What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs
|
has third author: false, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1772549698856, 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=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/John%20McIntyre.png',altText='John McIntyre',fileId=201584594055}, 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=195821592097, hs_child_table_id=0, hs_updated_at=1757598947835, hs_published_at=1772549698856, 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=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Nicholas%20Richardson.png',altText='Nicholas Richardson',fileId=195817841672}, linkedin=https://www.linkedin.com/in/nicholas-richardson-do-mph-049784113/, team=[{id=163080551773, name='Clinical Solutions Leadership'}], lastname=Richardson, DO, MPH, hs_initial_published_at=1757528527317, hs_created_by_user_id=51739740, hs_created_at=1757528274871, hs_is_edited=false, hs_deleted_at=0, name=Nicholas, job=Vice President, Clinical Development, slug=nicholas-richardson-clinical-solutions, hs_updated_by_user_id=26433386}, third={hs_id=178046423372, hs_child_table_id=0, hs_updated_at=1754641388766, hs_published_at=1772549698856, description=Rosamund (Roz) Round is a seasoned expert in patient engagement and innovation bringing over 20 years of experience. She is focused on listening to and learning from patients and care partners to understand how to better improve trial access and experience. Roz successfully built and led decentralized clinical trials service through the pandemic and is now addressing the implementation of AI across various aspects of clinical research. She has a strong focus on diversity, equity, and inclusion (DEI) to drive health equity in clinical research. Roz holds an MSc in Health Psychology, studied Psychology and Immunology at Harvard University, and is a recognized thought leader with an extensive portfolio of publications, conference presentations, webinars, and vlogs., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Round-Rosamund.png',altText='Round-Rosamund',fileId=194123714174}, lastname=Round, hs_initial_published_at=1725972637852, hs_created_by_user_id=51739740, hs_created_at=1725972446462, hs_is_edited=false, hs_deleted_at=0, name=Rosamund, job=Vice President, PAtient Engagement & Innovation, slug=rosamund-round, hs_updated_by_user_id=26433386}})
EMA PRIME Scheme Explained: Eligibility, Benefits, Risks, and When to Apply
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1772549698856, 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=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/John%20McIntyre.png',altText='John McIntyre',fileId=201584594055}, 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=159488778852, hs_child_table_id=0, hs_updated_at=1765558855468, hs_published_at=1772549698856, 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=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Chris-Ingram.png',altText='Chris-Ingram',fileId=202456722303}, linkedin=https://www.linkedin.com/in/chris-ingram-0255b216, hs_name=, hs_path=, lastname=Ingram, hs_initial_published_at=1772549698923, 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={}})
The EU Biotech Act: What Sponsors Need to Know About Europe's Biotechnology Transformation
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1772549698856, 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=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/John%20McIntyre.png',altText='John McIntyre',fileId=201584594055}, 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={}, third={}})
MHRA's International Recognition Procedure: Fast-Track Access to the UK Market
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1772549698856, 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=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/John%20McIntyre.png',altText='John McIntyre',fileId=201584594055}, 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=200435431440, hs_child_table_id=0, hs_updated_at=1763745269993, hs_published_at=1772549698856, avatar=Image{width=636,height=476,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/AQ_GlobalAccess_AlexGrosvenor-3.jpg',altText='AQ_GlobalAccess_AlexGrosvenor-3',fileId=182031301743}, lastname=Grosvenor, hs_initial_published_at=1763745278294, hs_created_by_user_id=26433386, hs_created_at=1763745229272, hs_is_edited=false, hs_deleted_at=0, name=Alex, job=Alex Grosvenor is a Senior Vice President and Managing Director at Precision AQ. Based in London, Alex leads the International Pricing & Market Access Strategy team, which he established in September 2015. Over the past decade, he has built this team into a successful, thriving practice, with a reputation for delivering high-quality work and excellent recommendation for its clients. Alex brings more than 20 years’ consulting experience in the biopharmaceutical industry, over 15 of these in pricing & market access.He specialises in complex pricing strategies, including cross-indication strategy, launch-sequencing and international price referencing. He has worked across multiple therapy areas, including oncology, immunology, cardiovascular, orphan indications and cell & gene therapies., slug=alex-grosvenor, hs_updated_by_user_id=26433386}, third={}})
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=1764696930757, hs_published_at=1772549698856, 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=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/John%20McIntyre.png',altText='John McIntyre',fileId=201584594055}, 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=1772549698856, 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={}})
Key Strategies for Future-Proofing Gene Therapy Assays
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1772549698856, 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=1772549698923, 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=26433386}, second={hs_id=159488778889, hs_child_table_id=0, hs_updated_at=1714461111815, hs_published_at=1772549698856, description=Travis Harrison, PhD, is Vice President of Diagnostic Development at Precision for Medicine. He brings more than 20 years of bioanalytical assay experience to the Precision team with expertise in ligand-binding and cell-based assays. Travis has experience supporting clinical and nonclinical studies for a broad range of indications, with an emphasis on diagnostic assays to evaluate immune responses to gene therapies., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Travis%20Harrison.webp',altText='Travis Harrison',fileId=165893006481}, linkedin=https://www.linkedin.com/in/travis-harrison-phd-6108852/, hs_name=, hs_path=, lastname=Harrison, hs_initial_published_at=1772549698923, hs_created_at=1709645745120, hs_is_edited=false, hs_deleted_at=0, name=Travis, job=, slug=travis-harrison, email=, hs_updated_by_user_id=26433386}, third={}})
FDA's Vision for Multiregional Clinical Trials in Oncology
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1772549698856, 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=26433386}, second={}, third={}})
FDA's Project Optimus: What Pharma and Biotech Need to Know
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1772549698856, 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=26433386}, second={}, third={}})
How to launch a clinical trial in South Korea: Investigational New Drug Application Process
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=185416008310, hs_child_table_id=0, hs_updated_at=1754641201258, hs_published_at=1772549698856, 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=26433386}, second={hs_id=167906611101, hs_child_table_id=0, hs_updated_at=1762899997332, hs_published_at=1772549698856, 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=26433386}, third={}})
