IMI2 Ebola and other filoviral haemorrhagic fevers programme. Webinar for SRG and SC 3 November 2014

Transcription

1 IMI2 Ebola and other filoviral haemorrhagic fevers programme Webinar for SRG and SC 3 November 2014

2 Background Ebola virus diseases (EVD) is a rare and deadly disease Filoviruses such as Ebola spread directly from person to person via bodily fluids Current outbreak is unprecedented in scale and geographical distribution: # of Ebola cases could reach 10,000 per week by December 2014 (WHO, 14 October) >4,900 deaths and 13,703 cases reported (WHO, 27 October)

3 Challenges Currently, no licensed treatment is available for EVD Currently, no good diagnostic tests are available Rapid scaling up of candidate vaccine doses needed for current epidemic is difficult Current vaccine candidates require very cold temperatures for stability during transport Deployment (reaching those most in need) is challenging Adherence to vaccination regimens is challenging Range of products needed for current and future outbreaks

4 IMI2 Ebola and other filoviral haemorrhagic fevers programme IMI2 offers a unique opportunity to complement the ongoing European and international efforts Comprehensive and coordinated programme Able to adapt to rapidly evolving environment Able to mobilise forces across companies, sectors and disciplines Entire innovation cycle: from early development to patient access Addressing current outbreak and future needs

5 Disclaimer The Programme was developed in just two weeks It will be further fine-tuned taking account of The evolution of the epidemics, The evolution of the regulatory landscape, Progress of other initiatives (national, EU, international), Input from different stakeholders Participation of additional pharma and non-pharma contributors

6 IMI2 Ebola and other Filoviruses Programme Overview: Development Manufacturing Deployment Diagnostics Pipelines Future topic: Immunotherapy Topic 1: Vaccine 1 Phase I-III Topic 2: Manufacturing infrastructure Topic 3: Stability during transport and storage Subtopics in 2015 Topic 4: Compliance Topic 5: Rapid diagnostics Subtopics in 2015 Future topic: Antivirals Developmen t and Repurposing including screening methods Future topic: Multivalent Filovirus Vaccines Central Information Repository & Scientific and Ethical Advice

7 Topic 1: Vaccine development Phases I, II, III The progression of vaccine candidates currently in development is an urgent public health need (WHO). Design and implementation of Phase I, II, or III clinical development of vaccine candidates, including prime boost combinations against Ebola virus disease (Zaire), to start in early 2015 The applicants must demonstrate the ability to roll out clinical trial vaccination programmes in EU / Africa / US, and to conduct studies in areas where Ebola virus disease is endemic The clinical development programme(s) need(s) to be aligned with the global effort coordinated by the WHO

8 Topic 2: Manufacturing capability Ebola vaccines are recombinant adenovirus or other viralbased vaccines and need to be produced in facilities meeting an appropriate biosafety level. Scaling up currently available production techniques to the necessary scale Fully compliant with good manufacturing practices (GMP) and biological safety level requirements Generation of additional data to provide the necessary scientific, technical and regulatory justifications to seek a reclassification of current vaccine vectors

9 Topic 3: Stability of vaccines during transport and storage Maintaining very low temperature required for the stability of currently available vaccine candidates in areas targeted for vaccination is challenging. Development of tools and technologies to allow distribution of Ebola vaccines requiring very low temperatures Stability testing and supporting analytical capabilities to be applied at all stages of the shipping, storage and deployment process Future topic: Development of alternative formulations to improve the thermo-stability of clinically active vaccines

10 Topic 4: Deployment and compliance of vaccination regimens Ensuring vaccination coverage and adherence to potential prime-boost vaccination regimen is challenging Development of technologies and tools that augment vaccination coverage and adherence to the vaccination regimen Environmental factors that impact compliance Projects might look at how to exploit mobile telecommunication and use of mobile apps in West Africa

11 Topic 5: Rapid diagnostic tests Rapid detection of Ebola infections is an urgent need in the current crisis and will remain important in the future. Development of rapid diagnostics to detect EVD at acceptable costs and with high sensitivity and specificity Need to be able to be deployed at decentralised health care facilities under conditions with minimum laboratory infrastructures available Includes clinical validation in current endemic regions, registration and launch Future topic: Follow-up of current topic to allow long-term surveillance (would include new tests and early development)

12 Thank you