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 Infectious Disease and Drug Development
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
- 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 Phase I
- Target Product Profile
- Target Selection
- Hit-to-Lead Data Package
- Lead Candidate Preclinical Proof of Concept
- Regulatory Submission
The Reality
Only 0% of Drug Development Programs Successfully Reach Phase I Trials.
Half of these programs fail due to poor preclinical efficacy. The rest are derailed by unclear target product profiles, manufacturing obstacles, or unmanageable drug toxicity.
Drug development from discovery to market launch costs between $1.7 billion and $2.7 billion. Of that, $300 to $500 million is lost due to errors and missteps in strategy and planning.
The Opportunity
Emerging Pharma is Currently Outpacing Big Pharma in Drug Launches.
In 2023, over 53% of new drug launches were done by emerging pharma companies.
New drug launches by emerging pharma are up from 35% in 2023.
Sources
- Wilson, D. Viscadia White Paper: Optimizing Early-Stage Commercial Assessments for Emerging Biopharma (Viscadia_WhitePaper_CommercialAssessments).
- IQVIA Institute for Human Data Science. Global Trends in R&D 2024: Activity, Productivity, and Enablers, February 2024. pp. 15, 37.
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
Our Process
How We Work Together
Every engagement follows a clear process with no surprises.
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 / product. This sharpens our understanding of your product characteristics 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-diluted funds to finance their development up to clinical entry. 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 the expertise of Dr. Marisela Rodriguez, who understands the critical choices required to get drug candidates into the clinic. 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 25+ years across infectious disease and drug development, 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, bringing 25+ years of experience into every engagement. There is no handoff to junior staff.
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.
Choose Wisely
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.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, PhD
Founder & Executive Consultant, EPD Consulting
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.