Clinical Pharmacology: Current Topics and Case Studies

Markus Müller, MD, born August 23, 1967 is a board certified specialist in Internal Medicine and Clinical Pharmacology. He has been trained in Austria, Sweden and the US and currently serves as tenured, full Professor and Head of the Department of Clinical Pharmacology of the Vienna Medical University at the Vienna General Hospital (AKH). He is responsible for ~ 80 staff members. The Department is specialized on clinical research in a wide variety of therapeutic areas and on the development of novel drugs in close collaboration with the pharmaceutical industry. Prof Müller serves on numerous national and international boards (e.g. council member of the European Association for Clinical Pharmacology and Therapeutics; Chairman of the Pharmacological Expert Committee, Association of Austrian Social Insurance Institutions; European Expert, European Medicines Agency (EMEA), London, UK; adjunct faculty member University of Florida, USA). He has also served as chairman of an FDA workshop and is a delegate of the Standing Committee of the European Medical Research Council. Prof. Müller is (Co) Inventor of 2 patents and has received several awards, e.g. the 2004 Tanabe Award of the American College of Clinical Pharmacology (ACCP) in acknowledgement of innovations in clinical pharmacology trials. He is deputy editor of the International Journal of Clinical Pharmacology and Therapeutics and reviewer for numerous scientific journals. He has published > 170 peer reviewed articles, e.g. in the New England Journal of Medicine, Nature Medicine or the British Medical Journal.

1. Introduction
The discipline of Clinical Pharmacology
Markus Müller; Professor of Clinical Pharmacology, Vienna, Austria
Example: EACPT – position paper
Current issues in drug development
Markus Müller; Professor of Clinical Pharmacology, Vienna, Austria
Example: Pfizer
Current issues in drug regulation
Marcus Müllner / Hans Georg Eichler; Professor and Head, Austrian Medicines Agency AGES, Vienna, Austria / Professor and Senior Medical Officer, EMEA, London, UK
Example: EMEA
Current issues in drug reimbursement
Anna Bucsics; Medical Director, Austrian Board of Social Security Institutions
Example: comparative effectiveness

2. Clinical Trials
Ethics of clinical research
Ernst Singer; Professor and Head, Ethics Committee, Medical University Vienna, Austria
Example: Nürnberg, Helsinki, Belmont
GCP, Scientific misconduct
Brigitte Blöchl-Daum; Professor of Clinical Pharmacology, Vienna, Austria
Example: Tuskegee, Vioxx
Phases of drug development, first in man studies
Bernd Jilma; Professor of Clinical Pharmacology, Vienna, Austria
Example: Tegenero
Clinical trials – interventional studies
Michael Wolzt; Professor of Internal Medicine, Vienna, Austria
Example: CAST
Clinical trials – observational studies
Ch. Male / H. Herkner; Professor of Pediatrics, Vienna, Austria/ Professor of Internal Medicine, Vienna, Austria
Example: CDC 'Outbreak'
Pharmacokinetics / Pharmacodynamics
Hartmut Derendorf; Professor of Pharmaceutics, University of Florida, USA
Example: Antibiotic drug development
Microdosing
Graham Lappin; Medical Director, Exceleron, UK
Example: CREAM trial
Epidemiology, statistics
L.Schmetterer / G.Garhöfer; Professor of Physics, Vienna, Austria/ Professor of Clinical Pharmacology, Vienna, Austria
Example: Star signs (multiple hypothesis testing)
Placeboeffects
Johannes Pleiner; Professor of Clinical Pharmacology, Vienna, Austria
Example: Arthroscopy



3. Tools in Clinical Pharmacology
Imaging
Oliver Langer; Professor of Radiopharmaceutics, Vienna, Austria
Example: Aprepitant
Genomics, Pharmacogenomics, druggable genome
Wolfgang Schmidt; Consultant of Genetics, Vienna, Austria
Example: Abacavir
Biomarkers
Volker Wacheck; Consultant of Internal Medicine, Vienna, Austria
Example: Cholesterol
Molecular tools in drug research - translational medicine
Volker Wacheck; Consultant of Internal Medicine, Vienna, Austria
Example: knockout animals - ACE2 (Apeiron)



4. Topics in Clinical Pharmacology

Pharmaceutical drug safety
Martin Brunner; Professor of Clinical Pharmacology, Vienna, Austria
Example: Lipobay

Drug Interactions
Markus Zeitlinger; Professor of Clinical Pharmacology, Vienna, Austria
Example: Saint-John’s-wort

Biological pharmaceuticals: antibodies, proteins, siRNAs
Markus Müller; Professor of Clinical Pharmacology, Vienna, Austria
Example: Alzheimer Vaccine

Advanced therapies
Bernd Jilma; Professor of Clinical Pharmacology, Vienna, Austria
Example: Gene Therapy

Individualization
Markus Müller; Professor of Clinical Pharmacology, Vienna, Austria
Example: breast cancer

Generic drugs, Enantiomers, mee-too´s, biosimilars
Brigitte Blöchl-Daum; Professor of Clinical Pharmacology, Vienna, Austria
Example: PPIs

Special situations, market fragmentation 1: Pediatric and elderly populations, Orphan drugs
Brigitte Blöchl-Daum/ Christoph Male; Professor of Clinical Pharmacology, Vienna, Austria Professor of Pediatrics, Vienna, Austria
Example: EMEA pediatric plan

Special situations, market