Rare disease drug development is evolving, driven by innovation and regulatory advancements. With many devastating rare diseases still lacking approved treatments, regulatory agencies are taking significant steps to support innovators, advance research and improve patient outcomes. Through updated and newly developed guidances, they aim to provide a roadmap for navigating the complexities of this specialized field.
In this webinar, they will highlight key regulatory guidances published within the past year, addressing artificial intelligence (AI), accelerated approval pathways and fostering diversity, equity and inclusion (DEI) in clinical research. Attendees will gain insights into the challenges these guidances aim to address, their potential to transform the rare disease landscape, and strategies for incorporating any necessary changes into drug development programs.
Register for this webinar to explore how the rare disease landscape is changing with guidance from AI, accelerated approval pathways and fostering DEI in clinical research.
Keywords: Drug Development, Clinical Research, CRO, Drug Manufacturing, Oncology Drugs, Clinical Data, Therapeutic Areas, Oncology Drug Development, Rare Diseases/Orphan Drugs