1 - Introduction

Promising pre-clinical nano-medicine proof-of-concepts have been developed for the therapy of cancer, but their translation into clinical therapies remains a major challenge. An important bottleneck is up-scaling under Good Manufacturing Practice (GMP) conditions for the production of the nanomedicines from the pre-clinical laboratory scale to the quantity needed for clinical testing.

2 - Scope

The aim is to translate promising novel nano-technology enabled therapies for cancer with pre-clinical proof-of-concept, from a pre-clinical lab stage up to Phase I clinical testing. The project shall start from an established pre-clinical proof-of-concept, with relevant efficacy and toxicity data. The project shall be focused on the translation process, so that ultimately new effective therapies can be introduced to the European healthcare market. An important aspect is the development of a pilot line for scaling-up the production of the nanomedicines and the quality control, taking into account GMP and medical regulatory requirements. Projects may include the later stages of pre-clinical testing and Phase 1 clinical testing, but the latter is not a requirement. Nanopharmaceuticals may be manufactured with either a top-down or a bottom-up approach, using for example self-assembling technology. Applicants must describe, according to industrial criteria, how the various barriers for advancing their new therapy to clinical application will be overcome, including technical, IPR, competitive, commercial and regulatory criteria, with efficacy and toxicity. Attention must be paid to clinical trial design and the foreseen research and commercial path to market introduction has to be well outlined. For this topic, proposals should include an outline of the initial exploitation and business plans, which will be developed further in the proposed project.

3 - Eligibility

At least three legal entities. Each of the three shall be established in a different Member State or associated country. All three legal entities shall be independent of each other.

4 - Budget

The total budget available for the action is of €148,370,000. The European Commission considers that proposals requesting a contribution from the EU between EUR 6 and 9 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

5 - Timeframe

Information on the outcome of two-stage evaluation: maximum 5 months from the final date for submission.

Signature of grant agreements: maximum 3 months from the date of informing successful applicants.

6 - Deadline

* VHIR deadline is 16/03/2015

* The official deadline for stage 1 is 26/03/2015

* The official deadline for stage 2 is 08/09/2015

7 - More information

More information can be found here:LINK