Strong science opens doors. A compelling compound, solid preclinical data, and a clear unmet need can secure a grant or attract initial interest. But funding socially responsible drug development from lab to patient requires more than that. Later-stage funders want proof that the full path is credible: regulatory strategy, clinical plan, CMC and manufacturing, and a realistic route to reimbursement and patient access. This article explains how to build a funding mix that works, and what to watch out for along the way.
This article is part of our series on socially responsible drug development. If you have not read the cornerstone guide yet, start there.
Why no single funder covers the full Journey
Funding only works when it matches the stage a project is in. Early on, the goal is reducing scientific and translational uncertainty. Later, the focus shifts to execution: CMC, clinical operations, regulatory work, and market access planning. That is why most projects need a mix of cash and in-kind contributions, and why sequencing matters. Each stage should reduce risk for the next.
Grants can fund early research and translation. But no grant programme funds the full journey from science to patient. Clinical development, regulatory work, and market access require additional sources of funding and expertise.
The same is true on the commercial side. Many financial venture capital investors focus on return on investment within a defined fund timeline. That can create tension with access-focused pricing commitments. Kang et al. (2024) found that venture-capital-funded drug development concentrates investment in high-return therapeutic areas such as cancer and neurology/psychiatry, in patterns that differ from NIH funding priorities and overall disease burden. Choosing the wrong funder at the wrong stage does not just waste time. It can push a project toward decisions that are hard to undo.
The layers of funding socially responsible drug development
Funding socially responsible drug development works best when you plan in stages. Each stage should reduce risk for the next.
Public grants are often the starting point. Programmes from ZonMW, disease-focused NGOs, EIC Pathfinder, and Horizon Europe can fund parts of the journey. But what they cover varies strongly by call, and the complexity sits in the details. EU programmes often describe scope in Technology Readiness Levels (TRL). EIC Pathfinder generally targets early-stage work, typically around TRL 1 to 4. Horizon Europe spans a wider range depending on the call. Many grants still exclude expensive later items such as CMC scale-up, GMP manufacturing, long regulatory trajectories, or market access preparation. Stacking grants adds constraints as well. Some funders prohibit co-funding the same activity from two public sources. Others require matched funding or specific consortium partners. Use grants to de-risk and build credibility, not to carry the full development plan.
In-kind contributions are always part of academic drug development. The science, infrastructure, and clinical networks rarely show up as cash, but they carry real value. For spin-offs and PPP ventures, the opportunity and challenge is to make that value explicit and usable for later funders. Academic centres may contribute disease expertise, cohorts, lab capacity, or access to trial sites. Product development partners may contribute CMC expertise and production capacity. These contributions reduce early cash needs, but only if you document them well. Agree upfront on scope, timing, data use, and decision rights.
Patient organisations can contribute on both sides. They bring funding, but also recruitment capacity, lived experience, and advocacy. Their involvement signals that the project addresses a recognised need. It can also strengthen endpoints and study design, which later funders care about.
Impact investors come in once enough de-risking is in place. They are not philanthropists. They want a credible business case, realistic projections, and evidence that access and pricing principles are embedded in the structure, not parked as future intentions.
What impact investors need to see
Impact investors do not only assess whether a project can become a medicine. They assess whether it can become an accessible medicine, and whether the team has built that goal into the structure. In socially responsible drug development, access and affordability must be operational and enforceable.
In practice, funders will expect clear answers on:
- Mission and safeguards: what access and pricing principles apply, and how are they protected if partners change?
- Team and partners: who owns clinical, regulatory, CMC, and access expertise today, and which gaps are covered by partners?
- Patient impact: what changes for patients if this succeeds, and how will impact be measured?
- Access path: how does the project move from authorisation to reimbursement and real uptake, and how do you prevent “approved but unavailable” outcomes?
- Economics under fair pricing: what does the model look like at a payer-defensible price, and what funding mix makes that feasible?
- Protection and freedom to operate: what reduces competitive risk without forcing a high-price strategy?
- De-risking plan: what milestones reduce the biggest risks next, and who pays for each milestone?
Underneath these questions sits one investor decision: does the project’s risk, timeline, and expected impact fit the investor’s mandate and portfolio, and is the access mission credible enough to survive scale-up?
How early choices shape later investability
The first funding round sets the pattern for everything that follows, both in the terms and conditions and in how later funders judge the project. If that round leaves core topics unclear, later investors often step back and the project stops moving forward.
Common gaps are practical. Decision-making is not defined, so it is unclear who can approve major spend or change the development plan. Access and pricing principles sit as intentions, not enforceable rules. Or the execution plan stays under-specified on CMC, regulatory, clinical, or reimbursement steps. Later investors then see avoidable governance and execution risk. They either demand a restructure first or do not invest at all.
This is why aligning all funders on access and pricing principles before they commit is not a formality. These principles belong in shareholder agreements or articles of association from the start, so they survive partner changes and later negotiations.
A real example of funding socially responsible drug development: Patient One
Patient One shows how these layers can work together. Tiofarma invested in-kind by taking on a substantial part of product development and producing clinical batches. Starodub contributed regulatory expertise in-kind. Rebel Group, Kidnie, The Kidney Foundation, and Fair Medicine covered out-of-pocket costs that in-kind contributions could not solve. From the start, the partners also embedded access and pricing principles into the company structure. That structural safeguard increases credibility for later investors, because it shows the mission is enforceable, not just aspirational.
How Orfenix can help
Mapping a funding mix, building a business case that satisfies mission-aligned investors, and structuring early agreements so they do not close doors later. This is work we do alongside academic teams from the start.
If you want to explore what a realistic funding structure could look like for your project, we would like to talk.
