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The Institute@Precision Radiopharmaceutical Series: Five New Whitepapers

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  • Clinical Research Insights

    All Clinical Research Articles
    • Read: China’s New Drug Regulatory Framework Positions the Country as a Global Hub for Innovative Medicine Launches China’s New Drug Regulatory Framework Positions the Country as a Global Hub for Innovative Medicine Launches

      Clinical Trials

      China’s New Drug Regulatory Framework Positions the Country as a Global Hub for Innovative Medicine Launches

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=209983237513, hs_child_table_id=0, hs_updated_at=1774533604788, hs_published_at=1775839468505, description=Calvin Niu received his BD in pharmaceuticals from Lanzhou University. He has brought over 22 years of drug development and regulatory experience in pharmaceutical companies and CROs. Calvin’s regulatory expertise covers regulatory agency engagements and all types of regulatory submissions throughout product development and post market life cycles in oncology, immunology, ophthalmology, clinical nutrition, cardiovascular, gastroenterology, women’s health, CNS, rare disease, etc. , avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Calvin%20Niu.png',altText='Calvin Niu',fileId=209991702802}, lastname=Niu, hs_initial_published_at=1774533614867, hs_created_by_user_id=51739740, hs_created_at=1774531720533, hs_is_edited=false, hs_deleted_at=0, name=Calvin, job=Director, Regulatory Affairs, China, slug=calvin-niu, hs_updated_by_user_id=51739740}, second={}, third={}})
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        Calvin Niu

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    • Read: Bringing Early Phase Oncology Closer to Patients in Los Angeles Bringing Early Phase Oncology Closer to Patients in Los Angeles

      Clinical Trials - Oncology

      Bringing Early Phase Oncology Closer to Patients in Los Angeles

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1754641583843, hs_published_at=1775839468505, 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=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/rob.png',altText='rob',fileId=194099000843}, linkedin=https://www.linkedin.com/in/rob-maiale/, hs_name=, hs_path=, lastname=Maiale, hs_initial_published_at=1775839468505, 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={}})
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        Rob Maiale

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    • Read: Radiopharmaceutical Clinical Trials: What Sponsors Need to Know About Selecting a CRO Radiopharmaceutical Clinical Trials: What Sponsors Need to Know About Selecting a CRO

      Clinical Trials - Oncology

      Radiopharmaceutical Clinical Trials: What Sponsors Need to Know About Selecting a CRO

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778843, hs_child_table_id=0, hs_updated_at=1774960706353, hs_published_at=1775839468505, 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=1775839468505, hs_created_at=1709645745074, hs_is_edited=false, hs_deleted_at=0, name=Robert, position=Vice President, Operational Strategy, job=, slug=robert-bauer, email=, hs_updated_by_user_id=51739740}, second={hs_id=185416008260, hs_child_table_id=0, hs_updated_at=1754641208207, hs_published_at=1775839468505, description=Sarika is a Senior Clinical Trial Manager with 14+ years of experience in clinical research, specializing in oncology, rare diseases, and cardiology. With a robust focus on Phase I-IV clinical trials, she has successfully led projects from start-up to close-out and has experience in cohort management and solid tumor studies. She is a strong advocate for cross-functional teamwork, streamlining processes, and optimizing project efficiency., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Sarika-David-Armogan-1-1.png',altText='Sarika-David-Armogan-1-1',fileId=194123711873}, lastname=David-Armogan, hs_initial_published_at=1737992355064, hs_created_by_user_id=26433386, hs_created_at=1737992180108, hs_is_edited=false, hs_deleted_at=0, name=Sarika, slug=sarika-david-armogan, hs_updated_by_user_id=51739740}, third={}})
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        Robert B.

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        Sarika D.

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  • Translational Research Insights

    All Translational Research Articles
    • Read: Developing a Comprehensive Strategy for Implementing AI & Multi-Omics for Translational Research Developing a Comprehensive Strategy for Implementing AI & Multi-Omics for Translational Research

      Translational Research

      Developing a Comprehensive Strategy for Implementing AI & Multi-Omics for Translational Research

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=199448088864, hs_child_table_id=0, hs_updated_at=1762810484868, hs_published_at=1775839468505, avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Kaylee%20Mueller.png',altText='Kaylee Mueller',fileId=199456336149}, lastname=Mueller, hs_initial_published_at=1762810487482, hs_created_by_user_id=26433386, hs_created_at=1762810467146, hs_is_edited=false, hs_deleted_at=0, name=Kaylee, slug=kaylee-mueller, hs_updated_by_user_id=51739740}, second={}, third={}})
      • Kaylee Mueller avatar

        Kaylee Mueller

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    • Read: Back to the Source: A Translational Leader on Extending the Living Legacy of Genomic Data Back to the Source: A Translational Leader on Extending the Living Legacy of Genomic Data

      Translational Research - Biospecimens - Oncology

      Back to the Source: A Translational Leader on Extending the Living Legacy of Genomic Data

