Academic Year:
2022/23
8047 - Master in Pharmaceutical and Biotechnology Industry
32031 - Drug Research and Development
Teaching Plan Information
Academic Course:
2022/23
Academic Center:
804 - Masters Centre of the Department of Medicine and Life Sciences
Study:
8047 - Master in Pharmaceutical and Biotechnology Industry
Subject:
32031 - Drug Research and Development
Ambit:
---
Credits:
7.5
Course:
1
Teaching languages:
Theory: | Group 1: Catalan |
Practice: | Group 101: Catalan |
| Group 102: Catalan |
| Group 103: Catalan |
| Group 104: English |
Teachers:
Elisabet Rosell Vives, Marc Güell Cargol, Alexandre Ripoll Vazquez, Maria Angeles Sierra Jimenez
Teaching Period:
First quarter
Schedule:
Presentation
Since 2006, the UFP offers the Master in Pharmaceutical and Biotechnology Industry, which is one of the most prestigious in its field. The program lasts one academic year and its main objective is to train students for their incorporation in companies, or research groups, that made medicines and biotechnological products for the prevention and treatment of diseases.
Teaching combines theory in different formats: lectures, training seminars and self-study seminars, during the first phase of work in the classroom. Starting in January, the training is completed with six months of full-time internships in companies or institutions in the sector.
In the first part, the student will take two specific subjects: Drug Research and Development (IDM) and Pharmaceutical Biotechnology (BTF). The two subjects complement each other and the evaluation is done jointly. To complement their training, the student must choose an optional subject.
Associated skills
Specific skills to achieve
The specific knowledge competencies of these subjects are:
- Analyze the main characteristics of the pharmaceutical and biotechnology industries
- Establish the principles of industrial manufacturing of pharmaceutical specialties
- Know the challenges and possibilities of pharmaceutical research
- Know the characteristics of preclinical and clinical research
- Become familiar with the patent, registration and quality processes involved in the development of a drug
- Gain knowledge of the research and development process
Metedological competences:
- Formulate working hypotheses based on bibliographic and experimental background
- Learn the dynamics of group work
- Learn the basics of communication
- Apply research knowledge of the information to a real situation
- Learn to apply decision elements to specific situations
Attitude skills:
- Establish the first contact with the world of research, private industry and the health world
- Learn the bioethical principles of work functioning
- Know the principle of company culture and research
The general and basic competences that the Master's students must achieve are in tune with those present in the current legislation:
CB6 - Possess and understand knowledge that provides a basis or opportunity to be original in the development and / or application of ideas, often in a research context.
CB7 - That students know how to apply the acquired knowledge and their ability to solve problems in new or unfamiliar environments within broader (or multidisciplinary) contexts related to their area of study.
CB8 - That students are able to integrate knowledge and face the complexity of formulating judgments based on information that, being incomplete or limited, includes reflections on social and ethical responsibilities linked to the application of their knowledge and judgments.
CB9 - That students know how to communicate their conclusions and the knowledge and ultimate reasons that support them to specialized and non-specialized audiences in a clear and unambiguous way.
CB10 - That students possess the learning skills that allow them to continue studying in a way that will be largely self-directed or autonomous.
Learning outcomes
General objectives:
The educational project of the activity aims to:
- Provide students with general knowledge about pharmaceutical and biotechnological processes applied to research in pharmaceutical and biotechnological companies, as well as biomedical research
- Discuss the ethical commitments that may arise in an environment of research and development of products of high social importance
- Present the different professional figures in which university graduates can choose within the sector
- Facilitate the acquisition of essential transversal skills in the communication processes of the biopharmaceutical industry
Specific objectives:
During the teaching process, students will have the specific material for each topic at their disposal (through the Global Classroom).
In some specific topics, students will have to contribute with the work of the self-assessment seminars, exposing the worked examples to the rest of their classmates.
