WHY NEW INCENTIVES ARE NEEDED TO DEVELOP ......Suite of push and pull incentives to support...

Suite of push and pull incentives to support antimicrobial innovation Too few antibiotics in the PIPELINE As of May 2017, 51 antibiotics and 11 biologicals were in the clinical pipeline. Only 5 are expected to reach the market Growing antimicrobial RESISTANCE Grants Pipeline coordinators Market Entry Rewards Reimbursement Reforms Transferable Market Exclusivity 10 mil. people are expected to die from infections caused by resistant bacteria by 2050 globally. Already there are 25,000 deaths in the EU alone every year. 25,000 deaths/year 700,000 deaths/year globaly Challenges of applying the traditional economic model Antibiotics are meant to be used appropriately and responsibly. BASIC SCIENCE PHASE I CLINICAL TRIAL PRECLINICAL DEVELOPMENT PHASE III CLINICAL TRIAL PHASE II CLINICAL TRIAL MARKETING AUTHORISATION PUSH INCENTIVES Non-repayable funds for R&D given to academic institutions, companies and others Governmental or non-profit organisations that closely track the antibiotic pipeline, identify gaps, and actively support R&D projects both financially and technically to fill these gaps Payment or series of payments upon approval or other potential milestones The developer would receive an exclusivity extension for another product or would be able to sell it to another company Constantly evolving bacteria Resistance difficult to predict Complex clinical trials Need to adapt regulatory pathways Low awareness about appropriate use Novel antibiotics are undervalued Lack of availability of diagnostics Over-prescription Growing resistance in hospitals Challenges of appropriate use WHY NEW INCENTIVES ARE NEEDED TO DEVELOP ANTIBIOTICS 1 2 Challenges in scientific research 3 3 https://www.ifpma.org/resource-centre/ifpma-infographic-ifpm a-members-antibacterial-compounds-pipeline-inventory-2015/ 1 https://ec.europa.eu/health/am- r/sites/amr/files/amr_summa- ry_action_plan_2017_en.pdf 2 http://drive-ab.eu/wp-content/uploads/2018/01/DRIVE-A B-Executive-Summary-Jan2018.pdf 3 https://www.ifpma.org/wp-content/uploads/2017/01/IFP MA_AMR_Policy_Position_January_2017_FINAL.pdf 4 3,4 4 4 AMR pipeline NEUROLOGICAL DISORDERS pipeline 1329 compounds 62 compounds PULL INCENTIVES Collaboration between all stakeholders

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Transcript of WHY NEW INCENTIVES ARE NEEDED TO DEVELOP ......Suite of push and pull incentives to support...

Suite of push and pull incentives to support antimicrobial innovation

Too few antibiotics in thePIPELINEAs of May 2017,51 antibioticsand 11 biologicalswere in the clinicalpipeline.Only 5 are expectedto reach the market

Growing antimicrobial RESISTANCE

Grants Pipeline coordinators Market Entry Rewards

ReimbursementReforms

Transferable Market Exclusivity

10 mil. people are expected to die from infections caused by resistant bacteria by

2050 globally. Already there are 25,000

deaths in the EU alone every year.

25,000deaths/year

700,000 deaths/year

globaly

Challenges of applyingthe traditional

economic modelAntibiotics are meant

to be used appropriately and

responsibly.

BASICSCIENCE

PHASE I CLINICAL

TRIAL

PRECLINICAL DEVELOPMENT

PHASE III CLINICAL

TRIAL

PHASE II CLINICAL

TRIALMARKETING

AUTHORISATIONPUSH

INCENTIVES

Non-repayable funds for R&D given to academic institutions, companies and others

Governmental or non-pro�t organisations that closely track the antibiotic pipeline, identify gaps, and actively support R&D projects both �nancially and technically to �ll these gaps

Payment or series of payments upon approval or other potential milestones

The developer would receive an exclusivity extension for another product or would be able to sell it to another company

Constantly evolving bacteria

Resistance di�cult to predict

Complex clinical trials

Need to adapt regulatory pathways

Low awareness about appropriate use

Novel antibiotics are undervalued

Lack of availability of diagnostics

Over-prescription

Growing resistance in hospitals

Challenges ofappropriate