Research and Development of New Medicines
Code: 103973Credits: 3
| Degree programme | Type | Course |
|---|---|---|
| Veterinary Medicine | OP | 5 |
Contact lecturer
- Name :
- Fernando de Mora Pérez
- Email :
- fernando.demora@uab.cat
Teaching staff (external to UAB)
- Alex Martino
- Pilar Brazis
Group languages
You can consult this information at the end of the document.
Prerequisites
It is advised to have passed the Pharmacology curriculum (3rd year veterinary graduate students) or to have attended a basic or applied pharmacology course.
Objectives
The Overall Objective is that the student acknowledges the rigor behind human and animal medicines approval and that such knowledge may be of use no matter the professional choice, including the pharmaceutical industry which is very unknown for them (human or veterinary industry).
The Specific Objectives are:
- that the student understand the scientific rationale behind the studies needed for medicines approval:quality, efficacy and safety (used in human and animals) 30%
- that the student acknowledges the benefit-to-risk concept as a key paradigm in health sciences 10%
- that the student questions the recommendations for medicines approval and holds the ability to debate and propose alternative approaches 15%
- that the student acquires knowledge on pharmaceutical companies corporate organization to undertake research and marketing of medicines 20%
- that the student understands that regulation is science and that it offers reassurance to patients 10%
- raise awareness for futur clinicians of the need to follow up the therapeutic performance of marketed medicines (pharmacovigilance) 5%
- that the student includes the pharmaceutical industry for her/his professional development based on the clear added value 10%
Learning outcomes
- Analyse, synthesise and resolve problems and make decisions.
- Work effectively in single or multidisciplinary teams and show respect, appreciation and sensitivity for the work of others.
- Recognise personal limitations and know when to ask for professional advice and help.
- Communicate information obtained during professional exercise in a fluid manner, orally and in writing, with other colleagues, authorities and society in general.
- Seek and manage information related with professional activity
- Have basic knowledge of the profession, and in particular of the organisation and functions of professional practice.
- Identify and define the concepts involved in the design of biological experiments and estimate sample size and potency of the test.
- Explain basic statistical inference and its relation with scientific behaviour.
- Identify the sources of drugs and biopharmaceuticals.
- Define the basic concepts for developing drugs.
- Conduct market studies applied to the obtainment of new drugs.
- Describe the bodies for evaluating and monitoring medicines, as well as the mechanisms for approving the same.
- Distinguish the different areas of the pharmaceutical industry.
- Recognise the standards in studies of quality, efficiency and safety as applicable to the development of drugs.
- Identify the standards for the development of non-pharmacological products.
- Design and apply toxicity tests to guarantee the safety of pharmacological and non- pharmacological products.
Contents
Live teaching: 26 hours per student
- 22 hours interactive theoretical sessions
- 2 hours: projects presentation
- 2 hours: visit to pharmaceutical company
+ Student's project + individual/team supervised work
Syllabus
Medicines R+D put into context
- Objectives of the course and sessions dynamics
- Brainstorming: R+D rationale
- Healthcare authroties role: regulation is science
- Recap: R+D steps
Setting up the project
- Projects setup
- Teams set up: subject per team
- Explanation of project execution
Discovery phase
- sources of identification and information of new molecules
Preclinical studies (1): objective and design
- Objectives of preclinical studies.
- Efficacy studies:Target identification and validation. Biological and in silico systems
Preclinical studies (2): toxicity
- Safety pre-assessmnt: Characterization of toxicity.
- NOAEL. Genotoxicity, Immunotoxicicty, etc
Production and formulation of medicines + quality control (1)
- Medicines manufacturing: chemically synthesized and biologics.
- Phases: active substance characterization.
