false
The Precision Blog
100% sourced from leading minds on the front lines of research
Recent and Featured Posts
View all articles-
Read Case Study: Conducting Autologous Cell Therapy Research Across 3 Continents with Zero Sample Loss
-
Read Key Strategies for Future-Proofing Gene Therapy Assays Key Strategies for Future-Proofing Gene Therapy Assays
Read Phase 1 Clinical Trial Designs Explained: BOIN, CRM, BLRM & Modern Adaptive Strategies Phase 1 Clinical Trial Designs Explained: BOIN, CRM, BLRM & Modern Adaptive Strategies
Read Empowering Clinical Operations with Enhanced Biospecimen Lifecycle Management Empowering Clinical Operations with Enhanced Biospecimen Lifecycle Management
-
-
Read: Case Study: Conducting Autologous Cell Therapy Research Across 3 Continents with Zero Sample Loss 
Case Study: Conducting Autologous Cell Therapy Research Across 3 Continents with Zero Sample Loss
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164725548848, hs_child_table_id=0, hs_updated_at=1716454310949, hs_published_at=1748379090824, 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=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Alexis-Hobbins-White-150x150.jpeg',altText='Alexis-Hobbins-White-150x150',fileId=164710912635}, 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=51739740}, second={}, third={}}) -
-
Read: Phase 1 Clinical Trial Designs Explained: BOIN, CRM, BLRM & Modern Adaptive Strategies 
Phase 1 Clinical Trial Designs Explained: BOIN, CRM, BLRM & Modern Adaptive Strategies
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1709645745122, hs_published_at=1748379090824, description=Kurt Preugschat has over 11 years of statistical experience from Phase I to Phase IV clinical trials. He is a lead statistician, providing statistical support and oversight for numerous clinical trials associated with new drug applications (NDA), supplemental new drug applications (sNDA), and medical devices. His expertise includes the development of study designs to meet complex clinical questions and the measurement of desired outcomes. In addition, Kurt has extensive experience generating statistical analyses and creating complex SAS programs and macros used by study team., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/kurt-preugschat.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/kurt-preugschat-97298923a, hs_name=, hs_path=, lastname=Preugschat, hs_initial_published_at=1716136551646, hs_created_at=1709645745122, hs_is_edited=false, hs_deleted_at=0, name=Kurt, job=, slug=kurt-preugschat, email=, hs_updated_by_user_id=51739740}, second={}, third={}}) -
-
Read: Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM) 
Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM)
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1709645745122, hs_published_at=1748379090824, description=Kurt Preugschat has over 11 years of statistical experience from Phase I to Phase IV clinical trials. He is a lead statistician, providing statistical support and oversight for numerous clinical trials associated with new drug applications (NDA), supplemental new drug applications (sNDA), and medical devices. His expertise includes the development of study designs to meet complex clinical questions and the measurement of desired outcomes. In addition, Kurt has extensive experience generating statistical analyses and creating complex SAS programs and macros used by study team., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/kurt-preugschat.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/kurt-preugschat-97298923a, hs_name=, hs_path=, lastname=Preugschat, hs_initial_published_at=1716136551646, hs_created_at=1709645745122, hs_is_edited=false, hs_deleted_at=0, name=Kurt, job=, slug=kurt-preugschat, email=, hs_updated_by_user_id=51739740}, second={}, third={}}) -
-
-
-
Read: Key Strategies for Future-Proofing Gene Therapy Assays 
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=1748379090824, 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=1716212769184, 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=51739740}, second={hs_id=159488778889, hs_child_table_id=0, hs_updated_at=1714461111815, hs_published_at=1748379090824, 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=1716212769184, hs_created_at=1709645745120, hs_is_edited=false, hs_deleted_at=0, name=Travis, job=, slug=travis-harrison, email=, hs_updated_by_user_id=51739740}, third={}}) -
