Case Study: Rapid Execution of Assay Validation Rescued Global Study
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=219184495938, hs_child_table_id=0, hs_updated_at=1786473626295, hs_published_at=1787681149919, description=Christie Bongel is a scientist by training, but her true passion lies in leadership, particularly in building leaders and shaping high-performing, trust-based cultures. She believes that many talented bench scientists are promoted into management roles without formal leadership development and is committed to helping close that gap. While culture and people development may not always appear on a balance sheet, she views them as essential drivers of long-term organizational success. As a leadership-focused operations executive, Christie leads laboratory operations and strategy within a global network, partnering with pharmaceutical and biotechnology organizations to navigate complex oncology challenges. Her work spans translational oncology, clinical trial strategy, and laboratory execution, with a focus on translating scientific and operational complexity into clear, actionable strategies that drive meaningful outcomes., avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/1781614819314.png',altText='Christie Bongel',fileId=219203862915}, lastname=Bongel, hs_initial_published_at=1786473638412, hs_created_by_user_id=65712240, hs_created_at=1786473568408, hs_is_edited=false, hs_deleted_at=0, name=Christie, job=Site Director, slug=christie-bongel, hs_updated_by_user_id=65712240}, second={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1787681149919, description=Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Kennon%20Daniels.webp',altText='Kennon Daniels',fileId=165893120790}, linkedin=https://www.linkedin.com/in/kennon-daniels-ph-d-84a90b6, hs_name=, hs_path=, lastname=Daniels, PhD, hs_initial_published_at=1775839468505, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, position=Vice President, IVD Regulatory Consulting, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=65712240}, third={}})
Case Study: Prescreening Intel Restores Phase 3 Colorectal Enrollment
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=217320686850, hs_child_table_id=0, hs_updated_at=1784229354065, hs_published_at=1787681149919, description=Erica Donnelly is a Senior Clinical Trial Manager with over 18 years of experience in the pharmaceutical and CRO industries. She has experience in Phase I-III clinical trials. She has experience in global vendor management and leading teams of CRAs and CTAs. Erica has oncology therapeutic experience including AML., avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/1604417210025.jpeg',altText='1604417210025',fileId=217303275102}, lastname=Donnelly, hs_initial_published_at=1784230182153, hs_created_by_user_id=65712240, hs_created_at=1784229139957, hs_is_edited=false, hs_deleted_at=0, name=Erica, job=Senior Clinical Trial Manager, slug=erica-donnelly, hs_updated_by_user_id=65712240}, second={}, third={}})
Case Study: Theranostic Radiopharm Trial and Evolving FDA Expectations
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=217320686763, hs_child_table_id=0, hs_updated_at=1784229018395, hs_published_at=1787681149919, description=Rachel Piacente is a Clinical Trial Manager at Precision for Medicine with over 15 years of clinical research experience. She specializes in oncology, hematology, cell and gene therapy, CAR-T, radiopharmaceuticals, and multinational Phase I–IV trials. Rachel has proven expertise in trial operations, site management, regulatory compliance, budgeting, vendor oversight, and cross-functional team leadership across US and global studies., avatar=Image{width=1010,height=1305,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Rachel%20Piacente_pic.jpg',altText='Rachel Piacente_pic',fileId=217303397279}, lastname=Piacente, hs_initial_published_at=1784230182153, hs_created_by_user_id=65712240, hs_created_at=1784228917126, hs_is_edited=false, hs_deleted_at=0, name=Rachel, job=Clinical Trial Manager , slug=rachel-piacente, hs_updated_by_user_id=65712240}, second={hs_id=217314606343, hs_child_table_id=0, hs_updated_at=1784229356581, hs_published_at=1787681149919, description=Jennifer Coates is a Project Manager at Precision for Medicine with over a decade of clinical research experience supporting global clinical trials across multiple phases of development and a broad spectrum of therapeutic areas. She specializes in driving the