Roger Schibli: Catalogue data in Autumn Semester 2021 |
| Name | Prof. Dr. Roger Schibli |
| Field | Radiopharmacy |
| Consultation hours | By 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 |
| roger.schibli@pharma.ethz.ch | |
| Department | Chemistry and Applied Biosciences |
| Relationship | Full Professor |
| Number | Title | ECTS | Hours | Lecturers | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 511-0000-00L | Drug Discovery and Development  Only for MSc Pharmaceutical Sciences. | 2 credits | 1G + 1S | J. Hall, U. Thibaut, K.‑H. Altmann, M. Arand, J. Scheuermann, R. Schibli, H. U. Zeilhofer | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract | This course provides an overview over the concepts and processes employed in today's drug discovery and development. It has an introductory character but will also provide more detailed insights employing real life examples. The course combines lectures and interactive elements with active participation of the students. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Learning objective | Students - Understand the drug discovery process and can explain major approaches and relevant technical terms (for details see lecture notes). - Understand and appreciate the content and timing of drug development process steps, development phases and decision criteria. - Understand the concepts underlying drug product development through all the phases from preclinical and clinical development to regulatory submission, approval and market launch. - Can differentiate between small molecule drug development and biological drug development. - Understand the most important differences between legal and regulatory requirements for drug development and approval for the major markets EU and USA. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Content | Course unit comprises weekly lectures covering the early phases of target and drug discovery (535-0901-01 S "From A to Z in Drug Discovery and Development I") with group work in the area of Drug Development (511-0000-00 G). Group work is 2 full days (Days 1 and 2) and comprises: introduction to the entire suite of drug product development processes in the pharmaceutical industry, covering: preclinical research and development, clinical development, regulatory processes and market launch. R&D support processes such as project management, quality management, pharmacovigilance and pharmacoeconomics will be covered as well as organizational and governance aspects of the pharmaceutical industry. In addition, important success factors for a later career in the pharmaceutical industry will be discussed and highlighted at the end of the course. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Lecture notes | Will be published on "mystudies" | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Literature | G. Nahler (Hrsg.) Dictionary of pharmaceutical medicine, Springer, Wien, 2013 (3rd edition) Further readings will be listed in the lecture notes. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Prerequisites / Notice | This course provides the essential basic knowledge required for the industry-specific modules of the spring semester. Safety conceptt: https://chab.ethz.ch/studium/bachelor1.html | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 535-0001-00L | Introduction to Pharmaceutical Sciences I | 2 credits | 2V | J. Hall, K.‑H. Altmann, M. Detmar, C. Halin Winter, J.‑C. Leroux, U. Quitterer, J. Scheuermann, R. Schibli, H. U. Zeilhofer | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract | First 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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Learning objective | First identification with Pharmaceutical Sciences; motivation for profiling in the Natural Sciences 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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Content | Introduction to Pharmaceutical Sciences by selected milestones of research and development. Overview on research activities at the Institute of Pharmaceutical Sciences that is focussed 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 notes | Handouts for individual lectures. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Prerequisites / Notice | Interactive teaching | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 535-0011-00L | Drug Seminar The course is reserved for students registered in the Master's programme in Pharmacy or in Pharmaceutical Sciences | 5 credits | 9S | A. Burden, K.‑H. Altmann, M. Detmar, K. Eyer, C. Halin Winter, J. Hall, S.‑D. Krämer, J.‑C. Leroux, C. Müller, V. I. Otto, U. Quitterer, J. Scheuermann, R. Schibli, C. Steuer | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract | The course provides a platform for the investigation, presentation and discussion of a topic with relevance to the field of pharmaceutical sciences. Students work in small groups on a chosen topic, they write a mini-review and present their work on a one day symposium. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Learning objective | The main objectives of this course are: - students develop their scientific reflection (Critical Thinking) and working skills by working independently on a relevant pharmaceutical topic - students gain in-depth knowledge of the topic investigated - students train their scientific writing and presentation skills - students train their ability to plan a project and work in a team | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Content | The Course Drug Seminar takes place during the first 7 weeks of the 1. Master semester. It is a compulsory course of the MSc Pharmacy curriculum and an elective course in the MSc PharmSciences. The course provides a platform for the investigation, presentation and discussion of a topic with relevance to the field of pharmaceutical sciences. During the course, students work in small teams on a topic of their choice and elaborate a written mini-review and an oral presentation. Each team is tutored by a lecturer of the Institute of Pharmaceutical Sciences. The work is mainly based on literature search / review, but may also involve conducting interviews or site visits, if appropriate. The final presentations of all groups will take place in the framework of a dedicated Symposium held in the middle of the semester. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Prerequisites / Notice | Only for students of MSc Pharmacy and MSc Pharmaceutical Sciences. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 535-0210-00L | Radiopharmaceutical Chemistry | 2 credits | 2V | R. Schibli, L. Mu | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract | -Molecular imaging in drug development -Radiopharmaceutical syntheses -Knowledge of the physical principles of radioactivity -Structure and function of radiopharmaceuticals -Examples of application in diagnosis and therapy in humans -Targeted radionuclide therapy | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Learning objective | - The students know and are able to describe the different imaging procedures in medicine, especially PET and SPET. - At the end of the lecture, the students are able to explain and describe the physical basics in connection with radioactivity and the different types of radioactive radiation that are relevant in radiopharmacy and nuclear medicine. - The students know how radionuclides can be produced and extracted. - The students can describe the structure and function of radiopharmaceuticals and are able to develop strategies for the design of new radiopharmaceuticals. - The students know selected examples of clinically relevant radiopharmaceuticals and can explain the structure and mechanism of action. - The students can discuss and apply the principles of internal dosimetry of systemically applied radiopharmaceuticals using selected examples. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Content | Introduction to molecular imaging, Radioactive decay, radiation and radionuclides relevant in nuclear medicine. Radionuclide generators Radiopharmaceutical synthesis strategies Heart, brain and tumour diagnostics with radiopharmaceuticals Kinetic modelling with radiopharmaceuticals Tumour therapy with radiopharmaceuticals Dosimetry of radiopharmaceuticals Practical aspect of nuclear medicine and radiopharmacy | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Literature | Book Title: Fundamentals of Nuclear Pharmacy Authors Gopal B. Saha DOI https://doi.org/10.1007/978-3-319-57580-3. Book Title: Radiopharmaceuticals Book Subtitle A Guide to PET/CT and PET/MRI Editors Ferdinando Calabria, Orazio Schillaci DOI https://doi.org/10.1007/978-3-030-27779-6. Book Title Radiopharmaceutical Chemistry Editors Jason S. Lewis Albert D. Windhorst, Brian M. Zeglis DOI https://doi.org/10.1007/978-3-319-98947-1. Access via ETH Library | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Prerequisites / Notice | Prerequisites: basic knowledge in physics and chemsitry | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Competencies |
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| 535-0900-00L | Seminars on Drug Discovery and Development | 1 credit | 1K | R. Schibli, K.‑H. Altmann, M. Detmar, K. Eyer, C. Halin Winter, J. Hall, J.‑C. Leroux, U. Quitterer, G. Schneider, H. U. Zeilhofer | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract | State-of-the-art information on drug discovery and development by experts from academia and industry. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Learning objective | State-of-the-art information on drug discovery and development. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Content | Seminar series of the Institute of Pharmaceutical Sciences. Experts from academia and industry report on relevant topics. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 535-0901-00L | From A to Z in Drug Discovery and Development | 1 credit | 2S | J. Hall, K.‑H. Altmann, M. Arand, J. Scheuermann, R. Schibli, H. U. Zeilhofer | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract | The 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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Learning objective | The 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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Content | Thirteen two hour lectures for life-science PhD students and students of the Pharmaceutical Sciences Master, 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 - Antibodies and therapeutic proteins: Targets and drugs - In vivo molecular imaging in drug discovery - 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 notes | Scripts to be uploaded into ILIAS | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Literature | To be distributed during the lecture | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Prerequisites / Notice | Formally 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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 541-0002-00L | Module 2: Project Management in the Pharmaceutical Industry Does not take place this semester. Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | 2.5 credits | 3G | R. Schibli | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract | Pharma Project Management and Communication | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Learning objective | Project Management Basics: -About projects, project management and the project environment -How to define and plan my project, how to deal with stakeholders and how to manage project risks -Managing my project team, developing the project plan and launching the project -Managing my project team, developing the project plan and launching the project -Monitoring and reporting, project close-out and project leadership -Project evaluation and portfolio management -Budget and resource management Workshop: -Development of a generic drug product in cross-functional project teams Communication: -Intercultural communication -Negotiation skills -Presentation power | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 541-0007-00L | Module 7: Clinical Development Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | 2.5 credits | 3G | R. Furegati Hafner, R. Schibli | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract | Module 7 gives an overview about the several steps that have to be followed during the process of clinical development. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Learning objective | • Preclinical bridge to clinical development • Strategy for clinical development • Regulatory aspects of clinical development • Good clinical practice (GCP) and quality assurance • First in human studies (Phase I), Proof of concept studies (Phase II), Registration studies (Phase III), Post-registration studies (Phase IV) • Monitoring • Organizational and financial aspects of clinical development • Portfolio and life cycle management • Data management and simulation of a clinical study • Personalized medicine | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 541-1000-00L | Essay Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | 1 credit | 2D | R. Furegati Hafner, R. Schibli | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract | The essay is an essential part of the CAS program „Pharmaceuticals – From Research to Market“ (CAS Pharm) and serves as final performance assessment. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Learning objective | The essay documents the student’s competence development during the program as well as the transfer of acquired knowledge to professional practice/activities. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Literature | www.postgraduate.pharma.ethz.ch documents: essay | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 542-0001-00L | Module I: Pharmacy and Legislation Only for CAS in Radiopharmazeutischer Chemie, Radiopharmacy. The enrolment is done by the CAS study administration. | 4 credits | 6G | R. Schibli, R. Furegati Hafner | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract | Module I: Knowledge of the fundamentals of development, preparation, testing and stability of sterile radiopharmaceutical preparations. Acquirement of basic information on European legislation in Radiopharmacy including GMP and Pharmacopoeia. Understanding basics of gene engineering and pharmacokinetics | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Learning objective | • Good manufacturing practice (GMP) of classical radiopharmaceuticals • GMP: industrial point of view • Molecular and cellular aspects of radiobiology • Pharmacopoeia • Pharmacopoeia – how to use it • Design of dosage forms for pharmaceuticals • Pharmaceutical packaging • Methods of preparation of sterile products • Aseptic preparation • The role of excipients in parenteral radiopharmaceutical preparations • Sterility testing and endotoxin determination • Particulate contamination • Principles of medicinal chemistry • An overview of modern pharmaceutical analysis • Genetic engineering • Stability and shelf-life of pharmaceuticals • (in)stability of radiopharmaceuticals • Legislation in radiopharmacy • European directives – GMP • Specific radiopharmaceutical legislation • Clinical trials directive and related documents • The small scale, non-commercial preparation of radiopharmaceuticals • GMP of PET radiopharmaceuticals • Quality assurance and preparation of SOP • Water for pharmaceutical use • Practicals: visit to hospital radiopharmacy • Basic concepts of pharmacokinetics • Drug regulatory affairs • Microbiology in Pharmacy • Visit to pharmaceutical company | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 542-0003-00L | Module III: Radiopharmacology and Clinical Radiopharmacy Does not take place this semester. Only for CAS in Radiopharmazeutischer Chemie, Radiopharmacy. The enrolment is done by the CAS study administration. | 4 credits | 6G | R. Schibli | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract | Knowledge about the fundamentals of pharmacokinetics and pharmacokinetic modelling, the basic concepts of pharmacology and toxicology, radiopharmaceutical monographs in the European pharmacopoeia, radiological imaging modalities and the basics of applied statistics in biomedical research. Understanding the fundamentals of nuclear medicine: Diagnostic applications in neurology and oncology therapy. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Learning objective | • Pharmakokinetics and kinetic-modelling • Statistics and practical session • Radiotracers in biochemistry and molecular pharmacology • Selective modification of peptides and proteins to target GPCRs • Demonstration of experimental set up: Peptide and protein modification, radioactive assays in biochemistry • Visit ABX Radeberg • Nuclear medicine: basics and therapy • Immunology • Drug interventions/interactions/adverse reactions • Pharmacology basics, special aspects, clinical studies • Toxicology • Testsystems in toxicology and targeted therapeutics and cucleic acids • Nuclear medicine: clinical diagnostic applications in neurology • Nuclear medicine: visit to SPECT facility and radiopharmaceutical GMP lag (Tc, Ga, therapy) • Radiological imaging modalities- technology and applications • Nuclear medicine: clinical diagnostic applications in oncology • Radiopharmaceutical monographs in the European pharmacopoeia • Practical session, visit: cyclotron, GMP PET production and quality control, PET and PET/CT, therapy unit • Radioligand-binding-assays/autoradiography • In house tours in groups: radioligand-binding-assays, autoradiography, metabolite analytics with LC-MS, cyclotron and radiochemistry, highlights in Leipzig • Biological effects of radiation • Radiotracer transport and blood brain barrier • Radiotracers for neuroimaging | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||