For founders & emerging biotech

Strong science, and one path that makes every dollar count.

You have biology worth backing and a runway measured in months. Every decision compounds: the indication you pick, the first study you design, the way you answer a regulator who has never seen your modality before. The mistakes are rarely obvious at the time. They surface eighteen months later as a trial that cannot answer the question your next investor will ask.

Request a call Who you would be working with

The questions

Four decisions that set the ceiling on everything after them.

At your stage, strategy is four choices that quietly determine whether the next raise happens.

Is this an asset, a platform, or a paper?

Founders often price a platform and sell an asset, or the reverse. What you actually have determines your first indication, your partnering posture, and what a sophisticated investor will pay for.

Developability assessment · platform versus asset value · indication selection · target product profile

What does your first regulator meeting have to establish?

A pre-IND is not an introduction. It is your one cheap chance to de-risk the assumptions that would otherwise cost you a year and a financing to discover.

Pre-IND strategy · IND-enabling package · briefing book and question design · novel-modality precedent

Will the first study answer the question that unlocks the next round?

A trial that is scientifically interesting and commercially uninformative is the costliest thing a small company can build. Endpoint and comparator choices decide this before enrollment starts.

First-in-human design · endpoint and comparator strategy · probability-of-success framing · investor narrative

Can you build this without building a company?

Most emerging biotechs hire a function when they needed a capability for nine months. The alternative is a virtual structure with senior experts around the asset rather than headcount around an org chart.

Lean / virtual development design · fractional CMC, regulatory and clinical experts · CRO and vendor architecture · spend sequencing

Why this read is different

I have built the lean version, and it worked.

Advice about capital efficiency is easy to give and hard to source. The model below was not theorised. It was built, run, and then adopted by someone else as standard practice.

A model a global CRO adopted

Pioneered a virtual-biotech outsourcing framework subsequently taken up as standard practice by a global contract research organization as its standard approach to biotech partnerships, achieving up to 45% per-patient cost reductions through risk-reward CRO architecture.

World-first programs, delivered early

Held asset accountability from preclinical through clinical at a clinical-stage company, leading the world’s first global uremic pruritus program to completion five months ahead of schedule, and the first successful social-media patient outreach in prurigo nodularis.

Regulators, from the first meeting on

Carried programs from pre-IND through approval with the FDA, EMA/CHMP, MHRA, PMDA and TGA, including expedited designations. I know what a first meeting has to accomplish because I have run the ones that went badly and the ones that did not.

I also serve on scientific advisory boards for early-stage companies, so I know what this looks like from your side of the table as well as from the buyer’s.

Situations this covers

These open the matching situation on the main site.

Platform to company →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 paperYour runway ends before your readout.Planning for the ReadoutCutting before you know the answer.Read the paper →

Before the First Patient →The Load-Bearing Questions →All insights →

How this works

Sized for a company that counts every month.

01

Founder session

A half-day working session on the decision in front of you, with a written summary. Deliberately candid. Most founders use it to assess next steps.

Fixed fee · one session · written follow-up

02

Development plan build

The full path from where you are to your next value inflection: indication, regulatory strategy, study design, CMC sequencing, and what it costs. Built to withstand a diligence process, because it will face one.

Fixed fee · typically three to six weeks

03

Fractional development leadership

Interim CDO or head of development capacity, plus the virtual expert bench around your asset, for companies that need senior judgment before they can justify a senior hire.

Retained · part-time · scoped by month

On stage. I work with pre-seed and pre-formation teams, and I will tell you plainly if the honest answer is that you are not ready to spend money on advice yet. That conversation costs you nothing and has saved founders a great deal.

Questions founders ask

Before we start.

We are pre-Series A. Can we afford this?

Sometimes yes, sometimes no, and I will say which. The founder session exists precisely so you can get real value at a price that does not distort your runway. If a full development plan is not affordable this quarter, I would rather tell you what to do yourself than sell you something you cannot use.

Do you take equity instead of fees?

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

Will you speak to our investors?

Yes, and it often helps. I can walk a board or a prospective investor through the development plan and defend the assumptions in it.

Do you replace our CRO or consultants?

No. Most emerging companies do not have a CRO problem, they have a specification problem, and a CRO will build exactly what you asked for even when what you asked for will not answer the question.

Are you willing to tell us to stop?

Yes, and I have. A recommendation to stop, delivered early is worth more than an approval pathway for something that was never going to make it.

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 platform was structured so ultra-rare programs could exist at all, and how a venture was built to hold both mission capital and equity.

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

Platform & venture architecture

Not quite your situation?

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

Get in touch

Tell me what you are building.

A few sentences on the science, the stage, and the decision in front of you. If I am not the right person, I will usually know who is.

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.