Invited speakers 2023

Dr Nazende Günday-Türeli
MyBiotech GmbH, Chief Innovation and Technology Officer

Dr Nazende Günday-Türeli

Nazende Günday Türeli is Chief Innovation and Technology Officer at MyBiotech responsible for defining and executing the long term strategy and vision roadmap, defining and managing the R&D/I landscape and establishing R&D/I partnerships. She is a continuous learner with the motto “can’t stop, won’t stop!”. She is a recognized coordinator and principle investigator of international, multidisciplinary research and innovation collaboration projects with experts and stakeholders across the pharmaceutical field and nanomedicine which contributed to advance nanopharmaceuticals, including PHOENIX project: Open Innovation Test Bed for GMP Manufacturing of Nanopharmaceuticals. Nazende led several multidisciplinary and interdisciplinary teams to conduct research in leading international contract research, development and manufacturing organisations. She is a passionate mentor and trainer, dedicated to support younger generations with strong motivation and to identify rising stars. Believes in gender equity and equality being imperative for leaving a better community for future generations.

Her talk will be about:

PHOENIX Open Innovation Test Bed – New insight to advancing nanopharmaceuticals

Prof. Dr Daan J.A. Crommelin
Professor emeritus of the Dept Pharmaceutics,
Utrecht Institute for Pharmaceutical Sciences, UIPS
The Netherlands

Prof. Dr Daan J.A. Crommelin

Prof. Daan Crommelin is professor emeritus from the Department of Pharmaceutics at Utrecht University. Until December 2011 he was scientific director of the Dutch Top Institute Pharma – a public private partnership – in Leiden. He was adjunct professor at the Department of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah. Crommelin is co-founder of OctoPlus (1995), a Leiden based company specialized in the development of pharmaceutical (mainly protein based) product formulations and advanced drug delivery systems. He published over 360 scientific articles, many book chapters and edited books among those the successful textbook: Pharmaceutical Biotechnology: Fundamentals and Applications. He was Editor-in-Chief of the AAPS book series ‘Advances in the Pharmaceutical Sciences’. He advises venture capital groups and acts as a consultant/expert witness for several big pharma companies and SME’s.

His research focused/s on site specific drug delivery with colloidal-nanosized carrier systems/self-assembling systems (in combination with monoclonal antibodies), purification, characterization and stabilization of pharmaceutical proteins, parenteral systems for (sustained) release of small molecules, proteins and nucleic acids, pharmaceutical aspects of vaccines (adjuvanticity/antigen presentation and delivery), immunogenicity of pharmaceutical proteins.

His talk will be about:

Stabilization of mRNA-lipid nanoparticle (mRNA-LNP) formulations: breaking the cold chain?

Prof. Dr Olivia Merkel
Department Pharmazie
Ludwig-Maximilians-Universität München

Prof. Dr olivia merkel

Olivia Merkel has been a Professor of Drug Delivery at LMU Munich since 2015 and Chair since 2022. She is a Registered Pharmacist, received a MS (2006) and a PhD (2009) in Pharmaceutical Technology as well as numerous awards, including an ERC Starting Grant, ERC Proof-of-Concept Grant and ERC Consolidator Grant, the APV Research Award and the Carl-Wilhelm-Scheele-Award. Merkel is the author of over 100 articles and book chapters. She served as NIH reviewer from 2014-2015, SNF reviewer from 2018-2022, is an Editorial Board member for JCR, EJPB, Molecular Pharmaceutics and other journals, was the President of the German Controlled Release Society in 2020 and the Chair of the CRS Focus Group on Transdermal and Mucosal Delivery from 2020-2022, and currently is a scientific advisory board member of Coriolis Pharma, Carver Biosciences, and AMW. Her research focuses mainly on RNA formulation and pulmonary delivery for the treatment of a variety of lung diseases.

Her talk will be about:

Selection and Prediction of Poly-beta-amino ester nanocarriers for RNA formulation and delivery

Romain Le Deun M.Sc.,
Director, Regulatory Affairs CMC – International,
Moderna Switzerland GmbH

Romain Le deun

Romain Le Deun is a biotechnology engineer, holding the position of Director, Regulatory Affairs CMC – International at Moderna Switzerland GmbH. He graduated from the INSA Lyon Engineering School, France (2006). Over the last 15 years, he worked in regulatory affairs for several pharmaceutical companies (VCLS, Genzyme Polyclonals, Baxter and Merck Serono) specializing on CMC components of regulatory filings for small molecules, recombinant proteins, cell-based products and mRNA lipid nanoparticles. He has been extensively involved in the management of CMC data required to support medicinal products life cycle from Phase I to registration and post-market activities. He recently participated in the development of a QbD Guide for the A3P association.

His talk will be about:

Integrating mRNA Technology Specificities to the Regulatory Evaluation Approach

Dr Fanny Caputo
LNE-Nanotech,
Laboratoire national de métrologie et d’essais,
Trappes, France

Dr Fanny Caputo

Fanny Caputo is a researcher and project manager at the LNE (French Metrology Institute). Her main interest is in the characterisation of advanced materials and nanomaterials, including food additives, industrial composites, medical devices and pharmaceutical products containing nanomaterials. She focuses on the (pre-)standardization of characterization methods for regulatory purposes. She is she is involved in multiple standardisation projects with the ASTM E56 related to liposomes, mRNA LNPs and fractionaction methods. She is also involved in the development of a technical specification developed by CEN TC 352 focusing on the identification and characterization of nano-objects in inorganic additives incorporated in food matrices.

