Advisory  ·  Intelligence  ·  Convening

Some decisions are only made once.

When the science is ready but the strategy, structure, or capital isn’t, that’s the gap I close. A principal-led advisory for the founders, executives, boards, and investors facing biopharma’s highest-stakes decisions that engender Trust, where science meets patients, capital, regulatory strategy, and leadership.

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The Load-Bearing Questions Five domains ring a single decision. Science and patient are emphasised at the top of the ring; capital, regulatory strategy and leadership sit below them as enablers. SCIENCE PATIENT CAPITAL LEADERSHIP REGULATORY THE DECISION
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Who brings me in

Where are you on the arc?

You’re holding a decision the standard playbook doesn’t cover. A newly acquired portfolio that now has to perform. A new modality reshaping your regulatory and capital path. A platform that has to become a company. When the science works but the economics don’t, that is the work.

Founder & emerging biotech

Strong science, an ambitious runway, and founder-led decisions where getting the regulatory path right early protects every dollar that follows.

If this is you

Clinical-stage & scaling biotech

Several promising programs, finite capital, and a board that wants a clear line of sight as you approach pivotal readiness.

If this is you

Established biotech & pharma

Complex portfolios, multiple functions, external partnerships, and public visibility that reward disciplined, well-governed decisions.

If this is you

Boards, investors & capital providers

A technology, company, or transaction to evaluate, and a need for an independent read from someone who has run the work.

If this is you

Foundations, funders & public health

A mandate measured in access and impact, where the science is tractable and the model still has to be built.

If this is you

The TMDG capability index provides insight into the greater depth and breadth of our expertise.

The through-line. Whatever the stage, I integrate science, regulatory strategy, capital, and leadership to surface risk early, build credibility, and guide the decision, with discretion and a human hand. See the eight situations →

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.

Straight to me, not a list. Confidential, and I reply personally.
From the founder

You’ll work directly with me.

Hi, I’m Roberta Duncan. For nearly thirty years I sat in the rooms where biopharma’s hardest decisions get made, accountable for the portfolios, the programs, and the people behind them. The same gap kept opening: the science was ready, but the strategy, structure, or capital wasn’t. Patients waited on the other side of it.

I built The Modeste Duncan Group to close that gap. A practice built so you work directly with me. Named collaborators come in for specialist scope and shape the answer with me. The accountability for it stays mine. You get an architecture built for your situation. What carries over from thirty years is judgment about where to look. The answer itself gets built here.

If you’re carrying one of those, I’d genuinely like to hear about it.

Roberta Duncan
Founder & Principal
Roberta Duncan, Founder and Principal, The Modeste Duncan GroupRD
28+
YEARS
$7B+
PROGRAM & PORTFOLIO VALUE
1st
OF ITS KIND
$4.6B
PROGRAM
5
CONTINENTS
A strong, diverse foundation.
Experience spanning
Arcturus Therapeutics·CSL Seqirus·Bristol Myers Squibb·Shire·CEPI·GAVI·Alliance for mRNA Medicines
Start here

One clear first step: the Load-Bearing Diagnostic.

TMDG’s entry engagement: bounded, fixed-fee, and designed to hand you a decision you can act on.

What it is

It starts from one question: what would have to be true for this to work? Then I go and find out, on the situation in front of you: your portfolio, a modality shift, a deal, a NewCo, a program where the economics don’t yet close. Deep, fast, and on your side of the table.

What you walk away with
  • A clear-eyed readout: what to advance, what to fix, what to stop
  • A decision architecture you can act on
  • A board-ready summary you own outright
Scope & terms

Fixed fee, agreed up front. You know the cost before the work starts. Typically one to three weeks, start to readout. NDA-first; your IP stays yours.

Request a call →

No open-ended relationship first. If you have already sent me the decision in front of you, this is what comes next. I answer those two questions against your actual assets, do the evidence work you cannot do from inside, and hand you the call.

When leaders reach out

Situations I am built for.

Different presenting problems, one operating discipline. These are the shapes the work usually takes; if yours isn’t here, it is still worth a conversation.

01

From programs to a portfolio

Newly licensed-in or acquired assets that must now perform as a portfolio.

02

A new modality

mRNA, gene or base editing, a novel platform, reshaping regulatory, CMC, capital, and IP at once.

03

A deal to get right

An acquisition, in-license, or partnership only as good as its diligence, and its integration.

04

A visible leadership moment

A financing, CEO transition, board build-out, or public milestone that defines credibility.

05

Ready for capital and scrutiny

A crossover, IPO, or major raise that turns every assumption into a diligence question.

