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The 3rd mRNA & CGT: CMC, Process Development and Manufacturing Summit, taking place on December 3–4, 2026 in Munich, Germany, will bring together leading experts to examine the newest advancements and unresolved challenges in the development and GMP manufacturing of mRNA-based therapeutics and cell & gene therapies.
As these modalities advance rapidly from early research into late-stage and commercial programs, the demand for robust CMC frameworks, scalable and automated processes, strengthened quality systems, and clear regulatory alignment continues to intensify.The #EmRNA summit provides an essential forum for data-driven discussions, cross-functional collaboration, and problem-solving.
Read moreThe 3rd mRNA & CGT: CMC, Process Development and Manufacturing Summit is the leading European platform dedicated to advancing the development, scale-up, and GMP manufacturing of mRNA-based therapeutics and cell & gene therapies.
Uniting specialists from biotech, pharma, CDMOs, regulatory bodies, and academia, the summit provides a high-level forum to dissect the technical, regulatory, and operational bottlenecks that define the future of advanced biologics.
As mRNA and CGT pipelines accelerate toward clinical and commercial readiness, the summit highlights the most pressing innovations in CMC strategy, process intensification, and manufacturability. Delegates will explore forward-looking topics such as:
The program focuses on industry-critical pain points and real-world approaches for accelerating development while maintaining regulatory compliance. Expert sessions will address how to:
Beyond the technical content, #EmRNA provides a focused environment for cross-functional collaboration among process developers, analytical scientists, regulatory leaders, QA/QC experts, and manufacturing teams. Attendees gain a unique opportunity to benchmark their approaches, exchange best practices, and build partnerships essential to advancing mRNA and CGT products from early development to commercial launch.
Whether you work in CMC, process development, regulatory affairs, manufacturing science & technology (MSAT), or quality, the #EmRNA Summit delivers the insights, data, and strategic direction needed to stay ahead in this rapidly evolving therapeutic landscape.
Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specialising in:
The Early Bird Offer expires in 82 days!
To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.
CMC, Process Development & Manufacturing Strategy
Manufacturing Platforms, Automation & Tech Transfer
Quality, Analytics & Regulatory Expectations
Formulation, LNP Technologies & Next-Gen Constructs
Digitalization, PAT & Real-Time Process Control
The Early Bird Offer expires in 82 days!
About Speaker
About Speaker
About Speaker
About Speaker
About Speaker
Dr. Roland Pach holds a PhD in molecular parasitology at the University Fribourg analyzing the intracellular trafficking of transgenic RNA in human pathogens.
Prior Roche, he was leading the Analytical Development department at Berna Biotech (former Swiss Vaccine and Serum Institute) and the QC department of Bio-Process Development at Merck Serono.
Roland is the global CMC Analytical Technical Lead in the cancer vaccines and cell- & gene therapy (CGT) area of Roche more than 10 years. In his assigned area, he represents Roche in external development projects, industrial consortiums like CGT BioPhorum and numerous due diligences of in-licensing candidates or companies in the CGT fields.
In his second role at Roche as global technical development leader, he had led successfully new formats like immunotoxins from pre-clinics into entry to human (EiH).
Miloud G. NICHANE currently serves as GMP Auditor and Head of Process Validation at LFB. He holds a PhD in Molecular and Cellular Biology, with a doctoral thesis focused on brain development and architect genes. Over the years, Miloud has built a dynamic career across the pharmaceutical landscape, contributing to both global leaders such as GlaxoSmithKline and the Bill & Melinda Gates Foundation, as well as innovative biotech pioneers like Legend Biotech.
Driven by a strong commitment to advancing the Belgian and broader European life sciences ecosystem, Miloud has worked on a diverse range of therapeutic modalities—including plasmids, mRNA, monoclonal antibodies, blood-derived proteins, and CAR-T T lymphocytes. His multidisciplinary experience offers a unique perspective on the vast potential of modern biomedicine.
Steve is the Founder and Chief Consultant for Sinawali Biotechnology Solutions. He was formerly the Vice President of Chemistry & Boulder Site Head for Editas Medicine, where he led the Advanced Technology, Analytical Sciences & Structural Biology, and Process Chemistry teams. He received his bachelor’s degree in Chemistry from UC San Diego, where he received the Harold Urey Award. He completed his Ph.D. work in Biophysical Chemistry at UC Berkeley under Dr. Ignacio Tinoco, where he used 2D-NMR and other spectroscopic techniques to characterize nonstandard DNA structures. In addition to an extensive history directing analytical groups for characterizing oligonucleotides, proteins, small molecules & polymers, he has led efforts to develop new technologies for delivery of CRISPR therapeutics, and has broad experience in leadership, including management, developing future leaders, creating/revising governance programs, and as a site head.
Ilaria Pettinati is a head of process development mRNA at Lonza Geleen. Before joining Lonza, she worked at eTheRNA Immunotherapies NV where she led the mRNA chemistry team. Previously she was at Oxford Biomedica focussing on process development in the field of lentiviral vectors and other biomolecules, including nucleic acids. Ilaria has a master’s in cellular and molecular biology and a PhD in biophysics in the field of drug discovery, obtained in collaboration with the University of Oxford, where she elucidated structural and mechanistic basis of RNA processing enzymes.
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