Rescuing a Complex Hematology Oncology Trial: Case Study in Precision
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Safety isn’t a Milestone but a Mindset in Clinical Research
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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=1741014119284, 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=26433386}, second={hs_id=159488778852, hs_child_table_id=0, hs_updated_at=1716212815818, hs_published_at=1741014119284, 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=26433386}, third={}})
Considerations for Your Pre-IND Meeting With the FDA
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Inside a CRO: The Impact of a Biostatistician in Clinical Research
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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=1741014119284, 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=26433386}, 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=1741014119284, 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=26433386}, 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=1741014119284, 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=26433386}, second={}, third={}})
