Conference to stimulate innovation in antibiotic R&D

On Thursday 2 June, 2016, the DRIVE-AB consortium, which is developing new economic models to stimulate antibiotic innovation and ensure global access to and sustainable use of antibiotics, held the “Stimulating innovation, sustainable use and global access to antibiotics” conference in Amsterdam.

Global leaders agree on the need to maintain a steady supply of new antibiotics for all as a critical part of the strategy to address antibiotic resistance and that new reward models are necessary to achieve this goal. While basic frameworks have been proposed, the DRIVE-AB consortium seeks a level of granularity that other initiatives have not, moving beyond discussions to concrete plans for policy implementation.

DRIVE-AB shared its preliminary proposals at the event, which attracted more than 180 high-level decision-makers and policy experts, economists, regulatory and public health experts and representatives of pharmaceutical companies and research institutions from around the world. The conference featured keynote speakers and panellists from the World Health Organization, the European Commission, the European Investment Bank, and the US Centers for Disease Control and Prevention, to name a few. The participation of a diverse group of stakeholders at the conference illustrates the level of global interest in the outcomes of DRIVE-AB, and will help the consortium secure the buy-in of stakeholders who can help to implement new incentive policies.

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DRIVE-AB Conference in Amsterdam

The DRIVE-AB Conference Stimulating innovation, sustainable use and global access to antibiotics will take place on 2 and 3 June 2016 in Amsterdam. This conference, generously funded by the Government of the Netherlands and organized by the IMI DRIVE AB consortium, will bring together about 150 invited decision-makers and policy influencers from around the world to explore current and proposed efforts to address antibiotic resistance. The main goal of the meeting is to move beyond discussions and instead identify key policies that can be implemented globally to both stimulate the innovation of critically-needed new treatments and ensure their availability and responsible use. Input from the conference will help inform DRIVE AB’s policy recommendations to the European Commission—an important part of growing global discussion on how to manage the looming public health threat of resistance.

Presenting at TATFAR meeting in Luxembourg

The Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) identifies and adopts recommendations for collaborations between the US and the EU to respond to the growing challenges posed by antimicrobial resistance. The biennial in-person TATFAR meeting will take place October 22-23, 2015 in Luxembourg City and I have been invited to present my views in the expert workshop “How do we keep new antibiotics effective? Balancing access and conservation”.

My slides will be available on the AIDA website after the meeting.

G7 Health Ministers address antibacterial resistance

The G7 Health Ministers discussed antibacterial resistance during the G7-Meeting in Berlin on 8 and 9 October 2015.

The “Berlin Declaration on AMR” includes strong committments to:

• Improve the coordination between global initiatives and  joint international efforts encompassing human and animal health, agriculture and the environment.
• National AMR Action Plans will take into account the requirements of the WHO Global Action Plan.
• Support other countries with the development and implementation of their National Action Plans, building global capacity to combat AMR and coordinating activity.
• Three-fold approach to AMR: improving infection prevention and control; conserving the effectiveness of existing and future antimicrobials; engaging in research to optimise such approaches and to develop new antimicrobials, vaccines, treatment alternatives and rapid diagnostic tools.
• Pool the national efforts in order to share best practices and promote the prudent use of antimicrobials among all relevant stakeholders.
• Increase awareness among the general public of the impact of AMR .
• Call on all countries to enforce the availability of antibiotics by prescription only.
• Strengthen antibiotic stewardship programs for professionals.
• Ensure the production of high quality antimicrobials in human and veterinary medicine.
• Strengthen surveillance systems on AMR and antimicrobial consumption.
• Inform research prioritization and encourage the research and development of new antimicrobials, vaccines, alternative treatment options and diagnostics.
• Explore innovative economic incentives to enhance the research and development of new antibiotics, other therapeutic options, and diagnostics, e.g. a global antibiotic research fund and a market entry reward mechanism for truly new antibiotics targeting the most important pathogens and most needed for global public health.
• Explore the feasibility and need of setting up a global antibiotic product development partnership.
• Encourage international cooperation on antimicrobial stewardship and regulatory dialogue on the approval and regulation for antibiotics.

DRIVE-AB supports this initiative and will provide scientific data to inform the decisions regarding antibiotic stewardship (metrics to define the prudent antibiotic use) and innovative economic incentives to encourage research and development of new antibiotics.

Re-development of old antibiotics

In the face of increasing antimicrobial resistance and the paucity of new antimicrobial agents it has become clear that new antimicrobial strategies are urgently needed. One of these is to revisit old antibiotics to ensure that they are used correctly and to their full potential, as well as to determine whether one or several of them can help alleviate the pressure on more recent agents. Strategies are urgently needed to ‘re-develop’ these drugs using modern standards, integrating new knowledge into regulatory frameworks and communicating the knowledge from the research bench to the bedside. Without a systematic approach to re-developing these old drugs and rigorously testing them according to today’s standards, there is a significant risk of doing harm to patients and further increasing multidrug resistance.

