Discovery and Development of Medicines

Overview course
Course code: FMIMB1011U (previously B-8101)

Lægemiddeludvikling

Course objectives

People involved in the drug development process have diverse educational backgrounds. Often their basic academic educations have not at all touched upon drug development. This course aims to convey knowledge of drug development in general to the participants so they may communicate across the different fields of the process. 

Target group

The course is intended for drug development professionals and regulatory affairs professionals who need an overview of the entire drug development process, or professionals who needs a brush-up course for continuing professional development (CPD).

Prerequisites

Applicants must meet the following criteria:

• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English

Learning outcomes

On completion of the course, participants will have comprehensive overview of drug development and a sound grasp of the fundamentals of the major implicated disciplines. Participants will be able to convey an understanding of the dynamics of the drug development and communicate across research fields.

Upon completion of the course, participants are expected to be able to:

Knowledge

• give a comprehensive overview of drug discovery and development,
• identify correct professional terms in drug discovery and development,
• list major steps and elements of the drug development process,
• outline definitions of key concepts and the fundamentals of the major disciplines in drug discovery and development,
• identify the important transition points that require involvement of authorities.

Skills

• appraise the integration of the various basic disciplines into the process of drug development,
• analyse the sequence and flow of the various steps in the process of drug development,
• plan a development process with in the regulatory framework.

Competencies

• liaise with all steps of drug development,
• identify critical factors and bottlenecks that influence the drug development process,
• promote and state milestones for the progress of the development of a drug product,
• communicate professionally with the various specialist groups in the drug development industry

Contents

The topics taught are:

• Genome and target evaluation
• Identification of lead structures
• Medicinal chemistry: Lead optimization and synthesis
• Non-clinical safety
• Animal biology and pharmacology
• Pre-formulation
• Pharmaceutical formulation
• Clinical trials
• Regulatory affairs
• Quality assurance
• Production and marketing

Course materials/syllabus

The syllabus comprises collections of review papers, textbook chapters and case stories and updated hands-out of lecture slides, corresponding to approximately 500 pages. All material is found in the binder indicated with “Need to know” except the recommended textbook chapters.

Participants are expected to purchase: Drug Discovery and Development. Technology in Transition, 1th edition Humphrey P. Rang, Churchill Livingstone, 978-0443064203.

The Textbook of Pharmaceutical Medicine, 6th edition, 2010. Eds.: John Griffin and John O'Grady, Blackwell BMJ Books serves as “nice to know” and it is used in other MIND courses.

Teaching methods

Lectures, group discussions, presentations and discussions. In order to emphasize the flow of the process, the course is to a large extent based on the use of cases in both lectures and assignments.

Examination and assessment

Type of examination: 2-hour written examination (anonymous).

Examination design: The test is composed of multiple choice questions and essay questions. The purpose of the examination is to test that the examinee has achieved the expected learning outcomes. The percentage of items on the test devoted to a particular topic will roughly correspond to the emphasis given the topic in teaching of the course:

• Discovery: 20 %
• Non-clinical (exploratory) development: 50 %
• Clinical development: 30 %

Assessment: According to the 7-point grading scale

Examiner(s): Course directors and an external examiner

Exam aids: All written exam aids are allowed. Calculators are not allowed.

Grading

Grade 12:

The examinee:

• demonstrates a well structured presentation with a clear outline providing exact and correct answers.
• demonstrates aplomb comprehensive view
• combines convincingly the learned elements.
• demonstrates with few unimportant deficits: aplomb mastering of relevant terms, principles and methods used for developing a process from discovery to production.

Grade 7:

The examinee:

• demonstrates a coherent presentation providing understandable unambiguous answers, the great majority of which should be correct.
• documents a certain overview over the learned elements.
• demonstrates with minor deficits a firm knowledge of relevant terms, principles and methods used for developing a process from discovery to production.

