Inhaled & Nasal Biologics | DNA Forum 2024

Keynote Talk: Alternative to LNPs – development of peptide-based RNA delivery systems for pulmonary delivery

Dr Lam’s research is focused on the development of novel delivery systems for RNAs and biologics, with a special interest in using particle engineering methods to produce dry powder aerosols for lung delivery, targeting various respiratory diseases and infections. She has published over 90 peer-reviewed articles and filed a number of patent applications on pulmonary drug delivery systems. In 2020, she was awarded the DDL Emerging Scientist Award which recognised her significant accomplishment and innovation in inhalation science. Additionally, Dr Lam recently co-edited ‘Respiratory Delivery of Biologics, Nucleic Acids and Vaccines’, a comprehensive review of pulmonary delivery of macromolecules and biologics.

Talk Title: Nasal delivery of vaccines - not as easy as expected

Prof. Dr. Regina Scherließ is a professor for Pharmaceutics and Biopharmaceutics, vice-dean for research of the Faculty of Natural Sciences at Kiel University (since 2022) and chair of the Department of Pharmaceutics at Kiel University, Germany. As such she leads the research unit in Pharmaceutics and is responsible for all teaching in Pharmaceutics and Biopharmaceutics at Kiel University. She is a pharmacist and received her Dr. rer. nat. (doctor of natural sciences) in 2008 for a work on “Formulation of inhalation combination products by co-precipitation”. In 2015 she finished her “habilitation” working on “Mucosal vaccination via the respiratory tract”. During her academic education she had research stays in Denmark, the US, New Zealand and Australia. She also received several young researcher awards including The Pat Burnell New Investigator Award 2010 of the Aerosol Society and is member of the DDL scientific committee (since 2015). She also is member of the board of the priority research area KiNSIS (Kiel Nano Interface and Surface Sciences) at Kiel University (since 2020). Her research interests include disperse systems and nanoparticles, stabilisation of biomolecules and particle engineering in spray drying, and formulations for mucosal vaccination with a focus on respiratory (nasal and pulmonary) dry powder delivery. She is a co-founder of the Nasal Research Focus Group, a research consortium from academia and industry focusing on nasal drug delivery.

Talk Title: Optimising Delivery of Biologics Through Inhalation; Challenges and Opportunities

Catherine is a Protein Scientist with over 20 years in the Biotechnology Industry. She has broad knowledge of all aspects of the drug discovery process for biologics and has been the Co-leader for four pre-clinical projects that successfully transitioned into early pre-clinical development for which she developed novel therapeutic recombinant proteins. Three of those projects were aimed at inhalation delivery; one is currently progressing in Phase 2 clinical trials. She is a contributor to three systemic pre-clinical projects and Co-Inventor on four patent applications in addition to three published ones. She is experienced in working in cross-functional teams in matrix structure and contributing to developability guidance for inhaled biologics. Catherine is interested in understanding better the quality attributes of inhaled biologics for spray drying stability.

Talk Title: Optimising Delivery of Biologics Through Inhalation; Challenges and Opportunities

Tanvir joined Astrazeneca about a year ago. He is based in Cambridge, UK, and is working as a Director in the Dosage Form Design and Development (DFDD) group of the company. The responsibilities of the DFDD group include developing pharmaceutically stable, market competitive, user centric biopharmaceutical dosage forms. Prior to joining Astrazeneca, Tanvir worked in the Biopharmaceutical industry, for a number of years, for Novartis, Takeda, Beaufour Ipsen and GSK.

Talk Title: Effective formulation strategy for pulmonary delivery of probiotics

Francesca Buttini currently holds an Associate Professor position at the Food and Drug Department, University of Parma (IT) and where now she is leading the unit dedicated to design of pharmaceutical products for inhalation. In 2014, she was appointed as Visiting Lecturer at the Institute of Pharmaceutical Science of King’s College London (UK). Combining her background in pharmaceutical technology, regulatory aspects, and device design, she is executing research programs aimed to deliver medicinal products that take into consideration the patient, industrial and regulatory requirements. To date, she has published more than 98 original papers and as a result of her research achievement, she obtained in 2017 the DDL Emerging Scientist Awards from the UK Aerosol Society. Francesca Buttini is a founder of PlumeStars, an innovative SME, dedicated to development of orphan drug products to treat lung and systemic disease by inhalation therapy.

Talk Title: Non-clinical and clinical development aspects of inhaled biologics

Jaap Wieling is a pharmacologist with a vast track record in development of new pharmaceutical products based on small and large molecules, as a scientist and as an executive in various pharma companies and contract organizations. He is an entrepreneur since 1999, and (co-)founded several biotech and service companies. In parallel he has been a part-time university teacher for almost 2 decades (Groningen), teaching clinical and bioanalytical aspects of drug development. He also serves on the board of various biotech companies.
Jaap is currently CEO of PureIMS, an innovative company in the Netherlands developing a pipeline of dry-powder inhalation products and also co-developing products with pharma partners.

