Clinical Sample Logistics and Biostorage

Read: Case Study: Rescue of a Global Phase 3 Trial in Multiple Myeloma

Case Study: Rescue of a Global Phase 3 Trial in Multiple Myeloma

Sep 16, ‘25 | 3 min read

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  Alexis Hobbins-White

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Read: FDA Draft Guidance on Overall Survival in Oncology Trials – What Sponsors Need to Know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FDA Draft Guidance on Overall Survival in Oncology Trials – What Sponsors Need to Know

Sep 12, ‘25 | 7 min read

has not third author: true, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1757700176991, hs_published_at=1758208109248, 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=1000,height=1000,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/John%20McIntyre.jpg',altText='John McIntyre',fileId=195809756215}, 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=13243181}, second={hs_id=195804116749, hs_child_table_id=0, hs_updated_at=1757598950007, hs_published_at=1758208109248, 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=13243181}, third={}})
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  John M.

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  Nick R.

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Read: How AI & Biomarkers Are Reshaping the Next Frontier in Drug Development

Translational Research - Biomarkers - Oncology

How AI & Biomarkers Are Reshaping the Next Frontier in Drug Development

Aug 25, ‘25 | 8 min read

has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1754641583843, hs_published_at=1758208109248, 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=1758208027822, 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=13243181}, second={}, third={}})
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  Rob Maiale

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