Hugh Laverty21 June 2018, UKRO Conference, Southampton

IMI2: linking academia with industry in pharmaceutical research’

IMI – Europe’s partnership for health

Partnership2008 - 2024 €2.5 bn

> €5 bn

€2.5 bn

IMI2: 2014-2024€3.3 bn budgetMore ambitious

More openGreater scope

IMI1: 2008-2017€2 bn budget59 projects

The way in which pharmaceutical companies develop new medicines is changing

New medicines development

Regulatory environment

EU Pricing

Generics

HC Reform

Rising R&D costs

Declining R&D productivity

RWE

Patients

IMI2 – building on successes of IMI1

Focused: stratified medicines and healthcare priorities Healthcare solutions: prevention and treatment End-to-end: R&D, regulatory and access – move

integration a step further Multi-sector: within and beyond life sciences

4

European CommissionFrom H2020

€ 1638 M

Associated Partners

€ 213 M

EFPIA & Partners in Research

€ 1425 M

IMI2

€ 3276 M

IMI2 overall objectives improve the current drug development process through

development of tools, standards & approaches to assess efficacy, safety & quality of health products

develop diagnostic & treatment biomarkers for diseases clearly linked to clinical relevance & approved by regulators

reduce time to clinical proof of concept (e.g. for cancer, immunological, respiratory, neurological/neurodegen. diseases)

increase success rate in clinical trials of priority meds (WHO) develop new therapies for diseases with high unmet need, (e.g.

Alzheimer’s) & limited market incentives (e.g. AMR) reduce failure rate of vaccine candidates in phase III trials

through new biomarkers for efficacy & safety checks- IMI2 legislation -

IMI 2 Strategic Research Agenda Antimicrobial resistance Osteoarthritis Cardiovascular diseases Diabetes Neurodegenerative diseases Psychiatric diseases Respiratory diseases Immune-mediated diseases Ageing-associated diseases Cancer Rare/Orphan Diseases Vaccines

IMI 2 Strategic Research AgendaPriority Themes

1. Neuro-degeneration

2. Immuno-inflammation

3. Metabolic disorders

4. Infection control

5. Translational Safety

6. Data and knowledge management

7. Oncology

1. Imaging

2. ICT

3. Medical devices….

Support Technologies

EnablersPatient access to innovative solutions (MAPPs)- Target validation - Stratified medicine, precision

medicine - Innovative trials - Data generation & interpretation

- Prevention, disease interception

- Patient adherence - Health disease management- Regulatory framework- Reimbursement/patient access

The Vision for IMI2Science is driving the manner in which we view disease

Molecular diagnosisbased on biological

knowledge

We “treat” a population.Some respond and some don’t

We “treat” a targeted populationThey all respond

Population Individual

IMI – Ecosystem for innovative collaborations

Allow engagment in a cross-sector and multi-disciplinaryconsortium at the forefront of cutting-edge research;

Provide the necessary scale by combination of funding, expertise, knowledge, skills and resources;

Build a trustful collaboration upon a creative spirit, innovative and critical thinking;

Gain from each other (new knowledge, skills, ways of working) Be transformative to make a difference in drug development and

ultimately patients’ life.

IMI is a neutral platform where all involved in drug developmentcan engage in open collaboration on shared challenges.

HOW DOES IMI WORK?

IMI 2 life cycle

Call topics definition Strategic Research Agenda Annual Work Plan Strategic Governing Groups Consultation Member-Associated States/Scientific Committee

Call Launch / Evaluation / Grant award

Consortium agreement, Grant agreement, Implementation and Reporting

Strategic Governing Groups - SGG (major actors in Topic Development Process)

Driven and Chaired by Industry, contribution from European Commission and IMI office

Translational Safety Immunology Infections Control Neurodegeneration Metabolic Disorders Knowledge and Data Management Oncology

Topic definition phase

How does IMI work? Two stage procedure

Granting phaseStage 1

Definition of topics by industry consortium

Signature of Consortium and Grant Agreements

SP Submission &Evaluation

Patients’ organisations

Academic research

teams

Regulators

Hospitals

SMEs

Mid-size enterprises

Industryconsortium

Stage 2

FP Submission &Evaluation

Industryconsortium

Applicantconsortium

Call launch

Selected stage 1 team merge with industry

team

Start of the Granting

phaseProject launch!

