Newsletter | March 5, 2025

03.05.25 -- FCPA Enforcement Paused At DOJ, But Biopharma Shouldn't Pause Compliance

NEW PODCAST EPISODE

CGT Manufacturing: Distributed & Digital with Deloitte Consulting's Omkar Kawalekar, Ph.D.

Join Omkar Kawalekar, Ph.D., Senior Manager at Deloitte Consulting, on Cell & Gene: The Podcast as he discusses how distributed manufacturing models tackle capacity and supply chain challenges, the role of automation in minimizing variability, and how digital technologies optimize production. Tune in as he shares his insights with host Erin Harris on key considerations for CGT companies when deciding between in-house manufacturing and CDMO partnerships.

FROM THE EDITOR

FCPA Enforcement Paused At DOJ, But Biopharma Shouldn't Pause Compliance

Criminal enforcement of the Foreign Corrupt Practices Act was paused on February 10 by a Trump administration executive order. That doesn't mean biopharmaceutical companies can backslide on compliance in global markets.

INDUSTRY INSIGHTS

Improving The Patient Experience In Clinical Research

To preserve the quality of care and build a more effective approach to trial design, a sponsor must consider their approach to patient recruitment and enrollment early and often.

Four Challenges That Stall Advanced Therapy Development

Many challenges can stall an advanced therapy’s development. The vast majority of them are tied to inadequate preclinical planning and partner vetting.

Nanoscale Technology's Potential: A Fireside Chat With Industry Leaders

Nanoform CEO Edward Haeggstrom and Shawn Davies, head of drug delivery, biopharmaceuticals development, AstraZeneca, discuss the potential of nanoscale medicines and delivery devices.

Transforming Field Rep Success

As the demand for efficient medical information access increases, adopting information management tools is essential. Certain tools can support effective communication and boost productivity.

How One Of Our Comic Books Helped A Teen Discover She Had VKC

In this video, a teenager living with vernal keratoconjunctivitis (VKC) shares her story of how a comic created by Jumo Health helped her identify the problems she was having with her eyes.