Roger Schibli: Catalogue data in Spring Semester 2019

Name Prof. Dr. Roger Schibli
FieldRadiopharmacy
Consultation hoursBy appointment
Address
Inst. f. Pharmazeutische Wiss.
ETH Zürich, HCI H 431
Vladimir-Prelog-Weg 1-5/10
8093 Zürich
SWITZERLAND
Telephone+41 44 633 74 64
Fax+41 44 633 13 67
E-mailroger.schibli@pharma.ethz.ch
DepartmentChemistry and Applied Biosciences
RelationshipFull Professor

NumberTitleECTSHoursLecturers
227-0383-00LMedical Imaging I Restricted registration - show details
Only for Human Medicine BSc
3 credits3GS. Kozerke, O. Göksel, R. Schibli, M. P. Wolf
AbstractThe course introduces the foundations of noninvasive imaging including X-ray imaging, Computed Tomography, Magnetic Resonance Imaging, Single Photon and Positron Emission Tomography, Ultrasound and Optical Imaging. Besides the physical and technical methodology, the assessment of imaging performance is covered to enable students to identify relative advantages and limitations.
ObjectiveThe course enables students to
1) explain the physical and technical foundations of medical imaging,
2) characterise imaging performance,
3) interpret and analyse image content and
4) make an informed choice of modalities for a given clinical question.
ContentIntroduction + Example case
X-ray and Computed Tomography
Magnetic Resonance Imaging
Nuclear Imaging
Ultrasound Imaging
Optical Imaging
Hybrid Imaging
Clinical imaging case pitches
Summary
535-0002-00LIntroduction to Pharmaceutical Sciences II3 credits2VC. Halin Winter, K.‑H. Altmann, S. M. Ametamey, J. Hall, S.‑D. Krämer, J.‑C. Leroux, D. Neri, U. Quitterer, R. Schibli, C. Steuer
AbstractFirst identification with Pharmaceutical Sciences; motivation for profiling in the Natural Sciences, which are focused on within the first two years as a preparation for the specialized studies; sensitization for the duties and the responsibilities of a person with a federal diploma in Pharmacy; information about job opportunities.
ObjectiveFirst identification with Pharmaceutical Sciences; motivation for profiling in the Natural Sciences, which are focused on within the first two years as a preparation for the specialized studies; sensitization for the duties and the responsibilities of a person with a federal diploma in Pharmacy; information about job opportunities.
ContentIntroduction to Pharmaceutical Sciences by selected milestones of research and development. Overview on research activities at the Institute of Pharmaceutical Sciences, which is focused on drug delivery and development (from concepts to prototypes). Sensitization for communication skills and information management. Demonstration of job opportunities in community pharmacies, in the hospital, in industry, and in the public sector by experts in the different fields.
Lecture notesHandouts for individual lectures.
Prerequisites / NoticeInteractive teaching
535-0900-00LSeminars on Drug Discovery and Development1 credit1KR. Schibli, K.‑H. Altmann, M. Detmar, C. Halin Winter, J. Hall, J.‑C. Leroux, D. Neri, U. Quitterer, G. Schneider, H. U. Zeilhofer
AbstractState-of-the-art information on drug discovery and development by experts from academia and industry.
ObjectiveState-of-the-art information on drug discovery and development.
ContentSeminar series of the Institute of Pharmaceutical Sciences. Experts from academia and industry report on relevant topics.
535-0901-00LFrom A to Z in Drug Discovery and Development2 credits2SJ. Hall, K.‑H. Altmann, M. Arand, M. Detmar, D. Neri, R. Schibli, H. U. Zeilhofer
AbstractThe lecture series takes place at the ETH Hönggerberg and covers a variety of major activities involved in drug discovery: selecting drug targets, technologies used in drug discovery, small, medium and large drugs, objectives of the medicinal chemist, assessing drug safety, principles of personalized medicine, designing clinical trials, how intellectual property is protected, as well as others.
ObjectiveThe objective of the course is to gain a global understanding of most of the important phases in the discovery and development of modern synthetic and biological drugs, from the first activities to clinical trials. The lecture is intended for students that have an interest in the area and/or may consider a career working in drug discovery. This lecture course complements knowledge and experience gained in the research project performed by the PhD student.
ContentFifteen two hour lectures for life-science PhD students, given by experts from the ETH, UZH, USZ and the pharmaceutical industry.
Introduction to the modern drug discovery process - Principles of drug pharmacokinetics and drug metabolism - Computer sciences in drug discovery - Drug targets - In vitro methods in drug discovery - Natural products in drug discovery - Medicinal chemistry: Chemical lead selection/optimization - Nucleic acid-based drugs - Antibodies and therapeutic proteins: Targets and drugs - In vivo molecular imaging in drug discovery - Personalized medicine in drug discovery and development - Drug formulation: Key development consideration, Current new APIs challenges and FDA rising standards - Preclinical safety, adverse drug events and drug-drug interactions - Clinical development steps including trial design - Intellectual property in drug discovery and development
Lecture notesScripts to be uploaded into ILIAS
LiteratureTo be distributed during the lecture
Prerequisites / NoticeFormally none, but a basic understanding in biochemistry, physiology and chemistry is highly desirable as it will certainly help to get the most from the lectures.
541-0001-00LModule 1: Health System, Pharmabusiness and Marketing
Does not take place this semester.
Only for CAS in Pharmaceuticals.

