Lectures

Introduction (Monday, 24. 8.): Principles of Gene Therapy and Its Role in Oncology (18:00 – 19:00)

DAY 1 (tuesday, 25. 8.): Development of phIL12 gene therapy drug product for first clinical use

Session 1: Basic principles of IL-12 gene therapy (9:00 – 10:30)

  • Plasmid vectors in cancer therapy: from molecular cloning to preclinical evaluation (Urška Kamenšek)
  • Interleukin-12 gene therapy in preclinical studies and veterinary medicine (Urša Lampreht Tratar)

Session 2: Strategic and Regulatory Pathways for Gene Therapy Translation in Slovenia (11:00 – 12:30)

  • Translation of Gene Therapy in Slovenia: An Overview of the SmartGene.si Project (Gregor Serša)
  • Development of medical device for electroporation in the clinical setting (Matej Reberšek)
  • Regulatory Aspects of Gene Therapy Development: The Transition of phIL12 GET from Preclinical Studies to First-in-Human Application (Tanja Jesenko)

Session 3: Process Development and GMP Manufacturing (13:30 – 15:00)

  • Production Technologies for DNA Vectors (Matjaž Peterka)
  • GMP Production of Biopharmaceuticals (Frenk Smrekar)

Session 4: From Nonclinical Evaluation to Phase I Clinical Trial (15:30 – 17:00)

  • Nonclinical Evaluation of phIL12 Therapy Prior to Clinical Translation (Boštjan Markelc)
  • Phase I clinical trial of phIL12 gene electrotransfer in basal cell carcinoma (Maša Omerzel)

DAY 2 (Wednesday, 26. 8.): CTGCT Workshop

Session 1: (9:00 – 10:30)

  • General Introduction of CAR T for Cancer (Tina Fink)
  • iPSCs As in vitro Models and Therapeutics (Darja Marolt Presen)

Session 2: Developing URBAGEN and the Role of AAVs in Gene Therapy (Duško Lainšček) (11:00 – 12:30)

Session 3: Manufacturing of Viral Vectors: Upstream/Downstream Processing and Process Development Strategies (Jort Altenburg) (13:30 – 15:00)

Session 4: Use Case: Tacrolimus-Resistant Regulatory T Cell Therapy and Its Legal Framework (Leila Amini) (15:30 – 17:00)

Lecturers

Name: Maja Čemažar
Background: Doctor of Philosophy
Specialization: Professor

Contacts:

Prof. Maja Cemazar obtained her PhD in basic medical sciences from the University of Ljubljana. She was a post-doctoral fellow and a researcher at the Gray Cancer Institute, UK and at the Institute of Pharmacology and Structural Biology, France. Currently, she is the Head of Research and Education at the Institute of Oncology Ljubljana and a lecturer in under and post-graduate courses of Cell and Tumor biology. Her main research interest is in the field of electroporation-based treatments – electrochemotherapy and gene electrotransfer – gene therapy. She is actively involved in development and execution of veterinary and human clinical trials on electrochemotherapy and immune based gene therapies. She was a supervisor of 16 PhD students, and more than 30 BSc theses. She is the author of more than 300 articles in peer-reviewed journals. Her H index is 48.


Name: Urška Kamenšek
Background: Doctor of Philosophy
Specialization: Senior Scientific Associate, Assistant Professor

Contacts:

Urška Kamenšek graduated in biology and obtained her PhD from the Faculty of Medicine at the University of Ljubljana in 2010. She is a Senior Research Associate at the Institute of Oncology Ljubljana, where she conducts research at the Department of Experimental Oncology in the field of experimental and translational oncology. Her work contributes to the development of new methods and knowledge, particularly in vector design for gene therapy, with an emphasis on gene electrotransfer. As an Assistant Professor at the Biotechnical Faculty, University of Ljubljana, she is also actively involved in supervising students’ practical work, and mentoring MSc and PhD candidates. Her current research focuses on innovative immunological approaches for cancer treatment.


