Principal-led biopharma strategic advisory

Some decisions are only made once.

The opportunity may be clear, or a consequential problem may be unfolding. Either way, the path forward is seldom obvious.

I work with biopharma leaders on the decisions the standard playbook does not cover. They rarely sit inside one function. A regulatory question reshapes the trial, the trial reshapes the financing, and the financing decides what the company can become. My work is helping leadership see how those pieces depend on each other, so their decisions have the impact they intend.

Start a conversationSee how TMDG works
One decision, five considerations Science and patient at the top, regulatory strategy, capital and leadership below, all five on one connected ring around the decision. SCIENCE PATIENT CAPITAL LEADERSHIP REGULATORY THE DECISION
Nearly 30
years of biopharma executive accountability
$7B+
combined program and portfolio value across three organizations
20+
therapeutic areas, from vaccines to rare disease
5
regulators: FDA · EMA · MHRA · PMDA · TGA
Roberta Duncan, Founder and Principal of The Modeste Duncan Group

For nearly 30 years I made these decisions and carried their consequences from the inside, at Arcturus, CSL Seqirus, Shire, Bristol Myers Squibb and Kendle. I have argued for programs and I have stopped them. When a decision went wrong without any new information to explain it, the cause usually sat in the space between functions, where everyone assumed someone else was holding the whole. TMDG exists to restore or create the connective tissue that space needs.

Roberta Duncan
Founder & Principal
More about Roberta →

Built for the moments the standard playbook does not cover.

Whether it starts as an opportunity or a problem, TMDG is usually brought in when the well-worn path runs out in one of four ways.

The science opens new ground.

A new modality or platform, where the development, manufacturing and regulatory path has not been walked before.

The program needs a different model.

A therapy that works scientifically and does not fit the conventional asset model, such as ultra-rare, pediatric, one-time or global-health, so its structure, evidence and access have to be designed differently.

The decision reaches across functions.

What presents as a regulatory, portfolio or partnership question also changes development, capital and the organization.

The organization has to grow into what comes next.

Growth, a partnership or a new mandate asks more of the leadership team: new capabilities, clearer decision rights, and a structure that can carry the next stage.

Start from your momentBuilding something newPreparing to scaleLeading through growing complexityGoverning or investingAdvancing a mission

The most important questions rarely belong to one function.

A worked example

“Should we partner this program now, or build it ourselves?”

It sounds like a business development question. It is really five questions, one in each domain, and the answer to each one shapes the others.

  • SCIENCEWhat would the next data set change about what the program is worth?
  • PATIENTWhich path reaches patients sooner, and which reaches more of them?
  • CAPITALWhat does each path cost, and what does it return, and when?
  • REGULATORYWho is best placed to carry the regulatory path, and does a partner change it?
  • LEADERSHIPWhat does each choice ask the organization to become?

Each answer is reasonable on its own. The decision is the combination of science, evidence, capital, timing and organizational capacity that gives the program its strongest path forward.

Find the assumption the plan depends on.

Most consequential plans rest on one or two assumptions that have to be true. TMDG finds them, tests them against the evidence, and shows leadership what else changes if they do not hold.

“Our next financing will follow the Phase 2 readout.”
What if the runway ends first?
“The agency will accept this endpoint.”
What if it asks for a different evidence package?
“Patients will enroll at the rate the plan assumes.”
What if enrollment takes twice as long?
How TMDG works →
Selected work

Structures built where the standard model fell short.

Global vaccines company

Standing up a portfolio and program function

Strong functions with no connective tissue between them, and decisions being made in five places at once. The result was one portfolio view, explicit decision rights and a forum where trade-offs were actually made, built while the programs kept running.

Read the case → Ultra-rare disease

The shared-core model

Each ultra-rare disease affects too few patients to carry the fixed cost of its own program. The design builds one core once, so each new indication joins at marginal cost and the cost per program falls as more join.

Read the case → Nasdaq-listed mRNA company

Corporate strategy at platform scale

More credible directions than capital, under public-market scrutiny. The strategy concentrated where it counted and stopped early where it did not, and it held up in front of the board and investors.

Read the case →
All selected work →

A sensible way to start.

Start a conversation

No charge

A few sentences on what you are working through. I reply with the two questions I would ask first and the evidence that would settle them.

The Load-Bearing Diagnostic

Fixed fee · typically one to three weeks

A fixed-fee answer to the decision in front of you: those questions, answered against your actual assets, with a readout you can test and a summary written for your board.

Carry it forward

Fixed fee · scoped with you

TMDG works the decision through with you and your team, from plan to execution.

Working with TMDG →
Insights

Questions worth examining.

White paper

What if the science works and the economics do not?

When the Science Works and the Economics Do Not

Entity, access and risk financing when the numbers refuse.

Read the paper →
White paper

What if the runway ends before the readout?

Planning for the Readout

Cutting before you know the answer.

Read the paper →
White paper

What would change the platform thesis?

Reading a Platform Claim

Read-through, and the risk that travels with it.

Read the paper →
All insights →

What are you working through?

A finished brief is not needed. I read every message myself and reply with the two questions I would ask first. If I am not the right person, I will tell you who is.

Book a 30-minute call
☎+1 317 985 1613✉roberta.duncan@tmdgimpact.com

Roberta Duncan, Founder and Principal

Confidential, and NDA-first if you prefer.
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