Grade 02:

The examinee:

• demonstrates a less structured presentation with less precise answers.
• demonstrates a limited overview and the ability to combine learned elements is limited.
• demonstrates only to a limited extent and with a number of deficits capability to handle relevant terms, principles and methods used for developing a process from discovery to production.

Student workload

Preparation: 60 hours
Confrontation: 78 hours
Examination: 2 hours
A total of 140 hours

Course directors

Professor Ole J. Bjerrum (MD, DMSc), Department of Pharmacology and Pharmacotherapy, The Faculty of Pharmaceutical Sciences, University of Copenhagen.

Associate Professor Harrie Boonen (PhD Pharm), Department of Pharmacology and Pharmacotherapy, The Faculty of Pharmaceutical Sciences, University of Copenhagen.

Lecturers

This list of lecturers may be subject to change.

• Andreas Ritzén. H. Lundbeck
• Anette Frost Jensen, H. Lundbeck
• Anette Hjelmsmark, Novo Nordisk
• Anette Seo Torstenson, H. Lundbeck
• Asser Sloth-Andersen, Novo Nordisk
• Birgitte Ursø, Novo Nordisk
• Birgit Thalsø-Madsen, LEO Pharma
• Bo Maach-Møller, Eli Lilly Danmark
• Fredrik Björkling, Faculty of Pharmaceutical Sciences
• Frank Larsen, H. Lundbeck
• Gitte Dyhr, H. Lundbeck
• Helle Northeved, H. Lundbeck
• Henning G. Kristensen, Faculty of Pharmaceutical Sciences
• Henrik Fylking Nielsen, Novo Nordisk
• Jesper Frank Bastlund, H. Lundbeck
• Jesper Lau, Novo Nordisk
• Jørgen Godt Olsen, Niels Clauson-Kaas
• Jørn Møller-Sonnergaard, Faculty of Pharmaceutical Sciences
• Karin Liltorp, H. Lundbeck
• Karsten Lollike, Novo Nordisk
• Karsten Petersson, LEO Pharma
• Kim Dekermendjian, H. Lundbeck
• Klaus Henning Jensen, Novo Nordisk
• Kurt Pfeiffer Petersen, AstraZeneca
• Lars Dalgaard, H. Lundbeck
• Lazlo Tanko, Ferring Pharmaceuticals
• Liselotte Langkjær, Novo Nordisk
• Mads Kreilgaard, H. Lundbeck
• Mogens Lauritzen, Novo Nordisk
• Niels Plath, H. Lundbeck
• Nina Bjarnason, Department of Internal Medicine, Roskilde Hospital
• Nya Feldthus, Eli Lilly Danmark
• Ole J. Bjerrum, Faculty of Pharmaceutical Sciences
• Ole K. Eskerud, Novo Nordisk
• Per Rexen, Novo Nordisk
• Paul Berthelsen, Nycomed Pharma
• Pontus Forsell, Astra Zeneca
• René Holm, H. Lundbeck
• Søren Berg Padkjær, Novo Nordisk
• Thomas Munk Plum, Novo Nordisk
• Torben Enstrøm, Novo Nordisk
• Troels V. Christensen, H. Lundbeck
• Vibeke Bjerregaard, Novo Nordisk

Practical information

Status: Master’s level (second cycle higher education). Compulsory for MIND, MPRA and DRA students, elective for other part-time master's students at the Faculty of Pharmaceutical Sciences (subject to study board approval) and open for freelance students who meet the admission criteria.

Date: 8-11 January, 21-25 January and examination 28 January 2013.

Application deadline: 1 November 2012

Course credits: 5 ECTS credits = a student workload of approx. 140 hours

Course fee: Part-time master’s students at the Faculty of Pharmaceutical Sciences DKK 15,780, freelance students DKK 18,700, non EU/EEA freelance students DKK 22,580. An additional fee of DKK 2,300 is charged for course materials and lunch. Prices may be subject to change. Textbook must be purchased by the participants.

Course capacity: 36 participants

Language of instruction: English

Preliminary course description