Joint EMA-FDA workshop: Efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants

• Date:
  Thursday, 15 December 2022, 13:00 - 17:00 Amsterdam time (CET)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

The workshop is organised to bring together scientists, clinicians, industry representatives and regulators to discuss alternative strategies to support the development of novel monoclonal antibody therapies including those based on prototype products that have demonstrated safety and efficacy in clinical trials. The current evidence for the use of surrogates of clinical efficacy to support the activity of already approved/authorised monoclonals and the development of novel monoclonal antibodies against variants of concern will be discussed.

The summary report and slides for the presentations given during the workshop are available below.

Documents

Agenda - Joint EMA-FDA workshop: Efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants

Reference Number: EMA/601355/2021

Summary report - Joint EMA-FDA workshop: Efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants

Reference Number: EMA/67738/2023

Presentation 01. SARS-CoV-2 Monoclonal Antibody Workshop: FDA Perspective

Presentation 01a. SARS-CoV-2 Monoclonal Antibody Workshop: EMA Perspective

Presentation 02. Overview of the clinical trials that led to the authorisation of monoclonal antibody therapies in the EU

Presentation 03. Viral diversity and antibody breadth

Presentation 04. Utility of virologic assessments as a marker of progression to severe disease based on data from the ACTIV-2 trial

Presentation 05. Translational PK-PD Modeling During COVID-19_Evusheld and Points to Consider

Presentation 06. Evidence in support of the use of serum neutralization data to justify a dose increase of monoclonal antibodies to tackle new variant

Presentation 07. Lessons on Correlates of Protection from COVID-19 Vaccines and HIV-1 Monoclonal Antibodies

Presentation 08. Correlation Between Protection and ex vivo Neutralization in the Context of Pre-exposure Prophylaxis

Presentation 09. Correlates of protection using a neutralisation approach

Presentation 10. Considerations Regarding Assessment of a Modified Monoclonal Antibody (mAb) Product Related to a Prototype mAb Production Addressing Emerging SARS-COV-2 Variants– a CMC Perspective

Presentation 11. Development Approach for Anti-Spike Monoclonal Antibodies to Keep Pace with SARS-CoV-2 Variants

Presentation 11a. Use of neutralizing antibody or PK_IC50 threshold to expedite clinical development for prophylactic monoclonal antibodies

Presentation 11b. Neutralising antibodies for the treatment of ambulatory patients

Presentation 11c. QSP Strategy to Support Development of Adintrevimab for Prevention and Treatment of COVID-19

Presentation 11d. Molecules Against Novel Targets