MRC Developmental Pathway Funding Scheme: How to Win Big Funding for Translational Health Interventions (Stage Two)

If you’ve made it to an invitation for Stage Two of the Medical Research Council’s Developmental Pathway Funding Scheme (DPFS), you’re not just in the game — you’re in striking distance.

This is one of the UK’s flagship pots of money for turning promising biomedical ideas into real-world interventions: therapeutics, medical devices, diagnostics, digital tools, and other health-related innovations that could actually reach patients.

The headline everyone notices first:
There’s no formal upper limit on the funding request.

That doesn’t mean “ask for the moon and see what happens.” It does mean this scheme is built for serious, properly costed translational projects that often don’t fit into neat, tiny grant boxes. If your work sits anywhere along the developmental pathway — from early candidate refinement through pre-clinical studies all the way to early-phase clinical trials (up to phase 2a) — this is the funding mechanism the MRC expects you to know inside-out.

But here’s the catch:

• You must have been invited to Stage Two.
• You must be based at an organisation eligible for MRC funding.
• And you must treat this like a major, high-stakes bid, because that’s exactly what it is.

This article is for you if you’ve:

• Just received the Stage Two invitation
• Are supporting a PI who has
• Or are planning ahead for future rounds and want to understand what “Stage Two” will involve if you make it that far

Let’s break it down so you can submit something that doesn’t just tick boxes, but competes at the top of the pile.

Developmental Pathway Funding Scheme (DPFS) Stage Two at a Glance

What This Opportunity Really Offers

This isn’t a “buy some reagents and see what happens” grant. DPFS is designed to move interventions along the pipeline toward patients.

Concretely, this scheme can support:

• Novel therapeutics

  • Small molecules, biologics, gene therapies, RNA-based interventions, cell therapies
  • Activities like candidate selection, optimisation, pharmacology, safety studies, formulation

• Medical devices and diagnostics

  • Class I/II/III devices, in vitro diagnostics, point-of-care tests, digital or software-as-a-medical-device tools
  • Prototyping, usability studies, validation, regulatory readiness, clinical performance evaluations

• Other interventions

  • Non-pharmaceutical strategies that still require rigorous development and testing (for example, complex interventions with mechanistic underpinnings and tangible deliverables)

Because it supports projects anywhere from early refinement through phase 2a, a single DPFS award might cover, for example:

• IND/CTA-enabling pre-clinical package for a novel drug
• Manufacturing scale-up plus first-in-human trial for a biologic
• Design freeze, regulatory engagement, and early clinical validation of a diagnostic
• Human factors testing and pilot clinical evaluation for a device

The no upper limit aspect is crucial. It means:

• You can budget realistically for GMP manufacturing, GLP toxicity studies, regulatory consultancy, clinical trial costs, trial management, patient recruitment, and the messy-but-essential operational bits that normally blow up small grants.
• You can think in terms of what’s needed to move the asset to a clear go/no-go decision point, not “what can we squeeze into £250k.”

Of course, “no limit” doesn’t mean “no scrutiny.” Oversized, bloated budgets without a razor-sharp rationale will die quickly. But if you can show:

• A clear development plan
• A line of sight to patient or population benefit
• Sensible costing aligned with that plan

…then this scheme can provide exactly the scale of support you need.

You also gain:

• Credibility with industry and investors – DPFS funding tells partners that your project has survived a serious translational review process.
• Stronger positioning for later-stage funding – both from MRC (e.g. Developmental Clinical Studies) and from other public or private funders.

In short: this is big, strategic money for teams that know where they’re going.

Who Should Apply (and Who Shouldn’t)

First, the basics:

You’re eligible to apply for Stage Two if:

• You have been explicitly invited following a successful Stage One outline or prior sift.
• You’re employed by an organisation eligible for MRC funding, such as:
  • UK universities
  • Certain NHS bodies with research capacity
  • MRC units and institutes
  • Approved independent research organisations

You’re a strong fit for this scheme if:

• You have a specific intervention, not just a general area of inquiry

  • “We want to develop Drug X targeting Y pathway for Z disease” is good.
  • “We want to understand mechanism A in disease B” without a tangible intervention is not.

• Your project sits on the developmental pathway, not at basic discovery

  • You’re past the initial “interesting target” or “cool biomarker” stage.
  • You’re at the “we now need to turn this into something usable for patients” stage.

