Bridging the Gaps: How Integration Accelerates Biotech Development

In the biotech industry, speed is more than a competitive edge—it’s essential for survival. Scientific innovation is moving faster than ever, but too often, therapies with great potential are delayed by gaps between strategy and execution. At Fortrea, we believe the solution is clear: bridge those gaps by integrating consulting, clinical pharmacology, and operational delivery from day one.

Evidence-Driven Success: Designing With the End in Mind

Integrated drug development is a complex journey. When strategic intent and operational execution are disconnected, progress slows and opportunities are missed. Fortrea’s approach is designed to help close these gaps by embedding evidence strategies early in development planning. This can include. This means:

• Aligning clinical trial design with payer-relevant endpoints from the start, ensuring acceptance  by regulators and value for  reimbursement bodies.
• Meeting the evolving requirements of regulators and payers, including diversity action plans and patient-centered outcomes.
• Supporting strategies to demonstrate  product value—economic, clinical, and patient-focused—regardless of your exit strategy.
• Differentiating products and accelerating time to market through special regulatory designations.

 A unified, experience CRO team works to anticipate regulatory and scientific inflection points, helping to shape pathways and enable efficient execution.

Strategic Engagement Across Regulatory Landscapes

Navigating regulatory pathways is complex and can take years. Delays or misaligned engagement with agencies can mean missed opportunities for designations or inefficient submission processes. Fortrea’s unified alliance model helps sponsors:

• Proactively pursue orphanand expedited program designations.
• Coordinate agency interactions to support investor strategy or expedited approval to gain concurrence on strategic plans.
• Plan early for regulatory requirements, such as pediatric considerations in oncology, to prevent costly delays.
• Begin with the end in mind, knowing where you want to commmericalize your product and building your strategy to support the global landscape.

Early, strategic engagement secures alignment with long-term development and commercialization goals at every step.

Optimizing Early-Phase Decisions for Faster Development and Success

Speed to proof-of-concept is critical in biotech. High-performing programs embed clinical pharmacology and consulting capabilities throughout the development lifecycle, generating high-quality, decision-enabling data for licensing or acquisition.

• Engage skilled teams early to shape strategy, not just validate decisions.
• Align pharmacology knowledge with clinical and regulatory intent from the outset.
• Use modeling and scenario planning to reduce downstream rework and accelerate timelines.
• Achieve confident decision-making through early integration of safety, dose selection, and feasibility thinking.

Closing the Gap Between Insight and Execution in Biotech Development

When strategy and execution are developed in isolation, misinterpretation and lost time are inevitable. Fortrea’s integrated approach connects consulting insights with operational delivery, preserving intent across phases and reducing friction at handoffs.

• Regulatory strategy informed by operational feasibility minimizes protocol amendments.
• Consulting support embedded into delivery helps keep execution aligned with original intent
• Early evidence consideration delivers efficient decision-making, de-risking regulatory pathways and aligning clinical and commercial objectives.

This model empowers teams to deliver with speed, confidence, and strategic clarity—minimizing risk and maximizing value 

Ready to Accelerate Your Biotech Development?

At Fortrea, we work with clients to bridge the gap between strategy and execution—helping enable faster, more confident development and supporting better outcomes

Contact us today to discover how our integrated consulting and operational capabilities can help you bring life-changing therapies to patients sooner.