For clinical-stage & scaling biotech

More promising programs than capital, and a board that wants a clear line of sight.

The science worked well enough to get here, which is exactly what makes the next phase exciting. Every program has an advocate, none has been formally stopped, and the pivotal study now costs more than the last two rounds combined. What used to be resolved in a hallway now needs a decision system, because the board has begun asking why the sequencing looks the way it does.

Request a call Who you would be working with

The questions

Four questions that decide whether you reach the readout with capital left.

At this stage the binding constraint is almost never scientific. It is that four questions are being answered implicitly, by momentum, rather than explicitly, by decision.

Is the pivotal design the one the agency will accept?

There is usually a gap between the study the regulator would endorse and the study the current budget permits. Closing that gap before enrollment opens is worth far more than finding it at end-of-Phase-2.

Integrated clinical development planning · protocol and trial design · pivotal readiness review · endpoint and comparator defensibility · agency engagement and submission strategy across regions · expedited-pathway realism

Which program gets the next dollar, and who decided?

Prioritization without a system defaults to whoever advocates hardest. A stage-gate architecture makes the tradeoff explicit and, critically, makes it defensible to a board that will ask.

Portfolio prioritization · stage-gate design · probability-of-success frameworks · portfolio councils · capital-efficient sequencing

Is the organization built for the scale you are about to hit?

A team that ran three sites well is not automatically a team that can run a hundred and twenty across a dozen countries. That transition breaks more programs than the underlying biology does.

Global trial operations and conduct oversight · program leadership and integrated program teams · portfolio and program management capability · vendor and CRO architecture · operating model and decision rights · program-leader development

What is the plan if a program slips?

Slippage is not the risk. Unplanned slippage is. The question is whether a six-month delay in one asset is absorbable or triggers a financing you did not intend to run.

Scenario and runway modeling · program recovery · resequencing · board and investor communication

Why this read is different

I have run the phase you are entering, at portfolio scale.

Pivotal transitions and portfolio triage are not adjacent to my experience. They are the substance of it, on assets carrying real revenue expectations and real regulatory scrutiny.

A rare and specialty portfolio, led

Led a $1.76B rare and specialty portfolio at Shire, including Gattex, from development through approval. Secured Breakthrough and Fast Track designations, a positive CHMP opinion for an ultra-rare pediatric indication, and a real-world evidence strategy negotiated with the FDA.

Programs recovered, first-hand

Led project rescue on a 33-country lupus study that had lost its footing, and global trial leadership on programs that became Eylea and Benlysta. Recovery work is a specific discipline, and it is one I have actually done.

The decision systems themselves

Built enterprise portfolio strategy and governance including probability-of-success frameworks, stage-gate systems, and portfolio councils, and stood up the portfolio and program management organization that ran them, with the career architecture underneath it.

As an Executive Committee member I partnered directly with CEOs and boards on exactly these tradeoffs, which means I know how the recommendation has to be built to survive the room it enters.

Situations this covers

These open the matching situation on the main site.

From programs to a portfolio →Ready for capital and scrutiny →A visible leadership moment →

Reading

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

White paperYour therapy works once and the framework assumes chronic dosing.Regulating the CureClassification, evidence and access for a therapy given once.Read the paper →

From One Trial to a Portfolio →All insights →

How this works

Three shapes, depending on what is binding.

Pivotal readiness review

An independent assessment of whether the pivotal plan will hold: design, endpoints, feasibility, agency posture, operational capacity, and cost realism. Delivered as a written opinion with the gaps named and ranked.

Fixed fee · typically three to five weeks

Portfolio prioritization sprint

The full triage: what advances, what is fixed, what stops, with the stage-gate architecture and decision criteria that make the answer repeatable after I leave.

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

Retained portfolio counsel

Ongoing senior counsel to the CEO and the board through the transition, including governance cadence, program recovery where needed, and interim leadership capacity.

Retained · board and observer roles considered

On the awkward part. Portfolio work usually produces at least one recommendation that somebody in the building will not welcome. I will bring it to you privately first, with the reasoning, so you decide how and when it enters the room.

Questions clinical-stage teams ask

Before we start.

We already have consultants and a CRO. Where do you fit?

During the assessment, I sit independently from them. Afterwards, I sit across from them in support of achieving critical objectives. Specialist advisors answer the questions they are asked within their function. The problems at this stage tend to sit in the seams, where a regulatory assumption and an operational assumption contradict each other and nobody owns both.

Will you work directly with our board?

Yes, and often that is the point. I have sat on the executive side of that table for years and I build recommendations to withstand board scrutiny.

Can you do this without destabilizing the team?

That is a real risk and worth planning for explicitly. I work with your program leaders rather than around them, and in my experience teams are usually relieved when the tradeoffs finally get named out loud. I will not conduct an assessment that is functionally a performance review in disguise.

What if the honest answer is to stop a program?

Then that is the recommendation, with the reasoning and the reallocation attached. A stop decision made deliberately, twelve months early, is one of the highest-return decisions available to a company at your stage.

Do you take interim or fractional roles?

Yes. Interim development or portfolio leadership through a transition is a common shape, particularly where you need senior capacity now and the permanent hire is six months out.

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 cluster IND, a real-world evidence and long-term follow-up design, and an incentive strategy were built for programs the standard route could not carry.

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

Regulatory, evidence & development strategy

Not quite your situation?

Boards, investors & capital providers →Founder & emerging biotech →Established biotech & pharma →Foundations, funders & public health →

Get in touch

Tell me where the pressure is.

The programs, the constraint, and the date by which a decision has to be made. That is enough for me to tell you whether this is a three-week piece of work or something else entirely.

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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.