Notable authority in global operations, dedicated to fostering team spirit of excellence and collaboration with internal and external partners. Veteran of the quest to improve oncology therapies and extend lives, including 15+ years in oncology drug development, building on 10 years in obstetrics and women’s health.
FDA's Vision for Multiregional Clinical Trials in Oncology
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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=1744844126301, 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=51739740}, second={}, third={}})
Contract Research Organization vs Clinical Research Organization (CRO vs CRO)
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1744830865620, hs_published_at=1744844126301, description=Rob Maiale is a marketing strategist and creative technologist with 17 years of experience turning complex ideas into growth. He currently leads content strategy, where he transforms insights from Precision experts into market-shaping narratives that drive the advancement of next-generation therapies. Rob’s career spans journalism, advertising, and brand storytelling, with a through-line of making the meaningful memorable. His work blends creative strategy with emerging AI tools to help Precision stay ahead of the curve—and above the noise., 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=1744843965759, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, position=Associate Director, Digital Content & Inbound Marketing, job=, slug=rob-maiale, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
The Amendment Trap: Why 76% of Clinical Trials Face Six-Figure Protocol Changes
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=187570680222, hs_child_table_id=0, hs_updated_at=1742413198455, hs_published_at=1744844126301, description=Christine has been ensuring high performance delivery of clinical research projects for more than 23 years. During this time, she has successfully led diverse teams across various cancer indications including renal, pancreatic, melanoma, lung, head and neck, breast, multiple myeloma, extra-nodal NK/T lymphoma, non-Hodgkin’s lymphoma, and Hodgkin’s lymphoma. Within the CRO setting she also supported the strategic development of over 50 hematology/oncology programs including complex Phase 1 projects in immuno-oncology and autologous cell therapy. She also led the establishment of a novel oncology research infrastructure which accelerated study activations for Phase 1 solid tumor studies. Christine obtained her master’s degree in public health at the University of Texas where she also trained in the development and implementation of clinical and epidemiologic research at the Coordinating Center for Clinical Trials as well as the Center for Occupational and Environment Health., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Christine%20Lusk-1.png',altText='Christine Lusk-1',fileId=187579105870}, lastname=Lusk, hs_initial_published_at=1742410730688, hs_created_by_user_id=26433386, hs_created_at=1742410650472, hs_is_edited=false, hs_deleted_at=0, name=Christine, job=Director, Project Management, slug=christine-lusk, hs_updated_by_user_id=51739740}, second={}, third={}})
Best Practices to Streamline Development of Safety Update Reports (DSURs)
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=182849803084, hs_child_table_id=0, hs_updated_at=1731697230236, hs_published_at=1744844126301, description=Lena Randhawa, PhD is a Principal Medical Writer at Precision for Medicine. She brings to Precision >23 years of written and oral communication experience and >12 years of regulatory medical writing experience, project management, and leadership roles. Lena has extensive experience across various regulatory documents including CSRs (interim CSRs, CSR amendments/addenda, and abbreviated/synoptic CSRs), CSR patient narratives, DSURs/IND annual reports, IBs and updates, clinical protocols and amendments, informed consent forms, IND/NDA components, and briefing packages., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Lena%20Randhawa-1.jpg',altText='Lena Randhawa-1',fileId=182849417502}, lastname=Randhawa, hs_initial_published_at=1731697233687, hs_created_by_user_id=26433386, hs_created_at=1731697009126, hs_is_edited=false, hs_deleted_at=0, name=Lena, job=Senior Manager, Medical Writing, slug=lena-randhawa, hs_updated_by_user_id=51739740}, second={}, third={}})
Webinar Insights: Optimizing Cohort Management in Early-Phase Oncology Trials
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1744830865620, hs_published_at=1744844126301, description=Rob Maiale is a marketing strategist and creative technologist with 17 years of experience turning complex ideas into growth. He currently leads content strategy, where he transforms insights from Precision experts into market-shaping narratives that drive the advancement of next-generation therapies. Rob’s career spans journalism, advertising, and brand storytelling, with a through-line of making the meaningful memorable. His work blends creative strategy with emerging AI tools to help Precision stay ahead of the curve—and above the noise., 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=1744843965759, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, position=Associate Director, Digital Content & Inbound Marketing, job=, slug=rob-maiale, email=, hs_updated_by_user_id=51739740}, second={hs_id=181884577650, hs_child_table_id=0, hs_updated_at=1729782746463, hs_published_at=1744844126301, 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=51739740}, third={}})
2025 Biotech Economics: CROs, Advanced Therapies & Trends in Funding
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1744830865620, hs_published_at=1744844126301, description=Rob Maiale is a marketing strategist and creative technologist with 17 years of experience turning complex ideas into growth. He currently leads content strategy, where he transforms insights from Precision experts into market-shaping narratives that drive the advancement of next-generation therapies. Rob’s career spans journalism, advertising, and brand storytelling, with a through-line of making the meaningful memorable. His work blends creative strategy with emerging AI tools to help Precision stay ahead of the curve—and above the noise., 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=1744843965759, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, position=Associate Director, Digital Content & Inbound Marketing, job=, slug=rob-maiale, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
FDA's Project Optimus: What Pharma and Biotech Need to Know
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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=1744844126301, 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=51739740}, second={}, third={}})
Case Study: Concurrent Phase 1 Solid Tumor Drug Development Successes
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=185838258545, hs_child_table_id=0, hs_updated_at=1738849388884, hs_published_at=1744844126301, 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=51739740}, second={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1709645745122, hs_published_at=1744844126301, 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=51739740}, third={}})
Progress in Gastrointestinal Oncology: 5 Key Insights from ASCO GI
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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=1744844126301, 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=51739740}, second={}, third={}})
Impact of US Tariffs on Biopharmaceutical Industry
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
Case Study Phase 3 NSCLC: Site Relationships Streamline Feasibility
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=185838258545, hs_child_table_id=0, hs_updated_at=1738849388884, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=183222587782, hs_child_table_id=0, hs_updated_at=1732630460690, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
How to launch a clinical trial in South Korea: Investigational New Drug Application Process
