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Research & Development
Optimizing the path from molecule to market
For R&D organizations, the world is more complex than ever. R&D leaders must keep pipelines moving while simultaneously dealing with radical transformations across the larger environment:
- New technologies—particularly those driven by artificial intelligence (AI)—are transforming all aspects of R&D including discovery, preclinical testing, clinical development, and even approaches to regulatory strategy and submissions.
- The need for more innovative therapies is straining discovery efforts, forcing biopharma companies to become much more adept at leveraging external sources of innovation and seamlessly integrating external assets into R&D pipelines.
- Clinical trial complexity is rising as patient-centric approaches become more critical and recruitment gets more challenging.
- Evolving regulatory environments require more strategic and innovative approaches from biopharma companies to help secure approvals in a timely manner.
Blue Matter’s R&D team is purpose-built to help biopharma clients successfully navigate this difficult environment. More than helping clients “keep up,” we help them get ahead of it and build competitive advantage. We bring a unique combination of scientific expertise, strategic mindset, deep familiarity with emerging technologies, and specialized capabilities in organizational excellence.
Services
- Innovation & Discovery
Discover optimal candidates through a more holistic disease understanding and by leveraging the right AI / machine learning (ML) platforms.
Disease Biology Deep-dives & Mechanism Of Disease Analysis
Gain a better understanding of the disease landscape, unmet needs, and opportunities within it:
- Multi-omics and real-world data integration
- Advanced pathway and network analysis
- Expertise-led data synthesis (PhD / physicians) complimented w/KOL research
- Hypothesis-driven approach resulting in testable therapeutic strategies
Ai / Ml Platform Evaluation & Vendor Selection
Identify the “right fit” platform and establish the right processes, governance, and metrics for getting the most from it:
- Needs-driven scoping
- Curated vendor landscape analysis
- Structured RFI/RFP process management
- Governance framework development
Hit Triage & Selection Criteria Development
Pursue higher-quality leads, accelerate decision making, and ensure transparent governance:
- Drive alignment with Target Product Profile (TPP) including hit criteria alignment to “must have” & “differentiator” attributes
- Align on multi-parameter framework
- Design triage cascade
- Define governance & decision-making framework
- Target to Indication Matching
Identify target-indication pairings that improve the odds of demonstrable clinical benefit.
Target Identification
Build a high-confidence target list with a robust plan for preclinical development:
- Convergent multi-modal data integration
- Computational & AI-driven analysis
- Literature review for biological rationale
- Prioritized outputs & path forward for experimentation
Translational Medicine Strategy
Translate strategy into a clear clinical development plan supported by optimized trial design:
- Blueprint for “bench to bedside” plan
- Biomarker strategy development
- Informed first-in-human (FIH) study design through pre-clinical data modeling
Indication Search & Development
Plot a strategic development pathway that maximizes asset value:
- Mechanism of action (MOA) deep dive & biological footprint
- Systematic indication mapping
- Clinical & commercial filtering
- Prioritization & high-level clinical development path
- Clinical Development & Operations
Achieve ambitious development timelines through optimized protocols, strategic oversight, accelerated clinical trial activation, enrollment, patient recruitment, and retention
Dynamic Protocol Design & Site Selection
Design protocols from the start that enhance the patient experience & speed up enrollment:
- Endpoint analysis
- Patient burden analysis vs. the competition
- Integration of decentralized & digital elements into protocol, as applicable
- Data-driven site selection
Accelerated Clinical Trial Activation & Enrollment
Compress start-up timelines, reduce patient burden, and speed up enrollment:
- Rapid activation PMO
- “Rescue” trial diagnostic
- Patient navigator support
- Targeted enrollment campaign management
Cro / Vendor Selection & Management
Select the right vendors & ensure proper oversight & accountability:
- Strategic needs assessment
- “Best-fit” CRO selection
- Partnership governance framework
- Central integration, oversight, & accountability
Optimized Patient Recruitment & Retention
Increase enrollment, reduce dropouts, & gather actionable patient insights:
- Data-driven recruitment strategy
- Patient-facing materials development & IRB support\Digital engagement & retention
- “Voice of the patient” feedback throughout the trial
- Regulatory Strategy & Post-Market Survelliance
Secure strategic approvals grounded in strong governance and monitored through robust, efficient pharmacovigilance.
Global Regulatory Strategy & Agency Interaction Planning
Proactively de-risk and accelerate the pathway to approval:
- Integrated regulatory pathway mapping
- Target Product Profile (TPP) pressure-testing based on regulatory agency precedent / expectations
- Agency interaction & briefing book preparation
- Regulatory risk & mitigation planning
Pharmacovigiliance (Pv) Program Design & Implementation
Reduce risk with a compliant, inspection-ready PV system:
- PV system & process architecture
- PV organizational design &/or sourcing strategy
- SOP & governance framework
- Corrective and preventive action (CAPA) development & monitoring
Governance Milestone Support
Enable efficient and effective governance while aligning key stakeholders:
- R&D governance charter development
- Strategic document facilitation
- Decision making frameworks
- Governance meeting management
- Strategy & Operations
Mitigate portfolio gaps and guide investments in innovation, with operating models that are ready to deliver on the future vision.
Portfolio Strategy & Prioritization
Maximize the value of the R&D portfolio :
- Strategic framework development
- Data-driven asset valuation
- Scenario modeling & trade-off analysis
- Governance & resource allocation
R&d Advisory Board Design & Execution
Maximize the actionable insights generated from advisory boards:
- Strategic design & advisor curation
- Charter & content development
- Facilitation &/or insight capture
- Insight synthesis & action plan
“Next Phase” Readiness Assessment
Validate readiness to deliver on early-stage and/or pivotal trials:
- Comprehensive, cross functional gap analysis
Next-phase requirements benchmarking - Risk identification & prioritization
- Actionable mitigation plan
- Strategic plan of action / next steps
Productivity & Continuous Improvement
Reduce operational inefficiency, accelerate R&D cycle times, and build a culture of improvement:
- Process & value stream mapping
- Bottleneck & root cause analysis
- Agile / lean solution design
- KPI & metrics development
Operating Model Transformation
Build a “Best Practice” R&D organization that is focused, agile, and ready to meet current and future demands:
- Current state diagnostic (structure, process, governance, technology)
- Future state design
- Role & competency mapping
- Implementation & change management / communications roadmap