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778886, hs_child_table_id=0, hs_updated_at=1763657611624, hs_published_at=1775839468505, description=Robert Snyder, PhD, is a seasoned expert with a 20-year track record in genomics, specializing in in vitro diagnostic assay development and bioinformatics. Committed to advancing medical science, he is proficient in regulatory V&V study designs and understands the nuances of orthogonal methods. A collaborative partner in biomedical development, Dr. Snyder champions the critical transition of biospecimens from benchtop to bedside., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Robert%20Snyder.webp',altText='Robert Snyder',fileId=165892444501}, linkedin=https://www.linkedin.com/in/robert-snyder-ph-d-9b67b035, hs_name=, hs_path=, lastname=Snyder, PhD, hs_initial_published_at=1775839468505, hs_created_at=1709645745117, hs_is_edited=false, hs_deleted_at=0, name=Robert, job=, slug=robert-snyder, email=, hs_updated_by_user_id=51739740}, second={hs_id=164691024166, hs_child_table_id=0, hs_updated_at=1716326265678, hs_published_at=1775839468505, description=Respected veteran of the biospecimen and biomarker laboratory services industry. Honed his expertise through leadership roles in organizations including Roche, Cancer Genetics, and BioServe. Holds a Master of Public Health and a Masters of Business Administration from the Johns Hopkins University., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Rob%20Fannon%20Headshot.webp',altText='Rob Fannon Headshot',fileId=165893006477}, linkedin=https://www.linkedin.com/in/rob-fannon-901378/, team=[{id=163072475009, name='Translational Sciences Leadership'}], lastname=Fannon, MPH, MBA, hs_initial_published_at=1713346931329, hs_created_by_user_id=62155952, hs_created_at=1713345787919, hs_is_edited=false, hs_deleted_at=0, name=Rob, job=General Manager, Biospecimen Solutions, slug=rob-fannon, hs_updated_by_user_id=51739740}, third={}})
      • Robert S. avatar

        Robert S.

      • Rob F. avatar

        Rob F.

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    • Read: Reflect on 20 Years of Cancer Research with MIRROR Biospecimens Reflect on 20 Years of Cancer Research with MIRROR Biospecimens

      Translational Research - Biospecimens

      Reflect on 20 Years of Cancer Research with MIRROR Biospecimens

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        has not third author: true, (SizeLimitingPyMap: {main={hs_id=199448088864, hs_child_table_id=0, hs_updated_at=1762810484868, hs_published_at=1775839468505, avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Kaylee%20Mueller.png',altText='Kaylee Mueller',fileId=199456336149}, lastname=Mueller, hs_initial_published_at=1762810487482, hs_created_by_user_id=26433386, hs_created_at=1762810467146, hs_is_edited=false, hs_deleted_at=0, name=Kaylee, slug=kaylee-mueller, hs_updated_by_user_id=51739740}, second={}, third={}})
      • Kaylee Mueller avatar

        Kaylee Mueller

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All articles

  • Read: What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs

    Clinical Trials - Regulatory

    What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs

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      has third author: false, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1775839468505, 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=51739740}, second={hs_id=195821592097, hs_child_table_id=0, hs_updated_at=1757598947835, hs_published_at=1775839468505, 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=51739740}, third={hs_id=178046423372, hs_child_table_id=0, hs_updated_at=1754641388766, hs_published_at=1775839468505, 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=51739740}})
    • John M. avatar Nicholas R. avatar Rosamund R. avatar
    • John M.

      Nicholas R.

      Rosamund R.

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  • Read: EMA PRIME Scheme Explained: Eligibility, Benefits, Risks, and When to Apply EMA PRIME Scheme Explained: Eligibility, Benefits, Risks, and When to Apply

    Clinical Trials - Regulatory

    EMA PRIME Scheme Explained: Eligibility, Benefits, Risks, and When to Apply

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1775839468505, 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=51739740}, second={hs_id=159488778852, hs_child_table_id=0, hs_updated_at=1765558855468, hs_published_at=1775839468505, 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=1775839468505, 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={}})
    • John M. avatar

      John M.

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      Chris I.

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  • Read: The EU Biotech Act: What Sponsors Need to Know About Europe's Biotechnology Transformation The EU Biotech Act: What Sponsors Need to Know About Europe's Biotechnology Transformation

    Clinical Trials - Regulatory

    The EU Biotech Act: What Sponsors Need to Know About Europe's Biotechnology Transformation

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1775839468505, 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=51739740}, second={}, third={}})
    • John McIntyre, PhD avatar

      John McIntyre, PhD

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  • Read: MHRA's International Recognition Procedure: Fast-Track Access to the UK Market MHRA's International Recognition Procedure: Fast-Track Access to the UK Market

    Clinical Trials - Regulatory

    MHRA's International Recognition Procedure: Fast-Track Access to the UK Market

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1775839468505, 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=51739740}, second={hs_id=200435431440, hs_child_table_id=0, hs_updated_at=1763745269993, hs_published_at=1775839468505, 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=51739740}, third={}})
    • John M. avatar

      John M.

    • Alex G. avatar

      Alex G.

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  • Read: FDA Draft Guidance on Overall Survival in Oncology Trials – What Sponsors Need to Know FDA Draft Guidance on Overall Survival in Oncology Trials – What Sponsors Need to Know

    Clinical Trials - Regulatory - Oncology

    FDA Draft Guidance on Overall Survival in Oncology Trials – What Sponsors Need to Know

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      has not third author: true, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1775839468505, 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=51739740}, second={hs_id=195804116749, hs_child_table_id=0, hs_updated_at=1757598950007, hs_published_at=1775839468505, 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=51739740}, third={}})
    • John M. avatar

      John M.

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      Nick R.

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