successful execution of theranostic and other complex clinical programs, providing operational leadership to cross-functional teams while ensuring compliance with regulatory requirements and quality standards. Jennifer is known for fostering strong partnerships with sponsors and study teams, enabling collaboration, operational excellence, and the production of high-quality project deliverables., avatar=Image{width=2185,height=3261,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/JenCoates.jpeg',altText='JenCoates',fileId=217308893107}, lastname=Coates, hs_initial_published_at=1784230182153, hs_created_by_user_id=65712240, hs_created_at=1784228926906, hs_is_edited=false, hs_deleted_at=0, name=Jennifer, job=Project Manager, slug=jennifer-coates, hs_updated_by_user_id=65712240}, third={}})
Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions
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has third author: false, (SizeLimitingPyMap: {main={hs_id=214928090133, hs_child_table_id=0, hs_updated_at=1781285625399, hs_published_at=1787681149919, description=Deborah Spencer is a Senior Director of Project Management at Precision for Medicine with over 25 years of experience in clinical research. She specialises in leading global clinical trials across multiple phases, with deep expertise in complex study delivery. Deborah provides strategic oversight of programmes, leads high-performing teams, and partners closely with sponsors to ensure successful execution and regulatory readiness., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Deborah%20Spencer.jpg',altText='Deborah Spencer',fileId=214838919278}, lastname=Spencer, hs_initial_published_at=1781285742914, hs_created_by_user_id=26433386, hs_created_at=1781285562019, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job=Senior Director, Project Management, slug=deborah-spencer, hs_updated_by_user_id=65712240}, second={hs_id=214928170660, hs_child_table_id=0, hs_updated_at=1781285676367, hs_published_at=1787681149919, description=Anthea Gates is a Project Director with approximately 30 years of drug development and medical device industry expertise across all phases, over a variety of indications including breast, lung cancer, solid tumors and lymphoma, cutaneous T-cell lymphoma, malignant melanoma, squamous cell carcinoma, rare haematologic disease, autoimmune rheumatology, osteoarthritis, ocular burns, liver cirrhosis, myopia and pre-eclampsia. Committed to delivering quality and passionate about building positive relationships with clients and study teams to promote cohesive business practices and ensure the successful management of projects from start to finish. Anthea holds a proven track record in effective leadership of cross-functional teams across programs of studies, to the accomplishment of operational excellence., avatar=Image{width=372,height=546,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/profile.jpg',altText='profile',fileId=214846873938}, lastname=Gates, hs_initial_published_at=1781285742914, hs_created_by_user_id=26433386, hs_created_at=1781285639221, hs_is_edited=false, hs_deleted_at=0, name=Anthea, job=Project Director, slug=anthea-gates, hs_updated_by_user_id=65712240}, third={hs_id=214928090141, hs_child_table_id=0, hs_updated_at=1781285738567, hs_published_at=1787681149919, description=Claire Delaville is a Senior Project Manager at Precision for Medicine. She brings 18 years of experience across preclinical and clinical research, including more than a decade leading Phase I to IV studies in oncology, rare diseases, and immunology, with direct experience in first-in-human and multicenter oncology trials. Claire is responsible for maintaining study quality through inspection readiness, corrective action planning, and proactive risk mitigation. She also oversees study budgets and vendor performance to support coordinated delivery across functions, drawing on a scientific foundation that includes a PhD in Neurosciences and Neuropharmacology. Based in Paris, France, Claire aligns scientific insight with operational execution to support successful trial outcomes., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Claire%20Delaville.jpg',altText='Claire Delaville',fileId=214838927033}, lastname=Delaville, hs_initial_published_at=1781285742914, hs_created_by_user_id=26433386, hs_created_at=1781285678112, hs_is_edited=false, hs_deleted_at=0, name=Claire, job=Senior Project Manager, slug=claire-delaville, hs_updated_by_user_id=65712240}})