• You can show a plausible route to clinical use or commercialisation

  • A regulatory path (even high-level)
  • Understanding of your comparator or standard of care
  • A realistic view of market or adoption potential

Examples of ideal applicants:

• A translational team with a lead small molecule ready for IND-enabling toxicology and formulation, aiming for a phase 1 trial.
• A clinician–engineer partnership with a novel class II medical device that’s gone through early prototyping and now needs design finalisation and a first human study.
• A lab with a promising diagnostic signature that’s been shown in retrospective cohorts and now needs prospective clinical validation.

Who probably shouldn’t be here (yet):

• Pure mechanistic or basic science projects with no defined product or intervention. Those belong in standard response-mode grants, not DPFS.
• Teams who can’t articulate a development plan beyond “we’ll do more experiments”.
• Applicants who haven’t done even basic freedom-to-operate or IP thinking. You don’t need patents granted, but you do need to show awareness of the IP situation.

If you read the DPFS brief and think, “Our idea is interesting but nowhere near translatable yet,” that’s a sign to seek earlier-stage funding first, then come back to DPFS when you have a robust, defined asset.

Insider Tips for a Winning Stage Two DPFS Application

Stage Two is where the serious triage happens. Everyone invited has something promising; the question is who can actually deliver.

Here are the things that make or break applications:

1. Tell a development story, not just a science story

DPFS reviewers expect you to think like a developer, not just an investigator.

Bad:
“We will test X in models Y and Z and see what happens.”

Better:
“We will complete these specific studies to generate the data required for regulatory submission and to make a go/no-go decision on progression to a phase 2 trial.”

Explicitly show:

• Where your project starts on the pathway
• Where it will end by the end of the grant
• What decision point it will enable (e.g. “ready for phase 1 trial,” “ready for CE marking,” “ready for industrial partnership”)

2. Nail the justification for your requested budget

With no formal cap, the budget becomes a sharp diagnostic tool for reviewers:

• Overly modest budgets for obviously expensive work (e.g. clinical trials, GMP manufacturing) scream “naïve planning.”
• Overblown budgets with vague justifications scream “lack of discipline.”

Treat the budget as a narrative:

• Show a logical flow of costs tied to work packages.
• Include realistic figures for regulatory, trial management, monitoring, and data management – the unglamorous but essential parts.
• Flag any co-funding, in-kind support, or institutional contributions clearly.

3. Respect the “80% FEC” model

MRC typically funds 80% of full economic cost. That means:

• You cost the project at its full institutional rate.
• MRC pays 80%; your organisation covers the remaining 20%.

Don’t breeze past this with a shrug and hope your finance office fixes it at the last minute. Engage with them early so:

• Figures are accurate.
• Internal sign-off doesn’t stall your submission the week of the deadline.

4. Be brutally honest about risks and mitigation

Translational projects are inherently risky. Pretending otherwise looks amateurish.

For each major risk, spell out:

• What could go wrong (scientific, technical, regulatory, recruitment, IP, manufacturing).
• The likelihood and impact.
• Your mitigation strategy and, where appropriate, plan B.

Reviewers are far more comfortable funding a team that says “Here’s what we’re worried about and how we’ll handle it” than one that pretends everything is straightforward.

5. Show the right team (and missing skills plugged by partners)

DPFS is rarely a solo sport. Strong applications often include:

• A PI with domain expertise and translational experience (or a very strong mentor team if early-career).
• Clinical collaborators if there’s any patient-facing work.
• Access to regulatory, trial management, statistics, and data management expertise.
• Industry partners where relevant (even informal advisory links help).

If you lack a skill set, don’t hide it. Show who will provide it and how (collaboration, contract, advisory board, etc.).

6. Use Stage One feedback as a blueprint

If you’re at Stage Two, you’ve already given MRC a sketch of the idea.

• Re-read any Stage One feedback like it’s a sacred document.
• Show clearly how you’ve addressed concerns, tightened aims, or reframed the project.
• Don’t resubmit the same idea slightly polished – reviewers remember.

7. Build in measurable, credible milestones

DPFS is milestone-driven. Don’t just have a vague timeline; have:

• Specific, measurable milestones tied to go/no-go points.
• Clear contingency plans if a milestone fails.
• A sense of what “success” actually looks like at each stage (regulatory-ready package, validated device performance, recruitment targets met, etc.).

Application Timeline: Working Back from 4 March 2026

Assuming the current Stage Two deadline is 4 March 2026 at 16:00, here’s a realistic backward plan.