The recently published paper REVIVING OLD ANTIBIOTICS describes factors to be considered and outlines steps and actions needed to re-develop old antibiotics so that they can be used effectively for the treatment of infections.

Theuretzbacher U, Van Bambeke F, Cantón R, Giske CG, Mouton JW, Nation RL, Paul M, Turnidge JD, Kahlmeter G: Reviving old antibiotics. J Antimicrob Chemother. 2015 Jun 10. pii: dkv157

G7 summit June 2015

The leaders of the G7 agreed on concrete steps with regard to antimicrobial drug resistsance to respond to some of the most pressing issues in the world:

“Antimicrobials play a crucial role for the current and future success of human and veterinary medicine. We fully support the recently adopted WHO Global Action Plan on Antimicrobial Resistance. We will develop or review and effectively implement our national action plans and support other countries as they develop their own national action plans.

We are strongly committed to the One Health approach, encompassing all areas — human, and animal health as well as agriculture and the environment. We will foster the prudent use of antibiotics and will engage in stimulating basic research, research on epidemiology, infection prevention and control, and the development of new antibiotics, alternative therapies, vaccines and rapid point-of-care diagnostics. We commit to taking into account the annex (Joint Efforts to Combat Antimicrobial Resistance) as we develop or review and share our national action plans.”

Let’s hope that real action will follow the nice words.

Antibiotic research and development: business as usual?

My recent publication in the Journal of Antimicrobial Chemotherapy describes the problem of global resistance, the dry antibacterial R&D pipelines and the new IMI-funded, multistakeholder, €9.4 million DRIVE-AB (Driving Re-InVEstment in R&D and responsible AntiBiotic use) project with a consortium, composed of 14 public and 9 private partners from 12 countries.

COMBACTE-MAGNET launched

I am partner of the newly launched project COMBACTE-MAGNET. The European Innovative Medicines Initiative’s (IMI) program New Drugs for Bad Bugs (ND4BB) leads the efforts to  combat antibiotic resistance in Europe by tackling the scientific, regulatory, and business challenges that are hampering the development of new antibiotics. The 7 year, €167 million project will investigate a new approach to preventing respiratory infections in patients in intensive care units and new treatment options for patients with life-threatening infections caused by multi-drug resistant bacteria.

It will be exciting to be part of this important project that will perform clinical trials and describe the epidemiology of antibiotic resistance and healthcare associated infections.

DRIVE-AB launched

DRIVE-AB (Driving Reinvestment in R&D and Responsible Antibiotic Use), a public-private consortium funded by the EU Innovative Medicines Initiative (IMI), hold its inaugural meeting which announced the launch of a €9.3million project to tackle the dual crisis of antimicrobial resistance and re-stimulate Pharma interest in antibiotic research and development. We will develop new economic models to incentivise antibiotic discovery and development activities while safeguarding the efficacy of antibiotics by researching and advocating their appropriate use.

I am responsible for  communication, engagement of all involved stakeholder groups, and dissemination of results of this multinational project. My partners are the British Society of Antimicrobial Chemotherapy (BSAC) and the Chatham House (Royal Institute of International Affairs, London).

Publicly funded antibacterial drug development in Europe

The urgent need for new antibacterial drugs to treat multidrug-resistant Gram-negative infections is well recognized as a public health emergency. Discovery and development of new drugs is hampered by a number of scientific and clinical development hurdles that cannot be tackled by any individual organisation working alone.  To reinvigorate research into new antibiotics the European public-private partnership Innovative Medicines Initiative (IMI) has launched the first two projects of its programme ‘New Drugs for Bad Bugs’ (ND4BB). The new projects, COMBACTE (Combatting Bacterial Resistance in Europe) and TRANSLOCATION (Molecular basis of the bacterial cell wall permeability), will focus on new models for the clinical development of antibiotics as well as address new ways of getting antibiotics into Gram-negative bacteria and preventing efflux of the drugs. An important topic of the current call is the discovery and development of new drugs combatting Gram-negative infections (Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and E. coli) from the discovery of hits to leads and Development Candidates to Phase 1 clinical studies. The planned EU budget for the current call is 59M €. The goal of this call is to deliver 1-2 novel mode of action Gram-negative antibacterial ready for Phase 1 clinical trials within 5-6 years.

At the same time, the European Commission is planning the details of the next funding frame work Horizon 2020. Special aspects of antibacterial drug R&D included in the next funding period will be discussed at the Superbugs & Superdrugs Conference in London, 4^th and 5^th March 2013. I will present the topic “Publicly funded antibacterial drug development in Europe” and will be a panel member of the Round Table Discussion including Richard Bax (TranScrip Partners), Richard Bergstrom (Director General, European Federation of Pharmaceutical Industries and Associations, EFPIA), Ursula Theuretzbacher (Center For Anti-Infective Agents), Line Matthiessen, Head of Infectious Diseases and Public Health Unit, European Commission). We hope for a lively discussion that will address key aspects of antibacterial drug development from the point of view of all involved stake holders. All these discussions and contributions of stake holders will be considered when finalizing the calls of the next funding round.