Medical Biotechnology and Drug Development Summer 2016 Session II - Study ...
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Medical Biotechnology and Drug Development
Summer 2016
Session II
Course Schedule
Tuesday, June 14- Friday, July 1
Location: Vestergade 10-A12 (unless stated otherwise)
Copenhagen Component: Tuesday, June 14 – Friday, June 17 and Monday, June 27 – Friday, July 1.
There will be 8 teaching days and one day with a final exam during the Copenhagen portion of the course.
Edinburgh Component (Study Tour): Monday, June 20 – Friday, June 24
Instructor
Susana LS Dietrich
Assistant Program Director of Science & Health, DIS.
Ph.D. (Biomedical Sciences, University of Porto, Portugal, 2007). M.Sc. (Biotechnology, De
Monfort University, 1998), Licenciatura (Microbiology, Portuguese Catholic University, Por-
tugal). Post-doc positions in immunology and microbiology (Biomedical Center, Lund Univer-
sity, Sweden; Biotech Research and Innovation Center, and Center for Medical Parasitology,
Copenhagen University, Denmark). With DIS since 2011.
Email:
Richard Karlsson
Ph.D. (Molecular Medicine, Lund University, Sweden, 2003) M.Sc. (Molecular Biology, Lund
University, 1996). IHCRA at PRA Health Sciences (since 2015). Post-doc (Inst. of Biomedical
Sciences, Univ. of Copenhagen, Denmark, 2011), Sales Manager Life Science (S & W, 2006),
Research Assistant (Dept. of Tumor Immunology, Lund University, 1999), Laboratory Engi-
neer (Pharmacia-Upjohn, 1997). With DIS since 2013.
Email:
DIS Contacts
Lisbeth Borbye, Program Director
Cameron Matticks, Program Assistant, phone:
Science & Health Office, Vestergade 10- B12
Description of Course
The emphasis of the course is on biomedicine, drug discovery & development, showcased through a focus on
the European pharmaceutical and biotech research community.
Medical Biotechnology and Drug Development Session II| DIS – Danish Institute for Study Abroad |
Related Disciplines: Biology. Biomedicine/Biotechnology. Pre-Medicine/Health Science 1You will learn about the general principles of drug discovery & development, including safety, toxicology, for-
mulation, registration, and clinical trials. The course will explore the opportunities and challenges biotechnolo-
gy has for medicine such as the different new types of biotechnological drugs, gene therapy, personalized med-
icine, stem cells, genetically engineered animals, and others.
The course will incorporate some group work in class, as well as a group study tour assignment.
Group work will prepare you for working environments in professional life, where people with different back-
grounds collaborate with a common goal.
Prerequisites
One year of biology and one year of chemistry at 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
Texts & Readings
Edited by Daan J. A. Crommeling and Robert D. Sinclair: Pharmaceutical Biotechnology – An Introduc-
tion 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)
Reading compendium (hereafter referred to as RC)
Additional readings will be found on Canvas
Course components
Lectures, class discussions, solution sessions (alone/in groups), case studies, group assignments and presenta-
tions, field studies and guest speakers.
Medical Biotechnology and Drug Development Session II| DIS – Danish Institute for Study Abroad |
Related Disciplines: Biology. Biomedicine/Biotechnology. Pre-Medicine/Health Science 2Evaluation
Participation 10%
Test 20%
Study tour assignment 20%
Drug development Project 20%
Final 30%
Participation
Participation is determined by attendance, preparation and engagement in class. Students are expected to
attend every course meeting, and attendance will be actively monitored; this will also help me learn your
names. If you are ill and unable to come to class you must email the instructors. Points will be deducted from
your grade for more than one “unexcused” absence. If you miss multiple classes, the Director of Teaching and
Learning and the Director of Student Affairs will be notified; both will follow-up with you to make sure that all
is well.
To prepare for each day, you are required to read all assigned material using the study questions for that day,
participate in a survey on Canvas, and vote on the most challenging study questions. Based on those results,
class time will be more focused on certain areas of study.
Students will also be asked to address some of the study questions in class: this will be a part of the evaluation
parameter, “preparation.” For those students that did not have a chance to share their input in class, they 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 stu-
dents 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 in-
to consideration when the student’s participation assessment is made.
Tests
There will be a 40-minute test on Drug discovery and development, and a comprehensive final exam. Tests will
be formatted to contain the following types of questions:
Information recall
Concept explanation and synthesis
Problem analysis
Field studies
Wednesday, June 29: 13:00-16:00: Novo Nordisk
Practical Information
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 obliga-
tion to your fellow classmates and yourself to come prepared to class.
