SMOK17001U  Development and Clinical Implementation of Innovative Treatment Modalities: From Initial Idea to Clinical Application

Volume 2017/2018
Education

Msc in Molecular Biomedicine - restricted elective

Content

 

The course will explore the basic molecular and cellular concepts and principles related to the development of novel and innovative treatment modalities covering medical applications to treatment and prevention of human diseases. To ensure that students acquire skills pertinent to the process of translation of basic discoveries into clinical practice, the continuum from basic research to clinical implementation is addressed, with emphasis on the concept of personalized medicine and the use of biomarkers. Throughout the course cancer cases will be used to illustrate key concepts. Disease models and molecular therapies will also be discussed and related to the biological makeup of diseased cells.

 

 

 

The following topics will be addressed during the course:

 

  • Signal transduction

  • Genome aberrations as biomarkers

  • Identification and selection of drug candidates including establishment of functional cellular assays

  • Preclinical and clinical development of drugs and companion diagnostic biomarkers

  • Preclinical in vivo assays in cancer

  • Regulatory and patent policies

  • Clinical trials of novel drugs including Good Clinical Practice

  • Innovative trial design

  • How to start your own biotech company

 

Learning Outcome

 

Knowledge:

 

A student who has met the objectives of the course will be able to:

 

  • Understand and explain the fundamental aspects and principles of translational medicine

  • Understand preclinical drug development

  • Understand the principles of drug screening and testing and the overall requirements for preclinical models

  • Understand requirements for entering into clinical trials and modern clinical trial designs

  • Understand the different steps from academic research to commercialization

 

 

 

Skills:

 

Upon completion of the course students should be able to:

 

  • Demonstrate a critical understanding of the causation and treatment of of major diseases like cancer

  • Apply knowledge to offer opinions and understanding of novel treatment strategies, with focus on personalized/precision medicine

  • Critically evaluate experimental animal models used in the development of investigational drugs

  • Understand and explain the major steps involved in the path from laboratory discovery to patient treatment with a new drug

 

 

 

 

 

Competences:

 

Upon completion, students will be better prepared to start a career in a biotechnology or pharmaceutical setting. They'll have had experience working on how one identifies a target and bring it all the way through to preclinical evaluation and clinical testing.

 

 

The Biology of Cancer, Second Edition by Robert A. Weinberg. Also additional lselected articles from the primary literature will be provided

 

The course consists of lectures and teoretical case discussions. It shoudl be noted that the case studies require student self-involvement with home study
Oral
Individual
Collective
Credit
7,5 ECTS
Type of assessment
Written examination, 4 hours under invigilation
Continuous assessment
Written exam with essay type questions as well as short questions and multiple option questios. Exam weighs 80% of final grade, remaining 20% from class evaluations.
Aid
Without aids
Marking scale
7-point grading scale
Censorship form
No external censorship
No external censorship
Several internal examiners/co-examiners
Criteria for exam assesment

 

Demonstration of a critical understanding of the causation and treatment of of major diseases like cancer

 

Ability to formulate opinions and show understanding of novel treatment strategies, with focus on personalized/precision medicine

 

Critically evaluate experimental animal models used in the development of investigational drugs

 

Understand and explain the major steps involved in the path from laboratory discovery to patient treatment with a new drug

 

  • Category
  • Hours
  • Exam
  • 4
  • Lectures
  • 40
  • Preparation
  • 112
  • Theory exercises
  • 60
  • Total
  • 216