Historically, the dosing strategy for oncology drugs has focused on use of the maximum tolerated dose. This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely being ignored in the dose decision making process. Thus, cancer patients often struggle to tolerate their medication long-term, requiring dose modifications including dose reductions and holidays. さらに、多くのがん治療薬では、承認後に安全性や忍容性の問題に対処するために投与量やスケジュールが変更されることがあります。
These challenges spurred the FDA’s Oncology Center of Excellence to develop a new initiative called “Project Optimus” to addresses issues relating to dose optimization in clinical trials assessing the safety and efficacy of oncology drugs.
医薬品開発における投与量最適化のシフトは、新規化合物の80%以上を開発する小規模バイオテクノロジー企業にとって、どのような意味を持つのでしょうか？また、今後の臨床試験は、どのようなステップを踏むべきでしょうか。
講演者
Julie Bullock, Ph.D.
Julie Bullock is currently a Senior Vice President in the Integrated Drug Development group at Certara. Dr. Bullock is a trained drug development scientist with clinical pharmacology and regulatory experience focused in the therapeutic areas of oncology, hematology and coagulation. She brings her unique insight into pediatric development, oncology dose finding strategy, and streamlining development for breakthrough therapies and accelerated approval. Dr. Bullock contributed to over 14 new molecular entity approvals during her 10-year FDA career. Julie holds a doctorate in pharmacy from Drake University in Des Moines, Iowa.
