Successful Early Phase Drug Development of mAb Drugs


Applied Clinical Trials

This webcast will provide insights into the better understanding of operational challenges in resourcing and executing seasonal infectious diseases studies. Live: Europe: Thursday, Jun. 27, 2019 at 3pm BST | 4pm CEST On demand available after airing until Jun. 27, 2020. Register free

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Event Overview:
Several monoclonal antibody (mAb) drugs have been approved or are in the late stage of clinical development within various therapeutic indications. The number of mAbs making it to market will continue to increase thanks to their characteristics.

mAbs have complex pharmacokinetic (PK) and pharmacodynamic (PD) properties compared to small chemical molecules. Analysis of a new compound’s PK and PD properties is an essential step in the early phases of all drug development; but this process is still more complicated for mAbs. Challenging steps in designing FIH trials with mAb drugs remain and include the selection of a safe and appropriate starting dose; the choice of dose escalation steps to achieve the goal of a FIH study; the planning of sufficient and correct follow-up procedures; and the necessary safety monitoring, which considers both the short-term infusion related reactions and delayed PD effects.

In addition, due to safety incidents in the past, authorities look more rigorously towards mAbs, considering many of them to be high-risk medicinal products. A sound early clinical development plan, including appropriate justifications, might help regulatory bodies with their evaluation of what they view as high-risk. 

Key Learning Objectives:

  • Pharmacological specificities of mAb drugs to consider when starting clinical development

  • Starting dose and dose escalation steps in FIH study with mAb drugs

  • Study conduct and safety monitoring particularities during FIH trial with mAb drugs

  • Regulatory strategies and approaches for smooth mAb development

  • Tips & tricks for successful agency interactions in early development

Time and date: Europe: Thursday, Sept. 26, 2019 at 3pm BST | 4pm CEST 

North America: Thursday, Oct. 3, 2019 at 11am EDT | 10am CDT | 8am PDT

On demand available after airing until Sept. 26, 2020.

Sponsor: SGS

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