Mission and Vision

The genomics revolution of recent years did not yield the expected windfall of new drugs to combat infectious diseases and drug-resistant microbes. Instead, the frequency of new antibiotic classes gaining approval for clinical use has decreased, and the costs associated with antibiotic development have risen. The AMR Accelerator has been created to respond to this challenge. More than 50 European partners in seven different consortia will work to progress a wide-ranging series of projects targeted at Gram-negative bacteria, tuberculosis (TB) and non-tuberculous mycobacteria (NTM). For the success of such consortia, capacity building to support the operation of each project with effective management is of critical importance. With these aims, the six-year project COMBINE has the following objectives:

  • COMBINE will coordinate the AMR Accelerator and support the delivery of projects across the Accelerator in order to progress a pipeline of potential new medicines to treat and prevent infections with resistant bacteria;
  • COMBINE will establish an IT infrastructure for management, integration and analysis of combined data from across all Accelerator projects, perform regular data management reviews, leverage best practices, create software specifications, review existing tools;
  • COMBINE will facilitate communication among Accelerator projects, with the AMR community and beyond as well as disseminate news and results, work in close collaboration with existing AMR drug development initiatives;
  • COMBINE will share and analyse vaccine and antibacterial data, to improve the design and analysis of clinical trials;
  • COMBINE will improve the understanding of animal infection model reproducibility and translation to clinical efficacy

Strategy

COMBINE has a coordination role (WP1,2,3) and a scientific mission (WP4,5):

Coordinating the AMR Accelerator: COMBINE will set up a Coordination and Support Office (CSO) to coordinate the support of the Accelerator projects. The CSO will establish a Coordination Committee, a Communication Advisory Board, and an Ethics Advisory Board, that will play key roles in overseeing progress in the AMR Accelerator. Part of the effort will also be that the CSO will provide support to project teams seeking regulatory advice. (WP1)

Achieving effective management of scientific data: COMBINE will establish a robust data management process based on FAIR principles. As a basis, the ND4BB InfoCentre – which was set-up within TRANSLOCATION – will be used and extended. The software developed within COMBINE enable cross-site access, flexible handling of experimental documentation from early discovery through to development. It will support a wide range of data formats, from simple office documents and chemical structures to preclinical and clinical data sets, while retaining compatibility with all common operating systems. Documentation covering data governance, quality, access, and analysis procedures have already been developed and will be transferred to the programmes in the Accelerator. (WP2)

Managing the communication: COMBINE will develop and implement communication and dissemination strategies and work to strengthen the interaction between AMR Accelerator participants and AMR stakeholders across the EU and globally. A strong corporate identity will be established, with logos and a joint website designed. COMBINE will coordinate the media outreach and social media activities, communicate results and attend conferences. (WP3)

Improving clinical trials: COMBINE will help improve clinical trial design to increase the success rate of vaccine and antibiotic trials. COMBINE will also develop strategies and methodology for the analysis of clinical trial data. To achieve this, COMBINE experts will compare and evaluate non-clinical data or clinical patient-level data supplied by Efpia partners, the BEAM Alliance and others. (WP4)

Standardising animal models: COMBINE will develop standardised protocols for rodent models, establish a reference strain data bank, and provide a framework to make use of the results to improve translation to the clinic via mathematical modelling approaches. All animal models will use clinically relevant, well-defined reference Gram-negative strains. The standard protocols will ease harmonisation of non-clinical data and facilitate the establishment of standardized high-quality infection models. (WP5)

Governance

In accordance with the individual project requirements, COMBINE will provide support to all AMR Accelerator projects in Coordination, IMI-related Programme Management, as well as Data Management and Communication.

Besides supporting the Accelerator, COMBINE also follows its own agenda: WP1 heads COMBINE, WP2 is responsible for the IT Infrastructure and Data Management and WP3 coordinates the communication among the Accelerator partners, the AMR network and beyond. WP4 and WP5 have a scientific focus and deal with the improvement of clinical trial design and animal models. All WPs will work together as indicated in the graphic below.

About BEAM Alliance

Since its inception in 2016, the BEAM Alliance (Biotech companies from Europe innovating in Anti-Microbial resistance research) has succeeded in uniting European SMEs working in the field of AMR. The BEAM Alliance now represents over 60 European SMEs that are collectively developing over 140 new, diversified R&D projects focused upon prevention, diagnosis and cure of microbial infections. The goal of the BEAM Alliance is to promote and maintain awareness of SME-driven innovation in the field. The BEAM Alliance also supports policymakers in understanding economic business models around AMR, highlighting the specific needs of SMEs and incentives required to develop innovative diagnostics and treatments. Collaborating with the existing community of global stakeholders, the BEAM Alliance is actively working to curb the AMR threat in a sustainable manner.  

https://beam-alliance.eu

About Uppsala University

Uppsala University is the Nordic region’s oldest university – founded in 1477 – and is ranked among the top 100 universities in the world. There are more than 40,000 students here and they are seen, heard and make their mark everywhere. The University’s nearly 5,000 researchers and teachers conduct world-leading research and offer a seemingly endless number of courses.

Among the University’s alumni there are 15 Nobel Prize laureates, of which 8 received their prizes for discoveries made during their time at Uppsala University. Carl Linnaeus, Anders Celsius and Olof Rudbeck the Elder are a few examples of prominent scientists in Uppsala University’s history.

https://www.uu.se

About Fraunhofer IME

The Fraunhofer-Gesellschaft is the leading organisation for applied research in Europe. Its research activities are conducted by 69 institutes and it employs a staff of 24,000; with an annual research budget of 2.1 billion euros. Fraunhofer Institute for Molecular Biology and Applied

Ecology  IME is participant in COMBINE and contributes their cross-domain expertise in drug discovery and life science informatics. The Fraunhofer Institute IME,  with 520 employees, conducts research in the field of applied life sciences from a molecular level to entire ecosystems.

Within IME, the Translational Medicine department develops new approaches for the diagnosis and treatment of diseases that are inadequately understood or controlled. The Department is involved in identification, functional characterization and validation of targets which play a role in human health, disease and toxicity.

https://www.ime.fraunhofer.de/en.html

About grit42

We’re grit42 from Copenhagen and we’ve been fixing data workflows since the Space Odyssey. Our core expertise is digital laboratory infrastructure, enabled by our scientific data management platform with user-friendly day-to-day lab workflows, as well as handling compound and sample logistics. By streamlining data across all the different pre-clinical drug discovery phases and integrating with all kinds of equipment, we facilitate structured and tagged quality data. In addition, the platform also features direct comparisons of data across experiments, links the data to other types of data, and it enables you to apply advanced analytics, including artificial intelligence (AI).

https://grit42.com

About Paul-Ehrlich-Institut (PEI)

The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main, is a senior federal authority reporting to the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). It is responsible for the research, assessment, and marketing authorisation of biomedicines for human use and immunological veterinary medicinal products. Its remit also includes the authorisation of clinical trials and pharmacovigilance, i.e. recording and evaluation of potential adverse effects. Other duties of the institute include official batch control, scientific advice and inspections. In-house experimental research in the field of biomedicines and life science form an indispensable basis for the manifold tasks performed at the institute. The Paul-Ehrlich-Institut, with its roughly 800 members of staff, also has advisory functions nationally (federal government, federal states (Länder)), and internationally (World Health Organisation, European Medicines Agency, European Commission, Council of Europe etc.).

https://www.pei.de/EN

About Statens Serum Institut (SSI)

Statens Serum Institut (SSI) is under the auspices of the Danish Ministry of Health. Our main duty is to ensure preparedness against infectious diseases and biological threats as well as control of congenital disorders. SSI has state-of-the-art laboratories and animal facilities and has extensive experience of designing, planning and execution of in vivo efficacy evaluation of antimicrobial compounds.

