Shifting the paradigm of biopharma innovation

This week’s Expert View, from Vanessa Almendro of Danaher Corporation, calls for a shift from traditional discovery to a platform-based design model in genomic medicine. She highlights how this approach, combined with regulatory and manufacturing innovation, could accelerate access to precision therapies.

Adopting a platform approach to designing new therapies will speed the delivery of innovative genomic treatments to patients—but only if developers, regulators, and manufacturers work together to evolve the current drug development paradigm, writes Vanessa Almendro, vice president of science and technology and head of innovation at Danaher Corporation, in an Expert View piece.

Biopharmaceutical innovation is on the cusp of a major revolution. Advances in genomics, proteomics, pathomics, and other molecular sciences are enabling researchers to move beyond the traditional method of screening hundreds of molecules against biological targets. Instead, they are leveraging rapidly expanding multi-omics knowledge to design therapies that precisely target genetic mutations, mRNA abnormalities, protein dysfunction, and dysregulated cellular pathways. This integrated approach has already led to groundbreaking therapies such as CRISPR gene editing, antisense nucleotides, and CAR-T cell therapies—and as we continue to unlock deeper insights into “programmable biology,” additional transformative innovations will follow.

One of the major challenges facing genomic medicines today is the lack of scalability and efficiency in translating discoveries into therapies that can reach patients quickly. Gene editing technologies, in particular, have demonstrated curative potential in the clinic, yet their widespread development remains slow, costly, and highly individualized—limiting their impact. Without a fundamental shift in how these therapies are developed, the commercialization of gene-editing technologies, particularly for rare diseases, will remain prohibitively expensive and unsustainable.