Specific
Challenge:
The
healthcare biotechnology sector offers huge business and commercial
opportunities; however it also requires heavy and risky investments
which are often lacking in Europe, hampering the development of the
industry.
The
challenge includes either:
a)
Cell technologies in medical applications (phase 1 only for 2016
deadlines and phase 2 for all deadlines in 2016 and 2017)
Cell
technologies include cell manufacturing (culture, multiplication,
scale-up and automation), preservation, banking and transport;
identification, cell sorting and delivery, imaging, tracking, process
and quality control; genetic engineering and gene editing; production
of therapeutic biomolecules. The medical applications of cell
technologies include diagnostics and biosensors; cell and gene
therapy, tissue engineering, bio-artificial organs, haematology,
immunotherapy, and vaccine and antibody production; predictive
toxicology, synthetic biology, and modelling development and disease
processes.
However,
the diversity, complexity and variability of living cells pose
challenges for bringing safe, reliable, regulatory-compliant and
cost-effective products to the market and to the patient. SMEs
developing cell-based products and processes have limited financial
resources to take the critical steps to move from proof of concept to
practical application while at the same time addressing
considerations such as scale-up/scale-out, automation, logistics,
regulatory pathways and business models.
Particular
attention should be given to dialogue with regulators and compliance
with safety and regulatory requirements, such as those pertaining to
cell procurement, GMP, ethics, clinical trials, ATMPs and medical
devices.
The
challenge addresses cells from any eukaryotic source though their
eventual application must be to human medicine.
Or:
b)
Clinical research for the validation of biomarkers and/or diagnostic
medical devices (only at the first cut-off date in 2017 and for phase
2 applications - phasing out of the topic PHC-12-2014/2015 introduced
in the Work Programme 2014-2015)
Biomarkers
are used in clinical practice to indicate both normal and
pathological conditions. They are also used for predictive or
prognostic purposes. They are being used increasingly in medicine and
many potential new biomarkers are proposed every year. However, only
a few of these have been validated for clinical use. To achieve
validation a robust analytical method is required and a link to a
pertinent clinical process or endpoint needs to be demonstrated.
This
validation process should provide evidence for high analytical value,
appropriate sensitivity and specificity, and clinical validity.
Particular attention should be given to validation of biomarkers with
potential for rapid uptake into clinical practice. Both in vivo and
in vitro potential biomarkers are eligible. Priority is given to the
validation of disease-related biomarkers (i.e. diagnostic,
susceptibility/risk, monitoring and prognostic biomarkers).
Validation of the clinical performance of new diagnostic devices can
also be supported, either in combination with the biomarker
validation or against existing standards.
Informações
Adicionais
Caso
deseje dados adicionais sobre este programa de financiamento,
requisite informações aos nossos serviços.
Todo
o processo de candidatura é formalizado em Inglês.
Este
Programa tem candidaturas abertas em contínuo, havendo várias fases
de avaliação
Propostas
à Fase 1:
15-02-2017,
03-05-2017, 06-09-2017, 08-11-2017
Propostas
à Fase 2:
18-01-2017,
06-04-2017, 01-06-2017
Orçamento
2017: 437,510,000€
