Engaging Commercial Supply Chain Professionals Early In Clinical Supply Selection

A conversation with M. Dave Malenfant, founder, MDM Consulting

As clinical trials become increasingly global and complex, supplier selection decisions made during early development can have far-reaching consequences that extend well beyond individual studies. Suppliers chosen to support early-phase clinical programs are often expected to scale manufacturing, packaging, distribution, and quality systems as products advance toward pivotal trials and commercialization. Yet clinical teams and commercial supply chain organizations frequently evaluate potential partners through different lenses. Clinical teams often prioritize speed, flexibility, and study-specific requirements, while commercial teams focus on scalability, operational resilience, long-term cost structures, and global supply capabilities. When these perspectives are not aligned early, sponsors may inadvertently introduce vulnerabilities that surface later as capacity constraints, quality challenges, packaging redesigns, distribution bottlenecks, or delayed commercialization efforts.

In this Q&A, Elizabeth Urbanek, executive editor of Clinical Supply Leader, speaks with M. Dave Malenfant, founder of MDM Consulting and co-owner of M&M Fitness and Training, LLC, about why commercial supply chain expertise should be incorporated earlier in clinical supplier selection discussions. He explores common areas of misalignment between clinical and commercial teams, the risks sponsors often overlook when evaluating suppliers, and how cross-functional collaboration can strengthen forecasting, packaging strategy, transportation planning, and global distribution readiness. As trials become more personalized, temperature-sensitive, and geographically dispersed, Malenfant argues that supplier selection must evolve from a study-focused decision into a life cycle-focused strategy designed to support both clinical execution and long-term supply chain resilience.

Why this misalignment matters becomes clear in the first question below.

Why are clinical teams often hesitant to involve commercial supply chain professionals early in clinical supplier selection, and what risks does that create later in the trial?

Clinical teams often delay involving commercial supply chain professionals because they fear loss of speed, loss of control, and misalignment with clinical priorities — even though early collaboration almost always improves cost, continuity, and long‑term scalability. There is a lot of concern that commercial will prioritize cost over science. From a clinical standpoint, the science is primary, but successful supplier selection requires balancing scientific requirements with commercial and operational considerations.

This can create real material risks later in the trial life cycle. These risks show up in Phase 2/3, during scale‑up, at tech transfer, and especially at commercialization, where supplier capabilities and long-term scalability become increasingly important.

At what point in the clinical trial planning process should commercial supply chain expertise be brought into supplier discussions, and what specific value can those professionals add before contracts are signed?

Commercial supply chain expertise should be brought in as soon as a clinical team begins identifying or shortlisting potential suppliers — before RFPs are issued and well before contracts are drafted. This is typically during protocol finalization and early feasibility planning (approximately six to nine months before first patient in). At this stage, supply chain can influence supplier selection, risk modeling, scalability, cost to serve, and long‑term manufacturability — all of which are nearly impossible to fix after contracts are signed.

I often say clinical teams optimize for speed; commercial teams optimize for scale. Bridging both perspectives into the supplier evaluation process early helps organizations balance near-term study needs with long-term operational requirements. There is much more I could say on this topic, but I’ll stop here for now.

Many suppliers can technically support a clinical study, but far fewer can scale successfully into commercialization. What are the biggest warning signs sponsors miss when evaluating suppliers too narrowly through a clinical lens?

Clinical teams tend to optimize speed, flexibility, and low volume. Commercial teams optimize scale, reliability, and long‑term cost. When commercial supply chain is not involved in supplier selection, sponsors often miss several key warning signs:

• limited clinical-only capacity, with no proven ability to scale beyond pilot batches
• no redundant equipment or backup capacity
• no global distribution capability.

These gaps can create significant challenges as programs advance into later-stage trials.

Another warning sign is weak quality systems that may not withstand commercial audits. Clinical suppliers often operate under lighter controls. Red flags include:

• no validated equipment
• incomplete batch documentation
• immature change‑control processes
• no history of FDA/EMA inspections.

What looks fine in Phase 1 may become problematic under commercial scrutiny.

Over-customized clinical packaging cannot be commercialized. Clinical teams love flexibility; commercial lines require standardization. Red flags include:

• nonstandard carton sizes
• labels incompatible with UDI/IVDR requirements
• formats that don’t fit automated lines.

This forces expensive redesigns and revalidation later.

Another area of concern is single-source dependencies with no backup plan. Clinical teams often pick the vendor they know. Commercial teams see:

• no dual‑sourcing
• no business continuity plan
• no geographic risk mitigation.

One disruption can result in trial delays or launch failure.

Hidden cold chain or logistics fragility is another key risk area. Clinical teams rarely pressure-test logistics. Common red flags include:

• no qualified shipping lanes
• seasonal risks not assessed
• weak 3PL performance
• packaging not validated for long-haul transport.

Commercial supply chain sees these risks immediately.

How can early collaboration between clinical supply and commercial supply chain teams improve resilience around forecasting, packaging, transportation, and global distribution as trials expand?

Early collaboration between clinical supply and commercial supply‑chain isn’t just nice to have — it’s the difference between a study that scales smoothly and one that collapses under its own complexity as it expands globally.

Clinical teams forecast based on protocol assumptions. Commercial teams forecast based on capacity, lead times, and real‑world constraints.