Name: Urša Lampreht Tratar
Background: Doctor of Philosophy
Specialization: Assistant Professor

Contacts:

Urša Lampreht Tratar graduated from the Veterinary Faculty in 2013 and obtained her PhD in 2018. She is currently employed as a research associate at the Institute of Oncology and the Veterinary Faculty. Her research focuses on preclinical studies combining electrochemotherapy and IL-12 gene electrotransfer, conducted on in vivo models as well as on spontaneous tumors in dogs and cats. In addition, she serves as an assistant professor, supervising and mentoring both master’s and PhD students.


Name: Gregor Serša
Background: Doctor of Philosophy
Specialization: Professor

Contacts:

Gregor Sersa, graduated from the Biotechnical Faculty at the University of Ljubljana in 1978, where he is currently a professor of molecular biology. He is employed at the Institute of Oncology Ljubljana as Deputy Head of the Department of Experimental Oncology. His specific field of interest is the effect of electric field on tumor cells and tumors as drug and gene delivery system in different therapeutic approaches. Besides experimental work, he is actively involved in the education of undergraduate and postgraduate students at the University of Ljubljana. Also, he is Editor in Chief of the international scientific journal Radiology and Oncology.


Name: Tanja Jesenko
Background: Doctor of Philosophy
Specialization: Senior Scientific Associate

Contacts:

Dr. Tanja Jesenko obtained her PhD in basic medical sciences from the Faculty of Medicine, University of Ljubljana in 2014, after completing her BSc in Biochemistry at the Faculty of Chemistry and Chemical Technology in 2010. She gained international research experience at the University of Trieste, Italy, and at the Institute of Pharmacology and Structural Biology in Toulouse, France, where she worked on advanced approaches in molecular oncology and tumor biology. She is now employed as a Senior Scientific Associate at the Institute of Oncology Ljubljana and at the University of Ljubljana, Faculty of Medicine, Department of Oncology. Her work focuses on liquid biopsy and gene therapy in cancer.


Name: Matjaž Peterka
Background: Doctor of Philosophy
Specialization: Chief Executive Officer COBIK

Contacts:

Dr. Matjaž Peterka is biotechnology executive and scientist with a strong track record in bioprocess development, vaccine technologies, and biotechnology innovation management. Currently serving as Chief Executive Officer of Centre of Excellence for Biosensors, Instrumentation and Process Control (COBIK), where he leads multidisciplinary teams working on advanced bioprocessing platforms, vaccines, and antimicrobial technologies. Matjaž has extensive experience bridging academic research and industrial biotechnology, translating scientific discoveries into practical applications and commercial solutions. Throughout his career he has led complex technology development programs, contributed to the introduction of biopharmaceutical products and services to global markets, and managed numerous national and international research and innovation projects. He is an inventor and author of patents and scientific publications and an active contributor to biotechnology entrepreneurship, including founding the vaccine biotechnology company Sferogen.


Name: Frenk Smrekar
Background: Doctor of Philosophy
Specialization: Chief Executive Officer Jafral

Contacts:

Dr. Frenk Smrekar is the Director of JAFRAL d.o.o., a contract development and manufacturing organization (CDMO) specializing in production of bacteriophages, plasmid DNA, mRNA and other biologics. His work focuses on GMP compliant manufacturing processes, quality systems, and technology transfer for various products. He has extensive experience in operational management, regulatory alignment (GMP/ISO), and coordination of international research and industry partnerships in the fields of phage therapy and antimicrobial resistance. At JAFRAL, he oversees facility operations, project execution, client collaborations, and strategic development of production capabilities.


Name: Boštjan Markelc
Background: Doctor of Philosophy
Specialization: Senior Scientific Associate, Assistant Professor

Contacts:

Bostjan Markelc, PhD, is a senior research fellow and Head of the Infrastructure Group at the Department of Experimental Oncology, Institute of Oncology Ljubljana. He obtained his PhD in Biomedicine from the University of Ljubljana in 2013, focusing on the effects of electroporation and electrochemotherapy on normal and tumor vasculature. Following his doctoral studies, he undertook postdoctoral training in France and at the CRUK/MRC Oxford Institute for Radiation Oncology, University of Oxford, where he received a Marie Curie Intra-European Fellowship. His research focuses on tumor vasculature, radiotherapy response, electroporation-based therapies, and gene electrotransfer. He has led several national and international research projects as principal investigator, including ARRS and Slovenia–USA bilateral grants, and currently coordinates the EU Horizon Twinning project ZAP Cancer.


