59th Edition – July 2016

Capturing cancer’s complexity – PREDECT models show the way

During the earlier stages of cancer drug development, researchers study cancer cells in the laboratory, for example in petri dishes. These two-dimensional models of cancer are relatively cheap and easy to use, so they are still widely used in research, yet they do not accurately replicate real tumours in the body. This hinders the ability of researchers to study cancer in detail and develop new treatments. IMI’s PREDECT project has developed and analysed a number of more complex, three-dimensional models of prostate, breast and lung cancer that may more accurately mimic the behaviour of tumours in the body. According to Boehringer Ingelheim’s Ralph Graeser, there is no single perfect model that fits all purposes. To help scientists pick the right model for the right situation, the project team has written a paper in the journal Scientific Reports. The article sets out the strengths and weaknesses of the different models and provides detailed protocols for their use as well as advice on when and how to use them. ‘Although people have called for an end to use of 2D cultures, these models are still predominantly used, even though they poorly represent human tumours,’ explained Dr Graeser. ‘The robust protocols for the set-up and analysis of 3D cultures, as well as the cross-comparison of the platforms presented in this paper, should help scientists both in academia and industry to better incorporate these complex models in the drug discovery pipeline.’

Luxembourg joins ELIXIR, sustainability of eTRIKS ensured

IMI projects gather vast amounts of data during their lifespan, and once they end, there is usually the question – how to ensure that this data becomes available to the public, benefiting society in the long run? Thanks to the work of the Luxembourg Centre of Systems Biomedicine (LCSB) at the University of Luxembourg and their involvement in IMI’s eTRIKS project, now there is a solution. The LCSB, one of eTRIKS project partners, was appointed by the Luxembourg state to host the latest node of ELIXIR, a European network for the sharing of scientific data. While eTRIKS provides projects with an open-source platform for knowledge management, ELIXIR provides an infrastructure, a kind of a highway system, which integrates research data from all corners of Europe and ensures a seamless service provision that is easily accessible to all. Luxembourg is the newest member in a network of 18 European countries and they are also the first node of ELIXIR, which will become a data repository for translational research, the interdisciplinary branch of the biomedical field. The inspiration to specialise in translational data came from IMI’s eTRIKS project, said Reinhard Schneider, Head of the Bioinformatics Core facility at the University of Luxembourg’s Centre for Systems Biomedicine, who is also involved in eTRIKS. 'The sustainability of eTRIKS is now secured,' he added. 'All IMI projects which will open their data are welcome to deposit their data on the Luxembourg ELIXIR node.'

CHEM21 launches a new online training platform

Interested in the greening of the drug development process? Don’t miss the new online training platform which was launched by IMI’s CHEM21 project as part of their recent workshop ‘Practical Aspects of Green Chemistry in the Pharmaceutical Industry’. The platform comprises a range of free, shareable, and interactive educational and training materials created to promote the uptake of green and sustainable methodologies, with a particular focus on the synthesis of pharmaceuticals. This online resource is supplemented by a book, Green and Sustainable Medicinal Chemistry, edited and authored by CHEM21 consortium members and collaborating external experts. Available in both hardcopy and electronic format, the book addresses current challenges in modern green chemical technologies and sustainability thinking. It covers a broad range of CHEM21 topics, providing an overview of the key green chemistry tools, guidance and considerations aimed at developing greener processes, as well as cutting-edge synthetic methodologies. IMI’s CHEM 21 project is Europe’s largest public-private partnership dedicated to the development of manufacturing sustainable pharmaceuticals. One of the primary aims of this project is to promote the uptake of green and sustainable methodologies and to embed them in everyday practice.

ENABLE project seeks antibiotic experts to join project

IMI antimicrobial resistance project ENABLE is looking for partners to join its consortium. Specifically, the team is looking for organisations with expertise in bacterial potentiation or small molecule uptake. Details of the expertise required, the types of organisations that are eligible for funding, and information on how to apply, can be found on the project website. The project will also hold a webinar on the process on 31 August. The deadline for submitting expressions of interest is 9 September 2016.

Meanwhile, ENABLE’s open Call for innovative anti-infective programmes remains open. The Call provides early stage anti-infective programmes with an exciting opportunity to progress through the challenging, earlier stages of drug development and draw on the extensive expertise of the ENABLE consortium.

ADAPT SMART makes the case for early access

The question of whether, and how, patients with serious diseases should be allowed early access to promising new treatments is hotly debated. Now IMI’s ADAPT SMART project has put together a simple guide to early access that begins with the story of two fictional patients. Jane has advanced cancer and has at best a year or two to live. John has a family history of cancer, but is currently fit and healthy. If both are told about an experimental new treatment that looks promising but needs more testing, their responses will likely be very different. John hopes that if he is diagnosed with cancer in several years’ time, the treatment will be thoroughly tested. Jane cannot wait so long, and is willing to accept the uncertainties that come with the experimental treatment. However, as the project notes, ‘healthcare decision-makers have an obligation to cater to the needs of both Jane and John’. The project goes on to explain how Medicines Adaptive Pathways to Patients (MAPPs) seek to foster access to beneficial treatments for the right patient groups at the earliest appropriate time and in a sustainable fashion. The key features of MAPPs are:

• focuses on the promise to address a high unmet need;
• provides timely access for the target population in need;
• uses an iterative development and assessment plan with evidence generation over the entire life-span of the drug;
• harnesses real world data to inform follow-on licensing and reimbursement decisions and to manage risks;
• provides for the adjustment of the treatment-eligible population;
• manages utilisation;
• facilitates the collaboration of all stakeholders (pharmaceutical companies, patients, regulators, HTAs, payers, health care providers);
• ensures the sustainability of the innovation and healthcare systems.

Contribute to WEB-RADR’s surveys on apps

IMI project WEB-RADR has launched a pair of surveys, one for healthcare professionals and one for patients and consumers of medicines. The goal of the surveys is to gather opinions on an app that people can use to report adverse drug reactions (side effects) and receive safety information about medicines. The results will help the project to improve the app they have already developed and raise awareness about reporting side effects and receiving safety information. The project will also use the results to quantify the main facilitators and barriers for a mobile app as a tool of two-way risk communication, and determine whether there are differences in preferences and expectations between stakeholder groups (type of patient, healthcare professionals, countries). The surveys are available in seven languages: Croatian, Dutch, English, French, German, Portuguese, and Spanish. The deadline for contributing to the survey is early September.

EUPATI wants your views on patient involvement in R&D

Patient education project EUPATI has launched a public consultation to review the guidance it has developed on patient involvement in the medicines research and development process. The guidance is divided into four distinct frameworks:

• patient involvement in industry-led R&D
• patient involvement in health technology assessment (HTA) bodies
• patient involvement in regulatory processes
• patient involvement in ethics committees (to follow by end of July 2016)

They were developed in response to the growing need to draw on the experience and specific knowledge of patients, and their day-to-day use of medicines, in order to improve medicines development and evaluation. The frameworks suggest approaches to allow structured interaction with patients, and thereby facilitate the exchange of information and constructive dialogue at national and European level where the views from users of medicines can and should be considered.

The four frameworks have already received feedback from a number of partners of the EUPATI consortium (including patient organisations), but further evaluation and feedback from patient organisations and other key stakeholders are essential in order to validate the guidance. Individuals and groups are invited to contribute to the review by commenting directly on the framework documents, which can be downloaded from the EUPATI website. The consultation will close on 15 September.

Sign up for SafeSciMET’s courses on clinical safety and in vitro models

Registrations are open for two SafeSciMET courses which will be held in September this year.

• Clinical safety: post-approval – 12-16 September 2016, Paris (France)
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• Innovative in vitro models in drug safety assessments – 13-16 September 2016, Liverpool (UK)
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IMI’s SafeSciMET consortium offers a variety of custom-tailored solutions to education and training needs for drug safety specialists. For current developments within the project and planning for the future, read the project’s InBrief newsletter.