- Meet IMI in Vienna at the DIA EuroMeeting
- SME – venture capitalist matchmaking event a success
- Webinars on IMI’s 11th Call: presentations now online
- FDA issues guidance note on qualification of drug development tools
Meet IMI in Vienna at the DIA EuroMeeting
IMI will have a stand at the exhibition of the DIA EuroMeeting 2014 that will take place in Vienna, Austria, from 25 to 27 March. This yearly event is organised by the Drug Information Association (DIA).
IMI will also be represented in the session ‘Innovation through public-private partnership collaboration’ that will take place on Wednesday 26 March from 11:00 to 12:30. Professor Michel Goldman, Executive Director of IMI, will take part in this conference session and present IMI as a ‘European Flagship to Address Major Health Challenges’. Other IMI projects will also be presented in other sessions.
The event is expected to attract over 3 000 participants, including professionals from the biopharmaceutical industry, contract research and service organisations, academic research centres, regulatory agencies and national policy-makers, as well as patient representatives.
If you plan to attend the DIA EuroMeeting in Vienna, please come and visit the IMI stand (number X.520)!
- Download the conference programme
SME – venture capitalist matchmaking event a success
On 18 February 2014, IMI and the International Venture Club (IVC) welcomed over 120 leading life science investors, health entrepreneurs, corporate investors and small and medium-sized enterprises (SMEs) involved to the first ‘Investing in excellence’ networking event.
The meeting focused on giving SMEs involved in IMI projects plenty of opportunities to meet specialist venture capitalists and industry investors, both formally and informally, and to hear from specialists in the finance and investment sectors on their views for new opportunities for entrepreneurship within life sciences. The event featured presentations on current challenges in drug development, opportunities for SMEs under Horizon 2020, and the role of SMEs in pharmaceutical research. Another highlight was a series of dynamic 45-second 'elevator pitches' from more than 26 SMEs and venture capitalists attending the event. The afternoon was dedicated to a series of private meetings between SMEs and investors.
- Presentations from the event are available via the event web page.
Webinars on IMI’s 11th Call: presentations now online
The presentations are a valuable source of information for all those who may be interested in submitting a proposal for one of the IMI’s 11th Call topics. All webinars featured a presentation by the EFPIA topic coordinator as well as time for questions and answers. The webinars represented an excellent opportunity for participants to learn more about the topics, interact directly with the topic coordinators, and network with potential project partners.
This webinar series also included a webinar on IMI’s rules and procedures, featuring presentations of IMI's rules and procedures, its intellectual property policy, and tips on the preparation of an Expression of Interest (EoI).
- All webinar presentations can be found on the IMI website
- Deadline for submitting an Expression of Interest (EoI): 8 April 2014
FDA issues guidance note on qualification of drug development tools
The US Food and Drug Administration (FDA) has issued a guidance note on the qualification process for drug development tools. Drug development tools (DDT) include biomarkers (e.g. a measurement a physiological or anatomical characteristic), clinical outcome assessments (which measure a patient’s symptoms or the impact of a disease on the patient’s life), and animal models (i.e. animals which mimic a certain human disease or condition). Tools like these play an essential role in drug development and when ‘qualified’ by regulatory agencies, scientists can feel confident of their use in a specific context of research and development. The European Medicines Agency also has recommendations on the qualification process of novel methodologies for drug development.
Many IMI projects focus on developing better, more reliable tools/methodologies for drug development and therefore IMI encourages its projects to interact with regulatory agencies like EMA and FDA to ensure that findings can be rapidly translated into regulatory practice. A number of projects have already taken steps to start this interaction with the aim of moving towards qualification.
- More information and advice on interactions with regulators can be found here.
Four reasons to sign up for the Eu2P Master programme
Registration is now open for the Eu2P Master programme in pharmacovigilance and pharmacoepidemiology for the academic year 2014-2015. According to the project, there are four reasons to sign up for the programme.
- Get a European academic Masters degree
The Eu2P Master is an academic post-graduate diploma in pharmacovigilance and pharmacoepidemiology jointly delivered by the seven European academic bodies working together as Eu2P partners.
- Get a job market proof diploma
The Eu2P European Master is built and recognised by all the 24 academic, regulatory and industrial Eu2P partners. Eu2P courses are grounded in the real job market and today's practices and research projects can be performed in public or private environments.
- Choose a flexible online programme
Awarded for the quality of the e-learning experience, Eu2P online courses can be attended at home or at work and full time or part time.
