Toxicity testing of oncology drugs: unraveling the last 15 years of progress

Published on February 29, 2024   54 min

A selection of talks on Oncology

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Welcome to the 'Toxicity Testing of Oncology Drugs: Unraveling the Last 15 Years of Progress'. My name is Krishna Allamneni and I'm a board certified toxicologist, currently working as a chief development officer for an oncology start-up. Across more than two decades, building and leading pre-clinical development departments in the pharmaceutical industry, I've gained extensive experience in strategically evaluating benefit/risk profiles for diverse therapeutic modalities, including small and large molecules in a range of therapeutic areas such as oncology, hematology, CNS, infectious diseases, autoimmune conditions, diabetes, and liver metabolism. This presentation is an overview of the last 15 years of progress in the nonclinical safety testing of oncology drugs.
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In our previous talk in 2009, we described the unique considerations for oncology drug development and how these considerations shape the design, scope, and timing of the toxicology studies that were conducted for cancer drugs. In addition, we focused on pharmacodynamic markers that were emerging as game changers for oncology drug development. We went through the similarities and differences in safety and toxicology testing, comparing and contrasting the programs that were developed for small molecules versus large molecules. The ICH S9 guidance had just come out and we introduced that as a nonclinical safety assessment guideline on oncology therapeutic development. We also shared the existing publications by De George and the guidance on the preclinical evaluation by EMEA along with ICH M3 that defined the timeline for various nonclinical safety studies. Since that 2009 presentation, there has been a tremendous progress in the field of oncology drug development in terms of modalities and mechanisms of cancer drugs, as well as guidances that help sponsors developing cancer drugs. Consequently, although not much has changed in the standard parameters to be tested in nonclinical toxicology, certain exemptions or additional parameters are added given the evolution of our understanding. In the 1980s, cancer drug approvals

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