The Amendment Trap: Why 76% of Clinical Trials Face Six-Figure Protocol Changes
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=187570680222, hs_child_table_id=0, hs_updated_at=1742413198455, hs_published_at=1742413203456, 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=26433386}, second={}, third={}})
Best Practices to Streamline Development of Safety Update Reports (DSURs)
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=182849803084, hs_child_table_id=0, hs_updated_at=1731697230236, hs_published_at=1742413203456, 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=26433386}, second={}, third={}})
Webinar Insights: Optimizing Cohort Management in Early-Phase Oncology Trials
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1741014116242, hs_published_at=1742413203456, description=Rob Maiale is a marketing strategist and creative technologist known for shaping content strategies that drive engagement, influence, and business impact. With more than 15 years of experience spanning clinical research, patient education, pharma, and diagnostics, he specializes in turning expert insights into market-shaping narratives. At Precision, Rob leads innovative storytelling initiatives that connect cutting-edge science with the right audiences—leveraging AI, emerging technologies, and deep industry expertise to keep content ahead of the curve., avatar=Image{width=400,height=400,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Rob%20Maiale.jpg',altText='Rob Maiale',fileId=184765575245}, linkedin=https://www.linkedin.com/in/rob-maiale/, hs_name=, hs_path=, lastname=Maiale, hs_initial_published_at=1741014119343, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, job=, slug=rob-maiale, email=, hs_updated_by_user_id=26433386}, second={hs_id=181884577650, hs_child_table_id=0, hs_updated_at=1729782746463, hs_published_at=1742413203456, description=Niveda Ramkumar is a seasoned growth strategist with over 15 years of experience in marketing, business development, and account management at leading CROs and life science research firms. She has successfully spearheaded the launch of new services and technologies in clinical development, genomics and biomarkers, regulatory affairs, safety, and commercialization., avatar=Image{width=753,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/niveda-ramkumar.jpg',altText='niveda-ramkumar',fileId=181890014492}, lastname=Ramkumar, hs_initial_published_at=1729782775265, hs_created_by_user_id=26433386, hs_created_at=1729782662277, hs_is_edited=false, hs_deleted_at=0, name=Niveda, job=Director, Marketing, slug=niveda-ramkumar, hs_updated_by_user_id=26433386}, third={}})
2025 Biotech Economics: CROs, Advanced Therapies & Trends in Funding
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1741014116242, hs_published_at=1742413203456, description=Rob Maiale is a marketing strategist and creative technologist known for shaping content strategies that drive engagement, influence, and business impact. With more than 15 years of experience spanning clinical research, patient education, pharma, and diagnostics, he specializes in turning expert insights into market-shaping narratives. At Precision, Rob leads innovative storytelling initiatives that connect cutting-edge science with the right audiences—leveraging AI, emerging technologies, and deep industry expertise to keep content ahead of the curve., avatar=Image{width=400,height=400,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Rob%20Maiale.jpg',altText='Rob Maiale',fileId=184765575245}, linkedin=https://www.linkedin.com/in/rob-maiale/, hs_name=, hs_path=, lastname=Maiale, hs_initial_published_at=1741014119343, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, job=, slug=rob-maiale, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
FDA's Project Optimus: What Pharma and Biotech Need to Know
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1742413203456, description=Industry-leading oncologist and demonstrated medical leader in precision medicine, novel trial design and innovative regulatory initiatives designed to expedite drug approvals. Draws on nearly a decade leading oncology and rare disease programs at the FDA. Former fellow at the National Cancer Institute and frequent featured speaker at ASCO and AACR. CDER technical authority on oncologic drug and biological products for thoracic and head and neck malignancies, neurologic tumors, pediatric solid tumors and rare tumors., avatar=Image{width=553,height=580,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Harpreet-Singh2.png',altText='Harpreet-Singh2',fileId=171747124346}, linkedin=https://www.linkedin.com/in/harpreetsinghmd/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Singh, MD, hs_initial_published_at=1715692570942, hs_created_by_user_id=2737751, hs_created_at=1715692477118, hs_is_edited=false, hs_deleted_at=0, name=Harpreet, job=Chief Medical Officer, slug=harpreet-singh, hs_updated_by_user_id=26433386}, second={}, third={}})
Case Study Phase 3 NSCLC: Site Relationships Streamline Feasibility
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=185838258545, hs_child_table_id=0, hs_updated_at=1738849388884, hs_published_at=1742413203456, description=Anna Rodecki is a results driven leader with 24 years of experience in clinical research across the pharmaceutical, device, and biotech industries. She has played a pivotal role in shaping clinical development plans on both Sponsor and CRO, successfully supporting First- In-Human (FIH) – Phase IV trials successfully across various therapeutics areas. Anan thrives on building strong, collaborative teams fostering innovation. Her expertise spans strategic planning, risk management, inspection readiness and cross-functional leadership – always with a focus on improving patient outcomes and advancing the future of medicine., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Anna%20Rodecki.png',altText='Anna Rodecki',fileId=185842773784}, lastname=Rodecki, hs_initial_published_at=1738849393727, hs_created_by_user_id=26433386, hs_created_at=1738849349748, hs_is_edited=false, hs_deleted_at=0, name=Anna, job=Director, Project Management, slug=anna-rodecki, hs_updated_by_user_id=26433386}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=183222587782, hs_child_table_id=0, hs_updated_at=1732630460690, hs_published_at=1742413203456, description=Jelena Alexander brings 18 years of industry experience across the CRO, biotech and R&D arenas, with the last eight years focused on clinical operations oversight and aligning resources with project needs. Prior to transitioning to clinical research, Jelena obtained a Master’s degree in infectious disease and immunology, specializing in the development of cross-reactive and neutralizing monoclonal antibodies to foot-and-moth disease virus. Jelena is a collaborative leader recognized for fostering relationships with stakeholders to embed sustainable workflow processes and for delivering high quality outputs to ensure business needs are accomplished on time and within budget. Jelena’s expertise extends to evaluating and assessing clinical proposals, with a focus on monitoring strategies, and operational feasibility. In this role, Jelena leverages operational and leadership expertise to deliver high-quality, client-focused solutions while enhancing efficiency and sustainability in proposal strategies. Jelena is devoted to driving innovation, mentoring teams, and achieving results through adaptability and commitment to quality., avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Jelena%20Alexander.jpg',altText='Jelena Alexander',fileId=183228271491}, lastname=Alexander, hs_initial_published_at=1732630470588, hs_created_by_user_id=26433386, hs_created_at=1732630317363, hs_is_edited=false, hs_deleted_at=0, name=Jelena, job=Senior Manager, Global Clinical Monitoring, slug=jelena-alexander, hs_updated_by_user_id=26433386}, second={}, third={}})
How to launch a clinical trial in South Korea: Investigational New Drug Application Process
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=185416008310, hs_child_table_id=0, hs_updated_at=1737992478996, hs_published_at=1742413203456, 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=26433386}, second={hs_id=167906611101, hs_child_table_id=0, hs_updated_at=1724924613816, hs_published_at=1742413203456, 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=26433386}, third={}})
