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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
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All articles
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Read: Precision Medicine in Pediatrics: Biomarkers and Assay Development 
Precision Medicine in Pediatrics: Biomarkers and Assay Development
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778880, hs_child_table_id=0, hs_updated_at=1714461214107, hs_published_at=1741014119284, 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=1741014119343, 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={}}) -
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Read: Conducting Pediatric Studies: Addressing Ethical and Clinical Challenges 
Conducting Pediatric Studies: Addressing Ethical and Clinical Challenges
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778880, hs_child_table_id=0, hs_updated_at=1714461214107, hs_published_at=1741014119284, 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=1741014119343, 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={}}) -
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Read: Methods for a Comprehensive Characterization of the Tumor Microenvironment 
Methods for a Comprehensive Characterization of the Tumor Microenvironment
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Read: Characterizing a Central Switch of Immune Suppression: Monitoring Treg Cells in Clinical Studies 
Characterizing a Central Switch of Immune Suppression: Monitoring Treg Cells in Clinical Studies
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Read: Using Epigenetic Immunophenotyping to Explore Potential Biomarkers in Hepatocellular Carcinoma 
Using Epigenetic Immunophenotyping to Explore Potential Biomarkers in Hepatocellular Carcinoma
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778880, hs_child_table_id=0, hs_updated_at=1714461214107, hs_published_at=1741014119284, 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=1741014119343, 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={}}) -
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Read: Non-Invasive Immune Monitoring to Predict COVID-19 Disease Course and Assess SARS-CoV-2 Vaccine Response 
Non-Invasive Immune Monitoring to Predict COVID-19 Disease Course and Assess SARS-CoV-2 Vaccine Response
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778880, hs_child_table_id=0, hs_updated_at=1714461214107, hs_published_at=1741014119284, 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=1741014119343, 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={}}) -
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Read: Next-Generation Immune Monitoring in Immuno-oncology Trials 
Next-Generation Immune Monitoring in Immuno-oncology Trials
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778880, hs_child_table_id=0, hs_updated_at=1714461214107, hs_published_at=1741014119284, 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=1741014119343, 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={hs_id=159488778885, hs_child_table_id=0, hs_updated_at=1714461091541, hs_published_at=1741014119284, description=Dr. Hoffmueller is a veteran biochemist, industry expert, and cofounder of Epiontis. He holds a Master’s in Biochemistry from Humboldt University, a PhD from the Charité University Clinic, receiving the Charité Research Award, and an MBA from the Berlin School of Economics and Law, Berlin, Germany., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Ulrich%20Hoffmueller.webp',altText='Ulrich Hoffmueller',fileId=165891429692}, linkedin=https://www.linkedin.com/in/hoffmueller, hs_name=, hs_path=, lastname=Hoffmueller, hs_initial_published_at=1741014119343, hs_created_at=1709645745116, hs_is_edited=false, hs_deleted_at=0, name=Ulrich, job=, slug=ulrich-hoffmueller, email=, hs_updated_by_user_id=26433386}, third={}}) -
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