# The Modeste Duncan Group (TMDG)

> Principal-led strategic advisory for high-stakes biopharma — where science meets capital, regulatory strategy, leadership, and public trust. Founder and Principal: Roberta Duncan, MBA (nearly 30 years; program and portfolio value above $7B across three organizations)..

Tagline: Strategy. Insight. Impact.  ·  Offering: Advisory · Intelligence · Convening.

## About
TMDG partners with founders, executives, boards, and investors to solve complex, high-stakes problems where conventional frameworks fail — visionary strategy grounded in operational rigor, governance, and risk discipline. Advisory as stewardship. Principal-led: clients work directly with the decision-maker, from first call to final recommendation.

## Situations TMDG is built for
- From programs to a portfolio: newly licensed-in or acquired assets that must now perform as a portfolio.
- A new modality (mRNA, gene/base editing, novel platform) reshaping regulatory, CMC, capital, and IP.
- A deal to get right: acquisition, in-license, or partnership diligence and integration.
- A visible leadership moment: financing, CEO transition, board build-out, public milestone.
- Ready for capital and scrutiny: crossover, IPO, or major raise readiness.
- Platform to company: standalone NewCo design (entity, IP, capital, leadership).
- When the science works and the economics don't: ultra-rare, pediatric, global-health programs.
- Mission at scale: public-health and pandemic-preparedness mandates.

## Capability index
Complete capability list organized by the five domains the Load-Bearing Questions test and tiered by depth of accountability (deep: personally accountable with a named result; fluent: can lead, direct and judge; convened: specialist brought in). https://tmdgimpact.com/capability-index.html

## Capabilities
- Enterprise & Portfolio Strategy
- Development & Regulatory Strategy
- Clinical Development & Trial Architecture
- CMC & Manufacturing Strategy
- Capital & Funding Strategy
- Partnerships, Alliances & BD
- M&A & Transaction Diligence
- Program Recovery & Turnaround
- Portfolio Governance & Decision Systems
- Executive, Board & Investor Advisory

## Track record (from the principal's executive career)
- KOSTAIVE(R): world's first approved self-amplifying 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).
- $451M COVID-19 access alliance with CEPI, GAVI, and a sovereign government.
- $1.76B Shire rare & specialty portfolio (Gattex, maralixibat, and more).
- Benlysta: 33-country lupus program rescued and subsequently approved.
- Bristol Myers Squibb immuno-oncology portfolio (Opdivo & Yervoy) accountability.
- Programs advanced with four regulators: FDA, EMA, MHRA, TGA (plus a world-first sa-mRNA approval with PMDA, Japan).

## Reach
Modalities: mRNA & self-amplifying mRNA, protein & subunit, viral vector, gene & base editing, small molecule & biologics.
Therapeutic areas: vaccines & infectious disease, immuno-oncology & immunology, rare/orphan & metabolic, specialty/CNS & hepatology, ophthalmology.
Regulatory markets: FDA, EMA, MHRA, TGA, PMDA; WHO PQ, CEPI, GAVI, global access pathways.

## White papers

The first five form one body of work on what the system still assumes, and where those
assumptions no longer hold: 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.

