Scientific Expertise. Strategic Clarity.
From target identification to IND-enabling studies, Renaistre Scientific delivers end-to-end consulting across the full oncology drug development arc.
Preclinical Pharmacology
De-risk your program before IND.
Our founder has designed and overseen thousands of preclinical oncology studies across Charles River Laboratories, Eurofins, Crown Bioscience, and Champions Oncology — contributing to 35 FDA-approved cancer therapy programs.
We design, oversee, and interpret rigorous in vitro and in vivo pharmacology studies tailored to your oncology program. From mechanism-of-action characterization to efficacy and safety profiling, we ensure your preclinical data package is compelling, defensible, and regulator-ready.
Areas of Expertise
- In vitro efficacy and selectivity profiling
- In vivo tumor model design and execution oversight
- PK/PD modeling and dose optimization
- Biomarker identification and validation
- IND-enabling study strategy and CRO management
AI Drug Development Consulting
Navigate the AI landscape with scientific rigor.
We evaluate AI platforms with the biological domain expertise, computational literacy, and IP sophistication that vendor sales teams can't replicate — and with zero financial relationships to any platform we assess.
The AI drug development ecosystem is crowded, complex, and rapidly evolving. We help biotech and pharma companies cut through the noise — evaluating AI tools and platforms, assessing the quality and suitability of target datasets, and building the strategic foundation to deploy AI effectively across your pipeline. From vendor due diligence to commercialization planning, we ensure your AI investments translate into real program value.
Areas of Expertise
- AI tool and platform evaluation and selection
- Target dataset due diligence and quality assessment
- AI vendor landscape analysis and benchmarking
- AI integration strategy for existing pipelines
- Commercialization strategy for AI-derived assets
- Market positioning and competitive differentiation
- IP strategy for AI-generated discoveries
- Partnership and licensing advisory for AI platforms
Business Development
Build the partnerships that move your program forward.
Our founder has forged multiple multi-year, multi-million-dollar strategic partnerships with leading pharma and biotech companies — bringing scientific credibility and genuine independence from buyers and sellers to every deal.
Successful drug development requires more than great science — it demands the right relationships, deals, and strategic alliances. Renaistre Scientific supports biotech and pharma companies in identifying, structuring, and executing business development opportunities that maximize program value and accelerate growth. From in-licensing and out-licensing to M&A advisory and alliance management, we bring deep industry networks and transactional expertise to every engagement.
Areas of Expertise
- In-licensing and out-licensing strategy and execution
- Partnership identification and outreach
- Term sheet negotiation and deal structuring
- M&A target identification and diligence support
- Alliance management and governance
- Strategic fit assessment and opportunity prioritization
- Investor and partner presentation development
- Due diligence coordination and data room management
- Commercial organization design and build-out
- KPI frameworks and commercial performance systems
- Market access, pricing, and reimbursement strategy
- Sales force design and field operations infrastructure
Scientific Operations
Keep your preclinical program on time and on budget.
With 10+ years of scientific operations leadership — including Program Lead for the establishment of the Charles River Laboratories PDX program in collaboration with the Mayo Clinic in Jacksonville, Florida, and Global Technical Director leading in vivo cancer pharmacology scientific operations at Eurofins in Taipei, Taiwan — we understand how major CROs operate from the inside, where programs stall, and exactly what it takes to hold them accountable.
Effective preclinical CRO management is critical to generating high-quality data that withstands regulatory scrutiny. Renaistre Scientific provides hands-on scientific operations consulting across the full preclinical CRO lifecycle — from vendor identification and study design through execution oversight, data review, and study close-out. We ensure your CRO relationships are productive, your studies are scientifically sound, and your data packages are IND-ready.
Areas of Expertise
- Preclinical CRO identification, evaluation, and selection
- Study design review and scientific oversight
- CRO contract and scope of work negotiation
- In-life study monitoring and progress tracking
- Raw data review and quality assessment
- Cross-CRO program coordination and integration
- Study close-out and final report review
- Data package gap analysis and remediation planning
Let's Build Your Program Together.
Whether you're at the earliest stages of discovery or preparing for IND, Renaistre Scientific has the expertise to accelerate your path forward.
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