Resolution Therapeutics' CEO warns that manufacturing process changes cannot wait for pivotal trials in cell therapy. The drug product used in a Phase 1/2 study must be highly comparable to the final commercial version to avoid extremely costly delays and extensive comparability studies later in development.
The company's therapy uses transient engineering with a single mRNA strand to deliver both anti-inflammatory and anti-fibrotic payloads into a patient's own macrophages. This enhances the cells' natural healing abilities, aiming to reduce inflammation and resolve fibrotic scars to allow organs like the liver to regenerate.
The CEO of Resolution Therapeutics views cell therapy development through the lens of boxing. He emphasizes that just as a boxer must get up after being hit, a leader in this volatile field must possess the resilience to absorb constant setbacks, stay focused, and keep moving the company forward.
To de-risk its EMERALD trial for a poorly documented patient population, Resolution Therapeutics first ran a natural history study (OPOL). This provided crucial data to inform the trial protocol and, more importantly, allowed the creation of a matched external control arm, a clever and capital-efficient strategy.
Rather than waiting for late-stage development, biotech startups should integrate commercial planning into early trials. This means building in data collection for payers, pricing, and patient access from the start. This "think with the end in mind" approach ensures the company has the right data for pivotal trials and market access.
Resolution Therapeutics' CEO builds his team with leaders from varied backgrounds across different diseases and drug modalities. He believes this diversity creates more robust problem-solving, as challenges that are novel in one area may have been solved in another, enabling faster and more informed decisions.