Medical Biotechnology and Drug Development
Fall 2010
Instructor: Regitze Illum
DIS Fall 2010 Medical Biotechnology and Drug Development
Course Description
Core course for semester students in the Biomedicine program. This course will examine biomedicine, drug
discovery and development, and biotechnological tools; exploration of the opportunities and challenges
biotechnology has for medicine: personalized medicine, biomaterials, stem cells, tissue engineering, etc.; and
the Danish pharmaceutical and biotech research community.
Course 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 biomedicals
• Research biotechnological information and present it in a clear and critical way
• Participate actively in discussions of biotechnology and biomedicines in class and with biomedical
professionals
Course Schedule
Meeting time: Monday and Thursday, 8:30-9:50.
Location: Vestergade 10-A11
Introduction to Course
The emphasis of the course will be on biomedicines and drug discovery & development, showcased through a
focus on the Danish pharmaceutical and biotech research community.
The general principles of drug discovery & development will be covered, including safety, toxicology,
formulation, registration, and clinical trials. The course will explore the opportunities and challenges
biotechnology has for medicine; among them the different new types of biotechnological drugs, gene therapy,
personalized medicine, delivery problems, stem cells, and genetically engineered animals.
The course will incorporate some group work in class and will finish with a group project, editing or writing a
Wikipedia entry on a biomedicine, technology, disease or company and preparing and presenting a report on
this.
Group work helps prepare students 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. The report will be graded as a
group effort, while individual grades will be given for the presentation.
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DIS Fall 2010 Medical Biotechnology and Drug Development
Instructor
Regitze Illum
Education: BSc (Pharmaceutical Science), Danish University of Pharmaceutical Sciences
1998. MSc (Human Biology), University of Copenhagen 2001. Diploma in adult training and
education 2007.
Employment: Research assistant, Bispebjerg Hospital (2001), IAESTE Trainee at Praecis
Pharmaceuticals, Waltham, Massachussets (2001), Research assistant, Danish University of
Pharmaceutical Sciences (2002), PhD student at Drug Research Academy, Danish
University of Pharmaceutical Sciences (2002-05). Lecturer at The Nursing College Roskilde, University College
Zealand (2007-09). With DIS since Fall 2007, Assistant Program Director of Science and Health (2009-present).
DIS Contacts
Anette Birck, Program Director, abi@[Link], tel: +45 3376 5485
Alison Stanley, Program Assistant, ast@[Link], tel: +45 3376 5450
Prerequisites
One year of biology and one year of chemistry at the university level.
Elements
Lectures, class discussions, solution sessions (alone/in groups), case stories, group presentations of case
stories, field studies visiting pharmaceutical and biotech companies, and the group project with presentation.
Evaluation
Wikipedia Project Paper 20%
Wikipedia Project Presentation 5%
Tests (3 at 10%) 30%
Final 25%
Engagement 10%
Study tour assignment 10 %
Engagement covers the following areas: Engagement and Contribution to Learning is critical for both class and
individual success. To prepare for each day, students are required to read all assigned material and
thoughtfully consider preparation questions.
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DIS Fall 2010 Medical Biotechnology and Drug Development
Strong engagement and contribution to learning can be evidenced by demonstrating thorough preparation of
the assigned topic, contributing value-added knowledge and insights, actively participating in class discussion,
engaging with company representatives and outside speakers, asking good questions, and providing regular
and meaningful posts to the course blog. Partner university faculty will provide input into your overall
Engagement and Contribution to Learning grade at the discretion of course faculty. Please note that
inadequate preparation for a given session may result in an unexcused absence grade.
Tests and Final
There will be three tests throughout the semester, one on drug discovery and development, one on
biotechnological tools and one on the different types of biomedical medicines/therapies.
These tests will consist of a mix of short answer questions and long answer questions. Tests in the class will
generally last approximately 30 minutes.
The final for this course will be cumulative and will be written in the same manner as the tests, but will be
based on all the material covered in class. The final will be one and a half hours in duration.
Wikipedia Group Project:
Objectives
After finishing the Wikipedia Group Project, the student should be able to:
• Gather information on biomedicines, biotechnologies and diseases, online and using library services
• Exercise source criticism
• Choose which information is interesting and relevant to communicate to a wider audience
• Assess and use information from Wikipedia in a more qualified way
The group must research a medical biotech company, paying special interest to their products and
technologies. Research should be conducted both online and using library services. The group will give a
presentation of the company’s products and technologies to the class during the semester and will visit the
company as the second field visit.
