For boards, investors & capital providers

When the science works and the economics don’t.

A tractable therapy, a population that cannot support a commercial model, and a mandate measured in reach rather than return. Closing that gap is a structure, capital, and access problem, and it is the work I have spent a career on.

Request a call Who you would be working with

The questions

Four questions that decide whether a mission-driven program ever reaches a patient.

Committed funding and good science get a program started. The structure that carries it through development, approval, manufacture, and delivery is what gets it to a patient, and that is where the hardest choices sit.

Who carries this after the grant ends?

Grant capital funds a phase. An entity, a balance sheet, and a named owner of record are what carry the program past the moment the tranche closes.

Entity and vehicle design · foundation and PBC structures · sustainability planning · asset stewardship after award

Is the capital stack built for the whole arc?

Blended finance works when each tranche is designed against a specific risk at a specific stage, so the obligations reinforce each other instead of colliding when a milestone moves.

Blended and non-dilutive capital architecture · grant and consortium positioning · milestone and tranche design · risk-financing structures

Will the regulator accept the evidence you can afford to generate?

Ultra-rare, pediatric, and global-health programs rarely support conventional trial designs. The evidence strategy is negotiated with the review division itself, which is where the achievable path gets defined.

Regulatory strategy for small populations · trial design and conduct under constraint · multi-agency and WHO pathways · expedited and priority review realism

Who is accountable when the consortium disagrees?

Multi-party programs live or die on governance. Funders, sponsors, manufacturers, and ministries each hold a veto, so the plan needs an owner and an agreed way to break a tie.

Public-private partnership architecture · consortium and alliance program leadership · decision rights and escalation · access and equity commitments

Why this is different

I have built these structures and stayed accountable for them.

Mission-driven programs attract a great deal of advice and very few people who have signed the agreements, carried the regulatory strategy, and stayed accountable when the manufacturing and access commitments came due.

Public-private capital, built and delivered

Built and delivered the infrastructure for a $451M COVID-19 development alliance spanning a global health funder, a vaccine alliance, and a sovereign government. Architected a cross-border public-private partnership representing approximately $1.3B in committed infrastructure, structured so that no single party carried the whole risk. That engagement was infrastructure, counted separately from the program and portfolio figures cited elsewhere.

Small populations, real approvals

Rare and specialty programs carried to approval across the FDA, EMA/CHMP, MHRA, PMDA, and TGA, including Breakthrough and Fast Track designations, a real-world evidence strategy negotiated directly with the FDA, and a Pediatric Written Request carried to completion.

Consortium programs, led

Led a multi-pathogen self-amplifying mRNA program through pivotal global milestones across sponsors, manufacturers, and regulators on three continents, and served as the accountable executive when funder priorities, supply constraints, and national commitments pulled in different directions.

Situations this covers

These open the matching situation on the main site.

When the science works and the economics don’t →Mission at scale →

Reading

Papers that take a position on the decision in front of you. Each is yours to read, quote and forward.

White paperThe science works, the model does not, and you are being told to walk away.When the Science Works and the Economics Do NotEntity, access and risk financing when the numbers refuse.Read the paper → White paperYour business case rests on a voucher you have not been awarded.The Zero-Dollar VoucherWhy the only defensible base case is $0.Read the paper →

Regulating the Cure →All insights →

How this works

Three shapes, depending on where you are.

01

Feasibility read

A structured read on whether a program can be built at all: the regulatory route for the population, the capital stack it would require, and the entity that would have to hold it. Delivered before a board or trustees commit.

Fixed fee · typically one to two weeks

02

Structure & capital build

The architecture itself: entity and vehicle design, blended and non-dilutive capital sequencing, access and equity commitments, and the governance that holds a multi-party consortium together once the money moves.

Fixed fee · typically four to eight weeks

03

Program leadership

Accountable leadership of the program itself across funders, sponsors, manufacturers, and ministries, including the integrated development plan, the regulatory strategy, and the decision cadence that keeps a consortium moving.

Retained · fractional or interim

How fees work. Fixed and agreed up front, so the cost is known before the work starts and the advice stays free of any stake in which way you go.

Questions funders ask

Before we start.

Do you work with organizations that are not companies?

Yes, and it is a large part of this work. Foundations, disease organizations, global-health funders, government programs, and academic consortia all run portfolios that need the same discipline a biotech portfolio needs, usually with harder constraints and less internal capacity to apply it.

We have the science and a funder. What is missing?

Usually the entity and the capital sequence. A funder can commit to a phase; someone still has to hold the asset, carry the regulatory strategy, contract the manufacturing, and be accountable when a milestone slips. That gap is where mission capital is most often lost, and it is the first thing I look at.

Can you work inside a consortium where no one party is in charge?

That is the normal condition of this work. Funders, sponsors, manufacturers, and ministries each hold a veto and none holds the plan. I design the decision rights and escalation path first, then run the program against them.

How do you handle access and equity commitments?

As design constraints from the start. Pricing, tiering, technology transfer, and volume guarantees shape the development and manufacturing plan, so building them into the architecture early is what makes them deliverable at approval.

Are your fees different for non-profits?

The structure is the same: fixed fee, agreed up front, so you know the cost before the work starts. Scope is what moves. Tell me the budget you have and I will show you what can be delivered inside it.

Who you would be working with

Roberta Duncan, Founder and Principal of The Modeste Duncan Group

Roberta Duncan, MBA

Founder and Principal, The Modeste Duncan Group

Every engagement runs on TMDG’s Load-Bearing Questions: two questions applied across the five domains that carry a decision. You get a firm’s method and a principal’s judgment on the same call.

Nearly 30 years in biopharmaceutical development, with accountability for programs and portfolios valued above $7B across three organizations
Former Chief Strategy Officer, Arcturus Therapeutics; Head of Portfolio & Program Management, CSL Seqirus
Programs advanced to approval with the FDA, EMA/CHMP, MHRA, PMDA and TGA
Executive Committee and Board Member, Alliance for mRNA Medicines

Full background →

Free · answered by me

The two questions I’d ask.

What is the decision in front of you? Two or three sentences is enough. I’ll come back with the two questions I would ask first, and what evidence would settle them. No pitch, no obligation. Give me enough context to be useful to your objective, and if we do speak afterwards, we both start ahead.

See the work itself

The decision instruments left behind: the scoring models, gating criteria and stress tests a committee can actually run.

De-identified case studies · challenge, design and outcome · no client named

The instruments

Not quite your situation?

Founder & emerging biotech →Clinical-stage & scaling biotech →Established biotech & pharma →Boards, investors & capital providers →

Get in touch

Tell me what you are trying to build.

A sentence or two on the program, the population, and the funding you have or expect is enough for me to tell you whether the structure is the problem, and whether I am the right person to help you build it.

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Confidentiality first. TMDG works NDA-first as a matter of course, with a written conflict check before any engagement begins. If I have a conflict, I will tell you at the outset.