The enrolment is done by the CAS in Pharmaceuticals study administration.
2.5 credits3GR. Schibli
AbstractStudents learn about the different health systems, primarily about the European and the Swiss specialities, then also in comparison with the US system. A short introduction is made about Marketing with focus on Pharma, the legislation and patents/licencing are discussed and pharmacooeconomic aspects and business development are explained and intensified through workshops.
ObjectivePharmabusiness and Corporate Governance;
Pharmamarketing with workshop;
Healthcare systems in Switzerland and in the EU;
Pharmacoeconomics with workshop;
Data integrity for supply chain powered by blockchain;
Opinion Leader Management, Workshop;
Legislation;
Patents and licences;
Building Pharma 4.0 – Future Directions;
Market Access, Pricing and Reimbursement;
Business Development:
Connected Health;
Lecture notesCourse documents in print and a link to the electronic version are distributed during the module.
541-0003-00LModule 3: Quality and GMP
Does not take place this semester.
Only for CAS in Pharmaceuticals.

The enrolment is done by the CAS in Pharmaceuticals study administration.
2.5 credits3GR. Schibli
Abstract
Objective
541-0004-00LModule 4: Health Communication
Does not take place this semester.
Only for CAS in Pharmaceuticals.

The enrolment is done by the CAS in Pharmaceuticals study administration.
2.5 credits3GR. Schibli
AbstractHealth Communication
Negotiation
Presentation Power
ObjectiveBasics of Health Communication
Knowledge Management
Internal and external communication
Publich Relations (PR)
Intercultural communication
Crisis Management
Communication with Health Authorities
Social media
541-0005-00LModule 5: Pharmaceutical Development and Production
Only for CAS in Pharmaceuticals.

The enrolment is done by the CAS in Pharmaceuticals study administration.
2.5 credits3GR. Furegati Hafner, R. Schibli
AbstractStudents learn about the pharmaceutical drug development process from the analytical characterisation of drug product both for small molecules and biotechnological drug substandes. The learnings include: formulation of clinical and market form, scale-up, 2D/3D printing technology for drugs, clinical trial supply, commercial packaging, supply chain management and continuous manufacturing.
Objective• Analytical characterization of the active pharmaceutical ingredient (API)
• Drug formulation: clinical form and market form
• Analytical characterization of formulations
• Scale-up of manufacturing processes
• Clinical trial supply
• Commercial packaging
• Technical project management
• Supply chain management
• Leading pharmaceutical operational excellence
• Research trends in drug formulation and delivery
Continuing Manufacturing
541-0006-00LModule 6: Regulatory Affairs
Only for CAS in Pharmaceuticals.

The enrolment is done by the CAS in Pharmaceuticals study administration.
2.5 credits3GR. Furegati Hafner, R. Schibli
AbstractStudents learn about the regulatory aspects of drug development, about the Swiss, European and FDA regulations, regulatory information and strategies, personalizing healthcare and the role of companion diagnostics, about special regulations for biosimilars, medical devices, generics, orphan drugs, GMOs and advanced therapeutics incl. gene therapy and pharmacovigilance.
Objective• European regulations for medicinal products
• Clinical trial directives and application procedures
• Marketing authorization procedures in the EU
• FDA regulations
• Swiss authorities and regulations
• Helvetisation of regulatory documents
• Variations and change control
• Pharmacovigilance
• Regulatory aspects of packaging
• Electronic submissions
• Health economics and outcomes research
• Special regulations: Biologics, Orphan drugs, Biosimilars, Pediatrics, Generics
• How to search the web for regulatory information
541-1000-00LEssay
Only for CAS in Pharmaceuticals.

The enrolment is done by the CAS in Pharmaceuticals study administration.
1 credit2DR. Furegati Hafner, R. Schibli
AbstractThe essay is an essential part of the CAS program „Pharmaceuticals – From Research to Market“ (CAS Pharm) and serves as final performance assessment.
ObjectiveThe essay documents the student’s competence development during the program as well as the transfer of acquired knowledge to professional practice/activities.
542-0002-00LModule II: Radiopharmaceutical Chemistry
Does not take place this semester.
Only for CAS in Radiopharmazeutischer Chemie, Radiopharmacy.

The enrolment is done by the CAS study administration.
4 credits6GR. Schibli
AbstractThis postgraduate certificate course consists of three 2-week-modules and enables natural scientists to assume responsibility for the small-batch production and quality control of radiopharmaceuticals.

Module II: Radiopharmaceutical Chemistry
6 x 4hours of laboratory practice in different locations (PSI, ETH Hönggerberg)
Objective• Introduction to radiopharmacy and physics
• Radionuclide production
• Generator systems
• In vitro- and in vivo-characterization of radiolabelled peptides and antibodies
• The chemistry of Tc and Re
• Kits and pitfalls
• Radiopharmaceutical chemistry with halogen isotopes
• 18F- and 11C-radiolabelled pharmaceuticals
• Chemistry of radiometals other than Tc and Re
• Animal and in vitro models
• Practical sessions:
• Radiolabelling and quality control of antibodies
• Mo/Tc-generator and use of kits including quality control and preclinical application
• Ge/Ga-generator and 68Ga-radiolabelling of peptides including quality control/video cell labelling
• Insight into the routine manufacturing of clinical PET radiopharmaceuticals
• 11C- and 18F- radiolabelling for research
• In vitro/preclinical characterization of PET radiopharmaceuticals