December 2025 – Early January 2026: First full draft

• Draft all core sections: case for support, workplan, milestones, budget justification, ethics/regulatory considerations.
• Get a skeleton Gantt chart and milestone table in place.
• Involve your clinical and operational partners now — not a week before submission.

Mid-January – Early February 2026: Refinement and external review

• Circulate the full draft to:
  • A translational colleague outside your exact niche
  • Someone who has previously held DPFS or similar MRC translational funding
  • Your research office for structure and compliance
• Strengthen:
  • Route to impact
  • IP and exploitation plan
  • Risk management

Early–Mid February 2026: Budget and institutional approvals

• Lock the detailed budget with your finance office (including 80% FEC calculations).
• Confirm costs for external providers (CROs, GMP manufacturers, trial units).
• Ensure internal approval processes (which can have their own earlier deadlines) are fully satisfied.

Mid–Late February 2026: Final polish

• Tighten language: remove waffle, clarify aims, ensure consistency between sections.
• Double-check that every expensive element has a visible, rational place in the workplan.
• Confirm all required attachments (CVs, letters, protocols, etc.) are complete.

By 2 March 2026: Submit early

• Aim to submit at least 48 hours before the 16:00 deadline.
• Late submissions typically don’t get sympathy, even for technical glitches.
• After submission, check confirmation emails carefully to ensure everything went through.

Required Materials and How to Prepare Them

Exact requirements are listed in the Funding Service, but you can expect something along these lines:

1. Case for Support / Project Description

This is the heart of your application. It should clearly explain:

• The intervention and target indication.
• Why it matters clinically or for public health.
• Current standard of care and your differentiation.
• The development plan, broken into coherent work packages.
• Timelines, milestones, and go/no-go points.

Use diagrams, timelines, or flow charts where they genuinely clarify the story.

2. Detailed Workplan and Gantt Chart

Show:

• Work packages with clear objectives.
• Dependencies between tasks.
• When key regulatory or clinical steps will occur.
• How you’ll sequence high-risk work (ideally early enough that you don’t waste money if it fails).

3. Budget and Justification

Include:

• Staff costs (with roles and responsibilities).
• Major equipment or service costs (CROs, manufacturing, regulatory consultancy).
• Trial-related costs (if applicable): recruitment, monitoring, data management, insurance.
• Justification that ties each line item to specific work packages.

4. CVs / Track Records

Highlight:

• Relevant translational experience.
• Prior industrial/clinical collaborations.
• Previous funding showing you can manage complex projects.
• For early-career PIs, emphasise mentors and team strength.

5. Letters of Support / Collaboration

These shouldn’t be generic “X is excellent” letters. They should:

• Confirm concrete commitments: access to facilities, contribution of in-kind resources, recruitment sites, trial unit support.
• Be specific about roles and resources.

6. Ethics, Regulatory, and IP Statements

You’ll need to address:

• Ethical issues (especially for clinical or human samples).
• Regulatory route (MHRA, device classification, CE/UKCA marking plans where relevant).
• IP ownership, current filings, and exploitation strategy.

What Makes a DPFS Stage Two Application Stand Out

Reviewers are effectively asking: “Is this the right project, with the right team, at the right time, with the right plan?”

They will focus heavily on:

1. Translational clarity

• Is there a clearly articulated intervention?
• Does the proposed work move it meaningfully closer to adoption?
• Is there a plausible route to patients, including regulatory and commercial steps?

2. Clinical and public health importance

• Is the unmet need significant?
• Are you solving something more interesting than just “incremental convenience”?
• Is there potential for medium-to-large scale impact, if successful?

3. Feasibility and realism

• Does the timescale make sense for the proposed work?
• Are risks acknowledged and managed?
• Does the team have the necessary skills, or explicit access to them?

4. Value for money

• Does the budget align with the ambition and complexity of the project?
• Are you clearly avoiding gold-plating while not under-resourcing critical steps?
• Are milestones structured so that further investment decisions can be made sensibly?

5. Team and environment

• Is this project located in an environment with the right infrastructure (labs, trial units, regulatory know-how)?
• Are key collaborators engaged, not just named?

Applications that tick these boxes and read like serious project plans, not wishlists, tend to rise quickly.

Common Mistakes to Avoid (and How to Fix Them)

1. Vague or shifting target product profile

If reviewers can’t tell what you’re actually trying to develop, they lose patience.

