For established biotech & pharma

The capability is already in the building. The decision is what is stuck.

You are not short of expertise. You are short of a mechanism that lets expertise resolve into a decision, across functions that each hold one piece of it and none of the whole. Add a modality nobody in the building has taken to a regulator before, a partnership whose incentives were never really aligned, and a program that many people privately have doubts about, and the constraint becomes obvious. It is not capability. It is judgment that spans the seams.

Request a call Who you would be working with

The questions

Four questions that reward a clear answer, and that scale tends to slow down.

Scale does not remove these questions. It distributes them across enough functions that no single owner ever holds the whole answer.

Does the portfolio have a decision system, or a calendar?

Many portfolio processes are review rituals: well attended, thoroughly documented, and slow to redirect. The test is simple: when did this system last stop a program that had a senior advocate?

Governance and decision architecture · stage-gate systems · portfolio councils · probability-of-success frameworks · prioritization criteria

What does a new modality actually change?

Bringing in a new modality (for example, mRNA or editing) into an established organization reshapes regulatory precedent, CMC and comparability, supply, IP, and the internal capabilities you assumed were transferable.

Modality entry strategy · novel-modality regulatory precedent · CMC and comparability · capability gap assessment · build versus partner

Is the partnership structured for the outcome you want?

Most partnership disappointment traces back to terms that aligned on price and diverged on incentive. That is a structuring problem, and it is far cheaper to solve before signature than after.

In-licensing and partnership structuring · public-private partnership design · CDMO strategy · transaction diligence · alliance governance

Which program needs an honest reassessment, and who will say so?

Large organizations rarely lack the information. They lack a person with standing, no stake in the outcome, and no reporting line into the function that would be embarrassed by the answer.

Independent program assessment · recovery and turnaround · resequencing · executive and board counsel · interim program leadership · integrated development replanning

Why this read is different

I have held these decisions from inside the executive committee.

As the executive accountable for the portfolio, the partnership, and the modality transition inside them.

Platform and franchise scale

Chief Strategy Officer at a Nasdaq-listed self-amplifying mRNA company, leading a $4.6B multi-pathogen program. Previously head of portfolio and program management for a global influenza business, including a $1.4B franchise and a $1.5B self-amplifying mRNA platform.

Partnerships that had to hold

Oversaw diligence and structuring of a multi-billion-dollar sa-mRNA platform in-license spanning COVID-19, influenza, pandemic preparedness and three further respiratory pathogens, with transaction architecture aligning partner incentives with public-health objectives. Oversaw a BARDA-funded H5N1 preparedness program and a $451M alliance with CEPI, GAVI and a sovereign government.

Regulators, in parallel

Delivered pediatric age-indication expansion across the FDA, CHMP, MHRA and TGA simultaneously, and secured a preferential 65+ recommendation in the United Kingdom. At BMS, accountable across ipilimumab, nivolumab and daclatasvir submissions.

On many occasions, I have been the internal advocate arguing for a program and the executive who had to stop one. Both experiences inform how I frame a recommendation for an organization that has to live with it afterwards.

Situations this covers

These open the matching situation on the main site.

A new modality →A deal to get right →From programs to a portfolio →

Reading

Two papers drawn from operating work at scale, as supporting evidence for the capability above.

Who Actually Decides →From One Trial to a Portfolio →All insights →

How this works

Scoped to a function, a transaction, or a transition.

Governance design

An assessment of how portfolio decisions are actually made, followed by the stage-gate architecture, criteria and cadence that let the organization stop things. Built to be run by your people, not by me.

Fixed fee or phased · typically six to ten weeks

Modality or transaction workstream

A defined piece of work on a specific question: entering a new modality, structuring an in-license or partnership, assessing a target, or designing a public-private arrangement.

Fixed fee · scoped to the question

Independent program assessment

A candid read on a program under pressure, delivered to the executive sponsor or the board, with a recovery plan or a stop recommendation and the reasoning behind whichever it is.

Fixed fee · typically three to six weeks · board-ready

On independence. The value of an outside read is that it has no reporting line. I will agree the sponsor and the disclosure path with you at the outset.

Questions large organizations ask

Before we start.

We have internal strategy and a PMO. Why bring in an outsider?

For two things internal teams structurally cannot supply: a view that crosses functions without carrying any of their incentives, and precedent from organizations you do not compete with. Where your internal capability is genuinely sufficient, I will say so rather than manufacture a mandate.

How do you handle conflicts with competitors in our space?

A written conflict check before engagement, and I decline where a live relationship touches your programs.

Can you work through procurement and a standard MSA?

Yes. I work under client paper routinely, including standard master services agreements, data protection terms and compliance onboarding. Fees are fixed and scoped in advance, which usually makes the procurement path straightforward.

What happens to the intellectual property in the work?

Deliverables prepared for you are yours. Pre-existing frameworks and methodologies remain mine and are licensed to you for use. That boundary goes in writing before the work starts so nobody discovers it later.

Will you work under our program leadership?

Where that is the right structure, yes. For independent assessments it usually is not, because a read that reports into the function being assessed is not independent. We agree the reporting line at the outset.

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

How a portfolio and program function was stood up inside a global vaccines business, and how corporate strategy was set at platform scale.

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

Enterprise leadership & team building

Not quite your situation?

Boards, investors & capital providers →Founder & emerging biotech →Clinical-stage & scaling biotech →Foundations, funders & public health →

Get in touch

Tell me what is stuck.

The decision, the functions involved, and what has already been tried. Confidentiality first, and under your paper if you prefer.

Prefer not to use a form?

Email directly Call +1 317 985 1613

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.