SFKKIL002U Biopharmaceuticals: Pharmacology of Biomacromolecules

Volume 2013/2014
Education
MSc in Pharmaceutical Sciences - elective, MSc in Medicinal Chemistry - elective, Cand.Scient.Pharm. - elective, Cand.Pharm. - elective
Content
The course will give the students insights into principles, technology and challenges for drug discovery of biopharmaceuticals based on biomacromolecules such as proteins, peptides and nucleic acids. Through examples of compounds from pre-clinical development as well as from the clinic, the course illustrates how the principles and knowledge from molecular biology and molecular medicine is exploited for discovering novel drugs based on the organisms “own” molecules, and especially focuses on challenges involved in biophamaceutical development. The examples include bioactive peptides (insulin, human growth factor, antibacterial peptides) proteins ((monoclonal) humanized antibodies), and nucleic acids (antisense oligonucleotides, siRNA, aptamers and GC-immunostimulants). The course has focus on in vivo behaviour and activity of biopharmaceuticals, and deals with the major challenges for optimizing biostability, bioavailability and pharmacokinetics behaviour. In particular the principles of pharmacokinetcs, metabolism and toxicity of biomacromolecules are discussed and illustrated with examples from the literature. Background lectures on basic immunology are also included.
Learning Outcome

Formål / Objective

The course covers theoretical biopharmaceutical drug discovery and development as a central part of contemporary and future drug development efforts in academia and in the biotech and pharmaceutical industry. The identification, discovery, exploitation and development of biomacromolecules such as nucleic acids, proteins and larger peptides as (potential) medical drugs is taught and discussed through literature examples from the discovery, development and (pre)clinical phase, with special emphasis on in vivo properties of the drugs,

Målbeskrivelse / Course outcome

At the end of the course the student is expected to have gained an understanding of biopharmaceutical drug discovery and deveopment relating to the mechanism of action of selected peptide, protein and nucleic acid drugs, the principles and methods employed for in vivo delivery of such molecules as well as an understanding of their general properties in terms of bioavailability, pharmacokinetics and pharmacodynamics, thereby allowing the student to read scientific literature on and to participate in biopharmaceutical drug discovery and development projects.
Literature
Pharmacokinetics and Pharmacodynamics of Biotech Drugs. B. Meibohm, Ed. Wiley-VCH, 2006. Scientific articles and notes distributed during the course.
Active participation in and oral presentations at the course.
Enrolment requires a bachelor degree (or equivalent qualifications) within the pharmaceutical, natural or medical sciences. Furthermore, basic knowledge in organic chemistry and molecular biology is a prerequisite, and knowledge of basic pharmacokinetics is an advantage.
•Lectures: 15 hours
•Class lessons: 20 hours
  • Category
  • Hours
  • Colloquia
  • 20
  • Exam
  • 56
  • Lectures
  • 15
  • Preparation
  • 108
  • Project work
  • 10
  • Total
  • 209
Credit
7,5 ECTS
Type of assessment
Written assignment, 2 weeks
Prøveform / Examination type:
Individual essay in the format of a scientific (review) paper based on literature studies on a subject agreed upon with the teacher and approved by the course director.(Size, no more than 50.000 characters including spaces).

Prøvedesign / Examination design
The exam consists of a written essay in form of a ”scientific review paper” in which a (potential) biotech drug candidate is described and discussed in terms of molecular target and mechanism, rationale for medical indications, in vitro and in vivo properties, drug discovery challenges (and their (possible) solution(s)), in vitro and in vivo properties and effects (pharmacokinetics/​pharmacodynamics), as well as clinical prospects/potential. (Alternatively, to an “established” drug or drug candidate, a proposal for a new biotech drug, based on biological evidence, and general knowledge on similar type of molecules may be presented.) The essay should be clearly presented and supported by adequately referenced argumentation. The exam paper must be written as a scientific (review) paper on a subject approved by the course director. It is evaluated in total with special emphasis on factual scientific content, comprehensive coverage and convincing scientific argumentation which has been adequately referenced.
Aid
All aids allowed
Marking scale
7-point grading scale
Censorship form
No external censorship
Exam period
Last weeks of blok 2
Criteria for exam assesment

Beskrivelse af prøven og bedømmelse / Description of examination and assessment criteria

Beståkrav / Pass criteria

The exam paper must reflect that the student has collected, read and understood the background literature and has extracted the essentials from this. It shall illustrate how biotech drugs are discovered and developed in terms of molecular target, mechanism of action, medicinal modification and/or formulation, in vivo properties (pharmacokinetics/​pharmacodynamics) and consequently the medical indication.

Karakterbeskrivelse / Description of grades

12 - Excellent performance
Is awarded for the excellent, exhaustive and clear paper covering all relevant aspects. 7 - Good performance
is awarded for a well acceptable paper covering all relevant aspects. 02 - Acceptable performance
Is awarded for the barely acceptable paper covering relevant aspects but with significant flaws and/or shortcomings.