The Wikipedia Group Project report must comprise a suggestion for an edit or a new entry on Wikipedia, with
some background given for the subject (disease entities, treatment possibilities, technology used), a discussion
of why the specific information was chosen and an evaluation of the sources used. The paper will be evaluated
by the teacher, suggestions for improvement given, and the improved edit/entry should then be entered on
Wikipedia and the report resubmitted to the teacher.
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DIS Fall 2010 Medical Biotechnology and Drug Development
Each group will write up a report and hand in a preliminary version on November 23. On November 25, groups
get individual feedback on their report. The final report is due on November 29, when the edit/entry must also
be uploaded to Wikipedia. At the final lecture on December 2, the groups present their Wikipedia edit/entry.
Finalized reports due November 29!
Novo nordisk – Hemostatic factor XIII
Virogates – suPAR as a diagnostic marker
Symphogen – recombinant polyclonal antibodies
Santaris – Oligonucleotides
Study Tours
Short study tour dates: September 9-11. Visit to Odense and Århus in Western Denmark.
Long study tour dates: October 3-8. Visit to Edinburgh.
Objectives:
• To obtain insights into biotechnology-based methods for diagnosis and treatment of disease through
academic visits
• To develop an understanding of the dynamics of drug discovery and development through observation
of biomedicine and biotech research facilities
• To learn how biotech research and biotech business work together in Western Denmark as well as
Edinburgh
• To understand technology transfer from university to business
Study tour assignment
Before your short study tour, you will form groups of 2-3 people. Within these groups, you will come up with a
question/research hypothesis to research during your study tours. After the study tour, you will, in the group,
write a short paper (4-5 pages) in which you reflect upon the academic visits on both the short and long study
tours. More information will be provided before the short study tour.
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DIS Fall 2010 Medical Biotechnology and Drug Development
Field Studies
Wednesday, Sep. 8. 13:00-[Link] Introduction class to Faculty Library of Natural and Health Sciences
Wednesday, Oct. 13. 8-[Link] Each group go visit the company they’re doing their project on. These will be
announced later.
Practical Information
Biotechnology & Biomedicine faculty and staff have put many hours into selecting and organizing the readings
and company cases for this course. Please make sure to read all the material assigned and to thoroughly
investigate the websites of the companies listed in the syllabus; 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.
If you have questions or need clarification about a reading or lecture material do not hesitate to speak up. This
is very important. The professor for this course is based in the Science and Health department. Please feel free
to drop by or email her. Alternatively email program assistant Alison Stanley at ast@[Link] to set up an
appointment or simply ask a question.
The program director for this course is Anette Birck.
DIS Forum
The DIS Forum is a web-based Blackboard system that allows you to access resources for your classes and
communicate with your classmates and teachers. You have been automatically enrolled in certain groups for
each class, as well as the student groups that have more social resources about trips, etc.
In your class page for Medical Biotechnology and Drug Development, you can find your syllabus and extra
readings under resources. Announcements will be posted with relevant information on the front page and
emails can also be directed toward you from this page regarding the class. To access the DIS Forum, you can go
to the DIS homepage and click the ‘DIS Forum’ link, or go to [Link] .
In the class page, a discussion forum named “Intriguing study questions” will be used throughout the course.
Before each class, you are expected to post any study questions, you are unsure how to answer, on this
discussion forum. This helps me as the teacher to focus on the areas perceived as most difficult during class.
Required readings
Textbooks
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DIS Fall 2010 Medical Biotechnology and Drug Development
Edited by Daan J. A. Crommeling and Robert D. Sinclair: Pharmaceutical Biotechnology – AnIntroduction for
Pharmacists and Pharmaceutical Scientists. Third Edition, 2007, Taylor and Francis. (hereafter referred to as PB)
H. P. Rang: “Drug discovery and development – technology in transition”, Churchill Livingstone/Elsevier, 2006.
(hereafter referred to as DDD)
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DIS Fall 2010 Medical Biotechnology and Drug Development
Reading compendium (RC)
Most assigned readings that are not in the textbook are in the reading compendium. This will be given to you
when you arrive and is for you to keep. Some assigned readings are posted on forum.
