As pharma companies rethink global manufacturing networks, Reliant Life Sciences Vice President Ben Locwin says resilience starts with understanding where risk is concentrated and making deliberate decisions about how to protect your assets smartly.
Introduction
After several years of disruption, pharmaceutical supply chains are no longer being evaluated primarily on cost and efficiency.
Tariffs, geopolitical uncertainty, concentrated sourcing, changing regulatory expectations, and pressure to expand domestic manufacturing are forcing companies to take a harder look at where their products, materials, and critical manufacturing capabilities actually come from.
The concern is showing up at the executive level. In Deloitte’s 2026 Life Sciences Outlook, 39% of surveyed leaders identified geopolitical tensions as a top issue influencing strategy, while 38% pointed to inflation, broader economic pressures, and supply chain risk.
For Ben Locwin, PhD, MBA, Vice President at Reliant Life Sciences, the question facing pharmaceutical leaders is becoming increasingly specific:
Where are our single points of failure?
And once they have been identified, what is the safest way to reduce that exposure without introducing a different set of problems somewhere else?
That second question matters. Moving or changinga supply chain is not the same as strengthening it.
Reshoring Is Accelerating, but Resilience Is the Real Objective
The push toward more U.S.-based pharmaceutical manufacturing is real.
FDA has made domestic manufacturing a strategic priority through initiatives such as its PreCheck program, noting that more than half of pharmaceuticals distributed in the United States are manufactured overseas and only 11% of API manufacturers are U.S.-based.
The industry is responding with major U.S. investments. DCAT’s 2026 outsourcing outlook tracks a long list of announced manufacturing and R&D expansions from companies including AbbVie, AstraZeneca, Eli Lilly, GSK, Johnson & Johnson, Merck, Novartis, Pfizer, Roche, Sanofi, and others.
But Locwin cautions against interpreting that movement as a simple reversal of globalization.
For many companies, a more realistic objective is reducing dependence on any one geography, supplier, CDMO, material source or logistics pathway.
“Reshoring is a location decision. Resilience is a risk decision. The two can intersect or overlap, but they are not the same thing.” Ben Locwin, PhD, MBA Vice President, Reliant Life Sciences
Start by Finding the Single Points of Failure
Supply-chain concentration often runs deeper than a list of approved manufacturing sites suggests.
A sponsor may have multiple CDMOs but rely on the same upstream supplier. Two regional suppliers may source the same key starting material from one country. A secondary manufacturing site may exist on paper but require months of qualification and regulatory work before it could actually absorb production.
Recent U.S. Pharmacopeia findings illustrate the problem. Among drugs experiencing shortages, 44% relied on at least one key starting material manufactured exclusively in a single country, demonstrating how concentration risk can begin far upstream of drug substance or finished product manufacturing.
That means the resilience conversation has to go beyond Tier 1 suppliers.
Four Questions Leaders Should Be Asking
For Locwin, the more useful starting point is a disciplined assessment of where concentration creates meaningful risk:
- Where would the loss of one supplier, site, region, or CDMO materially disrupt the program?
- Which critical materials or processes have no truly qualified low-risk alternative?
- How long would it take to activate a backup source in practice, not just on a sourcing plan?
- What quality, regulatory, validation, and technology transfer work would be required to make that alternative viable?
Those questions expose an important distinction between having a backup and having an executable backup.
A second supplier provides little protection if the process has never been transferred, methods are not bridged, equipment is not qualified, or regulatory requirements make a site change impractical within the required timeline.
Reducing China Exposure Is Not a Single Decision
China remains deeply embedded in pharmaceutical supply chains through established infrastructure, technical capability, material availability, and long-standing supplier relationships.
At the same time, boards and operating teams are reassessing concentrated China exposure because of trade uncertainty, geopolitical risk, intellectual-property concerns, supply continuity, and stakeholder perception.
The right approach will vary by product, modality, and stage of development.
For one program, it may mean qualifying an additional API supplier outside China. For another, it may mean moving drug product closer to the end market while retaining parts of the upstream supply chain in Asia. A third may justify transferring the full process to a U.S. or European CDMO.
Recent industry discussion points toward regionalization with redundancy rather than wholesale reshoring as a more realistic model for many organizations. The goal is to identify critical nodes where additional sources or qualified backups materially reduce risk, without adding cost and complexity everywhere.
That is a very different exercise from issuing a broad mandate to “exit China.”
Diversification Can Create Its Own Failure Points
Every additional supplier or manufacturing site creates work.
A new source may require some combination of:
- technology and analytical method transfer and new planning
- supplier qualification and comparability work
- equipment and process validation
- Quality agreements and regulatory changes
- ongoing governance across a larger network
For Locwin, diversification is as much an execution challenge as a sourcing decision.
A company can reduce geographic concentration and still increase operational risk if the transition is poorly planned.
