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={}})
