Can the US Catch Up? Brian Scanlan on FDA Delays, China’s Edge, and the Race for Early Stage Speed

Late last week, FDA Commissioner Marty Makary said the United States risks ceding leadership in early-stage drug development to China because of avoidable regulatory and operational delays in initiating clinical trials.¹ In a televised interview, Makary identified hospital contracting, institutional review board processes, and Investigational New Drug application review timelines as key bottlenecks that may be slowing first-in-human and early-phase studies in the US.

We connected with Brian Scanlan, managing partner at Freedom Bioscience Partners and life sciences partner at Edgewater Capital Partners—who will present at Interphex in April on whether China’s surge in biotech innovation will upend global CMDO demand²—to get his perspective on, and good practical advice on what to do with, the development.

PharmTech: How do you expect China’s growing lead in early‑stage trials to reshape capital allocation and M&A priorities in the pharma services sector over the next 3–5 years?

Scanlan: China’s growth in both clinical trials and new therapeutic innovation has sent alarm bells through the pharma services world, the investor community, and within our own federal government. The US is now playing defense, which has prompted the BIOSECURE act,³ tariffs, and executive orders. I think geopolitics will ultimately be the major force that governs how this plays out—where the regional balance of therapeutic innovation and pharma services infrastructure will ultimately land. Generally speaking, capital flows will favor speed, but directed by geopolitics.With that in mind, over the next 3-5 years, pharma service M&A priorities could shift back to early-stage, tech-enabled, services businesses (a welcome site after 3-4 years of tepid demand). However, this will only happen in conjunction with a cooperative regulatory environment that enables streamlined approval pathways as well. Much of this is already starting to happen.

How should US and European development and manufacturing leaders balance the apparent speed and scale advantages in China with rising geopolitical, regulatory, and data‑security risks?

The US and EU are really a tale of two cities. The US is moving much more rapidly to enact regulatory streamlining; both FDA streamlining reforms, and removal of barriers so big infrastructure projects can be fast-tracked. In the EU, there has been a lot of talk, but thus far, very little action.

Separately, there is an entire ecosystem of both small and large CDMOs that are getting significant traction in the introduction of real AI/ML models into their process development workflows, and a lot of the “AI noise” is starting to subside. I have seen some very compelling data out of several CDMOs that are reducing process development times,developing novel chemistries and formulations in a fraction of time it took just a year ago.Examples of this are Lonza,⁴ Excelsior Sciences,⁵ and Persist AI.⁶ Over the next 3-5 years, actual implementation of functional/validated AI process development models will be the key to bridging the divide between China and the western CDMOs. It’s all about speed now.

Where do you see the biggest operational gaps in Western CDMOs and biotechs that must be closed to stay competitive with Chinese earlydevelopment capabilities?

Regulatory agility followed closely by cycle time reduction (ie productivity enhancement).

For a mid‑size pharma or services company that can’t simply ‘follow the herd’ into China, what practical playbook would you recommend to remain globally competitive in early development and manufacturing?

For the smaller players, specialization trumps scale, and they match up very well with the emerging biotech community in terms of culture. My advice to these companies is to “stay in your swim lane” and own that specialization, which includes tools to unlock speed and efficiency in process development, manufacturing, and continuous improvement. Small-/mid-sized pharma service companies also play a vital role to provide key capability/service advantages within their regions versus the large and mega pharma services counterparts.

References

1. CNBC. FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals. February 18, 2026. https://www.cnbc.com/amp/2026/02/18/fda-chief-warns-us-is-losing-ground-to-china-in-early-drug-trials.html
2. Interphex. Biotech Whiplash: Will China’s Surge in Biotech Innovation Upend Global CDMO Demand? Access Feb 24, 2026.
3. US Congress. H.R.8333 - BIOSECURE Act. Accessed Feb 24, 2026.
4. Lonza. AI-Enabled Route Scouting Service. Accessed Feb 24, 2026.
5. Choudhury K. Excelsior Sciences Raises $95 Million to Speed Small Molecule Drug Development Using AI. Reuters.com. Dec 3, 2025.

Persist AI. Beyond the $12M: Revolutionizing Drug Formulation Development at Persist AI. Press Release. May 19, 2025.