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ToxStrategies scientists present at Biotech Symposium

When the Charles River Biotech Symposium convened on September 8, 2019, in Carlsbad, California, Dr. Janice Lansita and Ms. Kirsten Mease were on hand to represent ToxStrategies. On the opening day, Dr. Lansita and her coauthor presented thoughts and insights gleaned from former FDA staff regarding the FDA’s process for reviewing Biologic License Applications. Later in the conference, Ms. Mease discussed a case-study example of dealing with immunogenicity without the benefit of an anti-drug antibody (ADA) assay.

The symposium was titled, “Biotechnology-Derived Therapeutics: Perspectives on Nonclinical Development.” According to Charles River, the get-together “unite[d] drug development professionals in an interactive setting to discuss the nonclinical development of biotherapeutics, including regulatory issues and innovative approaches to problem solving.” Dr. Lansita’s talk was a key aspect of the opening workshop, titled, “Demystifying the Late States of Nonclinical Development of Biotherapeutics.” Ms. Mease’s presentation kicked off the final day’s discussion of “Overcoming Immunogenicity Associated with the Use of Biopharmaceuticals.”