Biologics, Biosimilars and Biobetters: Strategies for Nonclinical Safety Testing

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.

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.

Our featured 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

Speakers

Judith Newmark, PhD, Program Manager, Pharmacology/Toxicology/Ocular, Toxikon Corporation

Judith Newmark, PhD, Program Manager, Pharmacology/Toxicology/Ocular, Toxikon Corporation – Dr. Newmark has an extensive background working with Pharma and Biotech companies to develop appropriate preclinical safety programs for drugs, biologics/ biosimilars, gene therapy, cell therapy, vaccines, combination products, and other therapeutic products. Her areas of expertise include regulatory guidance, pharmacology, toxicology, and safety for a diverse range of therapeutic areas including oncology as well as dermal and ocular diseases. She has global experience working with regulatory agencies to gain approval of program designs and to assist companies in bringing their products to clinical trial. Dr. Newmark has presented and published on these programs in order to provide education on the decision making process and key influential factors that will impact the design of the preclinical program.

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Franck Grall, PharmD, PhD, Director, Cellular and Molecular Toxicology, Toxikon Corporation

Dr. Franck Grall heads the in-vitro department at Toxikon Corporation. In this capacity, Dr. Grall oversees numerous safety and toxicology studies involving Pharmaceutical, biologics, and medical devices, in particular Immunogenicity, Bioanalytical, Biocompatibility, as well as genetic toxicology. Dr. Grall holds Doctorates in Pharmacy and in Molecular Biology from the University of Paris, France. Before joining Toxikon in 2007, Dr. Grall was an Instructor at Harvard Medical School and Beth Israel Deaconess Medical Center researching novel biomarkers and studying gene regulation.

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