Satellite Symposium - Getting the dose right first!
Regulatory perspective and impact of Project Optimus on RP2D selection in
oncology
Date: 25th June 2024, 13:00-18:00h CET
Venue: Orange Hall, Ergife Palace Hotel, Largo Lorenzo Mossa, 8, 00165 Rome,
Italy
UCL Clinical Pharmacology & Therapeutics Group together with a panel of
representatives from pharmaceutical R&D, clinical oncology research, and
regulatory agencies (U.S. Food and Drug Administration and European Medicines
Agency) has the pleasure to invite PAGE delegates to attend this satellite
event in person. We also invite the wider clinical pharmacology community to
participate online.
WHY THIS SYMPOSIUM: The objective of this public symposium is to reflect on
current practices and discuss approaches for dosage optimization for medicinal
products progressing in clinical development in oncological indications and
provide further context for the Project Optimus initiative.
Historically, dose-finding studies for oncology drugs following 3+3 designs
have been used to determine the “maximum tolerated dose" (MTD). However, this
approach can lead to poorly tolerated doses for many modern medications,
including targeted therapies and immunotherapies, which defy the premise that
efficacy and toxicity increase monotonically with dose, in contrast to
traditional cytotoxic chemotherapy.
WHAT IS GOING ON: The FDA Oncology Center of Excellence launched Project
Optimus to address this issue. Project Optimus has been trying to revolutionize
the paradigm of dose selection and optimization in oncology drug development
since its start in 2021. The emphasis on determining the optimal dose
necessitates the evaluation of modern designs, moving away from the traditional
3+3 design for dose escalation, and the evaluation of the totality of the data,
including careful integration of data on the pharmacokinetics and
pharmacodynamics (i.e., exposure-response relationships) as basis for the
characterisation of the safety, efficacy and benefit-risk profile of novel
medicinal products.
This symposium will provide a forum for discussion on expectations, best
practices for dose finding, and on the role of clinical pharmacology approaches
based on modelling and simulation in achieving this goal.
AGENDA: An outline of the preliminary agenda can be found
https://www.page-meeting.org/content_assets/Getting_the_dose_right_first_-_Satellite_Symposium_Agenda_V2.pdf.
REGISTRATION: Participation in person or online is free of charge, but
registration is mandatory due to venue capacity limitations. Delegates will be
enrolled on a first-come first served basis. Registration will be open until
31st May 2024.
Please fill in the form in this link to
https://docs.google.com/forms/d/e/1FAIpQLScFb8xH-9H6cx7YAtNWup4iqif7gkejCXsUrVAnxfpDNvmFcQ/viewform.
Participants are expected to submit a question, outline an issue, or share
their experience with regard dose selection in oncology. These questions will
support the discussion and highlight common issues faced by different
stakeholders.
You can email Salvatore D’Agate (s.d’[email protected]) if you have any queries
regarding the event.