21st ETPN Annual Event 2026 Recap

Key themes from ETPN 2026

• Translation emerged as the central theme of the conference. Across scientific sessions, regulatory discussions, and clinical panels, speakers repeatedly emphasized that technical innovation alone is insufficient. Scalability, manufacturing robustness, reproducibility, regulatory acceptance, and cost-effectiveness ultimately determine whether nanomedicine technologies can reach patients.
• Manufacturing scalability is increasingly being considered from the earliest stages of development. There is a growing recognition that manufacturability must be integrated into nanoparticle design and development from the onset.
• Advanced analytical characterization is essential. New approaches for single-particle analysis, field-flow fractionation, and Raman spectroscopy are helping researchers better understand nanoparticle composition, loading, and other critical quality attributes.
• The regulatory aspect is moving toward a platform-based approach. Discussions around regulatory assessment reflected a platform mindset, where prior knowledge of established nanoparticle systems facilitates future product development and regulatory evaluation.
• Biology continues to reveal new opportunities for delivery technologies. Insights into protein coronas, nanoscale recognition and cellular communication pathways may inspire future generations of delivery systems with higher delivery efficiency.
• Close collaboration between researchers, clinicians, industry, and regulators is becoming increasingly important. Several discussions highlighted the need to align technology development with real clinical needs and translational requirements early in the innovation process.

Selected presentation highlights from ETPN 2026

Among the many talks presented at ETPN 2026, we selected a few that particularly resonated with our team due to their relevance to RNA-LNP delivery, targeted therapeutics, manufacturing, and clinical translation.

Nucleic acid nanomedicines: Design rules and surprises (Prof. Raymond Schiffelers, University Medical Center Utrecht & NanoCell Therapeutics)

Prof. Raymond Schiffelers delivered a keynote lecture exploring the evolution of nucleic acid nanomedicines, from clinically established lipid nanoparticle (LNP) systems to emerging strategies for targeted delivery and in vivo cell engineering.

Key highlights:

• MC3-based LNPs established the foundation for RNA delivery to the liver. Originally developed for siRNA delivery, MC3 enabled the first approved siRNA-LNP therapeutic. The same platform can also efficiently deliver mRNA, resulting in rapid liver accumulation, transfection of virtually all hepatocytes, and high protein expression.
• The next challenge is extra-hepatic delivery. Several examples illustrated how subtle changes in LNP composition, including PEG-lipid type and PEG-lipid/ionizable lipid content, can dramatically influence biodistribution and immune responses. Optimized formulations showed strong potential for targeting immune organs such as the spleen and enhancing T-cell activation.

• RNA therapeutics continue to expand beyond vaccines. Applications discussed included enzyme replacement therapies, personalized cancer immunotherapies, and immune-modulating RNA cocktails combining cytokine-encoding mRNAs such as IL-7, IL-21, and 4-1BBL.
• Manufacturing innovation remains critical for translation. A strategy involved loading mRNA into pre-formed LNPs, effectively decoupling nanoparticle production from payload incorporation.
• Extracellular vesicles (EVs) versus LNPs. A head-to-head comparison highlighted the strengths and limitations of both delivery systems. While EVs demonstrated approximately 1000-fold higher biological activity in vitro, quantitative analyses revealed surprisingly low sgRNA cargo loading, with an estimated 1 RNA molecule per 1,000,000 EVs, compared with roughly 200 RNA molecules per LNP. In contrast, LNPs offer major practical advantages, including reproducibility, scalability, rapid manufacturing, and well-defined compositions. The findings reinforce the clinical utility of LNPs while raising intriguing biological questions about the mechanisms underlying the remarkable activity of EVs and their role in natural intercellular communication.
• In vivo CAR-T generation is emerging as a promising strategy to make cell therapies more accessible. Prof. Raymond Schiffelers presented the NanoCell Therapeutics’ targeted LNP platform for DNA-based gene delivery designed to generate CAR-T cells directly in patients. The approach combines a 4-lipid LNP formulation, minicircle DNA (mcDNA) encoding CAR or TCR constructs, transposase in RNA format, and T-cell targeting and activation ligands. Using the SB100X Sleeping Beauty transposon system for stable genomic integration, the platform aims to eliminate complex ex vivo manufacturing workflows while enabling the generation of CAR-T cells (CD19, CD19/CD22 dual CAR-T cells) in vivo. Although initially focused on oncology, the technology could also have broader applications in autoimmune diseases.

