Event Recap: Successful Gating Strategies When Building Your Commercial Supply Chain

By June Stevens

Today’s landscape combines heightened uncertainty spanning scientific, regulatory, clinical, and operational risks with an economic environment where many emerging companies have limited capital and human resources. It is essential now more than ever to plan gating strategies for commercial supply chain launch while critical opportunities are still within reach. Converge Consulting recently hosted Successful Gating Strategies When Building Your Commercial Supply Chain, a webinar where Senior Consultant Alex Spivak and Chris Wixson, Senior Director for Distribution & GPOs at AVEO Oncology provided actionable insights for facing uncertainty in commercial launches. The session emphasized how gating investments and careful outsourcing of expertise can preserve planning options to successfully balance risk and launch readiness.

Informed Decision-Making Shapes Launch Readiness

Alex began the session by introducing strategic considerations when launching innovative treatments amid the significant uncertainty inherent in the biopharma industry. He described the advantages and disadvantages of tying investments to evidence-based triggers and indicators that reduce uncertainty, such as clinical data readouts, development milestones, or regulatory feedback. Alex underscored the need to  manage risk while maintaining momentum – deciding what can wait and what must start early to ensure launch readiness.

He later discussed an approach for gating effectively by choosing a gating point aligned with a company’s readiness and strategic priorities rather than only reacting to financial inflection points. Alex also emphasized the importance of planning in advance, even if investments are gated, so organizations can move quickly and confidently once trigger points are reached.

Gating Strategies for an Accelerated Launch

Chris shared his past experience with a biotech company developing targeted therapies for difficult-to-treat cancers, detailing their strategic approach to launching in the U.S. market despite limited domestic infrastructure and internal experience. Faced with a compressed timeline following an accelerated approval decision, the company relied on a combination of internal capabilities and selective application of external expertise to manage U.S. importation and commercialization. By outsourcing key supply chain activities, they achieved launch success while keeping post-launch operations lean – an appropriate move given modest volume expectations.

His experience navigating the launch revealed four key lessons:

Organizational Self-Awareness is Key to Successful Gating & Resourcing Decisions

Company leadership assessed their organizational strengths and gaps honestly. They recognized early that building a large U.S. organization would add unnecessary overhead when market approval was still uncertain. The company acknowledged their limited in-house expertise, maintained a lean approach, and relied on external partners such as Converge to bring the required experience. This ensured a smooth and compliant launch.

Strategic Outsourcing Enables Focus & Execution

The company deferred U.S. supply chain buildout until receiving NDA acceptance. While this postponed capital investments, it increased pressure when accelerated approval was granted. Facing this new timeline with limited commercial experience and infrastructure in the U.S., they chose to outsource critical supply chain functions. This allowed internal teams to concentrate on downstream commercialization.

Precision is Critical in Accelerated Launches

With only months to prepare for their accelerated launch, every delay or mistake would have a cascading effect across labeling and importation. Success depended on anticipating bottlenecks early, engaging experienced directors, and executing with precision to prevent small missteps from compounding.

Agility Turns Uncertainty into Opportunity

With limited time and infrastructure, the company remained agile. They made swift course corrections, reallocated resources for maximum impact, and resolved supply chain challenges through close coordination with partners. Their ability to pivot exemplifies how flexibility can transform a risk-aware plan into operational excellence despite uncertainty.

What You Can Do Today

The path to a successful commercial launch in life sciences is paved with uncertainty, risk, and critical decision points. In preparing for a successful launch, gating strategies preserve capital, resources and flexibility. Emerging biotherapeutics companies should:

• Start Early, Plan Strategically: Begin mapping your high-level supply chain and launch roadmaps as early as Phase 2. Identify all critical activities and tie them to clear milestones. Do not wait for final budgets before preparing your strategy.
• Outsource Where It Matters: Recognize your organization’s strengths and gaps. Work with trusted external partners for critical supply chain buildout activities.
• Stay Agile & Reassess: Continuously revisit your gating strategies and resource allocation as market conditions and internal capabilities evolve. Proactive planning will help avoid last-minute errors and maintain a competitive edge.

For help developing your own gating strategies and overall Commercial Supply Chain Launch Readiness, contact the Converge team today at info@convergeconsulting.com.