Case Studies
Real Programs, Real Results
Emerging biopharma accounts for more than 50% of all new drug launches. These teams need strategic clarity more than anyone. Below are anonymized examples of how we help biotech teams navigate from concept to regulatory milestones. Every engagement is different. These illustrate our approach.
Early-Stage Oncology Biotech: Discovery to IND in 18 Months
The Challenge
A seed-funded oncology startup had promising preclinical data but no regulatory strategy, no Target Product Profile, and no clear development timeline. Their investors required a credible development plan before committing the next round of funding.
Our Approach
- Mapped the competitive landscape across approved and pipeline oncology assets to identify evidence gaps and differentiation opportunities
- Built a comprehensive Target Product Profile defining efficacy endpoints, safety thresholds, and label claims with explicit go/no-go criteria
- Designed the optimal FDA regulatory pathway, including an orphan drug designation strategy
- Prepared pre-IND briefing materials and mock Q&A sessions for regulatory readiness
- Created a phase-gated development roadmap with decision criteria at each stage
Results
18 mo
Discovery to IND filing
Series A
Funding secured post-strategy
0
Clinical holds from FDA
3 mo
Ahead of projected timeline
Reflection
This program reminded me why clarity matters more than speed. The team had brilliant science, but no shared definition of what success looked like. Once we built the TPP together and forced explicit choices on endpoints and patient population, every subsequent decision fell into place. The investors did not fund the molecule. They funded the roadmap.
Academic Spinout: From University Lab to Funded Development Program
The Challenge
A university research group in Germany had developed a novel drug delivery platform with strong preclinical evidence. They needed to translate academic research into a commercially viable development plan to attract venture funding and form a spinout company.
Our Approach
- Translated academic research into a Target Product Profile structured for investor clarity
- Identified the strongest lead indication based on unmet need, regulatory feasibility, and competitive positioning
- Developed a dual FDA/EMA regulatory strategy leveraging proximity to European regulatory authorities
- Created a realistic budget framework and development roadmap from seed through Series A
- Prepared investor-ready materials including a development strategy summary and risk navigation plan
Results
Seed round
Funding secured
2
Viable indications identified
1
Strong lead indication selected
12 mo
To EMA Scientific Advice meeting
Reflection
Academic founders know the science better than anyone, but the journey from lab to clinic requires a different kind of evidence. This team needed to tell a regulatory and commercial story, not just a scientific one. We closed that gap by building a development roadmap that spoke the language investors and regulators expect. Watching them secure funding and move toward their first regulatory interaction was deeply satisfying.
Rare Disease Program: Dual FDA/EMA Filing Strategy
The Challenge
A biotech developing a therapy for a rare pediatric disease needed to file in both the US and Europe simultaneously. The team had no prior regulatory experience in either jurisdiction and faced a tight timeline driven by patient advocacy group expectations.
Our Approach
- Mapped regulatory requirements for FDA and EMA side by side, identifying overlapping and jurisdiction-specific evidence needs
- Designed a unified clinical development program that satisfied both agencies without duplicative studies
- Prepared the company for an FDA Type B Pre-IND meeting and EMA Scientific Advice meeting within the same quarter
- Developed orphan drug designation applications for both jurisdictions
- Created a regulatory submission roadmap with critical milestones, resource requirements, and go/no-go decision points
Results
2
Orphan designations granted
40%
Fewer duplicative studies
6 mo
Saved on parallel filing preparation
100%
Regulatory milestones met on schedule
Reflection
Dual-jurisdiction filings terrify small teams, and for good reason. The complexity is real. But complexity is not the same as impossibility. The key choice here was designing one clinical development program that served both FDA and EMA, rather than running parallel tracks. That single decision saved months of execution time and eliminated redundant studies. Strategic clarity at the front end creates efficiency everywhere downstream.
Infectious Disease Platform: Building a Multi-Indication Development Engine
The Challenge
A Series A infectious disease biotech had a powerful platform technology but lacked a coherent strategy for which indications to pursue first. The team had identified 12 potential applications and was attempting to pursue all of them. Internal misalignment was costing time and capital.
Our Approach
- Conducted market sizing and regulatory analysis across all 12 indications to identify addressable opportunity and pathway complexity
- Defined a Platform Target Profile capturing the desired characteristics of the technology engine itself
- Prioritized indications using a multi-factor scoring model: unmet need, regulatory pathway clarity, manufacturing feasibility, and capital efficiency
- Built TPPs for the three lead indications, each with distinct regulatory strategies and clinical endpoints
- Created a platform-level development roadmap showing how early learning from indication 1 informs decisions in indications 2 and 3
- Designed go/no-go decision criteria for advancing between indications to preserve capital and focus
Results
3
Prioritized lead indications from 12 candidates
35%
Faster advancement to IND (early indication data sharing)
$8M
Capital preserved through focused strategy
18 mo
First three INDs filed in parallel
Reflection
Platform companies sit at a unique crossroads: they own powerful technology but face paralyzing choice about where to apply it. This team wanted to pursue everything because they could. I had to help them see that choosing three indications well beats pursuing twelve indications poorly. The turning point came when we modeled how clinical data from the first indication could derisk the second. That realization transformed the conversation from "which indication do we do?" to "in what order do we do them to minimize risk?" They shipped faster and raised more capital.
Vaccine Development: Navigating Accelerated Regulatory Pathways
The Challenge
A biotech developing a vaccine for an emerging infectious threat needed to navigate the FDA's accelerated development programs (Breakthrough Designation, Fast Track, Priority Review). The company was approaching regulators for the first time and lacked experience with expedited pathway eligibility criteria.
Our Approach
- Assessed vaccine candidate eligibility against FDA criteria for Breakthrough Designation and Fast Track programs
- Built a Target Product Profile that explicitly addressed regulatory decision-making points expected by FDA reviewers
- Designed a clinical development program that fulfilled both accelerated pathway requirements and strong scientific evidence generation
- Prepared comprehensive pre-IND meeting materials demonstrating program feasibility, safety monitoring, and regulatory engagement strategy
- Created a strategic engagement plan with FDA including timing of meetings, discussion topics, and anticipated decision points
- Developed contingency pathways in case accelerated designation was not granted
Results
Breakthrough
Designation granted post-IND
Fast Track
Priority Review pathway approved
50%
Reduced Phase II development timeline
6 mo
Earlier interaction with FDA than industry standard
Reflection
Accelerated pathways are not free grants—they are pathways earned through clear evidence of benefit in a serious unmet need. This team had both the science and the need, but they did not yet have the language to communicate it to regulators. By building a TPP that explicitly mapped to FDA decision criteria and demonstrating feasibility through our roadmap, we positioned them to have a productive conversation with regulators from day one. The designation followed. The pathway cleared. The execution continues.
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