The keynote highlighted a clear shift in the field from demonstrating that RNA delivery works toward optimizing where therapeutics are delivered, which cells they reach, and how delivery systems can be manufactured and translated efficiently into clinical applications.

The silent carrier? Regulatory recognition and management of lipid nanoparticle-associated risks in EU-authorised medicinal products (Olivia Lewis, Utrecht University / NANOSPRESSO-NL)

This presentation explored how lipid-based nanoparticles (LBNPs), including liposomes and lipid nanoparticles (LNPs), are currently assessed by European regulators and whether these delivery systems are increasingly being recognized as active contributors to therapeutic performance rather than passive excipients.

Key highlights:

• Lipid nanoparticles are active carriers, not inert delivery vehicles. Beyond simply transporting payloads, LNPs influence biodistribution, efficacy, safety, and immunogenicity.
• Regulatory scrutiny is higher for RNA-LNP therapeutics than for traditional liposomal products. An analysis of EU-authorized lipid-based nanomedicines showed that RNA-LNP products receive greater regulatory attention because they enable new therapeutic modalities (nucleic acids) and incorporate more complex formulations and novel excipients.
• Novel lipid components trigger additional regulatory evaluation. Particular attention is given to ionizable lipids and PEGylated lipids, with regulators assessing aspects such as immunogenicity and potential hypersensitivity reactions.
• RNA-LNPs are driving a shift in regulatory thinking. Unlike conventional liposomes, which primarily improve the delivery of existing drugs, RNA-LNPs enable new nucleic acid based therapeutic modalities and therefore require more extensive characterization of the nanoparticle itself.
• A platform-based regulatory approach is emerging. The analysis suggested that prior knowledge generated for established LNP platforms may increasingly support the evaluation of future products, potentially reducing redundant development and regulatory efforts.

As RNA therapeutics continue to expand, LNPs are increasingly being recognized as active delivery technologies that influence product efficacy, safety, and regulatory strategy. This evolving regulatory landscape started to support platform-based approaches for the development of future nucleic acid medicines.

A new grammar of bionanoscale interactions, and potential role in advanced therapeutics (Prof. Kenneth A. Dawson, University College Dublin & Centre for BioNano Interactions (CBNI))

The conference opened with a thought-provoking keynote from Prof. Kenneth A. Dawson, a pioneer in the field of nano–bio interactions. His presentation explored how biological systems recognize, process, and transport nanoscale structures, and how these mechanisms could inspire the next generation of nanomedicines.

Key highlights:

• Biological systems recognize nanostructures through a combination of pattern recognition domains/epitopes, shape, and spatial organization, forming a complex “grammar” of nanoscale interactions.
• The talk introduced the concept of a “horizontal transfer program in eukaryotes”, describing a biological communication pathway that enables the transfer of functional protein and RNA networks between cells. This process begins with the creation of protected nanoscale protein and RNA cargoes that can survive exposure to the bloodstream for extended periods. Upon reaching recipient cells, these cargoes undergo selective recognition and uptake, followed by condensate melting, intra-endosomal recognition, and intracellular sorting processes. Importantly, the cargoes can escape endo-lysosomal pathway and traffic to specific intracellular destinations as intact functional biomolecules, enabling the transfer of complex biological functions between cells. [3]
• Understanding how cells naturally traffic and deliver biological cargoes may help address one of the major challenges in nanomedicine: efficient endosomal escape.

Rather than focusing solely on synthetic nanoparticle design, this keynote highlighted how studying natural nanoscale communication pathways could reveal new strategies for intracellular trafficking and RNA delivery.

Further discussions from ETPN 2026

• The clinical needs panel reinforced the importance of aligning nanomedicine innovation with unmet medical needs. Challenges discussed included brain metastases, rare metabolic disorders, cardiovascular diseases, and other conditions where current treatment options remain limited. Several speakers emphasized that overcoming the blood-brain barrier remains one of the most important opportunities for the field. Moreover, a recurring message was the importance of involving healthcare professionals early in technology development.
• Discussions repeatedly stressed the need to incorporate translational considerations early in development. Beyond scientific performance, factors such as manufacturing scalability, regulatory requirements, accessibility, and overall treatment cost will ultimately determine whether promising nanomedicine technologies can reach patients and achieve clinical adoption.
• One presentation highlighted the growing importance of metrology and standardized measurements in nanomedicine, particularly for characterizing complex delivery systems and ensuring reproducibility across laboratories and manufacturing sites.