Course Syllabus
Medical Biotechnology and Drug Development
Fall 2017, Section B
Course Schedule
Monday and Thursday
8:30-9:50
Classroom: V10-A11
Instructor
|
Susana Dietrich |
DIS Contacts
Lisbeth Borbye, Program Director
Bethany Cucka, Science & Health Program Assistant
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 both in Denmark and in 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 will finish with a group project, in which you will focus on drug development in Scandinavia and prepare and present a report on this.
Group work helps you prepare for the way work is organized in professional life and can improve the quality of the work produced, by adding the different strengths of the students.
Prerequisites
One year of biology and one year of chemistry at the university level.
Learning objectives
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
- 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)
- Edited by Raymond G. Hill and Humphrey P. Rang: “Drug discovery and development – technology in transition”, Churchill Livingstone/Elsevier, 2013. (hereafter referred to as DDD)
- Reading compendium (hereafter referred to as RC)
- 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 posted on Canvas
Elements
Lectures, class discussions, solution sessions (alone/in groups), case studies, group presentations of case studies, field studies visiting pharmaceutical and biotech companies, and the group assignment with presentation.
Evaluation
| Tests (1 x 15%, 2 x 20% each) | 55% |
| Study tour assignment | 15% |
| Drug Development Project Report | 12,5% |
| Drug Development Project Presentation | 7,5% |
| Participation | 10% |
The three tests are spaced as evenly as possible throughout the semester. There is no final, but instead the class wraps up with the Drug Development in Scandinavia Assignment. The project report is graded as a group effort, while grades for the project presentation are a combination of group and individual performance.
Participation
To prepare for each day, you are required to read all assigned material, using the study questions for that day as well as 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 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.
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 that 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 taken into consideration when the student’s participation assessment is made.
There are three tests throughout the semester, on these topics:
- Drug discovery and development
- Peptides and nucleotides as biopharmaceuticals
- Immune-defense related biopharmaceuticals
You will take the tests in class. They will be a combination of information recall, concept explanation and synthesis (five questions), and problem analysis (one question). Tests will generally last 40 minutes, unless otherwise stated.
Drug Development Assignment (you will receive detailed information separately)
In groups of 4 to 6, you will investigate the clinical drug development of a Scandinavian biopharmaceutical company. 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. More information will be provided at a later date.
Core Course Week and Study Tours
Core Course week and study tours are an integral part of the core 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 on two study tours: a short study tour during Core Course Week and a long study tour to a relevant European destination.
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 UK within the Biomedicine field
- To visit cultural landmarks and institutions in several cities in Denmark (Copenhagen, Odense and Århus) and Edinburgh in the UK
- 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 program 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.
Study tour assignment (You will receive a more detailed ST Assignment document)
Before your short study tour, you will be organized into groups of 2-3 people. Within these groups, you will construct a group paper, topic areas from which to choose include:
- In-depth exploration of a biotech research topic encountered on the study tours
- Relationship between academia and private enterprise
- Collaboration and/or competition – relationships between groups and companies
- Careers and work-life in biotechnology: niches, educations and different fields
Each group will decide on a specific subject on which to focus their paper. Please note that the themes above are general and the final paper topic/research question should be more refined and related to study tour visits.
It is recommended that you research your visits prior to the study tour to raise the quality of your questions and observations on the trips. More information will be provided prior to the Core Course Week.
Biopharmaceutical Company Visits
- In assigned groups, you will visit the company whose product you’re researching for the Drug Development Project; the exact companies will be announced later.
Practical Information
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.
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 assistant Bethany Cucka at bcu@dis.dk to setup an appointment or ask a question. The program director for this course is Lisbeth Borbye, lbo@dis.dk. The program assistant and the program director can be found in the Science and Health office in Vestergade 10-B12.
Academic Honesty: Plagiarism and Violating the Rules of an Assignment
DIS expects that students abide by the highest standards of intellectual honesty in all academic work. DIS assumes that all students do their own work and credit all work or thought taken from others. Academic dishonesty will result in a final course grade of “F” and can result in dismissal. The student’s home universities will be notified. DIS reserves the right to request that written student assignments be turned in electronic form for submission to plagiarism detection software. See the Academic Handbook for more information, or ask your instructor if you have questions.
Disability resources
Any student who has a need for disability accommodations should contact Academic Support (acadsupp@dis.dk) to coordinate this. Upon DIS approval, students should inform the instructor of accommodations within the first 2 weeks of class.
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 authorised.
Policy on late papers and/or assignments
Late papers will be accepted, but your grade for the paper will be reduced by half a letter grade for each day that it is late.
Awards
Academic Excellence Award
Each semester we recognize one outstanding student from the Biomedicine Program with an Award of Academic Excellence. It is reserved for a student who has distinguished him- or herself through diligence, commitment, academic performance, and ideally a student who contributes to a good, collaborative learning environment in class.
Course Summary:
| Date | Details | Due |
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