Defining Strong Program Management In CDMO Partnerships

A conversation with George Stephen, director of global program management, Gilead Sciences

George Stephen has been Gilead Sciences’ director of global program management since early 2023. In this three-part series, Life Science Connect’s Michelle Raley caught up with him to discuss program management when working with CDMOs. In this first article of the series, we discuss the pitfalls that program managers help sponsor companies avoid, how program managers accelerate timelines or reduce risk, and how program managers align diverse stakeholders.

From your perspective, what are the most common pitfalls companies face when partnering with contract manufacturers, and how can strong program management help avoid them?

Stephen: When partnering with contract manufacturers (CMOs), companies often encounter recurring pitfalls. In my experience, the biggest traps and how proactive program management prevents them include:

• Unclear Project Scope and Expectations: Rushing into execution without a detailed scope can lead to misunderstandings that balloon into missed timelines and budget overruns. A strong program manager mitigates this by facilitating early alignment on specific deliverables, success metrics, and quality criteria. For example, we ensure there are a written scope document and phase-gate milestones so both the internal team and CMO share a clear definition of “done.” This up-front clarity makes it easier to hold all parties accountable and avoid scope creep.
• Underestimating Technology Transfer Complexity: Transferring a virology process (e.g., a vaccine cell culture or antiviral synthesis) to an external site is rarely plug and play. I’ve seen companies assume their lab protocol will work identically at the CMO, only to hit major delays. Strong program management anticipates these challenges: we conduct feasibility runs, insist on detailed SOPs/tech transfer packages, and designate point people on both sides to manage the data exchange. By investing time in a robust tech transfer plan, the team can surface and solve scale-up issues early, rather than firefighting later.
• Regulatory or Compliance Oversights: Especially in virology (where products may be fast-tracked or destined for global markets), missing a compliance step can be disastrous. Common pitfalls include assuming the CMO meets all global GMP standards or forgetting region-specific regulations. A program manager with regulatory insight will verify the CMO’s compliance certifications up front and integrate regulatory affairs support into the program. We set up ongoing compliance checks and even mock audits if needed. By baking in quality and regulatory requirements from day one, we avoid costly delays like production holdups or remediation work before clinical trials.
• Assuming Infinite Capacity and Instant Timelines: A frequent mistake is expecting that the CMO can start a project immediately or produce any volume on short notice. In reality, leading CDMOs juggle many projects and often have constrained suites or long lead times for raw materials. Program management can prevent surprises by realistic scheduling — during contract negotiations we ask for capacity forecasts and identify any resource bottlenecks. We also build buffer time into the schedule. For instance, if a clinical trial needs drug supply by Q4, I’ll pad the timeline for possible equipment delays or reagent shortages. This risk-adjusted planning avoids last-minute scrambles and keeps the overall program on track.
• Uncontrolled Changes and Budget Creep: In drug development, changes in scope (a new formulation, batch size adjustments) are inevitable, but unmanaged changes can sink a partnership. I’ve observed teams making “small” changes that accumulate into significant cost overruns. A disciplined program manager sets up a change control process in which any change is evaluated for impact on cost, timeline, and regulatory filings before approval. We also maintain a contingency budget (often ~10%–15%) for unplanned scope changes. This financial oversight ensures sponsors and CMOs stay aligned and avoid resentment. Strong program management thus protects both timeline and budget by making trade-offs explicit and agreed upon.
• Sporadic Communication and “Black Box” Operations: Perhaps the most common pitfall is poor communication. The CMO only provides infrequent updates, leaving the sponsor in the dark until a major issue erupts. I insist on frequent, transparent communication channels to avoid this. For example, we set weekly project calls and monthly joint steering meetings with our CMO partners. We also agree on communication protocols (e.g., immediate notification of critical deviations or virology assay failures). Having a dedicated program manager as the single point of contact greatly improves this flow of information. Regular check-ins build trust and allow us to address minor problems before they escalate into full-blown crises. In short, robust program management culture turns a one-way vendor relationship into a collaborative partnership with no surprises.

Can you share examples where program management accelerated timelines or reduced risk in drug development?

Stephen: Effective program management isn’t just about avoiding pitfalls — it can actively accelerate development and de-risk programs. Here are a couple of examples, including one from virology, where strategic program leadership made a tangible impact:

• Rapid Scale-Up of Remdesivir Production (Antiviral for COVID-19): In 2020, our company faced the urgent task of supplying the antiviral remdesivir during the COVID-19 pandemic. Through exceptional program management, we cut several months off the normal manufacturing timeline to meet global demand. This involved coordinating an unprecedented network of about 40 manufacturing partners across North America, Europe, and Asia – far more than a single company could normally handle. We divided tasks among multiple CMOs (for APIs, formulation, fill/finish) and ran many steps in parallel. By actively managing this consortium of sites, aligning their schedules, and troubleshooting in real time, we scaled output dramatically. The result: production time for a batch was shrunk from ~nine to 12 months to about six months, and we were able to deliver millions of treatment courses in 2020. This example shows how strong program management can accelerate timelines in drug development – in this case, by orchestrating parallel efforts and multisite collaboration in a high-stakes virology program.
• Accelerating a Vaccine from Lab to Billions of Doses (mRNA Vaccine Collaboration): Another powerful example is the Moderna–Lonza partnership for the COVID-19 vaccine. Moderna, a smaller biotech with an mRNA vaccine candidate, strategically partnered with Lonza to vastly speed up manufacturing. The program management on both sides set up a plan to produce vaccine at multiple sites in parallel even before final approval. This strategic program approach enabled Moderna to scale manufacturing “10x faster” than normal — up to 1 billion doses per year output capacity. Suites were prepared in the U.S. and Switzerland in mere months, with production starting while clinical trials were still underway. By front-loading tech transfer and leveraging Lonza’s capacity through a tightly managed collaboration, they compressed a process that often takes years into less than one year. This not only accelerated the timeline to vaccine availability but also reduced risk by diversifying production across sites. If one facility had an issue, another could pick up the slack – a risk mitigation strategy only possible via careful program orchestration. The COVID vaccine race showcased how next-level program management (integrating development, regulatory, and manufacturing streams in parallel) can deliver lifesaving therapies faster without compromising quality.
• “At-Risk” Parallel Manufacturing to Reduce Launch Risk: A more general example seen in virology programs (and others) is the use of parallel or at-risk manufacturing. In critical projects — say a Phase 2 antiviral that looks promising – a program manager might initiate certain manufacturing activities before final clinical confirmation to shave months off a potential launch. This is inherently risky (you spend resources that might be wasted if the trial fails), but strong program management weighs these risks versus the time saved. In one of my previous projects, we prepared commercial-scale production and started stockpiling key raw materials during Phase 3, guided by probability-of-success models. This strategy, overseen by program management, meant that when the drug proved effective, we already had material ready and CMO production lines validated, cutting down the time to distribution. The risk was managed by contingency plans (if the trial failed, the materials could be repurposed for other research). Such examples underline that program managers don’t just passively track timelines — they can actively design the program strategy (in agreement with leadership) to accelerate development and hedge against risks like supply shortages or regulatory delays.

