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The Precision Blog
100% sourced from leading minds on the front lines of research
(BlogPostResults: [BlogPost 184234293631 Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity, BlogPost 182713459551 Optimizing Immunohistochemistry Validation and Regulatory Strategies])
(BlogPostResults: [BlogPost 184705549432 Advancing Diversity in Oncology Clinical Trials: 5 Key Insights from Clinical Trial Sites])
(BlogPostResults: [BlogPost 183945824174 The BIOSECURE Act’s Impact May Outlive the Bill Itself])
Recent and Featured Posts
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Read Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity
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Read Optimizing Immunohistochemistry Validation and Regulatory Strategies Optimizing Immunohistochemistry Validation and Regulatory Strategies
Read Advancing Diversity in Oncology Clinical Trials: 5 Key Insights from Clinical Trial Sites Advancing Diversity in Oncology Clinical Trials: 5 Key Insights from Clinical Trial Sites
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: Advancing Diversity in Oncology Clinical Trials: 5 Key Insights from Clinical Trial Sites 
Advancing Diversity in Oncology Clinical Trials: 5 Key Insights from Clinical Trial Sites
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Read: Top Functional Service Providers (FSPs) in Clinical Research for 2025 
Top Functional Service Providers (FSPs) in Clinical Research for 2025
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Read: Clinical Trial Trends: Non-malignant Hematology 
Clinical Trial Trends: Non-malignant Hematology
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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=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={}}) -
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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=1736962071401, 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=26433386}, second={hs_id=182710436924, hs_child_table_id=0, hs_updated_at=1731419754428, hs_published_at=1736962071401, 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: Advancing Diversity in Oncology Clinical Trials: 5 Key Insights from Clinical Trial Sites
Advancing Diversity in Oncology Clinical Trials: 5 Key Insights from Clinical Trial Sites
has not third author: true, (SizeLimitingPyMap: {main={hs_id=184750975030, hs_child_table_id=0, hs_updated_at=1736962069119, hs_published_at=1736962071401, description=Melanie Morris brings over two decades of experience in pivotal roles supporting Phase I to IV clinical trials within Site, CRO and Sponsor organizations. As Associate Director of the Precision Site Network at Precision for Medicine, Melanie is dedicated to fostering collaborative, mutually beneficial partnerships with clinical research sites, transforming transactional relationships into enduring alliances that drive shared success. With a career spanning leadership in clinical operations, functional service provider models, and decentralized trial execution, Melanie has consistently delivered innovative strategies that enhance site engagement and operational excellence. Passionate about creating impactful collaborations, Melanie aims to advance the clinical research landscape and support the development and acceleration of life-changing rare disease and oncology therapies., avatar=Image{width=1218,height=1218,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Melanie%20Morris.jpg',altText='Melanie Morris',fileId=184761298465}, lastname=Morris, hs_initial_published_at=1736540185270, hs_created_by_user_id=26433386, hs_created_at=1736527212397, hs_is_edited=false, hs_deleted_at=0, name=Melanie, job=Associate Director, Precision Site Network, slug=melanie-morris, hs_updated_by_user_id=26433386}, second={hs_id=178046423372, hs_child_table_id=0, hs_updated_at=1725972626778, hs_published_at=1736962071401, description=Rosamund (Roz) Round is a seasoned expert in patient engagement and innovation bringing over 20 years of experience. She is focused on listening to and learning from patients and care partners to understand how to better improve trial access and experience. Roz successfully built and led decentralized clinical trials service through the pandemic and is now addressing the implementation of AI across various aspects of clinical research. She has a strong focus on diversity, equity, and inclusion (DEI) to drive health equity in clinical research. Roz holds an MSc in Health Psychology, studied Psychology and Immunology at Harvard University, and is a recognized thought leader with an extensive portfolio of publications, conference presentations, webinars, and vlogs., avatar=Image{width=600,height=600,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Round%20Rosamund.jpg',altText='Round Rosamund',fileId=177993009992}, lastname=Round, hs_initial_published_at=1725972637852, hs_created_by_user_id=51739740, hs_created_at=1725972446462, hs_is_edited=false, hs_deleted_at=0, name=Rosamund, job=Vice President, PAtient Engagement & Innovation, slug=rosamund-round, hs_updated_by_user_id=51739740}, third={}}) -
