DRIVE-AB

Driving re-investment in R&D and responsible antibiotic use
DRIVE-AB logo

FACTS & FIGURES

Start Date
End Date
Call
IMI1 - Call 9
Grant agreement number
115618

Type of Action: 
RIA (Research and Innovation Action)

Contributions
IMI Funding
6 299 987
EFPIA in kind
3 105 250
Other
1 563 439
Total Cost
10 968 676

Summary

There is a contradiction at the heart of antibiotic development. On the one hand, we urgently need new antibiotics to treat resistant infections. At the same time, the use of new antibiotics should be restricted, so as to minimise the risk of bacteria developing resistance to them. As a result of this situation, the potential return on investment is much lower than in most other medical fields. DRIVE-AB is developing concrete recommendations for new economic models that would provide industry with an incentive to invest in this area while reconciling this with the need to use new antibiotics wisely.

Antibiotic resistance (ABR) represents a serious and growing threat to human and animal health worldwide. In the EU alone, ABR is responsible for some 25 000 deaths every year, and the annual treatment and social costs have been estimated at some €1.5 billion. Meanwhile, new forms of resistance continue to arise and spread, leaving clinicians with few weapons to bring infections under control. Yet despite the recognised need for new antibiotics, the reality is that only two new classes of antibiotics have been brought to the market in the last three decades.

The reasons for this are manifold. On the scientific front, there is an urgent need for a greater understanding of how antibiotics work. In the regulatory arena, running clinical trials on new antibiotics is extremely challenging and costly. However, efforts to develop new antibiotics are also hampered by economics.

When bacteria are exposed to a new antibiotic, there is a risk that they will develop resistance. Therefore, new antibiotics should only be used when absolutely necessary, and ‘wise’ or ‘responsible’ use of antibiotics in both humans and animals represents a key aspect of wider efforts to tackle the spread of AMR. This means that sales of new antibiotics should be low, and as a result, the costs of development often exceed any potential return on investment. In other words, antibiotic development is simply no longer a financially viable option for large pharmaceutical companies, and only a few of such companies remain focused on this field.

Reconciling responsible use and economic incentives

DRIVE-AB’s goal is to design the building blocks of an innovative economic model that simultaneously incentivises the development of new antibiotics while ensuring they are used wisely.

One of the first tasks of the project is to deliver an evidence-based, consensus definition of ‘responsible antibiotic use’. They will also use data from surveillance systems, antibiotic prescription databases, and the scientific literature to estimate the current burden of ABR from clinical and economic standpoints. This information will feed into simulation models designed to estimate how ABR will impact on future public health needs in a range of socio-economic settings. These resources will enable the project team to devise valuation models capable of estimating the true value of new and existing antibiotics from the perspectives of patients, physicians, payers, and society as a whole.

The team will draw on all of these resources to generate alternative economic strategies and reward models that are in line with the project’s objective of promoting wise antibiotic use, incentivising antibiotic development, and ensuring access to all patients in need. The models will be tested extensively, and the most promising ones will be analysed, tested and explored in detail in collaboration with a multidisciplinary platform that brings together key stakeholders concerned about this issue.

At the end of the project, the strongest models and their implementation strategies will be presented at a stakeholder conference. The project is also committed to communicating its outcomes to governments and policymakers worldwide.

A strong team

The DRIVE-AB project brings together partners from academia and large pharmaceutical companies, with expertise in ABR, education and campaigning, health economics, health policy, political science, entrepreneurship, and pricing and market access. As such it is well placed to deliver solutions to the economic part of the puzzle of tackling ABR.

Achievements & News

DRIVE-AB recommends ecosystem approach to drive antibiotic development
January 2018

A mix of economic drivers and incentives is needed to stimulate antibiotic development, according to the final report of IMI’s DRIVE-AB project. The report, based on input from diverse stakeholders, highlights four incentives that would be the most effective in stimulating the antibiotic pipeline while also ensuring that critical antibiotics are used sustainably and are accessible to all who need them. ###The incentives picked out by the report are:

  • Grants: non-repayable funds for R&D given to academic institutions, companies and others;
  • Pipeline coordinators: governmental or non-profit organizations that closely track the antibiotic pipeline (or subsets thereof), identify gaps, and actively support R&D projects both financially and technically to fill these gaps;
  • Market entry rewards: a series of financial payments to an antibiotic developer for successfully achieving regulatory approval for an antibiotic that meets specific predefined criteria to address a defined public health need, with obligations for sustainable use, equitable availability and supply;
  • Long-term supply continuity model: a delinked payment to create a predictable supply of important generic antibiotics.