Fix:
Write a concise “target product profile” in plain English: who it’s for, what it does, how it’s delivered, how it improves on current practice.

2. Underestimating clinical or regulatory complexity

Many applications act as if ethics, MHRA approval, or device classification are minor footnotes.

Fix:
Show you’ve spoken to the right people (trial unit, regulatory expert, device specialist) and built their advice into your timeline and budget.

3. Treating the budget as an afterthought

Rushed, round-number budgets with no detail undermine the whole proposal.

Fix:
Cost from the bottom up. Anchor each major cost in a specific work package and justify briefly but clearly.

4. Overambitious scope

Trying to “do everything” — full pre-clinical, phase 1, and phase 2a — in one grant with limited capacity.

Fix:
Focus on a realistic stretch: a well-defined piece of the pathway that gets you to a clear decision point. Save the next stages for later applications.

5. Ignoring Stage One feedback

If you were warned about something at Stage One and haven’t addressed it, that’s a red flag.

Fix:
Explicitly signpost where you’ve responded: “At Stage One, reviewers queried X; we have now done Y and incorporated Z to address this.”

Frequently Asked Questions

Do I really have no upper funding limit?

There’s no fixed cap, but that doesn’t mean “anything goes.” MRC expects:

• A rigorous justification for every major cost.
• Costs to be in line with the kind of work you’re proposing (clinical trials and GMP are expensive; basic in vitro work is not).

If you’re heading into seven-figure territory, your argument for value and feasibility needs to be especially sharp.

Can early-career researchers be PIs?

Yes, in principle — but:

• Translational projects are complex, so MRC will look carefully at your support structure.
• If you’re early-career, it helps enormously to have:
  • A strong co-investigator team
  • Clear mentorship
  • Evidence that you can manage substantial projects (or that your environment can support you to do so)

Can I include industry partners?

Absolutely, and often that’s a strength, provided:

• The collaboration arrangements are clear and fair.
• IP and exploitation plans are transparent.
• The academic team still has sufficient control to deliver the objectives.

What if I need more than one round of DPFS support?

That’s not uncommon. You might, for example:

• Use one DPFS award for pre-clinical work.
• Then a later one for early-phase clinical work.

The critical thing is that each application stands on its own merit, with clear objectives and milestones.

What’s the difference between Stage One and Stage Two?

• Stage One: typically a shorter, outline-level pitch to check fit, significance, and broad feasibility.
• Stage Two: a full, detailed application with comprehensive plans, budgets, milestones, and supporting documentation.

By Stage Two, reviewers expect something that looks and feels like a polished, fundable project plan.

Can non-UK collaborators be involved?

Yes, they can be collaborators or subcontractors, but:

• The lead organisation must be eligible for MRC funding (usually UK-based).
• Funding to overseas partners must be well justified and proportionate.

How to Apply (Next Steps and Official Link)

Because this is an invited Stage Two process, you can only apply if MRC has already requested a full application from you following Stage One.

Here’s how to move from “invited” to “submitted with confidence”:

1. Read the official guidance carefully

   • Start with the UKRI page for this call:
     • Developmental pathway funding scheme: invited stage two
   • Then log into the UKRI Funding Service for the detailed section-by-section instructions.

2. Coordinate early with your research office

   • Confirm internal deadlines, which can be well before 4 March 2026.
   • Get help with the 80% FEC costing and institutional sign-offs.

3. Map your developmental pathway explicitly

   • Sketch your start and end points on the pathway.
   • Decide on milestones and go/no-go criteria before you write long prose.
   • Sense-check this with your clinical, regulatory, or industrial advisors.

4. Draft, review, and iterate

   • Produce a first complete draft at least 6–8 weeks before the deadline.
   • Seek critical feedback from people who’ve held translational or MRC funding.
   • Refine, tighten, and remove anything that doesn’t directly serve the development story.

5. Submit early and confirm receipt

   • Aim to submit at least 48 hours before 4 March 2026, 16:00.
   • Save all confirmation emails and PDFs.

If you have questions about eligibility, the online system, or the scheme itself, you can contact:

• Technical / funding service queries: [email protected]
• Scheme-specific scientific queries: [email protected]
• Policy or programme-related questions: [email protected]

Ready to go deeper and start your Stage Two application?
Head straight to the official opportunity page:
Apply or read full details on the MRC DPFS Stage Two page.