Independent scientific and strategy advisory

Is the science actually as good as the deck says?

I give investors, boards, and biotech leaders an independent read on the science, and a plan for what to do about it. From mechanism diligence through evidence, launch, and study design, grounded in what a reviewer, a regulator, and a market will each accept.

Span
Mechanism to market
Vantage
Sponsor & CRO
Record
25 years, published
Three ways to work together

Scientific judgment across the arc, from mechanism to market.

Most advisors sit at one point on the line: the science, or the trial, or the launch. I work the whole arc, so a diligence read connects to an evidence plan, and an evidence plan connects to a study that can actually run. Each engagement is scoped, fixed, and written for the person who has to defend the call.

01

Asset Diligence & Strategic War-Gaming

An independent read on whether an asset holds together, and what it is worth doing about it. I pressure test the mechanism and the readout, then war-game the strategic paths using probability-weighted scenarios and deal comparables, not false-precision spreadsheets.

  • Mechanism plausibility and readout overstatement risk
  • Probability-weighted scenario trees and M&A comparables
  • Board-ready memo with a clear go, watch, or pass call

For: VCs, boards, expert networks, founders pre-raise

02

Integrated Evidence & Launch Strategy

One operating framework that ties what you have to prove to what you have to do, from evidence generation through launch readiness. What the data must show, in what order, at what cost, and where the two agendas overlap so you fund them once.

  • Integrated evidence and launch plans with shared-cost mapping
  • Comparative positioning via network meta-analysis and ITC
  • Probability-impact risk matrix with named decision owners

For: Clinical-to-commercial biotech, medical affairs and launch leads

03

Study Design, Endpoint & Analysis Strategy

The operational translation: turning a mechanism and an endpoint into a study that can actually enroll and read out. Endpoint selection, feasibility and site-network modeling, and an analysis plan built to survive a board, a journal, or a regulator.

  • Endpoint framing across imaging, EEG, digital, and clinical anchors
  • Enrollment feasibility and decentralized site-network modeling
  • Leakage, overfitting, and claim-calibration review

For: Sponsors and clinical leads designing or defending a study

About

A scientist who reads the data the way your reviewers will, and a strategist who knows what to do next.

The source of truth lives inside the primary literature and the raw analysis, not the summary slide. My research applies functional connectivity analysis and machine-learning classification to subcortical signals in epilepsy and neuropsychiatric disease, asking a hard question: when does a brain signal actually distinguish one clinical phenotype from another, and when is it noise dressed as insight. That work is published in Neurology, Brain Imaging and Behavior, and Epilepsia, with a fourth manuscript in preparation.

The through-line matters more than the indication. Neurological and neuropsychiatric conditions often present through overlapping signs and semiology, and asking the right question in the right context is what separates a shared surface pattern from a shared underlying mechanism. That distinction is where a candidate marker earns, or fails to earn, a therapeutic rationale. It is the same judgment whether the asset is an epilepsy program or something adjacent.

The same discipline carries across the development arc. I hold candidate markers to a validation standard, I look for the leakage and overfitting that inflate a classifier, and I separate the technically adequate from the clinically overstated. Twenty-five years across sponsor and CRO, at Merck, CSL Behring, IQVIA, and Syneos, means I read the science with an eye on what a board, a regulator, and a market will each need to see, and I can translate that judgment into an evidence plan, a launch strategy, or a study that will actually run.

Ventral anterior thalamic dysfunction distinguishes seizure generalization in temporal lobe epilepsy

Epilepsia, 2026 · Resting-state fMRI, thalamic graph-theoretic topology in 166 patients; candidate connectivity marker and neuromodulation-target rationale, not a validated biomarker

Association of normative and non-normative brain networks with cognitive function in temporal lobe epilepsy

Neurology, 2024 · Normative modeling of brain networks against neuropsychological outcomes; separates cognitively intact from impaired TLE

Cerebellar and subcortical interplay in cognitive dysmetria: functional network signatures across schizophrenia, bipolar II, and ADHD

Brain Imaging and Behavior, 2025 · Shared and distinct connectivity signatures across three psychiatric phenotypes; the cross-disorder work behind the through-line above

Novel subcortical features discriminating FBTCS severity via SVM classification

In preparation · Nested cross-validation, permutation testing, convergent feature analysis

From the published work

This is what a defensible subcortical contrast looks like.

Axial slices from my subcortical connectivity analysis in temporal lobe epilepsy, contrasting the pooled TLE group against healthy controls to show where thalamic and striatal signals deviate from the control pattern. Warm clusters mark higher, cool clusters lower group differences on the T-statistic scale. Separately, in laterality-stratified models, those deviations concentrate in right TLE while left TLE runs closer to null.

