Course Syllabus

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Medical Biotechnology and

Drug Development, C

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Semester & Location:

Fall 2024 - DIS Copenhagen
Type & Credits:

Core Course - 3 credits
Core Course Study Tours:

Western Denmark and London
Major Disciplines: Biology, Biomedicine / Biotechnology, Pre-Medicine / Health Science
Prerequisites:

One year of biology and one year of chemistry at the university level
Faculty Member:

Reza Yarani

(current students, please use the Canvas Inbox to contact)
Program Director:

Susana LS Dietrich - shsupport@dis.dk 
Time & Place:

Mondays and Thursdays 8:30-9:50, Classroom, N7 - B13

Instructor

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Reza Yarani

Ph.D. (Cellular and Genetic Medicine, Department of Cellular and Molecular Biology, University of Copenhagen, 2016). Assistant Professor, Translational Type 1 Diabetes Research, Department of Clinical Research, Steno Diabetes Center Copenhagen, 2021-Present. With DIS since 2023.

reya@dis.dk

 

 

Course Description

The course will emphasize biomedicine and drug discovery and development, focusing on the European pharmaceutical and biotech research community.

You will learn about the general principles of drug discovery & development, including safety, toxicology, formulation, and clinical trials. Furthermore, the course will explore the opportunities and challenges biotechnology has for medicine, such as the different new types of biotechnological drugs, gene therapy, personalized medicine, delivery problems, stem cells, etc.

Additionally, and primarily through academic visits in Denmark and the UK, you will get a good overview of the different players involved in the drug discovery and development process, including research laboratories, start-up companies, biotech companies, contract research organizations, and pharmaceutical companies.

The course will incorporate some group work in class and finish with a group project. For this project, you will focus on drug development in Scandinavia and prepare and present a report on this.

Group work helps you prepare for how work is organized in professional life and can improve the quality of the work produced by combining the students' different strengths.

 

Expected Learning Outcomes

Upon completion of this course, students will be able to:

  • Give a basic explanation of biomedical drug discovery and development
  • Review characteristics and principles of  biotechnological tools, methods, and classes of drugs
  • Research biotechnological information and present it in a clear and critical way
  • Participate actively and critically in discussions of biotechnology and different types of drugs in class and with biomedical professionals
  • Assess the challenges that researchers and people working in the biopharmaceutical area are faced with when dealing with drug discovery and development 

 

  • Required Readings

    • Pharmaceutical Biotechnology – Fundamentals, and Applications edited by Daan J. A. Crommeling, Robert D. Sinclair and Meibohm B. Springer, Fourth Edition, 2013 (hereafter referred to as PB)
    • Drug discovery and development – technology in transition edited by Raymond G. Hill and Duncan B. Richards. Churchill Livingstone/Elsevier, 3rd edition, 2021 (hereafter referred to as DDD2021)
    •  
      • Examples of links to readings on Canvas:
  1. Murphy, Kenneth P.: Basic Concepts in Immunology. Janeway's Immunobiology, 9th Edition Garland Science, Taylor and Francis Group, LLC, 2017 ISBN: 9780815345053
  2. Murphy, Kenneth P.: Fighting Infectious Diseases with Vaccination. Janeway's Immunobiology, 9th Edition. Garland Science, Taylor and Francis Group, LLC, 2017 ISBN: 9780815345053
  3. Walsh, Gary: The Drug Development Process. Pharmaceutical Biotechnology. John Wiley & Sons, 2007. ISBN: 9780470012444
  4. Lipp, Ralph; Pungor, Erno: Formulation of Biotech Products.Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications. Wiley-Blackwell, 2004. ISBN: 3527305548
  5. Resnik, David B.: Patents in the Pharmaceutical Biotechnology Industry: Legal 74 and Ethical Issues. Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications. Wiley-Blackwell, 2012. ISBN: 9783527651269
  1. Ellington, Andrew; Keefe, Anthony D.; Pai, Supriya: Aptamers as therapeutics. Natural Reviews Drug Discovery, Vol. 9, 2010. Nature Reviews Drug Discovery. ISSN: 14741776
  2. Fellmann, Christof, et al.; Gowen, Benjamin G.: Cornerstones of CRISPR-Cas in drug discovery and therapy. Nature Reviews Drug Discovery, Volume 16, 2017 Macmillan. ISSN: 1474-1776
  • Extra materials are continually posted on Canvas 

Evaluation and Grading

Participation 15%
Study Question Presentation 10%

Wegovy: A Case Study in DDD

 7.5%
Final Canvas Test 20%
Drug Development Assignment (DDA) Report 12.5%
Drug Development Assignment (DDA) Presentation 10%
Study Tour Assignments (STA)   25%

 

 

 

 

 

 

 

 

 

Elements

Lectures, class discussions, solution sessions (alone or in groups), case studies, group presentations of case studies, field studies visiting pharmaceutical and biotech companies, and the group project with presentation.

There is one shorter test early in the semester and a more extended test at the end of the semester. There is no final; the class wraps up with the Drug Development Assignment. The project is graded as a group effort, while grades for the project presentation combine group and individual performance.

