Is your consortium ready for the FP7 call?

The European Commission announces its FP7 health call for proposals on Wednesday this week, with millions earmarked for rare disease research. If you haven’t set up a consortium to answer this call, you should definitely get cracking asap. FP7 proposals are tough and time consuming, and you need an excellent set of partners, including academia, industry (preferably small or medium sized enterprises – SMEs) and of course patient groups.

The most interesting sub-call for rare disease patient groups is the one on preclinical and/or clinical development of orphan drugs. This provides up to 6m euros in funding, including for phase 3 clinical trials. I’ve enclosed below text from the draft of the call for proposals that was circulated a few weeks ago.

We’ve already put together an excellent AKU consortium, which brings together industry, SMEs, academia, hospitals and patient groups from across Europe and the USA. We’ve developed a strong plan of action for the development of an orphan drug for AKU. But we know it’s going to be super competitive.

If you’re also going to apply to FP7, do get in touch so we can exchange ideas and advice.

Extract from FP7 draft call for health proposals: Preclinical and/or clinical development of substances as orphan drugs

-preclinical studies in models (PK.PD, toxicology..)

-clinical studies in humans (safety, efficacy)

-will fund Phase III

Max €6million/project. Max 10 projects. 30% must go to industry or SMEs

Support will be provided to preclinical studies (pharmacological, pharmacodynamics, pharmacokinetics and toxicological) in models and/or clinical studies (including phase III clinical trials) of EU designated orphan medicinal products. Clinical studies should focus on biopharmaceutical studies (including bioavailability, bioequivalence, in vitro-in vivo correlation), human pharmacokinetic and pharmacodynamic studies, human efficacy and safety studies. Clinical trials must be appropriately powered to produce statistically significant evidence. Involvement of industry, in particular SMEs, is strongly recommended. Diagnostics and therapies for cancer and nervous system diseases will not be considered. The orphan medicinal product will need to be granted the EU orphan designation at the latest on the date of the call closure. It is expected that the project will have appropriate plans to engage with relevant stakeholders such as patient organisations and the European Medicines Agency. Projects funded under this topic should contribute towards the goals of the International Rare Diseases Research Consortium (IRDiRC) that include the development of 200 new therapies for rare diseases by 2020. The partners in all projects selected for funding should adhere to IRDiRC policies.

Note: Limits on the EU financial contribution apply. These are implemented strictly as formal eligibility criteria.

Funding scheme: Collaborative Project (small or medium-scale focussed research project). One or more proposals can be selected.

Expected impact: Projects should deliver appropriate information toi) start clinical development of orphan drugs (if the project includes preclinical development) and/or ii) improve care of rare diseases patients (if the project includes clinical development). Collected data should be of sufficient quality to be further exploited in marketing authorisation requests.The projects should contribute to the International Rare Disease Research Consortium (IRDiRC) goals.