Suttons Creek ads

Why does pharma push risk downstream to suppliers? It's not that they don't understand the burden it creates. Nathan Kast of Stevanato Group puts it plainly in this episode of Navigating the Combination: pharma is managing clinical risk, regulatory exposure, and high asset concentration — and preserving flexibility under real asymmetric risk is a rational response to that, not a lack of awareness. Worth sitting with if you've ever been frustrated by a partner's risk posture and assumed it was about you.

Built for the people making the calls: VPs of Regulatory Affairs, program directors, and executives protecting multi-million-dollar drug investments. Navigating the Combination cuts through the complexity of combination product development — device selection, quality systems, OEM alignment, FDA submissions — with the people who've actually done it.

650+ years of combined combination product experience. 120+ launches. One podcast. Hosted by Parth Kothari and Jonathan Amaya-Hodges, Navigating the Combination brings pharma and device leaders into candid conversations about what actually works — device selection, regulatory strategy, OEM relationships, and the decisions that make or break a program. Give it a listen.

Check out the first-ever episode of the "Navigating the Combination" podcast featuring Jeff Gensler, Chief Quality Officer at Exela Pharma Sciences LLC. Some key takeaways: - Pharma and device quality systems differ fundamentally in CAPA philosophy - pharma treats CAPA as actions from investigations, while device uses it systemically for trend violations and major issues - Switching from attribute to variable data requires process improvement work first — you'll surface capability gaps that were invisible before - Variable data allows earlier detection of process drift, as demonstrated by catching a degraded mould cavity before a single out-of-spec part was produced - Quality improvements need a business case, not just a compliance argument — linking changes to cost savings significantly increases the chance of leadership buy-in - Run towards the fires — warning letters, drug shortages, and enforcement actions are where quality professionals learn the most, the fastest

When Jeff Gensler walked into Pfizer Meridian on day one, FDA had left the building just a week earlier. What followed — a warning letter response, 15 FDA meetings in four months, a CDRH site audit, and an agency directive to redesign the entire product — was a challenge, but also an opportunity for in-depth examination of the company’s quality systems. In this episode, Jeff joins Parth Kothari and Jonathan Amaya-Hodges to unpack those early days, the gaps he found between pharma and device quality thinking, and how that experience shaped his entire approach to process capability, CAPA, and compliance.

What's the difference between a combination product program that launches on time and one that stalls in review? Usually, it's not the science. It's how early the device conversation started. Navigating the Combination is where pharma and device leaders talk through those decisions — the ones that don't make it into the SOP. New episodes from Suttons Creek.