Participation

To prepare for each day, you are required to read all assigned material, use the study questions for that day, take a survey on Canvas, and vote on the study questions that were more challenging. Based on those results, more focus will be given in class to certain areas of study. 

Participation is determined by attendance, tardiness, and engagement in class. You are expected to attend all DIS classes and activities when scheduled, and we will actively monitor attendance. Absences will jeopardize your grade and your standing at DIS. Allowances will be made in cases of illness, but you must email your instructor in advance. If you miss multiple classes, the Director of Academic Support and the Director of Student Affairs will be notified and follow up with you to ensure that all is well.

Students will also be asked to address some of the study questions in class: this will be a part of the evaluation parameter, “preparation.” Additionally, for those students who did not have a chance to give their input in class, you will have the opportunity to do so on Canvas: a) on the discussion board, there will be an open “Continue today’s class discussion/debate,” where students can share thoughts/questions related to the topic discussed in class, b) if relevant, there will also be a specific question/topic related to the day’s class, to which students can address/answer/debate on Canvas. The participation of the students in these debates will be considered when the student participation assessment is made.

The Science & Health Department faculty and staff have spent many hours selecting and organizing this course's readings and material. Please make sure to read all the material assigned; the reading material and the websites have been carefully chosen and are relevant to your success in Medical Biotechnology and Drug Development. You'll have to have a duty to prepare for class, both to your classmates and yourself. 

 

Test

There is one canvas test covering these topics:

  • Immune-defense related biopharmaceuticals, Immunogenicity, Genetics/Genomics, Gene therapy, Nucleotides and Cell therapy. 

They will be a combination of information recall, concept explanation and synthesis, and problem analysis. The Tests last 60 minutes unless otherwise stated.  You will take the test at home or in class during class time.

 

Drug Development Assignment (DDA)

In groups of 4 to 6, you will investigate the clinical drug development of a Scandinavian biopharmaceutical company you visit. Focusing on a current or recent pharmaceutical product, you will explore the science, research, methodology, and challenges of developing the product, culminating in a paper and presentation. I'll be sure to give you more information at a later date. 

Biopharmaceutical Company Visits

  • In assigned groups, you will visit the company whose product you’re researching for the Drug Development Assignment; the exact companies will be announced later.

Core Course Week and Study Tours

Core Course Week (CCW) and study tours are integral to the core course. We take the classroom on the road to see how theory presented in the classroom is translated to practice in the field. You will travel with your classmates and DIS faculty/staff on two study tours: a short tour during Core Course Week and a long study tour (LST) to Scotland.

Expectations for study tours:

  • Participate in all activities
  • Engage in discussions, ask questions, and contribute to achieving the learning objectives
  • Respect the destination, the speakers, DIS staff, and your fellow classmates
  • Represent yourself, your home university, and DIS in a positive light 

Learning objectives:

  • To learn about the newest and most innovative biotechnology-based methods for diagnosis and treatment of disease through academic visits
  • To observe the dynamics of drug discovery and development through visiting biomedicine and biotech research facilities
  • To meet some of the players active in the transfer of technology from university to business and explore their work
  • To explore the differences between Denmark, the US, and Portugal within the Biomedical field
  • To visit cultural landmarks and institutions in historical cities of Denmark and Portugal
  • To develop questions for further learning/research
  • To engage in your personal learning process outside the classroom by actively participating and challenging your current ideas and assumptions.
  • To get to know your fellow students and professors in an educational and social setting outside DIS. 

While on a program study tour, DIS will provide hostel/hotel accommodation, transportation to/from the destination(s), approximately two meals per day, and entrances, guides, and visits relevant to your study area or the destination. You will receive a more detailed itinerary prior to departure.  

Travel Policies

You will need to travel with your group to the destination. If you have to deviate from the group travel plans, you need approval from the program director and the study tours office. 

Study Tour Assignment (STA)

Before your short study tour, you will be organized into teams. With your team, you will construct a fact sheet and small presentation of an academic visit on tour and finish with a more comprehensive final presentation based on what you have learned during both the Core Course Week and the Long Study Tour. Each team will decide on a specific topic for their final presentation. Topic areas to choose between include:

  1. An in-depth exploration of a biotech research topic encountered on the study tours
  2. Relationship between academia and private enterprise
  3. Collaboration and/or competition – relationships between different players involved in the drug development process
  4. Careers and work-life in biotechnology: niches, educations, and different fields

The themes above are general, and the final topic/research question should be more refined and related to study tour visits.

Research your visits before the study tour to improve the quality of your questions and observations during the academic visits. More information will be provided prior to Core Course Week.

Questions and feedback

If you have questions to the readings, lectures, or assignments, you are always welcome to contact me by email. Alternatively you can email program S&H support (shsupport@dis.dk) to setup an appointment or ask a question. 

 

Policies

Use of Laptops or Phones in Class

Phone use in class is not allowed. Laptop use is allowed for group and project work only and when authorized. 

Policy on late papers and/or assignments

Late papers will be accepted, but your grade for the paper will be reduced for each day that it is late. 

 

Academic Regulations  

Please make sure to read the Academic Regulations on the DIS website. There, you will find regulations on: 

 DIS - Study Abroad in Scandinavia - www.DISabroad.org

Course Summary:

Date Details Due