How Inovia Bio helped a Medium Sized Biotech successfully Launch with an IEP that Bridged Clinical to Medical Affairs

The Challenge: Bridging the Gap – From Clinical Trial Success to Real-World Market Impact

Achieving positive pivotal trial data and nearing regulatory approval is a monumental step. For this medium biotech, it also signalled the beginning of a profound operational and strategic pivot. The intense focus on clinical development, aimed at securing regulatory milestones, now needed to broaden significantly to encompass the multifaceted evidence requirements for a successful product launch and sustained market presence.

The core challenges they faced in this transition were:

• The Clinical-to-Medical Affairs Handover: Ensuring a seamless and strategic transfer of knowledge and evidence planning from the clinical development teams, whose primary objectives were nearing completion, to the burgeoning Medical Affairs function, which would now lead post-approval evidence generation and scientific engagement.
  
  
• Anticipating Post-Launch Evidence Needs: The team recognised that the evidence package that satisfied regulators was only the starting point. For successful commercialisation, they urgently needed to identify and plan for evidence generation that would resonate with payers, healthcare technology assessment (HTA) bodies, prescribing clinicians, and patients – focusing on real-world effectiveness, safety, and value.
  
  
• Avoiding a "Launch Lag" in Evidence: There was a risk of an "evidence lag" post-launch if Medical Affairs priorities weren't proactively integrated into the evidence plan before approval. This could hamper early market access efforts and the ability to address key clinician questions effectively.
  
  
• Static Planning for Dynamic Needs: Previous encounters with evidence planning had resulted in static documents, ill-suited to the dynamic needs of a product entering the market, where new questions and competitive pressures emerge constantly. They needed a living evidence strategy.
  
  
• Aligning on Value Demonstration: Ensuring all functions – late-stage clinical, new Medical Affairs teams, and early commercial strategists – were aligned on what constituted "value" in the real world and what evidence was needed to demonstrate it.

They needed a robust, forward-looking Integrated Evidence Plan that could act as a strategic bridge, ensuring continuity and proactively addressing the diverse evidence demands of the launch and post-launch environment.

Solution: An Agile, Launch-Ready IEP Driven by Platform and Expertise

Inovia Bio was engaged to help the biotech craft an IEP specifically designed to navigate this critical transition and prepare Medical Affairs for success. The approach was agile, collaborative, and tech-enabled:

1. Cross-Functional IEP Development: Utilising the Inovia IEP platform and its collaborative framework, Inovia Bio facilitated a focused IEP development process involving key stakeholders from clinical development, the emerging Medical Affairs team, and other relevant functions. This ensured all perspectives were integrated from the outset. The entire core IEP was shaped in an average of just 12 days.
   
   
2. Bridging Pre- and Post-Launch Needs: The IEP explicitly mapped out how existing and ongoing pre-launch evidence (e.g., from pivotal trials) would be leveraged post-launch, while also identifying and prioritising new evidence generation activities critical for Medical Affairs and market access (e.g., Phase IV studies, patient registries, HEOR analyses, RWE studies for comparative effectiveness).
   
   
3. Proactive RWE Strategy for Medical Affairs: Leveraging RWE360 for comprehensive data source landscaping and Inovamine for rapid analytics, Inovia Bio helped identify opportunities to use RWE to efficiently address key Medical Affairs objectives. This included planning for studies to understand real-world usage patterns, confirm effectiveness in broader populations, and generate data to support payer value stories.
   
   
4. A Dynamic Roadmap for Lifecycle Management: The resulting IEP, hosted on the Inovia IEP platform, provided a dynamic, easily accessible, and updatable roadmap. This "living plan" allowed Medical Affairs to continuously track progress, adapt to new insights, and manage the product’s evidence strategy throughout its lifecycle, far beyond the initial launch.

Using RWD360 allowed the company in this case study to have a complete, regulatory-grade landscape of every RWD asset relevant to their disease, as well as a landscape of KOLs, complete in less than a week

The Impact: Seamless Transition, Strategic Alignment, and Launch Readiness

The Inovia Bio IEP engagement provided critical strategic advantages as the biotech prepared for launch:

• Smooth Strategic Handover: The collaborative IEP process and the resulting shared plan facilitated a much smoother and more strategically aligned handover of evidence responsibilities from Clinical Development to Medical Affairs.
  
  
• Proactive Medical Affairs Strategy: Medical Affairs was equipped from day one with a clear, prioritised plan for post-launch evidence generation, enabling them to hit the ground running in demonstrating real-world value.
  
  
• Enhanced Launch Preparedness: The biotech approached launch with greater confidence, knowing they had a robust plan to address the evidence needs of diverse stakeholders, including payers and clinicians.
  
  
• Improved Cross-Functional Alignment: The Inovia IEP platform provided a single source of truth, ensuring all teams were aligned on evidence priorities, activities, and timelines, minimising silos and maximising efficiency.
  
  
• Significant Time and Cost Savings: The rapid, platform-driven IEP development process saved considerable time and resources compared to traditional, manual methods, allowing the biotech to focus its budget on high-impact evidence generation. The proactive planning also helped avoid costly reactive studies post-launch.

The Inovia Advantage: Powering Successful Product Launches with Strategic Evidence Planning

For medium-sized biotechs navigating the complex transition from clinical development to product launch, Inovia Bio’s IEP solution offers:

• Strategic Bridging: Seamlessly connecting pre-approval evidence with post-approval Medical Affairs and market access needs.
• Future-Proof Planning: Creating dynamic, adaptable evidence strategies fit for the entire product lifecycle.
• Cross-Functional Clarity: Providing a platform that ensures all stakeholders are aligned and informed.
• Embedded RWE Expertise: Integrating real-world evidence planning proactively to demonstrate real-world value.

By providing a clear, actionable, and dynamic Integrated Evidence Plan, Inovia Bio empowered this biotech to not just prepare for launch, but to lay a strong evidence foundation for their product’s sustained success in the market, ensuring Medical Affairs could effectively articulate its value from the moment of approval.