SMIMB1011U Discovery and Development of Medicines

Volume 2013/2014
Education
Compulsory for Master of Industrial Drug Development (MIND) students, Master of Pharmaceutical Regulatory Affairs (MPRA) students and DRA students, elective for other part-time master's students at the Faculty of Health and Medical Sciences (subject to study board approval) and open for freelance students who meet the admission criteria.

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 need a brush-up course for continuing professional development (CPD).
Content
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
Learning Outcome
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.

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 within 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
Literature

The syllabus comprises collections of review papers, textbook chapters and case stories and updated hand-outs 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, 2th edition Humphrey P. Rang, Churchill Livingstone, 978-0702042997.

The Textbook of Pharmaceutical Medicine, 7th edition, 2013. John P. Griffin (Editor), John Posner (Editor), Geoffrey R. Barker (Edito) BMJ Books serves as “nice to know” and it is used in other MIND courses.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
The course is organized as an intensive 10-day course and comprises 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.
  • Category
  • Hours
  • Exam
  • 2
  • Lectures
  • 40
  • Preparation
  • 78
  • Theory exercises
  • 20
  • Total
  • 140
Credit
5 ECTS
Type of assessment
Written examination, 2 hours under invigilation
Examination design: The test is composed of essay questions and multiple choice questions.The purpose of the examination is to test that the examinee has achieved the expected learning outcomes. The percentage of items in 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 %
Aid
Written aids allowed
Calculators are not allowed
Marking scale
7-point grading scale
Censorship form
External censorship
Exam period
Exam on the last day of the course 27 January 2014 at 3-5 pm
Criteria for exam assesment

The grade 12 is given when 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


The grade 7 is given when 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


The grade 02 is given when 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