SOURCE: Xtalks

Xtalks Webinars

February 19, 2015 07:05 ET

Biologics, Biosimilars and Biobetters: Strategies for Nonclinical Safety Testing, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - February 19, 2015) - This webinar will discuss new Biologics, Biosimilars, and Biobetters programs using case studies to illustrate strategy choices and the similarities and differences between each program. Join speakers Judith Newmark, Program Manager, Pharmacology/Toxicology/Ocular at Toxikon Corporation, and Franck Grall, Director, Cellular and Molecular Toxicology at Toxikon Corporation, for the live broadcast on Thursday, March 12, 2015 at 11:00am EDT (15:00 GMT).

New biologics are submitted through an IND process similar to small molecules and require a full battery of safety testing. Biosimilars follow a specific pathway, designed based on an innovator (reference product), and they often have an abbreviated safety testing program.

The speakers will focus on the applicable regulatory guidance that provides a framework for developing a preclinical testing strategy. Biologic programs require careful consideration with respect to species selection, dosing regimens, incorporation of safety pharmacology parameters, pharmacodynamics, bioanalytical/toxicokinetic analysis, and immunogenicity. Biosimilars require particular consideration of the innovator product in order to incorporate design elements from the original preclinical program and to ensure appropriate comparative testing of the biosimilar to the innovator product within the preclinical studies. As the biologic market has grown, the development of Biobetters has been introduced. The intention of producing a Biobetter is to modify an existing Biologic such that there are improvements in efficacy or minimization of toxicity, and a full preclinical safety program is required.

For all types of Biologic programs, custom method development and validation are required for the bioanalytical analysis and immunogenicity. Toxicokinetic (TK) analysis of the bioanalytical data is performed to follow exposure of the test article within the test system. Immunogenicity assessment is a measure of the development of antibody against the test article. This is not a toxicology endpoint, but the information is necessary to evaluate TK and pharmacodynamic data. All of these aspects work together to culminate in a successful regulatory submission.

Key Topics:

  • Regulatory Guidance (FDA, EMA, and ICH)
  • Reference Products
  • Preclinical Safety Testing: Toxicity and Safety Pharmacology
  • Bioanalytical and Toxicokinetic Analysis
  • Immunogenicity

To learn more about this event visit: Biologics, Biosimilars and Biobetters: Strategies for Nonclinical Safety Testing

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