Navigating the Current Landscape of Anti-Drug Antibodies Testing from Preclinical to the Clinical Stages

Life Sciences, Pharmaceutical, Drug Discovery & Development, Cell and Gene Therapy,
  • Thursday, August 29, 2024

The bioanalytical field relative to how anti-drug antibody (ADA) assays are used has evolved tremendously. In this webinar, the expert speakers will discuss current strategies for the gating of bioanalytical ADA/immunogenicity testing to support preclinical and clinical programs. The attendees will specifically have the benefit of learning about the implications in their ADA/immunogenicity data interpretation when you apply — or don’t apply — the new lean approach for ADA preclinical and clinical testing.

The expert speakers will give a historical overview of the evolution of concepts around ADA assays in the last ten years. From the lessons learned, they will share their thoughts on the future of ADA assays strategies, and case studies will also be presented to support the discussion.

This session will cover the current protocols and best practices for conducting ADA assays during clinical immunogenicity assessments. Moreover, the speakers will delve into immunogenicity risk assessment, providing insights into evaluating potential immune responses and their impact on drug efficacy and safety.

Register for this webinar today to gain critical insights into the evolving landscape of ADA and immunogenicity testing in bioanalytical settings.

Speakers

Cheikh Kane, KCAS Bio

Cheikh Kane, PhD, Executive Director, Biopharma Services, KCAS Bio

Cheikh Kane, PhD, is currently the Executive Director BioPharma at KCAS Bio where his team is focused on bioanalytical ligand binding assays (LBA) and cell-based neutralizing antibody assays (NAB) to support drug development programs for biologics. Dr. Kane has more than two decades of experience in the bioanalytical and biomarkers assays and related strategies spanning from biopharmaceutical/biotechnology industry to the CRO business.

Prior to joining KCAS Bio, Dr. Kane held different roles at Nexelis US, Boehringer Ingelheim-US and Charles River Laboratories in Canada. Part of his role at KCAS Bio is to define and implement strategic and technical initiatives to expand KCAS Bio’s footprint in the bioanalytical and biomarkers fields. During his career, he supported numerous programs for a variety of scaffolds (monoclonal antibodies, ADCs, peptides, pegylated molecules, nanobodies, bispecific and multispecific molecules and ATMPs).

Message Presenter
Dominic Warrino, KCAS Bio

Dominic Warrino, PhD, Senior Director of Scientific Services, KCAS Bio

Dominic Warrino, PhD, is a Senior Director of Scientific Services. His role is to lead a team of Sr. Scientific Advisors and Scientific Advisors who are liaisons for both clients and internal teams regarding development, validation and application of bioanalytical PK, immunogenicity, PD and biomarker methods for all therapeutic modalities (biopharmaceutical, pharmaceuticals, gene therapies, and cell based gene therapies).

Dominic joined the company in 2013 and brought with him expertise in a full range of bioanalytical techniques, including ECL, ELISA, RIA, flow cytometry, ELISpot, cell-based assays and Luminex. He has 30 years of experience developing and validating immunological assays for biotechnology and pharmaceutical companies.

Prior to working at KCAS Bio, he spent several years in the Biopharma Services department at Viracor-IBT (formally IBT; MO, USA), and previously also worked for Cytogen (formally Cellcor; NJ, USA), Eligix (MA, USA) and Streck Laboratories (NE, USA) developing novel compounds for the treatment of various cancers.

Message Presenter

Who Should Attend?

This webinar will appeal to professionals in the following fields:

  • Biologics
  • ADCs
  • ARCs
  • Gene therapies and cell-based gene therapies that are responsible for anti-drug antibodies’ testing and the implementation of related strategies

What You Will Learn

Attendees will learn about:

  • Current recommendations for pre-clinical immunogenicity, specifically lean anti-drug antibodies’ testing
  • Current recommendations for clinical immunogenicity anti-drug antibodies’ assay testing
  • Immunogenicity risk assessment

Xtalks Partner

KCAS Bio

KCAS Bio is a leading contract research organization (CRO) employing top scientific talent which provides comprehensive bioanalytical services to the global biopharmaceutical industry from early discovery support through product registration and beyond. KCAS Bio offers bioanalytical, biomarker, immunogenicity, cellular and molecular assay services along with clinical kitting and sample management. KCAS Bio operates in state-of-the-art facilities in the United States and Europe, with the expertise, capacity, and flexibility to support the development of all types of drugs, biologics, cell and gene therapies to improve health worldwide.

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