Where AI Meets ROI in Translational R&D
Accelerating breakthrough medicine through digital-biological innovation and regulatory strategy that cuts development timelines while advancing scientific ethics.
I don't just consult; I architect transformation
Our clients cut development timelines, reduce risk, and deliver more predictive, humane research by integrating digital biomarkers, AI, and regulatory strategy. With deep scientific expertise and proven experience shaping $486M in federal innovation investment, we bridge the gap between cutting-edge technology and practical implementation.
Core Capabilities
Strategic Biopharma Transformation
Challenge
Pharma R&D faces 90% failure rates, $2.6B average drug costs, and growing regulatory complexity while investors demand faster, more predictable returns.
Approach
Combine deep scientific expertise with strategic communication to build organizational capabilities and industry influence through targeted thought leadership.
Key Capabilities
- Digital biomarker strategy & implementation
- AI/ML-powered drug discovery acceleration
- Regulatory pathway optimization
- Portfolio risk assessment & prioritization
- Alternative methodology integration
Value Drivers
5-37% reduction in study timelines, 2-25%% decrease in animal testing needs, improved regulatory approval rates, and enhanced investor confidence through data-driven decision making.
Academic Transformation & Research Modernization
Challenge
Academic institutions struggle to adopt new technologies, secure funding for infrastructure modernization, and translate research into commercial applications.
Approach
Develop institutional transformation roadmaps that align with federal funding priorities while building sustainable, ethics-driven research capabilities.
Key Capabilities
- Federal funding strategy & grant development
- Research infrastructure modernization
- Technology transfer acceleration
- Industry partnership facilitation
- Alternative methods implementation
Value Drivers
Increased funding success rates, enhanced research impact, improved industry collaboration, and leadership in next-generation research methodologies.
Venture & Startup Acceleration
Challenge
Biotech startups face complex regulatory landscapes, limited resources for comprehensive R&D, and investor pressure for rapid, validated progress.
Approach
Provide strategic guidance on technology selection, regulatory positioning, and investor communication while accelerating proof-of-concept development.
Key Capabilities
- Technology validation & optimization
- Regulatory strategy development
- Investor deck & pitch development
- Partnership & licensing guidance
- IP strategy & competitive analysis
Value Drivers
Accelerated time-to-market, improved investor readiness, reduced regulatory risk, and enhanced competitive positioning through differentiated technology approaches.
Thought Leadership & Capability Building
Challenge
Organizations need to build internal expertise, influence industry standards, and position themselves as leaders in rapidly evolving scientific landscapes.
Approach
Combine deep scientific expertise with strategic communication to build organizational capabilities and industry influence through targeted thought leadership.
Key Capabilities
- Scientific publication strategy
- Conference speaking & positioning
- Industry consortium participation
- Team capability development
- Stakeholder engagement strategy
Value Drivers
Enhanced market positioning, increased industry influence, improved talent attraction, and accelerated business development through thought leadership recognition.
What Sets Us Apart
Rare Translational Expertise
Veterinary-scientist background with deep understanding of both human and animal biology, enabling unique insights into drug development and safety assessment.
Bi-Directional Learning
Forward translation from bench to bedside and reverse translation from clinical failures back to improved preclinical models—maximizing learning from every experiment.
Hands-on Implementation
Direct experience shaping federal policy, including contributions to the National Academies report that drove $486M in NIH investment in alternative research methods.
Regulatory Influence
Direct experience shaping federal policy, including contributions to the National Academies report that drove $486M in NIH investment in alternative research methods.
Ethics-Driven Innovation
Committed to advancing science while reducing animal use through digital biomarkers, AI modeling, and alternative methodologies that improve both ethics and outcomes.
Client Success Stories
Challenge: Global pharma company needed to reduce animal testing while maintaining regulatory confidence for CNS drug development.
Solution: Implemented digital biomarker platform with AI-powered behavioral analysis and regulatory qualification strategy.
Result: 60% reduction in study duration, 40% decrease in animal use, successful regulatory submission with enhanced data package.
Challenge: Academic medical center struggling to compete for federal funding and translate research innovations to industry.
Solution: Developed comprehensive modernization strategy aligned with NIH priorities, including digital infrastructure and industry partnerships.
Result: Secured $15M in federal funding, established three major industry collaborations, positioned as national leader in alternative methods.
Challenge: Biotech startup needed investor-ready validation of AI-powered drug discovery platform with clear regulatory pathway.
Solution: Provided technology validation, regulatory strategy development, and investor communication framework with competitive positioning.
Result: Successful Series A funding, FDA qualification discussions initiated, strategic partnerships with two major pharma companies.
Engagement Models
Strategic Assessment
Comprehensive analysis of current capabilities, market positioning, and transformation opportunities with actionable roadmap development.
Transformation Partnership
Deep, hands-on collaboration to implement digital biomarkers, AI platforms, and new methodologies with your internal teams.
Ongoing Advisory
Continuous strategic guidance as your trusted advisor for technology decisions, regulatory strategy, and market positioning.
Executive Advisory
Board-level strategic counsel for major decisions, industry positioning, and stakeholder communication on scientific innovation.
What Industry Leaders Say
Meet Dr. Szczepan Baran
Veterinarian-Scientist & Digital Innovation Leader
Dr. Szczepan Baran brings a unique combination of deep scientific expertise and strategic innovation leadership to the life sciences industry. As former Chief Scientific Officer at VeriSIM Life and Head of Emerging Technologies at Novartis, he has pioneered the integration of digital biomarkers, DCTs and hybrid AI/ML technologies in biomedical research.
His contributions to the National Academies 2023 report on nonhuman primate research helped shape federal policy and drive $486M in NIH investment in alternative research methodologies. Dr. Baran’s work demonstrates how digital innovation can accelerate scientific discovery while advancing ethical research practices.
- Vice President, 3Rs Collaborative
- Co-Chair (representing Industry), NAMs Validation & Qualification Network (VQN) Steering Committee
- Founder & Co-chair, AI Initiative
- Co-chair, MPS and Translational Digital Biomarker Initiatives, 3Rs Collaborative
- Key contributor National Academies’ Nonhuman Primate Model Systems: State of the Science and Future Needs
- Key contributor to Catalyzing the Development and Use of Novel Alternative Methods / Report to the Advisory Committe to the NIH Director
- Pioneer in digital biomarker development and AI-powered research platforms
- Expert in regulatory science and technology qualification pathways
- Chair, IQ MPS Affiliate
Lead the Next Decade of Life Sciences Innovation
The convergence of AI, digital biomarkers, and regulatory modernization represents an unprecedented opportunity for competitive advantage. Organizations that act now will define the future of biomedical research and drug development.