Course Syllabus
Medical Biotechnology andDrug Development |
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| Semester & Location: |
Summer 2023 Session 2- DIS Copenhagen |
| Credits: |
3 credits |
| Study Tour: |
Denmark |
| 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: |
Jeanette Erbo Wern (please use the Canvas Inbox when mailing me) |
| Program Director: |
Susana Dietrich |
| Time & Place: |
9:00 - 16:00 & F24-303 |
Faculty
|
|
Jeanette Erbo Wern |
Course Description
The emphasis of the course will be on biomedicine and drug discovery & development showcased through a focus 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 especially through academic visits in Denmark and Edinburgh, you will get a good overview of the different players involved in the drug discovery and development process, including research institutions, (start-up) biotech companies, hospitals and contract research organizations.
The course will incorporate some group work in class and will finish with a group project, in which you will focus on drug development in Scandinavia and prepare and present a paper.
We love group work in Denmark as you will notice! Working together as a group improves the quality of your assignment as you can each bring your different academic backgrounds & experiences to the table. This is also how work is very likely to be organized in your future professional life.
Your success in this course is important to me!
Expected Learning Outcomes
Upon completion of this course, you 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 Reading
- Edited by Daan J. A. Crommeling, Robert D. Sinclair and Meibohm B.: Pharmaceutical Biotechnology – Fundamentals and Applications. Fourth Edition, 2013, Springer. (hereafter referred to as PB)
- “Drug discovery and development – technology in transition” Edited by Raymond G. Hill and Humphrey P. Rang, 2013. (hereafter referred to as DDD)
- Drug discovery and development – technology in transition” Edited by Raymond G. Hill and Duncan B. Richards, 2021 (hereafter referred to as DDD2021)
Links you find include (but are no limited to):
- Murphy, Kenneth P.: Basic Concepts in Immunology. Janeway's Immunobiology, 9th Edition Garland Science, Taylor and Francis Group, LLC, 2017 ISBN: 9780815345053
- Murphy, Kenneth P.: Fighting Infectious Diseases with Vaccination. Janeway's Immunobiology, 9th Edition. Garland Science, Taylor and Francis Group, LLC, 2017 ISBN: 9780815345053
- Walsh, Gary: The Drug Development Process. Pharmaceutical Biotechnology. John Wiley & Sons, 2007. ISBN: 9780470012444
- Lipp, Ralph; Pungor, Erno: Formulation of Biotech Products.Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications. Wiley-Blackwell, 2004. ISBN: 3527305548
- 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
- Ellington, Andrew; Keefe, Anthony D.; Pai, Supriya: Aptamers as therapeutics. Natural Reviews Drug Discovery, Vol. 9, 2010. Nature Reviews Drug Discovery. ISSN: 14741776
- Oh, Bermseok; Hong, Kyung-Won: Overview of personalized medicine in the disease genomic era. BMB Reports, Vol. 43, 2010 Biochemistry and Molecular. ISSN: 19766696
- Rao, Mahendra; Condic, Maureen L.: Regulatory Issues for Personalized Pluripotent Cells Stem Cells, Vol. 26, 2008. Stem Cells ISSN: 15494918
- 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 material will be posted on Canvas
Evaluation and Grading
| Participation | 10% |
| Final Exam | 40% |
| Drug Development Assignment (DDA) | 25% |
| Study Tour Assignments (STA) | 25% |
Elements
Lectures, including guest lecturers, class discussions, problem solving sessions (alone/groups), case studies, group projects with presentations and field studies visiting research institutions and biotech industry bridging theory and real-life practices.
There will be a Study Tour Assignment (STA), which is a group assignment. The STA grading will include your study tour fact sheet and how you present it on tour, your research question and your argumentation when you answer it at the final STA group presentation at a wrap-up session.
There will also be a Drug Development Assignment (DDA), where you, as a group, investigate the drug development of a biopharmaceutical company. It will culminate in a presentation during the final week in class. The DDA is graded as a group effort with regard to plan and content of the presentation, while grades for the project presentation are a combination of both group and individual performance.
The summer course, will finish with a canvas tests on the last day of the course covering all the material we have discussed in class.
Participation
Participation is determined by attendance, tardiness, and engagement in class. You are expected to attend all DIS classes and planned 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 will need to 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 they will follow-up with you to make sure that all is well.
To prepare for each day, you are required to do all assigned readings and assignments. The Science & Health department faculty and staff have put many hours into selecting and organizing the readings and material for this course. Please make sure to read all the material assigned; the reading material and the websites have been carefully chosen and are pertinent to your success in Medical Biotechnology and Drug Development. You have an obligation to your fellow classmates and yourself to come prepared to class.
A hugh part of the participation grade is also that you participate actively in class as well as on field study & study tour by coming up with ideas and input to topics and being part of discussions.
Tests
There will be a comprehensive final exam covering all the material we have discussed in class including drug disscovery and development, peptides and nucleotides as biopharmaceuticals and immune defense-related biopharmaceuticals.
The test will be a combination of information recall, concept explanation and synthesis and problem analysis.
Drug Development Assignment (DDA)
As a group, you will investigate the challenges and circumstances surrounding the clinical development of a drug/product by a Scandinavian biopharmaceutical company of your choosing. The drug will currently be or have recently been in clinical development. You will explore the science behind the drug/product, the latest research, the methodology, and the challenges of developing the product.
You will present the company to the class as if the class were venture capitalists considering to invest in "your" company (role play). Can you convince them to invest in your company?
You will be introduced to the assignment in class and receive a detailed description of it.
Study Tour
The study tour is an integral part of the summer course as we take the classroom on the road and see how theory presented in the classroom is translated to practice in the field. You will travel with your classmates and DIS faculty/staff during the second week of the summer course.
Learning objectives of the study tour:
- 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 and the US within the Biomedicine field
- To visit cultural landmarks and institutions in the historical city of Edinburgh
- 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 professor in an educational and social setting outside DIS.
While on a study tour DIS will provide hostel/hotel accommodation, transportation to/from the destination(s), approx. 2 meals per day and entrances, guides, and visits relevant to your area of study or the destination. You will receive a more detailed itinerary prior to departure.
Travel policies
You are required 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. On the study tour you are expected to:
- 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
Study Tour Assignment (STA)
Before you go on the study tour, you will be organized into groups and together you will brainstorm topic ideas for a final group presentation. Prior to the study tour, you will prepare a research question based on the chosen topic. Through the academic visits on the study tour, you should find information to answer your research question. Each group will also be assigned an academic visit to research and write a fact sheet. Based on the fact sheet (but not restricted to) you will make a short presentation of the visit to the class on tour. This will ensure that all are adequately prepared for each visit in order to ask relevant questions.
On the study tour, you will use an observation booklet for your notes, some of which might be very important for the STA presentation. There will be a wrap-up session, where each group will spend 1½-2 hours discussing the observations and discoveries from the academic visits (together with supplemented readings when needed/relevant) and through that, answer the study question. The wrap-up session will finish with each group presenting their conclusions to the class.
Workload
This is an intensive course, and in just three weeks, you will receive three credits. In order to merit this you should expect a high workload. You should expect to use on average 1-2 hours preparing for each day of classes.
Policies
Use of Laptops or Phones in Class
Use of phones 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 assignments will be accepted, but your grade for the assignment will be reduced by half a letter grade for each day it's late.
DIS Contacts
Susana Dietrich, Program Director, shsuport@dis.dk
Science & Health Program Office: Vestergade 7-37
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 |
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