Eleni Samaridou - Head of Early-stage Formulation Development & Process Design - Merck KGaA
Eleni Samaridou - Head of Early-stage Formulation Development & Process Design - Merck KGaA
Biography
Eleni is the Head of Early-stage Formulation Development & Process Design team, part of the Early Formulation Screening Service team in Merck KGaA, Darmstadt, Germany. She is a chemical engineer by training and holds a MSc in Biochemistry and a PhD on Nanomedicine, followed by 3-year postdoctoral research experience on advanced drug delivery, as part of the esteemed group of Prof. María José Alonso at the University of Santiago de Compostela (USC). Eleni brings over 10 years of hands-on experience on the development of both polymer- and lipid-based formulations for protein and RNA delivery applications, and more than 6 years of industrial experience, having served previously as Scientist at BioNTech SE, Mainz, Germany, and, at Genevant Sciences, Vancouver, Canada. The focus of her research currently is the preclinical development of high-performing lipid nanoparticles (LNP) to enable the development and clinical translation of RNA therapies and vaccines.
Interview
NanoSphere: Tell us a bit about yourself—your background, journey, and what led you to where you are today.
Eleni: I've been passionate about science – biology & the way things work – since I was a kid. I blame my parents for this – both being in the STEM field – they have raised me to be curious, feeling that I could do anything I put my mind to, and, importantly, without gender-based constraints. I knew very early that I wanted to pursue a career in the biotechnology field. I decide to study chemical engineering in the Aristotle University in Thessaloniki, Greece (where I am originally from), due to the versatile options that I could have though these studies. During my time there, I've become fascinated with the field of nanotechnology and its use for advanced drug delivery for therapeutic applications. The inspiration for this was the dean of Chemical Engineering department and later my PhD mentor, Prof. Costas Kyparissides, who gave an inspiring lecture about the versatility and rational design of nano-based drug delivery systems and how they can help us address diseases that were untreatable before. I was given the opportunity to have my PhD studies under his supervision, as part of a large EU-funded scientific consortium, called ALEXANDER. This multidisciplinary project comprised of 14 partners (industry & academia) from 8 European countries and aimed at the development of novel nano-delivery systems to overcome the mucus gel barrier without destroying it, focusing on oral and ocular delivery. This project was marked with great success (>20 publications, 3 patents and more) and it was my door-opener to this field.
I completed my PhD studies in 2015. That same year I met Prof. María José Alonso at a conference (CLINAM 2015, Basel), where I was giving a talk. I was privileged to be offered a postdoctoral researcher position at her esteemed group in the University of Santiago de Compostela (USC), Spain, where I got to be involved in several, diverse and fascinating projects in the field of nanomedicine. Initially, my work was part of the EU-funded project, called TRANS-INT. The objective of my research within this project was to develop novel nanocarriers for oral protein delivery the treatment of diseases with high economic and social impact and to understand the interaction of the nanomaterials with GI barriers. After this project, I got the opportunity to be involved in a HORIZON 2020 project, called B-SMART. This project assembled an amazing multi-national team of leading experts from 9 partnering institutions (both academia and industry), focusing in developing RNA-based nanomedicines against Alzheimer’s and spinal and bulbar muscular atrophy (SBMA). Overall, working for almost 3 years in the lab of Prof. María José Alonso, I got to build a very strong network in the field and got the opportunity to make the jump from academia to an industrial career.
In 2018, I moved to Vancouver, Canada, where I served as Scientist in the Technology Development team at Genevant Sciences. My experience at Genevant built up my proficiencies in cutting-edge technologies in the RNA delivery field for therapeutic applications, and specifically in the lipid nanoparticle (LNP) field. I was privileged to work there with brilliant scientific minds that hold enormous knowledge of the field, having been the same scientists that had developed the LNP technology some years back. The same technology that later gave us the lifesaving COVID-19 mRNA vaccines.
In 2020, when COVID-19 hit, I decided I wanted to return to Europe to be closer to my home country and family. For this transition, and inspired by the developments at that time, I decided to be part of BioNTech, Mainz, Germany, as a scientist in the Early Formulation development & process team. Being part of BioNTech, I got to be there for the first-ever approval of the Comirnaty mRNA-LNP vaccine against Covid-19 that same year, and further I got to be involved in 2 fascinating Bill & Melinda Gates Foundation funded projects to develop mRNA-LNP vaccines against HIV and tuberculosis.
