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

Antibacterial innovation in European SMEs

This analysis provides a current snapshot of the innovation potential for antibacterial R&D among European small and medium-sized enterprises (SMEs). It has been recently published in Nature Reviews Drug Discovery. The report shows that far more effective coordination and well-targeted support by public and philanthropic funders will be crucial to sufficiently fill antibiotic R&D pipelines according to priorities based on the greatest public health needs.

Ursula Theuretzbacher: Antibacterial innovation in European SMEs. Nature Reviews Drug Discovery 2016, 15:812–813

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.

More….

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.

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.

Gram-negative R&D pipelines dry up

Gram-negative R&D pipelines dry up

GSK has pressed the “pause” button and halted collaboration on one of the few promising novel anti-Gram-negative compounds that had progressed beyond Phase 1. Here is yet another warning sign that antibacterial pipelines are under close scrutiny and may dry up quickly and completely.

My recent review article “Accelerating resistance, inadequate antibacterial drug pipelines and international responses” in the International Journal of Antimicrobial Agents details the critical health problem of growing multidrug resistance in the face of slim prospects for novel treatments. However there is hope, as the threat of untreatable infectious diseases has spurred national and international government responses. Read more in my new publication.

Anti-Infectives: Special issue in Current Opinion in Pharmacology

The special issue on anti-infectives in Current Opinion in Pharmacology has been recently published. Together with my colleague J. Mouton I developed the concept of this issue that focuses on the global resistance problem and includes important aspects of resistance, from R&D of  novel antibiotics to improved usage of existing antibacterial as well as antifungal drugs to minimize the emergence of resistance.

Our Editorial Overview concludes:

For decades clinicians have overused antibiotics and thus exploited apparently exhaustible resources. Abuse in livestock, agriculture, aquaculture, consumer industry, as well as persistence of antibacterial drugs in the environment all contribute to high selection pressure on bacteria including, of course, pathogenic ones. Nearly dry antibacterial and antifungal R&D pipelines will fall short of addressing currently untreatable infections caused by MDR bacteria and fungi. That meticulous infection control, consistent stewardship programs, and restrictive usage in all fields can and do work is beyond dispute. To drive antibacterial drug R&D forward and to improve clinical practice, we must effectively use recently gained insights into the mechanisms of emergence, into the spread of resistance and into drug exposure-resistance relationships. We have much to lose if we do not work in concert. All members of society and, most critically, stakeholders including researchers, clinicians, drug developers, health care managers, regulatory agencies, policy makers and, yes, patients must collaborate in sustainably managing our critically limited and invaluably precious cache of antibacterial and antifungal drugs.

Public Research should benefit Society

In an open letter sent today to the President and Members of the European Commission as well as the European Parliament and the EU Member states, 98 civil society and research organisations from across Europe warn that the Commission’s draft proposals for the next Research funding framework (2014-2020) fail to address the real challenges faced by European societies and call for a research agenda geared towards the needs of society and the environment rather than those of big business.

Our recent React meeting in Brussels to discuss the challenges in discovery and development of new antibiotics “Collaboration for Innovation – The Urgent Need for New Antibiotics”  provided strong input for the upcoming action plan from the EU commission. Among invited key stakeholders were representatives from the European Commission, the European Medicines Agency, the World Health Organization, academia, the pharmaceutical industry as well as several civil society organizations. Key issues discussed at the meeting were put in the perspective of the upcoming action plan from the EU commission and included the nature of the scientific challenges, possibilities for open source solutions, and the need for a new business logic for antibiotic discovery and development where the return of investment is decoupled from sales to the extent possible.

We hope that our ideas and analysis will find their way into the next Research funding framework (2014-2020).