On Wednesday, November 10th, Friends of Cancer Research hosted the second day of its 2021 Annual Meeting as a virtual event focused on improving patient outcomes through dose optimization. The first panel discussed the recent white paper on dose optimization and the second panel was a conversation between regulators at the FDA Oncology Center of Excellence (OCE).
The live event was broadcast through YouTube and is available to watch here.
Jeff Allen, President and CEO of Friends, welcomed attendees and thanked all of the working group members who helped to develop the event white paper. He then introduced Dr. Atik Rahman from the FDA, who gave a presentation to set the stage for the first panel. Rahman reviewed some of the challenges of dose optimization and why reducing adverse effects due to treatments is important for patients with cancer.
Atik Rahman, FDA: “We are here to discuss a pragmatic, holistic approach for dose finding and dose optimization for cancer drug development and have a commitment to work together in advancing innovative strategies for dose optimization for cancer therapy.”
Moderator Dr. Mark Ratain, University of Chicago, introduced the first panel, which included Dr. Lokesh Jain from Merck, patient advocate Anne Loeser, Dr. Mirat Shah from CDER at the FDA, and Dr. Laurie Strawn from Pfizer. They discussed several topics surrounding dose optimization, including its importance to patients, effects on clinical pharmacology, FDA regulatory timelines, Project Optimus, and how drug sponsors should run trials to ascertain the optimal dose.
Anne Loeser explained how dose optimization can benefit patients in a variety of ways, including increasing patient retention in clinical trials and reducing the negative side effects for those going through treatment. Lokesh Jain described the advantages of early dose optimization in drug development. Laurie Strawn and Mirat Shah focused on regulatory challenges that come with the new FDA guidance and how early interaction between the FDA and sponsors can help ensure treatments are still developed in an expeditious manner.
Anne Loeser, patient advocate: “Information about the efficacy at lower doses is going to be a key point […] as patients see the information they will begin to have confidence” in lower doses.
Jeff Allen then turned the event over to the next panel, which consisted of key leaders at the OCE. These panelists included Director Dr. Richard Pazdur, Chief of Medical Oncology Dr. Julia Beaver, Director of Regulatory Affairs and Regulatory Policy Dr. Tamy Kim, and Deputy Center Directors Dr. Paul G. Kluetz and Dr. Marc Theoret. They reviewed the projects they are currently working on at the OCE including Project Orbis, Project Catalyst, the Patient Focused Drug Development Program, the Pediatric Oncology Program, the Immuno-Oncology Therapeutics Program, Project Optimus, Project Facilitate, Real Time Oncology Review, and Project Beyond Breakthrough. Dr. Pazdur also emphasized “Speed is very important,” however, it can’t come at the expense of the “foundation of drug development.”