How a strategic partnership enabled commercial launch readiness.
Background
A biopharmaceutical company was preparing for the commercial rollout of a novel therapy. With deep in-house scientific expertise but limited commercialization infrastructure, the company needed a strategic partner to guide it through the complex operational setup, particularly in selecting and implementing a U.S.-based third-party logistics (3PL) provider.
The Challenge
The internal team’s experience was mainly rooted in clinical development, leaving them unfamiliar with the operational nuances of commercial launch. Entering a new logistics environment, the company required a knowledgeable partner to guide them through the 3PL landscape, lead vendor selection, and help ensure regulatory readiness. The team needed hands-on support and collaborative integration across cross-functional workstreams—many of which were engaging in commercial operations for the first time.
The Two Labs Solution
Two Labs stepped in early to support operational planning across market access, compendia, and supply chain strategy. Acting as an embedded extension of the team, Two Labs brought clarity and cohesion to the process while maintaining momentum.
Key areas of support included:
- Managing the 3PL RFP and selection process
- Overseeing regulatory and operational readiness
- Providing commercialization education to internal stakeholders
- Streamlining and standardizing operational processes for compliance and scalability
Two Labs adapted quickly to assist with responses to FDA requests, including coordinating with the logistics partner and internal teams to address the request without disrupting timelines. The client noted that “a less collaborative partner could have said this wasn’t in scope—but Two Labs just made it work,” underscoring the team’s adaptability and collaborative mindset.
Two Labs’ cultural alignment with both U.S. and international stakeholders also played a key role in establishing trust and accelerating decision-making. Their practical approach helped demystify unfamiliar processes and empower internal teams with the tools and knowledge to succeed.
Results
By the time commercialization was impending, the organization’s infrastructure was fully operational and launch-ready. Two Labs’ early and consistent engagement ensured the foundation was built to support success.
Key success factors included:
- Pragmatic project management balancing urgency and flexibility
- In-depth guidance on regulatory and operational preparedness, resulting in cost efficiencies
- Team enablement through training, documentation, and support
- Clear operating models aligned with compliance expectations
- Strong collaboration and cultural fit across global teams
Looking Ahead
Following the successful support of this program, the company has expressed interest in re-engaging Two Labs as they prepare to potentially bring another therapy to market. The previous collaboration — described by the client as “smooth,” “pleasant,” and “delivered without surprises” — has set the stage for continued partnership.