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=185416008310, hs_child_table_id=0, hs_updated_at=1737992478996, hs_published_at=1744844126301, description=MeeHyun has over 15 years of experience with MFDS, multinational pharmaceutical companies, and CROs, specializing in regulatory affairs and clinical development. In her current role, MeeHyun supports regulatory affairs activities in Australia and South Korea. She is a certified pharmacist in South Korea and holds a BSc in pharmacy, avatar=Image{width=1500,height=2100,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/MeeHyun%20Byun.jpg',altText='MeeHyun Byun',fileId=185417806426}, lastname=Byun, hs_initial_published_at=1737992486362, hs_created_by_user_id=26433386, hs_created_at=1737992417320, hs_is_edited=false, hs_deleted_at=0, name=MeeHyun, job=Senior Regulatory Associate, slug=meehyun-byun, hs_updated_by_user_id=51739740}, second={hs_id=167906611101, hs_child_table_id=0, hs_updated_at=1743507158804, hs_published_at=1744844126301, description=Helen brings over 30 years of experience in multinational healthcare, biotech, and pharmaceutical industries, including work with Medical Research Institutes and CROs. She specializes in leading clinical research, drug and device development, and fostering innovative research collaborations. Based in Sydney, Australia, Helen has a strong track record of delivering clinical trials across the APAC region., avatar=Image{width=600,height=700,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Helene-Ormandy.png',altText='Helene-Ormandy',fileId=168387434767}, lastname=Ormandy, PhD, hs_initial_published_at=1716212950394, hs_created_by_user_id=2737751, hs_created_at=1716212897654, hs_is_edited=false, hs_deleted_at=0, name=Helen, job=Senior Director, Clinical Operations, slug=helen-ormandy, hs_updated_by_user_id=51739740}, third={}})
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=1744844126301, 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=51739740}, second={hs_id=178046423372, hs_child_table_id=0, hs_updated_at=1725972626778, hs_published_at=1744844126301, 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=1744830865620, hs_published_at=1744844126301, description=Rob Maiale is a marketing strategist and creative technologist with 17 years of experience turning complex ideas into growth. He currently leads content strategy, where he transforms insights from Precision experts into market-shaping narratives that drive the advancement of next-generation therapies. Rob’s career spans journalism, advertising, and brand storytelling, with a through-line of making the meaningful memorable. His work blends creative strategy with emerging AI tools to help Precision stay ahead of the curve—and above the noise., 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=1744843965759, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, position=Associate Director, Digital Content & Inbound Marketing, job=, slug=rob-maiale, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=176359181458, hs_child_table_id=0, hs_updated_at=1724336086523, hs_published_at=1744844126301, 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={}})
Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity
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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=1744830865620, hs_published_at=1744844126301, description=Rob Maiale is a marketing strategist and creative technologist with 17 years of experience turning complex ideas into growth. He currently leads content strategy, where he transforms insights from Precision experts into market-shaping narratives that drive the advancement of next-generation therapies. Rob’s career spans journalism, advertising, and brand storytelling, with a through-line of making the meaningful memorable. His work blends creative strategy with emerging AI tools to help Precision stay ahead of the curve—and above the noise., 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=1744843965759, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, position=Associate Director, Digital Content & Inbound Marketing, job=, slug=rob-maiale, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=180784353404, hs_child_table_id=0, hs_updated_at=1728665282155, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
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The BIOSECURE Act’s Impact May Outlive the Bill Itself
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Custom FSP Models That Help Biotechs Scale Smarter
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=164680191818, hs_child_table_id=0, hs_updated_at=1716326381066, hs_published_at=1744844126301, description=Visionary executive with a distinguished track-record fostering an environment of continuous innovation and growth through people-centric strategies. Data sciences leader focused on data analysis, visualization, and solutions to solve key issues in clinical trials. On a personal level, deeply committed to supporting educational excellence, particularly for underprivileged children., avatar=Image{width=661,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Nithiyanandhan-Ananthakrishnan-1.png',altText='Nithiyanandhan-Ananthakrishnan-1',fileId=167393416229}, linkedin=https://www.linkedin.com/in/nithiyanandhan/, team=[{id=163080551773, name='Clinical Solutions Leadership'}], lastname=Ananthakrishnan, hs_initial_published_at=1713346931329, hs_created_by_user_id=62155952, hs_created_at=1713346306368, hs_is_edited=false, hs_deleted_at=0, name=Nithiya, position=Senior Vice President, job=Biometrics, slug=nithiya-ananthakrishnan, hs_updated_by_user_id=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
Protocol Study Design: Bridging Clinical Goals with Patient Needs
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Optimizing Immunohistochemistry Validation and Regulatory Strategies
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Expediting Clinical Trial Study Start-up in Australia
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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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Women Leaders Share Raw Truths About Leadership in Life Sciences
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Challenges & Opportunities in Cell and Gene Therapy
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How European Oncology Site Networks Streamline Clinical Trial Site Selection
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=180784353404, hs_child_table_id=0, hs_updated_at=1728665282155, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
The Dose Dilemma: Lessons from Sotorasib and the Future of Oncology Drug Optimization
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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=1744844126301, 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=51739740}, second={}, third={}})
Therapeutic Genome Editing – Reshaping the Landscape of Advanced Therapies
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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=1744844126301, 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={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=176359181458, hs_child_table_id=0, hs_updated_at=1724336086523, hs_published_at=1744844126301, 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={}})
US Crackdown on Chinese Clinical Trials: What’s at Stake for Biopharma?
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1744844126301, 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=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=1744844126301, 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={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1744844126301, 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=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=1744844126301, 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=1744844126301, 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=51739740}, third={}})
Case Study: Effective Management of a Rescue Study
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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=1744844126301, 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=51739740}, second={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1709645745122, hs_published_at=1744844126301, 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=51739740}, third={hs_id=178210036535, hs_child_table_id=0, hs_updated_at=1727959047559, hs_published_at=1744844126301, 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}})
How South Korea Became a Leading Destination for Clinical Trials
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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=1744844126301, 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=1744844126301, 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={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
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Clinical Trial Trends: Rare Oncology vs Non-Oncology
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AI's Role in Reshaping Drug Development: FDA Workshop Recap
