Webcast series:
Development of RNA-based
drugs and oligonucleotides

Anika Schröter holds a PhD in toxicology and is a registered European Registered Toxicologist. Since 2014 she has been working as a consultant for clients in the pharmaceutical and biotech industry on issues related to non-clinical drug development (e.g. small molecules, biologics, vaccines). Her expertise includes the creation of non-clinical development programs, design and supervision of GLP toxicology studies, or support in consultations with European or non-European authorities. Since 2021 she runs her own consulting company in Vienna.

Vice President of Drug Product Development Satish is Vice President of Drug Product Development at Astria Therapeutics Inc. Satish was until very recently at Moderna Inc, where he was responsible for Drug Product Development and was deeply involved with the development, scale-up, manufacturing, launch, commercialization, of Moderna's Covid-19 vaccine. Satish has held similar positions at Lonza Pharma in Basel (2016 - 2018), and at Pfizer prior to 2016. Satish has long experience in the biopharma industry in product development activities and is an internationally recognized expert in all aspects of biopharmaceutical Drug Product (biologics, vaccines) development. Satish has a strong technical background in biologics drug product development, complemented by a deep understanding of regulatory challenges and the evolving regulatory landscape, and has more than 90 peer-reviewed scientific publications as well as several book chapters covering multiple topics. He is involved in various professional groups through the AAPS as well as the USP and is a member of the expert panels that wrote USP<787>, <1787>, and <771>. He was elected as a Fellow by the AAPS in 2018. His research interests also include the investigation of impact of freezing processes on proteins, use of computational approaches to mitigate develop-ability issues, protein aggregation and immunogenicity. Satish obtained his B.Tech. Chemical Engineering from the IITD Delhi and an M.S. and Ph.D. in Chemical Engineering from Kansas State University. Satish also holds the positions of Adjunct Professor at the Dept. of Physical Pharmaceutical Chemistry at Uppsala University, Sweden, and at the School of Pharmacy, University of Michigan, Ann Arbor, USA.

Regulatory Expert Clara Ferloni, PhD, has been Regulatory Fellow at ten23 health (Basel Switzerland) since July 2023. She has 20 years of experience in regulatory affairs within the pharma and CDMO industry, supporting, among others, several clinical trial and market license application submissions for biological products, including ATMPs. Dr. Ferloni studied Chemistry at the University of Milan, Italy and Imperial College London, UK, and holds a PhD in Enzyme Technology from the RWTH Aachen University, Germany.

Dr M.-A. Schwarz currently acts as Principal Scientist in the ‘Large Molecule and ATMP Services’ business unit at Solvias AG, Switzerland. In this role she supports the different centres of excellence with application development approaches by offering her deep scientific expertise. Her scientific journey started at the Martin Luther University (Halle/Saale, Germany) where she also obtained her PhD in Chemistry in 1998. After her habilitation (post-doctoral lecturing qualification) at the university of Basel (Switzerland) with the focus of miniaturized electrophoretic chip-based systems, she joined Solvias in 2006. Beside her role as private docent and supervisor at the university of Basel she has shaped the analytical offering of Solvias in different positions especially in the field of CE where she also led the ‘research and development‘ team for several years. During these 17 years of building up and establishing industrial bioanalytical chemistry, she has also gained considerable experience in the GMP world together with the technical, operational, and scientific strengthening of the biopharmaceutical analytics.

Analytical Biochemist, QC Method Development Dr Andrei Hutanu is a professional in analytical development, specializing in nucleotide-based therapeutics. His academic foundation was laid at the Technical University of Munich, where he earned a degree in Biochemistry before embarking on a PhD at F. Hoffmann-La Roche Ltd, focusing on refining capillary electrophoresis (CE) for biopharmaceuticals. During his PhD, he innovated CE methods for novel biologics, including monoclonal antibody co-formulations and bispecific mAbs. In 2019, Andrei pivoted to advancing analytical methodologies for cell and gene therapy products, with a keen focus on recombinant adeno-associated viruses. Since 2023, he has been a part of Ten23, where he applies his expertise to the analytical development of RNA- and oligonucleotide-based drugs.

Chief Scientific Officer Andrea Allmendinger, PhD, has been Chief Scientific Officer at ten23 health (Basel Switzerland) since November 2021. Dr Allmendinger is also Adjunct Professor and Group Leader at the University of Freiburg (Baden-Württemberg, Germany), researching novel parenteral drug formulations including mRNA-LNPs and associated device solutions to improve stability, usability and cost of goods. Between 2010 and 2021, she was Principal Scientist, Pharmaceutical Development at Roche, working on, inter alia, manufacturability and injectability of high-concentration protein formulations, formulation and process development of freeze-dried formulations, syringe and high volume drug/device combination products, particulates and surfactant strategy. Dr. Allmendinger studied Pharmacy at the University of Heidelberg, Germany, and University College London, UK, and holds a PhD in Pharmaceutical Sciences from the University of Basel, Switzerland. She obtained the venia legendi (German Habilitation) from the University of Freiburg in 2021, and until lately served as Editor-In-Chief for the AAPS Open Journal.

Senior Scientist - Drug Product Design Dr. Michal M. Raczy is a Senior Scientist for Drug Product Design at ten23 health. Since joining the company in January 2022, he has led formulation and process development projects, while also driving innovation within biologics and surfactants analytics. With a strong background in chemistry and nanotechnology, Dr. Raczy obtained his PhD in molecular engineering from the University of Chicago (USA). During his doctoral studies, he conducted research on novel drug delivery systems and immunomodulatory biomaterials, leading to several published papers in prestigious peer-reviewed journals.