From Lab To Launch: Navigating The Transition To Commercial Readiness

By Rick van der Vegte, Jim Polson, Michael Rachlin, Andrew Bonasera, and Brendan Brbich, FTI Consulting

As life sciences companies approach pivotal clinical trials, the stakes shift dramatically. The science is largely proved and make-or-break decisions come into focus. This transition from late-stage clinical development into commercial readiness marks a moment of transformation, when success depends not on whether the product works but on how effectively the organization can deliver a commercially successful drug to patients, at scale.

Many clinical-stage companies start thinking about commercialization too late and then are left playing catch up by the time approvals arrive. In our experience, the most successful organizations begin commercial preparation as soon as clinical data indicates commercial potential. That early planning protects what’s been built in R&D while setting the foundation to transform and scale responsibly, ensuring scientific success translates into commercial availability with appropriate returns for investors.

Harmonizing Commercialization Efforts

Drug commercialization must balance strategy, operations, and finance while shaping a story that builds confidence inside the company, with investors, and across the market. Success depends on how well these dimensions work together: strategic direction informs required operating capabilities, building new operating capabilities dictates cash needs, and financial profile/liquidity grounds strategic and operational feasibility.

The choices made at this stage define the growth trajectory of these organizations, along with investor confidence. How do you protect coveted scientific innovation while at the same time positioning for sustained growth? How do you allocate each dollar, signal strategic direction, and establish nimble, compliant operating capabilities before scaling the system?

Strategic Pathways: Go Alone, Partner, Or Transact

Every company approaching commercialization faces defining questions surrounding what kind of business they want to become and how they will bring innovation to market. The right path depends on ambition, financial flexibility, and risk tolerance — as well as how ready the organization is to operate at commercial scale. Key pathways include:

• Build It Yourself: Build full commercial capabilities and retain full control.
• Partner/Hybrid: Share risk and access infrastructure through a joint venture, co-promotion, or licensing partnership.
• Transact: Pursue an M&A, carve-out, or tax beneficial spin to achieve market access or scale.

Each path has its own merits and shortcomings, but all require tight alignment between strategy, operations, and investment to succeed.

Every strategic choice is only as strong as how well it’s understood. Experienced leadership must clearly communicate the rationale for the decision and what it means for employees, investors, and partners, and how it positions the organization for the next phase. The story behind the strategy drives confidence and alignment. When that story is owned early and communicated consistently, it keeps stakeholders moving in the same direction and reduces friction when plans evolve.

What This Looks Like In Practice

For some early-stage biotechs, the question isn’t just how to commercialize, it’s whether to commercialize at all. A company with a strong R&D backbone, with assets approaching a pivotal Phase 2 trial or close to readout with promising data, might be deciding whether to build the infrastructure required for commercialization itself or seek a partnership. Alternatively, they may even decide not to grow beyond their core competence of R&D, sell the promising asset, and keep the company identity unchanged.

Each option impacts the organization’s identity. It changes the capital needs and influences the timeline to value creation. While scientific progress creates optionality, the decision is also informed by being cognizant of the return horizon for investors: the ambition has to satisfy all that are involved and should be a risk-reward balanced decision.

Operational Pathways: Build, Integrate, Or Scale

For organizations that go at it alone or pursue a partner/hybrid approach, the focus shifts to how to operationalize and scale. Success begins with a clear capability blueprint: what’s already in place, what must be built or acquired, and when. This spans people, facilities, technology, supply and manufacturing, compliance, and field readiness.

Most launch teams start in silos, with commercial, quality, supply chain, IT, and compliance moving at different speeds. The most effective organizations create cross-functional governance early to harmonize decisions and reduce inefficiencies. In hybrid or partnered models, this alignment becomes even more critical, as both sides must agree on decision rights, timelines, and resource allocation for the partnership and the product to succeed. This foresight matters: capacity, supply networks, and compliance systems built for 100 patients must often stretch to 100,000 without pausing to redesign. Building scalability and flexibility from the outset safeguards long-term growth and operational resilience.

That culture shift is often underestimated. Moving from an R&D-focused organization to a commercial one brings new roles, new reporting lines, new expectations, and potentially a different compliance framework in this heavily regulated industry. People need to understand why things are changing and what it means for them: they need to realize how the expectations and capabilities change and have the self-reflection to judge whether they are still right for the job. Clear, consistent messaging builds confidence in the company’s direction and reinforces a shared sense of purpose as the organization scales.

How To Build Nimble Compliance And Risk Management Into The System (Compliance-By-Design)

As sales and marketing capabilities scale, new risks emerge — especially around HCP engagement and Sunshine/Open Payments tracking. Embedding controls early avoids the regulator’s “if you could have known, you should have known” scrutiny. A pathway-agnostic compliance model tailors oversight to existing systems and integrates new tools where needed. Beyond risk mitigation, disciplined governance signals deal readiness and minimizes legacy liability, positioning compliance as a foundation for sustained growth — not a last-minute fix.

