We help pharmaceutical and biotech organizations accelerate the path from discovery
to proof of concept through biomarker strategies, clinical frameworks, and regulatory innovations.
We need senior translational medicine thinking but don't have it in-house.
Building a full internal translational medicine function is a significant investment. We offer senior TM expertise embedded into your program when and how you need it.
Our preclinical data is strong. Why isn't our IND moving forward?
Strong data is necessary but rarely sufficient. The path to IND requires biomarkers, dose rationale, patient selection, and the scientific narrative that connects them.
We have operational support — but our scientific strategy needs a stronger foundation.
Operational excellence gets studies done. Scientific strategy determines whether those studies answer the right questions. We help you generate data that drives decisions.
We sit at the intersection of translational science, precision medicine, and early clinical strategy. Every engagement is built around your specific program, your data, and your next critical decision — not a templated deliverable.
A rigorous review of your preclinical package — gaps identified, risks ranked, next steps defined.
A first-draft biomarker framework covering PD confirmation, patient stratification, and early efficacy signals.
A rigorous Target Product Profile grounded in your MoA and aligned to the clinical and regulatory landscape.
Focused advisory built around your most pressing questions — IND strategy, biomarker design, or regulatory approach.
Independent review of your preclinical package — gaps ranked by risk, clear action plan toward IND.
Scientifically rigorous TPP capturing your MoA, target population, and evidence bar at each development stage.
Multi-indication evaluation across scientific fit, unmet need, stratification opportunity, and development risk.
Biomarker strategies, patient selection frameworks, and regulatory precedents mapped across your competitive space.
PD confirmation, patient selection, safety biomarkers, and regulatory positioning — integrated into your study design.
Biomarker-driven inclusion/exclusion criteria that translate your biological rationale into a clinical reality.
Literature, mechanistic rationale, and clinical precedent structured into an IND-ready evidence document.
Complete CDx roadmap from biomarker hypothesis through co-submission planning aligned to FDA and EMA.
Dose justification, escalation rules, endpoint selection, and expansion cohort strategy in one defensible plan.
Reverse-engineered from your clinical development plan — required studies mapped, gaps ranked by regulatory necessity.
Independent review covering dose escalation, biomarker integration, and PoC endpoint strategy.
Right questions, strengthened briefing document, mapped FDA responses — your team enters the room ready.
Senior TM expertise at your most critical external conversations — investors, partners, SABs, and boards.
For organizations that need more than a one-time engagement — flexible advisory relationships providing consistent translational medicine expertise at the level your program requires.
Reliable access to senior TM thinking between milestones — without a full embedded commitment.
Consistent, embedded TM support for programs approaching IND or navigating early clinical development.
Senior TM leadership without a full-time hire — strategic direction, board representation, scientific credibility.
Strong science, ambitious goals — and a need for TM infrastructure to match.
Translating compelling academic science into a credible development program.
The scientific strategy layer that lean, externally-partnered models often lack.
Specialized TM expertise for specific programs, indications, or critical milestones.
Development strategy and scientific narrative that drives program value.
From IND-enabling science through early proof-of-concept — wherever your program is.
If you are looking for a partner who will engage deeply with your science and build a program that holds up under scrutiny, we would welcome the opportunity to connect.