06

Platform to company

Spinning a platform, asset, or program into a standalone NewCo from a blank sheet.

07

When the science works and the economics don’t

Ultra-rare, pediatric, and global-health programs that need structures the default playbook lacks.

08

Mission at scale

Public-health and pandemic-preparedness mandates spanning funders, regulators, and governments.

Don’t see your situation here? That’s still the conversation. Tell me the decision in front of you: if I can help, I’ll show you how, and if I can’t, I’ll point you to someone who can.

Request a call
The Load-Bearing Questions

Five domains decide whether a program works.

Five domains carry any decision. Two questions test whether each one is answered from evidence: what impact do you want to have, and what would have to be true. That is the Load-Bearing Questions, TMDG’s operating model. The capability index sets out everything that sits under each one.

I

Science

Is the biology real, and can it be made?

Platform & Modality Strategy

What the platform can actually carry, and what a new modality changes.

PROOF · As Chief Strategy Officer of a Nasdaq-listed self-amplifying mRNA company, set platform, pipeline, and partnership strategy across a multi-program portfolio.

CMC & Manufacturing

Making sure the science can be made, at quality, cost, and scale.

PROOF · Advanced first-of-its-kind sa-mRNA products from platform through approval and launch.
II

Patient

Who receives it, and can they?

Access & Equity Architecture

The structures that get a therapy to people the default market will not serve.

PROOF · Led the $451M COVID-19 development and access alliance with CEPI, GAVI, the University of Queensland, and the Australian Government; structured a multi-billion-dollar platform in-license whose terms aligned partner incentives with public-health objectives.

Rare & Ultra-Rare Program Design

Small populations, thin evidence, and economics the standard model cannot close.

PROOF · Secured a positive CHMP opinion and approval for an ultra-rare pediatric indication; negotiated a Pediatric Written Request with the FDA; Breakthrough and Fast Track designations across rare and high-unmet-need indications.

Patient Evidence & Reach

Finding the patients, and generating evidence a regulator will accept from them.

PROOF · Negotiated a real-world evidence strategy with the FDA supporting a subsequent approval; ran the first successful social-media patient outreach in prurigo nodularis; cut per-patient trial cost by 45% through risk-reward CRO architecture.
III

Capital

Who funds this, on what terms, at what stage?

Capital & Funding

Non-dilutive, blended, and public-health capital matched to each asset.

PROOF · Structured non-dilutive, blended, and partnered capital across vaccines and rare disease with sovereign, foundation, and multilateral funders including CEPI, GAVI, and BARDA.

Partnerships & BD

The right partner, on the right terms, managed well.

PROOF · Led the ARCT–CSL partnership behind KOSTAIVE®, the first approved sa-mRNA vaccine.

M&A & Transaction Diligence

Independent, technically grounded diligence, and what comes after.

PROOF · Assessed multi-party pipelines across CSL, BMS, and Shire.
IV

Regulatory

What evidence does the approving body actually require?

Development & Regulatory

Target product profiles, pathways, and novel-modality precedent.

PROOF · Secured Breakthrough and Fast Track designations; advanced programs with the FDA, EMA, MHRA, TGA, and PMDA.

Clinical & Trial Architecture

First-in-human through pivotal, designed to answer the right question.

PROOF · Delivered the world’s first successful programs in uremic pruritus (five months ahead of plan) and prurigo nodularis; led the rescue of a 33-country SLE program.
V

Leadership

Who decides, with what authority, on what cadence?

Portfolio Governance & Decision Systems

The operating system for running a portfolio with discipline.

PROOF · Designed a global vaccines company’s product operating model and Program Governance Committee.

Program Recovery & Turnaround

A clear-eyed read on a struggling program, and a path forward.

PROOF · Led the project rescue of a 33-country trial subsequently approved as Benlysta.

Executive, Board & Investor Advisory

Helping leaders earn the trust of boards, investors, regulators, and partners.

PROOF · Executive Committee and Board Member, Alliance for mRNA Medicines; advisor to CEOs and boards.

Deep fluency in one or two of these is common; holding all five at once is rarer. The situations I am called into almost never turn on a single domain. They turn on a decision made well inside one and left unresolved across the others. Science and patient are the two ends of the arc: what the thing is, and who actually receives it. Capital, regulatory strategy, and leadership are how you get from one to the other. Enterprise and portfolio strategy is the discipline of holding all five at once.

See the de-identified case studies →

Clinical and trial architecture sits in two places at once: the trial has to be scientifically sound, and it has to answer the regulator’s question. I file it under Regulatory because that is the question that decides the label.