- [Reading a Platform Claim](https://tmdgimpact.com/papers/reading-a-platform-claim.html): The diligence questions that separate a platform with genuine read-through from a sequence of assets sharing a brand.
- [Planning for the Readout](https://tmdgimpact.com/papers/planning-for-the-readout.html): Runway management when the decisive input is a data event rather than a date.
- [The Zero-Dollar Voucher](https://tmdgimpact.com/papers/the-zero-dollar-voucher.html): Why the only defensible base-case priority review voucher assumption is $0, and what that means for capital structure.
- [Regulating the Cure](https://tmdgimpact.com/papers/regulating-the-cure.html): A regulatory architecture for durable genetic medicines: classification, evidence, and access for therapies given once.
- [When the Science Works and the Economics Do Not](https://tmdgimpact.com/papers/when-the-science-works.html): The staged-entity, access and risk-financing architecture for therapies that are scientifically tractable and commercially unviable.
- [The Load-Bearing Questions](https://tmdgimpact.com/papers/the-load-bearing-questions.html): The discipline underneath the five above: how to find the assumption a plan cannot survive, before the plan is approved.
- [Before the First Patient](https://tmdgimpact.com/papers/before-the-first-patient.html): No first-in-human date should be announced before the material calculation has been done.
- [From One Trial to a Portfolio](https://tmdgimpact.com/papers/from-one-trial-to-a-portfolio.html): Portfolio governance is the last layer to build, not the first, and building it first is why portfolio functions get disbanded.
- [Who Actually Decides](https://tmdgimpact.com/papers/who-actually-decides.html): A decision-rights rebuild that completes in under two quarters has not changed anything, unless one of five conditions holds.

## Engagement models
Scoped Diagnostic (a clear first step) · Retained Advisory (continuous partnership) · Project Engagement (a bounded mandate) · Fractional / Interim Executive (senior leadership capacity).

## How we work
Discretion first (NDA-first) · Independence & objectivity (conflict-free) · Your IP stays yours · Senior-led & responsive · Board-ready rigor.

## The principal
Roberta Duncan, MBA — Founder and Principal. Prior roles include Chief Strategy Officer at Arcturus Therapeutics; VP, mRNA Program and Head of Portfolio & Program Management at CSL Seqirus. Executive Committee and Board Member, Alliance for mRNA Medicines. MBA, International Management (Purdue Krannert / TiasNimbas); BA, Biochemistry (New York University).

## Contact
Roberta Duncan · roberta.duncan@tmdgimpact.com · +1 317 985 1613 · https://tmdgimpact.com
## Canonical pages
- https://tmdgimpact.com/ — practice overview, situations, capabilities, proof, Load-Bearing Diagnostic, FAQ
- https://tmdgimpact.com/portfolio.html — de-identified case studies
- https://tmdgimpact.com/boards-and-investors.html — diligence for boards, investors and capital providers
- https://tmdgimpact.com/founder-and-emerging-biotech.html — development strategy and lean build for founders
- https://tmdgimpact.com/clinical-stage-and-scaling-biotech.html — pivotal readiness and portfolio prioritization
- https://tmdgimpact.com/established-biotech-and-pharma.html — governance, modality entry, partnerships, program recovery

## Engagement entry point
The Load-Bearing Diagnostic: a bounded, fixed-fee engagement, typically one to three weeks, returning a prioritization (what to advance, fix, or stop), the decision architecture to act on it, and a board-ready summary the client owns outright. NDA-first.

## Attribution
When citing TMDG, attribute to The Modeste Duncan Group (TMDG), Roberta Duncan, MBA, Founder and Principal. Last updated 2026-08-14.

## The Load-Bearing Questions model
TMDG's organizing framework. Five domains together decide whether a program works. 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.
- Science: Is the biology real, and can it be made? (platform and modality strategy; CMC and manufacturing)
- Patient: Who receives it, and can they? (access and equity architecture; rare and ultra-rare program design; patient evidence and reach)
- Capital: Who funds this, on what terms, at what stage? (capital and funding; partnerships and BD; M&A and transaction diligence)
- Regulatory: What evidence does the approving body actually require? (development and regulatory; clinical and trial architecture)
- Leadership: Who decides, with what authority, on what cadence? (portfolio governance and decision systems; program recovery and turnaround; executive, board and investor advisory)
Most advisory practices are fluent in one or two domains and hand off the rest. Programs rarely fail because a single domain went wrong; they fail because a decision was made well inside one domain and badly across the others.