An international, cross-sector community

Over 11 500 researchers working for: open collaboration improved R&D

productivity innovative approaches

to unmet medical needsFigures from Jan 2018

IMI1 budget distribution per disease area

IMI 1

IMI contributions

EFPIA contributions

Budget distribution per disease area Updated January 2017

Infectious diseases 671 635 805 € •

35%

Drug Discovery 214 201 208 € •

11%

Brain disorders 188 239 313 € • 10%

Drug safety 115 383 536 € • 6%

Metabolic disorders 119 468 874 € • 6%

Cancer74 371 979 € • 4%

Data Management 74 291 023 € • 4%

Inflammatory disorders 67 869 654 € • 4%

Vaccines 47 642 719 € • 2%

Geriatrics 47 453 831€ • 2%

Lung diseases 38 499 367 € • 2%

Sustainable chemistry 32 399 640 € • 2%

Education and Training 39 650 498 € • 2%

Stem cells77 380 311 € •4%

Biologicals 56 023 072 € • 3%

Drug kinetics 18 118 248 € • 1%

Drug Delivery 21 336 248 € • 1%

Relative effectiveness 14 910 397 • € • 1%

Total contributions 1 918 875 722 €

Data

IMICall TopicAcronymDisease AreaIMI contribution euroEFPIA contribution euroAssociated Partners contribution euroTotal contribution euroIMI contribution %EFPIA contribution %Associated Partners contribution %