How I work

One path from inventory to roadmap.

01

Diligence

Technical, regulatory, CMC & IP read on each asset.

02

Prioritize

Lead, fast-follow, or partner, and sequence the spend.

03

Roadmap

Stage- and indication-appropriate development & regulatory plans.

04

Capital

Non-dilutive and partnered funding matched to each asset.

05

Govern

Decision architecture and stage-gates to run with discipline.

The Load-Bearing Diagnostic runs this path in compressed form, on the one decision in front of you, and returns a prioritization, stage-appropriate roadmaps, and a capital map. Retained work takes it the rest of the way.

Proof · track record

This is not theoretical advice.

Every line below is a decision I was accountable for, at a scale where being wrong was measured in billions of dollars, years of development time, and patients who kept waiting. That is what you are hiring.

KOSTAIVE®
World’s first approved sa-mRNA vaccine, via the ARCT–CSL partnership.
$4.6B
Multi-pathogen sa-mRNA program advanced through pivotal global milestones.
$1.4B
Global influenza franchise (seasonal and pandemic), stewarded end to end.
$451M
COVID-19 access alliance with CEPI, GAVI, and a sovereign government.
$1.76B
Rare & specialty portfolio: three products at Shire, including Gattex.
Benlysta
33-country lupus program rescued and subsequently approved.
Opdivo & Yervoy
BMS immuno-oncology portfolio accountability.
5 regulators
FDA · EMA · MHRA · TGA · PMDA. Programs advanced, approvals secured.
Roberta Duncan serving as guest panel moderator at mRNA: A Key to National Security, an Alliance for mRNA Medicines forum, Washington DC, January 2025
Guest panel moderator, mRNA: A Key to National Security · Alliance for mRNA Medicines, Washington DC · January 2025.An Alliance for mRNA Medicines forum convening senior leaders from defense, intelligence, public health and biotechnology. Hosted by AMM; moderated by invitation.
See the de-identified case studies →Selected proof of the experience behind the work.
Reach

Fluent across modalities, therapeutic areas, and markets.

Fluency across the platforms, the disease areas, and the regulators that decide whether any of it reaches patients.

MODALITIES

  • mRNA & self-amplifying mRNA
  • Protein & subunit
  • Viral vector
  • Gene & base editing
  • Small molecule & biologics

THERAPEUTIC AREAS

  • Vaccines & infectious disease
  • Immuno-oncology & immunology
  • Rare & ultra-rare (10+ indications)
  • Hepatology: PFIC, ALGS, PBC, PSC, OTC
  • GI, renal, dermatology, CNS & more

REGULATORY MARKETS

  • FDA (US) · EMA (EU)
  • MHRA (UK) · TGA (Australia)
  • PMDA (Japan)
  • WHO PQ · CEPI · GAVI
  • Global access pathways
“

TMDG connects the domains others treat as silos: science, patients, capital, regulatory strategy, and leadership. My work is turning that whole picture into a path leadership can act on.

The Modeste Duncan Group
Who you work with

Roberta Duncan, MBA

FOUNDER AND PRINCIPAL
You work directly with the decision-maker, from the first call to the final recommendation.

A senior biopharmaceutical executive with nearly 30 years leading enterprise portfolio strategy, governance, and development across vaccines, therapeutics, rare disease, and pandemic preparedness. Executive accountability for programs and portfolios valued above $7B across three organizations, and partnerships spanning CEPI, GAVI, BARDA, sovereign governments, and industry.

IN HER WORDS

“The load-bearing questions have to be asked across all five at once, where science, patients, capital, regulatory strategy, and leadership intersect. That is the discipline I built TMDG around, and my job is to find the move others miss. Getting it right is never abstract to me: it decides whether a therapy reaches the people waiting for it.”

Selected credentials
  • Former Chief Strategy OfficerArcturus Therapeutics
  • Former VP, mRNA ProgramCSL Seqirus · Head, Portfolio & Program Mgmt
  • Executive Committee & Board MemberAlliance for mRNA Medicines
  • Scientific Advisory BoardAMPTIV Biosciences · Intelisci
  • MBA, International ManagementPurdue (Krannert) · TiasNimbas
  • BA, BiochemistryNew York University
How we engage

Three ways in.

However you come in, you leave with the same three things: a decision you can act on, evidence that holds up in a board room, and a structure that still works after I have gone.

The three

Advisory

You get a call you can defend, made with someone who has carried one like it before. Retained or project: strategy, structure, regulatory and capital architecture, board-level counsel.