C. A. Janeway, P. Travers, M. Walport and M. J. Shlomchik: “Immunobiology – the immune system in health and
disease”, Garland Science Publishing, 2005, Chapter 1: “Basic Concepts in Immunology”.
Gary Walsh: “Pharmaceutical Biotechnology – Concepts and Applications”, John Wiley and Sons Ltd., 2007,
Chapter 4: “The drug development process”, p. 80-89.
O. Kayser & R.H. Müller: “Pharmaceutical Biotechnology”, Wiley-VCH, 2004, Chapter 9 by R. Lipp og E. Punger:
“Formulation of Biotech products”, p. 173-185.
O. Kayser & R.H. Müller: “Pharmaceutical Biotechnology”, Wiley-VCH, 2004, Chapter 10 by D. B. Resnik:
“Patents and in the Pharmaceutical Biotechnology Industry: Legal and Ethical Issues”, p. 187-200.
H. Ulrich, A. H B. Martins, J. B. Pesquero, 2004: “RNA and DNA aptamers in cytomics analysis”, Cytometry Part
A, Volume 59A, Issue 2, pages: 220-231.
Gary Walsh: “Pharmaceutical Biotechnology – Concepts and Applications”, JohnWiley and Sons Ltd., 2007,
Chapter 14: “Nucleic-acid- and cell-based therapeutics”, p. 442.
R. J. Y. Ho & M. Gibaldi: “Biotechnology and Biopharmaceuticals – Transforming Proteins and Genes into
Drugs”, John Wiley and Sons, 2003: Chapter 8: “Hormones”, p. 209-214.
T. Eschenhagen & W. H. Zimmerman, 2005: ”Engineering Myocardial tissue”. Circulation research, Vol. 97, p.
1220-1231.
R. J. Y. Ho & M. Gibaldi: “Biotechnology and Biopharmaceuticals – Transforming Proteins and Genes into
Drugs”, John Wiley and Sons, 2003: Chapter 14: “Individualization of drug regimens: integration of
Pharmacokinetic and Pharmacogenetic Principles in Drug Therapy”, p. 381-399.
S. P. Wainwright, C. Williams, M. Michael, B. Farsides, A. Cribb, 2006: “Ethical boundary-work in the embryonic
stem cell laboratory”, Sociology of Health & Illness, Volume 28, Issue 6, Date: September 2006, p: 732-748.
M. P. Faggioni, 2008: “Anthropological and ethical reflections on the production and use of embryonic stem
cells”, Cell Proliferation, Vol. 41, Suppl. 1, p. 71-77.
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Other required readings (files or links on forum)
Q&A: Drug trials: [Link]
Drug Volunteer’s Living Hell: [Link]
Doubt cast over drug trial safety: [Link]
Horror Clinical Trial in Test Tube Recreation: [Link] clinical-
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Team Creates Rat Heart Using Cells of Baby Rats:
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Useful Links and Online Biotech and Biomedicine Dictionaries
Medicon Valley Alliance: [Link]
Glossary of Biotechnology Terms: [Link]
Biotech Research and Innovation Centre, Copenhagen: [Link]
Nature Biotechnology: [Link]
Biotech Industry Organisation: [Link]
Technology Review – Biomedicine section: [Link]
The Weblog Biotech: [Link]
Medicon Valley Patent Guide: [Link]
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DATE LECTURE TEXT
1. Thursday, Course introduction DDD: Chapter 1: “The Development of the
Aug. 26 The structure and didactics of the course pharmaceutical industry”, p. 14-18.
- What is biotech? Where do you meet Chapter 3: “Therapeutic modalities”, p. 34-40.
biotech? Chapter 4: “The Drug discovery process: general
- History of biotech, and why should you principles and some case histories”, p. 43-45.
learn about biotech in Denmark? Chapter 15: “Drug development: introduction”, p.
Overview of drug discovery and development 221-227.
process Chapter 22: “Drug discovery and development –
- Phases in DD & DD facts and figures”, p. 324-326.
- Introduction to pharmacology
- Terms and concepts
- Small molecules vs. biopharmaceuticals
2. Monday, Drug discovery and development DDD: Chapter 16: “Assessing drug safety”, p. 229-
Aug. 30 Safety assessment and toxicology 238.
