Strategic Research for Clinical Trial Success: Optimizing Curevo Vaccine’s Phase 3 Strategy
Redesigning clinical trial strategy to save costs and align with regulatory requirements
Background & The Problem
Curevo Vaccine, a mid-sized biotech company, was preparing to launch Phase 3 clinical trials for CRV101, a shingles vaccine.
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Curevo faced multiple challenges:
Therefore, Curevo needed a strategy that would not only meet regulatory approval standards but also position CRV101 competitively in the U.S. shingles vaccine market.
The Approach
Identifying Key Stakeholders
Decoding the U.S. Shingles Vaccine Landscape
Competitive Analysis: Learning from GSK’s Clinical Trial Strategy
Since Zostavax (Merck) was a live-attenuated vaccine, it wasn’t the best benchmark for CRV101. Instead, Shingrix (GSK) was the closest competitor, as it was also a two-dose recombinant vaccine.
I created a centralized repository of all Shingrix clinical trial data, spanning from early-stage Phase I to post-marketing surveillance, which included detailed information on:
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Participant criteria (age, health conditions, exclusions)
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Sample sizes and study arms
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Dosage, administration methods, and co-administration trials
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Outcome measures (primary vs. secondary efficacy, safety, immunogenicity)
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etc.​
Example of the Repository Directory
One of Shingrix Clinical Trials
This repository gave Curevo’s team a comprehensive view of how GSK strategically designed trials to maximize approval chances at different stages.
Regulatory Agencies: Understanding the FDA and EMA Approval Process
I examined FDA and EMA documentation for Shingrix’s approval to identify critical factors in their decision-making process.
This included:​
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FDA’s specific concerns and follow-up questions regarding trial results.
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Supplementary data requirements beyond clinical efficacy, such as real-world adherence and safety monitoring.​
​Based on the information collected, I created a timeline mapping all Shingrix clinical trials to its FDA approval milestones, providing insights into trial sequencing, the key data FDA evaluates at different stages, and how each trial contributed to the approval process
Public Health & Reimbursement: Understanding ACIP’s Influence
Vaccine approval alone wouldn’t guarantee CRV101’s success—CDC recommendations were crucial for adoption in national immunization programs like Medicare.
I investigated how ACIP (Advisory Committee on Immunization Practices) influenced the U.S. shingles vaccine landscape, including:
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Analyzing ACIP conference recordings where experts discussed vaccine effectiveness, safety, and public health impact.
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Studying CDC cost-effectiveness models used to justify vaccine recommendations.
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Examining the rationale behind ACIP’s 2017 preferential recommendation of Shingrix over Zostavax, which led to Zostavax’s discontinuation in 2020.
Cost-effectiveness Analysis Comparing Shingrix and Zostavax
This research highlighted key factors ACIP considered for vaccine approval—such as long-term effectiveness, safety, compliance rates, and public health burden reduction—allowing Curevo to tailor its trial design to strengthen its CDC recommendation potential.
Final Deliverable: A Playbook for Regulatory and Market Success
Armed with competitive insights, regulatory intelligence, and public health analysis, I conducted a gap analysis comparing CRV101’s trial design vs. GSK's approach.
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Key recommendations include:​​​
The Impact
1. Cost Savings: Optimized trial design saved Curevo 30% of projected costs, freeing up resources for other research and development initiatives.​
2. Operational Efficiency: The centralized repository became a go-to resource for the company, referenced daily by team members for decision-making.
3. ​​Regulatory Confidence: Ensured alignment with FDA and EMA requirements, reducing the risk of delays and maximizing the likelihood of approval.
4. ​Strategic Value: Positioned Curevo as a competitive player in the shingles vaccine market by delivering a cost-effective and well-aligned trial strategy.
Lessons Learned
1. Bridging Science and Strategy: Translating complex clinical data into actionable business insights required balancing scientific rigor with strategic thinking.​
2. Structured Information Drives Decisions: Organizing scattered data into a clear repository and approval timeline streamlined decision-making.