IMI112MARCARDrug safety6,049,5785,155,60411,205,18254%46%

IMI113eTOXDrug safety6,910,01810,157,59017,067,60840%60%

IMI115SAFE-TDrug safety13,901,97118,326,52132,228,49243%57%

IMI116PROTECTDrug safety11,009,71510,864,49121,874,20650%50%

IMI117IMIDIAMetabolic disorders8,060,76016,940,65925,001,41932%68%

IMI118SUMMITMetabolic disorders14,654,55915,252,05029,906,60949%51%

IMI119EUROPAINBrain disorders6,229,34311,165,74017,395,08336%64%

IMI1110NEWMEDSBrain disorders8,986,21613,789,41222,775,62839%61%

IMI1111PHARMA-COGBrain disorders9,658,38811,690,33321,348,72145%55%

IMI1112U-BIOPREDLung diseases9,935,50114,574,65224,510,15341%59%

IMI1113PRO- ActiveLung diseases6,767,5977,221,61713,989,21448%52%

IMI1115SafeSciMETEducation and Training2,374,9043,607,5405,982,44440%60%

IMI1116PharmaTrainEducation and Training3,510,3003,489,1816,999,48150%50%

IMI1118EU2PEducation and Training3,708,2254,019,6617,727,88648%52%

IMI1114EMTRAINEducation and Training4,324,9993,664,5107,989,50954%46%

IMI126BTCUREInflammatory disorders17,362,87215,616,59532,979,46753%47%

IMI123QUIC-CONCEPTCancer7,000,0006,809,60613,809,60651%49%

IMI124RAPP-IDInfectious diseases6,828,4386,379,04813,207,48652%48%

IMI127DDMoReData Management10,399,42610,616,33621,015,76249%51%

IMI121PREDECTCancer8,756,6419,661,20118,417,84248%52%

IMI129EHR4CRData Management7,194,0447,555,88314,749,92749%51%

IMI128Open PHACTSData Management11,466,4336,412,90517,879,33864%36%

IMI122OncoTrackCancer16,757,28211,201,55727,958,83960%40%

IMI135EU-AIMSBrain disorders20,490,9819,773,54330,264,52468%32%

IMI132ABIRISKBiologicals18,170,2179,450,21127,620,42866%34%

IMI133BioVacSafeVaccines17,425,6647,999,68325,425,34769%31%

IMI136DIRECTMetabolic disorders21,388,64318,816,52740,205,17053%47%

IMI137EUPATIEducation and Training5,250,0005,701,17810,951,17848%52%

IMI131MIP-DILIDrug safety15,335,53812,648,46627,984,00455%45%

IMI134PreDiCT-TBInfectious diseases14,778,8559,296,10624,074,96161%39%

IMI145CHEM21Sustainable chemistry9,829,63813,871,77223,701,41041%59%

IMI143CompactBiologicals10,184,90918,217,73528,402,64436%64%

IMI147K4DDDrug kinetics8,286,9309,831,31818,118,24846%54%

IMI144OrBiToDrug delivery8,975,39212,360,85621,336,24842%58%

IMI141EMIF-ADBrain disorders12,178,42512,177,25224,355,67650%50%

IMI141EMIF- metabMetabolic disorders12,178,42512,177,25224,355,67650%50%

IMI146StemBANCCStem cells26,000,00020,761,38646,761,38656%44%

IMI142eTRIKSData Management10,309,81810,336,17820,645,99650%50%

IMI151EUC²LIDDrug Discovery79,999,15791,337,070171,336,22747%53%

IMI161COMBACTEInfectious diseases109,433,01090,055,721199,488,73155%45%

IMI162TranslocationInfectious diseases15,984,2028,135,83324,120,03566%34%

IMI172GetRealRelative Efectiveness8,000,0006,910,39714,910,39754%46%

IMI171ADVANCEVaccines4,999,8115,017,35310,017,16450%50%

IMI183PRECISESADSInflammatory disorders9,999,3239,890,86519,890,18850%50%

IMI184AETIONOMYBrain disorders7,993,2348,021,46016,014,69450%50%

IMI185EBiSCStem cells21,840,3798,778,54630,618,92571%29%

IMI182ENABLEInfectious diseases58,900,00022,952,36081,852,36072%28%

IMI181APCInfectious diseases0ERROR:#DIV/0!ERROR:#DIV/0!

IMI191WEB-RADRDrug safety2,270,0002,754,0445,024,04445%55%

IMI192SPRINT-TGeriatrics23,999,43923,454,39247,453,83151%49%

IMI193Combacte-CareInfectious diseases23,871,50059,317,76083,189,26029%71%

IMI194DRIVE ABInfectious diseases6,299,9873,105,2509,405,23767%33%

IMI1101FLUCOPVaccines6,100,0006,100,20812,200,20850%50%

IMI1111APPROACHInflammatory disorders7,500,0007,499,99914,999,99950%50%

IMI1112EPADBrain disorders25,880,00030,204,98656,084,98646%54%

IMI1113Cancer IDCancer6,620,0007,565,69214,185,69247%53%

IMI1114ZAPIInfectious diseases9,538,6889,875,00019,413,68849%51%

IMI1115ULTRA-DDDrug Discovery21,200,00021,664,98142,864,98149%51%

IMI1116Combacte-MAGNETInfectious diseases75,340,00091,662,413167,002,41345%55%

IMI1117IABCInfectious diseases24,331,60925,550,02549,881,63449%51%

IMI1118IPIESustainable chemistry3,000,0005,698,2308,698,23034%66%

Sheet4

IMIIMI1

Call (All)

Row LabelsSum of IMI contribution euroSum of EFPIA contribution euroSum of Total contribution euroCount of IMI contribution euro

Infectious diseases34530628932632951667163580510

Drug Discovery1011991571130020512142012082

Brain disorders91416586.596822725.51882393127

Metabolic disorders56282386.563186487.51194688744

Drug safety55476820599067161153835366

Stem cells4784037929539932773803112

Cancer3913392335238056743719794

Data Management3936972134921302742910234

Inflammatory disorders3486219533007459678696543

Biologicals2835512627667946560230722

Vaccines2852547519117244476427193

Geriatrics2399943923454392474538311

Education and Training1916842820482070396504985

Lung diseases1670309821796269384993672

Sustainable chemistry1282963819570002323996402

Drug delivery897539212360856213362481

Drug kinetics82869309831318181182481

Relative Efectiveness80000006910397149103971

Grand Total965730983953144739191887572260

IMI 1 Charts

IMI1 projects

Interest areaIMI contributionEFPIA contribution Total contribution Percentage TotalNumber of projects

Infectious diseases345,306,289326,329,516671,635,80535%10

Drug Discovery101,199,157113,002,051214,201,20811%2

Brain disorders91,416,58796,822,726188,239,31310%7

Metabolic disorders56,282,38763,186,488119,468,8746%4

Drug safety55,476,82059,906,716115,383,5366%6

Stem cells47,840,37929,539,93277,380,3114%2

Cancer39,133,92335,238,05674,371,9794%4

Data Management39,369,72134,921,30274,291,0234%4

Inflammatory disorders34,862,19533,007,45967,869,6544%3

Biologicals28,355,12627,667,94656,023,0723%2

Vaccines28,525,47519,117,24447,642,7192%3

Geriatrics23,999,43923,454,39247,453,8312%1

Education and Training19,168,42820,482,07039,650,4982%5

Lung diseases16,703,09821,796,26938,499,3672%2

Sustainable chemistry12,829,63819,570,00232,399,6402%2

Drug Delivery8,975,39212,360,85621,336,2481%1

Drug kinetics8,286,9309,831,31818,118,2481%1

Relative Efectiveness8,000,0006,910,39714,910,3971%1

Grand Total965,730,983953,144,7391,918,875,722100%60

The total number of projects is 60 because project EMIF (IMI1 Call 4) has two areas of interest.