-
Read: Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity 
Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1748379090824, 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=1716212769184, 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=51739740}, second={hs_id=159488778840, hs_child_table_id=0, hs_updated_at=1716132440837, hs_published_at=1748379090824, description=Maham Ansari, MS, RAC is a Senior Director, IVD Regulatory Affairs. Her focus is on companion diagnostic co-development programs, where she leverages her regulatory expertise to secure approvals in the US, Europe and beyond for companion diagnostics with a specific focus on gene therapy. She brings more than 16 years of global regulatory leadership experience in the medical device and in vitro diagnostics industry, spanning major multinationals to small start-ups, including full life cycle management across all stages of product development, execution of global regulatory strategies, and post-market surveillance.sh, avatar=Image{width=710,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Maham_Ansari.png',altText='Maham_Ansari',fileId=167373022876}, linkedin=https://www.linkedin.com/in/maham-ansari-ms-rac-6a735739, hs_name=, hs_path=, lastname=Ansari, hs_initial_published_at=1716212769184, hs_created_at=1709645745071, hs_is_edited=false, hs_deleted_at=0, name=Maham, job=, slug=maham-ansari, email=, hs_updated_by_user_id=51739740}, third={}}) -
-
Read: Optimizing Immunohistochemistry Validation and Regulatory Strategies 
Optimizing Immunohistochemistry Validation and Regulatory Strategies
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1714461729999, hs_published_at=1748379090824, 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, hs_initial_published_at=1716212769184, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=51739740}, second={hs_id=182710436924, hs_child_table_id=0, hs_updated_at=1731419754428, hs_published_at=1748379090824, description=Christie Bongel, MS, CT(ASCP), brings nearly two decades of experience in both research and clinical medicine. As the site director for Precision for Medicine’s IHC Center of Excellence in North Carolina, she excels in managing scientific operations and collaborating with clients. Christie is skilled in cytology, laboratory medicine, and molecular diagnostics. Her role focuses on building an energized team dedicated to delivering life-changing outcomes for patients. Christie earned her MS in Applied Biotechnology and is an ASCP certified cytotechnologist., avatar=Image{width=260,height=260,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Christie%20Bongel_Square_260px.jpg',altText='Christie Bongel_Square_260px',fileId=178044303113}, lastname= Bongel, hs_initial_published_at=1731517828480, hs_created_by_user_id=28386183, hs_created_at=1731419696820, hs_is_edited=false, hs_deleted_at=0, name=Christie, job=Site Director - Histology, slug=christie-bongel, hs_updated_by_user_id=51739740}, third={}}) -
-
All articles
-
Read: Rescuing a Complex Hematology Oncology Trial: Case Study in Precision 
Rescuing a Complex Hematology Oncology Trial: Case Study in Precision
has third author: false, (SizeLimitingPyMap: {main={hs_id=164713188766, hs_child_table_id=0, hs_updated_at=1714747844927, hs_published_at=1748379090824, description=Anne Kopko is a Clinical Science Analytics & Insights Principal Scientist with fifteen years of professional oncology clinical research experience supporting Phase 1-3 clinical trials across a variety of therapeutic areas, including first-in-human, Phase 1-2 combination trials, dose escalation and expansion hematology and solid tumor studies. She plays a pivotal role in navigating the complex landscape of clinical data quality and supporting the cross-functional data cleaning process. She is a knowledgeable and collaborative partner with a passion to deliver quality data to her clients through a holistic, clinical sense data review approach., avatar=Image{width=300,height=300,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Anne-Kopko-300x300.jpeg',altText='Anne-Kopko-300x300',fileId=164721973774}, linkedin=https://www.linkedin.com/in/anne-kopko-39b16888/, lastname=Kopko, hs_initial_published_at=1713363230550, hs_created_by_user_id=5166971, hs_created_at=1713362764236, hs_is_edited=false, hs_deleted_at=0, name=Anne, job=Manager, Clinical