Biotech investors have long considered scientific uncertainty, clinical setbacks, and commercial risk when making investments. John Stanford, founder and executive director of the policy advocacy organization Incubate argues that the life sciences venture capital firms he represents need to pay increasing attention to Washington due to instability at the U.S. Food and Drug Administration, competitive threats from China’s emergence as an innovation powerhouse, and reduced federal investment in research. Stanford discusses how drug-pricing policy and FDA leadership turnover influence which companies get funded, why he sees the Inflation Reduction Act’s treatment of small-molecule drugs as a particular problem, and why protecting American leadership requires supporting the entire drug-development ecosystem.

For patients with metastatic breast cancer, successive treatments can lose effectiveness as tumors evolve and resistant cancer cells survive, leaving those who have received multiple therapies with limited options. BriaCell is seeking to address that problem with an experimental, off-the-shelf, cell-based immunotherapy designed to stimulate the immune system against multiple cancer-associated targets rather than a single target. Its lead candidate, Bria-IMT, is being studied in combination with a checkpoint inhibitor in a phase 3 trial, while its next-generation programs aim to offer personalized treatment using off-the-shelf cells. William Williams, CEO of BriaCell, discusses how its therapies work, what earlier clinical findings suggest, and the development path forward.

GLP-1 medicines have transformed obesity treatment, but what happens when patients stop taking them? For Fractyl Health, the challenge of preventing weight regain has become the focus of its development strategy. The company is advancing Revita, an experimental outpatient procedure designed to regenerate the lining of the duodenum and potentially change how the body regulates weight and blood sugar. Harith Rajagopalan, co-founder and CEO of Fractyl Health, discusses the company’s shift from focusing on type 2 diabetes to maintaining weight loss after patients stop taking GLP-1 medicines, the biology behind its approach, and what it takes to turn the promise of a metabolic reset into a treatment option.