Souvik Bhattacharya

Company: Astellas Pharma US

Job title: Associate Director, Pharmacometrics

Seminars:

Roundtable Discussions: Improving the Usage of MIDD for Better Dose Optimization In Different Therapeutic Areas to Balance Treatment Safety & Efficacy Whilst Accelerating Development Timeline 4:00 pm

In this interactive session, join focused roundtables discussions tailored to key therapeutic areas including Oncology, CNS and Immunology & Inflammation.  Each table will provide an opportunity for in-depth conversation around the unique challenges within these areas. Share experiences, explore innovative approaches and gain practical insights to help improve and streamline development timelines in your specific field.Read more

day: Day 1

Regulatory Readiness: Mastering the M15 Blueprint to Strengthen Submissions & Accelerate Approvals 1:00 pm

With the draft ICH M15 guidance set to formalize how modeling data is communicated in regulatory submissions, many leaders are asking: What does this look like in practice? While global agencies have signaled support for MIDD, translating that support into submission-ready content remains a challenge for most teams.  This workshop is not about high-level regulatory vision – it’s…Read more

day: Pre-Conf Workshop Day