Medical Biotechnology and Drug Development Session II| DIS – Danish Institute for Study Abroad |
Related Disciplines: Biology. Biomedicine/Biotechnology. Pre-Medicine/Health Science 3Questions and feedback
If you have questions regarding the readings, lectures, or assignments, you are always welcome to contact us
by email. You can also email Program Assistant Cameron Matticks, , to set up an appointment or ask a ques-
tion. The Program Director for this course is Lisbeth Borbye,. Both the Program Assistant and the Program Di-
rector 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 as-
sumes that all students do their own work and credit all work or thought taken from others. Academic dishon-
esty 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 Sean Green, ,
to coordinate this. Upon DIS approval, students should inform the instructor of accommodations within the
first 2 days 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.
Policy on late papers and/or assignments: Late assignments will be accepted, but your grade for the paper will
be reduced by half a letter grade for each day that it is late.
DIS Canvas
DIS Canvas is a web-based system that allows you to access course resources and communicate with your
classmates and faculty. To access the DIS Canvas, you can go to the DIS homepage and click the ‘DIS Canvas’
link, or go to: disabroad.instructure.com/. You can also download the Canvas App (By: Instructure) on iPhone
and Android mobile smart phones.
For each class there is a set of study questions related to the topic. These are to help you go through the mate-
rial. There is a survey on “which questions were challenging” for each set of study questions. Before each class,
you are expected to use the survey to indicate which study questions you found difficult. This helps the teacher
to during class to focus on the areas perceived as most challenging.
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.
Medical Biotechnology and Drug Development Session II| DIS – Danish Institute for Study Abroad |
Related Disciplines: Biology. Biomedicine/Biotechnology. Pre-Medicine/Health Science 4Study Tour
Study tour dates: Monday June 20- Friday June 24.
Location: Edinburgh, Scotland
Objectives:
To learn about the newest and most innovative biotechnology-based methods for diagnosis and treat-
ment 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 ex-
plore their work
To explore the differences between Denmark, the US and UK within the Biomedicine field
To visit cultural landmarks and institutions in the historical cities of Denmark and Europe
To develop questions for further learning/research
To engage in your personal learning process outside the classroom by actively participating and chal-
lenging your current ideas and assumptions.
To get to know your fellow students and professor in an educational and social setting outside DIS.
Study tour assignment (You will receive a more detailed hand-out of ST Assignment in class)
Assignment will be carried out in groups.
Final group presentation in class on Thursday June 30.
Reflection Write up due on Thursday June 30.
Drug development Project (You will receive a more detailed information in class)
As a group, you will research the clinical development of a drug by a Scandinavian Biotechnology/Drug Devel-
opment company of your choosing. The drug must currently be or have recently been in clinical development.
You will present your work orally in class.
Medical Biotechnology and Drug Development Session II| DIS – Danish Institute for Study Abroad |
Related Disciplines: Biology. Biomedicine/Biotechnology. Pre-Medicine/Health Science 5LECTURE TEXT
Week I (June 14 – June 17)
Tuesday *Pick Up your textbooks and compen-
June 14 dium before or after classes today, DIS
Book pick up: Tuesday June 14, 13.00-
20.00, Vestergade 23 – 2nd floor
13.30- 15.30 Introduction to the course DDD: Chapter 1: “The Development of the
- What is biotech? pharmaceutical industry”, p. 14-18 (Concluding
Susana - History of biotech remarks)
Dietrich (SD) - Why biotech in Denmark? Chapter 3: “Therapeutic modalities”, p. 34-40
(from conventional therapeutic drugs).
Chapter 4: “The Drug discovery process: general
Overview of drug discovery and principles and some case histories”, p. 43-46
development process (until “Some case stories”) + p. 50 (“Comments
- Phases in DD & DD and Conclusions”).
- Introduction to pharmacology Chapter 14: “Drug development: introduction”,
- Terms and concepts p. 203-209.
- Small molecules vs. biopharma-
Links on CANVAS:
ceuticals
Biotechnology industry - E&Y Report 2013
RC: Chapter 2: “The drug development pro-
cess”, p. 29-33.
Wednesday
June 15
8.30- 9.50 Drug discovery DDD: Chapter 2: “The nature of disease and
Guest lecture by Morten Grunnet the purpose of therapy” p. 24-27 (until
Target identification “Pharmacoepidemiology and Pharmacoeco-
- Disease models nomics).