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1744830865620, hs_published_at=1744844126301, description=Rob Maiale is a marketing strategist and creative technologist with 17 years of experience turning complex ideas into growth. He currently leads content strategy, where he transforms insights from Precision experts into market-shaping narratives that drive the advancement of next-generation therapies. Rob’s career spans journalism, advertising, and brand storytelling, with a through-line of making the meaningful memorable. His work blends creative strategy with emerging AI tools to help Precision stay ahead of the curve—and above the noise., 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=1744843965759, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, position=Associate Director, Digital Content & Inbound Marketing, job=, slug=rob-maiale, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778887, hs_child_table_id=0, hs_updated_at=1715690972359, hs_published_at=1744844126301, description=Andy Kinley, Ph.D. is Vice President of Innovation and Clinical Science at Precision for Medicine. He is a clinical researcher with over 25 years of combined experience leading basic and clinical research in oncology and hematology. His early scientific career focused on cancer cell signaling, setting a foundation to complement his clinical research roles in trial design and implementation of effective strategies for oncology clinical trials. Andy specializes in immuno-oncology trials (checkpoint inhibitors, T-cell agonists, bispecifics, cytokines, oncolytic viruses, neoantigen cancer vaccines), including autologous and allogeneic adoptive cell therapies (CAR-T, TCR, TIL, NK cells). Today, Andy identifies and implements innovative tools, datasets, and services that can impact clinical trial execution including quality, patient diversity, site identification, and trial timelines., avatar=Image{width=720,height=829,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/AndyKinley_headshot.png',altText='AndyKinley_headshot',fileId=167369936018}, linkedin=https://www.linkedin.com/in/andy-kinley-phd-5759551, hs_name=, hs_path=, lastname=Kinley, hs_initial_published_at=1716212769184, hs_created_at=1709645745118, hs_is_edited=false, hs_deleted_at=0, name=Andy, job=, slug=andy-kinley, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778894, hs_child_table_id=0, hs_updated_at=1714461151531, hs_published_at=1744844126301, description=Vincent Shortino is a Principal Clinical Trial Manager, bringing more than 20 years of experience to Precision. His experience spans all major therapeutic areas with a heavy emphasis on Cardiovascular and Rare Indications, across Phases I–IV. He brings solid perspectives inclusive of sites, pharma and CROs from his previous roles of Study Coordinator, Site Director, CRA, and Clinical Trial Manager., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Vincent%20Shortino.webp',altText='Vincent Shortino',fileId=165892429964}, linkedin=https://www.linkedin.com/in/vincent-shortino-954b3857, team=[{id=163080551773, name='Clinical Solutions Leadership'}], hs_name=, hs_path=, lastname=Shortino, hs_initial_published_at=1716212769184, hs_created_at=1709645745125, hs_is_edited=false, hs_deleted_at=0, name=Vincent, job=Principal Clinical Trial Manager, slug=vincent-shortino, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778887, hs_child_table_id=0, hs_updated_at=1715690972359, hs_published_at=1744844126301, description=Andy Kinley, Ph.D. is Vice President of Innovation and Clinical Science at Precision for Medicine. He is a clinical researcher with over 25 years of combined experience leading basic and clinical research in oncology and hematology. His early scientific career focused on cancer cell signaling, setting a foundation to complement his clinical research roles in trial design and implementation of effective strategies for oncology clinical trials. Andy specializes in immuno-oncology trials (checkpoint inhibitors, T-cell agonists, bispecifics, cytokines, oncolytic viruses, neoantigen cancer vaccines), including autologous and allogeneic adoptive cell therapies (CAR-T, TCR, TIL, NK cells). Today, Andy identifies and implements innovative tools, datasets, and services that can impact clinical trial execution including quality, patient diversity, site identification, and trial timelines., avatar=Image{width=720,height=829,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/AndyKinley_headshot.png',altText='AndyKinley_headshot',fileId=167369936018}, linkedin=https://www.linkedin.com/in/andy-kinley-phd-5759551, hs_name=, hs_path=, lastname=Kinley, hs_initial_published_at=1716212769184, hs_created_at=1709645745118, hs_is_edited=false, hs_deleted_at=0, name=Andy, job=, slug=andy-kinley, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
FDA Approves Breakthrough Cell Therapy for Synovial Sarcoma
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778887, hs_child_table_id=0, hs_updated_at=1715690972359, hs_published_at=1744844126301, description=Andy Kinley, Ph.D. is Vice President of Innovation and Clinical Science at Precision for Medicine. He is a clinical researcher with over 25 years of combined experience leading basic and clinical research in oncology and hematology. His early scientific career focused on cancer cell signaling, setting a foundation to complement his clinical research roles in trial design and implementation of effective strategies for oncology clinical trials. Andy specializes in immuno-oncology trials (checkpoint inhibitors, T-cell agonists, bispecifics, cytokines, oncolytic viruses, neoantigen cancer vaccines), including autologous and allogeneic adoptive cell therapies (CAR-T, TCR, TIL, NK cells). Today, Andy identifies and implements innovative tools, datasets, and services that can impact clinical trial execution including quality, patient diversity, site identification, and trial timelines., avatar=Image{width=720,height=829,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/AndyKinley_headshot.png',altText='AndyKinley_headshot',fileId=167369936018}, linkedin=https://www.linkedin.com/in/andy-kinley-phd-5759551, hs_name=, hs_path=, lastname=Kinley, hs_initial_published_at=1716212769184, hs_created_at=1709645745118, hs_is_edited=false, hs_deleted_at=0, name=Andy, job=, slug=andy-kinley, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
FDA ODAC Vote: Key Changes for Perioperative Cancer Trials
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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=1744844126301, 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=51739740}, second={}, third={}})
Top Clinical Research Organizations for Oncology in 2024
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1744830865620, hs_published_at=1744844126301, description=Rob Maiale is a marketing strategist and creative technologist with 17 years of experience turning complex ideas into growth. He currently leads content strategy, where he transforms insights from Precision experts into market-shaping narratives that drive the advancement of next-generation therapies. Rob’s career spans journalism, advertising, and brand storytelling, with a through-line of making the meaningful memorable. His work blends creative strategy with emerging AI tools to help Precision stay ahead of the curve—and above the noise., 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=1744843965759, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, position=Associate Director, Digital Content & Inbound Marketing, job=, slug=rob-maiale, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778843, hs_child_table_id=0, hs_updated_at=1714461297945, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778843, hs_child_table_id=0, hs_updated_at=1714461297945, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778887, hs_child_table_id=0, hs_updated_at=1715690972359, hs_published_at=1744844126301, description=Andy Kinley, Ph.D. is Vice President of Innovation and Clinical Science at Precision for Medicine. He is a clinical researcher with over 25 years of combined experience leading basic and clinical research in oncology and hematology. His early scientific career focused on cancer cell signaling, setting a foundation to complement his clinical research roles in trial design and implementation of effective strategies for oncology clinical trials. Andy specializes in immuno-oncology trials (checkpoint inhibitors, T-cell agonists, bispecifics, cytokines, oncolytic viruses, neoantigen cancer vaccines), including autologous and allogeneic adoptive cell therapies (CAR-T, TCR, TIL, NK cells). Today, Andy identifies and implements innovative tools, datasets, and services that can impact clinical trial execution including quality, patient diversity, site identification, and trial timelines., avatar=Image{width=720,height=829,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/AndyKinley_headshot.png',altText='AndyKinley_headshot',fileId=167369936018}, linkedin=https://www.linkedin.com/in/andy-kinley-phd-5759551, hs_name=, hs_path=, lastname=Kinley, hs_initial_published_at=1716212769184, hs_created_at=1709645745118, hs_is_edited=false, hs_deleted_at=0, name=Andy, job=, slug=andy-kinley, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
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Protein Assays: Choosing the Most Effective Method for Biopharmaceutical Development
