Advanced Therapies

Code:

MI255103

Acronym:

TERA

Keywords
Classification	Keyword
OFICIAL	Health Sciences

Instance: 2025/2026 - 1S

Active?	Yes
Web Page:	https://moodle2526.up.pt/course/view.php?id=18
Responsible unit:	Microbiology Laboratory
Course/CS Responsible:	MSc in Pharmaceutical Sciences

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
MICF	172	MICF - Transition Study Plan 2023/24 - 2024/25 - 2025/26	5	-	1,5	14	40,5

Teaching language

Portuguese
Obs.: Português

Objectives

The objective of this Curricular Unit is to provide knowledge on different Advanced Therapies, namely their scientific basis, applications and limitations, as well as their requirements and specificities of development, production and regulations. The integration of this knowledge is also planned, towards their application on the different pharmaceutical hospital activities, given the decisive role of pharmacists in the preparation and surveillance of these therapies.

The Curricular Unit also intends to develop cognitive transversal competences, namely development of analytical, critical, reflexive and creative thinking.

 

Learning outcomes and competences

At the end of this Curricular Unit, students should be able to:

1. Knowledge and understanding
   • Identify and describe the scientific foundations of different advanced therapies, including gene therapies, cell-based therapies, immunotherapies, and regenerative therapies.
   • Understand the main applications, limitations, development requirements, production, and regulatory aspects of advanced therapies.
   • Recognize the role of hospital and community pharmacists in the preparation, application, and monitoring of these therapies.
2. Application of knowledge
   • Integrate scientific, technical, and regulatory knowledge with a view to its practical application in pharmaceutical activities.
   • Relate new therapeutic approaches to clinical cases and real contexts of hospital practice.
3. Analytical and reflective competences
   • Critically analyze the advantages, limitations, and ethical implications of different advanced therapies.
   • Reflectively assess recent scientific advances and their relevance to clinical and pharmaceutical practice.
4. Transversal and communication competences
   • Develop analytical, critical, reflective, and creative thinking in the context of innovative therapies.

Working method

Presencial

Pre-requirements (prior knowledge) and co-requirements (common knowledge)

Knowledge in the areas of Cellular and Molecular Biology, Microbiology and Immunology is required

 

Program

The classes will consist in 11 thematic seminars.

 

Theme 1 – Introduction to Advanced Therapies

1. Introduction
2. Advanced therapy drugs: characterisation of the concept;
3. Regulatory framework;
4. Underlying ethical aspects;
5. Pharmaceutical intervention.

 

Theme 2 – Gene therapies

 

Theme 3 – Therapies based on the RNAi mechanism

 

Theme 4 - Cellular immunotherapies I

Chimeric antigen receptor (CAR) T-cell therapy.

 

Theme 5 – Cellular immunotherapies II

Tumor-Infiltrating Lymphocyte (TIL) Therapy

Engineered T Cell Receptor (TCR) Therapy

Natural Killer (NK) Cell Therapy

 

Theme 6- Cell therapies with stem cells

 

Theme 7 – Therapeutic microorganisms

 

Theme 8 – Therapies with virus

 

Theme 9 – Therapeutic vaccines

 

Theme 10 - Precision Medicine in support of Advanced Therapy in Oncology

Theme 11 - Tissue regenerative therapy

Mandatory literature

Behrouzieh, S., Sheida, F., & Rezaei, N.; Review of the recent clinical trials for PD-1/PD-L1 based lung cancer immunotherapy., Expert Rev Anticancer Ther, 21(12), 1355-1370. , 2021. ISBN: doi:10.1080/14737140.2021.1996230
Iglesias-Lopez, C., Agusti, A., Obach, M., & Vallano, A.; Regulatory Framework for Advanced , Front Pharmacol, 10, 921. , 2019. ISBN: doi:10.3389/fphar.2019.00921
Naing, A., & Haijar, J.; Immunotherapy (3 ed.). , Publisher: Springer, 2020. ISBN: ISBN: 978-3-030-41007-0.
Ramezankhani, R., Torabi, S., Minaei, N., Madani, H., Rezaeiani, S., Hassani, S. N., . . . Hajizadeh-Saffar, E.; Two Decades of Global Progress in Authorized Advanced Therapy Medicinal Products: An Emerging Revolution in Therapeutic Strategies., Front Cell Dev Biol, 8, 547653. , 2020. ISBN: doi:10.3389/fcell.2020.547653
Sawarkar, S. P., Nikam, V. S., & Syed, S. (Eds.).; Immunotherapy – A Novel Facet of Modern Therapeutics (1 ed. Vol. VIII). , Publisher: Springer., 2021. ISBN: ISBN: 978-981-15-9040-5.
Schantz, J.-T., & Hutmacher, D. W. (Eds.).; Advanced Therapies In Regenerative Medicine (Current Therapies in Regenerative Medicine) (Vol. 2). , Publisher: World Scientific. ISBN: 978-981-4630., 2015
Seimetz, D., Heller, K., & Richter, J.; Approval of First CAR-Ts: Have we Solved all Hurdles for ATMPs?, Cell Med, 11, 2155179018822781. , 2019. ISBN: doi:10.1177/2155179018822781

Teaching methods and learning activities

This Curricular Uni is organized in 11 thematic seminars. The programmatic content will be ministered with the support of audio-visual means (PowerPoint and videos), whenever possible including interactive activities with the students, such for example by launching questions and discussions during the seminars.

The theoretical fundamentals of each theme will be given during the seminars, mentioning updated scientific, technical and legislation aspects.

The proposed approach for teaching the seminars intends to develop in the student the acquisition of knowledge in the different mentioned themes, as well as capacity to integrate that knowledge in the perspective of possible application in the different activities of hospital and community pharmacy, in which the pharmacist has a relevant and unique role in society.

This teaching methodology with interactive multidisciplinary seminars will also allow the development of competences in the framework of application of knowledge, namely in the context of scientific discussions, giving the students an opportunity to demonstrate capacity of reflecting and integrating knowledge as well as communicating their reasoning and conclusions in an objective manner.

Evaluation Type

Evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	100,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Estudo autónomo	20,00
Total:	20,00

Eligibility for exams

Not applicable

Calculation formula of final grade

The evaluation will consist in one final exam only. The exam is obligatory and the students will need to obtain a minimum classification in the final exam equal or superior to 9.5 (out of a possible total of 20 points).

Examinations or Special Assignments

Not applicable

Internship work/project

Not applicable

Special assessment (TE, DA, ...)

The special assessment follows the same parameters as the regular assessment.

Classification improvement

The improvement of the UC classification can only be carried out in the following evaluation period.