Blueprint for Breakthroughs is a LinkedIn newsletter published by Adrienne B. Mendoza, MHA, SVP BioBridge Global and Chief Operating Officer (COO), BBG Advanced Therapies
Originally published on LinkedIn on April 8, 2025
The infrastructure behind Advanced Therapies is deeply rooted in global supply chains, and that foundation is shifting.
With new U.S. tariffs taking effect and global trade tensions escalating, cell and gene therapy programs are facing renewed pressure to protect continuity — the seamless, dependable flow of materials, manufacturing, and logistics that moves therapies from concept to care.
Your product may not be on a tariff list. But if your critical inputs are, your program could still feel the impact.
Why This Matters for Cell and Gene Therapy
Advanced therapies depend on highly specialized materials that are often sourced from around the world:
- Growth factors, plasmids, and media
- Viral vectors and gene editing reagents
- Single-use consumables (bags, filters, tubing)
- Lab automation systems and QA testing platforms
- Cold chain sensors and data loggers
While finished pharmaceuticals may be largely exempt, many critical upstream inputs are not.
The Biotechnology Innovation Organization (BIO) recently reported that nearly 90% of U.S. biotech companies rely on imported components for at least half of their FDA-approved products. That’s a vulnerability — not just in cost, but in timing, quality, and delivery.
What We Learned From COVID
We’ve seen the movie before.
During the pandemic, shortages of filters, bags, tubing, and PPE disrupted even the most advanced programs. Timelines slipped. Patients waited. Sites scrambled.
Tariffs and shifting trade rules could cause similar friction, not overnight, but gradually — through delays, increased costs, and tighter inventory across global suppliers.
And in cell and gene therapy, where timing is tightly linked to patient readiness, a few days’ delay can be the difference between treating and missing a window of care.
What Teams Can Do Right Now
You don’t need all the answers to take action. Here are five steps to build continuity now:
- Map your material origins: Know which materials — or suppliers — are exposed to regions affected by new tariffs or export controls.
- Check in with vendors: Many partners are already modeling impact. Ask what mitigation strategies they’re preparing.
- Review inventory buffers: For high-risk items with long lead times, consider proactive stocking while pricing and availability remain stable.
- Incorporate tariff exposure into your risk planning: Don’t wait for downstream impacts to appear. Get it on the radar now — with your clinical and finance teams, too.
- Strengthen operational flexibility: Create room in your timelines, procurement practices, and QA handoffs to absorb uncertainty without jeopardizing the patient journey.
The Glass-Half-Full View: A Chance to Build Smarter
While these challenges are real, they also reveal an opportunity. One that many in the industry have quietly known was overdue.
The healthcare industry, including cell and gene therapies have become highly dependent on global vendors, custom supply chains, and just-in-time delivery models.
But perhaps this moment, tariffs, trade friction, and all, is the push we need to invest in greater self-reliance.
That could mean:
- More local or regional sourcing strategies
- Diversified supply chains not tied to a single geography
- Incentives for domestic manufacturing of critical inputs
- Strengthening relationships with suppliers closer to your primary markets
- Investing in platform approaches that reduce custom material needs
Disruption can be a teacher. And if it drives us to build stronger, more reliable infrastructure, infrastructure that works not just in ideal conditions but in moments of pressure… then it may be a turning point worth embracing.
Final Thought
Every disruption holds a mirror to what we’ve built, and what we’ve overlooked. While this is a challenging time, it’s also an invitation to rethink how we source, scale, and serve.
Not for the sake of efficiency alone, but to protect the patients waiting at the end of the line.
If your organization needs help reviewing and responding to these risks and a changing world, the team at BBG Advanced Therapies would be glad to help. Visit us at BBGAT.org.
