P&C Global Practices: AI, Data, & Cognitive Sciences, Organization & Human Capital, Strategy & Innovation
Fast-Tracking Drug Approval to Expedite Patient Access
An emerging biotech firm with a breakthrough therapeutic platform was poised to enter late-stage development for its first product—an innovative therapy addressing a critical unmet need. With speed to market essential and the stakes high, the client faced a dual challenge: securing regulatory approval and executing a first-time commercial launch on a highly compressed timeline—despite an industry norm that often spans a decade or more.
Recognizing that first-time launchers frequently experience setbacks in obtaining approval and falter in commercialization, the firm engaged P&C Global as its strategic partner. The decision was driven by P&C Global’s unique blend of strategic insight, advanced data science capabilities, and organizational change experience—a combination uniquely suited to compress the timeline and ensure a successful approval and launch.
P&C Global collaborated with the client to architect and operationalize an accelerated regulatory and commercialization strategy. Drawing on cross-practice expertise spanning Strategy & Innovation, AI, Data, & Cognitive Sciences, and Organization & Human Capital, P&C Global deployed an integrated approach across regulatory, manufacturing, and commercial functions—driving full-spectrum alignment and flawless execution.
This partnership resulted in a first-cycle Food & Drug Administration (FDA) approval, one of the fastest go-to-market timelines in biotech history, and an immediate and successful commercial launch.
Challenge: Overcoming Inexperience Under Compressed Timelines
Entering Phase III trials and preparing a regulatory submission, the client faced multiple intersecting challenges:
- Unprecedented Timeline Pressure: Industry averages for drug development run 10-15 years, yet public health urgency demanded this therapy to be readied in under one year. The organization had no prior regulatory approvals, creating pressure to “get it right” on the first try.
- Complex Trial Design: The therapy’s novel mechanism required optimizing a Phase III trial for both speed and rigor. The client needed to design and execute a 30,000+ participant Phase III trial to determine safety and efficacy while incorporating adaptive protocols and diverse populations.
- Regulatory Dossier Preparation: As a first-time sponsor without prior submission experience, the client needed to assemble a Biologics License Application (BLA) that could withstand first-cycle scrutiny. This meant interpreting nuanced FDA guidelines, validating manufacturing processes, and preparing for regulatory adaptations.
- Launch Readiness Under Uncertainty: The client quickly needed to transform from an R&D organization into a commercial-ready industry pioneer. This included scaling manufacturing to millions of doses, establishing supply chains, and enabling distribution for immediate rollout upon approval. Organizationally, this also meant identifying and filling talent gaps across regulatory, quality, supply chain, and go-to-market functions.
Compressing the regulatory approval and go-to-market process ultimately required a fundamental reinvention of the client’s operating model. The organization had to transform from a scientific research hub into a patient-centric commercial enterprise while under intense public scrutiny This, in turn, would demonstrably boost investor confidence and establish the firm’s reputation through positive market feedback and industry recognition.
Solution: Embedding Strategic, Analytical, and Organizational Agility
P&C Global deployed a cross-functional taskforce for the client, crafting an end-to-end solution that addressed both the technical and human elements of the challenge.