Oncology Solutions, slug=anne-kopko, hs_updated_by_user_id=51739740}, second={hs_id=182260357962, hs_child_table_id=0, hs_updated_at=1730486118009, hs_published_at=1748379090824, description=Andrea Chavlovich is Senior Clinical Scientist and contact for Clinical Science Analytics & Insights (CSAI). She is a hematology/oncology nurse (BSN, RN, BS) with over seven years of clinical research experience, both at the CRO and site levels. Andrea has worked on Phase 1-4 Oncology studies, including First-In-Human (FIH), Dose Escalation, and Dose Expansion. She has experience in hematology, cellular therapy, solid tumor, and rare disease studies, including but not limited to AML, breast cancer, and pancreatic malignancies. , avatar=Image{width=250,height=248,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Andrea%20Chavlovich%E2%80%8B.jpg',altText='Andrea Chavlovich',fileId=182263330445}, lastname=Chavlovich, hs_initial_published_at=1730486124094, hs_created_by_user_id=26433386, hs_created_at=1730485944077, hs_is_edited=false, hs_deleted_at=0, name=Andrea, job=Senior Clinical Scientist, slug=andrea-chavlovich, hs_updated_by_user_id=51739740}, third={hs_id=164713188782, hs_child_table_id=0, hs_updated_at=1714747852941, hs_published_at=1748379090824, description=Hasni M’hidi, PhD is a seasoned oncology clinical research professional, passionate about advancing medical science. As Global Project Manager, Hasni oversees operations in the US and EU. His expertise spans all phases of clinical trials, and his commitment to improving patient outcomes is unwavering., avatar=Image{width=300,height=300,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Hasni-Mhidi-300x300.jpeg',altText='Hasni-Mhidi-300x300',fileId=164721971514}, linkedin=https://www.linkedin.com/in/hasni-m-hidi-4902b086/, lastname=M’hidi, PhD, hs_initial_published_at=1713363230550, hs_created_by_user_id=5166971, hs_created_at=1713362890341, hs_is_edited=false, hs_deleted_at=0, name=Hasni, job=Project Manager, slug=hasni-mhidi, hs_updated_by_user_id=51739740}}) -
-
Read: Case Study: AML Phase 1-2 Trial 
Case Study: AML Phase 1-2 Trial
has not third author: true, (SizeLimitingPyMap: {main={hs_id=164713188766, hs_child_table_id=0, hs_updated_at=1714747844927, hs_published_at=1748379090824, description=Anne Kopko is a Clinical Science Analytics & Insights Principal Scientist with fifteen years of professional oncology clinical research experience supporting Phase 1-3 clinical trials across a variety of therapeutic areas, including first-in-human, Phase 1-2 combination trials, dose escalation and expansion hematology and solid tumor studies. She plays a pivotal role in navigating the complex landscape of clinical data quality and supporting the cross-functional data cleaning process. She is a knowledgeable and collaborative partner with a passion to deliver quality data to her clients through a holistic, clinical sense data review approach., avatar=Image{width=300,height=300,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Anne-Kopko-300x300.jpeg',altText='Anne-Kopko-300x300',fileId=164721973774}, linkedin=https://www.linkedin.com/in/anne-kopko-39b16888/, lastname=Kopko, hs_initial_published_at=1713363230550, hs_created_by_user_id=5166971, hs_created_at=1713362764236, hs_is_edited=false, hs_deleted_at=0, name=Anne, job=Manager, Clinical Oncology Solutions, slug=anne-kopko, hs_updated_by_user_id=51739740}, second={hs_id=164713188782, hs_child_table_id=0, hs_updated_at=1714747852941, hs_published_at=1748379090824, description=Hasni M’hidi, PhD is a seasoned oncology clinical research professional, passionate about advancing medical science. As Global Project Manager, Hasni oversees operations in the US and EU. His expertise spans all phases of clinical trials, and his commitment to improving patient outcomes is unwavering., avatar=Image{width=300,height=300,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Hasni-Mhidi-300x300.jpeg',altText='Hasni-Mhidi-300x300',fileId=164721971514}, linkedin=https://www.linkedin.com/in/hasni-m-hidi-4902b086/, lastname=M’hidi, PhD, hs_initial_published_at=1713363230550, hs_created_by_user_id=5166971, hs_created_at=1713362890341, hs_is_edited=false, hs_deleted_at=0, name=Hasni, job=Project Manager, slug=hasni-mhidi, hs_updated_by_user_id=51739740}, third={}}) -
You've reach the end