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NMBP-12-2017

Development of a reliable methodology for better risk management of engineered biomaterials in Advanced Therapy Medicinal Products and/or Medical Devices -

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Call text (as on F&T portal)

View on F&T portal
Specific Challenge:

The development of new biotechnology-based products needs to be complemented with a scientifically valid identification of the potential hazards from these biomaterials to human health and to the environment, together with the monitoring and reduction of the risk that these new technologies pose. Current knowledge is still incomplete and the established methods may be inappropriate for specific materials in view of their eventual deployment. The necessary integration of physical, chemical, biochemical and clinical methods is an open challenge. Hence, future production system engineering requires development of integrated and validated methodologies as basis for an appropriate integrated risk management.

Scope

The development of new biotechnology-based products needs to be complemented with a scientifically valid identification of the potential hazards from these biomaterials to human health and to the environment, together with the monitoring and reduction of the risk that these new technologies pose. Current knowledge is still incomplete and the established methods may be inappropriate for specific materials. Hence, future production system engineering requires validated methodologies as basis for an appropriate integrated risk management. As relevant, the proposed activities should address sex and gender specific aspects[1].

Projects are expected to initiate and support standardisation of the proposed biomaterials and methods, including methods that will reflect their eventual deployment as part of Advanced Therapy Medicinal Products and/or Medical Devices.

The expected projects should be related to validating, adapting and/or developing a reliable methodology for risk assessment and thorough overarching hazard identification for engineered biomaterials and should address the following areas:

  • Comparison and validation of current (and/or development including validation of new) test methods and test schemes, including in vitro and in silico methods, to detect adverse effects from biomaterials to:
    • human health including acute and chronic toxicity (oral, inhalation, dermal);
    • modelling toxicity behaviour of engineered Biomaterials, including development of ready-to-use predictive models (web services etc);
    • the environment; eco-toxicity tests, bioaccumulation, persistence, bioavailability and life cycle impacts onto all forms of biota.
  • Relevant reference and/or certified reference materials;
  • Management of accidental risk including explosion and massive release;
  • Methods for performance assessment of hazard and exposure monitoring systems and on the field detection systems;
  • Methods for evaluation of risk reduction strategies and systems.

The implementation of this topic is intended to start at TRL 4 and target TRL 6.

This topic is particularly suitable for international cooperation.

The Commission considers that proposals requesting a contribution from the EU between EUR 5 and 8 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Expected Impact:
  • Development of comprehensive understanding of the properties, interaction and fate of engineered biomaterials in relation to human health and environment;
  • Support to policy and decision making concerning biomaterials research in respect to various stakeholders: public authorities, industry, researchers and citizens;
  • Validated test methods and schemes for the identification of potential adverse effects from biomaterials and contribution to the future definition of appropriate measures, where needed;
  • Support to pre and co-normative activities, such as with reference to the implementation of the REACH regulation[2];
  • Support to good governance in biomaterials research following the safe, integrated and responsible approach as laid down in "Nanosciences and Nanotechnologies: An action plan for Europe".
Cross-cutting Priorities:

GenderInternational cooperationOpen Innovation

[1]See definition of the 'gender dimension approach' in the introduction of this Work Programme part.

[2]Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC and amendments

News flashes

2017-07-06

FLASH INFORMATION ON THE CALL RESULTS2017 two-stage TOPICS

Published: 14 October 2015Deadline: 4 May 2017Available budget: 235.47 M€

The Commission has now completed the evaluation of the proposals submitted to the above-mentioned call.The results of the evaluation are as follows:

Number of proposals submitted (including proposals transferred from or to other calls): 107Number of inadmissible proposals: 0Number of ineligible proposals: 0Number of above-threshold proposals: 55Total budget requested for above-threshold proposals:343.422.171 €

We recently informed the applicants about the evaluation results for their proposals.

For questions, please contact the Research Enquiry Service.

