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 participant will be people actively working in the development and the quality of the ATMPs such as Manufacturing Science and Technology (MSAT), QA and Regulatory Affair.

 

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
Andrea Di Luca
Info

Andrea Di Luca

Life Science consultant at QbD

Dr. Di Luca obtained his bachelor’s degree and master’s degree in medical biotechnology with curriculum in molecular medicine at the University of Trieste. Following an internship at the National University of Ireland in Galway, he gained his doctorate degree in Regenerative Medicine by the Twente University – MIRA group. During his PhD, he worked on an ATMP development project building a Tissue Engineering construct for the regeneration of the osteochondral interface. After that he spent 2 years in the University of Eindhoven as Application scientist developing medical devices for the regeneration of the heart valves, followed by a position of Application scientist by the company Vivolta for the development of implantable medical devices. After that he was responsible for the Technology Transfer of a gene and cell therapy product by Lonza Netherlands. In the last 3 years he was the Team Leader of the ATMP core team at QbD and drug product technical owner of 2 products of Johnson and Johnson.

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

 

After the registration, 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 October 2024)

Ordinary: € 1.105,00*

Freelance – Academy – Public Administration**: € 590,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – 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.

Registrati
Early bird
Acquistabile fino al 09/10/2024
€910,00
Ordinary
Acquistabile fino al 29/10/2024
€1.105,00
Freelance - Privato - Accademia - Pubblica Amministrazione
Acquistabile fino al 29/10/2024
€590,00
Svuota
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Define the different classes of ATMP
Risultato atteso
Follow the different regulations between the FDA and EMA in the ATMP field
Risultato atteso
Know the CAT and being able to know how can help in the commercialization of the ATMPs
Risultato atteso
Know the manufacturing process of the major classes of ATMPs
Risultato atteso
Identify the mayor challenges to be faced during the ATMP development
<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>
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Advanced Therapy Medicinal Products