How to Apply Fit-for-Purpose Biomarker Assay Validation to Your COU

How to Apply Fit-for-Purpose Biomarker Assay Validation to Your COU

Managing Sensitivity in Neutralizing Antibody Assays: When Wide Dynamic Range Makes Yes Mean No and No Mean Yes

On-Demand Recording: Creating an Effective & Sustainable Employee Testing Strategy: Live Q&A with the Experts!

ELISpot Method Development and Validation for Gene Therapies: Building on 2019 WRIB Recommendations, Practical Case Studies, Lessons Learnt and Evolving Trends

On-Demand Webinar: Impact of Pre-Existing Immunogenicity Against AAV on Gene Therapy Trials

Science On-Demand: Novel CAR-T Therapies and Bioanalytical Assay Implementation

On-Demand Webinar:
The Latest Science & Thinking on COVID-19 Testing

On-Demand Webinar: Translation of a Diagnostic Virus Neutralization Method to a Quantitative Relative Potency Assay for an Anti-Viral Antibody

On-Demand Webinar: What the New AAPS White Paper Recommends for Immunogenicity Assays Supporting Biosimilars

Presenter: Todd Lester, Associate Director at BioAgilytix

Co-Hosted with: Bioanalysis Zone

The demonstration of similar immunogenicity is a critical requirement for the demonstration of biosimilarity between a biosimilar candidate and the respective reference product. In their webinar, Mr. Lester discusses what the new AAPS White Paper recommends for immunogenicity assays supporting biosimilars., addressing questions such as:

  • What are the requirements for immunogenicity assessments of biosimilars?
  • Why do the FDA and EMA recommend the use of a single, biosimilar-based assay?
  • How are anti-drug antibody (ADA) assays developed and validated for the support of biosimilar drug development programs?
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On-Demand Webinar: Exploratory Biomarker Testing – to Qualify or Validate the Assay?

Presenter: Dr. Afshin Safavi, Founder & Board Member at BioAgilytix

Co-Hosted with: Bioanalysis Zone

With the question ‘should we qualify or validate an exploratory biomarker assay before sample testing?’ in mind, Dr. Safavi will review and discuss the latest scientific and regulatory considerations for the analytical validation of assays for fluid-based biomarkers used in the qualification of drug development tools (DDTs). Topics will cover:

  • Latest industry practices in exploratory biomarker testing
  • Considerations for assay design and technology selection
  • Optimization of pre-analytical factors
  • Core assay performance expectations
  • Setting minimally acceptable assay performance criteria


You can learn more about the topics Dr. Safavi covers in his pre-webinar blog.

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On-Demand Webinar: Principles of Immunogenicity Assessment Using Biacore™ T200 SPR System

Presenters: PD Dr. Arno Kromminga, SVP & Chief Scientific Officer at BioAgilytix and Dr. Daniel Worms, Associate Principal Investigator at BioAgilytix

Host: GE Healthcare

The assessment of unwanted immunogenicity is a key parameter in the development process of biological protein drugs. In this webinar, BioAgilytix’s experts Dr. Arno Kromminga and Dr. Daniel Worms discuss aspects of when and how to use the Biacore™ T200 SPR System to obtain a deeper understanding of unwanted immunogenicity. Learn more about the Biacore™ T200 system in this blog.

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Webinar Recording: Immunogenicity assessment of gene therapy compounds: discussion on current and future concepts

Presenters: PD Dr. Arno Kromminga, Chief Scientific Advisor at BioAgilytix

Host: Bioanalysis Zone

This webinar discusses the strategies and challenges of immunogenicity assessment for gene therapy compounds, addressing questions such as: What is particular to the immunogenicity of gene therapies as compared to other biologics drugs? Which immunogenicity assessments are recommended from the scientific point of view? What are the bioanalytical tools available? And what are the technical challenges? Learn more about the topics covered in this blog.

