Jump toSciencePatientCapitalRegulatoryLeadershipWhere you sit
Capability index

The full range, and where it runs deepest.

Three decades of biopharmaceutical development, organized so you can find what you need quickly. Everything here sits under one of the five domains that decide whether a program works, and each entry shows how far the accountability goes.

IScienceIs the biology real, and can it be made? IIPatientWho receives it, and can they? IIICapitalWho funds this, on what terms, at what stage? IVRegulatoryWhat evidence does the approving body require? VLeadershipWho decides, with what authority, on what cadence?

Two questions run across these five domains to find the part of a plan carrying weight it cannot bear: what impact do you want to have, and what would have to be true. That is the Load-Bearing Questions, the model every TMDG engagement runs on, and the range below is what it reaches.

DeepPersonally accountable, with a named result behind it. This is where you are hiring judgment built from having done the work.
FluentEnough depth to lead it, direct it, and know when it is going wrong, drawn from the same career.
ConvenedA specialist gives the “best” answer. I frame the question, bring the right persons into the room, and deliver the answers that matter most.
I

Science

Is the biology real, and can it be made?
Deep
  • Platform and modality strategyChief Strategy Officer of a Nasdaq-listed self-amplifying mRNA company: platform, pipeline and partnership strategy across a multi-program portfolio.
  • Developability and platform-versus-asset judgmentCarried an asset from preclinical through clinical development, including indication selection and delivery route.
  • CMC, comparability and manufacturability riskLed a self-amplifying mRNA platform from pre-IND to clinical readiness.
  • Target product profiles and indication selectionSet the TPP and selected the lead indication on a development-stage asset.
  • Pre-IND and IND-enabling strategyBuilt and executed the pre-IND package for a novel modality.
  • Integrated clinical development planningBuilt the development and regulatory plans carrying assets from pre-IND through approval.
  • Full development path, first-in-human through post-approvalCarried assets across Phase 1 to Phase 3 and into Phase 4 commitments: first-in-human design, dose and regimen selection, pivotal design and execution, and post-approval evidence obligations including pediatric commitments.
Fluent
Protocol and trial designDose and regimen selectionPivotal study designPivotal readiness reviewTrial design under constraintTechnical kill criteriaNovel-modality feasibilityDelivery and formulation strategyComparator and benchmark selection
Convened
Analytical method developmentProcess development and tech transfer executionPreclinical toxicology executionBioinformatics and computational biology
Papers that evidence thisReading a Platform ClaimThis is for you if you are being asked to fund a platform and you want to know whether it is one.Before the First PatientThis is for you if you have a molecule that works and a board asking when you will name an IND filing date.
II

Patient

Who receives it, and can they?
Deep
  • Rare and ultra-rare program designRare and specialty programs across more than ten indications, carried to approval.
  • Pediatric program designRan a Pediatric Written Request process with the FDA to completion and secured CHMP pediatric approval.
  • Real-world evidence strategyNegotiated a real-world evidence strategy directly with the FDA.
  • Access and equity architectureBuilt the access structure for a $451M development alliance spanning a global health funder, a vaccine alliance and a sovereign government.
Fluent
Patient-reported and functional endpointsEnrollment feasibility and site assumptionsPatient advocacy engagementNatural-history and registry strategyDiagnosis and referral pathway designGlobal access pathway design
Convened
Health economics and outcomes researchPayer modeling and reimbursement negotiationPatient recruitment executionHealth equity field implementation
Papers that evidence thisRegulating the CureThis is for you if your therapy is meant to work once, and the framework you are held to assumes chronic dosing.
III

