Decision-grade CNS drug development.
Physician-scientist-led translational systems for neuroscience programs where human relevance matters. We do not sell studies. We de-risk programs.
Most CNS programs fail after entering clinical development.
The evidence supporting advancement is often weaker than the decision requires. That disconnect is the Translation Gap.
Species mismatch
Rodent circuits don't recapitulate human cortical complexity.
Endpoint mismatch
Behavioral proxies lack translational face validity.
Behavioral ambiguity
Subjective scoring introduces irreproducibility.
Post hoc interpretation
Thresholds defined after the data is reviewed.
No translational continuity
Preclinical endpoints disconnect from human measures.
No validated alternatives
Non-animal endpoints lack regulatory-grade measurement bridges.
An integrated translational architecture
Connected thinking across the development pathway.
Gavalgana Advisory
Operational todayPhysician-scientist translational strategy and program guidance.
Gavalgana Preclinical Sciences
ActiveDecision-grade NHP neuroscience platform.
Gavalgana Clinical Sciences
In developmentEmerging regional clinical and longitudinal infrastructure.
Gavalgana BioMedical Engineering
In developmentComputational measurement systems and validated alternative methodologies, built on the same infrastructure that powers GPS.
From hypothesis to proof-in-concept, one continuous intellectual and experimental architecture.
Structured physician-scientist engagements
Defined deliverables. Contracted individually or sequentially. GA-1 frequently serves as the entry point.
Translational Readiness Review
4-6 weeksAsset-level go/no-go assessment; translational evidence review; species and endpoint rationale; written recommendation with decision logic.
Discuss this engagementIND Pathway Strategy
6-10 weeksPreclinical package design; biomarker framework; dose rationale; CMC alignment guidance; regulatory interaction plan for pre-IND meeting.
Discuss this engagementClinical Proof-of-Concept Blueprint
8-12 weeksPhase I/II design logic; primary endpoint selection; patient stratification; dose escalation rationale; go/no-go risk map.
Discuss this engagementMeasurement replaces interpretation.
Measure objectively. Decide deliberately.
- Observer scoring with inter-rater variability
- Behavioral assessments capture moments in time.
- Subjective endpoint calls
- Post hoc QC threshold definition
- Data that collapses under regulatory scrutiny
- Continuous behavioral measurement
- High-resolution longitudinal behavioral analytics
- Quantitative, auditable digital endpoints
- Pre-locked QC criteria before study initiation
- IND-ready, regulatory-structured data packages
- Measurement architecture designed to support both animal and non-animal endpoints
EEG telemetry incl. ear-EEG · computer-vision motor analytics · oculomotor battery · CSF / plasma biomarkers · sleep staging · histopathology
Feature extraction & signal engineering · cross-study comparability · biomarker generation from behavioral data · decision-level interpretability · AI-assisted endpoint extraction · validated, reproducible pipelines
Predefined endpoints · locked QC thresholds · fully traceable datasets · IND-ready reporting · audit-ready execution · protocolized, versioned SOPs
Internationally recognized neuroscience expertise.
Gavalgana's senior scientific and clinical staff are recognized across neuroanatomy, neurophysiology, neuropharmacology and neuropsychology, with particular depth in movement disorders, neurodegeneration and cognition. The value is not in the infrastructure. It is in knowing how to use it.
Neuroanatomy
Circuit- and region-level structural mapping.
Neurophysiology
EEG / qEEG telemetry, evoked potentials, sleep staging.
Neuropharmacology
Target engagement, dose rationale, mechanism.
Neuropsychology & cognition
Behavioral and cognitive endpoint design.
Movement disorders
Parkinsonian and dyskinesia phenotyping.
Translational & regulatory medicine
Bench-to-IND evidence strategy.
Expert consultancy
We advise on the design of preclinical and translational programs within our areas of special expertise, including model selection, scientific endpoints, and protocol design.
Decision-grade research
Laboratory studies run flexibly, from fee-for-service through risk-sharing collaboration, in purpose-built rodent and non-human-primate translational neuroscience facilities.
When the evidence must withstand scrutiny, Gavalgana was built for that moment.
Physician-scientist strategy, decision-grade translational neuroscience, and purposeful preclinical systems, including active investment in validated alternatives, for programs where the evidence must hold up. Before the boardroom. Before the agency. Before first human exposure.