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778889, hs_child_table_id=0, hs_updated_at=1714461111815, hs_published_at=1744844126301, description=Travis Harrison, PhD, is Vice President of Diagnostic Development at Precision for Medicine. He brings more than 20 years of bioanalytical assay experience to the Precision team with expertise in ligand-binding and cell-based assays. Travis has experience supporting clinical and nonclinical studies for a broad range of indications, with an emphasis on diagnostic assays to evaluate immune responses to gene therapies., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Travis%20Harrison.webp',altText='Travis Harrison',fileId=165893006481}, linkedin=https://www.linkedin.com/in/travis-harrison-phd-6108852/, hs_name=, hs_path=, lastname=Harrison, hs_initial_published_at=1716212769184, hs_created_at=1709645745120, hs_is_edited=false, hs_deleted_at=0, name=Travis, job=, slug=travis-harrison, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1744844126301, 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}, third={}})
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Navigating Site Activation Strategy Under the EU Clinical Trials Regulation
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=169565849890, hs_child_table_id=0, hs_updated_at=1723217327146, hs_published_at=1744844126301, avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Barbara%20Kathage.jpg',altText='Barbara Kathage',fileId=168426405902}, lastname=Kathage, hs_initial_published_at=1718988967067, hs_created_by_user_id=26433386, hs_created_at=1717603865843, hs_is_edited=false, hs_deleted_at=0, name=Barbara, job=Vice President, Site Start Up, slug=barbara-kathage, hs_updated_by_user_id=51739740}, second={hs_id=159488778852, hs_child_table_id=0, hs_updated_at=1716212815818, hs_published_at=1744844126301, description=Chris Ingram, BSc (Hons) is Head of Regulatory Consultancy (Europe) for Precision for Medicine. Chris received his BSc(Hons) in immunology and pharmacology from the University of Strathclyde and has since spent over 21 years working in regulatory affairs with a focus on clinical development. Chris’ regulatory expertise covers clinical development across all phases, regulatory strategy, marketing authorisations, scientific advice, orphan drug designation and paediatric investigation plans across a wide variety of therapeutic areas, including but not limited to, oncology, CNS, metabolic, endocrinology, analgesia and cardiovascular., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Chris%20Ingram.webp',altText='Chris Ingram',fileId=165893120791}, linkedin=https://www.linkedin.com/in/chris-ingram-0255b216, hs_name=, hs_path=, lastname=Ingram, hs_initial_published_at=1716212950453, hs_created_at=1709645745083, hs_is_edited=false, hs_deleted_at=0, name=Chris, job=Executive Director, Regulatory Affairs, Europe, slug=chris-ingram, email=, hs_updated_by_user_id=51739740}, third={}})
Considerations for Your Pre-IND Meeting With the FDA
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778884, hs_child_table_id=0, hs_updated_at=1709645745115, hs_published_at=1744844126301, description=Vann Parker is the Head of Regulatory Consultancy (North America) for Precision for Medicine. He received his PhD in Molecular Biology from The California Institute of Technology and spent the past 30 years supporting biopharmaceutical and drug development. He currently focuses on strategies for clinical development and interactions with FDA and other regulatory agencies. In addition to support of pre-IND activities, Vann has supported sponsors throughout the drug development process including applications for Fast Track, Breakthrough Therapy and Orphan Designations, formal meetings with FDA and full NDA/BLA submissions., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/vann-parker.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/vann-parker-69565a6/, hs_name=, hs_path=, lastname=Parker, hs_initial_published_at=1716136551646, hs_created_at=1709645745115, hs_is_edited=false, hs_deleted_at=0, name=Vann, job=, slug=vann-parker, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Precision Medicine in Pediatrics: Biomarkers and Assay Development
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778880, hs_child_table_id=0, hs_updated_at=1714461214107, hs_published_at=1744844126301, 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=1716212769184, hs_created_at=1709645745111, hs_is_edited=false, hs_deleted_at=0, name=Eva, job=, slug=eva-raschke, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
FDA Draft Guidance Encourages Broader Inclusion Criteria in Oncology Trials
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778884, hs_child_table_id=0, hs_updated_at=1709645745115, hs_published_at=1744844126301, description=Vann Parker is the Head of Regulatory Consultancy (North America) for Precision for Medicine. He received his PhD in Molecular Biology from The California Institute of Technology and spent the past 30 years supporting biopharmaceutical and drug development. He currently focuses on strategies for clinical development and interactions with FDA and other regulatory agencies. In addition to support of pre-IND activities, Vann has supported sponsors throughout the drug development process including applications for Fast Track, Breakthrough Therapy and Orphan Designations, formal meetings with FDA and full NDA/BLA submissions., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/vann-parker.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/vann-parker-69565a6/, hs_name=, hs_path=, lastname=Parker, hs_initial_published_at=1716136551646, hs_created_at=1709645745115, hs_is_edited=false, hs_deleted_at=0, name=Vann, job=, slug=vann-parker, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
When Should Biopharma Companies Buy, Partner or Develop Innovative Assets?
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1744844126301, 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=51739740}, second={hs_id=164426546562, hs_child_table_id=0, hs_updated_at=1716310587164, hs_published_at=1744844126301, description=Pharmaceutical industry veteran with extensive experience in high-purity utilities, large molecule biological processes and advanced therapies. Expert in early-phase manufacturing strategy, conceptual design, user requirement specifications, verification, validation, facility turnover, and facility operations. Trusted lead on operational and commercial readiness programs. Leader on the cell and gene therapy task force., avatar=Image{width=517,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Jim-Watson_Square_Full.png',altText='Jim-Watson_Square_Full',fileId=167392679461}, linkedin=https://www.linkedin.com/in/jimwatsonvpatpf/, team=[{id=163080551774, name='Manufacturing Solutions Leadership'}], lastname=Watson, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713169765041, hs_is_edited=false, hs_deleted_at=0, name=Jim, job=Vice President, slug=jim-watson, hs_updated_by_user_id=51739740}, third={}})
Strategic Portfolio Management in Cell and Gene Therapy: Keys to Growth and Impact
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546556, hs_child_table_id=0, hs_updated_at=1716454242082, hs_published_at=1744844126301, description=Long-standing biotech/pharmaceutical industry executive and global authority in cell and gene therapy facility builds. Key force in industrializing the world’s largest CGTx manufacturing footprint. Trusted strategic partner in make vs buy analysis, site and vendor selection, tech transfer execution strategies, and facility start-ups. Facilitated partnerships with 100+ life science organizations including startups, established biologics and CGTx innovators. Extensive experience with small and large molecules, including biologics and biosimilars. Dedicated champion for patient advocacy and philanthropy, who leads his team in contributing thousands of volunteer hours in support of patient-focused not-for-profit organizations., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/John%20Khoury.webp',altText='John Khoury',fileId=165892782091}, linkedin=https://www.linkedin.com/in/john-khoury-017b592/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Khoury, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713169591886, hs_is_edited=false, hs_deleted_at=0, name=John, job=Executive Vice President, Manufacturing Solutions, slug=john-khoury, hs_updated_by_user_id=51739740}, second={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1744844126301, 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=51739740}, third={}})
Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics
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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=1744844126301, 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=159488778882, hs_child_table_id=0, hs_updated_at=1714461102447, hs_published_at=1744844126301, description=Dr. Curnutte has more than ten years of research and regulatory affairs experience focused on in vitro diagnostics (IVDs). She has held regulatory positions at both device and pharmaceutical companies, during which she led seven U.S. and ex-U.S. companion diagnostic registrations. She has extensive expertise in CDx development and clinical trial integration, IVD product development, next-generation sequencing technologies, and translation of U.S. regulatory strategy to major markets., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Margaret%20Curnutte.webp',altText='Margaret Curnutte',fileId=165892782094}, linkedin=https://www.linkedin.com/in/margaret-curnutte-93558913, hs_name=, hs_path=, lastname=Curnutte, hs_initial_published_at=1716212769184, hs_created_at=1709645745113, hs_is_edited=false, hs_deleted_at=0, name=Margaret, job=, slug=margaret-curnutte, email=, hs_updated_by_user_id=51739740}, third={}})
Optimizing Investigator Databases for Oncology Trial Enrollment
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778894, hs_child_table_id=0, hs_updated_at=1714461151531, hs_published_at=1744844126301, description=Vincent Shortino is a Principal Clinical Trial Manager, bringing more than 20 years of experience to Precision. His experience spans all major therapeutic areas with a heavy emphasis on Cardiovascular and Rare Indications, across Phases I–IV. He brings solid perspectives inclusive of sites, pharma and CROs from his previous roles of Study Coordinator, Site Director, CRA, and Clinical Trial Manager., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Vincent%20Shortino.webp',altText='Vincent Shortino',fileId=165892429964}, linkedin=https://www.linkedin.com/in/vincent-shortino-954b3857, team=[{id=163080551773, name='Clinical Solutions Leadership'}], hs_name=, hs_path=, lastname=Shortino, hs_initial_published_at=1716212769184, hs_created_at=1709645745125, hs_is_edited=false, hs_deleted_at=0, name=Vincent, job=Principal Clinical Trial Manager, slug=vincent-shortino, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164713188766, hs_child_table_id=0, hs_updated_at=1714747844927, hs_published_at=1744844126301, description=Anne Kopko is a Clinical Science Analytics & Insights Principal Scientist with fifteen years of professional oncology clinical research experience supporting Phase 1-3 clinical trials across a variety of therapeutic areas, including first-in-human, Phase 1-2 combination trials, dose escalation and expansion hematology and solid tumor studies. She plays a pivotal role in navigating the complex landscape of clinical data quality and supporting the cross-functional data cleaning process. She is a knowledgeable and collaborative partner with a passion to deliver quality data to her clients through a holistic, clinical sense data review approach., avatar=Image{width=300,height=300,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Anne-Kopko-300x300.jpeg',altText='Anne-Kopko-300x300',fileId=164721973774}, linkedin=https://www.linkedin.com/in/anne-kopko-39b16888/, lastname=Kopko, hs_initial_published_at=1713363230550, hs_created_by_user_id=5166971, hs_created_at=1713362764236, hs_is_edited=false, hs_deleted_at=0, name=Anne, job=Manager, Clinical Oncology Solutions, slug=anne-kopko, hs_updated_by_user_id=51739740}, second={hs_id=164713188782, hs_child_table_id=0, hs_updated_at=1714747852941, hs_published_at=1744844126301, description=Hasni M’hidi, PhD is a seasoned oncology clinical research professional, passionate about advancing medical science. As Global Project Manager, Hasni oversees operations in the US and EU. His expertise spans all phases of clinical trials, and his commitment to improving patient outcomes is unwavering., avatar=Image{width=300,height=300,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Hasni-Mhidi-300x300.jpeg',altText='Hasni-Mhidi-300x300',fileId=164721971514}, linkedin=https://www.linkedin.com/in/hasni-m-hidi-4902b086/, lastname=M’hidi, PhD, hs_initial_published_at=1713363230550, hs_created_by_user_id=5166971, hs_created_at=1713362890341, hs_is_edited=false, hs_deleted_at=0, name=Hasni, job=Project Manager, slug=hasni-mhidi, hs_updated_by_user_id=51739740}, third={}})
Navigating Cell and Gene Therapy Acquisitions: A Strategic Blueprint
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1744844126301, 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=51739740}, second={hs_id=164426546553, hs_child_table_id=0, hs_updated_at=1716454239819, hs_published_at=1744844126301, description=Life sciences leader who helped pioneer the industrialization of biologics and advanced therapies. Deep expertise in small and large molecules, honed through work with a range of life science organizations, from start-ups and academic centers to financial institutions and CMOs/CROs. Spearheaded significant global turnkey facility builds, automation, validation, engineering, and serialization track and trace, deploying billions in capital across the life sciences sector. Led the creation of the Advanced Therapy Manufacturing Playbook which has helped develop the world’s largest advanced therapy manufacturing footprint. Actively serves on multiple boards including academic, philanthropic, biotech, and financial investment institutions., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Tony%20Khoury.webp',altText='Tony Khoury',fileId=165893018152}, linkedin=https://www.linkedin.com/in/tony-khoury-7470755/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Khoury, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713169549303, hs_is_edited=false, hs_deleted_at=0, name=Tony, job=Executive Vice President, Manufacturing Solutions, slug=tony-khoury, hs_updated_by_user_id=51739740}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778866, hs_child_table_id=0, hs_updated_at=1716212949488, hs_published_at=1744844126301, description=Frances Murphy is a leading authority in clinical CROs, focused on client services and regional growth implementation. Murphy is a dedicated proponent of harnessing truly personalized medicine to develop more effective treatments for patients and brings a high ethical standard to discussions and values transparency and collaboration., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Frances%20Murphy.webp',altText='Frances Murphy',fileId=164429952326}, linkedin=https://www.linkedin.com/in/frances-murphy-24800112, hs_name=, hs_path=, lastname=Murphy, hs_initial_published_at=1716213113382, hs_created_at=1709645745097, hs_is_edited=false, hs_deleted_at=0, name=Frances, job=Regional Vice President, Clinical Business Solutions, EU & APAC, slug=frances-murphy, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778895, hs_child_table_id=0, hs_updated_at=1714461623383, hs_published_at=1744844126301, description=Michael Towse is a dedicated communication specialist with a 20-year background spanning development across a diverse range of CRO environments; from business development to training. His diverse career includes working through the development of communication material, the delivery of communication and initiatives, and time spent on the strategic alignment of sales and marketing strategies to corporate objectives and those objectives central to motivating staff, building teams, and driving business forward., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Mike%20Towse.webp',altText='Mike Towse',fileId=165892372601}, linkedin=https://www.linkedin.com/in/michaeltowse/, hs_name=, hs_path=, lastname=Towse, hs_initial_published_at=1716212769184, hs_created_at=1709645745126, hs_is_edited=false, hs_deleted_at=0, name=Michael, job=, slug=michael-towse, email=, hs_updated_by_user_id=51739740}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778887, hs_child_table_id=0, hs_updated_at=1715690972359, hs_published_at=1744844126301, description=Andy Kinley, Ph.D. is Vice President of Innovation and Clinical Science at Precision for Medicine. He is a clinical researcher with over 25 years of combined experience leading basic and clinical research in oncology and hematology. His early scientific career focused on cancer cell signaling, setting a foundation to complement his clinical research roles in trial design and implementation of effective strategies for oncology clinical trials. Andy specializes in immuno-oncology trials (checkpoint inhibitors, T-cell agonists, bispecifics, cytokines, oncolytic viruses, neoantigen cancer vaccines), including autologous and allogeneic adoptive cell therapies (CAR-T, TCR, TIL, NK cells). Today, Andy identifies and implements innovative tools, datasets, and services that can impact clinical trial execution including quality, patient diversity, site identification, and trial timelines., avatar=Image{width=720,height=829,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/AndyKinley_headshot.png',altText='AndyKinley_headshot',fileId=167369936018}, linkedin=https://www.linkedin.com/in/andy-kinley-phd-5759551, hs_name=, hs_path=, lastname=Kinley, hs_initial_published_at=1716212769184, hs_created_at=1709645745118, hs_is_edited=false, hs_deleted_at=0, name=Andy, job=, slug=andy-kinley, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1744830865620, hs_published_at=1744844126301, description=Rob