Developability Assessment

A clearer view of
the path ahead.

Connect the evidence behind your next development decision. DEP reviews how your molecule’s properties, solid form, formulation, and absorption may affect the path forward, then prioritizes the uncertainties and work that matter most.

Prefer a short video? Learn how the Developability Assessment can help.

Watch the overview to learn when an assessment fits, what DEP reviews, and what you could receive. Select Play below to begin.

When it fits

When you need to define or review the development path.

Use an assessment to shape a new program, before a substantial development commitment, during technical diligence, after acquiring an asset, or when an active program’s direction has become uncertain.

We work with you to define the decision the assessment should support and tailor the review to your program’s stage and available evidence. A narrow technical question may be better served by Focused Technical Support.

Evaluation scope

Connected science. A practical decision.

01

Molecular properties

Review physicochemical evidence such as ionization, lipophilicity, solubility, and precipitation risk.

02

Biopharmaceutics

Evaluate evidence on permeability, dissolution, absorption, and potential exposure limitations.

03

Translation to development targets

Examine exposure and dose assumptions, relevant PK evidence, and the uncertainties in extrapolating to the intended clinical use.

04

Formulation strategy

Assess the rationale and evidence for the proposed formulation, alternatives, stability, and practical development constraints.

05

Solid-state strategy

Review solid-form selection, polymorph risk, characterization, crystallization, and implications for manufacturing.

06

Development integration

Connect the findings to analytical, process, manufacturing, and regulatory planning needs within the agreed scope.

What you provide

Start with the evidence you have.

Start with the data you have. A complete dossier is not required.

Bring the evidence you have ? Existing reportsProgram goalsOpen questions Your starting evidence package
Start with what’s available. DEP helps identify the gaps.
  • Program goals and target product profile, if available.
  • Relevant physicochemical, solid-state, formulation, analytical, and PK reports.
  • Any current development plan, provider proposals, or work in progress. If no plan exists, bring the program objectives and evidence available.
  • Known uncertainties, constraints, upcoming milestones, and decision deadlines.

DEP identifies missing information during scoping. Confidential material is shared only through an agreed process after appropriate arrangements are in place.

Tangible deliverables

A record you can use to make decisions.

01

Executive decision brief

The question, evidence considered, principal findings, options, and recommended next decision.

02

Prioritized risk and gap register

Technical concerns, underlying assumptions, and missing evidence, prioritized by their potential effect on the development decision.

03

Development roadmap

Focused next steps, dependencies, and decision points, including what new evidence would justify changing the plan.

04

Review of findings and recommended next steps

A discussion with your team, including any proposed specialist review, experiments, or provider requirements within scope.

What follows

You choose how to proceed.

Your team can act on the findings, commission focused work to address a gap, or engage DEP for ongoing leadership.

The recommendation may be to advance, modify the approach, obtain additional evidence, pause, or stop. An assessment supports judgment using the available evidence; it cannot guarantee technical feasibility or a development outcome. Continuation is optional and separately scoped.

Sample deliverable

Examples of what you could receive.

Illustrative outline only—not an actual client document or result. Content and depth depend on the agreed scope and available evidence.

Illustrative deliverable · Not client data

A roadmap for your next development decision

Example question: What evidence do we need before choosing a formulation?

1 · What we know

Existing solubility and solid-form reports provide a starting point.

2 · What remains uncertain

The effect of particle size on dissolution has not yet been compared under relevant conditions.

3 · What to do next

Agree a focused comparison, define how results will inform the decision, and review the findings with DEP’s experts.

Decision supported

Choose the next formulation step—or identify the additional evidence needed before proceeding.

The assessment is tailored to the molecule, available data and agreed scope. This example illustrates the format, not a study recommendation.

Explore the approach and expertise

See how the work connects.

Read a fictional illustration of the team’s reasoning. It demonstrates an approach, not a client result or a fixed service package.

See a development-planning example →

Relevant expertise

Profiles describe relevant experience. The people involved, their availability, and their roles are confirmed for each engagement.

Before you spend, be sure™.

Start with the decision you need to make.

Tell us what you need help with, the question you have, or the milestone you’re working toward. DEP can help define the next steps and coordinate the work.

Drug Engine Pharma

You can contact DEP without sharing technical details.