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=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={}})
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=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={}})
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={}})
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={}})
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={}})
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={}})
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={}})
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={}})
Overcoming Hurdles in Rare Disease Research and Development
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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 Accelerated Approval for Oncology Therapeutics: Clinical Trial Considerations
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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={}})
Decentralized Clinical Trials: Strategies that Work in Rare Diseases
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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={}})
Centralized vs Decentralized Raters: When to Use Which in CNS 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=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}, third={}})
Pros and Cons: Innovative Study Designs vs. Traditional FIH
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778854, hs_child_table_id=0, hs_updated_at=1715695005945, hs_published_at=1744844126301, description=Rosa Canals López has 15 years of experience in managing Phase I-IV clinical trials, including >7 years of Clinical Management experience. Her focus is on Phase I studies and CAR-T, with additional experience in oncology, hematology, pediatrics, infectious diseases, cardiology, and nephrology., avatar=Image{width=533,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Rosa-Canals.png',altText='Rosa-Canals',fileId=167374630834}, linkedin=https://www.linkedin.com/in/rosa-maria-canals-l%C3%B3pez-74902194, hs_name=, hs_path=, lastname=Canals López, hs_initial_published_at=1716136551646, hs_created_at=1709645745085, hs_is_edited=false, hs_deleted_at=0, name=Rosa, job=, slug=rosa-canals-lópez, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Overview: Innovative Study Designs vs. Traditional FIH
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778854, hs_child_table_id=0, hs_updated_at=1715695005945, hs_published_at=1744844126301, description=Rosa Canals López has 15 years of experience in managing Phase I-IV clinical trials, including >7 years of Clinical Management experience. Her focus is on Phase I studies and CAR-T, with additional experience in oncology, hematology, pediatrics, infectious diseases, cardiology, and nephrology., avatar=Image{width=533,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Rosa-Canals.png',altText='Rosa-Canals',fileId=167374630834}, linkedin=https://www.linkedin.com/in/rosa-maria-canals-l%C3%B3pez-74902194, hs_name=, hs_path=, lastname=Canals López, hs_initial_published_at=1716136551646, hs_created_at=1709645745085, hs_is_edited=false, hs_deleted_at=0, name=Rosa, job=, slug=rosa-canals-lópez, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
Advancing the Use of Biomarkers in CNS Drug Discovery and Development
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778867, hs_child_table_id=0, hs_updated_at=1714461162887, hs_published_at=1744844126301, description=Tracey Owens is a Director of Project and Clinical Trial Management at Precision, having 28 years of experience in managing Phase I-IV clinical trials. Tracey is highly experienced in providing directional oversight on rare disease, CNS, psychiatric and oncology clinical trials. Her experience notably includes: ALS, bipolar disorder, epilepsy, major depressive disorder, schizophrenia, idiopathic hypersomnia, CIDP, traumatic brain injury, multiple myeloma and dementia (including Alzheimer’s and Parkinson’s Disease.), avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Tracey%20Owens.webp',altText='Tracey Owens',fileId=165892372604}, linkedin=https://www.linkedin.com/in/trowens, hs_name=, hs_path=, lastname=Owens, hs_initial_published_at=1716212769184, hs_created_at=1709645745098, hs_is_edited=false, hs_deleted_at=0, name=Tracey, job=, slug=tracey-owens, email=, hs_updated_by_user_id=51739740}, second={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}, third={}})
Five Considerations for Global Phase 3 Trials in Oncology
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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={}})
Using electronic patient-reported outcome (ePRO) technology to address key challenges in CNS trials
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778867, hs_child_table_id=0, hs_updated_at=1714461162887, hs_published_at=1744844126301, description=Tracey Owens is a Director of Project and Clinical Trial Management at Precision, having 28 years of experience in managing Phase I-IV clinical trials. Tracey is highly experienced in providing directional oversight on rare disease, CNS, psychiatric and oncology clinical trials. Her experience notably includes: ALS, bipolar disorder, epilepsy, major depressive disorder, schizophrenia, idiopathic hypersomnia, CIDP, traumatic brain injury, multiple myeloma and dementia (including Alzheimer’s and Parkinson’s Disease.), avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Tracey%20Owens.webp',altText='Tracey Owens',fileId=165892372604}, linkedin=https://www.linkedin.com/in/trowens, hs_name=, hs_path=, lastname=Owens, hs_initial_published_at=1716212769184, hs_created_at=1709645745098, hs_is_edited=false, hs_deleted_at=0, name=Tracey, job=, slug=tracey-owens, email=, hs_updated_by_user_id=51739740}, second={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}, 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={}})
Increased Complexity and Therapeutic Combinations Pave the Way in Immuno-oncology
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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 Procedural Guidance: Expansion Cohorts in FIH Oncology Clinical 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={}})
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={}, third={}})
Why Caregivers Are the Key to Patient-Centric 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={}})
Leveraging genetic laboratories in rare disease patient identification
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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={}})
Best Practices for Database Transfer in a Rescue Study
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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={}})
Transitioning a Rescue Study: Data Management Considerations
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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={}})
