In this episode, the focus is on planning #FDA meetings and the significance of pre-IND meetings. We discuss how pre-IND meetings are crucial for identifying and addressing any roadblocks or gaps in the preclinical program before the actual filing. By doing so, potential delays or complications during the clinical trial phase can be mitigated. The discussion also includes insights into optimizing dosing strategies in oncology phase two studies, prioritizing patient experience, and finding tolerable doses that allow for extended drug administration. The conversation touches on cultural differences in FDA approval approaches across regions and the collaborative nature of successful FDA meetings. Overall, the episode emphasizes the importance of preparation, data-driven justifications, and effective collaboration to advance drug development and ensure safe treatments for patients. Points discussed: FDA meetings and Pre-IND significance: 1:30- 3:48 Optimizing oncology dosing strategy: 3:49- 8:32 Navigating maximum tolerated dose across cultures: 8:33- 13: 56 Key Indicators to address: 13:57- 15:38 Collaborative FDA meetings: 15:39- 21:59 FDA meeting composition: 22:00- 25:16 Learning from virtual FDA meetings: 25:17- 27:42 Strategic planning for FDA meetings: 27:43- 28:42 #FDAMeetings #FDA #FDAInsights #DrugDevelopment #PatientCentric #FDAapproval #FDAteam patientexperiences #medicalinnovation #patientsafety #clinicaltrials #clinicalresearch #darshantalks #kulkarnilawfirm #dt #klf #recentrecap 

Support the show