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Should you need further information please contact:

Amélia Kossi

Communications Coordinator

Tel: +32 2 626 25 71 

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The sustainability of the biopharmapharmaceutical sector depends on a continual flow of new startups to both feed Big Pharma's pipelines and to create the next generation of emerging mid-cap companies.

11 December 2012 - London - European Biopharmarceutical Enterprises (EBE) is organising a Forum entitled European Biopharmaceutical Industry - Future for Patients

Brussels, 4 October. EBE Board together with Richard Bergström, have agreed to appoint Titta Rosvall-Puplett as Executive Director for EBE as from 1 October, 2012.

3 & 4 December 2012 – Lille (France) - BioFIT 2012 Conference will take place on 3 & 4 December 2012 at the "Lille Grand Palais" Convention Center in Lille, France. The event is being co-organized by the Economic Development Agency Eurasanté and IDIS in partnership with EFPIA & EBE.

The EBE Annual Meetings 2012 took place in conjunction with the EFPIA Annual Meetings on 26-27 June. in Brussels. All EBE events were held on 26 of June, whilst EFPIA events ran through to 27 June.

The overall EBE programme included:

• EBE Board of Directors
• EBE General Assembly
• EBE/EFPIA SMES CEO's lunch
• EBE Networking Lunch
• A specific session entitled 'China connect' (in partnership with the Belgian-Chinese Chamber of Commerce)
• A specific session entitled 'IMI, an opportunity for SMEs' (hosted by Michel Goldman, Executive Director of IMI and Hugh Laverty, Scientific Project Manager IMI and in charge of relations with SMEs)
• EFPIA Networking Reception at the European Parliament                 

Setting specifications is an area of great interest to both the regulatory agencies and industry particularly as our knowledge of product and process continuously evolves. More experience in manufacture of recombinant proteins is being gained with the use of these types of products and the correlation of potential safety concerns with product variants and impurities. Analytical techniques are constantly being improved and products are becoming better characterised.

The European Commission (DG Research and Innovation, DG Enterprise and Industry, DG Health and Consumers, DG for Regional Policy) organised a conference on "Innovation in Healthcare without borders", in consultation with other relevant DGs, major health associations and stakeholders on 16-17 April at Flagey, Brussels. This event  was supported by EBE. 

The Innovative Medicines Initiative (IMI) is Europe's largest public-private partnership that fosters improvement of the drug development process by supporting a more efficient discovery and development of better and safer medicines for patients. This €2 billion-budget initiative supports collaborative research projects in addition to building networks of industrial and academic experts in Europe that will boost innovation in healthcare.

The European Commission has disclosed its action plan to improve access to finance for SMEs.  http://ec.europa.eu/enterprise/policies/finance/files/com-2011-870_en.pdf 
 
In this document, the Commission acknowledges the difficulties faced by SMEs in obtaining the financing they need to develop their activities.  It also stresses the crucial role for a healthy financial system to support growth, notably for SMEs.

We invite you to carefully read this document that will be discussed intensively within EBE relevant committees and tasks forces.  However, we would like to emphasise the following items:

Marc de Garidel discusses the founding principles of EBE and its influence in policy making. He addresses the main challenges of representing biopharmaceutical companies and presents the current priorities for EBE.

EBE is pleased to publish a Position Paper on biologicals substitution. This paper outlines policy recommendations applicable for all biological medicinal products taking into account their specific nature, including the fact that biosimilars are comparable, but not identical to their reference products.

Please click on download to read the recent article from Scrip on “Biotech industry welcomes EU’s Innovation Union”, with quotes from EBE.

The College of Commissioners formally adopted on 6 October a new “Innovation Union” flagship initiative. 

Click on 'download' to access an instructive slide deck on this new major initiative prepared by the cabinet of the Research and Innovation Commissioner Mrs. Geoghegan-Quinn.

Additionally, you can download the content of the very interesting speech by Commissioner Geoghegan-Quinn gave to the media on 6 October. She has championed this initiative quite effectively during her first 6 months in office and has possibly become our best supporter amongst Commissioners. We are considering having an EBE Board delegation meet with her in the coming months to discuss the implementation of this initiative in more detail.

On the occasion of the EBE Annual Meetings on 21 June in London, EBE has published its new Annual Report, Highlights 2010          

This conference will focus on the growing importance of Personalised healthcare and its impacts on clinics, hospitals and laboratories across Europe. It will investigate the barriers to adoption of this emerging technology in Europe.

There will be over 250 researchers, executives, academics and policy makers to answer questions and debate the findings of a major research project organized by Science Business, in partnership with Stockholm’s Karolinska Institutet, and a coalition of industry and non-profit partners.  EBE has been acting as one of the knowledge partners for this research project.

The 5th European Conference on Rare Diseases, “From policy to effective services for patients”, will be held in Krakow on 13-15 May 2010. This conference is organized by the European Organisation for Rare Diseases (EURORDIS) and its partners. It should enable patients, healthcare professionals, policy makers and industry representatives to interact with decision-makers from the European Commission and Member States on rare diseases issues. 

The services of the European Commission organised a “Conference on Innovation in Healthcare: from Research to Market – SMEs in focus” on 20 - 21 May 2010 in Brussels. This European conference was jointly organized by DG Research and DG Industry. It focused on SMEs operating in the health sector and on the drivers and challenges affecting their innovative capability. It provided a forum to highlight and discuss policy developments at the European and national level, widening and enriching the research and innovation debate.

The Innovative Medicines Initiative (IMI) has officially launched a second call for proposals with a total funding of €156.3 million out of which, €76.8 million will be provided by the European Commission and €79.5 million expected to be provided in kind from EFPIA member companies.