Legend:EFPIA contribution

IMI contribution

671 635 805 €

Infectious diseases - 35%

Infectious diseases345306289326329516

47 453 831€

Geriatrics - 2%

Geriatrics2399943923454392

38 499 367 €

Lung diseases - 2%

Lung diseases1670309821796269

32 399 640 €

Sustainable chemistry - 2%

Sustainable chemistry1282963819570002

39 650 498 €

Education and Training - 2%

Education and Training1916842820482070

18 118 248 €

Drug kinetics - 1%

Drug kinetics82869309831318

77 380 311 €

Stem cells - 4%

Stem cells4784037929539932

56 023 072 €

Biologicals - 3%

Biologicals2835512627667946

Drug Delivery - €

21 336 248 - 1%

Drug Delivery897539212360856

14 910 397 €

Relative Efectiveness - 1%

Relative Efectiveness80000006910397

214 201 208 €

Drug Discovery - 11%

Drug Discovery101199157113002051

188 239 313 €

Brain disorders - 10%

Brain disorders9141658796822726

115 383 536 €

Drug safety - 6%

Drug safety5547682059906716

119 468 874 €

Metabolic disorders - 6%

Metabolic disorders56282386.563186487.5

74 371 979 €

Cancer - 4%

Cancer3913392335238056

74 291 023 €

Data Management - 4%

Data Management3936972134921302

67 869 654 €

Inflammatory disorders - 4%

Inflammatory disorders3486219533007459

47 642 719 €

Vaccines - 2%

Vaccines2852547519117244

Infographics

Vaccines2852547519117244Geriatrics2399943923454392Lung diseases1670309821796269Sustainable chemistry1282963819570002Education and Training1916842820482070Stem cells4784037929539932Biologicals2835512627667946Drug kinetics82869309831318Drug Delivery897539212360856Relative Efectiveness80000006910397Infectious diseases345306289326329516Infectious diseases345306289326329516Drug Discovery101199157113002051Drug Discovery101199157113002051Drug Discovery101199157113002051Drug Discovery101199157113002051Brain disorders9141658796822726Drug safety5547682059906716Metabolic disorders56282386.563186487.5Cancer3913392335238056Data Management3936972134921302Inflammatory disorders3486219533007459

Total contributions 1 918 875 722 €

IMI contributions

EFPIA contributions

Total contributions 1 918 875 722 €

IMI2 budget distribution per disease area

Distribution of funding per scientific areaUpdated February 2017

Infections control 316 925 777 €

•48%IMI 2

Total contributions 663 895 301 €

Neurodegeneration 82 362 270 €

• 12%Other54 785 976 € • 8%

Diabetes / metabolic desorders 64 576 544 € • 10%

Translational safety 38 251 191 € • 6%

Oncology 55 277 396 € • 8%

IMI contributionsEFPIA contributions Associated partners contributions

Data and knowledge management 51 716 147 € • 8 %

IMI2 projects

IMICall TopicProject AcronymScientific area main categoryScientific area subcategoryIMI contribution euroEFPIA contribution euroAssociated Partners contribution euroTotal contribution euroIMI contribution %EFPIA contribution %Associated Partners contribution %

IMI211INNODIADiabetes/metabolic desordersType 1 diabetes17,630,00012,745,1915,577,31635,952,50749%35%16%

IMI221VSV-EBOVACInfections controlVaccines3,887,260003,887,260100%0%0%

IMI221EBOVAC1Infections controlVaccines58,336,88533,745,758092,082,64363%37%0%

IMI221EBOVAC2Infections controlVaccines22,790,82013,880,240036,671,06062%38%0%

IMI225Mofina Infections control1,162,622001,162,622100%0%0%

IMI225FILODIAGInfections control2,260,105002,260,105100%0%0%

IMI225EbolaMoDRADInfections control4,300,935004,300,935100%0%0%

IMI222EBOMANInfections controlVaccines1,023,32547,642,879048,666,2042%98%0%

IMI224EBODACInfections controlVaccines20,328,8565,412,000025,740,85679%21%0%

IMI231RADAR-CNSData and knowledge managementPsychiatry AND Neurology AND Immunology AND Digital health11,000,00013,322,379024,322,37945%55%0%

IMI232RHAPSODYNeurodegenerationType 2 diabetes8,130,0006,882,049015,012,04954%46%0%