Sustainable Development Goals
From the Master we want to contribute and raise awareness to meet the objectives:
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SDG3Good Health and Well-Being – Ensure healthy lives and promote well-being for all at all ages
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SDG 4. Quality Education – Ensure inclusive and equitable quality education and promote lifelong learning opportunities for all
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SDG 55. Gender Equality – Achieve gender equality and empower all women and girls
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SDG l8. Decent Work and Economic Growth – Promote sustained, inclusive and sustainable economic growth, full and productive employment and decent work for all
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SDG 9. Industry, Innovation and Infrastructure – Build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovations
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SDG 13. Climate Action – Take urgent action to combat climate change and its impacts
For this reason, work will also be done on acquiring the transversal competencies recommended by UNESCO:
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Systems thinking competency: the abilities to recognize and understand relationships; to analyse complex systems; to think of how systems are embedded within different domains and different scales; and to deal with uncertainty.
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Anticipatory competence: the abilities to understand and evaluate multiple futures – possible, probable and desirable; to create one’s own visions for the future; to apply the precautionary principle; to assess the consequences of actions; and to deal with risks and changes.
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Normative competency: the abilities to understand and reflect on the norms and values that underlie one’s actions; and to negotiate sustainability values, principles, goals, and targets, in a context of conflicts of interests and trade-offs, uncertain knowledge and contradictions.
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Strategic competency: the abilities to collectively develop and implement innovative actions that further sustainability at the local level and further afield.
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Collaboration competency: the abilities to learn from others; to understand and respect the needs, perspectives and actions of others (empathy); to understand, relate to and be sensitive to others (empathic leadership); to deal with conflicts in a group; and to facilitate collaborative and participatory problem solving.
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Critical thinking competency: the ability to question norms, practices and opinions; to reflect on own one’s values, perceptions and actions; and to take a position in the sustainability discourse.Self-awareness competency: the ability to reflect on one’s own role in the local community and (global) society; to continually evaluate and further motivate one’s actions; and to deal with one’s feelings and desires.
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Integrated problem-solving competency: the overarching ability to apply different problem-solving frameworks to complex sustainability problems and develop viable, inclusive and equitable solution options that promote sustainable development, integrating the above-mentioned competences.
Prerequisites
For the admission to the master's degree, candidates must prove a recent university degree in disciplines in the field of health sciences. Exceptionally, they may be graduates in basic science disciplines that accredit the appropriate training complements. In addition, they must have an interest in biopharmaceutical research in its different aspects. Previous merits in the field of medical-pharmaceutical research and experience in the sector will also be recognized.
Necessary documentation for admission:
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Official university degree degree (or the degree of bachelor, engineer, in the case of foreign degrees, the equivalent degree granted by an accredited institution of higher education). The academic fields of the degree must be: scientific-natural or health. The ideal profile of the participant of the Master's Degree in Pharmaceutical and Biotechnology Industry will be one who has a bachelor's degree or a degree in Medicine, Pharmacy, Biology, Human Biology, Biochemistry, Biotechnology, Biomedical Sciences, or Veterinary Medicine.
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Academic record of the official training accredited with the average grade of the university of origin.
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Motivation letter in Spanish or Catalan, in which the interest in taking the master's degree is exposed, with an extension of between 400 and 600 words.
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National identity document or passport
- For English natives: Spanish level accreditation, minimum B2, preferably C1. For spanish: english minimum B2, preferably C1
Additional documentation:
- recommendation letters. A letter from a university professor and another more professional letter will be especially valued.
- work / research experience. It will be valued that the participant has experience of at least one year in the biopharmaceutical area both nationally and internationally (private industries, biotechnology companies, research centers).
- complementary academic or professional training.
Contents
Master classes in Drug Research and Development (IDM)
Topic 1. Introduction. Challenges and strategies in pharmaceutical research.
Topic 2. Evolution of the professional profiles in the biopharmaceutical industry.
Topic 3. Chemical research applied to the discovery of drugs.
Topic 4. Preclinical research (I): from discovery to drug development.
Topic 5. Preclinical research (II): pharmacokinetic and metabolism studies
Topic 6. Preclinical research (III): toxicological studies.
Topic 7. Clinical research (I): historical aspects and bases of the clinical trial. Design and methodology of clinical trials.
Topic 8. Clinical research (II): clinical trials in daily practice.
Topic 9. Relevant aspects of patents in drug research.
Topic 10. Regulatory issues: the registration of drugs.
Topic 11. Role of pharmaceutical marketing in the research environment of new drugs.
Topic 12. Pharmacovigilance in the research and marketing of new drugs
Self-learning seminars for Drug Research and Development (IDM)
Seminar 1 COVID-19, an ecological and socio-economic view
Seminar 2 Generic medicines and bioequivalence studies.
