Vice President – Business Development
LGM Pharma

Mike Stenberg

PharmTech recently caught up with Mike Stenberg, vice president of business development at LGM Pharma, to follow up on predictions he made back in December on what the pharma manufacturing industry would face this year. Check out all three parts of the 2025 interview with Stenberg:

Strategies for Building Pharmaceutical Supply Chain Resilience in a Shifting Market

How GLP-1s, Digital Tech, and 505(b)(2) Strategies Are Reshaping the CDMO Landscape

Navigating Financial and Opportunity Risks in Accelerated Drug Launches

In this three-part interview, Stenberg predicted that inspections in China and India—already at or above pre-COVID levels—would continue to climb in 2026. At the time, he described the 

 (CNPV) program as shifting the bottleneck from FDA approval to the production floor, and said companies have to onshore manufacturing to the US to take advantage of it. Stenberg also predicted that the GLP-1 boom would push real advances in transdermal microneedles, subdermal delivery, and oral solid doses with enhanced GI uptake. Additionally, he said AI adoption on the production floor and in supply-chain vetting would be real but slowed by a lack of structured datasets and the need to rewrite SOPs and retrain staff in a highly regulated industry.

Now that 2026 is half over, Stenberg offers his thoughts on what predictions he made came to fruition, which didn't, and why, as well as what's in store for the second half of the year.

PharmTech: Have inspections in China and India continued to climb as you predicted?

Stenberg: It's still too early to know where we stand as an industry with 2026 inspection data, but FDA released its 

FY2025 Report on the State of Pharmaceutical Quality

 in June, and it complicates the story a bit. Inspections did increase, but growth was almost entirely domestic, with foreign inspections in countries like China and India seeing far more modest growth despite the number of registered facilities there continuing to increase. Citations per inspection actually ticked down year-over-year, so there are more visits happening, just not necessarily more citations found per visit.

What hasn't budged is what they're finding when they do show up. FDA data show that the same handful of core issues keep topping the list: written procedures and documentation, investigations of discrepancies and failures, and equipment and quality control lapses.

Have you seen clients make the onshoring move and commit to “day one” commercial-scale planning in response to CNPV?

It's still too early to speak to the voucher program specifically, since it's still in pilot phase. What we are seeing more broadly is real client interest in onshoring drug product manufacturing, closer to the end market. For the majority of products supplying the US market, APIs and raw materials tend to stay globally sourced, but finished dose is where the domestic investment makes the most sense, offering greater operational, regulatory, and economic control in that last mile.

Which of the alternate GLP-1 delivery formats has progressed furthest?

The biggest story for me is what's spilling over into how people access these drugs. Direct-to-consumer platforms have gone from a novelty to nearly universal in under two years, and it's not just Lilly and Novo. Telehealth providers and other manufacturers are building similar access models around GLP-1 demand that is expanding access to other drugs as well. Meanwhile, we continue to see new routes of dosage administration being explored, but the development of these dosage forms is still in early phases. The approval of the first oral solid dose forms of GLP-1s is the first new route of administration, but I doubt it will be the last.

Has the AI adoption curve moved faster or slower than you expected?

first warning letter that specifically cites improper use of AI in manufacturing

 with a major oversight related to specifications and procedures. In most industries, you can plug in a tool and move quickly with minimal repercussions, but the pharmaceutical industry proceeds more carefully given the regulatory scrutiny and what's at stake for patients if it gets this wrong. The pace will keep looking slow next to tech or even other regulated industries, and that's the system working as intended.

What's the most unexpected development in pharma manufacturing and development so far in 2026?

With the volatility we've witnessed in this decade, it would be more of a surprise to not have an unexpected development in 2026. Tariffs continue to shift, we've seen more regulatory turnover, and geopolitics can sometimes seem like a month-to-month calculation. It is our job to remain well-positioned and proactive for the next disruption with second sourcing lined up, safety stocks negotiated, and onshore production where it matters. We've learned as an organization to remain focused on what's in our sphere of influence and expect the unexpected.

What do you see as the biggest challenge facing pharma manufacturing and development for the remainder of 2026?

The challenge I'd point to is what's not getting funded. Early-stage biotech financing is on pace for its worst year this decade, while the capital that is moving chases assets that are already de-risked. We see a growing share of US and European investment and licensing deals flowing toward China instead of new companies in the US. The pipeline we'll all be manufacturing in a few years depends on what gets seeded today, and right now a lot of that isn't happening.

Articles

Mid-2026 signals mixed validation of prior pharma-manufacturing forecasts. FDA quality reporting shows inspection growth driven largely by US sites, with modest increases abroad and fewer citations per inspection, yet persistent repeat deficiencies in documentation, investigations, and equipment/QC. Interest in US-based drug-product finishing is rising, even as APIs remain globally sourced, and CNPV implications remain uncertain. GLP-1 demand is accelerating direct-to-consumer/telehealth access models; novel delivery routes are early, with oral solids emerging first. AI adoption remains cautious after an FDA warning letter. Funding contraction in early biotech threatens future pipelines.

Checking in at 2026's midyear mark, LGM Pharma's Mike Stenberg revisits his 2025 predictions on inspections, onshoring, GLP-1 delivery, and AI adoption.