Case Study: Advancing IHC Assays from RUO to Clinical Trials and CDx
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1787681149919, description=Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Kennon%20Daniels.webp',altText='Kennon Daniels',fileId=165893120790}, linkedin=https://www.linkedin.com/in/kennon-daniels-ph-d-84a90b6, hs_name=, hs_path=, lastname=Daniels, PhD, hs_initial_published_at=1775839468505, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, position=Vice President, IVD Regulatory Consulting, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=65712240}, second={hs_id=164426546714, hs_child_table_id=0, hs_updated_at=1778171432595, hs_published_at=1787681149919, description=Angélique Heckmann, PhD is a people‑driven leader who combines scientific expertise and business acumen with a strong foundation in human values. With a background in therapeutic drug development and an MBA‑shaped strategic mindset, she focuses on building meaningful, long‑term relationships with teams, partners, and clients. By bridging science and strategy, she supports informed decision‑making, fosters collaboration, and helps translate innovation into real‑world impact—always guided by a shared purpose: advancing solutions that ultimately improve patients’ lives, avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/angelique-1.png',altText='angelique-1',fileId=194126030110}, lastname=Heckmann, PhD, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713172107894, hs_is_edited=false, hs_deleted_at=0, name=Angelique, job=Regional Vice President, Translational Business Solutions, slug=angelique-heckmann, hs_updated_by_user_id=65712240}, third={}})
Case Study: How Monitoring Caught a Silent PK Crisis in a CAR T Rescue
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=209924378674, hs_child_table_id=0, hs_updated_at=1774452297064, hs_published_at=1787681149919, description=Marlise Conrad is a Senior Clinical Trial Manager – Clinical Operations at Precision for Medicine, bringing more than 25 years of clinical research experience across CRA, start-up, and clinical trial management roles. She has over 17 years of experience as a Clinical Trial Manager, with prior experience as a CRA and global clinical lead, and a strong track record supporting multicenter Phase I–III clinical trials, including rescue studies. Marlise has extensive oncology experience across multiple solid tumor indications, including early-phase CAR‑T studies, and holds a Registered Nurse (RN) degree, which informs her patient-centered and detail-driven approach to trial execution., avatar=Image{width=5184,height=2920,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/marlise_conrad.jpg',altText='marlise_conrad',fileId=209132467611}, lastname=Conrad, hs_initial_published_at=1774452315067, hs_created_by_user_id=26433386, hs_created_at=1774452226032, hs_is_edited=false, hs_deleted_at=0, name=Marlise, job=Senior Clinical Trial Manager – Clinical Operations, slug=marlise-conrad, hs_updated_by_user_id=65712240}, second={}, third={}})
Case Study: Scaling a First Line NSCLC Trial in a Hesitant Market
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=208638641305, hs_child_table_id=0, hs_updated_at=1772549693775, hs_published_at=1787681149919, description=Lisa is a Director, Project Management who has been with Precision since Jan 2019. Lisa has over 18 years of clinical research experience, with a proven track record in leading cross-functional teams across programs of studies. Lisa is a collaborative communicator capable of cultivating key relationships focused on customer satisfaction. In 2018, Lisa was granted the CEO Excellence Award for exceptional project management., avatar=Image{width=378,height=339,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Lisa%20Lopez_Headshot.jpg',altText='Lisa Lopez_Headshot',fileId=208044988231}, lastname=Lopez, hs_initial_published_at=1772549698856, hs_created_by_user_id=26433386, hs_created_at=1772549635830, hs_is_edited=false, hs_deleted_at=0, name=Lisa, job=Director, Project Management, slug=lisa-lopez, hs_updated_by_user_id=65712240}, second={hs_id=208600974006, hs_child_table_id=0, hs_updated_at=1772549671531, hs_published_at=1787681149919, description=Adrien (Ash) Mtibaa, MD is a clinical research leader with 10+ years of experience in global clinical trials and deep expertise in Site Start‑Up (SSU). Currently Manager, Site Start‑Up at Precision for Medicine, he leads and mentors