Overview
Objectives
- Discover therapeutic advances in standardized transplants, cell-based products, blood products, complex and personalized medicines and innovative drug combinations
- Acquire specialized knowledge of the different innovative therapies and their interaction with biological tissues
- Understand the good manufacturing practices (GMP) required for these new types of medicines
- Develop skills in quality control, quality assurance, and regulatory affairs
- Understand the determinants of clinical applications of ATMPs and combinatorial therapies
Audience
Programme
7 modules :
- Cellular therapy – from bench to bedside
- Immunology
- Transfusion medicine – science and technology from donor to patient
- Combinatorial strategies in cancer treatment
- Oncology: innovative therapies
- Phage therapy
- Nanomedicines
Diploma awarded
Registration
Registration deadline
Fees:
CHF 6'000.-
Admission criteria
- Hold a bachelor’s or master’s degree from a Swiss or foreign university (HEU), from a University of Applied Sciences (HES), or hold another title deemed equivalent by the Steering Committee, and
- Have a minimum of 1 year of professional experience in the health care field
Application File
Admission on file to submit to Formation Continue UNIL-EPFL. Please join to the registration form:
- Letter of motivation
- CV
- Copies of diplomas obtained
Curriculum
Period
Credits
Teaching hours
Providing healthcare professionals with a thorough understanding of these therapeutic breakthroughs is essential to ensure the effective transition of these innovative treatments and care techniques from the bench to the bedside.
Description
- Principles of translational science
Cell biology / Preclinical relevance and evaluation / Biological products specificities - Types of cellular therapy
Sources of cells / Clinical targets / Clinical strategies / Histocompatibility - Clinical trials of cellular therapy
Examples of human applications: burn patients, orthopedics, neuroscience - Regulatory aspects of cellular therapy
Basis in EU and Switzerland for Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) & ATMPs specificities - Production of cellular therapy
GMP / Clean room / Manufacturing technologies / T cells - Visit of a GMP cellular manufacturing facility
Speakers
Description
- Introduction to immunology
Organs, tissues, functions of the immune system / Innate & adaptive immunity - Analytical immunology
Overview / Biomarkers / Immune correlates - Limitations of immunotherapies
Tolerance and autoimmunity / Toxicity /Side effects
Speakers
Description
- Introduction to transfusion medicine
Historical developments / Transfusion chain / Blood groups / Immunohematology / Transfusion-related risks - Biology and biochemistry of blood products
Red blood cells and platelets / Fresh frozen Plasma - Medical aspects
Needs and use of blood products / Apheresis / Hematopoietic stem cells / Clinical cases and practices - Production and regulatory aspects
Blood & special products preparation and manufacturing / Regulations and GMP - Visits of production site and diagnostic labs
Speakers
Description
- Combination therapy
Advantages vs. monotherapy / Combinations strategies in various cancer types / Anti-angiogenic immunotherapy / Pharmacokinetics and pharmacodynamics / Drug resistance principles / Cell death in cancer therapy - Preclinical development
Drug repurposing / Drug interactions and synergies / Immunotargeting / Cell mitosis - Clinical development
Clinical trial development / Successful clinical trials examples / New combination strategies for cancer treatment design - Visit of research laboratories of cell biology and pharmacology
Speakers
Description
- Immunotherapy
Cellular and drug immunotherapies / Checkpoint inhibitors / Monoclonal antibodies - Personalized cellular immunotherapy
Chimeric Antigen Receptor (CAR) T cell / Vaccines / HSCT / Personalized medicine
Speakers
Description
- Introduction to phage therapy
Antibiotic resistance / Bacteriophages / History of phage discovery & phage therapy - Phage banks and production
Personalized phage therapy / Phages production processes - Phage-based pharmaceutical products regulations
Regulation challenges / GMP Basics - Modern translational studies and clinical studies
Phage-antibiotic synergism / Human applications - Practical course
Bacteriophage isolation from the environment
Speakers
Description
- Introduction to nanomedicines
Nanomedicines types / Nanotechnology applications to drug therapies and vaccines / Pharmacokinetics & pharmacodynamics - Nanomedicines technology
Physiochemical properties biocompatibility / Nanoformulations / Critical Quality Attributes (CQAs) - Production and regulatory aspects
FDA and EMA regulations / The many challenges of nanomedicines development, production and clinical practices
Speakers
Partnerships / Collaboration
Diploma delivered jointly by
Director(s)
Prof. Chantal CSAJKA, Faculty of Science, University of Geneva and Prof. Lana KANDALAFT, Faculty of Biology and Medicine, University of Lausanne
Coordinator(s)
Steering committee
- Prof. Chantal CSAJKA, Full professor, Director of the Centre for Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and UNIL; School of Pharmaceutical Sciences, UNIGE
- Prof. Lana KANDALAFT, Chief of Service – Center of Experimental Therapeutics, Lausanne University Hospital and UNIL ; Associate Director for Clinical Translation – Ludwig Institute for Cancer Research
- Prof. Patrycja NOWAK-SLIWINSKA, Associate Professor, Head of the Molecular Pharmacology Group, School of Pharmaceutical Sciences, UNIGE
- Prof. Michel PRUDENT, Associate Professor, Head of Innovation and Therapeutic Products, Transfusion Interrégionale CRS SA; Centre for Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and UNIL
- Dr Grégory RESCH, Senior Lecturer, Head of the Bacteriophage and Phage Therapy Laboratory, Centre for Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and UNIL
Scientific committee
- Dr Grégory RESCH, Senior Lecturer, Head of the Bacteriophage and Phage Therapy Laboratory, Centre for Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and UNIL
- Dr Jean-François BRUNET, Head of the Cell Manufacturing Center, Service of Pharmacy, Lausanne University Hospital and UNIL
- Prof. Lana KANDALAFT, Chief of Service – Center of Experimental Therapeutics, Lausanne University Hospital and UNIL ; Associate Director for Clinical Translation – Ludwig Institute for Cancer Research
- Prof. Alexandre HARARI, Associate Professor, Head of the Tumor Immunology laboratory, Department of Oncology, Lausanne University Hospital and UNIL
- Dr Francesco CEPPI, Lecturer and Medical Oncologist, Unit of Pediatric Oncology Hematology, Lausanne University Hospital and UNIL
- Prof. Patrycja NOWAK-SLIWINSKA, Associate Professor, Head of the Molecular Pharmacology Group, School of Pharmaceutical Sciences, UNIGE
- Prof. Michel PRUDENT, Associate Professor, Head of Innovation and Therapeutic Products, Transfusion Interrégionale CRS SA; Centre for Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and UNIL
- Prof. Gerrit BORCHARD, Full Professor, Head of the Biopharmaceutics laboratory, School of Pharmaceutical Sciences, UNIGE