All of the recommended incentives would include mandatory provisions for equitable access and sustainable use in order to ensure these critical medicines are available to patients who need them globally, and remain effective over time. ‘The models are meant to be complementary and don’t operate in isolation. Instead, they’re designed to form an ecosystem that maximizes R&D while ensuring access and sustainable use of new antibiotics over time,’ said Christine Årdal, DRIVE-AB partner and Senior Advisor at the Norwegian Institute of Public Health.

Read the project’s press release

DRIVE-AB recommendations to stimulate the development of new antibiotics
December 2017

New antibiotics will have to be used sparingly to preserve their efficacy. IMI’s DRIVE-AB focuses on ways to stimulate their development. A combination of incentives is required, the researchers note. In particular, they highlight the need to ‘delink’ the revenue generated by new drugs from the quantities sold. To do so, they propose a combination of push and pull mechanisms. ### Priority grants could, for example, be used to get the innovation process moving. A system of rewards for market entry could be set up to encourage its completion. This type of approach would contrast with the business model traditionally applied to drugs, where income depends on the volume of sales.

DRIVE-AB ends in December 2017, and the partners are preparing to publish their final report along with detailed recommendations. ‘We have aimed to encourage a balance between innovation and responsible use,’ says Nicole Mahoney of Merck Sharp & Dohme (MSD), one of the project partners. Policymakers and other stakeholders could find ample inspiration in DRIVE-AB’s conclusions. As a first step, the project’s findings might, for instance, feed into pilot studies at national levels, says Mahoney. ‘We may well see individual countries trialling some of these ideas and setting up reward mechanisms that work within their local context,’ she concludes.

‘Revitalising the Antibiotic Pipeline’ – DRIVE-AB’s final conference
July 2017

'Revitalising the Antibiotic Pipeline', the final conference of IMI’s DRIVE-AB project, will be held in Brussels, Belgium on 5-6 September 2017. The event will bring together high-level policy makers, regulatory and public health experts, economists and representatives of pharmaceutical companies, the medical community and civil society to discuss DRIVE-AB’s results and recommendations and suggest solutions for their implementation around the globe.###Some confirmed faculty members include representatives from the World Health Organization, the European Investment Bank, the Biomedical Advanced Research and Development Authority, the Drugs for Neglected Diseases initiative, and the EU Joint Programming Initiative for AMR. In addition, over 20 posters on DRIVE-AB research and results will be showcased at the conference. Spaces are filling up fast - if you are interested in attending the conference, register your interest with Victoria Wells at VWells@BSAC.org.uk.

DRIVE-AB discusses proposals on economic models for antibiotic innovation
June 2016

IMI project DRIVE-AB is working to define new, alternative economic models for antibiotic development that balance the need to reward those who develop new antibiotics with the need to use new antibiotics only when absolutely necessary. Now the project has shared its preliminary ideas with 180 high-level experts at a conference in Amsterdam, the Netherlands on 2 June. ###Some key points arising from discussions at the event include:

  • Hospital stewardship programmes and antibiotic regulation are either lacking or insufficient in many parts of the world.
  • Efforts to address antibiotic resistance should be coordinated globally.
  • Reward models for antibiotics should align with sustainable use policies and delink the volume of sales from return on investment.
  • New reward models should be piloted in appropriate settings as soon as possible, with support from pharmaceutical companies.
  • Innovation and sustainable use are only part of the equation for addressing antibiotic resistance. Infection prevention and control, vaccine use and a One Health approach are necessary as well.
  • There is a need for coordinated global public investment, which should direct antibiotic research and development to meet public health needs that are defined by a global body.

DRIVE-AB to hold conference on sustainable development and use of antibiotics
April 2016

IMI’s DRIVE-AB project will hold a high-level conference entitled ‘Stimulating innovation, sustainable use and global access to antibiotics’ on 2 June in Amsterdam, the Netherlands. The goal of the event is to bring together policy makers, regulatory and public health experts, and economists to identify and evaluate reward models that are feasible, practical and can be implemented globally.### At the event, DRIVE-AB will present the preliminary results of its research and seek feedback from stakeholders regarding feasibility and implementation of research and development (R&D) incentive policies. The conference also seeks to determine how on-going European and international initiatives addressing antimicrobial resistance can complement each other, and to identify opportunities for DRIVE-AB to interact with other initiatives. If you would like to apply for a space at the conference, contact DRIVE-AB Communications Officer Victoria Wells at vwells@bsac.org.uk.