Maiale is a marketing strategist and creative technologist with 17 years of experience turning complex ideas into growth. He currently leads content strategy, where he transforms insights from Precision experts into market-shaping narratives that drive the advancement of next-generation therapies. Rob’s career spans journalism, advertising, and brand storytelling, with a through-line of making the meaningful memorable. His work blends creative strategy with emerging AI tools to help Precision stay ahead of the curve—and above the noise., 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=1744843965759, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, position=Associate Director, Digital Content & Inbound Marketing, job=, slug=rob-maiale, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778892, hs_child_table_id=0, hs_updated_at=1715691877459, hs_published_at=1744844126301, description=Estelle Roger is a senior program manager at Precision Medicine Group and supports strategies related to public funding of research and innovation. With more than 5 years building and managing R&D Tax incentives strategies for both CROs and pharmaceutical industries, Estelle’s expertise covers a meaningful panel of R&D tax relief regimes across North America and Europe., avatar=Image{width=720,height=812,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Estelle-roger.png',altText='Estelle-roger',fileId=167371301904}, linkedin=https://www.linkedin.com/in/estelle-roger-n, hs_name=, hs_path=, lastname=Roger, hs_initial_published_at=1716212769184, hs_created_at=1709645745123, hs_is_edited=false, hs_deleted_at=0, name=Estelle, job=, slug=estelle-roger, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Administering Event-Driven Clinical Trials: A Biostatistical Analysis
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Streamlining Clinical Trials in an Age of Complexity: Insights from Sofia Baig
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1744830865620, hs_published_at=1744844126301, description=Rob Maiale is a marketing strategist and creative technologist with 17 years of experience turning complex ideas into growth. He currently leads content strategy, where he transforms insights from Precision experts into market-shaping narratives that drive the advancement of next-generation therapies. Rob’s career spans journalism, advertising, and brand storytelling, with a through-line of making the meaningful memorable. His work blends creative strategy with emerging AI tools to help Precision stay ahead of the curve—and above the noise., 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=1744843965759, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, position=Associate Director, Digital Content & Inbound Marketing, job=, slug=rob-maiale, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Inside a CRO: The Impact of a Biostatistician in Clinical Research
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778887, hs_child_table_id=0, hs_updated_at=1715690972359, hs_published_at=1744844126301, description=Andy Kinley, Ph.D. is Vice President of Innovation and Clinical Science at Precision for Medicine. He is a clinical researcher with over 25 years of combined experience leading basic and clinical research in oncology and hematology. His early scientific career focused on cancer cell signaling, setting a foundation to complement his clinical research roles in trial design and implementation of effective strategies for oncology clinical trials. Andy specializes in immuno-oncology trials (checkpoint inhibitors, T-cell agonists, bispecifics, cytokines, oncolytic viruses, neoantigen cancer vaccines), including autologous and allogeneic adoptive cell therapies (CAR-T, TCR, TIL, NK cells). Today, Andy identifies and implements innovative tools, datasets, and services that can impact clinical trial execution including quality, patient diversity, site identification, and trial timelines., avatar=Image{width=720,height=829,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/AndyKinley_headshot.png',altText='AndyKinley_headshot',fileId=167369936018}, linkedin=https://www.linkedin.com/in/andy-kinley-phd-5759551, hs_name=, hs_path=, lastname=Kinley, hs_initial_published_at=1716212769184, hs_created_at=1709645745118, hs_is_edited=false, hs_deleted_at=0, name=Andy, job=, slug=andy-kinley, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Strategies to Elevate Your Study at Saturated Sites
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Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778887, hs_child_table_id=0, hs_updated_at=1715690972359, hs_published_at=1744844126301, description=Andy Kinley, Ph.D. is Vice President of Innovation and Clinical Science at Precision for Medicine. He is a clinical researcher with over 25 years of combined experience leading basic and clinical research in oncology and hematology. His early scientific career focused on cancer cell signaling, setting a foundation to complement his clinical research roles in trial design and implementation of effective strategies for oncology clinical trials. Andy specializes in immuno-oncology trials (checkpoint inhibitors, T-cell agonists, bispecifics, cytokines, oncolytic viruses, neoantigen cancer vaccines), including autologous and allogeneic adoptive cell therapies (CAR-T, TCR, TIL, NK cells). Today, Andy identifies and implements innovative tools, datasets, and services that can impact clinical trial execution including quality, patient diversity, site identification, and trial timelines., avatar=Image{width=720,height=829,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/AndyKinley_headshot.png',altText='AndyKinley_headshot',fileId=167369936018}, linkedin=https://www.linkedin.com/in/andy-kinley-phd-5759551, hs_name=, hs_path=, lastname=Kinley, hs_initial_published_at=1716212769184, hs_created_at=1709645745118, hs_is_edited=false, hs_deleted_at=0, name=Andy, job=, slug=andy-kinley, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy
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Biopharma Manufacturing and Supply: Where Experts Predict We’re Headed
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1744830865620, hs_published_at=1744844126301, description=Rob Maiale is a marketing strategist and creative technologist with 17 years of experience turning complex ideas into growth. He currently leads content strategy, where he transforms insights from Precision experts into market-shaping narratives that drive the advancement of next-generation therapies. Rob’s career spans journalism, advertising, and brand storytelling, with a through-line of making the meaningful memorable. His work blends creative strategy with emerging AI tools to help Precision stay ahead of the curve—and above the noise., 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=1744843965759, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, position=Associate Director, Digital Content & Inbound Marketing, job=, slug=rob-maiale, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Inside a CRO: The Critical Role of Regulatory and Startup Specialists in Clinical Research
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778850, hs_child_table_id=0, hs_updated_at=1709645745081, hs_published_at=1744844126301, description=Mar Galan is Sr. Start-up Line Manager for several EMEA countries at Precision. She has a Pharmacy Degree and a MSc in pharmaceutical industry and has spent over 16 years working in the CRO industry, mainly in the start-up area, in different roles. Mar’s experience covers for a wide variety of studies, from phase I to IV. Her well-rounded background spans multiple disease states across the various stages of drug development., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/mar-galan.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/mar-galan-dalmau-9b068a1a, hs_name=, hs_path=, lastname=Galan, hs_initial_published_at=1716212769184, hs_created_at=1709645745081, hs_is_edited=false, hs_deleted_at=0, name=Mar, job=, slug=mar-galan, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Case Study: International Phase 1 Non-small Cell Lung Cancer (NSCLC) Trial
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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=1744844126301, 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={}})
Clinical Trial Trends: Non-small Cell Lung Cancer (NSCLC)
