SMIMIL171U Biopharmaceuticals Drug Development
The course is for professionals in the pharmaceutical industry
who need an interdisciplinary overview of the specific requirements
for development of biopharmaceuticals.
The course is preapproved as an elective in the Master of
Industrial Drug Development (MIND) programme, the Master of
Pharmaceutical Regulatory Affairs (MPRA), and the Master in
Medicines Regulatory Affairs (MRA) programme and open for
freelance students who meet the admission criteria.
The commercial and scientific prominence of biopharmaceuticals is beyond dispute. This course provides an interdisciplinary introduction to the new advances in our ability to develop macromolecules into effective biopharmaceuticals.
At first sight, development of biopharmaceuticals appears straightforward since the biology of endogenous compounds, such as proteins or peptides, and clinical proof of concept and safety profile often are given beforehand (e.g. insulin, growth hormone, coagulation factors). However, given by tremendous recent advances in genetic understanding, biotechnology, and knowledge of protein function in the biology of diseases, an explosion of novel opportunities for development of biopharmaceuticals has occurred. Even though discovery of novel biopharmaceuticals may be void of typical small molecule pitfalls, the complexity of drug development, in particular pharmaceutical development and safety assessment, may still pose large challenges in the overall development of novel biopharmaceuticals.
The course will teach the specific characteristics and procedures within the development of biopharmaceuticals. Morning lectures held by experts touch upon basic concepts and specific issues related to biopharmaceuticals within their fields of expertise. Emphasis is put on issues and complexities related to development of biopharmaceuticals. There will be focus on project initiation, discovery phase, including pharmacology and protein engineering. Particular emphasis will be given to pharmaceutical development and safety assessment of biopharmaceuticals. Regulatory aspects will be taught as well. Afternoon group sessions are allocated to cases addressing potential issues during biopharmaceutical drug development and their solutions.
A student who has concluded the course will be able to:
Knowledge
- Understand potential major issues during development of biopharmaceuticals regarding pharmaceutical development, safety and efficacy testing
Skills
- Identify and suggest solutions for issues during development of biopharmaceuticals regarding pharmaceutical development, safety and efficacy testing
- Design and develop novel interdisciplinary approaches within the field of expertise thereby improving current practice in the development of biopharmaceuticals
Competencies
- Communicate field specific issues and solutions regarding development of biopharmaceuticals to other specialists, and project stake-holders
- Cooperate within a multi-disciplinary development project team
The common course syllabus is approximately 300 pages: collections of review papers, textbook chapters, case stories and hand-outs from course presentations.
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
- Category
- Hours
- Class Instruction
- 40
- Exam
- 20
- Preparation
- 22,5
- Total
- 82,5
- Credit
- 3 ECTS
- Type of assessment
- Written assignmentA written report based on a case story. The report must be based on the common course syllabus and an individual selection of literature (scientific articles, regulatory documents, etc.) relevant for the selected case.
- Exam registration requirements
Active participation in the course is a prerequisite for assessment.
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
- Exam period
Deadline for submission of report: 24 October 2016
- Re-exam
Announced at the MIND programme's webpage
Criteria for exam assesment
Knowledge
- Understand potential major issues during development of biopharmaceuticals regarding pharmaceutical development, safety and efficacy testing
Skills
- Identify and suggest solutions for issues during development of biopharmaceuticals regarding pharmaceutical development, safety and efficacy testing
- Design and develop novel interdisciplinary approaches within the field of expertise thereby improving current practice in the development of biopharmaceuticals
Competencies
- Communicate a comprehensive and structured report on a selected case in his/hers own words, which is based on relevant literature. The report is based in a field specific issue and solution regarding development of biopharmaceuticals
Course information
- Language
- English
- Course code
- SMIMIL171U
- Credit
- 3 ECTS
- Level
- Part Time Master
- Duration
- 15 - 19 August 2016
- Placement
- Summer
- Schedule
- 5 days
- Course capacity
- 25 participants
- Continuing and further education
- Price
DKK 19,000/EUR 2,600. Fee includes teaching, course materials, all meals during course and examination.
- Study board
- Study Board for Part-time Master’s Programmes of Pharmaceutical Sciences
Contracting departments
- Department of Drug Design and Pharmacology
- Department of Pharmacy
Course responsibles
- Morten Skøtt Thomsen Lindskov (16-727477796a73337833796d7472786a7345787a736933707a336970)
- Lene Jørgensen (14-6f687168316d72756a68717668714376787167316e7831676e)
Lecturers
List of lecturers may be subject to change