Drug Development Strategy Consulting
0% of drug programs fail before reaching Phase I clinical trials.
Most of these failures are strategic, not scientific. Unclear choices and vague product characteristics quietly derail programs long before preclinical proof-of-concept data are generated.
We help biotech startups and researchers define their product characteristics and make the right choices to advance their programs from discovery through Phase I.
Decades of Expertise. Proven Results. Strategic Impact.
0+
Years in Preclinical Research
BioNTech · CDC · USDA
€0M+
Portfolio Managed
At BioNTech
0+
License Acquisitions
For Critical Assets
0+
Experts Led
Across 5 Multidisciplinary Programs
Track Record
Blending experience from industry, government, and academia
Big names in infectious disease and drug development worldwide.
- WHOWorld Health Organization
- CDCCenters for Disease Control and Prevention
- NIHNational Institutes of Health
- USDAU.S. Department of Agriculture
- GFGates Foundation
- GAVIThe Vaccine Alliance
The Journey
Navigating the Journey from Discovery to Clinic
- Target Product Profile
- Target Selection
- Hit-to-Lead Data Package
- Lead Candidate
- preclinical Proof of Concept (pPoC*)
- IND / CTA Submission
- *pPoC — preclinical proof of concept
The Reality
Only 0% of drug development programs successfully reach Phase I clinical trials.
Drug development from discovery to market launch costs between $1.7 billion and $2.7 billion. Of that, $300 to $500 million are lost due to errors and missteps in pre-clinical development, manufacturing, and regulatory compliance. Half of these programs fail due to poor pre-clinical efficacy. The rest are derailed by unclear target product profiles, manufacturing obstacles, or unmanageable drug toxicity.
Who We Help
Navigate Your Development Path with Confidence
We work with teams at different developmental stages.
What We Do
Services Built Around Your Current Needs
Anatomy of a TPP
Every attribute is a decision.
The Target Product Profile is the artifact that aligns everyone. Below is an illustrative sample for a drug-resistant tuberculosis candidate.
Our Process
How We Work Together
Every engagement follows a clear, proven process. No surprises. No wasted time.
Discovery Call, Landscape & Gap Analysis
We begin by understanding your needs, goals, and challenges. Then we transition into discussing your indication, patient population / customers and modality. This sharpens our understanding of your target product profile (TPP) and your competitive landscape.
45 minutes, freeProject & Consultancy Design
Together, we create a project plan and consultancy agreement that empowers you to map your pathway forward. Support is tailor-made for your stage of development and specific needs.
Adjustable timeframesOngoing Advisory
As you execute, we stay available. As data sets come in and landscapes shift, we can help you adapt your strategy and roadmap to maintain momentum.
Optional retainerClient Story
Building a University Spin-out Company: From Promising Data to a Clear Development Roadmap
A university laboratory specializing in molecular glues had promising data and were working towards obtaining preclinical proof of concept results. They were seeking non-dilutive funds (GO-BioNext Grant) to finance their developments up to Regulatory-enabling activities. Their goal is to eventually spin out from the university and build a start-up company.
5
Critical strategy choices framed
1
Indication + route locked
TPP
Built from scratch
Pitch
Deck + grant pathway designed
Why EPD Consulting
Gain A Drug Development Partner, not Just a Consultant.
EPD Consulting is powered by Dr. Marisela Rodriguez, who understands the critical choices you need to make for clinical entry. Every drug development team comes equipped with unique competencies and capabilities that, when managed effectively, increase your chances of clinical success. Therefore, every engagement is a boutique service, personalized to your developments.
Dr. Rodriguez's expertise is grounded in drug development portfolio management and strategic logic. With over 25+ years of infectious disease research from Drug Discovery to Phase I, she brings her insights from industry, government, and academia directly to you.
Work directly with an expert.
Dr. Rodriguez works directly on your project. No handoff to junior staff. 25+ years of experience on every engagement.
Proven Strategic Frameworks
We apply business strategy frameworks and logic (Blue Ocean, Five Forces, Playing to Win, etc.) to early stage drug and platform developments.
BioNTech, CDC, USDA Experience
From managing a $150 million drug development portfolio at BioNTech to building a vaccine core facility for the USDA. We generate results with real impact.
The Global Emerging Biotech Landscape
Based in Frankfurt, Germany, with insights on VCs, non-dilutive funds, and emerging trends in the EU, USA, and Chinese markets.
Fundamentally, strategy is choice.Successful teams make clear choices about what they will and will not do, and also effectively communicate them so plans can be executed.Having a cool scientific innovation is simply not enough.Given the uncertainty surrounding early-stage drug and platform developments, we are forced to think strategically (i.e., thinking in terms of bets, trade-offs, probabilities, etc.) to develop cost-conscious roadmaps and beat the Phase I failure rate.
Dr. Marisela Rodriguez
Founder & Principal Consultant, EPD Consulting
The Opportunity
The Opportunity
These teams are outpacing Big Pharma in innovation.
New drug launches by emerging pharma. Up from 35% in 2023.
In 2023, over 53% of new drug launches were done by emerging biopharma companies.
Sources: Viscadia — Optimizing Early-Stage Commercial Assessments for Emerging Biopharma (white paper); IQVIA Institute for Human Data Science — Global Trends in R&D 2024: Activity, Productivity, and Enablers (February 2024).
Partner with us to navigate your development journey with clarity and focus.
Book a 45-minute Discovery call to discuss your project and the next steps.
Choose wisely.