Capital Pathways: Spend, Stage, Or Secure

The next question: Where should the next dollar go? Commercialization success depends on staging spend in a way that balances risk and reward, investing early enough to be launch-ready but not so early that capital is wasted if trial results shift the outlook.

Of course, financial strategies differ by circumstance. Some organizations are well capitalized, while others rely on investors or debt to fund both R&D and commercial build-out. Scenario-based capital planning, supported by integrated financial modeling, helps balance these pressures and define the expected return for the risk incurred. The goal: a financing strategy that keeps optionality alive while advancing toward value creation.

A clear financial narrative also matters. Investors, boards, and employees need to understand how capital is being deployed and what return profile to expect. A disciplined investor narrative builds confidence in how resources are being used to fund growth. Consistent financial storytelling ensures that the funding strategy supports not just the balance sheet but the company’s credibility in the market.

What This Looks Like In Practice

At this stage, a company can face difficult choices about when and how to invest for launch. Building go-to-market infrastructure can easily take 12 to 18 months and require significant investment, but waiting too long risks missed revenue and cash flow once approval is granted. We have seen companies that chose to stage spending in phases, funding critical systems and partners early while deferring major investments until confidence increased. This approach balanced readiness with discipline and allowed the team to accelerate once approval came through.

Bottom Line

Commercialization success doesn’t hinge on a single decision. It’s how strategy, operations, and finance move together. When one shifts, the others have to flex. A great strategy can fail without the operational backbone to deliver it; a flawless launch plan can stall without the funding or story to sustain it.

The leaders who win are the ones who treat these as connected systems, not separate workstreams, recalibrating across all three as new data, risks, and market realities emerge. That’s how you protect what you’ve built and create the space to grow.

Additional References:

1. https://fticommunications.com/preparing-for-a-pivotal-clinical-trial-readout-what-biopharmaceutical-companies-should-consider-to-prepare-for-a-potential-transformational-moment/?utm_medium=linkedin-organic-employee&utm_source=social-media&utm_campaign=clinical-trials&utm_content=article-preparing-clinical-trails-readout
2. https://fticommunications.com/from-development-to-commercial-solutions-for-biotech-organizations-navigating-critical-transformations/

Note: The views expressed herein are those of the author(s) and not necessarily the views of FTI Consulting, Inc., its management, its subsidiaries, its affiliates, or its other professionals. FTI Consulting, Inc., including its subsidiaries and affiliates, is a consulting firm and is not a certified public accounting firm or a law firm.

About The Authors:

Rick van der Vegte, senior managing director, is the leader for the Life Sciences Core Operations practice and is known for his ability to solve highly complex operational challenges across the people, process, and technology domains, while bringing deep international experience. Mr. van der Vegte has been an active member of C-level advisory teams during major events for organizations, including new product launches,restructuring, and bankruptcy.

Jim Polson, senior managing director,  FTI’s healthcare & life sciences financial communications practice, providing financial communications counsel to a broad range of private and public companies spanning across biotech and pharma, medical devices, tools and diagnostics, healthcare services, hospitals/providers, digital health, and insurance/managed care. As a result of implementing and managing best practice investor relations programs for his clients, Mr. Polson has more than 20 years of experience advising companies on critical investor communication issues. and event drive catalysts such as mergers and acquisitions, initial public offerings or capital raises, shareholder activism, and business transformation.

Michael Rachlin, senior managing director, co-leads the Life Sciences practice within the corporate finance segment, specializing in assisting clients in the biopharmaceutical, medical technology, and cannabis industries evaluate transaction opportunities and larger growth-related initiatives, as well as valuation, deal modeling, and strategic alternatives. Mr. Rachlin has approximately 20 years of experience advising life sciences clients through their most critical transaction and transformation challenges.

Andrew Bonasera , is a senior managing director in the FTI consulting healthcare risk management & advisory practice and is based in Washington, D.C. Mr. Bonasera has over 20 years of experience providing services in litigation consulting and forensic investigations.  He works with healthcare organizations and their counsel to address regulatory compliance and business performance issues.

Brendan Brbich, managing director, specializes in managing complex strategic programs across the life sciences value chain, with more than 10 years’ industry experience advising and delivering corporate strategy initiatives and managing operational improvement programs within commercial, R&D, and SG&A functions. Mr. Brbich advises on growth strategy and pathways to commercialization. He has developed commercial strategies and insights for pharma, medtech, and contract service providers — including commercial assessments and due diligence.