Certificate of Advanced Studies (CAS)

From November 2023 to
June 2024

Online and onsite ; Lausanne University Hospital ; Blood transfusion center, Bern

Advanced Therapy Medicinal Products

Product manufacturing and clinical use of ATMPs

Certificate of Advanced Studies (CAS)

From November 2023 to
June 2024

Online and onsite ; Lausanne University Hospital ; Blood transfusion center, Bern

Target audience

Healthcare professionals and scientists interested in the emerging field of advanced therapies, including pharmacists, physicians, medical researchers, biologists, healthcare engineers, biostatisticians

Introduction

Advanced therapy medicinal products (ATMPs) such as cell therapy, tissue-engineered medicine or immunotherapy, as well as innovative medicines like phage therapy or nanomedicine, are pushing the boundaries of currently available treatments. Oncology, reconstructive surgery, orthopaedic surgery, neurosurgery, blood transfusion, infectious diseases – clinical applications are numerous.

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.

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

Cursus & Certification

The Certificate of Advanced Studies (CAS) in Advanced Therapy Medicinal Products is combining face-to-face and synchronous online teaching. It totals 392 hours of training, divided into 7 modules.

  • Face-to-face teaching (38h) Plenary sessions, panel discussions, practical laboratory activities, visits of labs and manufacturing facilities
  • Online teaching (84h) Synchronous online teaching, video conferencing, panel discussions
  • Individual work (270h) Readings, work on case studies, report writing

Title obtained: Certificate of Advanced Studies (CAS) in Advanced Therapy Medicinal Products delivered by the universities of Lausanne and Geneva, 16 ECTS credits.

Program

Module 1
Cellular therapy – from bench to bedside

7h face-to-face teaching + 14h online teaching + ~ 45h individual work
Thur November 16, 2023 / Fri November 17, 2023 / Fri February 9, 2024

  • 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

Module leaders: Prof. Lana Kandalaft and Dr Jean-François Brunet

——————————————–

Module 2
Immunology

7h online teaching + ~15h individual work
Fri December 15, 2023

  • 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

Module leader: Prof. Alexandre Harari

——————————————–

Module 3
Transfusion medicine – science and technology from donor to patient

7h face-to-face teaching + 14h online teaching + ~ 45h individual work
Thur Januray 11, 2024 / Fri January 12, 2024 / Thur February 8, 2024

  • 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

Module leader: Prof. Michel Prudent

——————————————–

Module 4
Combinatorial strategies in cancer treatment 

7h face-to-face teaching + 21h online teaching + ~ 60h individual work
Thur March 14, 2024 / Fri March 15, 2024 / Fri March 22, 2024 / Wed June 12, 2024

  • 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

Module leader: Prof. Patrycja Nowak-Sliwinska

——————————————–

Module 5
Oncology: innovative therapies

7h face-to-face teaching + 14h online teaching + ~ 45h individual work
Thur April 11, 2024 / Fri April 12, 2024 / Fri June 14, 2024

  • Immunotherapy
    Cellular and drug immunotherapies / Checkpoint inhibitors / Monoclonal antibodies
  • Personalized cellular immunotherapy
    Chimeric Antigen Receptor (CAR) T cell / Vaccines / HSCT / Personalized medicine

Module leader: Dr Francesco Ceppi

——————————————–

Module 6
Phage therapy

10h face-to-face teaching + 7h online teaching + ~ 45h individual work
Fri April 19, 2024 / Wed June 12, 2024 / Thur June 13, 2024

  • 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

Module leader: Dr Grégory Resch

——————————————–

Module 7
Nanomedicines

7h online teaching + ~ 15h individual work
Fri May 17, 2024

  • 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

Module leader: Prof. Gerrit Borchard

Organisation

  • Faculty of Biology and Medicine (FBM), University of Lausanne (UNIL), Switzerland
  • Faculty of Science, University of Geneva (UNIGE), Switzerland

Steering committee

Co-presidents

  • 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

Members

  • 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

President

  • 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

Members

  • 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

Pour toutes les questions académiques

Dr. Michele Graciotti, Programme coordinator; Project Manager, Center of Experimental Therapeutics, Department of Oncology, Lausanne University Hospital and UNIL

CAS.ATMP@unil.ch

Practical Information

Course venue

Online and onsite:

  • Lausanne University Hospital
  • Blood transfusion center, Bern

Course fee *

6 000.– Swiss francs **

* based on the price of the last edition
** Payment in instalments possible

Enroll

Admission requirements

  • 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

Registration

Admission on file to submit to Formation Continue UNIL-EPFL. Please join to the registration form:

  • Letter of motivation
  • CV
  • Copies of diplomas obtained

Registration deadline

Registration Closed

Be alerted as soon as registration opens for the next edition of this course, register on our Stay Informed platform.

In the media

BROCHURE S'INSCRIRE