In all these cases, the common thread is that program management provided the foresight and coordination to either speed up the project or build in resilience. Whether it’s aligning multiple manufacturing partners or initiating work early, a strategic program manager weighs the business and scientific factors to make bold moves that deliver treatments faster and safer to patients in need.

How do you align diverse stakeholders — internal teams, CMOs, and external vendors — toward shared project milestones?

Stephen: Aligning diverse stakeholders, from internal R&D and QA teams to external CMOs and vendors, is one of the program manager’s most important duties. It’s also uniquely challenging in pharma, where each group has its own priorities. I tackle this by establishing a single integrated project framework that everyone operates within:

• One Team Mentality with Shared Goals: I start by creating a unified project plan that all parties buy into. This means mapping out key milestones (e.g., tech transfer completion, GMP batch release, clinical trial supply delivery) and explicitly showing how each stakeholder contributes to those milestones. By having a single, cross-functional project plan visible to internal teams and the CMO, we ensure everyone is literally on the same page. For example, the virologists, the process engineers, the QA unit, and the CMO’s production team all see the timeline and how their tasks interlink. This transparency helps prevent the silo effect. We frame success in shared terms – e.g., “product X ready for Phase 1 by Q2” – so internal scientists, external manufacturers, and even third-party vendors feel mutual accountability for hitting that target.
• Clear Roles, Governance, and Communication Channels: As the program manager, I set up governance structures that include all stakeholders. A best practice is to have regular cross-organization meetings: weekly technical syncs for internal functional teams and CMO team leads, and monthly steering committee meetings that also involve executives from our company and the CMO. In these forums, we review progress against the shared timeline, surface any issues, and make joint decisions. Having formal touchpoints keeps momentum and trust. We also define communication protocols — for instance, the CMO project manager and I speak almost daily for quick updates, and any critical issue (like a sterility test failure or yield problem) triggers an immediate escalation process defined in advance. By agreeing on how we communicate and who the point people are, we avoid confusion. Essentially, I function as the central coordinator, funneling information to and from all parties so nothing falls through the cracks.
• Integrated Tools and Metrics: To align everyone, I leverage project management tools that all stakeholders can access. We often use a shared online platform (could be as simple as a collaborative Gantt chart or a dedicated project portal) where we track tasks, responsibilities, and progress in real time. For example, if the analytical testing vendor updates a result or the CMO completes a batch, it’s logged where all can see it. I also establish common metrics for success such as yield targets, purity criteria, timeline adherence, etc., and we track these openly. By measuring performance in a uniform way, it aligns incentives: our internal teams and the CMO know exactly what success looks like. This shared scoreboard approach fosters collaboration rather than finger-pointing, because everyone rises and falls together on those metrics.
• Addressing Conflicts and Ensuring Alignment: Of course, even with structure, conflicts can arise if, say, the CMO wants to pause to recalibrate equipment, but the clinical team is pressuring for material. In these cases, I act as a mediator. Active stakeholder management often means realigning priorities and negotiating solutions. For instance, I might work with our internal researchers to adjust a noncritical experiment’s timeline to give the CMO a window to perform necessary maintenance, trading a small delay now to avoid a bigger issue later. I also keep senior leadership in the loop on critical path items; their support can be crucial in aligning internal resource allocation or expediting decisions. Regular status reports up the chain ensure executives know where we stand and can intervene if needed. By translating the technical details into business impact (e.g., “A one-week delay in manufacturing now could push the trial start by a month.”), I help leadership understand the stakes and thus keep everyone focused on the shared milestones.

In summary, aligning diverse stakeholders requires structured communication, a single source of truth, and a culture of collaboration. The program manager orchestrates this by being the point guard; we pass the ball (information) effectively so that internal scientists, CMO partners, and other vendors move in lockstep toward our common goals. When done right, it turns a complex web of players into one cohesive project team that delivers on time.

As we continue the conversation in an upcoming Q&A, we will discuss program manager alignment and integration.

About The Expert:

George Stephen is director of global program management at Gilead Sciences. He is an accomplished pharmaceutical executive with over 15 years of global experience leading cross-functional drug development programs, strategic planning initiatives, and portfolio management in the biotech and life sciences industries. He holds an MBA from the University of Chicago Booth School of Business and has been featured in Science Times for his leadership in COVID-19 treatment development.