2017-05-17

DEADLINE (second stage) of 2017 two-stage topics: 04.05.17107 proposals were submitted in response to this call.The number of proposals for each topics is shown below:

NMBP-04-2017: 7NMBP-05-2017: 10NMBP-06-2017: 14NMBP-07-2017: 6NMBP-12-2017: 6NMBP-14-2017: 2NMBP-15-2017: 10NMBP-19-2017: 7NMBP-20-2017: 6NMBP-22-2017: 8NMBP-25-2017: 3NMBP-28-2017: 2NMBP-29-2017: 2NMBP-35-2017: 4BIOTEC-05-2017: 10BIOTEC-06-2017: 7BIOTEC-07-2017: 3

2017-04-27

FLASH INFORMATION ON THE CALL RESULTS H2020-NMBP-2016-2017 (2017single-stage TOPICS)

Published: 14 October 2015Deadline: 19 January 2017Available budget: CSA : 8.4 M€ + NMBP-13-2017 (X-KET): 15 M€

The Commission has now completed the evaluation of the proposals submitted to the above-mentioned call.The results of the evaluation are as follows:

CSA topicsNumber of proposals submitted (including proposals transferred from or to other calls): 16Number of inadmissible proposals: 1Number of ineligible proposals: 0Number of above-threshold proposals: 10Total budget requested for above-threshold proposals: 14,398,535.25 €

NMBP-13-2017 topicNumber of proposals submitted (including proposals transferred from or to other calls): 62Number of inadmissible proposals: 0Number of ineligible proposals: 0Number of above-threshold proposals: 7Total budget requested for above-threshold proposals: 28,946,700.00 €

We recently informed the applicants about the evaluation results for their proposals.For questions, please contact the Research Enquiry Service.

2017-02-07

Corrigendum - FLASH INFORMATION ON THE CALL RESULTS

H2020-NMBP-2016-2017 (2017 two-stage TOPICS)Please read "Deadline: 27 October 2016"

2017-01-30

FLASH INFORMATION ON THE CALL RESULTS H2020-NMBP-2016-2017 (2017 two-stage TOPICS)

Published: 14 October 2015Deadline: 27 October 2017Available budget: 235,470,000 €

The Commission has now completed the evaluation of the proposals submitted to the above-mentioned call. The following overall thresholds were applied:NMBP-04-2017 8,5/10NMBP-05-2017 8,5/10NMBP-06-2017 8,5/10NMBP-07-2017 8,5/10NMBP-22-2017 8,5/10NMBP-25-2017 8,5/10NMBP-28-2017 8,5/10NMBP-29-2017 8,5/10NMBP-35-2017 8,5/10NMBP-12-2017 8/10NMBP-14-2017 8/10NMBP-15-2017 8/10NMBP-19-2017 8/10NMBP-20-2017 8/10BIOTEC-05-2017 8/10BIOTEC-06-2017 8/10BIOTEC-07-2017 8/10

The results of the evaluation are as follows: Number of proposals submitted (including proposals transferred from or to other calls): 421Number of inadmissible proposals: -Number of ineligible proposals: 2Number of above-threshold proposals: 108Total budget requested for above-threshold proposals: 653,198,271 €We recently informed the applicants about the evaluation results for their proposals. Above-threshold proposals have been invited to submit a full proposal by 4 May 2017.Information on the selected projects will be published on CORDIS after that date. For questions, please contact the Research Enquiry Service.

2017-01-24

Deadline of 2017 single-stage topics: 19.01.2017

A total of 78 proposals were submitted in response to this call. The number of proposals for each topic is shown below:

BIOTEC-08-2017: 2NMBP-13-2017: 62NMBP-16-2017: 2NMBP-31-2017: 2NMBP-34-2017: 7NMBP-37-2017: 1NMBP-38-2017: 2

2017-01-11

Switzerland as associated country

From 1 January 2017 Switzerland is associated to the whole Horizon 2020 programme instead of the previous partial association.

This applies to all the grant agreements signed on 1 January 2017 and afterwards.

For more information please see the relevant Note on the Participant Portal.

