“How innovative platform approaches can help overcome gene therapy manufacturing challenges”

Hanna Lesch (Exothera) is a Chief Technology Officer at Exothera, Belgium. Her main responsibilities are technology development and innovation in bioproduction platforms. Hanna has made her whole career in the gene therapy field. Over the years she has been in several directors positions leading research and development at FKD Therapies, Finvector, and Kuopio Center for Gene and Cell Therapy. Her research interest has focused on gene therapy and translational development, including early-stage analytics and the development of scalable, robust manufacturing processes operating under current regulatory guidelines. Her PhD was in Molecular Medicine, obtained from the University of Kuopio. She followed up her Ph.D. with post-doc work at the University of California San Diego UCSD, CA, the USA, and the University of Eastern Finland, Kuopio, Finland. She has several patents related to vector manufacturing.

“How Data Analytics strengthen daily activities”

François Balbin (Merck KGaA): After some years developing the first generation of MES systems and integrating early version of 21CFRp11 compliant systems for pharmaceutical industry, François BALBIN joined -Millipore, then- Merck KGaA group as a Software specialist. He then spent a decade managing product development at Merck before finally landing in Sales Development for Europe, Middle East and Africa as the Automation and Software expert for commercial organization. Deeply involved in digital transformation journey for customers, he actively contributes to key product development to enter this new digitization era by supporting commercial awareness of digital product portfolio.

CAR-T cells for HIV cure

Wojciech Witkowksi (Ugent) is a Postdoctoral researcher and a team leader in HIV Cure Research Center in Gent where I develop braodly neutralizing antibody based approaches for HIV cure

“Bridging study for equipment comparability in cell culture monitoring”

Dimitri Gayraud (UCB Pharma S.A.): Bachelor of Sciences in Mathematics from Aristotle University of Thessaloniki (Greece), Master of Sciences in Statistics (Major in Industrial Statistics) from KU Leuven (Belgium). During my studies I was involved in the teaching sector in different ways (private tutoring and sports) and during my studies in Belgium I acquired experience as a statistical consultant in the field of medicine. I have been a statistician with UCB since December 2014, with most of my activities being related to biological products (mAbs). 

“View on the challenges and opportunities for AAV development : from client-based needs to R&D strategies”

François Côte (CER groupe) is Biologist from Namur. He hold a master thesis in URBC on identification of mechanism of action of fragmented pectin on cancer cell death. He joined CER groupe 13 years ago as as a project manager focusing on development and characterization of productions of antibodies. He is now a business developper specialized in in vitro activities where he develops european network and collaboration.

“Development of a transplantable engineered ovary to restore fertility in cancer patients” 

Christiani Amorim (UCLouvain) received her PhD in Veterinary Medicine from the Universidade Federal de Santa Maria, in Brazil, and transitioned from animal reproduction to human fertility in 2007 as a postdoctoral fellow at the Catholique University of Louvain in Belgium, developing alternatives to restore fertility in cancer patients. Currently, she is a professor at the Catholique University of Louvain, where she also serves as head of the Research Pole in Physiopathology of Reproduction. Her group conducts research on ovarian tissue preservation, photodynamic therapy, cell differentiation, and ovarian tissue engineering. Christiani is also an honorary research associate at the Belgian National Fund for Scientific Research, Chief Scientific Officer from ProFaM Health, and serves as ESHRE’s Basic Scientific Officer of the Stem Cell Special Interest Group. 

“Advances in Muscle Regenerative Medicine: Exploring Stem Cell Therapy and 3D Modeling”

Maurilio Sampaolesi (KU Leuven)

“Imaging-assisted organoid research to address tissue engineering, neurodevelopmental disorders and biomedical impact of nanoplastic pollution”

Ruslan I. Dimitriev (Ghent university)

“Reliably Assessing Comparability in Autologous Cell Therapy Change Protocols: A Compliance Perspective” 

Jean-François Michiels (Cencora-PharmaLex) has been working as a statistical consultant in Cencora Pharmalex since 2013 and he is mostly involved in CMC projects. He has a bioengineering degree from the Université Catholique de Louvain (Belgium-2003). He has a PhD degree in animal cell culture (2004-2011-UCL-Belgium). He accumulates more than 10 years of experience in several areas of pharmaceutical research and industry including bioassay and process development/validation, drug and vaccine discovery and manufacturing, with the usage various statistical tools such as design of experiments and advanced statistical models (e.g. nonlinear and mixed models). Drawing upon his extensive background and experience, he adeptly communicates statistical concepts to individuals with limited statistical knowledge and skillfully establishes appropriate analytical frameworks.