|Curricular Unit (UC)||
Advanced Medical Therapies
Course category: B - Basic; C - Core Engineering; E - Specialization; P - Complementary.
|Year: 3rd||Semester: 1st||ECTS: 5||Total Hours: 130|
|Contact Hours||T: 45||TP: 15||PL:15||S:||OT:3|
|Professor in charge||
T - Lectures; TP - Theory and practice; PL - Lab Work; S - Seminar; OT - Tutorial Guidance.
- Learning outcomes of the curricular unit
knowledge of Bio-pharmaceutical substances as innovative therapeutic way in present clinical practice.
Adquire the basis of human gene therapy, including vectors and systems used for the applied examples, overview its limitations and advantages over conventional therapies.
Review the basis for pharmacogenomics personalized therapy as well as the advantages and limitations associated with this technology.
Cell therapy and tissue engineering main strategies applied to regenerative medicine.
Raising awareness of bioethical issues associated with genetic testing, gene therapy, pharmacogenomics, regenerative medicine and protection of intellectual property in biotechnology products and processes.
1. Concepts of general pharmacology and strategies for new drugs development.
2 Biopharmaceutical substances: Main characteristics. Protein engineering andpost-translational modifications. Biosimilar. PAT and QbD.
3 Gene Therapy: Vectors-enhanced Systems; Security; Production of gene therapy. Gene silencing: RNA interference technology (RNAi). Gene therapies associated with cell & tissue engineering.
4 Pharmacogenomics: Genetic mechanisms. Examples of the variation in the patient sensitivity to drugs due to genetic polymorphisms. Application examples in personalized therapy, for biomarkers and development of new drugs.
5. Tissue organization, extracellular matrix, adhesion molecules, cellular communication and relevant interactions; Cell metabolism. Cell culture and tissue culture; Methods for obtaining primary and stem cells. Isolation and cell immortalization techniques. Methods for cell line maintenance. Examples of cell therapy and tissue engineering.
6 Bioethics associated with genetic testing, gene therapy, pharmacogenomics and protection of intellectual property in biotechnology products and processes.
- Demonstration of the syllabus coherence with the curricular unit's objectives
In order to students understand the Advanced Therapies, in this unit general concepts of pharmacology and process development of new drugs will be discussed. Then, protein engineering using nucleic acids and proteins will be addressed as an innovative application. Its limitations and advantages will be also addressed.
Afterwards notions of gene therapy by Key-vectors, its security issues will be reviewed as well as some application examples that already are in clinical trials. After that, the gene therapy, pharmacogenomics concepts for personalized human therapy will be presented as well its advantages and limitations. Along that, the ethical issues in the application of genetic testing and gene therapy, pharmacogenomics, regenerative medicine and intellectual property protection for biotechnology products and processes will be discussed.
- Teaching methodologies (including evaluation
In this curricular unit two types of class were used: expositive to explore the theoretical concepts, and active lessons (TP or Lab) involving the participation of students in problem solving in order to explore aspects of each principal physiological system.
The evaluation is based on a continuous evaluation (CE) and by an Exam (WE), as follows:
Continuous evaluation (CE):
The continuous evaluation is constituted by the accomplishment of an oral presentation (OP) of an scientific article concerning an technique used to study a physiological system function, and by Laboratory reports (LAB), as follows:
CE = 0.7OP + 0.3LAB
The written exam (WE) is 2h long, and to be approved, Students must have a score WE >=9.5
Formula for the calculation of Final Score (FS) is:
FS = 0,3 CE + 0,7 WE. To be approved, Students must have a FS >= 9,5
Rounded to units. By defect, beneath five tenths, per excess, from five tenths.
- Demonstration of the coherence between the teaching methodologies and the learning outcomes
The use of expository lectures and active classes in the learning process allows to understand the application of theoretical concepts taught to students. During classes students are stimulated to participate in problem solving. In the problem solving they connect the topics taught in this course and the topics taught in previous courses.
The introduction of the continue component evaluation force students to maintain an ongoing study and monitoring during the semester contributing to the improvement of learning outcomes. The evaluation component exam involves all concepts transmitted allowing a correct evaluation of students that met the learning objectives stipulated.
- Main Bibliography
Gabrielsson, J., Hjorth, S . Quantitative Pharmacology: An Introduction to Integrative Pharmacokinetic-Pharmacodynamic Analysis. Swedish Pharmaceutical Press, 2012.
Khan, F.A. Biotechnology in Medical Sciences. CRC Press, 2014.
Park, S.J. and Cochran, J.R. Protein Engineering and Design. CRC press. 2009.
Templeton, N.S. Gene and Cell Therapy: Therapeutic Mechanisms and Strategies. Third Edition. CRC Press, 2008.
Fisher, J.P., Mikos, A.G., Bronzino, J.D., Peterson, D.R. Tissue Engineering: Principles and Practices. CRC Press, 2012.
Jan Trost Jorgensen, Henrik Winther. Molecular Diagnostics: The Key in Personalized Cancer Medicine. Pan Stanford , 2010.
Liu, Y. Omics in Clinical Practice: Genomics, Pharmacogenomics, Proteomics, and Transcriptomics in Clinical Research. Apple Academic Press, 2014.
Vaughn, L. Bioethics: Principles, Issues and Cases. 2nd ed. Oxford University Press, 2012.