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Mechanistic model-informed discovery & development of bispecific antibodies for immuno-oncology: It takes 2 to tango

More than 50 bispecific antibodies are in oncology clinical development with a large diversity in formats, directed at a range of immune and tumor targets. Bispecifics have demonstrated the potential for enhanced efficacy and reduced systemic toxicity. However, they are complex modalities with challenges to overcome in early clinical trials, including selection of relevant starting … Continued

Getting Real with RWE

By Taren Grom Real-world evidence, important for regulatory decision-making, is beginning to touch all areas of the healthcare value chain.

Regulatory submissions and transactions with Health Canada

By Robert Labriola We’ve seen recent trends and activity with regards to pharmaceutical regulatory submissions to Health Canada. Several questions and queries have come into our regulatory operations department, and the following information will address a few popular topics.  Health Canada implements eCTD for Clinical Trial Applications Health Canada accepts electronic Common Technical Document (eCTD) … Continued

How PBPK Modeling Can Replace Drug-Drug Interaction Studies

Patients often take more than one drug at a time, especially elderly patients and those with complex diseases, such as cancer and neurological disorders. Therefore, it is crucial to determine what the potential risk might be of a new drug candidate interacting with existing marketed medications. …

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