DRIVE-AB project participant wins leadership award
December 2015

The Alliance for the Prudent Use of Antibiotics (APUA) has named Professor Kevin Outterson of Boston University School of Law and Boston University School of Public Health as the recipient of its 2015 leadership award.### Professor Outterson is a partner in the DRIVE-AB, which is working on developing new economic models that simultaneously incentivise antibiotic development while promoting the responsible use of antibiotics. ‘We recognise Professor Outterson as a thought leader in the worldwide effort to contain antibiotic resistance,’ said APUA President Stuart B. Levy. ‘His intellectual commitment to the economic realities of developing new drugs that affect the global aspects and consequences of antibacterial resistance alter our thinking about answers to these complex problems.’ In DRIVE-AB, Professor Outterson contributes to the project’s activities on the creation and testing of new economic models.

DRIVE-AB highlights human costs of rising antimicrobial resistance
October 2015

A 30% drop in the efficacy of antibiotics could result in an additional 6 300 deaths per year in the US alone among people who undergo common surgeries and chemotherapy treatments. This is the stark finding of a study, published in the Lancet Infectious Diseases, by the IMI project DRIVE-AB.### Patients who undergo surgery or immune-system suppressing chemotherapy are routinely given antibiotics to prevent infections. The DRIVE-AB team analysed the number of additional infections and deaths that would occur if these antibiotics were less effective. They focused their analysis on the 10 most common surgeries (e.g. caesarean sections, prostate biopsies, hip replacements, and appendix removals) as well as on chemotherapy treatments that suppress the immune system. They found that a 30% reduction in the efficacy of these preventive antibiotic treatments could result in 120 000 additional infections and 6 300 deaths. ‘Most of us will take antibiotics at some point in our lives and everyone should be mindful of the fact that resistance is a potential problem if we are going in for minor surgery, hip or knee replacement, transplant or chemotherapy,’ said lead author Ramanan Laxminarayan of the University of Strathclyde, the Center for Disease Dynamics, Economics & Policy, and Princeton University. ‘Our findings are likely to hold true in many other developed countries, given the common use of surgical procedures.’ The researchers conclude by noting that clinical studies are needed to determine how recommendations on the use of antibiotics should be modified as drug resistance rises.

Antimicrobial resistance project DRIVE-AB seeks stakeholders
July 2015

Antimicrobial resistance project DRIVE-AB is looking for stakeholders willing to provide input on its reports and recommendations. Launched in 2014, the project’s goal is to develop economic models that would simultaneously incentivise the development of new antibiotics while reconciling this with the need to use new antibiotics wisely.### The project is keen to gather input from a broad range of stakeholders to ensure their findings are as robust as possible. Groups interested in becoming stakeholders should fill in the form on the DRIVE-AB website.  The project has already attracted a number of high profile stakeholders including international institutions like the World Bank and European Medicines Agency, as well as clinical societies and universities. DRIVE-AB was also instrumental in the creation of the BEAM Alliance (‘Biotechs from Europe innovating in Anti-Microbial Resistance’), which is working to improve the regulatory, investment, and commercial environments in Europe for research, development, approval and market viability of new products combating antimicrobial resistance.

Participants Show participants on map

EFPIA companies
  • Astellas Pharma Europe LTD, Chertsey, United Kingdom
  • Astrazeneca AB, Södertälje, Sweden
  • F. Hoffmann-La Roche AG, Basel, Switzerland
  • Glaxosmithkline Research And Development LTD., Brentford, Middlesex, United Kingdom
  • Merck Sharp & Dohme Corp, Whitehouse Station, New Jersey, United States
  • Pfizer Limited, Sandwich, Kent , United Kingdom
  • Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
Universities, research organisations, public bodies, non-profit groups
  • British Society for Antimicrobial Chemotherapy, Birmingham, United Kingdom
  • Eberhard Karls Universitaet Tuebingen, Tuebingen, Germany
  • Folkehelseinstituttet, Oslo, Norway
  • London School Of Economics And Political Science, London, United Kingdom
  • Royal Institute of International Affairs, London, United Kingdom
  • Ruprecht-Karls-Universitaet Heidelberg, Heidelberg, Germany
  • Stichting Katholieke Universiteit, Nijmegen, Netherlands
  • Tel Aviv Medical Center, Tel Aviv, Israel
  • Universite De Geneve, Genève 4, Switzerland
  • Universite De Lorraine, Nancy Cedex, France
  • Universiteit Antwerpen, Antwerp, Belgium
  • University of Rijeka Medical Faculty, Rijeka, Croatia
  • University of Strathclyde, Glasgow, United Kingdom
  • Uppsala Universitet, Uppsala, Sweden
  • Wageningen UR, Wageningen, Netherlands
Small and medium-sized enterprises (SMEs)
  • Ursula Theuretzbacher, Vienna, Austria

CONTACT

Project coordinator
Judith Hackett
AstraZeneca AB
United States
781 839 4062
judith.hackett[at]astrazeneca.com
Managing entity
Stephan Harbarth
Université de Genève
00 41 22 372 3357
stephan.harbarth[at]hcuge.ch