IMI233PRISMOtherPsychiatry AND Neurodegeneration8,080,0008,479,551016,559,55149%51%0%

IMI234VAC2VACInfections controlVaccines7,850,0008,128,429015,978,42949%51%0%

IMI235PERISCOPEInfections controlVaccines14,000,0007,125,1157,000,00028,125,11550%25%25%

IMI241ADAPT-SMARTOtherInnovative clinical paradigms 1,130,0001,979,13103,109,13136%64%0%

IMI251PREFEROtherInnovative clinical paradigms6,000,0006,000,000012,000,00050%50%0%

IMI252BEAt-DKDDiabetes/metabolic desordersDiabetic kidney disease15,085,93711,687,1001,851,00028,624,03753%41%6%

IMI253PHAGONeurodegenerationAlzheimer's disease8,838,0009,092,496017,930,49649%51%0%

IMI254AMYPADNeurodegenerationAlzheimer's disease11,999,88612,233,950024,233,83650%50%0%

IMI255MOPEADNeurodegenerationAlzheimer's disease2,043,0001,967,25104,010,25151%49%0%

IMI256ADAPTEDNeurodegenerationAlzheimer's disease3,510,0003,286,74006,796,74052%48%0%

IMI261TransQSTTranslational safety8,000,0007,802,874015,802,87451%49%0%

IMI262RESCEUInfections controlrespiratory diseases AND vaccines14,498,12514,673,665029,171,79050%50%0%

IMI263ROADMAPData and knowledge managementAlzheimer's disease and Data Knowledge Management (Big Data) 3,998,2503,768,72607,766,97651%49%0%

IMI264HARMONYOncologyCancer & Data Knowledge Management (Big Data)20,000,00019,294,265039,294,26551%49%0%

IMI271TRISTANTranslational safetyDrug safety12,000,00010,448,317022,448,31753%47%0%

IMI272IMPRINDNeurodegenerationAlzheimer's & Parkinson's disease 4,684,9986,365,900011,050,89842%58%0%

IMI273NGN-PETNeurodegenerationPain AND Aging related diseases1,500,0001,828,00003,328,00045%55%0%

IMI274MACUSTAROtherOphtalmology8,025,0007,937,644015,962,64450%50%0%

IMI275ITCC-P4OncologyCancer 7,370,0008,613,131015,983,13146%54%0%

IMI276DO-ITOther3,549,8333,604,81707,154,65050%50%0%

IMI277BigData4HeartData and knowledge managementCardiovascular disease and Data Knowledge Management (Big Data) 9,664,9709,961,822019,626,79249%51%0%

IMI281VSV-EBOPLUSInfections controlVaccines8,553,7507,208,545015,762,29554%46%0%

IMI281PEVIAInfections controlVaccines6,189,5706,926,893013,116,46347%53%0%

IMI291Clostridium difficileInfections controlantimicrobial resistance

IMI292Rheumatic DiseasesImmunologyImmune-mediated diseases

IMI293Data quality in pre-clinicalNeurodegenerationNeurodegeneration & Drug Safety

IMI294NEXGETSTranslational safety

IMI295LITMUSDiabetes/metabolic desordersNon alcoholic fatty liver disease

IMI296DRIVEInfections controlVaccines

IMI2101HypoglycaemiaDiabetes/metabolic desordersDiabetes

IMI2102Data for prostate cancerOncologyCancer and Data Knowledge Management (Big Data)

IMI2103Chronic painNeurodegenerationPain AND Aging related diseases

IMI2104Paediatric trial networkOtherPaediatric

IMI2105BiomanufacturingOther

IMI2106Solute carrierOther

IMI2107Patient perspectiveOtherInnovative clinical paradigms

IMI2108AutismOtherPsychiatry

Pies

Call (Multiple Items)

Row LabelsSum of IMI contribution euroSum of EFPIA contribution euroSum of Associated Partners contribution euroSum of Total contribution euroCount of Project Acronym

Infections control165182253144743523.657000000316925776.6513

Neurodegeneration40705884416563860823622707

Diabetes/metabolic desorders32715937244322917428316645765442

Oncology27370000279073960552773962

Other26784833280011430547859765

Data and knowledge management24663220270529270517161473

Translational safety20000000182511910382511912

Grand Total337422127312044857.6514428316663895300.6534

IMI 2 project by scientific area

IMI2 calls 1 to 8

Row LabelsIMI contribution euroEFPIA contribution euro Associated Partners contribution euroTotal contribution euroPercentage TotalNumber of projects

