Thoughtful Supply Strategy Is No Longer Optional In Drug Development

By Lisa Sellers, Ph.D., advisory board member, San José State University

In drug discovery and development, supply chain decisions are often treated as a downstream concern, an issue to deal with once a candidate has shown promise, or when clinical timelines start to crystallize. In reality, supply strategy is a development decision from the very beginning. The choices researchers make around critical components can influence everything from experimental reproducibility to regulatory readiness, cost structure, and long-term scalability. Those considerations include what active pharmaceutical ingredients (APIs), intermediates, reagents, and/or specialty chemicals to order, how much, and when.

This challenge is particularly acute in therapeutic areas, such as oncology, genomics, and infectious disease, where development programs increasingly depend on complex inputs sourced from a global network of suppliers. Tariffs, geopolitical uncertainty, and long lead times now sit alongside more familiar concerns like quality, consistency, and documentation. For small and emerging companies in particular, navigating these factors requires a level of rigor that is often difficult to achieve with limited resources. Yet supply decisions made without alignment to a program’s actual stage can introduce unnecessary cost and complexity that slow scientific progress rather than support it.

Supply Strategy Is Not One-Size-Fits-All

One of the most common misconceptions in early-stage drug development is the belief that all materials must meet the highest possible regulatory standard from day one. In practice, this binary view (GMP or not) oversimplifies the reality of how therapies move from discovery to patients.

An analogy that often resonates is buying a car. If you have a large family and need space, safety, and durability, a two-seat sports car is probably not the right choice. Conversely, if you are retired and simply want a nimble vehicle for short trips, a full-size family minivan is likely excessive. The “best” car depends entirely on how you plan to use it.

The same principle applies to critical components in drug development. If a program is one step away from producing a pill that someone will ingest or a dose that will be injected into a patient, then full GMP compliance is clearly required. At that point, rigorous documentation, validated processes, and tight quality controls are nonnegotiable. However, many developers at the discovery or early preclinical stage are far from that reality. Frequently, teams are still defining their target product profile, refining their modality, or even determining which components will ultimately be part of the final formulation.

Despite this, it is not uncommon for early-stage teams to request full GMP materials immediately, often driven by uncertainty or the desire to “do everything right” from the outset. While well intentioned, this approach can become a significant sticking point. Full GMP readiness comes with extensive requirements and, more importantly, substantial cost. For programs that may still change direction, those investments can be premature and, in some cases, counterproductive.

Education As A Critical Part Of The Development Journey

What many early-stage teams need most is not simply access to materials but education around what is truly required at each phase of development. Drug discovery is an iterative process, and supply strategy must evolve alongside it. That evolution benefits from open, honest conversations about where a program is today, where it aims to go, and what level of rigor is appropriate along the way.

In early engagements, it is entirely normal for developers to not know exactly what they want or need. The challenge arises when uncertainty leads to overspecification. Requesting the highest level of compliance before it is necessary can introduce financial strain and slow experimentation. Conversely, underestimating future regulatory expectations can create problems later when materials must be replaced or data must be regenerated under more stringent conditions.

The most productive discussions focus on right-sizing solutions rather than forcing binary choices. Instead of asking whether something must be GMP or not, it is often more useful to ask:

• What decisions does this material support today?
• What data will regulators expect at the next milestone?
• How likely is it that this component will remain part of the program long term?

These questions help align supply decisions with scientific and regulatory realities, rather than fear of future scrutiny.

The Hidden Risks Of Global Sourcing

Layered on top of these stage-related challenges is the growing complexity of global sourcing. Many APIs, intermediates, reagents, and specialty chemicals are manufactured outside the regions where final drug development occurs, often in countries such as China or India. While global sourcing can offer cost advantages and specialized expertise, it also introduces risks that extend beyond price.

Tariffs can significantly alter the economics of a development program with little warning. Geopolitical tensions or regulatory shifts can disrupt supply or lengthen lead times. Differences in quality systems, documentation standards, or regulatory transparency can create downstream challenges when materials need to support IND filings or clinical manufacturing.

These risks tend to be magnified for smaller companies. Large pharmaceutical organizations often have diversified supplier networks, dedicated procurement teams, and the leverage to negotiate contingencies. Emerging biotechs, by contrast, may rely on a single supplier for a critical component and lack the internal expertise to fully assess supply chain resilience.

For this reason, supplier evaluation should extend beyond immediate availability and cost. Developers benefit from understanding where materials are manufactured, how quality systems are maintained, and how adaptable a supplier can be as requirements change.

Planning The GMP Transition Without Stalling Innovation

Eventually, most successful programs will need to transition to GMP-grade materials. That transition is not optional if the goal is to reach the clinic and, ultimately, patients. The question is not whether GMP will be required, but when.

In many cases, the full development journey from early discovery through clinical stages can span anywhere from three to five years, and often much longer. GMP readiness represents a major inflection point along that path, both operationally and financially. It is not unusual for GMP-related investments to reach six- or seven-figure levels, reflecting the infrastructure, validation, and documentation required.

For early-stage companies, committing that level of capital too soon can be prohibitive. The key is to anticipate the transition rather than react to it. Mapping the development life cycle, identifying decision points, and modeling future requirements allow teams to make incremental investments that support progress without derailing innovation.

This approach also reduces the risk of unpleasant surprises. When teams understand what GMP will entail, in terms of cost and operational demands, they are better positioned to plan funding strategies, manage investor expectations, and avoid last-minute scrambles that can delay clinical entry.

Supply Strategy As A Core Development Capability

Ultimately, successful drug development depends on alignment: alignment between science and operations, short-term needs and long-term goals, and ambition and practicality. Supply strategy sits at the intersection of these forces. It is not merely a logistical function but a core development capability that can enable or hinder progress.

Treating supply decisions as part of an ongoing dialogue helps ensure that materials, quality standards, and sourcing strategies evolve alongside the program itself. By matching rigor to the development stage, understanding the implications of global sourcing, and planning thoughtfully for GMP transition, developers can protect both their science and their resources.

In an environment where timelines are tight, capital is constrained, and therapeutic complexity continues to grow, thoughtful supply strategy is no longer optional. It is an essential component of turning promising discoveries into viable medicines.

Acknowledgement

I thank Kim Mung Woo for input during the writing process of this article.

About The Author

Lisa Sellers, Ph.D., is a C-suite leader in the life sciences industry, with more than 20 years of experience. As a leading innovator for companies that provide essential reagents in immunohistochemistry, diagnostics, and pharmaceutical innovation, she has built frameworks for multiple partnerships to help advance tool innovation in research and development. She has advised numerous life science companies on accelerating product development to advance scientific discovery.

A recognized advocate for leadership development in STEM, Lisa serves on advisory boards for Santa Clara University, Notre Dame Belmont High School, and San Jose State University. She earned her Ph.D. in chemistry from the University of Colorado Boulder and a BS in chemistry from Santa Clara University.