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Read Case Study: Rapid Execution of Assay Validation Rescued Global Study
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Read Receptor Occupancy in the Era of Multispecific Therapeutics Receptor Occupancy in the Era of Multispecific Therapeutics
Read Clinical AI at Scale: Why Trust Matters More Than Speed Clinical AI at Scale: Why Trust Matters More Than Speed
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Read: Clinical AI at Scale: Why Trust Matters More Than Speed 
Clinical AI at Scale: Why Trust Matters More Than Speed
has third author: false, (SizeLimitingPyMap: {main={hs_id=219402396746, hs_child_table_id=0, hs_updated_at=1787057935787, hs_published_at=1787135938204, description=Zulfat Kapadia is a Statistical Programmer with a scientist's heart and a programmer's precision, bringing over 11 years of experience in clinical data analytics. She currently works as a Statistical Programmer at Precision for Medicine, focusing on clinical data transformations and safety analytics. She is a SAS-certified Statistical Programmer with strong expertise in CDISC standards (SDTM and ADaM), turning raw clinical data into clean, submission-ready datasets and TLFs (Tables, Listings, and Figures). Her journey began with an M.Sc. in Microbiology from Gujarat University, followed by years as a Research Associate, where she worked hands-on with method development, validation, and LC-MS/MS analysis in GLP-regulated labs, including navigating regulatory audits. She later moved into SAS programming at Cognizant, building the technical foundation for her current specialization. A resourceful team player, she continues expanding her expertise across clinical and pharmaceutical domain., avatar=Image{width=1024,height=1536,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Zulfat%20Headshot.jpg',altText='Zulfat Headshot',fileId=219402357006}, lastname=Kapadia, hs_initial_published_at=1786648737451, hs_created_by_user_id=65712240, hs_created_at=1786648684030, hs_is_edited=false, hs_deleted_at=0, name=Zulfat, job=Statistical Programmer, slug=zulfat-kapadia, hs_updated_by_user_id=92535535}, second={hs_id=219402396744, hs_child_table_id=0, hs_updated_at=1786648683717, hs_published_at=1787135938204, description=As Principal Statistical Programmer, Shakila plays a key role in leading statistical programming activities for clinical development programs at Precision for Medicine. She has extensive experience managing study deliverables, supporting regulatory submissions, implementing CDISC standards, and collaborating with cross-functional teams to ensure high-quality and compliant clinical data outputs. Prior to joining Precision for Medicine, she held programming roles at ICON and Quintiles, where she contributed to global clinical trials across Oncology, Cardiovascular, Vaccine, and Diabetes therapeutic areas. She has led the development and validation of SDTM, ADaM, TLFs, define.xml, and submission-ready datasets for major health authorities including the FDA, PMDA, and EMEA. Beyond her expertise in SAS programming and clinical data standards, Shakila is passionate about process improvement, automation, and mentoring teams. She has recently expanded her capabilities in Data Science, gaining practical experience in Python, Machine Learning, R, and Tableau, and is keen on leveraging modern analytics and AI-driven approaches to enhance clinical research solutions., avatar=Image{width=1024,height=1536,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Shakila%20J%20Headshot.png',altText='Shakila J Headshot',fileId=219402114740}, lastname=Jagadeesan , hs_initial_published_at=1786648737451, hs_created_by_user_id=65712240, hs_created_at=1786648634345, hs_is_edited=false, hs_deleted_at=0, name=Shakila, job=Principal Statistical Programmer , slug=Shakila-Jagadeesan, hs_updated_by_user_id=92535535}, third={hs_id=219402097154, hs_child_table_id=0, hs_updated_at=1786648633237, hs_published_at=1787135938204, description=As Senior Manager of Statistical Programming, Sugumaran brings a wealth of experience to his role at Precision for Medicine, since March 2021. Prior to Precision for Medicine, he was associated with ICON Clinical Research for over 10 years across various roles in statistical programming. He has been actively involved in leading large and complex submissions for a diverse client base including large biopharma, biotech, and CROs. In addition to building his expertise in statistical programming, data analytics, and data visualization, he is deeply passionate about developing talent and cutting-edge software solutions. He is also actively involved with several social causes and CSR activities. Sugumaran holds an MBA in Pharmaceutical Management and a Master's in Bioinformatics. He is also currently pursuing a PhD in Bioinformatics., avatar=Image{width=1024,height=1536,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Sugumaran%20headshot.png',altText='Sugumaran headshot',fileId=219402130472}, lastname=Muthuraj, hs_initial_published_at=1786648737451, hs_created_by_user_id=65712240, hs_created_at=1786647962706, hs_is_edited=false, hs_deleted_at=0, name=Sugumaran, job=Senior Manager, Statistical Programming , slug=Sugumaran-Muthuraj, hs_updated_by_user_id=92535535}}) -
