How to launch a clinical trial in South Korea: Investigational New Drug Application Process
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Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity
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Therapeutic Genome Editing – Reshaping the Landscape of Advanced Therapies
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FDA ODAC Vote: Key Changes for Perioperative Cancer Trials
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Navigating Site Activation Strategy Under the EU Clinical Trials Regulation
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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=1738849393727, 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=26433386}, second={}, third={}})
FDA Draft Guidance Encourages Broader Inclusion Criteria in Oncology Trials
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Inside a CRO: The Critical Role of Regulatory and Startup Specialists in Clinical Research
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Unpacking FDA’s Draft Guidance on Psychedelic Research for Clinical Success
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Conducting Pediatric Studies: Addressing Ethical and Clinical Challenges
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Case Study: An Advanced Approach to Integrated Summary of Safety Studies
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778876, hs_child_table_id=0, hs_updated_at=1709645745107, hs_published_at=1738849393727, description=Michelle Clark, Ph.D. is a Senior Lead Biostatistician. She received her Ph.D. in Biostatistics from UCLA and has more than 12 years of combined research experience in academic, hospital, and CRO settings. As both lead statistician and statistical oversight, Michelle has successfully supported Phase I-III clinical trials across a broad range of therapeutic areas including oncology, genetic disorders, and rare disease., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/michelle-clark.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/michellemarieclark, hs_name=, hs_path=, lastname=Clark, hs_initial_published_at=1716212769184, hs_created_at=1709645745107, hs_is_edited=false, hs_deleted_at=0, name=Michelle, job=, slug=michelle-clark, email=, hs_updated_by_user_id=26433386}, second={hs_id=159488778893, hs_child_table_id=0, hs_updated_at=1709645745124, hs_published_at=1738849393727, description=Veronica Ruvolo is a Senior Manager of Biostatistics with more than 7 years of experience covering a range of therapeutic areas, including strong experience in oncology that spans various clinical phases. She has successfully led and supported projects, including department initiatives, and is knowledgeable and practiced in statistical analysis and statistical programming ., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/veronica-ruvolo.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/veronica-wessel-ruvolo-0abba179, hs_name=, hs_path=, lastname=Ruvolo, hs_initial_published_at=1716212769184, hs_created_at=1709645745124, hs_is_edited=false, hs_deleted_at=0, name=Veronica, job=, slug=veronica-ruvolo, email=, hs_updated_by_user_id=26433386}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778862, hs_child_table_id=0, hs_updated_at=1709645745093, hs_published_at=1738849393727, 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=26433386}, second={hs_id=159488778847, hs_child_table_id=0, hs_updated_at=1714461476003, hs_published_at=1738849393727, 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=26433386}, third={}})
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Overcoming Hurdles in Rare Disease Research and Development
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FDA Accelerated Approval for Oncology Therapeutics: Clinical Trial Considerations
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Five Considerations for Global Phase 3 Trials in Oncology
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5 Considerations for Managing DEA-Controlled Substances in CNS Clinical Trials
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IVD Manufacturers & EU IVD Regulation Changes (May 2022)
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Regulatory Risk Management Using Third-party Distributors
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The 10 Proposed Revisions to UK Clinical Trial Regulations
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Proposed Legislative Changes for UK Clinical Trials
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BREXIT: What has Changed in the United Kingdom Clinical Trial Regulatory Landscape?
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The Multistakeholder Healthcare Environment – The Evolving Role of Regulators
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