Name: Urška Kamenšek
Background: Doctor of Philosophy
Specialization: Senior Scientific Associate, Assistant Professor

Contacts:

Maša Omerzel received her Ph.D. in Basic Medical Sciences from the Medical Faculty, the University of Ljubljana in 2015. She is employed at the Institute of Oncology Ljubljana at the Department of Experimental Oncology. Her main research interest is in vitro and in vivo preclinical oncology focused on delivery of drug and genes to the cells and tumors with electrohmeotherapy and gene electrotransfer.


Name: Matej Reberšek
Background: Doctor of Philosophy
Specialization: Associate Professor

Contacts:

Matej Reberšek, PhD, is an Associate Professor at the Faculty of Electrical Engineering, University of Ljubljana, Slovenia, and an expert in pulsed power engineering and electroporation technologies. His research focuses on the development of electroporation devices and the application of advanced pulsed electric field technologies in biomedical and biotechnological settings, including electrochemotherapy, gene electrotransfer, and pulsed field ablation. He has authored and co-authored more than 40 scientific publications, which have received over 1,600 citations, and he has an h-index of 20. He actively participates in international collaborations. His work aims to bridge engineering and life sciences, driving innovative solutions for healthcare and industry.


Name: Tina Fink
Academic Background: PhD in Biomedicine, MSc in Biotechnology
Specialization: Research assistant professor

Employer: National Institute of Chemistry, Center for the Technologies of Gene and Cell Therapy (CTGCT)

Contacts:

Dr. Tina Fink is a Research Assistant Professor at the Department of Synthetic Biology and Immunology, National Institute of Chemistry, Slovenia, where she has been employed since 2012. She obtained her Masters degree in Biotechnology from the University of Ljubljana in 2012 and completed her PhD in Biomedicine in 2019. Her doctoral thesis, Designed Protease-Based Signaling Networks, focused on engineering synthetic signaling pathways in mammalian cells. This work resulted in a publication in Nature Chemical Biology and laid the foundation for her current research in synthetic biology and immunotherapy. Her research focuses on the development of innovative gene and cell therapies for cancer, with a particular emphasis on CAR-T cell engineering, lentiviral vector development, and cancer immunotherapy. She is actively involved in the establishment of the Slovenian Center for the Technologies of Gene and Cell Therapy (CTGCT), where she contributes to the development of GMP-compliant upstream manufacturing processes for lentiviral vectors and other technologies required for the production of clinical-grade gene and cell therapy products. Her work also includes the development and characterization of viral vectors, engineering of novel CAR receptors, and the optimization of mammalian cell-based production platforms. In addition to her research, Dr. Fink has led her own postdoctoral research project funded by the Slovenian Research and Innovation Agency (ARIS). She also mentors PhD and MSc students and has supervised student teams in synthetic biology competition iGEM.


Name: Darja Marolt Presen
Academic Background: PhD in Biotechnology
Specialization: Research Associate Professor

Employer: National Institute of Chemistry, Center for the Technologies of Gene and Cell Therapy (CTGCT)

Contacts:


Name: Duško Lainšček
Academic Background: DVM by professional training, PhD in Biomedicine – field Biochemistry and Molecular Biology
Specialization: Research Associate Professor

Employer: Department of Synthetic Biology and Immunology, National Institute of Chemistry, Center for Technologies for Gene and Cell therapies, NIC

Contacts:


Name: Jort Altenburg
Academic Background: BSc in Industrial Engineering, MSc in Biotechnology, PhD in Bioprocess Engineering
Specialization: Bioprocess Engineer, Translational Scientist

Employer: UMC Utrecht

Previous Positions: Upstream Scientist MSD, Key Account Manager Securecell AG

Contacts:


Name: Leila Amini
Academic Background: MSc Molecular Medicine, PhD in Regenerative Therapies
Specialization: Head of Regulatory Affairs BeCAT and Group Leader “Process Development for Cell and Gene therapy” BCRT

Employer: Charité – Universit

Contacts: