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Hugh Laverty ‘The importance of microbiota in human health’ 07 November 2018, Warsaw

Hugh Laverty ‘The importance of microbiota in human health’ 07 November 2018, Warsaw. IMI2: Towards public-private collaboration in microbiome research. IMI – Europe’s partnership for health. IMI2: 2014-2024 €3.3 bn budget More ambitious More open Greater scope. IMI1: 2008-2017

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Hugh Laverty ‘The importance of microbiota in human health’ 07 November 2018, Warsaw

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  1. Hugh Laverty ‘The importance of microbiota in human health’ 07 November 2018, Warsaw IMI2: Towards public-private collaboration in microbiome research

  2. IMI – Europe’s partnership for health • IMI2: 2014-2024 • €3.3 bn budget • More ambitious • More open • Greater scope • IMI1: 2008-2017 • €2 bn budget • 59 projects €2.5 bn €2.5 bn > €5 bn Partnership 2008 - 2024

  3. IMI – Europe’s partnership for health IMI mission IMI facilitates open collaboration in research to advance the development of, and accelerate patient access to, personalised medicines for the health and wellbeing of all, especially in areas of unmet medical need.

  4. IMI – Why Europe’s partnership for health? Because drug development is very… complex inefficient risky lengthy expensive Because… • Biological mechanisms underlying disease are complex • Clinical trial designs need to be adapted to scientific knowledge • Regulatory pathways should be adapted due to scientific drivers

  5. New approaches are needed “Deciphering the complexity of human diseases and finding safe, cost-effective solutions that help people live healthier lives requires collaboration across scientific and medical communities throughout the health care ecosystem. Indeed, we must acknowledge that no single institution, company, university, country, or government has a monopoly on innovation.”

  6. IMI – Why Europe’s partnership for health? Because despite decades of research we still don’t have… a cure for diabetes an Ebola vaccine enough antibiotics in development a cure for dementia So IMI is… • supporting projects across the whole spectrum of medical R&D and drug development, incl. understanding diseases; • identifying & developing potential drugs; • testing safety / efficacy; • improving clinical trial design…

  7. The Vision for IMI2Science is driving the manner in which we view disease Population Individual Molecular diagnosis based on biological knowledge We “treat” a targeted population They all respond We “treat” a population. Some respond and some don’t

  8. IMI 2 budget (2014 – 2020) EU funding goes to: Universities SMEs Mid-sized companies Patient groups etc… EFPIA companies receive no funding contribute to projects ‘in kind’ €1.638 bn €1.425 bn Associated Partners e.g. charities, non-EFPIA companies Other €213 m IMI 2 total budget €3.276 billion

  9. IMI2 calls: Two stage procedure Stage 1 Stage 2 Topic definition phase Granting phase Industry consortium Academic research teams Hospitals Applicant consortium Mid-size enterprises Regulators Industry consortium SMEs Patients’ organisations Signature of Consortium and Grant Agreements Definition of topics by industry consortium SP Submission & Evaluation FP Submission & Evaluation Project launch!

  10. IMI investment in majorresearchareas - 2017

  11. An international, cross-sector community – end 2017 Over 11 500 researchers working for: open collaboration improved R&D productivity innovative approaches to unmet medical needs

  12. What does an IMI project look like? Industrial partners align themselves around a real challenge for industry and agree to work together and commit resources New ideas from public sector, universities, SMEs etc. are needed to address the challenge Scale is a key to success and is provided by IMI funding and the outcomes should be transformative for the industry as well as having a clear “public” value Non-competitive collaborative research

  13. Microbial systems and disease states: establishing a causality • the microbiome drives the disease? • the disease drives the microbiome? • both are modified by a confounding factor? Gilbert et al. (2016), Nature 535, 94–103

  14. Incentives to collaborate and create a partnership • Different industry sectors, e.g., food and pharma, have complementary experience and expertise, tools and methods that could be shared and leveraged to common benefit • There is significant new knowledge and important assets (databases, biobanks, standards) in the public space that could be taken to the next level by the interaction with industry • Regulators need data to move regulatory science in order to enable new products reaching the market • Create an open innovation space to de-risk biotech activities in the field • Patients need new treatments that have been developed in partnership with them to ensure these will have a real impact on quality of life

  15. IMI2 projects/topics addressing the microbiome • IMI2 Call 1 – INNODIA • Translational approaches to disease modifying therapy of type 1 diabetes • Analysis of the gut microbiome in at risk individuals • IMI2 Call 3 – RHAPSODY • Assessing risk and progression of juvenile prediates and type 2 diabetes to enable disease modification • IMI2 Call 6 - RESCEU • Establishing the impact of RSV (human Respiratory Syncitial Virus) infection, resultant disease and public health approach to reducing the consequences of infection • IMI2 Call 14 – Topic 1 • Target immune intervention of non-response and relapse • 2 sub topics: Ulcerative colitis and Crohns disease, Asthma and COPD

