Case Studies
Real Programs, Real Results
Anonymized examples of how we have helped 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 Series A funding.
Our Approach
- Conducted a competitive landscape analysis across 12 approved and pipeline oncology assets
- Developed a comprehensive Target Product Profile defining efficacy endpoints, safety thresholds, and label claims
- Designed the optimal FDA regulatory pathway including orphan drug designation strategy
- Created pre-IND briefing materials and mock Q&A preparation
- Built a phase-gated development plan with go/no-go decision criteria at each stage
Results
18 mo
Discovery to IND filing
$24M
Series A secured
0
Clinical holds from FDA
3 mo
Ahead of projected timeline
“EPD gave us the strategic clarity our board needed. Instead of debating the path forward, we had a clear roadmap that everyone — scientists, investors, and regulators — could align around.”
— CEO, Oncology Biotech (Series A)
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 their academic research into a commercially viable development plan to attract venture funding and form a spinout company.
Our Approach
- Translated the academic research into a Target Product Profile suitable for investor presentations
- Identified the strongest initial indication based on unmet need, regulatory feasibility, and competitive positioning
- Developed a dual FDA/EMA regulatory strategy leveraging Germany's proximity to EMA-adjacent authorities
- Created a realistic budget framework and development timeline for seed through Series A
- Prepared investor-ready materials including development strategy summary and risk mitigation plan
Results
€8M
Seed funding secured
2
Indications identified
1
Strong lead indication selected
12 mo
To EMA Scientific Advice meeting
“As academics, we knew the science but not the regulatory or commercial landscape. Marisela bridged that gap completely. Our investors told us the development plan was the strongest they had seen from an academic spinout.”
— Co-Founder & CSO, Platform Biotech
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. They had a small team with no prior regulatory experience in either jurisdiction and a tight timeline driven by patient advocacy group expectations.
Our Approach
- Mapped the regulatory requirements for both FDA and EMA side by side, identifying overlapping and jurisdiction-specific data needs
- Designed a single clinical development program that would satisfy both agencies, avoiding 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 timeline with critical milestones and resource requirements
Results
2
Orphan designations granted
40%
Reduction in duplicative studies
6 mo
Saved on parallel filing prep
100%
Regulatory milestones met on time
“We were terrified of the dual-filing complexity. Marisela made it manageable. She designed a program that satisfied both FDA and EMA without us running two separate development tracks.”
— VP Regulatory Affairs, Rare Disease Biotech
Your Program Could Be Next
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