Transcript Slides - View the full AIDS 2016 programme

Symposium at AIDS2016:
Every mother, every child: closing the gaps in HIV management
Durban, 20 July 2016
The EU Framework Programme for Research and Innovation
HORIZON 2020
EC strategy and
opportunities for research
on HIV research for
maternal and child health
Alessandra Martini, PhD
European Commission
Directorate-General "Research and Innovation"
'Fighting infectious diseases and advancing
public health'
EU response to HIV/AIDS
a coordinated approach..
Research
Health
Develop and validate effective
tools to prevent,
treat and cure HIV/AIDS.
Training and education.
Optimise treatment & care
Public health policy and
programes (priority
regions, key populations),
registration of drugs,
joint-procurements,
surveillance (ECDC)
AIDS-free
world
Development
Equitable access to
health systems in
developing countries,
GFATM
Trade
TRIPS Provisions
to allow
procurement of
affordable
medicines
Justice
Protect human rights,
fight stigma,
discrimination.
Monitoring Drugs and
Drug Addiction
(EMCDDA)
Role of EC on Research
Develop and implement European research and innovation policy agreed by the EP and European
Council
Provides financial support to research through multi-annual framework programmes (since 1984)
FP7 portfolio on HIV/AIDS collaborative research
highlights of outcomes
Drugs
Treatment
-Pre-clinical development of drug candidates tackling 4 novel targets
-
Large network of cohorts >350.000 HIV+ individuals. Standardised methods &
protocols for data collection and sharing.
-
New mechanism of drug resistance
-
European cohorts for HIV-comorbidities and identification of new biomarkers in adults
-
PK, PD studies (incl. 5 clinical trials) for new drugs formulations for paediatric use
- clinical trials, cohort studies collaborations with studies for children and
pregnant women, training/ educational programmes
Cure
Vaccines
Microbicides
- In-vitro and in-vivo models of HIV latency and persistence
-Development of several new vaccine candidate, of which 11 into phase I/IIa clinical trial
Development of novel candidates microbicides; 1 combination proved safety in phase I CT
-Development of a platform for microbicides optimisation and formulations
-Development of a new point-of-care diagnostic tool for testing HIV-Syphilis in newborn and pregnant women.
Diagnostics
-Validation of a low-cost viral-load test (now under H2020 InnoFin ID)
H2020 funding programme
structure and funding instruments
Excellent science €24bn
Future and Emerging
Technologies
European Research
Council
Research
Infrastructures
Industrial leadership €17bn
Fast Track to
Innovation
SME
instrument
Marie Skłodowska
Curie
Eureka Eurostars-2
LEIT Biotech
Societal challenge 1 Health €7.5bn
IMI-2
Collaborative
projects
EDCTP-2
AAL-2
Financial
instruments
H2020 portfolio (first 2 years 2014-15)
HIV/AIDS research € 74 million*
Relevant topics in SC1 WP 2016-17
2016
(call for proposal closed. Evaluation on-going)
SC1-PM-04–2016 Networking and optimising the use of population and patient cohorts
•
at EU level (€ 30m)
•
SC1-PM-09–2016: New therapies for chronic diseases (€ 60m)
•
SC1-PM21-2016: Implementation research for scaling-up of evidence based
interventions and good practice in Europe and LMIC (€ 40m)
2017 (call for proposal open 29 July. First deadline: 6 October 2016.
2-stages evaluation)
•
SC1-PM-07–2017: Promoting mental health and wellbeing in the young (20m€)
•
SC1-OA2*: InnovFin Infectious Diseases - Loans
•
Birth Day Prize**: Prize on reducing maternal and newborn morbidity and
mortality
** deadline 6 September 2017
A New Financial Instrument for Infectious
Diseases R&D
•
Jointly developed by the European Commission and European
Investment Bank.
