WHO priority pathogen list for R&D published

The WHO priority pathogen list for R&D was recently published. I contributed my R&D expertise to this intense work. The list should prioritise and guide R&D of new antibiotics, as part of WHO’s efforts to address growing global resistance to antimicrobial drugs. The process was based on collecting all available evidence to develop criteria that were used in a multi-criteria decision analysis technique vetted by a group of international experts.

The list is an important step to spur governments to put in place policies that incentivize basic science and R&D by both publicly funded agencies and the private sector investing in new antibiotic discovery.

List

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.

Where are new antibiotics coming from?

While most big pharma companies left the field of antibiotic drug discovery, small companies—mostly backed by academic institutions—are stepping in to drive research and early clinical development in the antibiotics field. Most small companies face serious hurdles when focusing on antibacterial drug R&D.  These challenges are not only financial limitations but also scientific problems, shortage of experienced personnel, dependence on external support, lack of appropriate diagnostics, the need for R&D short cuts, and IP issues in collaborations may impact directly on these companies.

My recent  GEN Exclusives article in Genetic Engineering & Biotechnology News (GEN), a widely read biotech publication and online portal highlights some of my activites related to antibiotics R&D in small companies.

An in-depth analysis of the role of small companies in anitbiotics R&D can be found on the DRIVE-AB website. The EU project DRIVE-AB (Driving reinvestment in research and development and responsible antibiotic use) is funded by the Innovative Medicines Initiative (IMI) to find ways policymakers can stimulate innovation, responsible use and global access to antibiotics to meet public health needs. A central objective of DRIVE-AB is to engage with all interested stakeholders including small companies.

New economic models to incentivice antibiotics R&D should strongly consider the contributions of small companies and publicly funded research institutions.

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.

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).

Progress on colistin

The European Medicines Agency recommended updating and harmonising the Summary of Product Characteristics of nationally approved colistin products throughout the EU to reflect what is currently known. The recommendations focus mainly on optimising dosing schedules but will also review the quality of the products and the way the potency of colistimethate sodium is measured and tested. Details here. This is a great success given the administrative challenges as the products have not been approved under the EU regulatory framework and knowledge is still evolving about how to use this drug.

In spring 2013 an expert conference in Prato summarised the current knowledge on polymyxin drugs and laid the ground for awareness and the need to update the information: The Lancet Infectious Diseases, 21 October 2014

R.L. Nation, J. Li, O. Cars, W. Couet, M.N. Dudley, K.S. Kaye, J.W. Mouton, D. L. Paterson, V. H. Tam, U. Theuretzbacher, B.T. Tsuji, J.D. Turnidge: Framework for optimisation of the clinical use of colistin and polymyxin B: the Prato polymyxin consensus.