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778887, hs_child_table_id=0, hs_updated_at=1715690972359, hs_published_at=1744844126301, description=Andy Kinley, Ph.D. is Vice President of Innovation and Clinical Science at Precision for Medicine. He is a clinical researcher with over 25 years of combined experience leading basic and clinical research in oncology and hematology. His early scientific career focused on cancer cell signaling, setting a foundation to complement his clinical research roles in trial design and implementation of effective strategies for oncology clinical trials. Andy specializes in immuno-oncology trials (checkpoint inhibitors, T-cell agonists, bispecifics, cytokines, oncolytic viruses, neoantigen cancer vaccines), including autologous and allogeneic adoptive cell therapies (CAR-T, TCR, TIL, NK cells). Today, Andy identifies and implements innovative tools, datasets, and services that can impact clinical trial execution including quality, patient diversity, site identification, and trial timelines., avatar=Image{width=720,height=829,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/AndyKinley_headshot.png',altText='AndyKinley_headshot',fileId=167369936018}, linkedin=https://www.linkedin.com/in/andy-kinley-phd-5759551, hs_name=, hs_path=, lastname=Kinley, hs_initial_published_at=1716212769184, hs_created_at=1709645745118, hs_is_edited=false, hs_deleted_at=0, name=Andy, job=, slug=andy-kinley, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Empowering Clinical Operations with Enhanced Biospecimen Lifecycle Management
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Inside a CRO: Essential Insights from Medical Monitoring
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778863, hs_child_table_id=0, hs_updated_at=1715692115431, hs_published_at=1744844126301, description=Etleva Pashaj, MD is a strategic, innovation-driven, drug discovery veteran—as well as a board-certified oncologist—with extensive international (EMA and FDA) regulatory experience. She has a record of excellence in clinical development, medical monitoring and medical strategy, and managing and mentoring cross-functional and global teams for phase 1-4 onco-hematology studies., avatar=Image{width=720,height=812,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Etleva-Pashaj.png',altText='Etleva-Pashaj',fileId=167370798473}, linkedin=https://www.linkedin.com/in/etleva-pashaj-0859223a, hs_name=, hs_path=, lastname=Pashaj, hs_initial_published_at=1716212769184, hs_created_at=1709645745094, hs_is_edited=false, hs_deleted_at=0, name=Etleva, job=, slug=etleva-pashaj, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Unpacking FDA’s Draft Guidance on Psychedelic Research for Clinical Success
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778843, hs_child_table_id=0, hs_updated_at=1714461297945, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
Inside a CRO: The Pivotal Role of Clinical Trial Manager in Clinical Research
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778894, hs_child_table_id=0, hs_updated_at=1714461151531, hs_published_at=1744844126301, description=Vincent Shortino is a Principal Clinical Trial Manager, bringing more than 20 years of experience to Precision. His experience spans all major therapeutic areas with a heavy emphasis on Cardiovascular and Rare Indications, across Phases I–IV. He brings solid perspectives inclusive of sites, pharma and CROs from his previous roles of Study Coordinator, Site Director, CRA, and Clinical Trial Manager., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Vincent%20Shortino.webp',altText='Vincent Shortino',fileId=165892429964}, linkedin=https://www.linkedin.com/in/vincent-shortino-954b3857, team=[{id=163080551773, name='Clinical Solutions Leadership'}], hs_name=, hs_path=, lastname=Shortino, hs_initial_published_at=1716212769184, hs_created_at=1709645745125, hs_is_edited=false, hs_deleted_at=0, name=Vincent, job=Principal Clinical Trial Manager, slug=vincent-shortino, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Best Practices for Biostatisticians: Preparing for Interim Analysis in Clinical Trials
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Clinical Trial Patient Recruitment: Why Concierge Services are a Game-Changer
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778896, hs_child_table_id=0, hs_updated_at=1714461464701, hs_published_at=1744844126301, description=Sarabeth Velazquez is an Associate Director of Project Management at Precision for Medicine, having 20 years of experience in managing Phase I-III clinical trials. Sarabeth’s expertise covers a wide variety of therapeutic areas in rare disease, oncology, dermatology, ophthalmology and cosmetic clinical trials. Her experience notably includes: abdominal bulging, submental subcutaneous fat, molluscum contagiosum, onychomycosis, neurofibromas, herpes labialis, hyperhidrosis, breast implants, colorectal cancer, solid tumors, breast cancer, ovarian cancer, lymphoma, cataracts, pulmonary arterial hypertension, classic galactosemia, and sorbitol dehydrogenase deficiency., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Sarabeth%20Velasquez%20Square.webp',altText='Sarabeth Velasquez Square',fileId=165892429960}, linkedin=https://www.linkedin.com/in/sarabeth-alcala-velazquez-17409811/, hs_name=, hs_path=, lastname=Velazquez, hs_initial_published_at=1716212769184, hs_created_at=1709645745127, hs_is_edited=false, hs_deleted_at=0, name=Sarabeth, job=, slug=sarabeth-velazquez, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
CROs in Clinical Trials: Keys to Successful Sponsor-CRO Partnerships
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1744830865620, hs_published_at=1744844126301, description=Rob Maiale is a marketing strategist and creative technologist with 17 years of experience turning complex ideas into growth. He currently leads content strategy, where he transforms insights from Precision experts into market-shaping narratives that drive the advancement of next-generation therapies. Rob’s career spans journalism, advertising, and brand storytelling, with a through-line of making the meaningful memorable. His work blends creative strategy with emerging AI tools to help Precision stay ahead of the curve—and above the noise., 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=1744843965759, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, position=Associate Director, Digital Content & Inbound Marketing, job=, slug=rob-maiale, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Conducting Pediatric Studies: Addressing Ethical and Clinical Challenges
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778880, hs_child_table_id=0, hs_updated_at=1714461214107, hs_published_at=1744844126301, 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=1716212769184, hs_created_at=1709645745111, hs_is_edited=false, hs_deleted_at=0, name=Eva, job=, slug=eva-raschke, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Phase I Clinical Trial Designs: Backfill i3+3 (Bi3+3)
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1709645745122, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
Driving Oncology Trial Execution with Novel Data-Driven Approaches to Site and Patient Identification
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778887, hs_child_table_id=0, hs_updated_at=1715690972359, hs_published_at=1744844126301, description=Andy Kinley, Ph.D. is Vice President of Innovation and Clinical Science at Precision for Medicine. He is a clinical researcher with over 25 years of combined experience leading basic and clinical research in oncology and hematology. His early scientific career focused on cancer cell signaling, setting a foundation to complement his clinical research roles in trial design and implementation of effective strategies for oncology clinical trials. Andy specializes in immuno-oncology trials (checkpoint inhibitors, T-cell agonists, bispecifics, cytokines, oncolytic viruses, neoantigen cancer vaccines), including autologous and allogeneic adoptive cell therapies (CAR-T, TCR, TIL, NK cells). Today, Andy identifies and implements innovative tools, datasets, and services that can impact clinical trial execution including quality, patient diversity, site identification, and trial timelines., avatar=Image{width=720,height=829,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/AndyKinley_headshot.png',altText='AndyKinley_headshot',fileId=167369936018}, linkedin=https://www.linkedin.com/in/andy-kinley-phd-5759551, hs_name=, hs_path=, lastname=Kinley, hs_initial_published_at=1716212769184, hs_created_at=1709645745118, hs_is_edited=false, hs_deleted_at=0, name=Andy, job=, slug=andy-kinley, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Case Study: An Advanced Approach to Integrated Summary of Safety Studies
