EMA PRIME Scheme Explained: Eligibility, Benefits, Risks, and When to Apply
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The EU Biotech Act: What Sponsors Need to Know About Europe's Biotechnology Transformation
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MHRA's International Recognition Procedure: Fast-Track Access to the UK Market
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FDA Draft Guidance on Overall Survival in Oncology Trials – What Sponsors Need to Know
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Key Strategies for Future-Proofing Gene Therapy Assays
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FDA's Vision for Multiregional Clinical Trials in Oncology
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FDA's Project Optimus: What Pharma and Biotech Need to Know
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How to launch a clinical trial in South Korea: Investigational New Drug Application Process
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=185416008310, hs_child_table_id=0, hs_updated_at=1754641201258, hs_published_at=1770252999853, 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=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/MeeHyun-Byun.png',altText='MeeHyun-Byun',fileId=194125196867}, 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=51739740}, second={hs_id=167906611101, hs_child_table_id=0, hs_updated_at=1762899997332, hs_published_at=1770252999853, 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=Executive Director, Clinical Operations, slug=helen-ormandy, hs_updated_by_user_id=51739740}, third={}})
Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1770252999853, description=Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Deb%20Phippard.webp',altText='Deb Phippard',fileId=165892372605}, linkedin=https://www.linkedin.com/in/deb-phippard-103b54, team=[{id=163072475007, name='Precision for Medicine Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1769114824102, hs_created_at=1709645745106, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job= Chief Scientific Officer, slug=deborah-phippard, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778840, hs_child_table_id=0, hs_updated_at=1767769675332, hs_published_at=1770252999853, description=Maham Ansari, MS, RAC is a Senior Director, IVD Regulatory Affairs. Her focus is on companion diagnostic co-development programs, where she leverages her regulatory expertise to secure approvals in the US, Europe and beyond for companion diagnostics with a specific focus on gene therapy. She brings more than 16 years of global regulatory leadership experience in the medical device and in vitro diagnostics industry, spanning major multinationals to small start-ups, including full life cycle management across all stages of product development, execution of global regulatory strategies, and post-market surveillance.sh, avatar=Image{width=710,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Maham_Ansari.png',altText='Maham_Ansari',fileId=167373022876}, linkedin=https://www.linkedin.com/in/maham-ansari-ms-rac-6a735739, hs_name=, hs_path=, lastname=Ansari, hs_initial_published_at=1769114824102, hs_created_at=1709645745071, hs_is_edited=false, hs_deleted_at=0, name=Maham, position=Senior Director, IVD Regulatory Consulting, job=, slug=maham-ansari, email=, hs_updated_by_user_id=51739740}, third={}})
Optimizing Immunohistochemistry Validation and Regulatory Strategies
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1770252999853, 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=51739740}, second={}, third={}})
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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FDA Draft Guidance Encourages Broader Inclusion Criteria in Oncology Trials
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Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics
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Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies
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