Victoria Coutinho

Company: GammaDelta Therapeutics

Job title: VP Regulatory Affairs

Seminars:

Mastermind Session: So, We are in the Clinic…Now What? 4:00 pm

Reviewing the clinical data presented, and discussing the key progress and remaining areas of unmet need in clinical development Creating ‘next steps’ for the industry in development, from enhancing persistence and efficacy to developing combination trials Outlining combination options, how to choose them, and what mechanisms need to be addressed through combination therapy Discussing where…Read more

day: Day Two

A Path to the Clinic: Sharing Experience of Working with Regulators to Bring ‘First-in-Class’ Therapies Through IND Approval 3:30 pm

Creating a preclinical package for gamma delta T cell-directed therapies and highlighting where pushback and further preclinical evidence has been required by regulators Discussing what regulators are looking for and how to align your IND package with regulatory frameworks, to ensure a fast journey through phase development and best patient outcomes Communicating the limitations and…Read more

day: Day Two