- Screening Chapter 4: “The Drug discovery process: gen-
- Small molecule pharmacy con- eral principles and some case histories”, p. 50-
trasted with biotech 54 (from “The Stages of Drug Discovery until
Project Planning).
Chapter 6: “Choosing the target”, p. 63-65
(until Conventional Strategies for Finding New
Drug Targets).
Chapter 11: Pharmacology: its role in drug dis-
covery”, p. 157-59 (until “Interpretation of bind-
ing assays”) + p. 161 (until “In vitro profiling”) +
p. 164-169.
10.00- 10.20 Introduction to Group work and
Richard Presentations
Karlsson Introduction to Drug Development
(RK) Assignment
Medical Biotechnology and Drug Development Session II| DIS – Danish Institute for Study Abroad |
Related Disciplines: Biology. Biomedicine/Biotechnology. Pre-Medicine/Health Science 610:30-12:00 Drug development DDD: Chapter 12: “Biopharmaceuticals”, p. 184-
- Formulation 186 (from “Pharmacological, Toxicological and
RK - Delivery Drug-Delivery issues with Proteins and Pep-
- Storage tides”).
- Small molecule pharmacy con- Chapter 14: “Drug development: introduction”,
trasted with biotech p. 203-209.
Chapter 16: “Pharmaceutical development”, p.
231-237 (Principles of Drug Delivery Systems).
Chaper 22: “Drug discovery and development –
facts and figures”, p. 329-330 (from “Pipelines
and attrition rates”)
RC: Chapter 3 by R. Lipp and E. Punger: “Formu-
lation of Biotech products”, p. 35-47.
Links on Canvas:
Pharmacokinetic properties (from “As discussed
in Chapter 8,…”)
12:00-13:00 Lunch Break
13:00-14:45 Clinical trials Links on Canvas:
- Ethics “Q&A: Drug trials”
RK - Organization and planning “Drug volunteers’ ‘living hell’”
- Clinical trial from hell: TeGenero “Doubt cast over drug trial safety”
- Patent law “Horror clinical trial in test tube recreation”
RC: Chapter 4: “Patents in the Pharmaceutical
Biotechnology Industry: Legal and Ethical Is-
sues”, p. 48-54.
15.00-16.00 Study Tour Orientation
- Introduction to Study Tour Assignment
RK - Practical Information
**Study Tour Groups Formed**
Drug Development group work
Thursday
June 16
9:00-11:30 Group work
** Study Tour Fact sheets are due by
16.00 via e-mail to Cameron Matticks
at
Medical Biotechnology and Drug Development Session II| DIS – Danish Institute for Study Abroad |
Related Disciplines: Biology. Biomedicine/Biotechnology. Pre-Medicine/Health Science 711:30-12:30 Lunch Break
12:30-14:00 Peptides PB: Chapter 5: “Pharmacokinetics and Pharma-
- Properties codynamics of Peptide and Protein Drugs”, p.
SD - Pharmacokinetics
95-108.
- PEGylation
Change of - Hormones as example Chapter 7: “Genomics, Other “Omics” Technol-
location:
ogies, Personalized.”, p. 161-162.
V10 – A33
RC: Chapter 7: “Hormones”, p. 79-84.
14:15-15:30 Safety assessment and toxicology DDD: Chapter 15: “Assessing drug safety”, p.
Guest lecturer: Louise Lauritsen 211-222 (until other studies).
Guest Chapter 20: “Regulatory affairs”, p. 294-296
- From animal testing to clinical (until “Environmental considerations”).
trials
RC: Chapter 2: “The drug development pro-
- Small molecule pharmacy con-
cess”, p. 25-30.
trasted with biotech
Friday
June 17
9:00-09:45 Test: Drug discovery and develop-
ment
10:00-11:20 Genetics in target identification DDD: Chapter 6: “Choosing the target”, p. 67-72
- Genomics and proteomics (from “New strategies for identifying drug tar-
RK - Microarray gets” until “Target Validation”).
- Bioinformatics
- Knockout mice Chapter 7: “The role of information, bioinfor-
matics and genomics”, p. 82-89 (until “Phase 0
clinical studies… ).
Chapter 7: “The role of information, bioinfor-
matics and genomics”, p. 77-79 (until “General
principles for data mining”).
PB: Chapter 7: “Genomics, Other “Omics” Tech-
nologies, Personalized..”, p. 133-135 .
