Case Study Phase 3 NSCLC: Site Relationships Streamline Feasibility
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=183222587782, hs_child_table_id=0, hs_updated_at=1732630460690, hs_published_at=1738849393727, description=Jelena Alexander brings 18 years of industry experience across the CRO, biotech and R&D arenas, with the last eight years focused on clinical operations oversight and aligning resources with project needs. Prior to transitioning to clinical research, Jelena obtained a Master’s degree in infectious disease and immunology, specializing in the development of cross-reactive and neutralizing monoclonal antibodies to foot-and-moth disease virus. Jelena is a collaborative leader recognized for fostering relationships with stakeholders to embed sustainable workflow processes and for delivering high quality outputs to ensure business needs are accomplished on time and within budget. Jelena’s expertise extends to evaluating and assessing clinical proposals, with a focus on monitoring strategies, and operational feasibility. In this role, Jelena leverages operational and leadership expertise to deliver high-quality, client-focused solutions while enhancing efficiency and sustainability in proposal strategies. Jelena is devoted to driving innovation, mentoring teams, and achieving results through adaptability and commitment to quality., avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Jelena%20Alexander.jpg',altText='Jelena Alexander',fileId=183228271491}, lastname=Alexander, hs_initial_published_at=1732630470588, hs_created_by_user_id=26433386, hs_created_at=1732630317363, hs_is_edited=false, hs_deleted_at=0, name=Jelena, job=Senior Manager, Global Clinical Monitoring, slug=jelena-alexander, hs_updated_by_user_id=26433386}, second={}, third={}})
How to launch a clinical trial in South Korea: Investigational New Drug Application Process
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Advancing Diversity in Oncology Clinical Trials: 5 Key Insights from Clinical Trial Sites
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=184750975030, hs_child_table_id=0, hs_updated_at=1736962069119, hs_published_at=1738849393727, 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=1738849393727, 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={}})
Top Functional Service Providers (FSPs) in Clinical Research for 2025
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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=1738849393727, 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={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=176359181458, hs_child_table_id=0, hs_updated_at=1724336086523, hs_published_at=1738849393727, 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={}})
Top Clinical Research Organizations for Rare Diseases in 2025
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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=1738849393727, 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={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=180784353404, hs_child_table_id=0, hs_updated_at=1728665282155, hs_published_at=1738849393727, 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={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=180784353404, hs_child_table_id=0, hs_updated_at=1728665282155, hs_published_at=1738849393727, 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={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778843, hs_child_table_id=0, hs_updated_at=1714461297945, hs_published_at=1738849393727, description=Robert Bauer is an Executive Director of Operational Strategy at Precision with over 20 years of clinical trial operations experience from both the sponsor and CRO perspectives. He has led teams in the conduct of trials from Phase I through IV and has experience across a wide variety of trial designs. Bob has experience across many therapeutic areas some of which include rare diseases, oncology, depression, schizophrenia, and substance use disorders., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Robert%20Bauer%20Square.webp',altText='Robert Bauer Square',fileId=165892429961}, linkedin=https://www.linkedin.com/in/robert-bauer-a78b704b, hs_name=, hs_path=, lastname=Bauer, hs_initial_published_at=1716212769184, hs_created_at=1709645745074, hs_is_edited=false, hs_deleted_at=0, name=Robert, job=, slug=robert-bauer, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
Custom FSP Models That Help Biotechs Scale Smarter
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Protocol Study Design: Bridging Clinical Goals with Patient Needs