Talk Title: Development Path of RNA Based Platform for Pulmonary Diseases

Mr. Cohen brings more than a decade of demonstrated experience in the pharmaceutical industry, focusing on production, device, and analytical development, most of them under GMP regulatory environments. Prior to SpliSense, Asaf has spent almost 7 years at Polypid Israel in various high responsibility positions in manufacturing, operations, logistics and engineering while playing a pivotal role in new product development, design of the scaled-up processes, tech transfers, process optimization as well as leading the design and construction of a new aseptic production facility.

Talk Title: Vibrating Mesh Nebulizers: insights into the delivery of biologics

Carolina’s expertise as a board certified pulmonologist adds to Pulmotree the valuable insight of both physicians and patients. Specialized in respiratory infectious diseases and lung related indications such as cystic fibrosis and bronchiectasis, she has a vast hands-on clinical experience with inhaled drug therapies.

As a Manager of Medical and Scientific Affairs her search for innovation in healthcare matches with Pulmotree’s forward-thinking approach to the evolution of respiratory therapies. Besides her knowledge in clinical research, Carolina is an accomplished communicator in science, counting with published scientific papers, a book chapter, and several presentations in international conferences. 

Carolina holds a Master’s degree in Medicine and is a member of the European Respiratory Society (ERS) and the International Society for Aerosols in Medicine (ISAM).

Talk Title: RNA-loaded dry powders for the treatment of pulmonary diseases

Benjamin Winkeljann is an engineer and entrepreneur, specializing in the development of drug delivery systems for RNA delivery and the optimization of pharmaceutical processes. He conducted his PhD in bioengineering within the Technical University of Munich’s Munich School of Bioengineering. Following a short postdoctoral phase at the same institution, he shifted his focus towards pharmaceutical technology by accepting a postdoctoral scientist position at the Ludwig-Maximilians-University Munich's Department for Pharmacy. Here, his work concentrated on simulation-assisted optimization for the formulation of RNA therapeutics. In 2023, he advanced to become a Group Leader and started pursuing a University Lecturer Qualification in Pharmaceutical Technology and Drug Delivery. In the same year, Winkeljann co-founded RNhale GmbH in Munich, where he currently serves as CEO. He is also a Principal Investigator at the Comprehensive Pneumology Center Munich (CPC-M), German Center for Lung Research (DLZ), Munich.

Talk Title: CSL787 - Biologics as Novel Strategy

Joseph is a seasoned toxicologist with nearly eight years of experience at CSL Behring/Innovation as a Senior Toxicologist. Before this, he served as a Study Director in Inhalation Toxicology at Charles River for five years. He also held a Senior Assistant Scientist (Project Leader) position for two years and began his career as a Pathology Technician in a trainee position.
He holds a BSc Hons in Biomedical Science from Edinburgh Napier University. Joseph is a Member of the Royal Society of Biology (MRSB) and a European Registered Toxicologist (ERT). He is also an active member of the Association of Inhalation Toxicologists (AIT) and the International Society for Aerosols in Medicine (ISAM).
Joseph has presented posters at numerous international conferences and has been invited to be a speaker at AIT and ISAM events. He is a named author on three CSL publications and was the CRO Tox lead for the approved Antisense Oligomer Exondys 53. Additionally, he is a patent-pending inventor.

Talk Title: The importance of high dose delivery to the lungs

Dave began his career as an Inhalation Scientist at Sanofi Aventis working on exploratory development products, through to commercial marketed products and the whole lifecycle in between and then held a similar role at Novartis where he further developed his inhalation knowledge. Following this, Dave moved to Vectura as Particle Engineering Specialist, leading on to become Principal Scientist, then manager of the Bioformulation and Particle Engineering group.  Dave then moved to Charles River, conducting safety assessment/toxicology studies with aerosols, building a large specialist group. Dave moved to Albany Molecular Research Inc. (now Curia) leading the R&D groups and business development activities before joining Nanopharm. Dave joined Nanopharm in January 2020 as the Director of Operations and moved into the position of Chief Operations Officer in April 2021. During the last four years, Dave has led and supported the significant growth post Aptar’s acquisition of Nanopharm. Dave was appointed to Director of Science and Technology for Aptar Pharma, in February 2024.

Talk Title: The importance of high dose delivery to the lungs

Jonathan holds an Engineering degree from École Centrale Paris as well as a master degree in Aeronautics from Beihang University in Beijing. After working for Airbus in Toulouse, Jonathan joined Aptar Pharma in 2018 and has since worked in inhalation in R&D up to being the head of the Pulmonary Product Development team, switching to his current Business Development role in January 2024.