Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Filters

Fabio Garofolo

Showing results (91-100 of 115) with videos related to

Pageof 12
Sort By:
Bioanalysis|December 14, 2019
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (<u>Part 2</u> - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)Brian Booth, Lauren Stevenson, Renuka Pillutla, et al.
Bioanalysis|November 19, 2016
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity)Susan Richards, Lakshmi Amaravadi, Renuka Pillutla, et al.
Bioanalysis|February 23, 2024
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard <u>(Part 3</u> - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)Johanna Mora, Rachel Palmer, Leslie Wagner, et al.
Bioanalysis|October 11, 2013
2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMSLauren Stevenson, Fabio Garofolo, Binodh DeSilva, et al.
Bioanalysis|January 25, 2025
2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (<u>PART 2A</u> - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) <u>PART 2B</u> - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation)Nicoletta Bivi, Danielle Graham, Laura Joglekar, et al.
Bioanalysis|May 17, 2022
2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (<u>Part 3</u> - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)Lina Loo, Shannon Harris, Mark Milton, et al.
Bioanalysis|December 16, 2014
8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validationJoseph Bower, Douglas Fast, Fabio Garofolo, et al.
Bioanalysis|January 25, 2025
2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation <u>(PART 3A</u> - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance <u>PART 3B</u> - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies)Omar Tounekti, Sandra Prior, Sarah Wassmer, et al.
Bioanalysis|January 6, 2026
2025 White Paper on Recent Issues in Bioanalysis: Redosing Patients with AAV Gene Therapy; CRS Immunogenicity Risk; Shedding Assays; NHP Studies Immunogenicity; CMC vs Bioanalytical Assays; Artificial Intelligence-Powered Genomic Pipelines for NGS (<u>PART 3A</u> - Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies; Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance <u>PART 3B</u> - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies)Omar Tounekti, Sophie Shubow, Sarah Wassmer, et al.
Bioanalysis|February 13, 2026
2025 White Paper on Recent Issues in Bioanalysis: What is the Future of Bioanalytical LIMS? AI/ML Integration in Bioanalysis; Tear Sample Collection; Radiolabeled Mass Balance Studies; Chiral Assays; Bioanalysis of Antibody-Oligonucleotide & Bicycle Drug Conjugates (<u>PART 1A</u> - Recommendations on Mass Spectrometry Assays, Chromatography, Sample Preparation and Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting <u>PART 1B</u> - Regulatory Agencies' Input on Regulated Bioanalysis/BMV)John Wojcik, Mark Qian, Anton I Rosenbaum, et al.
Pageof 12

Showing results (91-100 of 115) with videos related to

Sort By:
Pageof 12
Bioanalysis|December 14, 2019
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (<u>Part 2</u> - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)Brian Booth, Lauren Stevenson, Renuka Pillutla, et al.
Bioanalysis|November 19, 2016
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity)Susan Richards, Lakshmi Amaravadi, Renuka Pillutla, et al.
Bioanalysis|February 23, 2024
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard <u>(Part 3</u> - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)Johanna Mora, Rachel Palmer, Leslie Wagner, et al.
Bioanalysis|October 11, 2013
2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMSLauren Stevenson, Fabio Garofolo, Binodh DeSilva, et al.
Bioanalysis|January 25, 2025
2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (<u>PART 2A</u> - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) <u>PART 2B</u> - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation)Nicoletta Bivi, Danielle Graham, Laura Joglekar, et al.
Bioanalysis|May 17, 2022
2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (<u>Part 3</u> - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)Lina Loo, Shannon Harris, Mark Milton, et al.
Bioanalysis|December 16, 2014
8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validationJoseph Bower, Douglas Fast, Fabio Garofolo, et al.
Bioanalysis|January 25, 2025
2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation <u>(PART 3A</u> - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance <u>PART 3B</u> - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies)Omar Tounekti, Sandra Prior, Sarah Wassmer, et al.
Bioanalysis|January 6, 2026
2025 White Paper on Recent Issues in Bioanalysis: Redosing Patients with AAV Gene Therapy; CRS Immunogenicity Risk; Shedding Assays; NHP Studies Immunogenicity; CMC vs Bioanalytical Assays; Artificial Intelligence-Powered Genomic Pipelines for NGS (<u>PART 3A</u> - Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies; Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance <u>PART 3B</u> - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies)Omar Tounekti, Sophie Shubow, Sarah Wassmer, et al.
Bioanalysis|February 13, 2026
2025 White Paper on Recent Issues in Bioanalysis: What is the Future of Bioanalytical LIMS? AI/ML Integration in Bioanalysis; Tear Sample Collection; Radiolabeled Mass Balance Studies; Chiral Assays; Bioanalysis of Antibody-Oligonucleotide & Bicycle Drug Conjugates (<u>PART 1A</u> - Recommendations on Mass Spectrometry Assays, Chromatography, Sample Preparation and Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting <u>PART 1B</u> - Regulatory Agencies' Input on Regulated Bioanalysis/BMV)John Wojcik, Mark Qian, Anton I Rosenbaum, et al.
Pageof 12