Skip to Menu Skip to Search Contact Us Global Websites & Languages Skip to Content

About

This hour-long webinar will provide a look at the multi-stage development for a biosimilar, including a review of the regulatory landscape, structural characterization techniques for biosimilarity assessment, and early phase clinical research challenges.

Starts

April 22, 2015

Ends

April 22, 2015

Location

Online

Description

The development pathway of a biosimilar is unlike that of a novel biotherapeutic. While there is an increased requirement for analytics throughout a biosimilars development project, and a Phase II clinical trial is generally omitted, careful consideration must be given to the planning of the other phases of development. Many regulatory authorities reference a “step-by-step” approach to establishing biosimilarity.

This hour-long webinar will provide a look at the multi-stage development for a biosimilar, including a review of the regulatory landscape, structural characterization techniques for biosimilarity assessment, and early phase clinical research challenges

  • Examine prevailing regulatory requirements
  • Provide appropriate analytical data particularly for antibodies where their size and complexity requires LC/MS/MS approaches
    • Establish the Quality Target Product profile (QTTP)
    • Strategies for primary and higher order structure determination of glycoproteins, including PTMs
    • Comprehensive physicochemical structural characterization to demonstrate “Biosimilarity” with the originator
  • Meet the challenges of early phase clinical research studies in biosimilars
    • Comparative clinical studies – a stepwise approach, including regulatory requirements
    • Clinical trial considerations, strategies and implementation of operational solutions

Presenters

Nadine M Ritter, PhD, President and Analytical Advisor, Global Biotech Experts, LLC  

Fiona M Greer BSc (Hons) MSc PhD, Global Director for Biopharma Services Development, SGS Life Science Services

Annick van Riel, PhD, Director CPU Antwerpen - Clinical Research, SGS Life Science Services

 

Register now for this event

April 22

11:00 am New York (Eastern Daylight Time)

16:00 London (GMT Summer Time)

17:00 Paris, Berlin (Europe Summer Time)