Webinar – Assessment and reporting of immunogenicity to support filing: tactical recommendations

Le GMP est heureux de vous inviter à une présentation de Khaled Benkali et Florian Chassereau (Certara) intitulée “ Assessment and reporting of immunogenicity to support filing: tactical recommendations”  jeudi 19 juin 2025 de 12h30 à 13h30 (CET). Le résumé de la présentation et la biographie de nos intervenants sont présentés ci-dessous.

Aucune inscription n’est nécessaire mais les participants seront accueillis dans la  limite de la capacité d’accueil.

Join the meeting now

Bien cordialement,

Le Conseil d’Administration du GMP

Dear Colleagues and Members,

The GMP is happy to invite you to a webinar untitled “Assessment and reporting of immunogenicity to support filing: tactical recommendations” presented  by Khaled Benkaliand Florian Chassereau (Certara)  on Thursday, June 19, 2025 12:30 PM-1:30 PM (CET). The abstract of the presentation and the biography of our speakers are summarized hereafter.

No registration will be needed, but the participants will be welcome within the limit of the connection capacity.

Join the meeting now

Best regards,

The GMP Board

Abstract:

Therapeutic Proteins may trigger immune responses that can impact their pharmacokinetics, efficacy, or their safety. This webinar outlines a strategic approach to immunogenicity assessment, emphasizing the importance of the Integrated Summary of Immunogenicity (ISI) in regulatory filings. Key topics include anti-drug antibody (ADA) assessment in clinical trials, interpretation of results and reporting these data to support drug filing. A case study will illustrate how a well-structured ISI supports regulatory review and benefit-risk evaluation. Practical recommendations are provided to streamline ISI preparation and enhance cross-functional collaboration.

Speakers:
Khaled Benkali is a Senior Director and Team Lead in Clinical Pharmacology at Certara, a role he has held since joining the company in February 2020. A trained pharmacist, Khaled holds a Master of Science and a PhD in Pharmacology, as well as an Executive MBA, combining deep scientific expertise with strong business acumen.

With over 15 years of experience—10 in the pharmaceutical industry and 5 in clinical pharmacology consulting—Khaled has played a key role in the development and successful approval of multiple drug products, including both new chemical entities and therapeutic proteins. His expertise spans in-licensing evaluations, gap analyses, regulatory interactions, and the application of Model-Informed Drug Development (MIDD) strategies to support clinical development.

Khaled is recognized for his strategic perspective and leadership in advancing innovative drug development programs.

Florian Chassereau is Director, Clinical Pharmacology at Certara Drug Development Solutions, with over a decade of experience in the pharmaceutical industry. He excels in supervising and managing project teams across various therapeutic areas, focusing on early and late-stage development of small molecules and biologics. His key contributions include pivotal regulatory submissions and involvement in Project Optimus-compliant oncology initiatives, highlighting his expertise in advancing innovative therapies.