C4B: Innovations in Biologicals: From Concept to Care
Tracks
Eureka Room 2&3 Breakout 2
| Tuesday, November 19, 2024 |
| 3:30 PM - 4:00 PM |
Details
Concept to commercialisation of ATMPS transforming innovative therapies into accessible treatments.
To explore the journey of ATMPs from innovative concepts to market-ready therapies. To highlight the importance of ATMPs in addressing unmet medical needs. ATMP represent a new frontier in medicine, offering potential cures and significant advancements for patients with severe or chronic conditions. This session will cover the definition and significance of ATMP? Key steps in the commercialisation process; Challenges faced during development; Importance of collaboration and strategic partnerships and a multidisciplinary approach to successful GMP licensing and market entry on the ARTG.
Speaker: Alyce Maksoud, Senior GMP Inspector & Team Leader, Inspections Section
Alyce Maksoud professional journey began in Haematology and blood bank, microbiology and immunology where Alyce developed a strong foundation in the complexities of blood product management. Alyce then transitioned into molecular, cord blood banking and cellular therapy honing her skills in cutting-edge techniques at the time that ensured safe and effective use of stem cells in therapeutic applications. Her work in cell therapy encompassed both production and quality, allowing her to understand the intricate balance between innovation and regulatory standards. As a GMP inspector, Alyce leveraged her extensive knowledge to uphold the highest standards of quality and safety in the industry. Her leadership role involves guiding a talented team in navigating the regulatory landscape while fostering a culture of excellence and continuous improvement. Alyce is passionate about the intersection of science and patient care, and remains committed to ensuring that the products they oversee are both safe and effective. In her spare time, Alyce enjoys spending time with family, reading, walking, dancing and listening to music which helps her maintain a balanced perspective in her professional life.
To explore the journey of ATMPs from innovative concepts to market-ready therapies. To highlight the importance of ATMPs in addressing unmet medical needs. ATMP represent a new frontier in medicine, offering potential cures and significant advancements for patients with severe or chronic conditions. This session will cover the definition and significance of ATMP? Key steps in the commercialisation process; Challenges faced during development; Importance of collaboration and strategic partnerships and a multidisciplinary approach to successful GMP licensing and market entry on the ARTG.
Speaker: Alyce Maksoud, Senior GMP Inspector & Team Leader, Inspections Section
Alyce Maksoud professional journey began in Haematology and blood bank, microbiology and immunology where Alyce developed a strong foundation in the complexities of blood product management. Alyce then transitioned into molecular, cord blood banking and cellular therapy honing her skills in cutting-edge techniques at the time that ensured safe and effective use of stem cells in therapeutic applications. Her work in cell therapy encompassed both production and quality, allowing her to understand the intricate balance between innovation and regulatory standards. As a GMP inspector, Alyce leveraged her extensive knowledge to uphold the highest standards of quality and safety in the industry. Her leadership role involves guiding a talented team in navigating the regulatory landscape while fostering a culture of excellence and continuous improvement. Alyce is passionate about the intersection of science and patient care, and remains committed to ensuring that the products they oversee are both safe and effective. In her spare time, Alyce enjoys spending time with family, reading, walking, dancing and listening to music which helps her maintain a balanced perspective in her professional life.