I show this for one reason: to make the standard concrete. This is a genuine, hypothesis-generating result from a cross-sectional cohort. It is a candidate connectivity marker and neuromodulation-target rationale, not a validated biomarker. Holding that line is exactly the judgment I bring to a diligence read or an endpoint plan.

Four axial brain slices at z = -20, -10, 0, and 10 millimeters, showing subcortical clusters of group functional-connectivity differences with a T-statistic color scale from -3.58 to 3.78
Representative subcortical connectivity contrast, TLE versus healthy controls, cross-sectional cohort. Axial slices z = -20 to +10 mm; color scale is the group T-statistic. Illustrative of analysis approach, not a validated biomarker.
Representative work

The kinds of questions I get hired to answer.

Illustrative of real engagements, described by mechanism and method only. No client names, no confidential figures. Each one starts with a decision someone needs to make with confidence, and spans the arc from a first diligence read to a study that has to run.

Diligence & war-game

A board needed a defensible valuation stance on a clinical-stage CNS asset with a novel receptor mechanism.

Standard discounted-cash-flow models gave a false sense of precision on a private company with binary clinical risk. The board needed a way to reason about the range of outcomes, not a single number.

War-game deliveredA probability-weighted scenario tree (base, bull, bear, platform pivot) anchored to named public M&A comparables in the class, with a one-sentence board takeaway and the class-specific risks that should drive capital allocation.

Integrated evidence & launch

A pre-launch cardiometabolic company was funding its evidence plan and its launch plan as two separate budgets.

The medical and commercial organizations were each building toward the same approval with overlapping studies, duplicated spend, and no shared view of what had to be proven versus what had to be done.

Framework deliveredOne integrated evidence and launch plan separating prove from do, with the roughly two-thirds workstream overlap mapped so shared activities were funded once, plus a probability-impact risk matrix with named decision owners.

Comparative positioning

A company entering a class behind a larger competitor needed a defensible head-to-head argument.

With no head-to-head trial, the team was tempted into marketing-style claims that would not survive scientific or payer scrutiny.

Positioning deliveredA comparative-effectiveness argument built on a published network meta-analysis and indirect treatment comparison, with evidence bars segmented by prescriber audience so each claim matched the evidence behind it.

Enrollment feasibility

A Fortune 500 sponsor's Alzheimer's registry design rested on an enrollment rate the sites could not deliver.

The design assumed a per-site monthly enrollment roughly double what comparable prevention cohorts had achieved, and confined recruitment to memory clinics.

Redesign deliveredA feasibility correction benchmarked to a published prevention trial, plus a primary-care and decentralized recruitment channel that nearly doubled the accessible screening pool, reframed for the sponsor as a cost-and-risk trade-off rather than a scope fight.

Endpoint strategy · Phase 2 to Phase 3

A sponsor with promising Phase 2 data in a hard-to-measure indication needed an endpoint package that could carry a Phase 3 commitment.

The program sat at the end of Phase 2, the point where a bigger investment turns on endpoint clarity, dose justification, and a defensible read of emerging efficacy and safety. The existing measures were not yet decision-ready, and the team was unsure which signals were validated enough to anchor a registrational study.

Transition strategy deliveredA Phase 2b protocol synopsis and a composite responder framework spanning imaging, patient-reported, biomarker, and functional measures, each ranked by feasibility and evidentiary weight. Candidate markers were stated as candidates and paired with an accepted clinical anchor, dose justification was tied to the emerging data, and the qualification gaps still standing between the program and Phase 3 were mapped rather than glossed.

Analysis review

A classifier with strong reported performance had an outcome variable leaking into the model.

The headline accuracy was real in the spreadsheet and false in the world, because an outcome-defining feature had entered preprocessing before the cross-validation split.

Review deliveredA refactor to nested cross-validation with fold-local preprocessing, the leaking feature moved to a sensitivity analysis, and every claim recalibrated to what the corrected numbers actually supported.

Endpoint architecture

How I build an endpoint set to protect a signal.

Two therapeutic areas where the treatment effect sits close to the measurement grain, so the endpoint set has to be engineered, not just listed. Instruments only, described by role and integrity risk. No sponsors, molecules, or trial identifiers.

Major depressive disorder

A Phase 2 signal smaller than the noise floor has to be engineered for, not just measured.

Two parallel double-blind studies reading a dose-effect gradient. The endpoint set is built as one assay-sensitivity architecture, harmonized across both arms so a pooled read holds.

Parallel study · low dose Parallel study · high dose Harmonized read
Efficacyprimary · secondary
HDRS-17 CGI-S

Regulatory-standard primary paired with a conservative global anchor. The two are watched for decoupling as the earliest site-level drift signal.