Seminar 3 Challenges and pitfalls to use omics
Seminar 4. Microbiota
Seminar 5 Reflections on the commercialization of new medicines: health is priceless but has a cost.
Seminar 6 Drug information and advertising.
Seminar 7 Superbugs, on the brink of a new pandemic?
Common sessions of the two courses:
Project based learning:
Case nº1. A contaminated career without a doctorate
Case nº2. New dog, old cats, trouble for all of them.
Case nº3. The hummingbird that changed the world.
Special sessions / Workshops:
- Special session / workshop on Talent Management and personal branding.
- Session / Workshop: how to make my CV
- Special information session on internships
- Special company presentation sessions
- Special biocinema session
Teaching Methods
Master classes:
The courses Research and Development of Medicines and Pharmaceutical Biotechnology are an obligatory assignment of the Master of Pharmaceutical and Biotechnological Industry. Each subject has 7.5 ECTS credits and is taught in the first quarter. Teaching activities will be taught by a group of UPF professors and a group of professors invited to participate in the master's professional field. The coordination of the assignments is troba a càrrec d ’Àngels Sierra Jimenez and Elisabet Rosell i Vives.
Self-study seminars:
Students in groups of 4-5 participants must prepare the following twelve theoretical topics for the rest of their classmates under the coordination and moderation of a responsible tutor. The guiding documentation for each seminar will be delivered one week in advance, the seminar will last a maximum of two hours and then the report that will constitute an assessable part of the subject will be delivered, also in one week.
Project-based learning sessions (PBL)
A total of 9 PBL sessions have been scheduled, divided into three cases that will each last for three sessions. Each session will consist of a two-hour tutorial given by the teachers in four small groups of students. In addition to the 2 hours of tutoring, each session will involve additional group and individual work by the students themselves without a tutor. Innovative teaching resources will be used to get students more involved.
Workshops
Special workshops will be held that will complete the training of students and help them to attend the transversal skills. One of the workshops will be carried out by alumni that will explain they professional experience to help the students to define their interst.
Biocinema:
Starting from a commercial film, a debate will be organized by a group that was supervised by a professor.
Evaluation
The evaluation of this course will be done jointly with that of the Pharmaceutical Biotechnology subject.
Characteristics of the evaluation:
The evaluation consists of five instruments:
Continuous evaluation:
Attendance, attitude and participation in PBL sessions and self-study seminars throughout the quarter is considered very important. For this reason, they will evaluate these for each student individually so that as a whole they will contribute 30% to the total grade in the following proportions:
- Attendance, participation and evaluation reports of the ABP sessions: 20%.
- Attendance, participation and evaluation of reports of self-learning seminars: 15%.
Final evaluation:
Multiple choice questions in an evaluation test that will be convened at the end of the term. Emphasis will be placed on factual knowledge and they will contribute 35% to the grade.
PBL case: Approach and resolution of a simplified PBL case in an evaluation test that will be convened at the end of the quarter. Students should read and analyze a PBL case in the usual format of the activities mentioned in the previous section. The analytical capacity of the student, the approach of the situations and the resolution of one of them chosen by the student will be evaluated. It will contribute 15% to the academic grade.
Analysis of an article published in an evaluation test (assay). Students must read and analyze a scientific article, which will be delivered a week before, in order to evaluate the integration of the acquired knowledge and critical reading ability. They will be asked to answer a series of short questions, both about the subject reflected in the publication and about the topics of the article. It will contribute 15% to the academic grade.
Pass criteria and qualitative qualifications
To pass the course, the student must participate in the scheduled activities and must obtain a minimum grade of 5. A grade of 7 will lead to a grade of notable and a grade of 9 to excellent. In his case, the best student can be recognized with an honor distinction (one per subject).
Bibliography and information resources
- Abbas AK, Lichtman AH , Pillai S. Cellular and Molecular Immunology. 9 edición .Elsevier Saunders, 2021
- Aiache JM, Aiache S, Renoux R. Introducción al estudio del medicamento. Barcelona: Masson, 1996.
- Alghabban A. Pharmaceutical medicine dictionary. Edinburg: Churchill-Livingstone, 2001.
