- This event has passed.
BRIDGE Webinar: Regulatory Affairs for Biologics
Regulatory Affairs for Biologics
Regulatory strategy and CMC considerations are fundamental components of biological drug development and can significantly influence the transition from discovery to clinical development. Early alignment on these aspects is critical for de-risking development programs and ensuring regulatory readiness.
In this webinar, Emma Eriksson and Marie Gårdmark from RegSmart Life Science will present key strategic regulatory elements in drug development. The presentation is divided into two parts: the first will address overarching regulatory strategy, while the second will focus on selected CMC aspects specific to biological drug development.
ABOUT BRIDGE
Running for 3 years and supported by SweLife through the Swedish Innovation Agency, Vinnova, BRIDGE aims to create a development platform spanning from identifying drug candidates to production. Project start: 2024.
PROJECT PARTNERS
Testa Center (Project Coordinator): A national “open access” laboratory and production environment for academics and companies looking to verify and upscale their biological process for large-scale production.
SciLifeLab Drug Discovery and Development Platform (DDD): A national research infrastructure providing state-of-the-art technology and expertise in drug development, from small molecules, biological pharmaceuticals, therapeutic oligonucleotides, and new modalities, from concept to preclinical stage.
Stem Cell Center & Pre-GMP Lund University (LU): Conducting research in cell, tissue, and gene therapy, and supporting researchers with pre-GMP services to bridge the gap from research findings to patient care. These units also closely collaborate with the ATMP center (SUS), a node for Region Skåne’s work with ATMP treatments.
STUNS: Foundation for collaboration between universities in Uppsala, industry, and society, promoting co-creation at the intersection of universities, industry, and society to create new opportunities.
ALIS (Association of Life Science Incubators): A national platform that brings together nine regional life science incubators (GU Ventures, KI Innovations, Lead, Medeon, Sahlgrenska Science Park, Smile Incubator, STING, Umeå Biotech Incubator och Uppsala Innovation Center) tasked with supporting and guiding startups and research groups in skills development, business development, coaching, and access to national and international private capital