The Ins and Outs of Cell & Gene Therapy

In Episode 1, Part 1, Jon Hamrick, Rena Goins and Bob Cochran discuss how 340B, the IRA, specialty therapies and launch planning have reshaped the role of commercial trade.

APIIC's Brian Doty says renovating shuttered US plants with advanced manufacturing is faster and cheaper than building new to reshore generics.

Joint clinical assessment, shifting HTA demands and pricing pressure are making launch the start of continuous evidence generation.

APIIC's Brian Doty says key starting materials are where domestic generic supply efforts must focus, and continuous flow chemistry makes the business case.

How the midterm results stall Trump’s MFN push, and why differential pricing, compulsory licensing and transparency dominate the WHO Fair Pricing Forum.

Bob Cochran, former senior director, trade relations at Incyte, discusses direct-to-patient models, specialty launches and distribution strategy.

A CMS final rule codifies Medicare drug price negotiation from 2029, adds a fixed combination drug policy and implements a small biotech price floor.

Generative AI has made pharma teams faster, but real value depends on redesigning commercialization workflows, especially as agentic AI raises the governance stakes.