[DIA Europe 2023] Enabling Early Patient Access Through Innovation in CMC

Presented by

Markus Goese, Evangelos Kotzagiorgis, Matt Popkin, Thierry Gastineau, Lyne Le Palaire, Mark Pellett.

About this talk

In continuation of the dialogue at previous DIA Europe conferences, this session provides an opportunity for further reflections on lessons learned from the response to the COVID-19 pandemic. The success achieved in the CMC development, manufacture, authorization and supply of new therapies and vaccines for COVID-19 in very rapid timescales provides a rich set of experiences. It built significantly on the outcomes from the collaborative work between industry and regulators in recent years, on the role of prior knowledge and innovative science and risk-based CMC strategies to the development of new, high-quality products for unmet medical needs. The challenges for rapid development & commercialization, as well as various approaches to facilitate accelerated development and global supply post initial authorization, will be revisited from a “post-pandemic” point of view. This will include the role of dialogue between sponsors and agencies to facilitate early decision-making and alignment, the value of improving reliance/collaborative assessments and increased collaboration between regulatory authorities (e.g. at the level of ICMRA) to reduce differences in global regulatory requirements and ultimately achieve earlier and greater access to high-quality critical medicines for patients worldwide. Objective: Learn how to navigate the Quality aspects of accelerated pathway/reliance & work-sharing initiatives and manage the “flood” of post-approval changes (PACs) appropriately. The session covers the entire lifecycle.
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The Drug Information Association (DIA) is a global and neutral association that mobilizes the life science community (regulators, industry, healthcare professionals, patients, payers, and students) to identify and tackle the most complex health challenges. DIA brings all these stakeholders together to find and discuss solutions, build a more robust and innovative healthcare ecosystem and, ultimately, improve patient outcomes worldwide. DIA executes its mission by fostering timely and critical conversations and networking sessions across many platforms, including conferences, workshops, DIA-led research projects, structured training, eLearning courses, digital content platforms, and publications, without corporate funding.