Capital

Who funds this, on what terms, at what stage?
Deep
  • Public-private partnership architectureArchitected a cross-border public-private partnership representing approximately $1.3B in committed infrastructure. This engagement is infrastructure, counted separately from the biopharmaceutical figures cited elsewhere.
  • Non-dilutive and blended capitalBuilt and delivered the infrastructure for a $451M COVID-19 development alliance.
  • Partnership and alliance structuringLed the partnership behind the world's first approved self-amplifying mRNA vaccine.
  • Transaction diligenceAssessed multi-party pipelines across three large biopharmaceutical organizations.
  • Lean and virtual development designBuilt a virtual-biotech outsourcing framework later adopted as standard by a top-five CRO, cutting cost per patient by 45%.
Fluent
Capital-efficient sequencingScenario and runway modelingMilestone and tranche designGrant and consortium positioningRisk-financing structuresEntity and vehicle designFoundation and public benefit corporation structuresInvestor narrativeInvestment committee preparationFund-level portfolio reviewPost-close value creationBuild versus partnerIn-licensing and external innovationCDMO strategyCost-per-patient benchmarking
Convened
Legal drafting and negotiationTax structuring and entity formationValuation modelingBanking and placement
Papers that evidence thisThe Zero-Dollar VoucherThis is for you if you are being asked to justify a rare-disease program whose case rests on a voucher you have not been awarded.When the Science Works and the Economics Do NotThis is for you if the science is tractable, the model does not close, and you are being told to walk away.Planning for the ReadoutThis is for you if your cash runway and your next readout are on a collision course.
IV

Regulatory

What evidence does the approving body actually require?
Deep
  • Multi-agency regulatory strategyPrograms advanced to approval with the FDA, EMA/CHMP, MHRA, PMDA and TGA.
  • Expedited designationsSecured FDA Fast Track and Breakthrough Therapy designations.
  • Agency engagement and briefing strategyDesigned and led agency interactions, briefing books and question strategy across regions.
  • Novel-modality regulatory precedentEstablished the regulatory path for self-amplifying mRNA where little settled precedent existed.
Fluent
Endpoint and comparator defensibilityPost-approval and Phase 4 commitmentsSubmission strategy and sequencingMulti-agency divergenceWHO prequalification pathwaysExpedited and priority review realismRegulatory strategy for small populations
Convened
Regulatory publishing and submission operationsBiostatistics and statistical analysis plansMedical writingPharmacovigilance operationsIP prosecution and freedom-to-operate
Papers that evidence thisRegulating the CureThis is for you if your therapy is meant to work once, and the framework you are held to assumes chronic dosing.
V

Leadership

Who decides, with what authority, on what cadence?
Deep
  • Portfolio and program management capabilityHead of Portfolio and Program Management for a global vaccines business: built the function and its Program Governance Committee.
  • Governance and decision architectureDesigned the operating model, portfolio councils and stage-gates for a global product organization.
  • Global trial operations and conductLed global trial delivery on programs that became approved medicines, and delivered a global program five months ahead of schedule.
  • CRO and vendor architectureRestructured CRO relationships on a risk-reward basis, cutting cost per patient by 45%.
  • Organization building across regionsBuilt and led development functions across four regions.
  • Consortium and alliance program leadershipLed a multi-pathogen self-amplifying mRNA program through pivotal global milestones across sponsors, manufacturers and regulators on three continents.
  • Program leadership and recoveryServed as the accountable executive advocating for programs and stopping them.
Fluent
Portfolio prioritizationStage-gate designProbability-of-success frameworksCapability gap assessmentOperating model and decision rightsProgram-leader developmentResequencing and replanningInterim and fractional program leadershipBoard and investor communicationManagement team assessmentHire and fractional-support planningAlliance governanceDecision rights and escalationExecutive and board counsel
Convened
Executive searchCompensation designOrganizational psychology and coachingChange management delivery
Papers that evidence thisWho Actually DecidesThis is for you if the same question is being answered in three forums and none is sure it owns it.From One Trial to a PortfolioThis is for you if your second and third programs are starting and the system that carried the first is straining.The Load-Bearing QuestionsThis is for you if you want to know which assumption is holding up the rest of the plan.
Find your situation

Or start from where you sit.

This index is the full inventory. Each page below carries only what bears on your position, with the engagements and terms that go with it.

Founder & emerging biotech → Clinical-stage & scaling → Established biotech & pharma → Boards & investors → Foundations & public health → Selected work →

Request a call