Guest lecturer: Henrik Tang Vestergaard, Chapter 20: “Regulatory affairs”, p. 290-292.
Danish Medicines Agency
- From animal testing to clinical trials RC: Chapter 4: “The drug development process”,
- Small molecule pharmacy contrasted with p. 80-85.
biotech
Groups must be formed
4. Wednesday, Class social at Regitze’s home,
Sep. 1 7pm-10pm
Meet in DIS We’ll go together to Osted Charter School (Fri- og efterskole) where I live, outside of Roskilde, for a
courtyard at tour of the school and an evening of games and biotechnological food products: red wine, bread
5:30pm and cheese.
3. Thursday, Drug discovery and development DDD: Chapter 2: “The nature of disease and the
Sep. 2 Drug discovery purpose of therapy” p. 24-28.
Guest lecturer: Morten Grunnet, Neurosearch Chapter 4: “The Drug discovery process: general
A/S principles and some case histories”, p. 50-54 (till
- Target identification Project Planning).
- Disease models Chapter 6: “Choosing the target”, p. 63-66 (till
- Screening Conventional strategies).
- Small molecule pharmacy contrasted with Chapter 11: “Pharmacology: its role in drug
biotech discovery”, p. 163-167 (till In vitro profiling) +
171-176.
Elect Class Representatives
4. Monday, Drug discovery and development DDD: Chapter 10: Pharmacokinetic issues in drug
Sep. 6 Drug development discovery”, p. 141-142.
- Formulation Chapter 12: “Biopharmaceuticals”, p. 190-192.
- Delivery Chapter 17: “Pharmaceutical development”, p.
- Storage 247-250 (till Modified-release.).
- Small molecule pharmacy contrasted with
biotech RC: Chapter 9 by R. Lipp og E. Punger:
*In-class Short Study Tour orientation “Formulation of Biotech products”, p. 173-185.
DIS Fall 2010 Medical Biotechnology and Drug Development
Wednesday, 13:00-17:00
Sep. 8 Field Study: Health Sciences Library
Sep. 9- Short Study Tour in Western
Sep. 11 Denmark
5. Monday, Drug discovery and development Links on DISforum:
Sep. 13 Clinical trials “Q&A: Drug trials”
- Ethics “Drug volunteers’ ‘living hell’”
- Organization and planning “Doubt cast over drug trial safety”
- Clinical trial from hell: TeGenero “Horror clinical trial in test tube recreation”
Patent law RC: Chapter 4: “The drug development process”,
- General principles p. 84-88.
- Special concerns regarding Chapter 10 by D. B. Resnik: “Patents and in the
biopharmaceuticals Pharmaceutical Biotechnology Industry: Legal
and Ethical Issues”, p. 187-197.
6. Thursday, TEST 1: Drug discovery and development RC: Chapter 1:”Basic concepts in Immunology”, p.
Sep. 16 1-7 + 10-35.
Biotechnological tools
Immunology PB: Chapter 6: “Immunogenicity of Therapeutic
- General and specific immunity Proteins”, p. 125-132.
- Cells of the immune defense
- Antibodies
- Immunological assays
- Immunogenicity of biopharmaceuticals
7. Monday, Biotechnological tools DDD: Chapter 6: “Choosing the target”, p. 67-72.
Sep. 20 Target identification Chapter 7: “ The role of genomics and
- Genomics bioinformatics”, p. 77-87 (till Pharmacogenetics..)
- Proteomics + 89-96.
- Bioinformatics
- Knockout mice PB: Chapter 7: “Genomics, Other “Omics”
Technologies, Personalized..”, p. 133-135 .
Student presentations: Epitherapeutics+Exiqon
8. Thursday, Biotechnological tools PB: Chapter 3: Production and downstream
Sep. 23 Production, fermentation and processing processing of Biotech Compounds, p. 49-57
- Bacterias and eukaryotic organisms (including figure 3) + 62-65.
- Bioreactors
- Processing
Example: Percell
9. Monday, Biotechnological tools PB: Chapter 7: “Genomics, Other “Omics”
Sep. 27 Genetically engineered animals Technologies, Personalized..”, p. 148-153 (till
- Chimeras and xenotransplants Knockout Mice). (5½)
- Drug producing animals (pharming)
*In-class Long Study Tour Orientation*
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DIS Fall 2010 Medical Biotechnology and Drug Development
10. Thursday, Test 2: Biotechnological tools DDD: Chapter 12: “Biopharmaceuticals”, p. 188.
Sep. 30
Biomedicines PB: Chapter 5: “Pharmacokinetics and
Peptides Pharmacodynamics of Peptide and Protein
- Properties Drugs”, p. 95-108.