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=183028185350, hs_child_table_id=0, hs_updated_at=1732123286400, hs_published_at=1738849393727, description=Ana Magalhaes is a Senior Manager of Medical Writing with over a decade of clinical trial experience, specializing in documentation and regulatory compliance. Leveraging an academic foundation in clinical research, health sciences, and statistics, Ana optimizes clinical trial processes through the development of regulatory documentation, ensuring consistency and efficiencies from study initiation to completion. , avatar=Image{width=3646,height=3646,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Ana%20Magalhaes.jpg',altText='Ana Magalhaes',fileId=183031140909}, lastname=Magalhaes, hs_initial_published_at=1732123288394, hs_created_by_user_id=26433386, hs_created_at=1732123205000, hs_is_edited=false, hs_deleted_at=0, name=Ana, job=Senior Manager, Medical Writing, slug=ana-magalhaes, hs_updated_by_user_id=26433386}, second={}, third={}})
Rescuing a Complex Hematology Oncology Trial: Case Study in Precision
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Lean Authoring: Bringing Efficiency and Speed to Clinical Study Reports
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1738849393727, 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={}})
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=1738849393727, 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=1738849393727, 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={}})
How European Oncology Site Networks Streamline Clinical Trial Site Selection
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=164713188870, hs_child_table_id=0, hs_updated_at=1714747858916, hs_published_at=1738849393727, description=Deana Demjen is Director of the Precision Site Network, bringing nearly 20 years of clinical research to the role. Most of her previous experience has been in feasibility and site-identification. She has been covering a wide range of therapeutic areas, but her main focus are rare diseases where she is an acting subject matter expert. She is responsible for relationships with PSN sites as well as the maintenance and expansion of the network., avatar=Image{width=650,height=650,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Deana%20Demjen.jpg',altText='Deana Demjen',fileId=164173345152}, lastname=Demjen, hs_initial_published_at=1713363230550, hs_created_by_user_id=5166971, hs_created_at=1713363112834, hs_is_edited=false, hs_deleted_at=0, name=Deana, job=Director of PSN, slug=deana-demjen, hs_updated_by_user_id=26433386}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=180784353404, hs_child_table_id=0, hs_updated_at=1728665282155, hs_published_at=1738849393727, 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={}})
The Dose Dilemma: Lessons from Sotorasib and the Future of Oncology Drug Optimization
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1738849393727, 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={}})
Why Antibody-Drug Conjugates Are Revolutionizing Precision Oncology
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=178509987433, hs_child_table_id=0, hs_updated_at=1728330014032, hs_published_at=1738849393727, description=Ivan Barrera, MD is a fellowship-trained expert in Research GI Oncology with over 15 years of clinical research experience across various healthcare systems and facilities. He is a methodical and strategic key player in interdisciplinary drug development teams, specializing in medical monitoring. Dr. Barrera has extensive experience in solid tumors, particularly Gastrointestinal Oncology, including Neuroendocrine Tumors, and has worked on FIH and Phase I-IV studies. His industry clinical development experience spans small molecules, antibodies, vaccines, cytokines, oncolytic viruses, radiopharmaceuticals, and cellular therapies., avatar=Image{width=685,height=649,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Ivan%20Barrera.jpg',altText='Ivan Barrera',fileId=180445483936}, lastname=Barrera, hs_initial_published_at=1726512636738, hs_created_by_user_id=26433386, hs_created_at=1726500269983, hs_is_edited=false, hs_deleted_at=0, name=Ivan, job=Senior Medical Director, slug=ivan-barrera, hs_updated_by_user_id=26433386}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=176359181458, hs_child_table_id=0, hs_updated_at=1724336086523, hs_published_at=1738849393727, 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={}})
Safety isn’t a Milestone but a Mindset in Clinical Research
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=178509987401, hs_child_table_id=0, hs_updated_at=1726513291967, hs_published_at=1738849393727, description=Renise Blythe brings over 20 years of extensive experience in pharmacovigilance, drug safety, regulatory affairs, and risk management. She brings a wealth of knowledge and a proven track record of success in oncology, critical care, and women’s health., avatar=Image{width=513,height=640,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Renise%20Blythe.jpg',altText='Renise Blythe',fileId=178541750861}, lastname=Blythe, hs_initial_published_at=1726512636738, hs_created_by_user_id=26433386, hs_created_at=1726499253453, hs_is_edited=false, hs_deleted_at=0, name=Renise, job=Vice President, Global Drug Safety, slug=renise-blythe, hs_updated_by_user_id=51739740}, second={}, third={}})