When they collaborate early, you get:

• scenario‑based forecasting (best case, base case, worst case)
• realistic lead‑time modeling that prevents stockouts
• better assumptions for enrollment variability
• visibility into supplier capacity limits before they become bottlenecks
• alignment on safety stock strategy for global expansion.

Forecasting becomes more accurate, more stable, and less reactive. This helps reduce the “Phase 2 surprise” where demand suddenly outstrips supply.

Packaging decisions support both clinical flexibility and commercial scalability. Clinical teams optimize for speed and customization. Commercial teams optimize for standardization and manufacturability. Early collaboration ensures:

• packaging formats that fit commercial lines later
• labeling choices that support global regulatory requirements
• cold chain packaging validated for long‑haul distribution
• avoidance of clinical‑only formats that require costly redesign.

This prevents the classic mistake: “The clinical kit worked great… but it can’t be commercialized.”

In your experience, where do clinical and commercial supply priorities most commonly clash during supplier selection, and how can organizations create better alignment between the two groups?

Clinical and commercial teams are both trying to de‑risk the program — but they define risk differently. That’s why they often choose different suppliers for the same problem. The most common friction points during supplier selection typically fall into five categories:

1. Speed vs. Scalability

The Clash: Clinical teams choose the fastest option. Commercial teams choose the most scalable option. Those are rarely the same supplier.

2. Customization vs. Standardization

The Clash: Clinical teams love flexibility. Commercial teams know flexibility doesn’t scale.

​3. Short-Term Cost vs. Long-Term Cost

The Clash: Clinical sees cost as a study expense. Commercial sees cost as a 10‑year P&L impact.

​4. Relationship-Driven vs. Capability-Driven Selection

The clash: Clinical chooses who they trust. Commercial chooses who can survive scale, audits, and launch.

​5. Minimal Contracting vs. Structured Contracting

The clash: Clinical wants speed. Commercial wants protection.

Organizations can improve alignment by bringing commercial supply chain into supplier discussions early, not after shortlist creation or the RFP process.

A joint supplier evaluation framework can also help standardize decision-making. This typically includes:

• clinical agility
• commercial scalability
• quality maturity
• cost to serve
• tech transfer readiness
• global distribution capability.

This ensures both teams evaluate suppliers through a shared lens.

A clinical-commercial governance model further strengthens alignment. Examples include:
• joint S&OP-style monthly reviews
• shared risk registers
• cross-functional decision rights
• early escalation pathways.

This shifts decision-making away from clinical vs. commercial dynamics toward shared accountability.

Finally, alignment improves when organizations focus on a long-term supply strategy rather than only a study-level strategy. Clinical teams often think in terms of study cycles, while commercial teams think in product life cycles. Bridging this gap requires:
• designing packaging that supports both phases
• selecting suppliers with scalable capabilities
• building contracts that anticipate future needs
• planning for global distribution early.

Incentivizing collaboration is also critical. Organizations that do this well:
• tie KPIs to shared outcomes
• reward cross-functional problem solving
• embed supply chain liaisons within clinical teams
• train teams on both clinical and commercial realities.

This helps shift the culture from “my priorities” to “our success.”

As trials become more global, personalized, and operationally complex, how should sponsors rethink supplier selection to avoid creating long-term supply chain vulnerabilities that only emerge after pivotal studies?

This is exactly the question sponsors should be asking as trials become more global, personalized, temperature‑sensitive, and operationally complex. The old model — “pick a clinical supplier fast and figure out the rest later” — is now one of the biggest hidden sources of long‑term vulnerability.

The new reality is that clinical complexity now predicts commercial vulnerability.

Global, decentralized, adaptive, and personalized trials introduce risks that clinical‑only suppliers simply aren’t always built to handle:

• multi‑country import/export complexity
• cold chain and ultra‑cold chain requirements
• personalized or small‑batch manufacturing
• serialization and global traceability
• rapid protocol amendments
• high‑variability enrollment patterns
• multi‑depot distribution networks.

Any final thoughts?

As clinical trials become more global, personalized, and operationally complex, sponsors can no longer afford to select suppliers based solely on clinical speed or early‑phase flexibility. The vulnerabilities that derail pivotal studies and delay commercialization are almost always created upstream — during supplier selection, contracting, and early planning — long before they become visible.

The path forward is straightforward: sponsors must shift from a study-centric mindset to a life cycle-centric one. That means selecting partners not only for Phase 1 speed but also for Phase 3 scalability and commercial readiness.

Across forecasting, packaging, transportation, global distribution, risk modeling, and supplier capability, one message is clear: resilience is built early through deliberate collaboration between clinical and commercial supply chain teams.

About The Contributor:

Dave Malenfant is a supply chain executive and industry advisor with more than 40 years of experience across the pharmaceutical, medical device, and life sciences sectors. He is the founder of MDM Consulting and co-owner of M&M Fitness and Training, LLC, where he helps organizations improve operational performance, leadership development, and supply chain effectiveness.

Previously, Dave served as Executive Vice President of Industry Liaison and Talent Development for the Biotech Supply Management Alliance (BSMA) and held leadership roles at Texas Christian University’s Center for Supply Chain Innovation. During a 21-year career at Alcon Laboratories, he advanced to Vice President of Global Supply Chain, leading worldwide supply chain strategy and establishing centers of excellence across procurement, distribution, transportation, customer service, and product launch operations. He remains an active consultant, mentor, speaker, and advocate for supply chain innovation and talent development.