global SSU teams with a strong focus on process improvement, SSU strategy, leadership influence, and line management. A trained Medical Doctor, Adrien brings a pragmatic, results‑driven approach to driving activation readiness, operational excellence, and cross‑functional alignment across multi‑regional studies., avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Adrien%20Mtibaa%2c%20MD.jpg',altText='Adrien Mtibaa, MD',fileId=208642032927}, lastname=Mtibaa, MD, hs_initial_published_at=1772549611983, hs_created_by_user_id=26433386, hs_created_at=1772488816847, hs_is_edited=false, hs_deleted_at=0, name=Adrien, job=Manager, Site Start Up, slug=adrien-mtibaa, hs_updated_by_user_id=65712240}, third={}})
Case Study: Swift Stabilization in Phase 1 Solid Tumor Rescue
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=205683637283, hs_child_table_id=0, hs_updated_at=1769114822287, hs_published_at=1787681149919, description=Karen Stokes is a dedicated, collaborative and solution-oriented drug development professional with over 25 years of experience in Data Management, Clinical Operations and Project Management on Phase I-IV studies in Academic and Contract Research Organization (CRO) environments. She has expertise in CNS, Rare and Oncology indications and have successfully led cross functional teams to deliver quality on time. , avatar=Image{width=208,height=246,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Karen%20Stokes.png',altText='Karen Stokes',fileId=205695655336}, lastname=Stokes, hs_initial_published_at=1769114824037, hs_created_by_user_id=26433386, hs_created_at=1769114779691, hs_is_edited=false, hs_deleted_at=0, name=Karen, job=Project Director, slug=karen-stokes, hs_updated_by_user_id=65712240}, second={hs_id=205683637278, hs_child_table_id=0, hs_updated_at=1769114711193, hs_published_at=1787681149919, description=Annie Raymond-Desgagné is a Principal Clinical Trial Manager specializing in oncology, known for her strong leadership, structured planning, and proactive mindset. She excels at building high‑performing teams, with a passion for mentoring and helping colleagues bring out the best in themselves. Skilled at implementing tools that improve forecasting and operational readiness, Annie consistently keeps teams two steps ahead in fast‑moving clinical environments. She has a particular affinity for first‑in‑human (FIH) studies, where the science unfolds in real time—an area that fuels her love of challenge and innovation. Collaborative, committed, and science‑driven, she brings clarity, foresight, and positive energy to every project she leads., avatar=Image{width=226,height=226,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/A%20person%20with%20short%20brown%20hair%20wearing%20glasses%20Description%20automatically%20generated.png',altText='A person with short brown hair wearing glasses Description automatically generated',fileId=205695412385}, lastname=Raymond-Desgagné, hs_initial_published_at=1769114715920, hs_created_by_user_id=26433386, hs_created_at=1769114644600, hs_is_edited=false, hs_deleted_at=0, name=Annie, job=Principal Clinical Trial Manager, slug=annie-raymond-desgagne, hs_updated_by_user_id=65712240}, third={}})
Navigating Complexity: Rescuing a Biomarker-Driven Breast Cancer Trial
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=164725548848, hs_child_table_id=0, hs_updated_at=1754641451547, hs_published_at=1787681149919, description=Alexis Hobbins-White is an accomplished leader who plays a pivotal role in navigating the complex landscape of global oncology and rare disease-focused clinical trials. With a career spanning over 15 years in the clinical trials industry, Alexis brings a wealth of experience across multiple therapeutic areas, showcasing her proficiency in diverse aspects of operational strategy. She specializes in early phase adaptive studies, particularly in immuno-oncology and advanced therapeutics. She has an MSc in Neuroscience and an MA in Biotechnology Law and Ethics., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Alexis-Hobbins.png',altText='Alexis-Hobbins',fileId=194096322982}, linkedin=https://www.linkedin.com/in/alexis-hobbins-white-400a1720/, lastname=Hobbins-White, hs_initial_published_at=1713362276020, hs_created_by_user_id=5166971, hs_created_at=1713361952861, hs_is_edited=false, hs_deleted_at=0, name=Alexis, job=Senior Director, Operational Strategy , slug=alexis-hobbins-white, hs_updated_by_user_id=65712240}, second={}, third={}})
