. Her expertise spans strategic planning, risk management, inspection readiness and cross-functional leadership – always with a focus on improving patient outcomes and advancing the future of medicine., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Anna%20Rodecki.png',altText='Anna Rodecki',fileId=185842773784}, lastname=Rodecki, hs_initial_published_at=1738849393727, hs_created_by_user_id=26433386, hs_created_at=1738849349748, hs_is_edited=false, hs_deleted_at=0, name=Anna, job=Director, Project Management, slug=anna-rodecki, hs_updated_by_user_id=26433386}, second={}, third={}}) -
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Read: Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity 
Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1741014119284, 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=1741014119343, 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=1741014119284, 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=1741014119343, 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={}}) -
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Read: Optimizing Immunohistochemistry Validation and Regulatory Strategies 
Optimizing Immunohistochemistry Validation and Regulatory Strategies
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1714461729999, hs_published_at=1741014119284, 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=1741014119343, 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=182710436924, hs_child_table_id=0, hs_updated_at=1731419754428, hs_published_at=1741014119284, 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={}}) -
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Read: Women Leaders Share Raw Truths About Leadership in Life Sciences 
Women Leaders Share Raw Truths About Leadership in Life Sciences
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1741014116242, hs_published_at=1741014119284, description=Rob Maiale is a marketing strategist and creative technologist known for shaping content strategies that drive engagement, influence, and business impact. With more than 15 years of experience spanning clinical research, patient education, pharma, and diagnostics, he specializes in turning expert insights into market-shaping narratives. At Precision, Rob leads innovative storytelling initiatives that connect cutting-edge science with the right audiences—leveraging AI, emerging technologies, and deep industry expertise to keep content ahead of the curve., 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=1741014119343, 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=1741014119284, 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={}}) -
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All articles
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Read: Immunohistochemistry in Precision Medicine: From Biomarker to Clinical Trial Assay 
Immunohistochemistry in Precision Medicine: From Biomarker to Clinical Trial Assay
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778881, hs_child_table_id=0, hs_updated_at=1716197119194, hs_published_at=1741014119284, 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=1741014119343, 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=1741014119284, 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=26433386}, third={}}) -
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Read: High-Quality Biospecimens in Therapeutic & Diagnostic Development: A Comprehensive Guide from Concept to Cloud 
High-Quality Biospecimens in Therapeutic & Diagnostic Development: A Comprehensive Guide from Concept to Cloud
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778881, hs_child_table_id=0, hs_updated_at=1716197119194, hs_published_at=1741014119284, 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=1741014119343, 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=159488778886, hs_child_table_id=0, hs_updated_at=1714461583598, hs_published_at=1741014119284, 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, hs_initial_published_at=1741014119343, hs_created_at=1709645745117, hs_is_edited=false, hs_deleted_at=0, name=Robert, job=, slug=robert-snyder, email=, hs_updated_by_user_id=26433386}, third={}}) -
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Read: Maximizing the Scientific Value of Tissue Biomarker Analysis: Case Studies in Immuno-Oncology and Dermatology 
Maximizing the Scientific Value of Tissue Biomarker Analysis: Case Studies in Immuno-Oncology and Dermatology
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778881, hs_child_table_id=0, hs_updated_at=1716197119194, hs_published_at=1741014119284, 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=1741014119343, 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=159488778872, hs_child_table_id=0, hs_updated_at=1716197090756, hs_published_at=1741014119284, 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=1741014119343, hs_created_at=1709645745103, hs_is_edited=false, hs_deleted_at=0, name=Darren, job=Senior Vice President, slug=darren-davis, email=, hs_updated_by_user_id=26433386}, third={}}) -
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Read: Strategies to Support Successful Translation of Preclinical Biomarker Assays 
Strategies to Support Successful Translation of Preclinical Biomarker Assays
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