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778876, hs_child_table_id=0, hs_updated_at=1709645745107, hs_published_at=1744844126301, description=Michelle Clark, Ph.D. is a Senior Lead Biostatistician. She received her Ph.D. in Biostatistics from UCLA and has more than 12 years of combined research experience in academic, hospital, and CRO settings. As both lead statistician and statistical oversight, Michelle has successfully supported Phase I-III clinical trials across a broad range of therapeutic areas including oncology, genetic disorders, and rare disease., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/michelle-clark.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/michellemarieclark, hs_name=, hs_path=, lastname=Clark, hs_initial_published_at=1716212769184, hs_created_at=1709645745107, hs_is_edited=false, hs_deleted_at=0, name=Michelle, job=, slug=michelle-clark, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778893, hs_child_table_id=0, hs_updated_at=1709645745124, hs_published_at=1744844126301, description=Veronica Ruvolo is a Senior Manager of Biostatistics with more than 7 years of experience covering a range of therapeutic areas, including strong experience in oncology that spans various clinical phases. She has successfully led and supported projects, including department initiatives, and is knowledgeable and practiced in statistical analysis and statistical programming ., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/veronica-ruvolo.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/veronica-wessel-ruvolo-0abba179, hs_name=, hs_path=, lastname=Ruvolo, hs_initial_published_at=1716212769184, hs_created_at=1709645745124, hs_is_edited=false, hs_deleted_at=0, name=Veronica, job=, slug=veronica-ruvolo, email=, hs_updated_by_user_id=51739740}, third={}})
Inside a CRO: The Critical Role of Clinical Data Managers in Clinical Research
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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=1744844126301, 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={}})
Inside a CRO: The Essential Role of a Clinical Project Manager
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778873, hs_child_table_id=0, hs_updated_at=1715693354219, hs_published_at=1744844126301, description=Lindsey Pierce, PhD is a Senior Project Manager with over 15 years of research experience, ranging from diagnostic development and patent acquisition, to genomic medicine advancements in viral and pathogen genotyping, and clinical research. She has successfully managed both local and global projects across many programs and therapeutic areas. While specializing in early phase oncology, she also has worked in late phase oncology trials as well as rare disease studies. Her passion is to bring treatment to patients in need to help them battle the unfortunate and let the family know that research is on their side every step of the way., avatar=Image{width=710,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Lindsey-Pierce.png',altText='Lindsey-Pierce',fileId=167373615946}, linkedin=https://www.linkedin.com/in/lindsey-pierce-phd-a252b812b, hs_name=, hs_path=, lastname=Pierce, hs_initial_published_at=1716212769184, hs_created_at=1709645745104, hs_is_edited=false, hs_deleted_at=0, name=Lindsey, job=, slug=lindsey-pierce, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Scaling Hope: The Growth of Allogeneic Cell Therapy Sector
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
Phase III Case Study: Adapting in the Face of Adversity
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778845, hs_child_table_id=0, hs_updated_at=1709645745076, hs_published_at=1744844126301, description=Brian Beus is a Principal Biostatistician with more than 25 years experience supporting the statistical analysis of data through all phases of clinical trials across many therapeutic areas. He has extensive experience in leading teams and working with sponsors through study design, protocol development, adaptive design, statistical analysis plans, statistical analysis, clinical study reports, regulatory submissions, and regulatory responses., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/brian-beus.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/brian-beus-66033333, hs_name=, hs_path=, lastname=Beus, hs_initial_published_at=1716212769184, hs_created_at=1709645745076, hs_is_edited=false, hs_deleted_at=0, name=Brian, job=, slug=brian-beus, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
High-Quality Biospecimens in Therapeutic & Diagnostic Development: A Comprehensive Guide from Concept to Cloud
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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=1744844126301, 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=159488778886, hs_child_table_id=0, hs_updated_at=1714461583598, hs_published_at=1744844126301, 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=1716212769184, hs_created_at=1709645745117, hs_is_edited=false, hs_deleted_at=0, name=Robert, job=, slug=robert-snyder, email=, hs_updated_by_user_id=51739740}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778862, hs_child_table_id=0, hs_updated_at=1709645745093, hs_published_at=1744844126301, description=Olya Demireva is a Senior CTM bringing over 15 years of experience. She is a certified psychiatrist and clinical immunologist with 15 years of clinical research in CNS diseases and solid medical scientific background in biological psychiatry with focus on Major Depression and Bipolar Disorders, and neuro-psycho-immunology. Her experience in clinical research spans over almost all therapeutic areas with emphasis on Oncology, Pulmonology, Cardiovascular Diseases, Sleep Disorders, Hematology, Endocrinology and Rare Diseases across phases I-IV., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/olya-demireva.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/olya-demireva-md-0a91809, hs_name=, hs_path=, lastname=Demireva, hs_initial_published_at=1716136551646, hs_created_at=1709645745093, hs_is_edited=false, hs_deleted_at=0, name=Olya, job=, slug=olya-demireva, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778847, hs_child_table_id=0, hs_updated_at=1714461476003, hs_published_at=1744844126301, description=Saoussen Brun is a Senior Director of Project Management at Precision for Medicine. She brings more than 18 years of Clinical and Project Management experience to the Precision team. Saoussen’s expertise covers a wide variety of therapeutic areas, with strong experience in oncology and neurology indication. She leads and motivates high-performing teams under tough deadlines to meet both project goals and company targets., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Saoussen%20Brun%20Square.webp',altText='Saoussen Brun Square',fileId=165892742326}, linkedin=https://www.linkedin.com/in/saoussen-bouali-brun-phd-2212b852, hs_name=, hs_path=, lastname=Brun, hs_initial_published_at=1716212769184, hs_created_at=1709645745078, hs_is_edited=false, hs_deleted_at=0, name=Saoussen, job=, slug=saoussen-brun, email=, hs_updated_by_user_id=51739740}, third={}})
Incorporating Decentralized Clinical Trial Strategies into CNS Studies
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778843, hs_child_table_id=0, hs_updated_at=1714461297945, hs_published_at=1744844126301, 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=51739740}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778884, hs_child_table_id=0, hs_updated_at=1709645745115, hs_published_at=1744844126301, description=Vann Parker is the Head of Regulatory Consultancy (North America) for Precision for Medicine. He received his PhD in Molecular Biology from The California Institute of Technology and spent the past 30 years supporting biopharmaceutical and drug development. He currently focuses on strategies for clinical development and interactions with FDA and other regulatory agencies. In addition to support of pre-IND activities, Vann has supported sponsors throughout the drug development process including applications for Fast Track, Breakthrough Therapy and Orphan Designations, formal meetings with FDA and full NDA/BLA submissions., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/vann-parker.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/vann-parker-69565a6/, hs_name=, hs_path=, lastname=Parker, hs_initial_published_at=1716136551646, hs_created_at=1709645745115, hs_is_edited=false, hs_deleted_at=0, name=Vann, job=, slug=vann-parker, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Navigating the Complex Ecosystem of Cell Therapy Clinical Trials
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1744830865620, hs_published_at=1744844126301, description=Rob Maiale is a marketing strategist and creative technologist with 17 years of experience turning complex ideas into growth. He currently leads content strategy, where he transforms insights from Precision experts into market-shaping narratives that drive the advancement of next-generation therapies. Rob’s career spans journalism, advertising, and brand storytelling, with a through-line of making the meaningful memorable. His work blends creative strategy with emerging AI tools to help Precision stay ahead of the curve—and above the noise., 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=1744843965759, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, position=Associate Director, Digital Content & Inbound Marketing, job=, slug=rob-maiale, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
