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Appendix A Statement of Task An ad hoc committee will plan and host a 1.5-day public workshop that will examine the opportunities to improve the clinical development of immune checkpoint inhibitors for cancer therapy, including in the context of site-agnostic indications. The workshop will feature invited presenta- tions and panel discussions on topics that may include the challenges and opportunities for improving: â¢ The development, validation, and standardization of biomarkers for patient selection. â¢ The assessment of safety and efficacy/clinical benefit in clinical trials. â¢ Innovations in clinical development programs for combination treatment strategies, such as approaches for prioritizing potential combinations (including multimodal therapy), the role of preclinical modeling to identify promising combinations, and mechanisms for facilitating access to the best drug candidates for combination trials. â¢ Evidence requirements and decision making in drug development and regulatory evaluation for site-agnostic indications. â¢ Collaboration and information exchange among clinicians, research- ers, and the pharmaceutical and diagnostic industries, including precompetitive collaboration, especially for the development of biomarkers predictive of immune-related toxicities and treatment response. 61 PREPUBLICATION COPYâUncorrected Proofs
62 CANCER THERAPIES WITH IMMUNE CHECKPOINT INHIBITORS The committee will develop the agenda for the workshop sessions, select and invite speakers and discussants, and moderate the discussions. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines. PREPUBLICATION COPYâUncorrected Proofs