Infections control165,182,253144,743,5247,000,000316,925,77748%13

Neurodegeneration40,705,88441,656,386082,362,27012%7

Diabetes/metabolic desorders32,715,93724,432,2917,428,31664,576,54410%2

Oncology27,370,00027,907,396055,277,3968%2

Other26,784,83328,001,143054,785,9768%5

Data and knowledge management24,663,22027,052,927051,716,1478%3

Translational safety20,000,00018,251,191038,251,1916%2

Total337,422,127312,044,85814,428,316663,895,301100%34

316 925 777 €

Infections control - 48%

Infections control165182253144743523.650000017000000

82 362 270 €

Neurodegeneration - 12 %

Neurodegeneration40705884416563860

64 576 544 €

Diabetes/metabolic desorders - 10%

Diabetes/metabolic desorders32715937244322917428316

55 277 396 €

Oncology - 8%

Oncology27370000279073960

54 785 976 €

Other 8%

Other26784833280011430

51 716 147 €

Data and knowledge management - 8 %

Data and knowledge management24663220270529270

38 251 191 €

Translational safety - 6 %

Translational safety20000000182511910

Total

[CELLRANGE][CELLRANGE], [CELLRANGE],

337422127312044857.6499999814428316IMI contribution euroEFPIA contribution euro Associated Partners contribution euro

Sheet1

Neurodegeneration40705884416563860

Diabetes/metabolic desorders32715937244322917428316

Translational safety20000000182511910

Infections control165182253144743523.650000017000000

Oncology27370000279073960

Other26784833280011430

Data and knowledge management24663220270529270

Infections control 316 925 777 ۥ 48%

Neurodegeneration 82 362 270 ۥ 12%

Other54 785 976 € • 8%

Diabetes / metabolic desorders 64 576 544 € • 10%

Translational safety 38 251 191 € • 6%

Oncology 55 277 396 € • 8%

Data and knowledge management 51 716 147 € • 8 %

IMI1Participations: 372 (1741) 21%Budget: €238,575,125 25%

IMI2Participations: 240 (1175) 20%Budget: €189,858,122 32%

UK participation in IMI

Figures as of June 2018

Some Specific Examples

The problem

Antibiotics resistance 'as big a risk as terrorism' – UK medical chief

Three million Europeans catch infections in hospital annually

Antibiotic resistance: we must act now, says WHO

17 Janvier 2008: La résistance des bactéries aux antibiotiques a atteint une dimension planétaire

IMI - New Drugs for Bad Bugs

How to get new drugs into bad bugs

Pan-European network of clinical/laboratory sites

Collaboration on clinical trials

Platform for antibiotic development

New business models

Part of EU AMR programme 7 projects €700 million budget

Cross-project communication & collaboration

ND4BB Information CentreAll data generated is submitted and made accessible to all partners

TRANS-LOCATION

Research on penetration & efflux in Gram-negativesData hub & learning from R&D experience

ENABLEDiscovery & development of new drugs combatting Gram-negative infections

COMBACTEEnabling clinical collaboration & refining clinical trial designClinical development of compounds for Gram positives

COMBACTE-CARE

Clinical development of antibacterial agents for Gram-negative, antibiotic resistant pathogens

COMBACTE-MAGNET

Systemic molecules against healthcare-associated infections

DRIVE-ABDriving reinvestment in R&D & responsible use of antibiotics

iABCInhaled antibact-erials in bronchiec-tasis and cystic fibrosis

Drug discovery

New Drugs for Bad Bugs (ND4BB)

Drug development

(Gram-positives)

Drug development

(Gram-negatives)

Economics & stewardship

ND4BB programme – Clinical development of new compounds against AMR

Phase I Phase II Phase III Regulatory Review

Clinical Development

Phase IV

Commercialisation

COMBACTE-MAGNET

COMBACTE

COMBACTE-CARE

iABC

Patients

MEDI4893 for prevention S. Aureus infections incl. MRSA; Minocycline in A. baumannii infections

Aztreonam-Avibactam for treatment Gram negative infections incl. MDR

MEDI 3902 for prevention P. aeruginosa infections AIC499 for treatment Gram negative infections

inhaled formulation of Murepavadin (POL7080) in CF patientstobramycin inhalation powder in BE patients

+ Observational studies to inform the development of new compounds

Sustainable clinical trial investigator (CLIN-NET), laboratory (LAB-NET) networks + methodological (STAT-NET) & epidomiological (EPI-NET) networks

