Satellite Meetings
The CRISPRMED Satellite Meetings provide an interactive forum for exploring the scientific, regulatory, and societal dimensions shaping the future of CRISPR medicine. Designed as focused, in-depth sessions, they bring together leading researchers, innovators, and regulators to exchange knowledge, address shared challenges, and identify opportunities for collaboration. Through this exchange, the meetings aim to accelerate responsible CRISPR innovation and promote the translation of gene editing technologies into safe and equitable clinical applications.
Participation in the satellite meetings is included in the CRISPRMED26 registration fee and can be selected during the registration process. Please note that a limited number of seats are available for each satellite meeting.
All satellite meetings will be at the CPH Conference Center, 2nd floor, same venue site as the CRISPRMED26 Event. Please also check the google map for details.
Insights and collaborations emerging from these sessions will continue to shape and strengthen the newly established non-profit European Genomic Medicine Consortium (EGMEDC), which will have its official launch at the CRISPRMED26 Opening Reception.
EU Regulatory Requirements
April 13th, 13:00 - 17:00 PM CEST (Sat Meeting Room C - Enghave plads/Kødbyen, CPH Conf Center)
This satellite meeting is intended for developers of CRISPR-based medicinal products across academia, small and medium-sized enterprises (SMEs), and the pharmaceutical industry. The satellite meeting will be structured in three parts. The first part will provide an overview of the applicable regulatory framework and requirements in the EU. The presentations will focus on the quality, non-clinical, and clinical requirements necessary for clinical trial applications and marketing authorizations. The second part will feature a panel discussion where questions from the audience will be discussed. In the last part a “Meet the Expert” session will offer participants the opportunity to engage directly with regulatory specialists and presenters to discuss specific questions and challenges.
Chairs:
Attila Sebe, MD, Ph.D., Clinical Assessor, Paul-Ehrlich-Institute (PEI), Federal Institute for Vaccines and Biomedicines, Division of Haematology, Cell and Gene Therapy, Germany
Lotte Dahl Nissen, Non-clinical Assessor, Danish Medicines Agency (DKMA), Denmark.
Speakers/Program (preliminary):
Patrick Celis, PhD, Lead Scientific Officer, Scientific Lead to Committee for Advanced Therapies (CAT), EMA: Title: EU regulatory framework
Silke Schüle, MSc, PhD, Quality Assessor, Paul-Ehrlich-Institute (PEI). Title: Ensuring quality in gene editing ATMPs: manufacturing, analytics, and future directions
Brigitte Anliker, MSc, PhD, Non-clinical Assessor, Paul-Ehrlich-Institute (PEI). Title: Safe translation of CRISPR-based NHEJ therapies: Non-clinical considerations
Michaela Jung, MSc, PhD, Non-clinical Assessor, Paul-Ehrlich-Institute (PEI). Title: Challenges in the non-clinical evaluation of emerging gene editing approaches
Attila Sebe, MD, PhD, Clinical Assessor, Paul-Ehrlich-Institute (PEI). Title: Trial design for gene editing clinical studies
Lotte Dahl Nissen, MSc, PhD, Non-clinical Assessor, DKMA. Title: The regulator´s perspective, challenges in the evaluation of submissions
Lina Jamis, PhD, Director, Regulatory Affairs & Compliance, Synthego: Enabling Regulatory Success in the CRISPR Space
Panel Discussion: All speakers
Meet the Experts
EU CRISPR Screening and Editing Facilities Forum
April 13th, 13:00 - 17:00 PM CEST (Sat Meeting Room B - Hovedbanegården, CPH Conf Center)
With the rapid expansion of CRISPR technology, dedicated CRISPR Centers and Facilities are emerging worldwide as hubs for innovation, infrastructure support, and education. The CRISPR Medicine conference provides an ideal platform to bring these centers together for the first time, to exchange experience and strengthen collaboration across Europe.
This inaugural CRISPR Screening and Editing Facilities Forum will feature a mix of presentations and discussions focused on advancing technical and organizational aspects of CRISPR infrastructure. Topics include improving HDR efficiencies, developing and sharing screening methodologies, and managing facility operations. The forum will conclude with a panel discussion on practical challenges and opportunities for long-term collaboration among CRISPR Centers.