https://www.ssi.dk

About GSK

GSK – is a science-led global healthcare company that researches and develops a broad range of innovative products. The R&D organization within the company has extensive expertise in designing, executing, analyzing and reporting clinical trials in many therapeutic areas, including infectious diseases. GSK is committed to reporting the results of clinical research that evaluate medicines and vaccines, irrespective of whether the outcomes are perceived to be positive or negative. GSK is an active member of several collaborations focused on developing new treatments for TB, including multi-drug resistant forms of the infection. In 2012, GSK Tres Cantos joined the TB Drug Accelerator Program – a partnership with several pharmaceutical and public-sector research institutions and the Bill & Melinda Gates Foundation, aiming to speed up the discovery of new medicines by collaborating on early stage research.

www.gsk.com

About Janssen

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. We have a longstanding commitment to develop and responsibly deploy innovative technologies and treatments to combat the growing threat of antimicrobial resistance (AMR) on multiple fronts. Follow us at @JanssenGlobal.

https://www.janssen.com

About Evotec

Evotec SE has built a strong, productive and successful business model serving as a partner to a variety of organisations (pharma and biotech companies, academic groups, foundations) to rapidly and efficiently advance assets from the discovery space to filing INDs (INDiGO) and on to early clinical development across multiple therapeutic areas. With the acquisition of Sanofi’s infectious diseases unit adding to the company’s already existing ID capacity, Evotec can serve as a key strategic partner for infectious diseases R&D. An internal team of the infectious diseases unit is dedicated to drug discovery and development, including in vitro and in vivo pharmacology, chemistry, development, and project management. Evotec will contribute to the enabling platforms by providing medicinal chemistry and design, in vitro and in vivo microbiological efficacy data, safety and ADME data. It will analyse PK/PD relationships, decipher modes of action, carry out CMC and fermentation and support clinical studies and modelling.

https://www.evotec.com/en

About Asclepia

The management team at Asclepia has in-depth experience in drug discovery. Before joining Asclepia, the founders have built their careers in companies such as Janssen Pharmaceutica (part of Johnson & Johnson), UCB, Astra Zeneca, Taminco and Devgen where they developed both scientific and managerial experience. They have been key contributors in discovery programs and are inventors of multiple New Molecular Entities in the field of Inflammation, Neuroscience and Oncology.

Within the previous companies they worked at, the founders have set up a network of drug discovery CRO ’s. Asclepia has a strong and strategic partnership with Assay Depot and is instrumentally involved in the development and implementation of the Assay Depot expansion strategy worldwide.

http://www.asclepia.com

 

About BIOCOM

BIOCOM is synonymous with professional communication skills and a wide range of specialist media for the life sciences. Content-driven and results-oriented since 1986.

For us, scientific ability goes hand in hand with sound communication skills – either as a double qualification offered by our individual employees or combined together in project teams. In addition, we offer a diverse spectrum of services, which is important for our customers. Alongside our contract work, we have also been successful in the market with our own high-quality products for more than 30 years: we are unparalleled in life sciences communication.

https://biocom.de/?lang=en

 

COMBINE Coordinator

Prof. Dr. Anders Karlén

Uppsala University
Von Kraemers Alle 4
751 05 Uppsala, Sweden

anders.karlen@ilk.uu.se

COMBINE Communication

Dr. Lilian Löwenau

BIOCOM AG
Luetzowstraße 33-36
10785 Berlin, Germany
Phone: +49 30 2649 2151

l.loewenau@biocom.de

COMBINE EFPIA Leader

Karen O’Dwyer

GlaxoSmithKline Pharmaceuticals
1250 S. Collegeville Road
Collegeville, PA
19426, USA

karen.m.odwyer@gsk.com

COMBINE Communication

Clément Robijns

BIOCOM AG
Luetzowstraße 33-36
10785 Berlin, Germany
Phone: +49 30 2649 2158

c.robijns@biocom.de

Follow us:

      

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under Grant Agreement No 853967. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA companies’ in kind contribution.

https://www.imi.europa.eu/