Introduzione
The ATMP field encompasses products of different types that, despite their differences, fall within the definition of an advanced therapy medicinal product. It is key to understand these differences and being able to properly classify them.
The market value of the ATMP sector is growing rapidly. In the US, the annual growth rate for the T-cell and tissue engineering markets between 2020 and 2027 is approximately 15% for the T-cell and 14% for tissue engineering, while the global cancer gene therapy market is expected to grow at an annual rate of 32.5%.
An additional challenge is the differing regulatory requirements of different health authorities. For example, a product that is an ATMP for the EMA is not an ATMP for the US and vice versa. Within the EU, there are several levels of legislation that can affect each EU country, and this will also be briefly discussed in the course.
Finally, there are several challenges that will be faced in the development and marketing of an ATMP and it is necessary to have a good view of these to see the point of improvement and to be able to anticipate them.
- Introduction and advance therapeutic medicinal products (ATMP) classification
- ATMP vs traditional medicines
- ATMP market
- Classification
- Dissecting the different ATMP classes with examples of marketed ATMPs
- Differences between US and EMA regulations in ATMPs
- Manufacture of Gene Therapy Product
- General concept
- CAR-T and TCR-T differences
- Dissecting the manufacturing process of T-cell technology, passing through the description of some process-related criticalities, including the use of closed systems and equipment exploiting that technology
- ATMP challenges from development to pre-marketing authorization
- Starting and raw materials: identification and evaluation to establish a robust supply chain in a production-oriented view
- Process development: risk assessment and Quality by Design(QbD) as tools to identify, evaluate and monitor your process and product (QTPP, CPP, CQAs and CMAs)
- Practical tips to make as smooth as possible the transition from pre-GMP to fully-GMP production
- Manufacturing: technical features to consider to avoid the dreaded bottlenecks while scaling up the process
- Hints on non-clinical and clinical development
In the course the regulations in EU and US will be discussed, the classification of the ATMPs with insight in the different classes and the challenges from development to clinical trials. Therefore, the course participants will be people actively working in the development and the quality of the ATMPs such as Manufacturing Science and Technology (MSAT), QA and Regulatory Affairs.
Participant’s experience
For some sections an undergrad’s biological knowledge is preferred but any question even basic will be answered during the course.
Interactive training based on a slide deck, with direct involvement of the audience.
Questions and quiz before and after discussing a specific topic.
Docente/i
Lieve De Wolf
Lieve De Wolf is an industrial pharmacist who graduated in 2015.
Her career spans several roles in the pharmaceutical industry, including:
- Validation Engineer & QA Project Engineer at Alcon-Novartis
- Downstream Process Expert at eTheRNA
- Technology Transfer Engineer at Prothya
In 2020, she joined the QBD ATMP core team, where she became the Core Team Leader in January 2023.
Lieve is currently doing a project as External Quality Manager for CAR-T & Advanced Therapies at Johnson & Johnson.
In her free time she likes to walk with her golden retriever Bruno and connect with family and friends.
Online Training in 2 modules:
MODULE 1 | 30 October 2024 from 9:00 am to 1:00 pm CET
MODULE 2 | 06 November 2024 from 9:00 am to 1:00 pm CET
Some days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 910,00* until 09/10/2024
Ordinary: € 1.105,00*
Freelance – Individual – Academy – Public Administration**: € 640,00*
*for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Barbara Rossi
Training & Quality Manager
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