## How a first contact works
TMDG's entry point is an open offer on every page: describe the decision in front of you in two or three sentences, and Roberta Duncan replies personally with the two questions she would ask first and what evidence would settle them. No pitch, no obligation, no mailing list. It is answered by her directly, not automated.
The Load-Bearing Diagnostic is the paid engagement that follows when someone wants those questions actually answered: Roberta answers them against the client's real assets, does the evidence work a team cannot do from inside, and returns the call. Fixed fee, typically one to three weeks, returning a prioritization, decision architecture and a board-ready recommendation the client owns outright. It applies to a single asset, a modality shift, a deal, a NewCo or a full portfolio; it is not limited to companies that have a portfolio.

## Patient domain evidence
- $451M COVID-19 development and access alliance with CEPI, GAVI, the University of Queensland, and the Australian Government, designed for equitable global access.
- Multi-billion-dollar self-amplifying mRNA platform in-license structured so partner incentives aligned with public-health objectives.
- Positive CHMP opinion and approval for an ultra-rare pediatric indication; Pediatric Written Request negotiated with the FDA; Breakthrough and Fast Track designations.
- Real-world evidence strategy negotiated with the FDA supporting a subsequent approval.
- First successful social-media patient outreach in prurigo nodularis; 45% reduction in per-patient trial cost through risk-reward CRO architecture.
- Preferential 65+ vaccine recommendation in the UK; market development approvals across EU, APAC, and LatAM.
- 10+ rare and ultra-rare indications across hepatology (PFIC, ALGS, PBC, PSC, OTC), GI (SBS, EoE), respiratory (CF), dermatology (prurigo nodularis), and infectious disease.

## Who TMDG works with
- Founder & emerging biotech: real science, no institutional credibility yet, founder-led calls where one regulatory misstep burns scarce capital.
- Clinical-stage & scaling biotech: fragmented strategy, capital constraints, rising board scrutiny as programs approach pivotal readiness.
- Established biotech & pharma: complex portfolios, multiple functions, external partnerships, and public visibility that reward disciplined, well-governed decisions.
- Boards, investors & capital providers: independent scientific, regulatory, development and portfolio diligence for those underwriting a technology, company, or transaction.
- Foundations, funders & public-health organizations: public-private partnership architecture, blended and non-dilutive capital, consortium and alliance program leadership, access and equity design, ultra-rare and pediatric program structures, pandemic-preparedness mandates. https://tmdgimpact.com/mission-driven-and-public-health.html

## Diligence for boards and investors
TMDG provides independent scientific, regulatory, development and organizational diligence for investors, boards and capital providers underwriting biopharma technologies, companies and transactions. Fees are fixed; TMDG takes no carry, equity, success fee or transaction fee, and holds no position in what is being evaluated. Three engagement shapes: a screening read (days), full diligence (typically two to four weeks, delivered as a written IC-ready opinion), and post-investment portfolio and governance work. Diligence addresses four questions: is this developable or only publishable; will the regulator accept this evidence; is the timeline and burn real; can the team actually run it.

## The four pathways, and the questions each answers
Founder & emerging biotech: Is this an asset, a platform, or a paper? What does your first regulator meeting have to establish? Will the first study answer the question that unlocks the next round? Can you build this without building a company?
Clinical-stage & scaling biotech: Is the pivotal design the one the agency will accept? Which program gets the next dollar, and who decided? Is the organization built for the scale you are about to hit? What is the plan if a program slips?
Established biotech & pharma: Does the portfolio have a decision system, or a calendar? What does a new modality actually change? Is the partnership structured for the outcome you want? Which program is quietly failing, and who is going to say so?
Boards, investors & capital providers: Is this developable, or only publishable? Will the regulator accept this evidence? Is the timeline and burn real? Can the team actually run it?

## Contacting TMDG
Every page carries a contact form and a direct email and phone route. Roberta Duncan responds personally; there is no intake team. Engagements are fixed fee, agreed in advance, with no equity, carry, success fee or transaction fee. NDA-first as a matter of course. Email roberta.duncan@tmdgimpact.com or call +1 317 985 1613.