Eligibility & enrichmentassay protection
SCID-5-CT MGH-ATRQ HARS ISI

Keeps true, drug-responsive MDD in and treatment resistance out, then enriches the comorbid phenotype. Effect-size protection before dosing starts.

Safety & differentiationmechanism-critical
C-SSRS CADSS Safety battery

Suicidality vigilance, the dissociation differential for the mechanism, and objective cardiac, hepatic, and renal gates. Where the differentiation thesis holds in the data or does not.

Exploratory biomarkerobjective backstop
Sleep-EEG / qEEG optional PSG sub-study

An algorithm-scored, inter-rater-free readout of target engagement across the dosing window. The objective corroboration the placebo-heavy subjective scales cannot provide. A candidate marker, not a validated one.

How I hold it together across two studies: one scientific source of truth. Harmonized endpoint conventions, aligned eligibility and medical-review logic, and a shared drift and safety-interpretation framework, so anything scored differently between the low- and high-dose arms is reconciled before it reaches a pooled interpretation.

Alzheimer's disease

In early AD, the measurement grain and the treatment effect sit at the same order of magnitude.

A biomarker-confirmed, early symptomatic program where a half-box move on an ordinal scale rivals the entire drug-placebo difference. The endpoint set is chosen and defended around that single fact.

Early symptomatic · Stage 3 to 4 Biomarker-confirmed
Efficacyprimary · integrated
CDR-SB ADAS-Cog13 iADRS

CDR-SB integrates cognition and function in one clinician-rated score; ADAS-Cog13 is the performance-based cognitive counterweight. iADRS is the same requirement answered in the opposite direction, pre-specified weighting versus clinician judgment, which decides where quality focus lands.

Eligibility & stagingpopulation integrity
MMSE CDR global ADCS-ADL

Stage-homogeneity gates that keep the enrolled band tight. MMSE is a coarse instrument controlling entry into a fine-grained trial, so the entry gate is a live inflation surface I watch first.

Safety & blindingintegrity-critical
ARIA (MRI) APOE genotype C-SSRS

ARIA is the dominant safety endpoint and, for this class, a functional unblinding cue. Its management has to be firewalled from the efficacy read, or the safety stream quietly contaminates the primary.

Biomarker confirmationpopulation & target
Plasma p-tau217 Amyloid PET / CSF

Two-tier triage-then-confirm eligibility that fixes the biological population before a single endpoint is scored. The objective anchor a coarse clinical scale cannot supply on its own, used as confirmation, not as a validated efficacy surrogate.

Where my quality focus goes: the endpoint set flexes with the design. Run the clinician-integrated primary and it shifts to rater judgment and adjudication; run the pre-specified integrated scale and it shifts to cognitive-test administration fidelity and informant consistency. Naming that trade before enrollment is the difference between catching drift as a signal and finding it at database lock.

Method and governance

How I keep the work honest at scale.

The judgment on this page does not scale by working more hours. It scales by encoding the rules into repeatable, auditable workflows, then keeping a human in the loop at the decisions that matter. I build these with large-language-model orchestration and rule-based governance, and I hold them to the same standard I hold a classifier: every claim traceable, every step reviewable.

I have published one such framework openly, as a working example of the pattern rather than a client tool: defensibility tagging on every output, human checkpoints as cost control, and an outcome feedback loop. In neuroimaging I work the other way, orchestrating established pipelines like fMRIPrep and the Conn toolbox and writing the custom statistics myself. What carries across is the governance discipline: the same rules that keep an automated workflow honest are the rules that keep an analysis free of leakage and overstatement.

View the open framework on GitHub
  • Defensibility tagging Every generated claim tagged as direct, adjacent, or inferred, so a reviewer sees exactly what rests on what.
  • Human-in-the-loop gates Automation handles retrieval and drafting; a person decides at the checkpoints that carry risk.
  • Hallucination governance Citation discipline and source-boundary rules, the same standard as a leakage-free analysis.
  • Outcome feedback Claims that fail scrutiny are retired across the system, not just fixed once.
How it works

Scoped, fast, and written to be defended.

Scope the question

A short call to define the exact decision and the material you can share. I confirm fit, timeline, and a fixed scope before anything starts.

Do the work

I read the primary evidence and the analysis directly. Most diligence reads and reviews turn around in a matter of days, not weeks.

Deliver a clear call

A written memo or briefing with a plain recommendation, the reasoning behind it, and the specific questions worth asking next.

Start a conversation

Have a CNS asset or study on your desk?

Tell me what you are evaluating and the decision you need to make. I reply personally, usually within one business day, and I will tell you plainly if it is not something I am the right person for.

  • Comfortable working under NDA and inside a data room
  • Available through major expert networks
  • Fixed-scope engagements, no long retainers required

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