Advancing CAR T-Cell Therapies with Clinical Trial Customization

Life Sciences, Clinical Trials, Drug Discovery & Development, Biomarkers, Cell and Gene Therapy,
  • Monday, April 15, 2024

Bringing together best practices in genomics, flow cytometry, biomarkers and clinical trial operations

In the ever-evolving landscape of healthcare, cell and gene therapy (CGT) stands at the forefront of groundbreaking advancements. With the power to precisely manipulate cells and genes for therapeutic purposes, it offers immense promise in treating diseases at their root. A significant breakthrough in CGT has been the use of chimeric antigen receptor-engineered T cells (CAR T cells) for treating cancer. The industry faces many challenges such as a changing complex regulatory environment and technology for CAR T-cell-based therapeutics. Introducing new CAR T-cell therapies to the market requires extensive strategizing and planning for clinical trials as well as post-marketing follow-up.

CAR T-cell therapies are highly personalized, and therefore clinical trials need customized testing solutions. The pharma and biotech communities preparing for clinical development and ultimately market launch need to consider this in their clinical trial strategies, including patient selection and therapy delivery. One key consideration is engaging with contract research organizations (CROs) and lab service providers at an early stage to ensure that clinical trials can be designed based on customized needs.


This webinar emphasizes the challenges encountered and the importance of customized solutions in genomics, flow cytometry, biomarkers and clinical trial operations for successful CAR T-cell therapy clinical trials. The expert speakers will showcase the criticality of early engagement through two case studies, demonstrating how it allows for the design of tailored trials. They will then share best practices for overcoming challenges related to (1) monitoring CAR T-cells, (2) patient safety assurance and (3) assessment of therapy response.

Having supported more than 20 CAR T-cell therapy trials, Cerba Research offers extensive laboratory solutions. Join Cerba Research’s webinar to learn more about customized solutions for successful CAR T-cell therapy clinical trials and stay tuned for subsequent webinars and podcasts on their other CGT solutions.

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Register for this webinar today to learn more about customized solutions for successful CAR T-cell therapy clinical trials. 


Goran Marinkovic, Cerba Research

Goran Marinkovic, Immunologist, Cerba Research

Goran Marinkovic obtained his Bachelor’s and Master’s degrees in Biology from Belgrade University, Serbia. After completing his PhD at the University of Amsterdam in 2014, Goran moved to Israel where he worked as a Postdoc at the Weizmann Institute of Science. Subsequently, Goran moved to Sweden where he was working on the development of immunomodulatory therapy for the treatment of myocardial infarction. For the past year and a half, Goran has been employed as an Immunologist at Cerba Research Netherlands.

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Nele Langenaken, Cerba Research

Nele Langenaken, General Manager, Cerba Research

Nele Langenaken has over 25 years of experience in the Cerba Lab & Testing industry. She joined Cerba Research in 1998 and founded Cerba Research in the USA, of which she is still the General Manager. She holds a Bachelor’s degree in Science from Ghent University.

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Nithianandan Selliah, Cerba Research

Dr. Nithianandan Selliah, PhD, Global Director, Flow Cytometry, Cerba Research

Nithianandan Selliah’s professional work spans academia, the biotech/pharma sector and most recently CROs. His PhD research at the University of Kentucky focused on the effect of epinephrine in the modulation of T cell activation. After his PhD, he joined Dr. Terri Finkel’s lab at the National Jewish Medical Center to study the mechanism of bystander killing of CD4 T cells by HIV. This work continued at the Children’s Hospital of Philadelphia. Later, he conducted pioneering research in CAR T cells for HIV therapy under the mentorship of Dr. Richard Junghans at Roger Williams Medical Center in Providence, RI. He then moved to a biotech company to identify biomarkers for lupus disease utilizing flow cytometry. He then joined Celgene to work on a specific project to explore the therapeutic potential of red blood cells derived from the in vitro differentiation of hematopoietic stem cells.

In 2015, Dr. Selliah joined LabCorp Drug Development (formerly Covance) to help facilitate their expansion of flow cytometry supporting clinical drug development. He has developed and validated more than ten flow cytometric methods that were deployed in numerous global clinical trials. His work has been represented at the International Clinical Cytometry Society (ICCS) Annual Course and the International Society for the Advancement of Cytometry’s annual meeting, CYTO. He has contributed to recommendation papers in Cytometry B: Clinical Cytometry and Current Protocols in Cytometry as well as a chapter on receptor occupancy assays.


He is an active member of the ICCS Quality and Standards Committee whose mission is to create educational modules for the international flow cytometry community on standardizing processes for flow cytometry assays, including reagent quality testing and instrument standardization.

Currently, Dr. Selliah is the Global Director of Flow Cytometry at Cerba Research, where he leads a team of scientists in developing and validating flow cytometry assays for global clinical trials. At Cerba Research, Dr. Selliah has implemented assays for CART enumeration, CART phenotyping and receptor occupancy assay, among others, for global clinical trials for major pharmaceutical companies.

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Karthikeyan Devaraju, Cerba Reseach

Dr. Karthikeyan Devaraju, PhD, Scientist, Cerba Reseach

Dr. Karthikeyan Devaraju joined Cerba Research in 2022 as Scientist, Cell and Gene Therapy R&D. Before that, Dr. Karthikeyan held scientific research positions related to cell and gene therapies for the brain using viral vectors, stem cells and non-viral delivery systems, at university research hospitals in Sweden and Switzerland; organoids with patient-derived stem cells at Max Planck Institute, Nijmegen, Netherlands; process and product development at Orchid Chemicals and Pharmaceuticals, India, and at an ATMP CDMO in the Netherlands. He holds a PhD in Stem Cells and Neurology from Lund University, Lund, Sweden.

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Who Should Attend?

This webinar will appeal to the following professionals:

  • Area Head of Cell & Gene Therapy
  • Therapeutic Leads
  • Biomarker Leads
  • R&D Directors, Managers
  • Translational/Medicine Biomarker Leads
  • Clinical Biomarker Leads
  • Clinical Development Directors/Medical Directors
  • Clinical Operations Directors, Managers
  • Medical Directors
  • Science Directors and Managers

What You Will Learn

In this webinar, attendees will learn:

  • How to successfully set up and manage highly customized CAR T-cell therapy clinical trials
  • Flow cytometry’s crucial role in monitoring CAR T cells in clinical trials
  • The importance of genomics to ensure patient safety
  • The critical role of cytokines as biomarkers to characterize disease progression and therapy response

Xtalks Partner

Cerba Research

Cerba Research, a strategic provider of diagnostic solutions, supports drug development by leveraging patient data and scientific insight to optimize R&D and commercialization globally. Providing early phase research, clinical development through central laboratory and diagnostic testing, assay and biomarker development and validation — through our global network of specialty laboratories. We partner with government agencies, non-government organizations, as well as pharma and biotech organizations to change the shape of clinical development and advance healthcare. Cerba Research is part of Cerba HealthCare, a leading player in medical diagnosis.

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