Advancing Equity in Clinical Trials: Unpacking the FDA’s Diversity Guidance
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=178046423372, hs_child_table_id=0, hs_updated_at=1725972626778, hs_published_at=1738849393727, 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}, second={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1738849393727, 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}, third={}})
Case Study: Effective Management of a Rescue Study
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=178051600269, hs_child_table_id=0, hs_updated_at=1725973652862, hs_published_at=1738849393727, description=Jason Valentino is a Sr. Director, Quality and Project Performance Management with ~25 years of experience within the clinical research industry. He has experience leading successful trials and developing organizational processes, both globally and domestically, for Phase I-IV across multiple indications and therapeutic areas. Mr. Valentino also has 6+ years of experience within Quality Assurance. , avatar=Image{width=1170,height=1124,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Jason%20Valentino.jpg',altText='Jason Valentino',fileId=177960237752}, lastname=Valentino, hs_initial_published_at=1725973680156, hs_created_by_user_id=51739740, hs_created_at=1725973578869, hs_is_edited=false, hs_deleted_at=0, name=Jason, job=Senior Director, Quality and Project Performance Management, slug=jason-valentino, hs_updated_by_user_id=51739740}, second={}, third={}})
Case Study: A Double Rescue in Advanced Solid Tumor Clinical Trials
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has third author: false, (SizeLimitingPyMap: {main={hs_id=178210036532, hs_child_table_id=0, hs_updated_at=1730121627841, hs_published_at=1738849393727, description=Joy Tune is a highly experienced Clinical Research professional with over 15 years in the field across all phases. She has proven track record in managing difficult studies, including double-rescue trials, ensuring timely and compliant execution under stringent conditions. With deep expertise in global study management, site selection, and various vendor coordination, Joy excels in overcoming obstacles and driving successful outcomes in even the most demanding research environment. Her comprehensive knowledge of ICH GCP guidelines and proficiency in clinical trial systems further solidify her as key contributor to the success of clinical trials., avatar=Image{width=800,height=533,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Joy%20Tune.jpg',altText='Joy Tune',fileId=177961357142}, lastname=Tune, hs_initial_published_at=1726084888202, hs_created_by_user_id=26433386, hs_created_at=1726081827286, hs_is_edited=false, hs_deleted_at=0, name=Joy, job=Senior Clinical Trial Manager, slug=joy-tune, hs_updated_by_user_id=26433386}, second={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1709645745122, hs_published_at=1738849393727, description=Kurt Preugschat has over 11 years of statistical experience from Phase I to Phase IV clinical trials. He is a lead statistician, providing statistical support and oversight for numerous clinical trials associated with new drug applications (NDA), supplemental new drug applications (sNDA), and medical devices. His expertise includes the development of study designs to meet complex clinical questions and the measurement of desired outcomes. In addition, Kurt has extensive experience generating statistical analyses and creating complex SAS programs and macros used by study team., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/kurt-preugschat.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/kurt-preugschat-97298923a, hs_name=, hs_path=, lastname=Preugschat, hs_initial_published_at=1716136551646, hs_created_at=1709645745122, hs_is_edited=false, hs_deleted_at=0, name=Kurt, job=, slug=kurt-preugschat, email=, hs_updated_by_user_id=26433386}, third={hs_id=178210036535, hs_child_table_id=0, hs_updated_at=1727959047559, hs_published_at=1738849393727, description=Ijeoma Obindu is a senior Clinical Trial Manager with 11+ years' experience in industry-sponsored, government-funded, and investigator-initiated clinical research. Her experience spans Phase 1–4 across a variety of therapeutic areas, including first-in-human, Phase 1-2 combination trials, dose escalation and expansion hematology and solid tumor studies., avatar=Image{width=1080,height=1303,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Ijeoma%20Obindu.jpg',altText='Ijeoma Obindu',fileId=177960240033}, lastname=Obindu, hs_initial_published_at=1726084888202, hs_created_by_user_id=26433386, hs_created_at=1726081899011, hs_is_edited=false, hs_deleted_at=0, name=Ijeoma, job=Senior Clinical Trial Manager, slug=ijeoma-obindu, hs_updated_by_user_id=51739740}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=176359181458, hs_child_table_id=0, hs_updated_at=1724336086523, hs_published_at=1738849393727, 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={}})