SFKKIL002U  Biopharmaceuticals: Pharmacology of Biomacromolecules

Volume 2017/2018
Education

MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.scient.pharm and cand.scient.pharm) - elective

MSc Programme in Medicinal Chemistry - elective

MSc Programme in Pharmaceutical Sciences (English programme) - elective

MSc Programme in Molecular Biomedicine and Biology (SCIENCE) - elective

Content

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.

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

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.

After completing the course the student is expected to be able to:

Knowledge

  • explain applications of biomacromolecules, including peptides, proteins and nucleic acids in drug discovery and development
  • define the major types of biomacromolecular drugs
  • discuss critical issues in exploiting the major types of biomacromolecules in drug discovery and development in terms of pharmacokinetics and pharmacology

 

Skills

  • collect and analyze literature data on novel biomacromolecular drugs
  • communicate - orally and in writing - literature data on novel biomacromolecular drugs

 

Competence

  • evaluate strengths and weaknesses of novel biomacromolecular drugs based on literature data search
  • independently take responsibility to further develop professionally within biopharmaceuticals
  • take responsibility for pharmacokinetics and pharmacology related aspects in project discussions on biopharmaceuticals

 

 

Pharmacokinetics and Pharmacodynamics of Biotech Drugs. B. Meibohm, Ed. Wiley-VCH, 2006. Scientific articles and notes distributed during 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
The students participate actively during class lessons and make oral presentations at the course.
Credit
7,5 ECTS
Type of assessment
Written assignment, 2 weeks
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) biopharmaceutical drug candidate is described and discussed in terms of molecular target and mechanism, rationale for medical indications, 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 biopharmaceutical 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 block two

Criteria for exam assesment

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 biopharmaceutical drugs are discovered and developed in terms of molecular target, mechanism of action, medicinal modification and/or formulation, pharmacokinetics and pharmacodynamics, and consequently the medical indication.

To achieve the grade 12 the student must be able to:

Knowledge

  • explain applications of biomacromolecules, including peptides, proteins and nucleic acids in drug discovery and development
  • define the major types of biomacromolecular drugs

 

Skills

  • discuss critical issues in exploiting the major types of biomacromolecules in drug discovery and development in terms of pharmacokinetics and pharmacology
  • collect and analyze literature data on novel biomacromolecular drugs
  • communicate - orally and in writing - literature data on novel biomacromolecular drugs
  • evaluate strengths and weaknesses of novel biomacromolecular drugs based on literature data

 

  • Category
  • Hours
  • Lectures
  • 15
  • Preparation
  • 105
  • Colloquia
  • 20
  • Project work
  • 10
  • Exam
  • 56
  • Total
  • 206