Intelligence

You can judge the thinking before you commit to it. Nine published papers, free to read, quote and forward.

Convening

The parties who have to agree get to a position each of them can hold. Funders, sponsors, regulators and governments, and governance that survives the first disagreement.

Roberta Duncan serving as guest panel moderator at Building RNA Medicine Excellence, hosted by Franklin Biolabs and the Alliance for mRNA Medicines, Philadelphia, June 2026
Guest panel moderator, Building RNA Medicine Excellence · Philadelphia, June 2026.Hosted by Franklin Biolabs and the Alliance for mRNA Medicines; moderated by invitation. Other participants are obscured for privacy.
Insights

What the system still assumes.

Five papers, five assumptions the science has outgrown. That programs on a platform fail independently. That a plan has one future. That a voucher is an asset. That dosing is chronic. That a revenue base exists. Each paper takes one and tests it.

White paper You are being asked to fund a platform and you want to know whether it is one. Reading a Platform Claim Read-through, and the risk that travels with it. Read the paper → White paper Your runway ends before your readout. Planning for the Readout Cutting before you know the answer. Read the paper → White paper Your business case rests on a voucher you have not been awarded. The Zero-Dollar Voucher Why the only defensible base case is $0. Read the paper → White paper Your therapy works once and the framework assumes chronic dosing. Regulating the Cure Classification, evidence and access for a therapy given once. Read the paper → White paper The science works, the model does not, and you are being told to walk away. When the Science Works and the Economics Do Not Entity, access and risk financing when the numbers refuse. Read the paper →

Every paper carries a request form. The questions come back shaped to the decision you describe. Roberta Duncan replies personally.

The method, and three papers on execution

The five above are about why good science fails commercially. These four are about doing the work.

The Load-Bearing Questions Finding the assumption a plan cannot survive. Framework → Before the First Patient No IND date before the material calculation. White paper → From One Trial to a Portfolio Portfolio governance is the last layer to build, not the first. White paper → Who Actually Decides Decision rights are conceded, never installed. White paper →
Before you reach out

Questions people ask first.

Will I actually work with you, or a team of associates?

You work directly with me. TMDG is principal-led by design, so the person who hears the problem is the person who solves it. When a mandate needs specialist hands, I bring in collaborators I know and trust. They shape the answer with me, and the accountability for it stays mine.

Is the two-questions offer the same thing as the Load-Bearing Diagnostic?

Same method, two depths. Send me the decision in front of you and I will come back with the two questions I would ask first and the evidence that would settle them. That costs nothing. The Load-Bearing Diagnostic is me answering those questions against your actual assets and handing you the call, with the decision architecture behind it. Most people start with the two questions and find that one or two of them need real work to answer.

How do you protect confidentiality and our IP?

NDA-first, always. Your IP stays yours. Engagements are structured so what you own walking in, you own walking out, with no work-for-hire capture of your assets. Discretion is the default, not an add-on.

Do you charge fees, or take equity?

Primarily fee-for-service: retained, project, or the fixed-fee Diagnostic above. Where it genuinely aligns interests, equity or success-based structures are available by mutual agreement. The first conversation carries no obligation.

How do you handle conflicts of interest?

I keep engagements conflict-free and independent. If I can’t take something on cleanly, I’ll tell you up front, and where I can, point you to someone who can. Objectivity is the product.

Will you work with pre-seed or pre-formation teams?

Yes. Some of the most valuable work happens before the entity exists, when the structure, IP, capital plan, and leadership are still being set. Getting those right early is far cheaper than fixing them later.

What if we already have advisors, a bank, or a board?

Good. I complement them. I sit on your side of the table on the strategy, structure, and decision architecture that bankers and generalist consultants don’t own, and I’m comfortable being the independent voice in a board or investor room.

How does a first engagement start?

A 30-minute discovery call about the decision in front of you, no pitch. If there’s a fit, the usual next step is the fixed-fee Load-Bearing Diagnostic, which gives you something to act on before any larger commitment.

Book a call

Request a discovery call.

Pick a time that works and it is booked.

Email or call directly and I’ll send two or three times that work, usually the same day. Calls are 30 minutes, held under NDA if you prefer.

Email directly Call +1 317 985 1613
Or send a message

Tell me the decision.

Tell me about the decision in front of you. You’ll talk with me directly. The first conversation is a discovery call: no obligation, full discretion.

Goes straight to me. No list, no sequence, no third party.
☎+1 317 985 1613 ✉roberta.duncan@tmdgimpact.com
I read every message myself. — Roberta
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