- Aulton ME, dir. Farmacia. La ciencia del diseño de las formas farmacéuticas. 2ª ed. Madrid: Elsevier, 2004.
- Baños JE, Brotons C, Farré M. Glosario de investigación clínica y epidemiológica. Barcelona: Fundació Dr. Antonio Esteve, 1999.
- Baños JE, Farré M. Principios de farmacología clínica. Barcelona: Masson, 2002
- Bartfai T, Lees GV. Drug discovery. From bedside to Wall Street. Amsterdam: Elsevier, 2006.
- Blass BE. Basic principles of drug discovery and development. London: Academic Press, Elsevier, 2015.
- Bosch F, Baños JE, Cobos A. Diccionari de recerca clínica de medicaments. Barcelona: Termcat i Fundació Dr. Antoni Esteve, 2014.
- Bosch F, Erill S, ed. From clinical research to clinical pharmacology. Pharmacotherapy Revisited: An Esteve Foundation Series, Vol. 7. Barcelona: Prous Science; 2006.
- Bravo Díaz, L. Farmacognosia. Madrid: Elsevier, 2003.
- Brunton LL, Lazo JS, Parker KL. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 12th ed. New York: McGraw-Hill; 2011.
- Chin JY. Practical Leadership for Biopharmaceutical Executives. Woodhead publishing, 2012.
- Cook AG. Forecasting for the pharmaceutical industry. Surrey: Gower Publishing, 2015.
- Dal-Re R, Carné X, Gracia D. Luces y sombras en la investigación clínica. Madrid: Triacastela; Fundació Víctor Grífols i Lucas, 2013.
- Doménech J, Martínez J, Plá JM. Biofarmacia y farmacocinética. Vol II. Barcelona: Síntesis, 1998.
- Edwards LD, Fox AW, Stonier PD. Principles and practice of pharmaceutical medicine. 3th ed. Oxford: Blackwell Publishing Ltd, 2011.
- Evans WC. Trease and Evans’ Pharmacognosy. London: WB Saunders, 1996.
- Flórez J, Armijo JA, Mediavilla A. Farmacología humana. 6ª ed. Barcelona: Elsevier Masson, 2013.
- Goodman and Gilman's The Pharmacological Basis of Therapeutics. Brunton L, Chabner B, Chabner BA, Knollman B. 12th ed. New York: McGraw-Hill; 2011.
- Griffin JP, Posner J, Barker GR. The Textbook of Pharmaceutical Medicine. 7th ed. Chichester: Wiley-Blackwell BMJ Books, 2013.
- Hernández Herrero G, Moreno González A, Zaragozá garcía F, Porras Chavarino A. Tratado de Medicina Farmacéutica. Madrid: Panamericana; 2011
- Kar A. Essentials of biopharmaceutics and pharmacokinetics. New Delhi: Elsevier, 2010.
- Laporte JR. Principios básicos de investigación clínica. 2ª ed. Barcelona: AstraZeneca; 2001. http://www.icf.uab.es/llibre/llibre.htm
- Rapport L, Lockwood B. Nutraceuticals. Londres: Pharmaceutical Press, 2002.
- Raviña E. The evolution of drug discovery. From traditional medicines to modern drugs. Weinheim: Wiley-VCH, 2011.
- Rogge MC, Taft DR. Preclinical Drug Development. 2nd ed. New York: Informa Healthcare, 2009.
- Samuelsson G. Drugs of natural origin. 4ª ed. Estocolm: Apotekarsocieteten, 1999.
- Sneader W. Drug discovery: a history. Chichester: Wiley; 2005.
- Spilker B. Guide to drug development. A comprehensive review and assessment. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins Health; 2009.
- Vila JL. Tecnología farmacéutica. Vol I: Aspectos fundamentales de los sistemas farmacèuticos y operaciones básicas. Madrid: Síntesis, 1997.
- Vila JL. Tecnología farmacéutica. Vol II: Formas farmacéuticas. Madrid: Síntesis, 1997.
- Villar del Fresno AM. Farmacognosia general. Madrid: Síntesis, 1999.
- Vogel HG. Drug discovery and evaluation. Pharmacological assays. 2nd ed. Berlin: Springer-Verlag; 2002.
- William B. Coleman, Gregory J. Tsongalis. The Molecular Basis of Human Cancer. Second Edition. Springer-Verlag; 2016.