Projects on Ad26.ZEBOV / MVA-BN-Filo prime-boost candidate vaccine regimenEBOVAC1, EBOVAC2: Clinical studies in Africa & EuropeEBOMAN: Vaccine manufactureEBODAC: Vaccine deployment & compliance

VSV-EBOVACGoal: characterise the immune response triggered by the rVSV-ZEBOV candidate vaccine

FILODIAG, MOFINA, EbolaMoDRADGoal: all aim to develop rapid diagnostic tests capable of delivering reliable results at the point of care in as little as 15 minutes

IMI2 Ebola+ programme

Mofina

Successfully miniaturised Altona RealstarFilovirus assay to fit Alere Q automated PCR system.

Allows accurate diagnosis in the field with 75 minute turnaround

CE-IVD approved for use in Europe FDA registration in progress

Alzheimer’s disease – a major unmet need

Alzheimer’s disease in numbers… 46.8 million

affected globally 10.5 million

in Europe Global cost

USD 818 billion (EUR 732 billion)

IMI action on Alzheimer’s disease

PHARMA-COGMatrix of biomarkers Test efficacy

of new treatments

EMIFLinking & analysing data Identify those

at risk

AETIONOMYNew classification of AD/PD Personalised

treatments

EPAD‘Adaptive’ clinical trials Faster drug

development & patient access

Total budget€169 million

Sharing data to improve clinical trials for schizophrenia

By redesigning clinical trials, you could: make them shorter (6 weeks 4 weeks)

require fewer people (79 46 patients per arm)

cut costs (savings of €2.8 million)

gain insights into effects of treatment on negative symptoms (e.g. lack of emotion)

23 000 patients 67 studies 25 countries 1 database

Collaborative Drug Discovery: ELF

Public contribution(200,000 cpds by 2017)

EFPIA contribution(>300,000 cpds)

- uHTS- Compound logistics- Hit triage- Medicinal Chemistry

JointEuropeanCompoundLibrary

EuropeanScreeningCentre

LIBRARY DESIGNS

DRUG TARGETS

European Lead Factory - results Motor neurone disease Based on the hits generated by the European Lead Factory, Dr Richard Mead, University of Sheffield, started the spin-out virtual biotech

Keapstone Therapeutics, a world-first type of partnership between Parkinson's UK and the University of Sheffield. Keapstone Therapeutics aims to develop a new therapy for motor neurone disease (MND/ALS) and/or Parkinson’s disease. https://www.europeanleadfactory.eu/node/227

Diabetes Scandicure, in collaboration with the IMI-funded European Lead Factory, has developed inhibitors of a novel biological target for non-

alcoholic steatohepatitis (NASH), type-2 diabetes and potentially other metabolic diseases. https://www.europeanleadfactory.eu/node/269

Antimicrobial resistance ENABLE takes on Oxford antibiotic resistance programme The University of Oxford takes the next step in targeting antimicrobial resistance, with help of the results and hit compounds delivered by the

European Lead Factory. The Oxford team, led by Professor Chris Schofield, has got the opportunity to collaborate with the European Gram-Negative Antibacterial Engine (ENABLE) project to further progress this programme towards clinical development. https://www.europeanleadfactory.eu/node/52

Oncology At the end of 2017, Prof Reuven Stein received an extraordinary Qualified Hit List from the European Lead Factory. His research group

studies the tumour microenvironment (TME) and has discovered a protein that plays an essential role in tumour progression. With the promising ELF compounds, they hope to develop new treatments for cancers such as glioma and melanoma. https://www.europeanleadfactory.eu/node/267

Depression and pain, African sleeping sickness, Chagas disease, Leishmania parasite & Dengue virus

https://www.keapstone.com/https://www.europeanleadfactory.eu/node/227https://www.europeanleadfactory.eu/node/269https://www.europeanleadfactory.eu/node/52https://www.europeanleadfactory.eu/node/267

Drug repurposing: a strategy to develop new treatments - IMI2 Call13 Large amount of data arising from terminated programmes are

available for these compounds This information is useful to test hypotheses in alternative therapeutic

indications may accelerate the transition of these compounds from bench to market in a cost effective way

Objective: To investigate the therapeutic potential of nine previously deprioritised clinical compounds in new clinical indications in areas of high unmet need: Cardiovascular diseases and diabetes Respiratory diseases Neurodegenerative diseases Rare/orphan diseases