•
Provides loans between EUR 7.5m and EUR 75m to innovative players
active in developing vaccines, drugs, medical and diagnostic devices,
and research infrastructures for combatting infectious diseases
• Applications must be in pre-commercial phase with pre-clinical phase
(PoC) completed and clinical validation required for further development, and
must have proven public health impact
• 1st InnovFin loan (June 2015) to CAVIDI to develop an automated, high-
throughput version of a low-cost HIV viral load testing device (validated
under FP7 EU project)
EIB: [email protected]
CONTACTS:
European Commission: Patricia Paukovits
[email protected]
#HorizonPrize
Horizon Birth Day Prize
• The Birth Day Prize joint initiative between the European
Commission,
Mothers.
Bill & Melinda Gates Foundation and MSD for
• Main Prize : €1 million from the European Commission.
Additional prizes from Bill & Melinda Gates Foundation (€1 million) and
MSD for Mothers (€0.5million)
• Deadline: 6 September 2017 - award decision: end 2017
http://ec.europa.eu/research/horizonprize/index.cfm?prize=birthday
Research and Innovation
#HorizonPrize
• Challenge:
Approximately 300 000 women still died from preventable causes related to
pregnancy and childbirth in 2013. Maternal and perinatal conditions are the
seventh contributors to the global burden of disease
• Scope:
A novel solution to improve the outcome of facility-based deliveries (
of a clinical, technological or managerial nature, or a combination of these). It
must take into account relevant social factors and have the potential of
scaling up rapidly
• Expected Impact:
Demonstrated reduction in maternal and/or new-born morbidity and mortality
and/or stillbirth during facility-based deliveries.
• Who can participate
The contest is open to all legal entities (i.e. natural persons or legal entities,
including International organisations) or groups of legal entities regardless of
place of establishment
Research and Innovation
what's next?
Identification of research gaps that can be addressed
by the SC1 work programme 2018-2020
•
2016/2017 Consultation with the research community through
conferences and workshops
•
On-going: Stakeholders consultation of the Health Advisory Group
Report for Health, Wellbeing and Demographic changes WP20182020
https://ec.europa.eu/research/health/index.cfm
•
2016/2017 Meetings with Member States representatives for SC1
•
end 2017 Adoption on the WP 2018-2020
Thank you!
 H2020 Participant Portal 
all information including call
documentation, guidelines
http://ec.europa.eu/research/participants/po
rtal/page/home
 Twitter
@Moedas  from Commissioner for Research, Science and Innovation
@innovationunion  from RTD on H2020 activities
@EU_H2020
Background slides
HISTORY and MISSION
Paediatric European Network for Treatment of AIDS (PENTA)
(www.penta-id.org)
 Established in 1991 as collaboration between paediatric HIV centres in
Europe. Aim: to undertake independent clinical trials to address
questions about antiretroviral therapy (ART) in HIV infected children
where answers cannot be extrapolated from trials in adults
 Activities: not just clinical trials, but cohort studies collaboration,
pregnancy studies and training/ educational programmes.
 Funding from:
- European Commission: 8 projects coordinated by PENTA since 1993
from Biomed 1 to H2020), involvement in more than 20 EU funded
projects
- Other major funding: MRC, INSERM/ANRS, US-NIH (project-based),
UNICEF, Industries
From the initial focus on HIV
to the broader area of Paediatric Infectious Diseases
 15 large Clinical trials in HIV infected children globally with more than 2500 children enrolled
 22 observational pediatric HIV cohorts (> 6000 pediatric patients) and 7 large HCV cohorts (>
6000 HCV infected children)
 42 international training courses in 32 countries worldwide (more than 2000 people trained)
 2011 onwards: from PENTA and PENTi to PENTAid
European funding:
- NeoMero (neonates)
- NeoVanc (neonates)
- GRiP (“medicine for children”)
- PREPARE (prevention of epidemics)
- EMIF (creation of a European epidemiology/ICT platform)
- COMBACTE-MAGNET (molecules against Gram Negative infections)
- GAPP (clinical trials on “off-patent” drugs)
- ZIKAction
 Specific contracts and agreements with major International Paediatric Hospitals
 2011: PENTAid recognised by the EnprEMA as a level 1 Paediatric Clinical Trial Network in
Europe to conduct clinical trials in pediatric HIV, antimicrobials and vaccinology.