Her talk will be about:

Nanomedicine: the Harmonisation & Standardisation roadmap of the French and European metrology community

Dr Andreas Wagner
Polymun Scientific Immunbiologische Forschung GmbH, Austria


Dr Andreas Wagner

Dr Andreas Wagner is Head of Liposome Technology at Polymun Scientific GmbH. He has significant expertise formulation of liposomes and LNPs and development of the respective processes for their clinical use. He and the team at Polymun Scientific have significantly contributed to the 1st successful mRNA vaccine Comirnaty by optimizing and up-scaling the LNP process as well as by supporting clinical and early market supply of the successful Covid-19 vaccine.

Dr Andreas Wagner studied Biotechnology at the University of Applied Life Sciences in Vienna, Austria and earned his Master and Ph.D. degrees in the field of biopharmaceutical technology. Dr Wagner is listed as inventor on multiple patents, like the liposome technology and some product patents of liposomal formulations. Furthermore, he has published several peer reviewed articles dealing with liposomes, the technology, products thereof and their application in preclinical and clinical studies.

His talk will be about:

mRNA vaccines – Polymun’s contribution in the transformation of an excellent idea to a marketed product.

Dr Peter Wick
Head Particles-Biology Interactions
Empa
Swiss Federal Laboratories for Materials Science and Technology

Dr Peter wick

Peter Wick heads since 2010 the research laboratory for Particles-Biology Interactions at the Federal Laboratories on Materials Science and Technologies Empa in St. Gallen. He got his PhD degree in 2002 at the University of Fribourg, Switzerland. His general research interest is to study the interactions of nanomaterials with human tissues including barrier tissue in vitro and ex vivo with the purpose to obtain detailed mechanistic understanding about their uptake, accumulation, biotransformation, transport and effect on different types of cells or entire tissue. He has published more than 150 papers, was member of the advisory board of the Swiss Action Plan on Nanomaterials, member of the EDQM working group for NBCs, Editorial Board Member of Nanotoxicology, associated editor of the Journal NanoImpact, member of the Swiss National COVID-19 Science Task Force and coordinator of the Swiss National Contactpointnano.ch.

His talk will be about:

Quality by design in nanomedicines

Prof. Dr Gerrit Borchard
President of the School of Pharmaceutical Sciences
PharmD, Ph.D. 

Prof. dr Gerrit Borchard

Gerrit Borchard is a licensed pharmacist and obtained his Ph.D. in pharmaceutical technology from the University of Frankfurt (Germany). After holding several academic positions at Saarland (Germany) and at Leiden University (The Netherlands), he joined Enzon Pharmaceuticals, Inc. (USA) as Vice President Research. In 2005, he was appointed Full Professor of Biopharmaceutics at the University of Geneva (Switzerland), and in 2015, he was an invited professor at Graz University (Austria). 
Prof. Borchard’s research interests lie in the fields of biopharmaceutical sciences, nanomedicine and vaccine development. He has published more than 150 scientific papers (12857 citations, h-factor 57) and 23 book chapters, he edited two books, is named as inventor on 10 patents, and gave over 230 invited lectures. Since 2014, he is president of the Swiss Academy of Pharmaceutical Sciences (SAPhS). In 2012 he joined the Non Biological Complex Drugs (NBCD) working group hosted at Lygature (Utrecht, The Netherlands), joining its steering committee in 2015. He was Chair of the NBC working party at the European Directorate for the Quality of Medicines & Health Care (EDQM) from 2016 to 2023 and joined the External Advisory board of the EU-Nanotechnology Characterization Laboratory (EU-NCL) in 2016. In November 2022 he was appointed Chair of the mRNA Vaccine working party at EDQM.
Having been exposed to a variety of different work environments, he became fluent in the Dutch, English, French and German languages. Being an enthusiastic long-distance runner, he loves to roam the trails and by-roads of the Swiss mountains.

His talk will be about:

Assuring the quality of nanomedicines: Activities of the European Pharmacopoeia

Prof. Dr Scott McNeil
Departement Pharmazeutische Wissenschaften 
Basel Universität

Prof. Dr SCOTT MCNEIL

Prof. Dr. Scott McNeil is the Head of the Nanopharmaceutical and Regulatory Science Group within the Department of Pharmaceutical Sciences at the University of Basel. Scientists within his group develop and characterize novel nano-based formulations, with the goal of improving the therapeutic index of active pharmaceutical ingredients. Prof. McNeil’s research involves Regulatory Science topics in nanomedicine, and using nanomedicines to deliver enzymes for the treatment of lysosomal storage diseases.  In collaboration with other research institutions, the Group also identifies and investigates the critical quality attributes (CQAs) of nanopharmaceuticals and nanosimilars, such as mechanisms of action, and overall safety. We also investigate many of the practical aspects of nanomedicine development, such as clinical trial design and reimbursement. Prior to joining the University of Basel in 2020, he was the Director of the Nanotechnology Characterization Laboratory (NCL) at the National Cancer Institute. In addition to his academic career, McNeil served for twenty years in the US Army.

His talk will be about:

Regulatory review and commercial reimbursement of nanomedicine products.

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Her talk will be about:

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