MVA Good Morning Meeting – Bioanalytical Support for Cell & Gene Therapies

Recent years have seen a resurgence and rapid growth in the field of cell and gene therapies as therapeutic options to treat diverse clinical indications including neuromuscular diseases, ophthalmic disorders, haemophilia, cancers and much more.

Designing and executing a complete bioanalytical strategy to support the preclinical and clinical development of cell and gene therapies can be challenging, requiring bioanalytical tools beyond the chromatographic and ligand-binding assay (LBA) platforms commonly used to evaluate the pharmacokinetics and immunogenicity of traditional chemical and biologic drug products. Additional expertise in cell-based functional assays, molecular techniques such as qPCR/ddPCR, ELISpot and flow cytometry are critical to the successful development of these therapeutic modalities.

During this Good Morning Meeting, scientific experts from BioAgilytix will share their experiences in bioanalytical assays utilized to evaluate cellular kinetics, biodistribution and shedding, methodologies to assess pre-existing immunity, and approaches to elucidate treatment-emergent humoral and cellular immune responses. Cases studies will take a deeper dive into the molecular bioanalytical aspects that are critical to successful development of these advanced therapeutic modalities.

Date: Tuesday, 5th of September, 2023
Time: 8:30 – 11:00 CET
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium

SIGN UP

Program

Speakers​​

	Ymke van der Geld, PhD, Senior Director, Business Development Europe at BioAgilytix Ymke is looking after Business Development for BioAgilytix in the Nordics region. She is your point of contact for BioAgilytix Bioanalytical offering including tailored services for biomarker, immunogenicity, pharmacokinetics (PK), and cell-based assays. This includes cell- & gene therapy, monoclonal antibodies, complex bi-/tri-specific and other fusion molecule/ protein formats and Antibody Drug Conjugates. Ymke has a background in medical biology with a PhD in Immunology. Ymke has over 20 years’ experience within Bioanalytical contract research.
	Robert Nelson, PhD, Scientific Officer at BioAgilytix  Robert Nelson, Ph.D., provides scientific and regulatory consultation, focusing on our EU team and customers, to help guide bioanalysis supporting drug development. Spending over fifteen years working in regulated (GLP/GCP) laboratory environments, Dr. Nelson supports preclinical and clinical drug development programs, with broad experience in bioanalysis, immunogenicity, and biomarkers. He joined BioAgilytix from Labcorp Drug Development’s Scientific Affairs team, where he partnered with clients, operations, and other scientists to address science, technology, and regulatory challenges. Prior to this, he led the bioanalytical laboratory team at Swiss biotech company Novimmune. Dr. Nelson holds his Ph.D. in Molecular Physiology and B.Sc. with Honours in Pharmacology from the University of Edinburgh.
	Lara Duchstein, M.Sc., Principal Investigator at BioAgilytix Lara Duchstein, M.Sc., works as Principal Investigator in BioAgilytix’s Operations Team for Molecular Bioanalysis, managing and overseeing PCR-based assay development, validation and sample analysis projects to support clinical and pre-clinical drug development programs.Prior to BioAgilytix, she had gained 7 years of CRO experience at Sysmex Inostics, a liquid biopsy company focusing on development, validation and application of ddPCR and PCR-based NGS tests for the detection of circulating tumor (ct)DNA. Lara Duchstein holds her M.Sc. and B.Sc. in Molecular Life Sciences from the University of Hamburg.

Organized by	In collaboration with