AMR: from science to patienttranslating. medical practice

Transcription

1 AMR: from science to patienttranslating research into medical practice Scientific support for public health: existing Actions, New challenges and European added value 14 th November

2 The Objective A sustainable supply of new antibiotics to treat severe resistant infections Managed to conserve effectiveness Available globally where needed at affordable prices Supplied by a group of large and small companies for whom this is a viable form of business IMI is key 2

3 The need for a new approach 5 yr 8 yr 20 years Disc. Ph 1-3 On market The typical antibiotic lifecycle can be modeled from start to finish 1 The model allows for failed drugs Spend and revenue by year are best on industry average data Note the Phase 3 bump in spend And then a sales curve: ~10 years of protected sales and then ~10 years of declining sales On standard industry models antibiotics offer limited returns Significant disinvestment over last 30 years 3

4 The need for a new approach 5 yr 8 yr 20 years The typical antibiotic lifecycle can be modeled from start to finish 1 The model allows for failed drugs Spend and revenue by year are best on industry average data Note the Phase 3 bump in spend And then a sales curve: ~10 years of Disc. Ph 1-3 On market protected sales and then ~10 years of declining sales On standard industry models antibiotics offer limited returns Significant disinvestment over last 30 years No single cause (research, development, commercialisation) No silver bullet No solution at all without collaboration No collaboration without a shared objective No achievement of objectives without an institutional context that can support a long-term perspective 4

5 ND4BB: Proposed Program, from 2014 ND4BB cross topic collaboration and dissemination Topic 1: COMBACTE a) Enabling Clinical Collaboration and refining clinical trial design b) Clinical Development of GSK c) Clinical Development of MEDI4893 Topic 2 : TRANSLOCATION Research penetration and efflux Gram-negatives Data Hub and Learning from R&D experience Topic 3 : ENABLE Discovery & development of new drugs combatting Gram negative infections Topic 4: Driving re-investment in R&D and Responsible use of Antibiotics Topic 5: Clinical development of antibacterial agents for Gram-negative antibiotic resistant pathogens Topic 6: Systemic molecules against HAIs due to clinically challenging Gram-negative pathogens Topic 7: Inhaled Antibacterials in CF and non-cf BE Development Discovery Economics & stewardship Development ND4BB Information Centre All data generated is submitted and is accessible to all consortium partners Development, Discovery, & Economics Call 6 Call 8 Call 9 Call 11 5

6 We re now tackling the entire model! 5 yr 8 yr 20 years ND4BB & Discovery Disc. Ph 1-3 ND4BB On market & Development The typical antibiotic lifecycle can be modeled from start to finish 1 ND4BB & New business models The model allows for failed drugs Spend and revenue by year are best on industry average data The tiered approach Note the Phase 3 bump in spend And then a sales curve: ~10 years of protected sales and then ~10 years of declining sales With ND4BB and tiered approach, we are truly taking a systems approach to this problem ND4BB s Discovery and Development support + the tiered approach is already having an impact It s not about subsidies, but about changing the way we do things And we re also pleased to be starting Topic 4 6

7 Topic 4: Just now starting: Economics & Stewardship Just now starting, no catchy name yet Driving re-investment in R&D and Responsible use of antibiotics DRIIRADARUOA? A better name is coming, I promise Aim: Address the tension between economics & stewardship Create a multi-disciplinary, multi-stakeholder community with an in depth comprehension of challenges Develop implementable options for new commercial models that address the needs of multiple stakeholders, Validate options through modelling We expect Topic 4 to explore a broad range of approaches Fee-based approaches. Insurance-based approaches We don t know how to do these... yet! 7

8 In closing Thank you for organizing this discussion Antibiotics are the most life-saving drugs invented But, a post-antibiotic era is now a real possibility The incredibly thin pipeline has many causes A path to a diverse, sustainable pipeline must be found We ve made a lot of progress! Thank you! Discovery: ND4BB is opening doors Development: Now improved! ND4BB will augment Economics: Tiered framework; new business models With many thanks to all who are part of these amazing endeavours! EFPIA perspective on PPPs, business models, & regulatory frameworks 8