Biotherapeutics Drug Development

Course content

The scientific and commercial prominence of biotherapeutics is beyond dispute. Molecules obtained from expression systems, (semi)synthetic macromolecules as well as biological material intended for therapy or prophylaxis require specialization on all levels to overcome the great challenges and complexity in regard to pharmaceutical formulation design, technological processing, and assessment in the process of developing and regulating such novel safe medicines. In this course, leading experts in the field will present selected topics and case-based approaches will be used to introduce examples of some of the newest advances related to different parts of the drug development process.

This course provides an overview of the drug development process and highlights crucial aspects of specific importance for the capability to develop biologically active macromolecules like peptides, antibodies, oligonucleotides, and other biological material such as living organisms and stem cells into effective medicines.

At first sight, utilization of biotherapeutics as drugs appears straightforward since the pharmacological activity of endogenous compounds such as hormones and coagulation factors are given. Avenues of oligonucleotide and cell therapy may seem less obvious, but due to tremendous advances in understanding disease biology, new targets for biotherapeutics are continuously identified, and this overall excels novel opportunities for new and improved products. Provided that the potent macromolecules or other biological material is druggable. This requires efficient formulation designs and novel delivery approaches, which are continuously emerging. Also, due to the structural complexity and instability of the active material, drug development requires specific processes and models for efficacy testing and safety assessment.

 

Course content

The course will address and highlight topics of relevance for the design and development of biotherapeutics. Experts from selected relevant fields will lecture on and discuss both fundamental concepts and specific selected issues related to biotherapeutics drug development. Topics of special attention are picked from the discovery phase through development and assessment, and include e.g. molecular engineering, pharmaceutical drug design and formulation, experimental models, efficacy and safety assessment and regulatory aspects. Case studies will form the basis for interactive discussion sessions.

Education

Master of Industrial Drug Development (MIND) - elective

The course is preapproved as an elective in the   Master Medicines Regulatory Affairs (MRA) programme and open for freelance students who meet the admission criteria.

The course is for professionals in the pharmaceutical industry; professionals, who need an interdisciplinary overview of the specific requirements for development of biopharmaceuticals.

 

Learning outcome

A student who has concluded the course will be able to:

Knowledge

  • Understand and address potential major challenges for biotherapeutics related to pharmaceutical formulation design, development, processing, efficacy, and safety.

 

Skills

  • Identify key challenges and suggest solutions for addressing critical issues in the development process for biotherapeutics.
  • Elaborate on novel interdisciplinary approaches to improve current practice in the development of biotherapeutics.

 

Competencies

  • Communicate field-specific issues and solutions regarding development of biotherapeutics to other specialists in multi-disciplinary project teams.

The course is organized as an intensive 5-day course and comprises lectures, group discussions, presentations and discussions in plenum. 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.

The common course syllabus is approximately 300 pages and consist of a collections of review papers, textbook chapters, case stories and hand-outs from course presentations.

Applicants must meet the following criteria: The course is aimed for professionals in the pharmaceutical industry and professionals, who need an interdisciplinary overview of the specific requirements for development of biotherapeutics.

Participants should:
• Hold a relevant bachelor degree or equivalent.
• Have minimum 2 years of relevant job experience in drug development.
• Be proficient in English.

Collective
Feedback by final exam (In addition to the grade)

Collective oral feedback during plenary session

ECTS
3 ECTS
Type of assessment
Written assignment
Type of assessment details
A 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.

Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Exam period

Deadline for submission of essay: Announced on the homepage of MIND and MRA programmes 

Re-exam

The exam form for the reexam is the same as the ordinary exam. See dates in the exam plan on the homepage of MIND and MRA programmes 

Criteria for exam assessment

Knowledge

  • Understand and address potential major challenges for biotherapeutics related to pharmaceutical formulation design, development, processing, efficacy, and safety.

 

Skills

  • Identify key challenges and suggest solutions for addressing critical issues in the development process for biotherapeutics.
  • Elaborate on novel interdisciplinary approaches to improve current practice in the development of biotherapeutics.

 

Competencies

  • Communicate field-specific issues and solutions regarding development of biotherapeutics to other specialists in multi-disciplinary project teams.

Part time Master and Diploma courses

  • Category
  • Hours
  • Class Instruction
  • 40
  • Preparation
  • 22,5
  • Exam
  • 20
  • English
  • 82,5

Kursusinformation

Language
English
Course number
SMIM23004U
ECTS
3 ECTS
Programme level
Part Time Master
Duration
5 days
Placement
Summer
Price

See course fee details at MIND-programme webpage

Schedulegroup
12-16 august 2024
Capacity
25-30 participants
Studyboard
Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
  • Department of Pharmacy
Contracting faculty
  • Faculty of Health and Medical Sciences
Course Coordinators
  • Hanne Mørck Nielsen   (11-6b6471716831707275666e4376787167316e7831676e)
  • Stine Rønholt   (14-797a6f746b3478756b746e75727a46797b746a34717b346a71)
Teacher

List of lecturers may be subject to change

Saved on the 17-04-2024

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Courseinformation of students