First-time biopharma launchers face interconnected challenges, including limited capital, lengthy preparation timelines, regulatory uncertainty and greater pressure to meet commercial forecasts. This white paper examines why traditional launch approaches often fall short and outlines practical strategies for building the right capabilities at the right time. Readers will learn how earlier planning, integrated execution and a flexible partnership model can help reduce launch risk, improve capital and time efficiency, and position a product to achieve its full commercial potential. [Transforma...WP_TL_0226 | PDF]
FDA grants accelerated approval to INOVIO’s Voceryq to reduce surgical burden in recurrent respiratory papillomatosis, Brox.AI’s Hamish Brocklebank on the three levels of digital clone use cases in pharma, and CytoDyn’s Dr. Jay Lalezari on his path from HIV clinician to CEO.
PhRMA's Scott LaGanga discusses the expanding influence of state policymaking on drug pricing, PBM reform, and efforts to translate policy changes into lower out-of-pocket costs for patients.
Brox.AI's co-founder and CEO on why telling an AI to pretend to be a doctor isn’t the same as cloning one — and why that distinction matters for pharma.
Earlier pediatric planning, innovative trial design, and closer collaboration among regulators, industry, and families are needed to close the persistent gap between the evidence available for adult and pediatric treatments.
