For boards, investors & capital providers

A read that is independent of the people selling it.

You are being asked to underwrite a technology, a company, or a transaction. The management team is fluent, the data room is organized, and the scientific case is presented by the people who need you to believe it. What you are missing is someone who has actually run programs like this one, on the other side of the table, and who has no stake in the answer.

Request a call Who you would be working with

The questions

The four questions that decide the investment, and rarely get answered honestly.

Most diligence establishes that the science is interesting. The read you need establishes something harder: that the program can be built, approved, funded, and reach a patient.

Is this developable, or only publishable?

Compelling biology and a viable development program are different assets. The gap usually sits in CMC, comparability, scale, or delivery, and that is where the value is won or lost.

Developability assessment · CMC and manufacturability risk · platform versus asset value · technical kill criteria

Will the regulator accept this evidence?

Novel modalities carry little settled precedent, so the evidence plan has to be built for the review division that will actually assess it.

Regulatory pathway risk · endpoint and comparator credibility · expedited-designation realism · multi-agency divergence

Is the timeline and burn real?

The most common failure in a biotech model is not the science. It is a clinical plan whose enrollment assumptions, site footprint, and CRO structure make the stated timeline arithmetically impossible.

Trial feasibility · enrollment and site assumptions · CRO and vendor architecture · cost-per-patient benchmarking · probability of success

Can the team actually run it?

A founding team that has published brilliantly and never filed an IND is a specific, assessable risk. So is a portfolio with no prioritization discipline and no stage gates.

Organizational capability · governance and decision architecture · gap assessment · hire and fractional-support plan

Why this read is different

I have sat on the side you are evaluating.

The most useful diligence comes from someone who has carried a program to a regulator. I have been the person accountable when the plan met the review division, the manufacturing site, and the enrollment curve.

Transactions, closed and integrated

Oversaw diligence and structuring of a self-amplifying mRNA platform in-license that became a multi-billion-dollar agreement across COVID-19, influenza, pandemic preparedness, and three further respiratory pathogens. Led diligence on CDMO strategic partnerships at double-digit-million scale. Led due diligence, acquisition, and integration of a global CRO’s Phase II–IV unit.

Regulators, in the room

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

Valuation inputs you can model

Supported the external-innovation strategy of a global pharmaceutical company running development across multiple business units, contributing valuation and probability-of-success assessments on acquisition candidates. Built two profit-generating service units end to end, securing 16 service awards valued at $30–50M within two quarters of approval. I have written the numbers a committee underwrites.

Fees are fixed and agreed up front, and I hold no position in what you are evaluating. That independence is what makes the read worth having.

Situations this covers

These open the matching situation on the main site.

A deal to get right →Ready for capital and scrutiny →

Reading

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

White paperYou are being asked to fund a platform and you want to know whether it is one.Reading a Platform ClaimRead-through, and the risk that travels with it.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 →

When the Science Works and the Economics Do Not →All insights →

How this works

Three shapes, depending on where you are.

Screening read

Days, not weeks. A fast technical and regulatory read on whether an opportunity merits the cost of full diligence, and the two or three questions that should decide it.

Fixed fee · typically under a week

Full diligence

Scientific, regulatory, development, and organizational assessment against the four questions, delivered as a written opinion with the risks named, ranked, and priced in time and capital.

Fixed fee · typically two to four weeks · written for your investment committee

Post-investment

Portfolio prioritization, stage-gate governance, and board-level counsel for a company already in the book, including program recovery where a thesis is intact but execution is not.

Retained or project · board and observer roles considered

On conflicts. I run a written conflict check before any engagement and will decline where a live advisory relationship touches the target. If I have worked with a company in your pipeline, you will hear it from me before you hear it from them.

Questions investors ask

Before we start.

Do you take carry, equity, or a success fee?

Fees are fixed and agreed up front, so the cost is known before the work starts and the read stays independent of which way you go.

How fast can you turn a read around?

A screening read is usually days. Full diligence is typically two to four weeks depending on data-room depth and how much management access I get. If your timeline is shorter than that, say so at the start and I will tell you honestly what can and cannot be established in the window.

Will you talk to the management team directly?

Yes, as it usually improves the read considerably. Sessions with members of the team have the potential to provide insight into what they believe, what insights they have gleaned from what has actually been tested, and to surface key nuances.

What do we actually receive?

A written opinion you own outright: the thesis as I understand it, the risks named and ranked, what would have to be true for the investment to work, and what evidence would settle each open question. Plus a call to walk your investment committee through it.

Can you serve on the board afterwards?

Yes, on a case-by-case basis. Let us discuss early in our engagement.

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 →Foundations, funders & public health →

Get in touch

Tell me what you are underwriting.

A sentence or two on the asset, the stage, and your decision date will aide in determining whether there is potential conflict with my other work prior to entering into an NDA.

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.