A More Useful Definition of Resilience
A More Useful Definition of Resilience
Resilience starts with knowing:
- Where you are exposed
- Which risks matter most
- Which alternatives are truly executable
- Who owns the response when conditions change
CDMO Diversification Requires More Than a Second Name on the List
Sponsors are also examining whether their CDMO strategies are too concentrated geographically or operationally. A second CDMO only improves resilience if that partner can actually support the program when needed.
As Reliant has explored previously in What Pharma Sponsors Need from CDMOs Now, capability, capacity, and cost are only part of a successful outsourcing decision. Regulatory maturity, operational fit, governance, and the ability to respond when conditions change matter too.
A credible secondary CDMO needs more than available capacity. It needs the right modality and process experience, appropriate quality and regulatory maturity, the technical-transfer capability to take on the program, and a realistic path from transfer through validated production.
This is particularly important because qualified capacity remains constrained in parts of the market. RLS has previously examined how reshoring and diversification can run into capacity, capability, and experienced-talent constraints, meaning the preferred alternative may not actually be available on the timeline the program requires.
Reshoring Is Really a Series of Controlled Transfers
Designing the future-state network may be the strategic challenge. Executing the transition is often the harder one.
Moving a manufacturing process from one geography or CDMO to another can affect CMC strategy, methods, materials, equipment, facilities, validation, quality systems, documentation, regulatory filings, and commercial supply continuity.
That makes technology transferone of the critical execution points in any reshoring or regionalization strategy.
For pharmaceutical leaders, that raises several practical questions:
- What must remain consistent across the transfer, and where are process differences acceptable? Can you quantify and defend the differences?
- What comparability, qualification, and validation work will be required?
- Can the current site maintain supply while the new facility and process comes online?
- Are Quality, Regulatory, MSAT, Engineering, and external manufacturing working from the same transition plan?
The risk is rarely one dramatic failure. More often, small assumptions and operating rhythm that seemed manageable on their own become consequential once the transfer is underway.
This is also where supply chain strategy intersects directly with inspection readiness. New facilities, systems, suppliers, and transferred processes create additional points where documentation, validation, Quality oversight, and regulatory expectations have to hold together. RLS has explored those pressures in its analysis of why biomanufacturing expansion can increase inspection risk.
The People Managing the Transition Matter
Supply chain redesign can look like a procurement or network-strategy exercise from the boardroom.
Execution cuts across far more functions.
Quality needs to assess supplier and process risk. Regulatory teams need to understand filing implications. MSAT and technical operations have to move process knowledge without losing control. Validation teams need to qualify new systems, equipment, and processes. External manufacturing leaders have to coordinate partners that may be working across different timelines and incentives.
This is where Reliant Life Sciences supports biotech and pharmaceutical organizations.
RLS provides experienced professionals across Quality, Validation, Regulatory, Manufacturing Science & Technology, technology transfer, risk management and related manufacturing functions. These specialists add critical capability during high-stakes transitions without increasing the burden on already stretched internal teams.
The value isn’t simply more capacity. It’s having people who understand regulated environments, know what needs to happen next and can keep execution moving without creating more work for the team already carrying the program.
Supply Chain Strategy Becomes Execution Across:
- Supplier & CDMO Management
- Tech Transfer
- MSAT
- Quality
- Commissioning, Qualification, & Validation
- Regulatory Strategy
- Risk Management
The Goal Is Not Independence. It Is Optionality.
For pharmaceutical leaders, there is an understandable appeal to eliminating dependence.
In practice, global pharmaceutical manufacturing will continue to rely on interconnected external partners, materials, technologies and geographies. The more practical goal is optionality: knowing where the most consequential vulnerabilities sit, having credible alternatives for the risks that matter most, and being confident those alternatives can be activated without creating a quality, regulatory or supply problem.
That also requires experienced people who can turn the contingency plan into an executable transition when conditions change.
For Locwin, those considerations increasingly define what meaningful pharmaceutical supply chain resilience looks like.
These issues will also be part of the broader industry conversation this fall. Locwin will represent Reliant Life Sciences at CDMO Live Americas, October 20–21 in Boston, as chairman of the Drug Development track as well as joining the panel “De-Risking Small Molecule CMC: Decision Gates, Global Capacity, and Supply Chain Strategy.”
But the challenge extends well beyond any one conference or therapeutic program.
The strongest supply chains will be built by leaders who understand where failure would hurt most, which alternatives are realistically executable, and what it will take to shift production without losing control.
About Reliant Life Sciences
Reliant Life Sciences partners with biotech, pharmaceutical, and medical device organizations to solve complex quality, validation, regulatory, manufacturing and technology transfer challenges. RLS brings experienced life sciences professionals into critical programs and transitions to strengthen internal teams and help protect timelines, quality and regulated outcomes.
Building a more resilient manufacturing or external supply strategy? Talk with a Reliant Life Sciences Expert.
Written by: Ben Locwin, Vice President at Reliant Life Sciences.