  16. IMI2 projects/topics addressing the microbiome • Call 13 Topic 2 - Genome –environment interactions in inflammatory skin disease • Identify shared and distinct disease mechanisms of atopic dermatitis and psoriasis • Establish a new disease ontology by defining the distinct and overlapping endotypes and co-morbidities • Identify molecular, immunological and microbial biomarkers that inform prognosis and response to therapy • Analysis of the microbiome central to the approach • Total budget 18.8 million(10.5 million IMI2 funding) • Synergies expected with Inflammatory Arthritis Microbiome consortium and MAARS (Microbes in Allergy and Autoimmunity Related to Skin)

  17. IMI2 projects/topics addressing the microbiome • Call 13 Topic 8 - Human tumourmicroenviromentimmunoprofiling • To improve our understanding of the host/tumour interaction at the cellular and molecular level in the absence of therapeutic intervention • To understand how current therapeutic approaches affect the host/tumour interaction • Tumours included in study: lung adenocarcinoma, head and neck cancer and colorectal cancer • Deep profiling of pre- versus post-treatment samples including microbiome analysis • Total budget of €34 million (€18 million IMI2 funding)

  18. Opportunities for a PPP approach in the human microbiome Large scale prospective longitudinal studies (causality) and prospective long-term follow up of intervention trials Standardized protocols and improved reproducibility of experiments ‘big data’ tools to integrate diverse ‘omics’ data Regulatory challenges to innovation at the food-drug interface (EMA, EFSA) More robust knowledge of ecological networks (resilience, resistance, persistence) Better animal models to improve understanding of host-microbiome signal interactions Moving towards the “one health” concept and going beyond the disciplinary silos

  19. IMI stakeholder forum 2017 Four potential themes were discussed: • Large longitudinal studies with open access to metadata • Bio-informatics solutions for strain level identification and analysis of hypothetical genes • Bio-banks of identifiable species with metadata, reference methods and standards • Translational studies addressing microbiome causality in human health and disease

  20. In the pipeline: • Challenging to align different sectors on a common goal • Concrete discussions between EFPIA companies and other industries (food, pharma, med-tech, diagnostics, etc.) around Theme 4 for the development of a cross-disease microbiome topic in 2019. • Translational studies addressing microbiome causality in human health and disease • SGG oncology also interested in leading a topic to be launched in 2019 with a more restricted focus on Microbiome & Cancer • Future calls planned for Jun 2019 / Jan 2020

  21. IMI2 Call 17 • Diabetes/Metabolic disorders • Optimising future obesity treatment • Other enablers of research topics • Open Access Chemogenomics Library and Chemical Probes for the Druggable Genome • Intelligent prediction and identification of environmental risks posed by human medicinal products Call Launch: 22 Jan 2019

  22. Stay in touch • Visit our new website www.imi.europa.eu • Sign up to our newsletter via the website • Follow us on Twitter @IMI_JU • Join our LinkedIn groupbit.ly/LinkedInIMI • E-mail usinfodesk@imi.europa.eu

  23. Thank you Hugh Laverty • Head of Scientific Operations Hugh.Laverty@imi.europa.eu

  24. The Role Of The Programme Office A neutral broker: • To implement programmes and activities in the common interest of all stakeholders • To monitor the use of public funds and industry investment • To guarantee fair and reasonable conditions for optimal knowledge exploitation and dissemination • To facilitate the interaction between stakeholders, including Intellectual Property agreements • To actively communicate and promote IMI and its activities

  25. Goals of IMI 2 programme Improve the drug development process by creating tools to assess the efficacy, safety and quality of medicines Increase the success rate of clinical trials of new medicines & vaccines Speed up the earlier stages of drug development Develop new treatments for areas of unmet need Develop new biological markers to diagnose diseases and assess treatments

  26. IMI Governance Governing Board Overall strategic orientation & operations States Representatives Group Consultation, opinions Scientific Committee Advice on scientific issues Associated Partners Input on specific Calls / projects Stakeholder Forum Information & feedback Strategic Governing Groups Advice on specific subjects Executive Director | Day-to-day management Programme Office | Day-to-day implementation

  27. IMI and scientific excellence No. publications produced per year is rising fast • In 2016 IMI projects produced 796 publications, bringing the total number of publications to 2 690. • Almost two thirds of all IMI project papers are co-authored by people from different sectors. • These cross-sector papers have a higher citation index (2.17) than papers where all authors are from the same sector (1.80).

  28. IMI and scientific excellence • The citation impact for all IMI papers is 2.03. • IMI’s citation impact is comparable to UK’s Medical Research Council (2.01), the Wellcome Trust (2.05) and the FNIH (1.96). • 26.1% of papers from IMI projects are ‘highly cited’, meaning they are in the top 10 % of papers by journal category and year of publication.

  29. Challenges in the human microbiome fit with a Public-Private Partnership-based approach • Understand the contribution of the microbiome to health and disease • Development of diagnostics • Development of prognostics • Patient monitoring • Identification of targets for modulation to improve human health • Regulatory acceptance

  30. Why get involved? Why apply? • Key research challenges can only be addressed through collaboration of all relevant stakeholders • Funding • Scientifically excellence • Develop your network of international collaborators • Benefit from access to industry data, researchers and resources • Boost the impact of your research, publications, future grants etc • Work in areas with a direct impact on the drug discovery and development process addressing key societal challenges

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