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Decision-Grade Science for Human Potential

Decision-grade CNS development.

Physician-scientist-led translational systems for neuroscience programs where human relevance matters. We do not sell studies — we de-risk programs.

The Translation Gap

Most CNS programs do not fail because the biology was wrong.

They fail because translational confidence was insufficient before first human exposure. The problem is not biology. It is translation.

94%
of CNS programs fail after entering clinical trials
Often for want of translational confidence before first human exposure — not because the biology was wrong. Hay et al., Nat Biotechnol 2014; Wong et al., Biostatistics 2019.
01

Species mismatch

Rodent circuits don't recapitulate human cortical complexity.

02

Endpoint mismatch

Behavioral proxies lack translational face validity.

03

Behavioral ambiguity

Subjective scoring introduces irreproducibility.

04

Post hoc interpretation

Thresholds defined after the data is reviewed.

05

No translational continuity

Preclinical endpoints disconnect from human measures.

06

No path beyond the animal model

The field lacks validated computational alternatives because the measurement infrastructure was never built to support them.

Gavalgana Advisory

Structured physician-scientist engagements

Defined deliverables. Contracted individually or sequentially. GA-1 frequently serves as the entry point.

GA-1Entry point

Translational Readiness Review

4–6 weeks

Asset-level go/no-go assessment; translational evidence review; species and endpoint rationale; written recommendation with decision logic.

Discuss this engagement
GA-2

IND Pathway Strategy

6–10 weeks

Preclinical package design; biomarker framework; dose rationale; CMC alignment guidance; regulatory interaction plan for pre-IND meeting.

Discuss this engagement
GA-3

Clinical Proof-of-Concept Blueprint

8–12 weeks

Phase I/II design logic; primary endpoint selection; patient stratification; dose escalation rationale; go/no-go risk map.

Discuss this engagement
Organizational Architecture

An integrated translational architecture

Not isolated service lines — a continuous architecture from hypothesis to human.

GA

Gavalgana Advisory

Operational today

Physician-scientist translational strategy and program guidance.

GPS

Gavalgana Preclinical Sciences

Active

Decision-grade NHP neuroscience platform.

On the roadmap
GCS

Gavalgana Clinical Sciences

In development

Emerging regional clinical and longitudinal infrastructure.

GBME

Gavalgana BioMedical Engineering

In development

Computational measurement systems and validated alternative methodologies, built on the same infrastructure that powers GPS.

From hypothesis to human — one continuous translational architecture.

Gavalgana Preclinical Sciences — Objective Measurement

Measurement replaces interpretation.

Not scored — measured. Not interpreted — documented.

Conventional NHP studies
  • Observer scoring with inter-rater variability
  • Behavioral snapshots — episodic, not continuous
  • Subjective endpoint calls
  • Post hoc QC threshold definition
  • Data that collapses under regulatory scrutiny
GPS platform
  • Computer-vision phenotyping — continuous, automated
  • 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
Objective measurement

EEG telemetry incl. ear-EEG · computer-vision motor analytics · oculomotor battery · CSF / plasma biomarkers · sleep staging · histopathology

Quantitative analytics

Feature extraction & signal engineering · cross-study comparability · biomarker generation from behavioral data · decision-level interpretability · AI-assisted endpoint extraction · validated, reproducible pipelines

GLP-grade infrastructure

Predefined endpoints · locked QC thresholds · fully traceable datasets · IND-ready reporting · audit-ready execution · protocolized, versioned SOPs

Expertise

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. Expertise — not infrastructure — is what de-risks a program.

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.

40+ Yearsof combined frontline research and translational practice
Peer-reviewedwidely published; novel models and therapeutic targets
Editorial boardsand international research funding bodies
Bench → Phase 3discovery through regulatory submission to human trials
01

Expert consultancy

We advise on the design of preclinical and translational programs within our areas of special expertise — the most suitable model systems, scientific endpoints, and protocol design.

02

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.

Why this matters

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.

info@gavalgana.com Boston, Massachusetts

Confidential. Reviewed by a physician-scientist, not a sales desk.

Optional — held in confidence.