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Project Optimus: How to Prepare for Success

For some time now, cancer drug developers have known “Project Optimus” and new dose optimization expectations are coming their way from the Food and Drug Administration’s (FDA) Oncology Center of Excellence for Oncology Drugs… By Julie Bullock, PharmD

Clinical Pharmacology Gap Analysis: Lessons Learned

Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these needs, and providing a framework for how to satisfy them. This tool can create value for drug development programs. While gap analysis can be performed at any point in the drug development continuum, early engagement is best for maximizing its benefits. … Continued

How Clinical Pharmacology Gap Analysis Can Create Value

During my years reviewing applications for the US FDA, I encountered a lot of poor planning concerning a drug’s clinical pharmacology program. This poor planning left the company either lacking data to make informed decisions or scrambling at the end of development to address unanswered issues. Early planning is key to regulatory success, not only … Continued

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