Shirley Bartido

Company: Takeda Pharmaceuticals

Job title: Director, Global Regulatory Affairs & Cell Therapy Oncology

Seminars:

Panel Discussion: Exploring Recent Guidance on Platform Technologies to Clarify Frameworks for Approaches Used Across the Cell & Gene Field 2:00 pm

Considering what should be included on a platform basis or potentially excluded from a CMC, non-clinical, or procedural basis Enhancing the developmental process and efficiency by understanding the versatility of platform technologies and clarifying guidance on approaches Leveraging standardized systems to expedite the production of several cell and gene therapy productsRead more

day: Conference Day Two

Unraveling Regulatory Challenges in Transitioning from Pre-Clinical to Clinical Phases, Focusing on the IND Process 1:01 pm

Cell and gene therapies span pipelines across every phase of development, from preclinical stages through to approval. This presents an opportunity to learn from various phases and make regulatory processes more efficient. Join this session to: Map out the regulatory landmarks from pre-clinical to clinical phases to gain a highlevel viewpoint of potential bottlenecks Focus…Read more

day: Pre-Conference Workshop Day