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Read: Hidden Strategic Edge in Clinical Trials: Financial Project Management 
Hidden Strategic Edge in Clinical Trials: Financial Project Management
has not third author: true, (SizeLimitingPyMap: {main={hs_id=218300089344, hs_child_table_id=0, hs_updated_at=1785358312044, hs_published_at=1787135938204, description=Global Finance leader with 35+ years of progressive experience and over two decades in the global CRO industry. Proven track record of building and developing high-performing teams, leading complex financial operations, and driving strategic initiatives that improve business performance and scalability. Deep expertise in financial planning and analysis, contract negotiation, budgeting and forecasting, process optimization, auditing, cash flow management, and credit and collections. Passionate about fostering collaboration across finance, operations, and executive leadership to deliver data-driven insights, strengthen governance, and enable informed decision-making both internally and for our Sponsors., avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/1576750031793.jpeg',altText='1576750031793',fileId=218305569797}, lastname=Kane, hs_initial_published_at=1785358316248, hs_created_by_user_id=65712240, hs_created_at=1785358281109, hs_is_edited=false, hs_deleted_at=0, name=Romy, job=Vice President, Operational Finance, slug=romy-kane, hs_updated_by_user_id=92535535}, second={}, third={}}) -
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Read: Why Global Oncology Evidence May Not Support U.S. Regulatory Approval 
Why Global Oncology Evidence May Not Support U.S. Regulatory Approval
has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1787135938204, 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=92535535}, second={}, third={}}) -
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Read: Case Study: Rapid Execution of Assay Validation Rescued Global Study 
Case Study: Rapid Execution of Assay Validation Rescued Global Study
has not third author: true, (SizeLimitingPyMap: {main={hs_id=219184495938, hs_child_table_id=0, hs_updated_at=1786473626295, hs_published_at=1787135938204, 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=92535535}, second={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1787135938204, 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=92535535}, third={}}) -
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Read: Receptor Occupancy in the Era of Multispecific Therapeutics 
Receptor Occupancy in the Era of Multispecific Therapeutics
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1787135938204, 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=1775839468505, 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=92535535}, second={hs_id=218178874459, hs_child_table_id=0, hs_updated_at=1785241362455, hs_published_at=1787135938204, description=Jenny Zilberberg has more than 20 years of combined experience across academia and biotechnology, with expertise in translational immunology, cancer immunotherapy, and biomarker strategy. Most recently, she served as Head of Research at Imvax, where she led preclinical development and biomarker activities for the company’s immunotherapy platform and lead glioblastoma program. At Precision, Jenny partners with sponsors to design and implement biomarker and bioanalytical solutions that support clinical development across oncology and autoimmune diseases., avatar=Image{width=480,height=480,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/JennyZilberberg.jpeg',altText='JennyZilberberg',fileId=218182303073}, lastname=Zilberberg, hs_initial_published_at=1785241367324, hs_created_by_user_id=65712240, hs_created_at=1785241302354, hs_is_edited=false, hs_deleted_at=0, name=Jenny, job=Vice President, Scientific Strategy, slug=Jenny-zilberberg, hs_updated_by_user_id=92535535}, third={}}) -
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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
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All articles
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Read: Considerations for Your Pre-IND Meeting With the FDA 
Considerations for Your Pre-IND Meeting With the FDA
