Approach

Model-informed development, integrated across the whole program

Modeling is usually bought one analysis at a time, after the study is designed. We start from the program instead: we look for every point where a model can change time, cost, risk or the chance of success, choose the strategy, build the models and take the evidence to the agencies.

Discuss your program See the packages

Four steps, one team

You can start at any step. The same pharmacometrician stays with the program from the scan to the agency meeting.

01

Scout

We read the program as a reviewer and as a development team would: the clinical development plan, the nonclinical and clinical data, the target product profile, the regulatory history and what competitors have published.

The scan runs on our proprietary evidence system, which weighs your data against the scientific literature, agency guidances and years of public regulatory decisions, approvals and rejections alike. We list every point where modeling could change the plan, and say plainly where it would not.

You get
An opportunity map: each opportunity with its lever, the decision it informs, the data it needs, and its expected impact and effort
We need
The development plan and the data or reports you already have, under NDA
02

Strategize

For the opportunities worth taking, we write the question of interest and the context of use, draft the ICH M15 assessment (model influence, consequence of a wrong decision, model risk), and sequence the work against the clinical plan so each model is ready before the decision it serves.

We also plan the regulatory interactions: which questions go to which meeting, and in what form.

You get
A model-informed strategy and regulatory interaction plan, with a draft M15 assessment for each question and a fixed price for each piece of work
Time and fee
Scout and Strategize together form the MIDD Strategy Sprint: 5 working days, at a fixed fee credited toward the work that follows
03

Implement

We build the models: population PK, exposure-response, PBPK, concentration-QTc, mechanistic PK/PD, model-based meta-analysis and clinical trial simulation. The analysis plan is approved before modeling starts.

Every run is logged and re-executed, the analysis dataset is double-programmed, and every deliverable goes through quality control before it reaches you.

You get
The model analysis plan, the models, the model analysis report, the completed M15 assessment table, the verification package, and all code and data
Time and price
Fixed price per question, paid at two milestones. Up to 6 weeks from a clean dataset
04

Deliver

We write the modeling sections of briefing documents, place the reports in the eCTD, prepare your team for FDA and EMA meetings, including requests to the FDA MIDD Paired Meeting Program and EMA scientific advice, and join the meeting when useful.

When the agency asks about our analyses, we answer.

You get
Briefing-document sections, eCTD-ready reports and datasets, and support through the interaction
Included
Agency questions on our analyses answered at no extra cost. New analyses are quoted at a fixed price before we start

What we look for

Every opportunity in a scan is tied to one of four levers, so you can weigh them against each other.

Accelerate

Reach decisions sooner

Models in the plan before the data arrive, so the decision follows the readout instead of a new analysis cycle.

  • First-in-human dose and escalation
  • Phase 2 dose from Phase 1 exposure
  • Pediatric plan drafted from adult PopPK
  • Formulation and route bridging
Reduce

Fewer, smaller studies

Where guidances allow modeling to answer the question, a clinical study can be replaced, reduced or resized.

  • Concentration-QTc in place of a TQT study (ICH E14/S7B)
  • PBPK for DDI questions (ICH M12)
  • Virtual bioequivalence (ICH M13A)
  • Sparse sampling, organ impairment
Improve

Better doses and designs

Quantify the trade-offs before you commit: dose, regimen, sample size, sampling and population.

  • Exposure-response for efficacy and safety
  • Dose optimization for Project Optimus
  • Clinical trial simulation
  • Covariate-based dose adjustment
Benchmark

Know where the asset stands

Put the asset next to standard of care and competitors, or audit the work that is already done.

  • Model-based meta-analysis
  • Effect size needed to differentiate
  • Due diligence for licensing
  • Audit of an inherited model against M15

Good moments to call

A scan is most useful a few months before a decision, while the plan can still change.

Before the IND or CTA

Starting dose, escalation and the modeling sections of the submission.

Before an end-of-phase meeting

Dose rationale, the questions to ask, and the model-informed evidence behind them.

Before a protocol is final

Doses, sample size and sampling tested by simulation, while they can still change.

Before filing

PopPK and exposure-response reports, datasets and code, ready for review.

During due diligence

An independent read on the PK, dose and exposure-response data of an asset.

After an agency question

A model-based answer, documented to the M15 framework.

Any asset, any stage

The methods follow the question and the data, not the modality. We have worked across small molecules and biologics, in innovative and generic programs.

  • Small molecules
  • Peptides
  • Monoclonal antibodies
  • ADCs
  • Antisense oligonucleotides
  • Complex generics
  • Biosimilars
  • Oncology
  • Immunology
  • Rare and metabolic disease
  • Infectious disease
  • Neuroscience

We guarantee the date and the documentation standard, never regulatory acceptance. How the work is checked →

Start with the scan

A 15-minute call with the pharmacometrician who would lead the work. A fixed proposal follows within 48 hours.

Discuss your program Pricing