Flow References

 

Therapeutic/
Disease 

Title

Journal

Conference

CAR T

Tracking Cellular Kinetics and Biodistribution of CAR T-Cells: Clinical Trial Considerations and Case Studies

 

WRIB

CAR T

Why implementation of patient centric biomarker solutions for cell & gene therapies is vital?

 

TriCon

ALL

Inotuzumab Ozogamicin for Relapsed/Refractory Acute Lymphoblastic Leukemia in the INO-VATE Trial: CD22 Pharmacodynamics, Efficacy and Safety by Baseline CD22 

Clinical Cancer Research

 

Heme

Development of DeepCytoFlow: A novel deep learning pipeline enabling automated gating of flow cytometry data

 

AACR

Melanoma

Neoadjuvant Pembrolizumab and High Dose Interferon Alfa-2b in Resectable Regionally Advanced Melanoma

Clinical Cancer Research

 

Heme

2020 White Paper on Recent Issues in Bioanalysis:
BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedbacks

Bioanalysis 

 

Melanoma

Multimarker scores of Th1 and Th2 immune cellular profiles in baseline peripheral blood mononuclear cells predict response and immune related toxicity with CTLA4 blockade and IFNα in Melanoma

Translational Research

 

Heme

Flow Cytometry in CAR-T Therapies: Challenges and Solutions

 

AAPS-OSD (Open Scientific Discussion) forum 

Heme

Best Practices for the development, analytical validation and clinical implementation of flow cytometric methods for chimeric antigen receptor T cell (CAR T) analyses 

Clinical Cytometry 

 

AML (heme)

Best Practices for Validation of Measurable Residual Disease Assessments by Multiparameter Flow Cytometry in Emerging Clinical Trials of Acute Myeloid Leukemia

 

ASH

Pan tumor

A multiparameter flow cytometry assay to monitor natural killer cell proliferation and activation in immuno-oncology clinical trials

 

SITC

MF (heme)

A multiparameter flow cytometry assay to monitor megakaryocytes and leukemic cells in clinical trials of myelofibrosis patients

 

ICCS

Heme

Monitoring CAR-T Cell Kinetics in Clinical Trials by Multiparameter Flow Cytometry: Benefits and Challenges

Clinical Cytometry 

 

Melanoma

Predictive value of circulating B cells and T cell subsets in melanoma patients treated with neoadjuvant ipilimumab and interferon α

 

ASCO

Heme

High Dimensional Flow Cytometry in Immuno-Oncology

 

WRIB

Heme

CAR-T monitoring by flow cytometry: Assuring Quality While Acknowledging Limitations

 

WRIB

Pan Tumor

High Dimensional Flow Cytometery in IO

 

PMWC

Heme

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (SECTION 3 – Flow Cytometry Validation in Drug Discovery & Development & CLSI H62).

Bioanalysis 

 

Heme

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (SECTION 5 – In vivo & Ex vivo Gene Therapy & Vaccine Bioanalytical Challenges).

Bioanalysis 

 

ALL

Impact of minimal residual disease status in patients with relapsed/refractory acute lymphoblastic leukemia treated with inotuzumab ozogamicin in the phase III INO-VATE trial

Leukemia Research

 

ALL

Efficacy and Safety Outcomes in the Phase 3 INO-VATE Trial by Baseline CD22-Positivity Assessed by Local Laboratories

 

ASH

Melanoma

Immunomodulatory effects of interleukin 2 in the circulation of melanoma patients and the added impact of VEGF inhibition with ziv-aflibercept 

 

SITC

Solid Tumor

Development of a slide-based multiplex immunofluorescent assay for detection of Helios degradation and DKY709 PD analysis

 

Novartis Onc Retreat

Pan Tumor

Efficacy and Safety Biomarkers of Cancer lmmunotherapies Identified by Novel Digital Pathology and Flow Cytometry Approaches

 

Biomarkers and Precision Medicine Conference

Melanoma

Application of High Complexity Flow Cytometry for Monitoring activated T-cells, T and B Regulatory Subsets in Combination Immunotherapy Trials, Melanoma Case Study

 

AACR

Heme

On-going developments in CAR-T Bioanalytical Strategies & Challenges by Flow Cytometry 

 

WRIB

Heme

Molecular and flow cytometry analytical approaches and challenges for assessing cellular kinetics, efficacy and product characterization for gene therapy products

 

WRIB

ALL

Comparison of CD22 Expression Levels Between Baseline and End of Treatment Among Patients treated with Inotuzumab Ozogamicin in Two Clinical Trials. 

 

ASH

Melanoma

Multimarker scores of Th1 and Th2 cellular profiles in baseline PBMCs predict response and toxicity with Ipilimumab and IFNα2b neoadjuvant therapy in Melanoma

 

SITC

ALL

Genetic alterations in CD19 lead to CD19 negative relapse to CAR19 therapy in children and young adults with relapsed/refractory acute lymphoblastic leukemia. 

Nature Medicine

 

Melanoma

High Complexity All-in-One Flow Cytometry Assay for the Measurement of T-cell Activation, Checkpoint Inhibitor Expression and Proliferation of T-cells in Periphery as a Biomarker for Novel Immuno-oncology Clinical Trials

 

ICCS

Melanoma

Assessment of Monocytes, MDSCs and Myeloid Cell Populations in Immuno-Oncology Clinical Trials by a Standardized High Complexity Flow Cytometry Approach

 

ICCS

ALL

CAR-T Characterization by Flow Cytometry: Hurdles and Successes. Bioanalytical Conference; Madison, WI; July 2018

 

Bioanalytical Conference

ALL

Inotuzumab Ozogamicin for Relapsed/Refractory Acute Lymphoblastic Leukemia in the Global Phase 3 INOVATE Trial: Efficacy and Safety by Baseline CD22 Expression Level

 

ASH

ALL

Flow Cytometry Approaches for Characterizing Functional Persistence

 

AAPS

Multiple

Biomarker Sample Stability: Why do we Care?

 

AAPS

Multiple Myeloma

Analytical validation and clinical verification of phosphoprotein biomarker modulation using a novel preservation system-based flow cytometry assay in multiple myeloma clinical trials. 

 

AACR

Hematomalignancy

High complexity flow cytometry panels to monitor target expression, T-cell activation and suppression by novel immunotherapies in hematomalignancy clinical trials. 

 

AACR

 

The Journey Towards Standardization for Validation of Fluorescent Cell-Based Assays.

 

 

ISCT