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Read: Top Functional Service Providers (FSPs) in Clinical Research for 2025
Top Functional Service Providers (FSPs) in Clinical Research for 2025
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={}, third={}}) -
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Read: Clinical Trial Trends: Non-malignant Hematology
Clinical Trial Trends: Non-malignant Hematology
has not third author: true, (SizeLimitingPyMap: {main={hs_id=176359181458, hs_child_table_id=0, hs_updated_at=1724336086523, hs_published_at=1736962071401, description=Jen Vance is a Senior Director of Operational Strategy at Precision whose career spans over twenty years within the CRO industry. She has provided portfolio and departmental oversight, clinical development planning, therapeutic strategy and provision of therapeutic expertise. Jen has vetted drug development experience in phase I through IV hematology / oncology studies, with a specialized focus on hematologic malignancies, targeted therapies and immunotherapies. , avatar=Image{width=557,height=554,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Jen%20Vance.jpg',altText='Jen Vance',fileId=176365370249}, lastname=Vance, hs_initial_published_at=1724336101839, hs_created_by_user_id=51739740, hs_created_at=1724336037903, hs_is_edited=false, hs_deleted_at=0, name=Jen, job=Senior Director of Operational Strategy, slug=jen-vance, hs_updated_by_user_id=51739740}, 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=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={}}) -
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Read: Top Clinical Research Organizations for Rare Diseases in 2025 
Top Clinical Research Organizations for Rare Diseases in 2025
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Read: Clinical Trial Trends: Late Phase Oncology 
Clinical Trial Trends: Late Phase Oncology
has not third author: true, (SizeLimitingPyMap: {main={hs_id=180784353404, hs_child_table_id=0, hs_updated_at=1728665282155, hs_published_at=1736962071401, description=Natacha Grand, PhD. is a Senior Operational Strategy Director at Precision for Medicine with a decade of clinical trial experience spanning site, sponsor, and CRO perspectives. Her scientific journey began with a focus on memory T-cells and immune exhaustion before she transitioned to clinical research to drive drug development and enhance patient’s health. Natacha has played critical roles in supporting Phase I-IV clinical trials, particularly in Oncology (Solid tumors and Hematologic malignancies) and chronic viral disease (HIV and HCV) with a focus on patient diversity and decentralized services. , avatar=Image{width=2533,height=2669,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Photo%202022_Natacha%20Grand_zoom.jpg',altText='Photo 2022_Natacha Grand_zoom',fileId=180773105730}, lastname=Grand, hs_initial_published_at=1728665285632, hs_created_by_user_id=26433386, hs_created_at=1728665205961, hs_is_edited=false, hs_deleted_at=0, name=Natacha, job=Senior Director, Operational Strategy, slug=natacha-grand, hs_updated_by_user_id=26433386}, second={}, third={}}) -
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Read: Clinical Trial Trends: Antibody-Drug Conjugates 
Clinical Trial Trends: Antibody-Drug Conjugates
has not third author: true, (SizeLimitingPyMap: {main={hs_id=180784353404, hs_child_table_id=0, hs_updated_at=1728665282155, hs_published_at=1736962071401, description=Natacha Grand, PhD. is a Senior Operational Strategy Director at Precision for Medicine with a decade of clinical trial experience spanning site, sponsor, and CRO perspectives. Her scientific journey began with a focus on memory T-cells and immune exhaustion before she transitioned to clinical research to drive drug development and enhance patient’s health. Natacha has played critical roles in supporting Phase I-IV clinical trials, particularly in Oncology (Solid tumors and Hematologic malignancies) and chronic viral disease (HIV and HCV) with a focus on patient diversity and decentralized services. , avatar=Image{width=2533,height=2669,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Photo%202022_Natacha%20Grand_zoom.jpg',altText='Photo 2022_Natacha Grand_zoom',fileId=180773105730}, lastname=Grand, hs_initial_published_at=1728665285632, hs_created_by_user_id=26433386, hs_created_at=1728665205961, hs_is_edited=false, hs_deleted_at=0, name=Natacha, job=Senior Director, Operational Strategy, slug=natacha-grand, hs_updated_by_user_id=26433386}, second={}, third={}}) -
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Read: The BIOSECURE Act’s Impact May Outlive the Bill Itself 
The BIOSECURE Act’s Impact May Outlive the Bill Itself
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1736962071401, 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=9297597}, second={}, third={}}) -
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Read: Clinical Trial Trends: Early Phase Rare Oncology 
Clinical Trial Trends: Early Phase Rare Oncology
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