Last few seats available – registration extended – new deadline 11th June 2024
------------------------------------------------------------------------------------------------------- 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 here<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 11th June 2024. Please fill in the form in this link to register<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]<mailto:s.d%e2%80%[email protected]>) if you have any queries regarding the event.