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Webinar Recording: Clinical relevance of (unwanted drug-induced) immune responses

Presenter: PD Dr. Arno Kromminga, SVP & Chief Scientific Officer at BioAgilytix Europe

Host: Bioanalysis Zone

Ultimately, all biological drugs are immunogenic. Over the last several years, methods for the detection of drug-induced antibodies have become more sensitive, which means that target sensitivities of 100 ng/mL (as recommended in most US FDA immunogenicity guidance) can be easily reached. While it is exciting to have technical tools in hand to detect antibodies at very low concentrations, the question remains to be answered: are antibodies at this low concentration level clinically relevant? In addition, do antibodies against biological drugs, that are detectable prior to the initiation of the treatment, have any clinical implication?

This webinar discusses why careful and thorough data interpretation is needed, which takes into account the clinical manifestation of clinically relevant biomarkers (including PK). Dr. Kromminga also covers how the kinetics and type of antibody responses should be monitored to assess the risk of developing a treatment-emergent immune response, and finally, why post-approval patient monitoring should be mandatory.

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Webinar on Demand: Challenges of Single and Multiplex Biomarker Validation on ‘Planet Earth’ Versus ‘Planet Biomarkertopia’

This presentation focuses on case studies through the eyes of a biomarker scientist working before and after being transported from ‘planet Biomarkertopia’ to ‘planet Earth’ to demonstrate the processes, challenges and some of the limitations of validating biomarker assays using single and multiplexing approach. You will also learn about the latest trends in single and multiplex biomarker assay validation.

 

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Webinar on Demand: Recent Aspects and Challenges in the Assessment of Immunogenicity

The assessment of immunogenicity of biological protein drugs is a key component in drug development. A basic knowledge in immunology is a prerequisite for understanding the principles of adverse, unwanted immune responses. In addition, emerging technologies are making analytical and clinical data interpretation more challenging. Likewise, the comparative immunogenicity analysis of an innovative therapeutic and biosimilar needs to be addressed closely.

 

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Webinar Recording: Considerations for Evaluation of Accuracy, Parallelism and Reagent Lot to Lot Variability in Single and Multiplex Biomarker Ligand-Binding Assays

The goal of this webinar, presented by Dr. Afshin Safavi, Co-Founder and CSO of BioAgilytix, is to review the concept of parallelism and relative accuracy for biomarker studies, using various case studies to increase awareness of the bioanalytical challenges and considerations as they pertain to these, as well as to reagent lot-to-lot variability.

 

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AAPS Webinar Recording: Bioanalytical Methods in Support of Biosimilar Drug Development

In this webinar, BioAgilytix’s Dr. Arno Kromminga summarizes the recommendations from the AAPS Ligand Binding Assay Biosimilar subcommittee and Biosimilars Action Program Committee on the Development and Validation of PK, Anti-Drug Antibody (ADA), and Neutralization Antibody Assays (NAB) for Biosimilar Drug Development, and describes how this information can be used to reduce the risks present in biosimilar drug development.

 

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Webinar: Assay and Kit Lot Considerations for Single and Multiplex Biomarker Analysis

Abstract: Biomarker analysis has become a common practice by many pharmaceutical companies to help PK/PD modeling.  The reliability of outcomes is heavily influenced by the quality of the reagents.  One of the challenges that bioanalytical labs face when running biomarker studies is the control of lot-to-lot variability of critical reagents and commercial immunoassay kits.  Case studies will be presented to highlight the key bioanalytical considerations involved in running successful biomarker analyses in support of clinical studies.

Afshin Safavi, Ph.D., Founder & Chief Scientific Officer, is a veteran biochemist with extensive experience in establishing and leading bioanalytical teams in support of the development of biological products in preclinical and clinical-trial laboratories.  Prior to founding BioAgilytix, he was the Director of Ligand Binding and Immunoassay, operating under GLP at AAIPharma.  At Talecris BioTherapeutics, he led the Preclinical and Clinical Assay Development team, building on his experience as a senior scientist at Nobex Corporation, GlaxoSmithKline and IGEN International.  Dr. Safavi is considered an expert in the area of immunoassay with a wide working knowledge of various platforms.  He obtained his B.S. in Biochemistry from UCLA, his Ph.D. in Biochemistry from University of Kentucky Medical School, and completed a two-year postdoctoral assignment at the Emory University, Department of Pathology.

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