2016-11-08

Erratum: Deadline (first stage) of 2017 two-stage topics: 27.10.16

2016-11-08

Deadline (first stage) of 2017 two-stage topics: 21.10.16421 proposals were submitted in response to this call.The number of proposals for each topics is shown below:

NMBP-04-2017: 51NMBP-05-2017: 53NMBP-06-2017: 81NMBP-07-2017: 21NMBP-12-2017: 10NMBP-14-2017: 3NMBP-15-2017: 27NMBP-19-2017: 25NMBP-20-2017: 15NMBP-22-2017: 35NMBP-25-2017: 6NMBP-28-2017: 8NMBP-29-2017: 14NMBP-35-2017: 27BIOTEC-05-2017: 16BIOTEC-06-2017: 18BIOTEC-07-2017: 7

2016-09-20
The submission session is now available for: NMBP-13-2017(RIA)
2016-09-20
The submission session is now available for: NMBP-16-2017(CSA), NMBP-37-2017(CSA), NMBP-31-2017(CSA), NMBP-38-2017(CSA), BIOTEC-08-2017(CSA), NMBP-34-2017(CSA)
2016-08-03
The submission session is now available for: NMBP-06-2017(RIA), NMBP-07-2017(RIA), NMBP-05-2017(IA), NMBP-28-2017(RIA), NMBP-19-2017(RIA), NMBP-14-2017(RIA), NMBP-04-2017(RIA), NMBP-15-2017(RIA), NMBP-25-2017(IA), NMBP-12-2017(RIA), NMBP-22-2017(RIA), NMBP-20-2017(IA), NMBP-29-2017(RIA), NMBP-35-2017(RIA)
2016-08-03
The submission session is now available for: BIOTEC-06-2017(IA), BIOTEC-05-2017(RIA), BIOTEC-07-2017(RIA)
2016-07-25

Horizon 2020 Work Programme 2017 update

After the update to the Horizon 2020 Work Programme 2017 of 25 July 2016,the following updates were made:

  • Open Access Data new provisions have been added for 2017 calls with an opening date on or after 26/07/2016.
  • The introduction of the following parts have been modified: o BIOTEC topics under call H2020-NMBP-2016-17. o MODELLING topics under call H2020-NMBP-2016-17
  • The text for evaluation criteria, scoring, threshold and procedure has been clarified.
  • The text for topics NMBP-22-2017, BIOTEC-05-2017, BIOTEC-06-2017 and BIOTEC-07-2017 has been modified.
  • The following two new CSA topics have been added to the call H2020-NMBP-2017: o NMBP-37-2017 Mapping a path to future supply chains o NMBP-38-2017 Support for the enhancement of the impact of PILOT projects.
  • Other Action 5. Exploitation Strategy and Innovation Consultants (ESIC) has been cancelled. Other Action 6. Exploitation Strategy and Innovation Consultants (ESIC) has been changed to other action 5. Exploitation Support Services and the text has been revised.
  • The following new actions have been added: o 8. Study on due diligence and risk assessment of KETs projects by investors o 9. Best practise for identifying and assessing the dual-use issues in enabling technologies research – preliminary study o 10. Addressing dual-use issues in enabling technologies research
  • The indicative budget for call H2020-NMBP-2017 was increased to €253.87 million in 2017.

2016-07-12

Flash Call Info

Call identifier: H2020-NMBP-2016-2017 (2016 Two-stage topics)Call title: Call for Nanotechnologies, Advanced materials, Biotechnology and ProductionPublished: 14 October 2015Deadline: 24 May 2016 17:00:00

Budget available: 174.08 M€

  • BIOTEC-02-2016 03-2016: 32 M€
  • NMBP-01-2016 + 020-2016 + 03-2016 + 23-2016 + 26-2016: 78.08 M€
  • NMBP-09-2016 + 10-2016: 32 M€
  • NMBP-17-2016 + 18-2016: 32M€

The Commission has completed the evaluation of the proposals submitted to the above call. The results of the evaluation are as follows:

TOPICS BIOTEC-02-2016 + 03-20016Number of proposals submitted (including proposals transferred from or to other calls): 17Number of inadmissible proposals: 0Number of ineligible proposals: 0Number of above-threshold proposals: 8Total budget requested for above-threshold proposals: 48,417,925 €