Strategy & Innovation
The Strategy & Innovation team ensured that every decision, from endpoints selection to manufacturing scale-up, aligned with the ultimate goal of saving lives quickly while satisfying regulatory expectations on safety and quality:
- Drawing on our healthcare-focused strategy expertise, we defined a clear “North Star” vision for the therapy’s impact and commercial trajectory to guide all downstream decisions
- Benchmarked against recent accelerated programs to set aggressive but achievable milestones
- Designed adaptive development roadmaps, scenario-planned regulatory pathways (e.g., standard versus expedited filings), and coordinated with public stakeholders
- Formulated rolling submission strategies, enabling regulators to review data in parallel with trial completion
AI, Data, & Cognitive Sciences
By infusing AI and analytics, P&C Global’s team optimized trial design, regulatory preparation, and market launch, reducing uncertainty in decision-making and accelerating learning cycles to meet the ambitious timeline:
- Built predictive models to simulate various trial outcomes, which informed adaptive trial protocols that could be adjusted in real-time based on interim results
- Analyzed vast datasets to select optimal trial sites and patient demographics, maximizing speed and diversity
- Applied natural language processing to previous successful submissions to extract insights for the client’s BLA dossier compilation (e.g. identifying phrases and data presentations that resonated with FDA reviewers)
- Created a data-driven launch plan using market analytics and drawing on a wide range of data sources including sentiment analysis to shape launch geography prioritization and target patient segments for rollout
Organization & Human Capital
By investing in key organizational capabilities and human capital ahead of the launch, the client built a high-functioning commercial organization to accomplish ambitious program objectives:
- Implemented a rapid organizational ramp-up plan by identifying critical new roles (e.g. regulatory affairs leads, supply chain managers, medical science liaisons) and helping the client recruit experienced talent for these positions
- Instituted a cross-functional taskforce blending client staff with P&C Global experts to drive daily coordination of launch-critical tasks
- Facilitated cultural workshops to transition the company’s mindset from purely science-driven to patient-focused and delivery-oriented
- Guided leadership in change management techniques to communicate the vision effectively across the organization and sustain morale during intense workloads
- Designed incentive structures and Objectives and Key Results (OKRs) aligned with launch success metrics so that every employee from R&D scientists to newly hired sales representatives understood their role in the bigger picture
Cross-practice collaboration was critical to the success of this engagement. Strategy decisions were immediately translated into operational actions. The tight integration of strategic planning, data insights, and regulatory preparation fed trial adjustments and commercial planning while also helping the client avoid pitfalls and remain agile. For example, recruitment analytics not only helped complete the trial faster but also informed manufacturing forecasts for launch. Regular joint sessions with the client’s R&D, regulatory, and commercial teams ensured everyone stayed aligned on the accelerated timeline.
P&C Global’s multi-practice team served as the catalyst and connective tissue for the client’s efforts – breaking silos between clinical development and commercial preparation – so that by the time FDA reviewers were evaluating the application, the company was simultaneously rehearsing its launch playbook. This one-team approach was vital given the high stakes and interdependencies: a delay in the trial would jeopardize launch timing, or a gap in launch readiness could squander a hard-won fast approval.
Outcomes: First-Pass Approval and Record-Speed Launch
P&C Global’s engagement delivered exceptional results, turning a high-risk endeavor into a landmark success for the client. The outcomes not only achieved the initial goals but also surpassed industry benchmarks for a first-time launch.
The result: a first-cycle FDA approval, one of the fastest go-to-market timelines in biotech history, and a successful commercial launch in approximately one year.
- FDA Approval on the First Attempt: FDA approval granted on the first review cycle with zero deficiencies noted, a rare feat for any new drug, let alone an innovative platform from a first-time sponsor.
- Immediate Market Launch: The client commenced production distribution within hours of approval. This meant high-priority patients began receiving the therapy within days, not weeks or months.
- Rapid Uptake in Target Population: Millions of doses delivered within the first month of launch. Over 100 million doses administered globally in the first year.
- Investor Confidence and Market Impact: In the months following launch, the emerging biotech firm’s market capitalization multiplied significantly, with the stock was trading over 4.5x higher than before the trial results. This surge reflected the market’s recognition that the company had matured into a major player with a validated platform. Beyond share price, the firm easily raised additional capital to expand manufacturing and pipeline programs, leveraging its newfound credibility.
- Industry Recognition: The clinical development and launch team received a major life sciences industry award and the therapy itself earned prestigious accolades for its innovative technology and impact on global health.
Conclusion: Building a Launch-Ready Biotech in Record Time
This engagement demonstrates how an emerging biotech firm, guided by strategic partnership and disciplined execution, can overcome the odds and deliver transformative therapies to patients faster than ever imagined. P&C Global’s multidisciplinary approach – uniting strategy, innovation, data science, and human capital development – was instrumental in driving this outcome.
Strategically, the initiative highlights the value of early vision-setting (defining a clear goal and “North Star”), data-driven decision making, and proactive talent and process investments. Insight-driven planning paid off in this instance with an approval timeline and launch trajectory that rank among the fastest ever recorded in the pharmaceutical sector. Practically, the collaboration left the client with enduring capabilities: a now-seasoned regulatory team, a scalable launch framework, and a culture oriented toward patients and results. These assets will continue to benefit the firm as it expands its portfolio.
Partner with P&C Global to Accelerate Market Readiness
P&C Global equips biotech firms with the strategic foresight, regulatory agility, and operational infrastructure to achieve accelerated approval and commercial success. Whether preparing for first launch or scaling a global pipeline, we deliver results that drive both patient outcomes and enterprise value. Contact us today to explore how we can support your next breakthrough.