- Pharmacokinetics Chapter 7: “Genomics, Other “Omics”
- Peptidomimetics Technologies, Personalized..”, p. 161-162.
- PEGylation
Student presentations: Virogates
Oct. 3- Long study tour to Edinburgh
Oct. 8
11. Monday, Biomedicines PB: Chapter 21: “Vaccines”, p. 405-407 (till
Oct. 11 Vaccines Uptake) + 411-412 (Conventional vaccines) + 414-
- Conventional vs. modern vaccines -425.
- Therapeutic vaccines
Wednesday, 8:30-12:30
Oct. 13 Field Study: Group company visits
12. Thursday, -
Oct. 14
13. Monday, Biomedicines Links on DISforum: “Monoclonal Antibodies” (6)
Oct. 18 Antibodies
- Structure and production PB: Chapter 15: “Monoclonal antibodies: From
- Therapeutic uses of antibodies structure to therapeutic Application”, 309+312-
- Example: Genmab 319.
Chapter 16: “Monoclonal antibodies in cancer”,
Student presentations: Symphogen p. 354-356 (till Cetuximab).
14. Thursday, Biomedicines PB: Chapter 8: “Gene therapy”, p. 175-185 (till
Oct. 21 Gene therapy Adenoviruses)+193-198 (till The role of drug..)
- Ex vivo vs. In vivo 202.
- Disease targets
- Vectors, viral and non-viral RC: Box 14.2 from “Nucleic-acid and cell-based
therapeutics”.
15. Monday, Biomedicines PB: Chapter 9: “Oligo-nucleotides”, p. 211-222.
Oct. 25 Nucleotides
- Antisense, triple helix, Transcription factor
decoys
- SiRNA
- Aptamers
Student presentations: Santaris
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DIS Fall 2010 Medical Biotechnology and Drug Development
16. Thursday, Biomedicines PB: Chapter 14: “Recombinant Coagulation
Oct. 28 Recombinant coagulation factors Factors and Thrombolytic Agents”, p. 293-297 +
Recombinant thrombolytic agents 298-305.
Student presentations: Novo Nordisk
Test 3: Biomedicines
Oct. 30- Travel Break/Adventure tours
Nov. 14
17. Monday, Biomedicines RC: Chapter 8: “Hormones”, p. 209-214.
Nov. 15 Hormones
- General principles PB: Chapter 12: “Insulin”, p. 265-278.
- Example: Insulin
Example: Novo Nordisk
18. Thursday, Miscellaneous PB: Chapter 7: “Genomics, Other “Omics”,
Nov. 18 Pharmacogenomics Technologies, Personalized..”, p. 140-146.
- Personalized medicine (theranostics):
- Which drug for which person RC: Chapter 14: “Individualization of drug
- High/low metabolizer regimens: integration of ..”, p. 381-399.
- Example: Medical Prognosis
19. Monday, Miscellaneous PB: Chapter 7: “Genomics, Other “Omics”
Nov. 22 Tissue engineering and stem cells Technologies, Personalized..”, p. 162-165.
- Externally grown organs Link on DISforum: “Embryonic stem cell therapy
- Stem cells for acute spinal cord injury”.
RC: Eschenhagen et al.: “Engineering Myocardial
tissue”, p. 1220-1231.
Link on DISforum: “Team Creates Rat Heart Using
Cells of Baby Rats
20. Thursday, Consultation with Regitze on project
Nov. 25
21. Monday, Projects Due RC: Wainwright: “Ethical boundarywork in the
Nov. 29 embryonic stem cell laboratory”, p. 732-748.
Miscellaneous Faggioni: “Anthropological and ethical reflections
Ethics on the production and use of embryonic stem
Stem cells cells”, p. 71-77.
22. Thursday, Presentations, discussion and wrap-up
Dec. 2
23. Thursday, FINAL EXAM 8:00-9:50
Dec. 9
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DIS Fall 2010 Medical Biotechnology and Drug Development
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