NMBP-01-2016 + 020-2016 + 03-2016 + 23-2016 + 26-2016Number of proposals submitted (including proposals transferred from or to other calls): 36Number of inadmissible proposals: 0Number of ineligible proposals: 0Number of above-threshold proposals: 20Total budget requested for above-threshold proposals: 116,470,292 €

NMBP-09-2016 + 10-2016Number of proposals submitted (including proposals transferred from or to other calls):16Number of inadmissible proposals: 0Number of ineligible proposals: 0Number of above-threshold proposals: 6Total budget requested for above-threshold proposals: 34,039,531 €

NMBP-17-2016 + 18-2016Number of proposals submitted (including proposals transferred from or to other calls): 15Number of inadmissible proposals: 0Number of ineligible proposals: 0Number of above-threshold proposals: 6Total budget requested for above-threshold proposals: 32,301,327 €

We recently informed the applicants about the evaluation results for their proposals.

The number of proposals that can finally be funded depends on the available budget and the formal approval of grant agreements by the Commission.

It is expected that the first grant agreements will be signed by November 2016.

Information on the selected projects will be published on CORDIS after that date.http://cordis.europa.eu/projects/home_en.html

In case of questions, please contact the Research Enquiry Servicehttp://ec.europa.eu/research/enquiries

2016-04-19

An overview of the following evaluation results (flash call info) is now available under the tab Topic conditions and documents:

  • 2016 NMBP single stage topics
  • 2016 NMBP two-stage topics (first stage results)
2016-01-25

Deadline of 2016 single stage topics: 21.01.1638 proposals were submitted in response to this call.The number of proposals for each topics is shown below:

Type of Action: CSA

BIOTEC-04: 3NMBP-24: 1NMBP-27: 2 NMBP-30: 1NMBP-31: 2NMBP-32: 1NMBP-33: 4NMBP-36: 1

Type of Action ERANET-co-FUND

BIOTEC-01: 2NMBP-11: 1NMBP-21: 1

Type of Action RIA (Green Vehicles topic)

NMBP-08: 19

2015-12-14

Deadline (first stage) of 2016 two-stage topics: 08.12.15305 proposals were submitted in response to this call.The number of proposals for each topics is shown below:

NMBP-01-2016: 25NMBP-02-2016: 17NMBP-03-2016: 37NMBP-09-2016: 17NMBP-10-2016: 61NMBP-17-2016: 42NMBP-18-2016: 4NMBP-23-2016: 9NMBP-26-2016: 17BIOTEC-02-2016: 47BIOTEC-03-2016: 29

call topic details
Call status: Closed
Opening date: 2016-05-11 (9 years ago)
Closing date: 2016-10-27 (9 years ago)
Procedure: two-stage

Budget: 40,000,000
Expected grants: not specified
News flashes

This call topic has been appended 18 times by the EC with news.

  • 2017-07-06
    flash information on the call results201...
  • 2017-05-17
    deadline (second stage) of 2017 two-stag...
  • 2017-04-27
    flash information on the call results h2...
  • 2017-02-07
    corrigendum - flash information on the c...
  • 2017-01-30
    flash information on the call results h2...
  • 2017-01-24
    deadline of 2017 single-stage topics: 19...
  • 2017-01-11
    switzerland as associated countryfrom 1...
  • 2016-11-08
    erratum: deadline (first stage) of 2017...
  • 2016-11-08
    deadline (first stage) of 2017 two-stage...
  • 2016-09-20
    the submission session is now available...
  • 2016-09-20
    the submission session is now available...
  • 2016-08-03
    the submission session is now available...
  • 2016-08-03
    the submission session is now available...
  • 2016-07-25
    horizon 2020 work programme 2017 updatea...
  • 2016-07-12
    flash call infocall identifier: h2020-nm...
  • 2016-04-19
    an overview of the following evaluation...
  • 2016-01-25
    deadline of 2016 single stage topics: 21...
  • 2015-12-14
    deadline (first stage) of 2016 two-stage...
Call

H2020-NMBP-2016-2017

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