Patient Centric solutions for Clinical Biomarkers and Companion Diagnostics
In the complex landscape of precision medicine, alignment is the difference between a breakthrough and a bottleneck. We provide the specialized expertise needed to synchronize therapeutic, biomarker, and companion diagnostic development from initial research through global commercialization.
Our approach begins and ends with the patient. By integrating strategic roadmap development, rigorous partner selection, and end-to-end regulatory oversight, we de-risk the Companion Diagnostic lifecycle to ensure that the right therapy reaches the right patient at the right time. We don't just manage the process; we build the operational infrastructure and strategic partnerships that turn scientific innovation into accessible, life-changing clinical outcomes.
What we offer
Precision Medicine, Synchronized for the Patient. We bridge the Gap Between Therapeutic Potential and Diagnostic Reality.
Strategic Consulting & Biomarker Discovery
Ensuring biomarkers are clinically relevant and minimize patient burden during testing.
Biomarker Strategy: Seamlessly bridging the gap from initial Research to Clinical Development.
Feasibility & Performance: Rigorous assessment of biomarker viability and technical performance.
Diagnostic Development Strategy: Leveraging specialized insights into the integrated drug-and-diagnostic ecosystem.
KOL Engagement: Facilitating strategic partnerships with global Key Opinion Leaders to validate your approach.
Implementation & Partner Integration
Selecting partners who prioritize the needs of clinicians and patients
Diagnostic Partner Selection: Identifying and vetting the right diagnostic collaborators for your program.
RFI/RFP Management: End-to-end development, deployment, and evaluation of vendor requests.
Contract Lifecycle Management: Expert handling of structure, negotiation, and execution.
Technical Advisory: Providing the "boots on the ground" expertise needed to navigate complex integrations.
CDx Lifecycle & Regulatory Oversight
Fast-tracking access to reduce the time patients spend waiting for targeted treatment options.
CDx Lifecycle Management: Guiding the companion diagnostic from initial research through full commercialization.
Regulatory Roadmaps: Developing streamlined submission planning and global regulatory strategies.
Comprehensive Operations: Program management, oversight, and logistical support to keep timelines on track.
Program Alignment: Ensuring the therapeutic and diagnostic arms of the project remain perfectly synchronized.
How we work together
To meet the evolving needs of your organization, we offer three primary ways to partner. Each is designed to provide the right level of oversight at the right stage of your development lifecycle.
Strategic Project-Based Advisory
Best for: Defined deliverables with a clear start and end date.
This model is ideal for high-impact, objective-driven needs such as:
Diagnostic Partner Selection: Managing the full RFI/RFP process and contract execution.
Regulatory Submission Planning: Developing a specific roadmap for global regulatory synchronization.
Biomarker Feasibility Audits: A deep-dive technical assessment of a specific program’s viability.
The Outcome: A finalized deliverable such as a clinical biomarker strategy, implementation plan or signed contract.
Fractional Precision Medicine Leadership
Best for: Emerging biotechs that need executive-level expertise without a full-time hire.
We serve as an embedded member of your team (e.g., "Fractional Head of Precision Medicine" or "CDx Lead") for a set number of hours per month. This provides:
Continuous Oversight: Ongoing program management and internal stakeholder alignment.
Matrix Leadership: Mentoring scientific staff and managing external diagnostic partners.
Budget Predictability: High-level leadership at a fraction of the cost of a full-time executive.
The Outcome: Long-term stability and expert guidance through complex development phases.
Retained Advisory (The "Expert-on-Call")
Best for: Established teams needing ad-hoc technical advisory facilitation.
A low-intensity, high-access model for teams that have the "doing" covered but need a "thinking" partner to:
Review technical data and provide a "second set of eyes."
Facilitate introductions to global KOLs or technology providers.
Join high-stakes board or steering committee meetings as a subject matter expert.
The Outcome: Rapid access to 20+ years of industry insight whenever a critical decision arises.
Who we are
Precision Medicine Strategist | 20+ Years of Drug Development, Clinical Biomarkers and Diagnostics Integration
With over two decades of leadership in the pharmaceutical industry, Marielena Mata is a specialist in synchronizing the development of therapeutics and companion diagnostics. Trained in immunology with a deep concentration in oncology, Maty has successfully navigated the entire drug development lifecycle, bringing precision medicine solutions from early development to global markets.
Having worked at the intersection of drug development, diagnostic manufacturing, and regulatory agencies, Marielena provides the operational and strategic oversight necessary to de-risk programs through practical clinical biomarker and patient selection strategies. Dedicated to a patient-centric approach, Maty ensures that the most innovative science is translated into accessible, life-changing clinical tools.
Highlights:
20+ Years of Pharma Leadership
End-to-End Drug/Diagnostic Lifecycle Expertise
Oncology & Immunology Specialist
Successful interactions with global regulatory authorities
Extensive Network of KOLs & Diagnostic Partners
Contact Us
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