Finally, having built important knowledge and expertise in the field of lipid-based RNA delivery, I was offered a position, as Principal Scientist in the Early Formulation Screening Service team, at Merck KGaA, Darmstadt, Germany, to support developers with the preclinical lipid nanoparticle formulation development for mRNA vaccines and therapeutics. Being part of Merck KGaA now for more than 3 years, I have grown and develop my career to my current position, alongside an amazing team of scientists and experts, who is obsessed with improving the lives of patients. We have been active on several programs, developing formulations for mRNA therapies for genetic diseases, metabolic diseases, vaccines for infectious diseases and cancer applications, but also other nucleic acid-based therapies (such as RNA interference approaches, novel modalities etc.) with developers’ requests coming from over 24 different countries.
Overall, I have been blessed to be able to work on my passion throughout my career. The most rewarding part of my job has been to see the effect of our work on people’s lives.
NanoSphere: You have experience in both academia and industry, working on cutting-edge RNA drug delivery systems. What are the biggest challenges and opportunities in translating RNA nanomedicine research from the lab to real-world clinical applications?
Eleni: It is important to note that currently there is a very strong momentum and purpose-driven focus from the scientific community, coming both from academia and industry, on the development of cutting-edge RNA drug delivery systems. Having been part of both worlds, I am a very strong supporter of the importance of the collaboration and synergies between the novelty coming from academia and the translation expertise and capabilities coming from the industrial world.
Following the recent pandemic and the solution provided by the mRNA-LNP vaccines, the field has identified the importance of academia- industry and industry-industry collaborations, open scientific exchange and the availability of dedicated CDMOs to support developers to bring their products successfully to the clinic and the market.
Having said that, still there are several challenges to the translation of RNA nanomedicine research from the lab to real-world clinical applications. Some of these challenges are technical, like the appropriate grade raw material availability, the safety/tolerability, the scalability, the long-term stabilization and the associated costs that come with these technologies, but there are also non-technical challenges, like the currently heavily populated IP landscape in this field that may prohibit scientists to have access to certain technologies, or the lack of harmonization of the regulatory requirements across countries and applications for clinical translation. These are all challenges that are raised and discussed among the scientific community and are being addressed as we speak.
NanoSphere: Your recent review (Analytical techniques for the characterization of nanoparticles for mRNA delivery) highlights the challenges in identifying and reliably quantifying CQAs for RNA-loaded nanoparticles. What are the most pressing gaps in our current understanding of CQAs, and how can emerging analytical techniques help bridge these gaps?
Eleni: As we know, the regulatory framework for RNA-loaded delivery systems is still an evolving field. It has been quite complex for developers to navigate through the diverse regulatory requirements, and, moreover, the diversity of the RNA delivery systems creates a great challenge for the identification and quantification of the CQAs for developers and regulatory agencies. Currently, there is a great need for the harmonization of the analytical techniques used for the identification and quantification of the CQAs in an orthogonal approach. Furthermore, the development and establishment of appropriate reference materials in this field will allow the universal comparison of analytical data, fusion of batched data and the proper evaluation of measurement reproducibility.
NanoSphere: If there’s one key message or insight you’d like to share with readers about the future of nanomedicine, what would it be?
Eleni: Nanomedicine is here to stay, having proven its contribution to offer new opportunities and solutions for diagnosing, treating, and preventing diseases that were untreatable, and even expanding to individualized therapeutic treatments. To ensure the future of nanomedicine, we need to work together as scientific community to overcome certain challenges and embrace our combined strengths.
Eleni`s references:
1) Analytical techniques for the characterization of nanoparticles for mRNA delivery - ScienceDirect
2) Combination treatment of mannose and GalNAc conjugated small interfering RNA protects against lethal Marburg virus infection - ScienceDirect
2) Combination treatment of mannose and GalNAc conjugated small interfering RNA protects against lethal Marburg virus infection - ScienceDirect
3) Lipid nanoparticles for nucleic acid delivery: Current perspectives - ScienceDirect