Curricula Guides

Uusi opinto-opas (sisältäen myös opetusohjelmat) lukuvuodelle 2018-2019 sijaitsee osoitteessa https://opas.peppi.utu.fi . Tältä sivustolta löytyvät enää vanhat opinto-oppaat ja opetusohjelmat.

The new study guide (incl. teaching schedules) for academic year 2018-2019 can be found at https://studyguide.utu.fi. This site contains only previous years' guides.

x !
Archived Curricula Guide 2016–2018
Curricula Guide is archieved. Please refer to current Curricula Guides
DRUG0012 Drug development learning project 10 ECTS
Organised by
Drug Discovery and Development
Person in charge
Markku Koulu and Ullamari Pesonen

Learning outcomes

The aim of this study module is, by applying a virtual drug discovery and development project, to practise and integrate all aspects of drug development from an evaluation of the biological significance of a given target protein and its possible involvement in the pathophysiology of a given disease to the design of an entire development program for the virtual drug molecule. Students first prepare an overview of the target and its possible involvement in diseases, utilize patent databases to learn of the IPR status of the target and finally analyze the financial/economical realism of the new development program. Next, students design a program for the drug discovery phase by analyzing methodological possibilities to find a lead compound and to optimize it for further development. After this, the students design an entire non-clinical development program for the drug candidate during which they plan all studies to demonstrate the mechanism of action of the drug molecule, its ADME properties, its efficacy in animal disease models and the toxicological and safety experiments that are required to demonstrate the safety of the candidate molecule. Finally, the students design a clinical development program for the study drug, from first-to-man dosing studies in healthy volunteers to phase 2 and 3 clinical trials in patients. Communication and presentation skills will be practised during the entire course of the study module as a built-in study component.

Contents

The study module is based on project and team work. Teams will be given the name of a target protein and start working to produce both written project reports and to give oral presentations on the following topics: a) evaluation of the target as a possible drug development target and outline of the project plan and time table, b) drug discovery phase of the project, c) non-clinical phase of the project and d) clinical phase of the project. Students also keep notes on the project meetings. Thus, during this study module, the students will write 4 project reports and keep 4 oral presentations. As a part of the project, students will have lectures on the general outlines of project work. They will also get advice on presentation skills by an expert. The language of the project reports will be checked by a native English teacher who gives feedback to students.

Teaching methods

Project work (250 h), seminars (12 h), lectures (4 h)

Teaching language

English

Modes of study

Evaluation criteria are based on the outcome of the project work. For this, both written project reports as well as oral presentations will be evaluated. Scientific quality and reasoning of approaches used during different phases of the project, innovative ideas, knowledge of regulatory requirements of drug development processes and linguistic performance will be taken into account in the evaluation.

Evaluation and evaluation criteria

Numeric 0-5.
Evaluation criteria are based on the outcome of the project work. For this, both written project reports as well as oral presentations will be evaluated. Scientific quality and reasoning of approaches used during different phases of the project, innovative ideas, knowledge of regulatory requirements of drug development processes and linguistic performance will be taken into account in the evaluation.

Recommended year of study

1. year spring

Study materials

Given material on the project and team work. Students are encouraged to seek information on relevant regulatory guidelines concerning drug discovery and development available on the web pages of EMA, FDA and ICH, and to utilize IPR (patent) databases, PubMed, Clinical Trials Registers

Belongs to following study modules

Institute of Biomedicine
2018–2019
Teaching
Archived Teaching Schedule. Please refer to current Teaching Shedule.
Implementation details are unavailable.
Institute of Biomedicine
DP in Biomedicine
Finnish Study Modules
MDP in Drug Discovery and Development
MDP in Biomedical Imaging
Biomedical Imaging