By fostering dialogue between facility leaders and method developers, this meeting aims to lay the basis for a sustainable network of CRISPR Screening and Editing Facilities.
Chairs:
Pia Johansson, Director and Scientific Coordinator of the Cell and Gene Therapy Core, Lund University, Sweden (chair)
Rob Wolthuis, Head of Oncogenetics & Oncogenomics (OG2), Amsterdam UMC, Netherlands
Agenda
13.00-13.10 Welcome and concept introduction
13.10-13.30 Round of introduction and ”group inventory”
13.30-14.00 Zacharias Kontarakis, Head, Genome Engineering & Measurement Lab (GEML), ETH Zürich. Engineering HDR: Small Molecules, Template Design, and Safety Constraints in Therapeutic Genome Editing
14.00-14.20 Group discussion - Improving HDR efficiencies
Fika break
14.45- 15.35 Method development bites
Valérie Prouzet-Mauléon, CRISP'edit, Université de Bordeaux, France: Optimizing Precise Genome Editing: Advanced Cas12-HDR and VLP-mediated Base Editing Strategies at the CRISP’edit Facility
Felix Neumann, Countagen AB, Sweden: LockSeq: A Scalable Padlock-Probes Based NGS Workflow for High-Fidelity Gene-Editing Validation
Giacomo Frati, National Facility for Genome Engineering and Disease Modelling, Fondazione Human Technopole, Italy; Streamlining hiPSC Genome Editing: Efficient Clonal Isolation and Multi-Layer Quality Control
Renad Khaled Nawafleh : Independent Researcher, affiliated with academic researcher at Al-Ahliyya Amman University, Amman A CRISPR Screening Strategy to Investigate Unfolded Protein Response Regulators in Multiple Myeloma
Cecilia Jimenez-Mallebrera, Institut de Recerca Sant Joan de Deu, Hospital Sant Joan de Deu Barcelona, and CIBERER: Gene Editing Efficacy Through Multiple “Glasses”: expanding the analytical tool box
Bio break 5 min
15.40-16.10 Bernhard Schmierer, Head of Unit, Functional Genomics unit, Stockholm, Sweden The SciLifeLab CRISPR Functional Genomics unit - From Precision Gene Editing to Massively Parallel Genetic Perturbation
16.10-16.35 Laura Battle Morera, Tissue Engineriing Unit head, Center for Genomic Regulation (CRG), Barcelona. The CorEUstem Network experience and the importance of core facilities
16.35-17.00 Panel discussion - establishing a CRISPR facility network?
Access, IP Landscape and FTO
April 13th, 13:00 - 17:00 PM CEST (Sat Meeting Room A - Tivoli - Vesterbros Torv, CPH Conf Center)
Speakers/Program:
Ulrich Storz, Patent Attorney, Co-founder and Senior Partner, Michalski Hüttermann & Partner, Germany. Title: Nobel Prize yes, but enforceable patents no: The complicated patent situation of CRISPR Cas 9 in Europe.
Franziska Bächler, Postdoctoral Researcher and Lecturer, Scientific Manager Center for Life Sciences Law, University of Basel, Switzerland. Title: Incentives in Genomic Medicine.
Jacob S. Sherkow, Professor of Law and Medicine, University of Illinois Urbana-Champaign, USA. Title: CRISPR Patent Licenses: Lessons from History.
Timo Minssen, Professor of Law at the University of Copenhagen (UCPH), Founder and Managing Director of UCPH's Center for Advanced Studies in Biomedical Innovation Law (CeBIL), Denmark. Title: Navigating the European IP Landscape in Genome Editing: Trends & policy options.
Kevin E. Noonan, PhD, Partner at McDonnell Boehnen Hulbert & Berghoff LLP and Co-chair of the Biotechnology Practice Group, USA. The CRISPR Patenting Saga in the U.S. (until now).
Final panel discussion will include: Dr. Meliha Negin, Theo Zacharis, MBA and Dr. Leonardo Martin.