FDA Draft Guidance on Overall Survival in Oncology Trials – What Sponsors Need to Know
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1757700176991, hs_published_at=1757700235512, description=John is an experienced regulatory affairs consultant with more than 15 years of professional experience in drug development. He brings a proven track record in providing regulatory strategy, regulatory document development and review, and liaising with regulatory authorities., avatar=Image{width=1000,height=1000,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/John%20McIntyre.jpg',altText='John McIntyre',fileId=195809756215}, lastname=McIntyre, PhD, hs_initial_published_at=1757516163742, hs_created_by_user_id=26433386, hs_created_at=1757515873736, hs_is_edited=false, hs_deleted_at=0, name=John, job=Senior Director, Regulatory Strategy, slug=john-mcintyre, hs_updated_by_user_id=26433386}, second={hs_id=195804116749, hs_child_table_id=0, hs_updated_at=1757598950007, hs_published_at=1757700235512, description=An expert in hematology and oncology and a veteran of the FDA with almost nine years of experience, culminating as a Deputy Director for the Division of Hematologic Malignancies 2. Possesses a profound understanding of regulatory strategy, particularly in the development of CAR-T cell therapies, bispecifics and T-cell engagers. Spearheaded initiatives to develop novel endpoints in blood cancer such as minimal residual disease (MRD) in lymphoma and chronic lymphocytic leukemia (CLL.), avatar=Image{width=1000,height=1000,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Nick%20Richardson.jpg',altText='Nick Richardson',fileId=195807970451}, linkedin=https://www.linkedin.com/in/nicholas-richardson-do-mph-049784113/, lastname=Richardson, DO, MPH, hs_initial_published_at=1757516163742, hs_created_by_user_id=26433386, hs_created_at=1757516077087, hs_is_edited=false, hs_deleted_at=0, name=Nick, job=Vice President, Clinical Development, slug=nick-richardson, hs_updated_by_user_id=26433386}, third={}})
Case Study: Early Genotype Confirmation Rescued a Phase 1-2 SCID Trial
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164725548848, hs_child_table_id=0, hs_updated_at=1754641451547, hs_published_at=1757700235512, description=Alexis Hobbins-White is an accomplished leader who plays a pivotal role in navigating the complex landscape of global oncology and rare disease-focused clinical trials. With a career spanning over 15 years in the clinical trials industry, Alexis brings a wealth of experience across multiple therapeutic areas, showcasing her proficiency in diverse aspects of operational strategy. She specializes in early phase adaptive studies, particularly in immuno-oncology and advanced therapeutics. She has an MSc in Neuroscience and an MA in Biotechnology Law and Ethics., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Alexis-Hobbins.png',altText='Alexis-Hobbins',fileId=194096322982}, linkedin=https://www.linkedin.com/in/alexis-hobbins-white-400a1720/, lastname=Hobbins-White, hs_initial_published_at=1713362276020, hs_created_by_user_id=5166971, hs_created_at=1713361952861, hs_is_edited=false, hs_deleted_at=0, name=Alexis, job=Senior Director, Operational Strategy , slug=alexis-hobbins-white, hs_updated_by_user_id=26433386}, second={}, third={}})
Phase 3 Prostate Cancer Case Study: Radiopharm Imaging at Scale
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778843, hs_child_table_id=0, hs_updated_at=1714461297945, hs_published_at=1757700235512, 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_created_at=1709645745074, hs_is_edited=false, hs_deleted_at=0, name=Robert, job=, slug=robert-bauer, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
Taiwan’s Clinical Trial Landscape: Fast, Efficient, and High-Quality Research
|
has third author: false, (SizeLimitingPyMap: {main={hs_id=167906611101, hs_child_table_id=0, hs_updated_at=1743507158804, hs_published_at=1757700235512, 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=26433386}, second={hs_id=192644417560, hs_child_table_id=0, hs_updated_at=1754641153599, hs_published_at=1757700235512, description=Gavin Phan is a pharmacist based in Melbourne, Australia, who leads Precision’s APAC CRA team. Gavin has over a decade of experience in diverse clinical operations and leading teams throughout AsiaPac, including Taiwan., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Gavin-Phan.png',altText='Gavin-Phan',fileId=194126240345}, lastname=Phan, hs_initial_published_at=1752501514571, hs_created_by_user_id=26433386, hs_created_at=1752501444306, hs_is_edited=false, hs_deleted_at=0, name=Gavin, job=Manager, Global Clinical Monitoring, slug=gavin-phan, hs_updated_by_user_id=26433386}, third={hs_id=192645526119, hs_child_table_id=0, hs_updated_at=1752501710597, hs_published_at=1757700235512, description=Kelly Lin is a Senior Clinical Research Associate supporting Precision clinical trials in the AsiaPac region., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Precision%20Expert.png',altText='Precision Expert',fileId=164175466823}, lastname=Lin, hs_initial_published_at=1752501630185, hs_created_by_user_id=26433386, hs_created_at=1752501557958, hs_is_edited=false, hs_deleted_at=0, name=Kelly, job=Senior Clinical Research Associate, slug=kelly-lin, hs_updated_by_user_id=26433386}})
Global Phase 1–2 ROS1 Inhibitor Case Study in NSCLC: Precision’s Path to Zero Data Issues Across 60+ Sites
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164725548848, hs_child_table_id=0, hs_updated_at=1754641451547, hs_published_at=1757700235512, description=Alexis Hobbins-White is an accomplished leader who plays a pivotal role in navigating the complex landscape of global oncology and rare disease-focused clinical trials. With a career spanning over 15 years in the clinical trials industry, Alexis brings a wealth of experience across multiple therapeutic areas, showcasing her proficiency in diverse aspects of operational strategy. She specializes in early phase adaptive studies, particularly in immuno-oncology and advanced therapeutics. She has an MSc in Neuroscience and an MA in Biotechnology Law and Ethics., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Alexis-Hobbins.png',altText='Alexis-Hobbins',fileId=194096322982}, linkedin=https://www.linkedin.com/in/alexis-hobbins-white-400a1720/, lastname=Hobbins-White, hs_initial_published_at=1713362276020, hs_created_by_user_id=5166971, hs_created_at=1713361952861, hs_is_edited=false, hs_deleted_at=0, name=Alexis, job=Senior Director, Operational Strategy , slug=alexis-hobbins-white, hs_updated_by_user_id=26433386}, second={}, third={}})
Case Study: Conducting Autologous Cell Therapy Research Across 3 Continents with Zero Sample Loss
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164725548848, hs_child_table_id=0, hs_updated_at=1754641451547, hs_published_at=1757700235512, description=Alexis Hobbins-White is an accomplished leader who plays a pivotal role in navigating the complex landscape of global oncology and rare disease-focused clinical trials. With a career spanning over 15 years in the clinical trials industry, Alexis brings a wealth of experience across multiple therapeutic areas, showcasing her proficiency in diverse aspects of operational strategy. She specializes in early phase adaptive studies, particularly in immuno-oncology and advanced therapeutics. She has an MSc in Neuroscience and an MA in Biotechnology Law and Ethics., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Alexis-Hobbins.png',altText='Alexis-Hobbins',fileId=194096322982}, linkedin=https://www.linkedin.com/in/alexis-hobbins-white-400a1720/, lastname=Hobbins-White, hs_initial_published_at=1713362276020, hs_created_by_user_id=5166971, hs_created_at=1713361952861, hs_is_edited=false, hs_deleted_at=0, name=Alexis, job=Senior Director, Operational Strategy , slug=alexis-hobbins-white, hs_updated_by_user_id=26433386}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1754641517766, hs_published_at=1757700235512, 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=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/kurt-preugschat.png',altText='kurt-preugschat',fileId=194097561372}, linkedin=https://www.linkedin.com/in/kurt-preugschat-97298923a, hs_name=, hs_path=, lastname=Preugschat, hs_created_at=1709645745122, hs_is_edited=false, hs_deleted_at=0, name=Kurt, job=, slug=kurt-preugschat, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM)
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1754641517766, hs_published_at=1757700235512, 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=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/kurt-preugschat.png',altText='kurt-preugschat',fileId=194097561372}, linkedin=https://www.linkedin.com/in/kurt-preugschat-97298923a, hs_name=, hs_path=, lastname=Preugschat, hs_created_at=1709645745122, hs_is_edited=false, hs_deleted_at=0, name=Kurt, job=, slug=kurt-preugschat, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
Phase I Clinical Trial Designs: Bayesian Logistic Regression Model (BLRM)
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1754641517766, hs_published_at=1757700235512, 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=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/kurt-preugschat.png',altText='kurt-preugschat',fileId=194097561372}, linkedin=https://www.linkedin.com/in/kurt-preugschat-97298923a, hs_name=, hs_path=, lastname=Preugschat, hs_created_at=1709645745122, hs_is_edited=false, hs_deleted_at=0, name=Kurt, job=, slug=kurt-preugschat, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