- Formulation
Production and formulation of medicines + quality control (2)
Projects presentation - Debate
- Presentation : teams
- Feed back
- Assessment
Clinical studies: Objectives
- Objectives of clinical research - Design rationale
- Phase I (First-in-human): PK, safety and tolerability
- Objectives and execution
Patient studies
Innovators – Biosimilars etc
Veterinary medicines development
Biopharmaceutical industry
Overview
Projects exhibition
Learning activities and methodology
| Title | Hours | ECTS | Learning outcomes |
|---|---|---|---|
| Field sessions | 2 | 0.08 | 6, 13 |
| Tutorials | 12 | 0.48 | 1, 2, 3, 7 |
| Theoretical sessions | 22 | 0.88 | 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 |
| Seminars | 2 | 0.08 | 1, 2, 4, 5, 7 |
Case-studies and problem solving
Theoretical sessions
Field sessions
Seminars
Project execution and search for information
Supervision and coaching
Assessment
Continuous assessment activities
| Title | Weight | Hours | ECTS | Learning outcomes |
|---|---|---|---|---|
| MCQ Exam (30% of final mark) | 30% | 12 | 0.48 | 6, 7, 9, 10, 12, 13, 14 |
| Team work (written + presentation) | 40% | 25 | 1 | 2, 5, 6, 7, 10, 11, 14, 16 |
| Engagement-participation (engagement in questioning and debating) | 30% | 0 | 0 | 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 |
WARNING: Any irregularity in an assessment activity, including academic misconduct, plagiarism, or improper use of AI unless such use is expressly authorised in the course guide, that may lead to a significant change in the grade will result in that assessment activity being graded as 0. If the course guide establishes that obtaining a minimum grade in that assessment activity is an essential requirement to pass the course, or if several irregularities occur in assessment activities within the same course, the final grade for that course will be 0. In addition, disciplinary proceedings may be initiated against any student who commits any of these irregularities.
IN THIS COURSE THE \"SINGLE ASSESSMENT SYSTEM\" IS NOT CONSIDERED
ACTIVITY 1 -Team Work (TeE): 40% of the final mark. The TeE grade will be the result of a team Oral Presentation. The members of the same team will have the same grade in the Work regardless of their contribution to it.
ACTIVITY 2 - Intervention in class (IeC): 30% of the final mark. The IeC mark can be (a) 10/10: intervenes (i.e. asks or gives an opinion spontaneously) in all or the vast majority of classes, (b) 7.5/10: intervenes frequently in most classes , (c) 5/10: intervenes sometimes, usually coming to class, (d) 2.5/10: intervenes rarely even though he attends class, and (e) 0/10: attends class very little or, even if he does attend, usually does not intervene except by direct questions from the teacher. Class attendance is NOT evaluated, although it should be remembered that low attendance prevents frequent intervention.
ACTIVITY 3 - Class Exam (EeC): 30% of the final grade. It can be exclusively multiple choice, or a combination of multiple choice and short question/s (hybrid), and never last more than 1 hour. Questions about all the content of the subject, including the Works presented by others, the interventions of invited directors or the visit to the Pharmaceutical Laboratory.
The final mark will result from the weighted average of the three evaluated activities.
Explanatory Notes
Team work:• The student will demonstrate the skills acquired throughout the course program by delivering a written team work and presenting it.
MANDATORY• Mandatory to attend (1) sessions with industry executives (2 sessions), (2) visit a productionfacility (1 session) and (3) work presentation (1 session) ES OBLIGATORIA.
Not attending one of those session would preclude from passing (unles justified ahead with a written document)
Attending theoretical sessions is not mandatory, but it is advised not to skip many of those sessions given that class interaction and participation is relevant to pass
NO ASSESSMENT
If the student does not comply with one of the following criteria, the subject will not be assessed and therefore will be passed:
- attend all the mandatory sessions
- attend and deliver the exam
- execute the team work (proved by the signing of the work or the appearance of her/his name on it)
- orally presenting the team work (co-presentation)
Bibliography
Se entregará a principio de curso.
Software
No software is used
Course groups and languages
The information provided is provisional until November 30. After this date, you will be able to consult the language of each group through this link. To access the information, you will need to enter the course CODE
| Type of teaching | Group | Language | Semester | Shift |
|---|---|---|---|---|
| (TE) Theory | 1 | Spanish | second semester | morning-mixed |
| (SEM) Seminars | 1 | Catalan | second semester | morning-mixed |
| (VEXT) Visites externes a entitats | 1 | Catalan | second semester | morning-mixed |