C7B: Advanced Therapy Medical Products - Medicines and Biologicals
Tracks
Eureka Room 2&3 Breakout 2
| Wednesday, November 20, 2024 |
| 1:30 PM - 2:00 PM |
Details
Advanced Therapy Medicinal Products (ATMPs) are complex medicines based on genes, tissues, or cells. They present opportunities for innovative treatments but also pose unique challenges to the current regulatory environment.
This session will explore the rapidly evolving landscape of ATMPs, highlighting the diversity of products approved for use and the complexity of maintaining compliance management over the product life cycle. The session will also cover products in development as well as the potential emerging regulatory approaches that will be required in the future.
Speaker: Amanda Louise, GMP Inspector, Inspections Section
Amanda Louise BSc, MClinTRes is a GMP Inspector in the Blood, Tissue, Cell, and Gene Therapy team at the TGA, with over 14 years of advanced biological manufacturing expertise. Her experience includes global technical roles overseeing CAR-T cell product production across EU, US, and APAC regions for clinical and commercial supply. At the GMP Forum 2024, Amanda will discuss regulatory and technical challenges in advanced therapies, drawing on her insights from global tech transfers and her role as a TGA Inspector. She is passionate about ensuring Australians have access to innovative medicines and the impact of digitalisation on manufacturing.
Speaker: Dr Fran Harding, GMP Inspector, Inspections Section
Dr. Fran Harding is a Technical Specialist in human blood, tissues, cell and gene therapies. She has over twenty years’ experience in bioprocess development and manufacturing in Australia and the USA. Her work has explored scale up, tech transfer and production of cell therapies and the development of biomaterials to mimic complex biological microenvironments. In her current role, she acts as an advisor on ATMP and as an inspector of blood and biologics manufacturers.
This session will explore the rapidly evolving landscape of ATMPs, highlighting the diversity of products approved for use and the complexity of maintaining compliance management over the product life cycle. The session will also cover products in development as well as the potential emerging regulatory approaches that will be required in the future.
Speaker: Amanda Louise, GMP Inspector, Inspections Section
Amanda Louise BSc, MClinTRes is a GMP Inspector in the Blood, Tissue, Cell, and Gene Therapy team at the TGA, with over 14 years of advanced biological manufacturing expertise. Her experience includes global technical roles overseeing CAR-T cell product production across EU, US, and APAC regions for clinical and commercial supply. At the GMP Forum 2024, Amanda will discuss regulatory and technical challenges in advanced therapies, drawing on her insights from global tech transfers and her role as a TGA Inspector. She is passionate about ensuring Australians have access to innovative medicines and the impact of digitalisation on manufacturing.
Speaker: Dr Fran Harding, GMP Inspector, Inspections Section
Dr. Fran Harding is a Technical Specialist in human blood, tissues, cell and gene therapies. She has over twenty years’ experience in bioprocess development and manufacturing in Australia and the USA. Her work has explored scale up, tech transfer and production of cell therapies and the development of biomaterials to mimic complex biological microenvironments. In her current role, she acts as an advisor on ATMP and as an inspector of blood and biologics manufacturers.
