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Translational Pharmacology, PhD-course
Translational Pharmacology (from idea to Drug and Biotech Company)
COOORDINATOR: Thue W. Schwartz, E-mail: tws@sund.ku.dk. Laboratory for Molecular Pharmacology, Department of Pharmacology, Institute of Neuroscience and Pharmacology, The Panum Institute.
For registration please send an e-mail to: helle.hegelund@sund.ku.dk before June 15, 2011. There are only few slots left, so be fast to register.
DEFINITION: Translational pharmacology is an overarching term encompassing the steps that must be taken to move (or translate) basic molecular pharmacological science into a final and fully approved drug. Thus “Translational Pharmacology” resembles the term “Translational Medicine” that covers the steps needed to translate basic research at the laboratory bench to the bed-side (to an ultimate clinical use for patients).
TEACHERS: From the Department of Pharmacology in close collaboration with guest teachers from the pharmaceutical industry and from Danish Biotechnology companies involved in drug discovery and development.
OBJECTIVES: The rapid and important translation of knowledge and discoveries concerning biomolecular target molecules to drug candidates and on to final, approved medical drugs involves multiple overlapping disciplines which will be cover in the course. It has become increasingly clear that this complex process needs extra focus to improve the outcome. It is the objective of the course in Translational Pharmacology to enable the student to understand the basics of the multiple interdisciplinary processes which are involved from the initial idea to the final drug at the marked.
DURATION: 2 weeks from 9.15 to 16.00 every day. The course starts Monday June 20, 2011 at 9.15 and ends Thursday June 30 at 16.00. The teaching takes place in the DAM auditorium at the Panum Institute.
FORM AND CONTENT: The number of lectures is 25 hours and the number of practical classes is 25 hours. The main topics in the lectures include:
1. Drug discovery – From drug targets to preclinical development candidate –
In vitro-
- Selection of drug targets – from clinical medicine (unmet medical need), pathophysiology, receptology, molecular biology to cloned drug target.
- Drug molecules – small molecule discovery, biopharmaceutical, monoclonal antibodies, SiRNA etc.
- In vitro efficacy on cloned targets - and ex vivo tissue / cellular models
- ADMET – in vitro models - microsomal stability, CACO cells etc.
In vivo –
- efficacy in disease models / predictability of animal model for human
disease, transgenic models / etc.
- pharmacokinetics (drug delivery devises etc.) / bioanalysis
- biomarkers
2. Preclinical drug development -
- chemical upscaling, CMC issues
- toxicology - acute / chronic, embryo/genetic etc.
3. Clinical Drug development –
- Phase-I – design / safety and tolerability (phase I/II) / biomarkers
- Phase-II – design / efficacy and safety in patients / end points real and
pseurogate etc.
- Phase-III (and IV) – design / efficacy and safety in larger populations
(pharmacogenomic aspects)
4. Regulatory affairs -
5. Marketing – the importance of marketing for in all phases of drug discovery – medical need versus real world, third world diseases etc.
The classes will be based on discussions of the topics in the lectures and practical courses. Case-studies and recent papers will be included when possible. The students will work in groups during most of the classes, and will work on a final project within drug chemistry (mainly computational chemistry) or biotech-company evaluation that should be presented for the rest of the students the last day of the course.
ECTS: 6.5 (only valid for Ph.D. students)
Recommended Reading: Principles of Pharmacology, The Pathophysiologic Basis of Drug Therapy, David E. Golan, LippincottWilliams and Wilkens, 2005, plus supplementary notes and distributed written exercise material.
Assessment: The course will be evaluated by a15 minutes oral presentation at the last day of the course.