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778884, hs_child_table_id=0, hs_updated_at=1754641534261, hs_published_at=1787135938204, description=Vann Parker is the Head of Regulatory Consultancy (North America) for Precision for Medicine. He received his PhD in Molecular Biology from The California Institute of Technology and spent the past 30 years supporting biopharmaceutical and drug development. He currently focuses on strategies for clinical development and interactions with FDA and other regulatory agencies. In addition to support of pre-IND activities, Vann has supported sponsors throughout the drug development process including applications for Fast Track, Breakthrough Therapy and Orphan Designations, formal meetings with FDA and full NDA/BLA submissions., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/vann-parker.png',altText='vann-parker',fileId=194125196869}, linkedin=https://www.linkedin.com/in/vann-parker-69565a6/, hs_name=, hs_path=, lastname=Parker, hs_initial_published_at=1775839468505, hs_created_at=1709645745115, hs_is_edited=false, hs_deleted_at=0, name=Vann, job=, slug=vann-parker, email=, hs_updated_by_user_id=92535535}, second={}, third={}}) -
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Read: FDA Draft Guidance Encourages Broader Inclusion Criteria in Oncology Trials 
FDA Draft Guidance Encourages Broader Inclusion Criteria in Oncology Trials
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778884, hs_child_table_id=0, hs_updated_at=1754641534261, hs_published_at=1787135938204, description=Vann Parker is the Head of Regulatory Consultancy (North America) for Precision for Medicine. He received his PhD in Molecular Biology from The California Institute of Technology and spent the past 30 years supporting biopharmaceutical and drug development. He currently focuses on strategies for clinical development and interactions with FDA and other regulatory agencies. In addition to support of pre-IND activities, Vann has supported sponsors throughout the drug development process including applications for Fast Track, Breakthrough Therapy and Orphan Designations, formal meetings with FDA and full NDA/BLA submissions., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/vann-parker.png',altText='vann-parker',fileId=194125196869}, linkedin=https://www.linkedin.com/in/vann-parker-69565a6/, hs_name=, hs_path=, lastname=Parker, hs_initial_published_at=1775839468505, hs_created_at=1709645745115, hs_is_edited=false, hs_deleted_at=0, name=Vann, job=, slug=vann-parker, email=, hs_updated_by_user_id=92535535}, second={}, third={}}) -
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Read: FDA Guidance on Pediatric Drug Development 
FDA Guidance on Pediatric Drug Development
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778884, hs_child_table_id=0, hs_updated_at=1754641534261, hs_published_at=1787135938204, description=Vann Parker is the Head of Regulatory Consultancy (North America) for Precision for Medicine. He received his PhD in Molecular Biology from The California Institute of Technology and spent the past 30 years supporting biopharmaceutical and drug development. He currently focuses on strategies for clinical development and interactions with FDA and other regulatory agencies. In addition to support of pre-IND activities, Vann has supported sponsors throughout the drug development process including applications for Fast Track, Breakthrough Therapy and Orphan Designations, formal meetings with FDA and full NDA/BLA submissions., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/vann-parker.png',altText='vann-parker',fileId=194125196869}, linkedin=https://www.linkedin.com/in/vann-parker-69565a6/, hs_name=, hs_path=, lastname=Parker, hs_initial_published_at=1775839468505, hs_created_at=1709645745115, hs_is_edited=false, hs_deleted_at=0, name=Vann, job=, slug=vann-parker, email=, hs_updated_by_user_id=92535535}, second={}, third={}}) -
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Read: FDA Accelerated Approval for Oncology Therapeutics: Clinical Trial Considerations 
FDA Accelerated Approval for Oncology Therapeutics: Clinical Trial Considerations
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778884, hs_child_table_id=0, hs_updated_at=1754641534261, hs_published_at=1787135938204, description=Vann Parker is the Head of Regulatory Consultancy (North America) for Precision for Medicine. He received his PhD in Molecular Biology from The California Institute of Technology and spent the past 30 years supporting biopharmaceutical and drug development. He currently focuses on strategies for clinical development and interactions with FDA and other regulatory agencies. In addition to support of pre-IND activities, Vann has supported sponsors throughout the drug development process including applications for Fast Track, Breakthrough Therapy and Orphan Designations, formal meetings with FDA and full NDA/BLA submissions., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/vann-parker.png',altText='vann-parker',fileId=194125196869}, linkedin=https://www.linkedin.com/in/vann-parker-69565a6/, hs_name=, hs_path=, lastname=Parker, hs_initial_published_at=1775839468505, hs_created_at=1709645745115, hs_is_edited=false, hs_deleted_at=0, name=Vann, job=, slug=vann-parker, email=, hs_updated_by_user_id=92535535}, second={}, third={}}) -
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Read: FDA Procedural Guidance: Expansion Cohorts in FIH Oncology Clinical Trials FDA Procedural Guidance: Expansion Cohorts in FIH Oncology Clinical Trials
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