Measures of Success

New models developed &

published

Better evidence-based decision making

Setting new standards

Useby industry

Impact on regulatory framework

Better drugs and impact on

medical practice

Future IMI Calls for proposalsThe following topics are currently under consideration for inclusion in future IMI Calls for proposals:

Integrated research platforms enabling patient-centric drug development Blockchain enabled healthcare Emerging translational safety technologies and tools for interrogating human

immuno-biology Digital transformation of clinical trials endpoints Microenvironment imposed signatures in tissue and liquid biopsies in immune

mediated disease Development and validation of translational platforms in support of

synaptopathy drug discovery

Antimicrobial resistance (AMR) accelerator programme:The AMR Accelerator programme consists of three pillars under which multiple projects are expected:

Pillar A: Capability building network (CBN) Pillar B: Tuberculosis drug development network (TBDDN) Pillar C: Company-specific portfolio building networks (PBNs)

Priorities and first batch of ideas for future IMI2 calls

Immunology

• Treatment of non-response and remission

• Non-invasive molecular imaging of immune cells

Antimicrobial resistance • Clinical trials networks • Accelerator of AMR R&D

Digital Health/Big Data

• Remote clinical trials • Biosensors/digital endpoints in clinical

development Modernisation of clinical trials and regulatory pathways

• Addressing the challenge of platform trials (Integrated Research Platforms)

Commission Communication 11 Jan. 2018"Horizon 2020 interim evaluation: maximising the impact of EU R&I" The Commission intends to explore in the Impact Assessment of

the future programme: rationalising partnerships (including KICs and Future and Emerging

Technologies Flagships), improve their openness and transparency, and Link them with future EU R&I missions and strategic priorities.

It will consider, as part of a strategic process, for example, the additionality of capabilities, relevance for political priorities agreed between the EU, Member States, industry and other stakeholders, flexibility, exit strategies integrated from the start, and delivery of impacts that cannot be achieved through the Framework Programme alone.

Expected Timelines FP9 and Partnerships June 2018 Commission adopted proposals for EU's long term

2018 budget and the proposals for the EU programmes Discussion/ negotiation with Council and European Parliament has

started

FP9 presents criteria for the selection, but does not identify specific, partnerships nor missions. End of 2018 Identification of potential partnerships

For partnerships established under Art 187 (public private partnerships established as Joint Undertakings) or Art 185 (public public partnerships)

During 2019 Impact Assessments and preparation of the legal basis of proposed partnerships for adoption by the new Commission

During 2020 Negotiation with Council and EP for proposals 2021 Implementation through the Work Programmes of FP9

New approaches are needed

“Deciphering the complexity of human diseases and finding safe,cost-effective solutions that help people live healthier lives requirescollaboration across scientific and medical communitiesthroughout the health care ecosystem.

Indeed, we must acknowledge that no single institution, company,university, country, or government has a monopoly oninnovation.”

Visit our new websitewww.imi.europa.eu

Sign up our newsletterbit.ly/IMInewsletter

Follow us on Twitter@IMI_JU

Join our LinkedIn groupbit.ly/LinkedInIMI

Email usinfodesk@imi.europa.eu

Thank you

Thank you

Hugh Laverty • Head of Scientific Operations

Hugh.Laverty@imi.europa.eu

Slide Number 1IMI – Europe’s partnership for healthSlide Number 3IMI2 – building on successes of IMI1 IMI2 overall objectivesIMI 2 Strategic Research AgendaIMI 2 Strategic Research Agenda The Vision for IMI2� Science is driving the manner in which we view diseaseIMI – Ecosystem for innovative collaborationsSlide Number 10IMI 2 life cycleStrategic Governing Groups - SGG �(major actors in Topic Development Process)How does IMI work? Two stage procedureAn international, cross-sector communityIMI1 budget distribution per disease areaIMI2 budget distribution per disease areaSlide Number 17Slide Number 18The problemIMI - New Drugs for Bad BugsNew Drugs for Bad Bugs (ND4BB)Slide Number 22IMI2 Ebola+ programmeMofinaAlzheimer’s disease – a major unmet needIMI action on Alzheimer’s diseaseSharing data to improve �clinical trials for schizophreniaCollaborative Drug Discovery: ELFEuropean Lead Factory - resultsDrug repurposing: a strategy to develop new treatments - IMI2 Call13 Slide Number 31Slide Number 32Slide Number 33Commission Communication 11 Jan. 2018�"Horizon 2020 interim evaluation: maximising the impact of EU R&I"Expected Timelines FP9 and PartnershipsSlide Number 36Slide Number 37Slide Number 38