In Vivo - Strategic Analysis For Medtech And Pharma Leaders since 1981

Israeli-American biotech Immunai is mapping the immune system and using AI to predict immune responses to drugs.

Richard Lowenthal, co-founder, and CEO of ARS Pharma, highlights the crucial unmet need for needle-free injections. Challenging issues posed by current epinephrine injectors, In Vivo questions the current and future progression of Neffy.

In the latest episode of the In Vivo podcast, Russ Lebovitz, the co-founder and scientist behind San Diego's Amprion Diagnostics, discusses the role alpha-synuclein misfolding plays in neurodegenerative diseases and how early alpha-synuclein testing could mitigate the impacts of conditions ranging from Parkinson's disease to Lewy body dementia. 

Radioligand therapies offer a resistance-proof mechanism that complements immuno-therapies and other drug classes. No wonder oncology players continue to pile in.

The early adoption of artificial intelligence/machine learning has centered around drug discovery, but the technologies are being applied to other fields, including pharma marketing.

Pharmaceutical manufacturing is developing at a lightning pace as the confluence of automation and AI creates opportunities for much higher efficiency and throughput. Experts from across the industry discuss these, and the challenges around implementation and standardization.

India is seeing a flurry of activity with big pharma either establishing or expanding their global capability centers in the country. Can these hubs reshape the contours of industry’s operating model across a range of functions and perhaps spawn a pipeline of new leaders along the way?

The pharma industry arguably suffered none of the downside risks that were possible during the first Trump administration, and their relationship with Biden could not have gone much worse. And while they may hope a Trump return could help their fortunes, having RFK Jr. supervising the FDA is likely not the prescription they want.

Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?

As the pharmaceutical industry readies itself to navigate the complexities of 2025, US pricing trends reveal a landscape shaped by regulatory and legislative changes, innovative pricing models, and the ongoing impact of inflation.

As talks continue on the EU pharmaceutical legislative reform proposals, drug firms may have to wait some time before they find out what the future periods of regulatory data protection and orphan market exclusivity will be.

The five-year roadmap aims to expand support for AI research and development in essential health care and new drug development, as well as advance medical data usage systems and enable its safe use.