11:20-13:00 Lunch Break
Medical Biotechnology and Drug Development Session II| DIS – Danish Institute for Study Abroad |
Related Disciplines: Biology. Biomedicine/Biotechnology. Pre-Medicine/Health Science 813:00-14:30 Nucleotides PB: Chapter 9: “Oligonucleotides”, p. 211-222.
- Antisense, triple helix, Transcription RC: Chapter 5: “Aptamers as therapeutics”
RK factor decoys p.64-75. Note: the “Aptamers in the clinic”
- siRNA should be considered as examples alone.
- Aptamers
14:45-15:45 Biotech Group Presentation I + 2
Week II
Study Tour to Edinburgh
Monday June 20 – Friday June 24
Week III (June 27 – July 1)
Monday
June 27
9:00 – 12:00 Gene therapy PB: Chapter 8: “Gene therapy”, p. 175-185 (till
- Vectors, viral and non-viral Adenoviruses) + 193-198 (till The role of drug)
RK - Ex vivo vs. in vivo 202.
- Disease targets and examples of ap- RC: Chapter 6: Product case study: Gendicine.
plications
Links on Canvas:
“Hemophilia B Gene Therapy Breakthrough”
“A Shield Against Chemotherapy
Stem cells PB: Chapter 7: “Genomics, Other “Omics” Tech-
- Introduction to stem cells nologies, Personalized”, p. 162-165
o Types of stem cells RC: Chapter 9: Regulatory Issues for Personal-
o Sources and uses of stem ized Pluripotent Cells
cells
- Paper debate/discussion Links on Canvas:
o Nat Methods paper “Small molecules facilitate rapid and synchro-
nous iPSC generation”, Abstract, Introduction
and Discussion
12:00-13:30 Lunch Break
13:30- 14:30 Group Presentation 3 + 4
14:45 -15:45 Group Presentation 5 + 6
Medical Biotechnology and Drug Development Session II| DIS – Danish Institute for Study Abroad |
Related Disciplines: Biology. Biomedicine/Biotechnology. Pre-Medicine/Health Science 9Tuesday
June 28
9:00-12:00 Immunology Links on Canvas:
- General and specific immunity Immunobiology’s Basic concepts in Immunology
SD - Cells of the immune defense - p. 1 to 7 + 10 to 16 + 21 to 31 (until end 1-
- Interplay of the immune defense 20) + 33 (from 1-23) to 35
cell
- Immunogenicity of biopharmaceu- PB: Chapter 6: “Immunogenicity of Therapeutic
ticals Proteins”: p. 125-132.
12:00-13:00 Lunch
13:00- 14:20 Antibodies PB: Chapter 15: “Monoclonal antibodies: From
- Structure and production structure to therapeutic Application”, 309+312-
- Therapeutic uses of antibodies 319.
- Examples Chapter 16: “Monoclonal antibodies in cancer”,
p. 354-356 (until Cetuximab).
Links on Canvas: “Monoclonal Antibodies” (6)
Wednesday
June 29
8:45-11:25 Vaccines I Links on Canvas: Immunobiology’s “Modulating
Guest lecture by Jes Dietrich the immune response to fight infection”: p. 577
Guest -Conventional vs. modern vaccines – 586 (until 14.23) + p.587 – 588 (14.24 ) +
-Adjuvants p.589 – 590 (14.26) + p.591 – 592 (14.28 and
summary).
SD Vaccines II PB: Chapter 21: p.412 (Conventional vaccines
- Vaccines recap onwards) – 425.
- Conventional vs. modern vaccines
- Therapeutic vaccine examples
- Adjuvants
- Immunization
- Cancer vaccines
- Immune complexes
11:25 Go to Novo Nordisk (lunch will be
provided by DIS)
13:00 – Visit to Novo Nordisk
16:00
Medical Biotechnology and Drug Development Session II| DIS – Danish Institute for Study Abroad |
Related Disciplines: Biology. Biomedicine/Biotechnology. Pre-Medicine/Health Science 10Thursday
June 30
9:00-11:30 Case study immunogenicity Links on Canvas:
“Minimizing immunogenicity of biopharmaceu-
ticals by controlling critical quality attributes of
proteins”
11:30-12:30 Lunch
12:30- 14:30 Course wrap- up Details TBA
- Study Tour Assignment presenta-
tions
- Study tour Reflection write up due
Course concluding social
Details TBA
Friday
July 1
10:00-12:00 Final Cumulative Exam
Medical Biotechnology and Drug Development Session II| DIS – Danish Institute for Study Abroad |
Related Disciplines: Biology. Biomedicine/Biotechnology. Pre-Medicine/Health Science 11You can also read