- Build your curriculum specialisation
In your second year, you can choose to specialise in a specific field or select ‘à la carte’ modules to match specific needs.
- Deadline for applications: 22 June 2014.
- Eu2P also offers short courses and PhDs. Details of all courses offered as well as information on how to apply can be found on the project website.
IMI scientist wins entrepreneurship award
The 2013 award for Hungarian Young Entrepreneur of the Year was won by Tamas Letoha, Chief Executive Officer of Pharmacoidea, which is a partner in two IMI projects. Tamas was selected as the winner from over 400 public nominations from more than 50 small and medium-sized enterprises (SMEs) from a number of different business sectors. Dr Letoha, a medical researcher by training, received his award from the Hungarian Prime Minister, Viktor Orbán at the Role Model of the Year Award gala in January. The annual award is sponsored by the Role Model Foundation which was set up in 2013 to recognise successful Hungarian entrepreneurs under the age of 40. Tamas heads up Pharmacoidea Ltd. which specialises in R&D in drug discovery, functional food development and experimental cellular therapeutics against carcinomas. Pharmacoidea is a partner in two IMI projects, COMPACT and AETIONOMY. Tamas said that his achievements ‘were pretty much due to international R&D projects like AETIONOMY ’ and that he highly valued his connections with IMI.
EUPATI launches a catalogue of successful PPPs
IMI’s project European Patients’ Academy on Therapeutic Innovation (EUPATI) has created a catalogue of existing successful working models of public-private partnerships (PPPs) between patient organisations, the pharmaceutical industry and academia. The catalogue provides examples of successful cooperation, as well as information which can serve as inspiration for future PPPs keen to ensure the involvement of patients in medicines research and development. While not singling out any one model as the best for PPPs, EUPATI’s catalogue provides guidance for the establishment, terms and rules of new PPPs and how to track their progress.
Save the Date! Conference on Novel Technologies for In Vitro Diagnostics
IMI’s RAPP-ID project along with four other European research projects (BioMaX, DiaTools, CareMore and NextDx) will organise the first European Conference on Novel Technologies for In Vitro Diagnostics in Leuven, Belgium from 6 to 8 October 2014. The conference will offer discussion and networking opportunities with major European players and experts in the field of in vitro diagnostics.
The goal of the meeting is to provide a forum for discussions on factors driving the development of new diagnostic tools, with particular emphasis on innovative devices and molecular technologies of medical or industrial relevance. Experts in the field will discuss exciting innovations in the sector, while keynote speakers will take an interdisciplinary approach by focusing on the technological, biological, clinical and regulatory aspects of in vitro diagnostics.
- More information on the programme and how to participate here.
Updates of the Drug Consumption Databases published
IMI’s PROTECT project has published an updated version of the Drug Consumption Databases – a comprehensive and structured source of information on drug consumption in the out- and inpatient healthcare sector in Europe.
The databases consist of two documents: a master document containing a detailed account of the information already available and methods to retrieve it and a country profile document summarising by country information on national health systems, reimbursement characteristics and a list of websites of interest. The databases contain information for the following countries: Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Slovenia, Spain, Sweden, the Netherlands, and the United Kingdom.
All interested readers are encouraged to review and comment on the two documents as they are a shared source among researchers, regulatory agencies, and pharmaceutical companies.
STEMBANCC recruitment on track
IMI’s stem cell project StemBANCC is advancing well with the recruitment of patients and control individuals (subjects). So far, around 50 subjects have been recruited to disease cohorts such as Alzheimer’s disease, neuropathy, diabetes, Parkinson’s disease, migraine and bipolar disorder by several project participants. The sites recruiting for the autism and schizophrenia cohorts expect to have their first patients in soon.
StemBANCC aims to generate and characterise 1 500 high quality human induced pluripotent stem (iPS) cell lines from 500 people that can be used by researchers to study a range of diseases and test for drug efficacy and safety. The raw materials for the project are largely skin samples taken from patients with certain diseases, people who display adverse reactions to drugs, and healthy individuals. The collection of these samples is carried out with the individuals’ informed consent and in line with strict ethical standards.
The recruitment of subjects began following the full ethics approval by the UK’s main research ethics committee in 2013. The University of Oxford, which is also the managing entity of the StemBANCC project, is responsible for recruiting more than half of the required target of 500 patient and healthy volunteers.
- Learn more about the StemBANCC project