Position Paper of the Joint EBE-EuropaBio Task Force on Rare Diseases and Orphan Medicinal Products (25 November 2009)

All interested parties, and especially SMEs, are invited to attend the Information Day of the Innovative Medicines Initiative to be held on 17 November 2009 in Brussels in follow-up to IMI's 2nd Call for Proposals to be launched on 30 October 2009.  

EBE would like to inform you that the European Commission is seeking to reinforce the pool of industrial expertise for Health FP7 evaluation

• The Health Directorate in EC DG Research is currently seeking top industrial/scientific experts to support the selection of the best 7th Framework Programme (FP7) proposals
• If you are a scientist working in the healthcare industry (large or small company), you can enrol yourself as an expert evaluator for Research Activities of FP7

The European Biopharmaceutical Enterprises (EBE) and BIO Deutschland are pleased to invite you to attend their 3rd joint European Business Development Conference on "Best Times for Good Deals? How Biotech and Pharma Could Partner Now", which will take place in Munich on 24-25 June 2009.

The European Biopharmaceutical Enterprises association has initiated discussions on the benefit and risk balance of new therapies. EBE calls for a greater understanding of the roles played by the different stakeholders involved in the management of disease and the introduction of new medicines.

EuropaBio and EBE congratulate EU leaders on the Commission Communication on Rare Diseases and calls for European action to turn principles and proposals into reality

This guide has been prepared for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector. Its aim is to facilitate understanding of the main aspects of medicinal product legislation. The guide is structured to follow the chronological stages of developing a medicinal product.

EPPOSI organized its 9th workshop on Partnering for Rare Diseases Therapy Development. 
Rare disease patients, academic researchers, NGOs and industry united their voices in a call to EU governments to take action this Autumn to address the issues facing patients affected by rare diseases in Europe.  The need is urgent because, for some patients, time is short.

A one-day meeting to present an up-to-date overview of the current requirements for the preparation and implementation of an EU Risk Management Plan.

It is anticipated that the Commission proposal to “Strengthen and rationalise EU Pharmacovigilance” will be released in Q4 2008. The programme provides a blend of the regulator’s perspective and input from industry experts who will provide advice on the key elements for the Risk Management Plan.

EBE supports BIO-Europe 2008.

BIO-Europe brings together international decision-makers from the biotechnology, pharmaceutical and financial sectors, offering networking opportunities, workshop participation, and private, pre-scheduled one-to-one meetings. Investment and collaboration opportunities developed in prior BIO- Europe conferences have produced many highly successful business partnerships.

Supported by EBE, EuroBiO 2008 will take place in Paris on 7-9 October. It is the opportunity for Europe’s life science community to make its collective voice clearly heard, to bridge the gap between the pro innovation rhetoric and the reality of the struggle to create and maintain life science businesses.

INNOVATIVE MEDICINES INITIATIVE (IMI)

A unique public-private partnership

The European Commission and EFPIA have jointly established a new, non-profit European Community body. This organisation has a legal mandate to award research grants to European public-private collaborations conducting innovative research projects that focus on implementing the recommendations of the IMI Research Agenda.

The aim of the Innovative Medicines Initiative (IMI) is to restore European leadership in R&D investments and boost the competitiveness of European life science R&D by directly addressing the challenges facing the biopharmaceutical sector in Europe. IMI foster early prediction of success or failure in drug development.

EBE tells you why you should care about biotechnology in healthcare. Biotechnology is essential for medical progress and the quality of healthcare. It has created a new generation of therapeutics – the biopharmaceuticals – and has supplied powerful research tools for drug discovery and new in-vitro diagnostics.

European Small & Medium-sized biopharmaceutical companies had the opportunity to network with counterparts from the larger pharmaceutical companies at the second edition of the Business Development Conference, organised by the industry associations European Biopharmaceutical Enterprises (EBE) and BIO Deutschland.

A major Information Day was held in Brussels on 30 April to present opportunities for submitting proposals under the new Innovative Medicines Initiative (IMI). This event provided a brief overview of the IMI concept and its potential impact, an overview of the first Call for Proposals as well as information about the proposal submission and evaluation procedures.

The European Commission DG Enterprise and Industry has just closed a 3-month public consultation on the “Future of pharmaceuticals in Europe” in order to make Europe a hub for safe and innovative medicines.  EBE participated in the consultation on behalf of the European biopharmaceutical industry sector and made specific recommendations for improving the regulatory framework.

The 2007 edition of the European Commission's annual scoreboard of companies' spending on research and development (R&D) shows that corporate R&D has increased by 10%, with EU-based companies increasing their R&D investment by 7.4%.

In the context of the 7th Framework Programme (FP7, 2007-2013), the European Commission will organise a special conference on research on rare diseases in Brussels on 13 September 2007.  On this occasion, the EBE President Dr. Carlo Incerti (Head of R&D Europe & Co-Chair of European Board, Genzyme) will present the industry views on Orphan Drugs development and lessons learnt from research on rare diseases.

The EMEA released in July 2007 the adopted guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products. 
The final guideline is taking into consideration more than half of EBE comments submitted to the EMEA in May 2007.

European Biopharmaceutical Enterprises is pleased to be associated as major partner to the European Congress on Biotechnology on 16 - 19 September in Barcelona. For information on the programme, please see http://www.ecb13.eu/.

This event will allow you to meet leading biotechnologists, scientists, CEOs, entrepreneurs, executives, top biotech sector stakeholders and decision makers from around the world. As of 18 July, there were already 1000 registrations from 50 countries.

In June 2007 EBE and PDA (the Parenteral Drug Association) organized a first joint Conference on Biopharmaceutical Development and Manufacturing “Challenges in the European Environment”.  Some 80 participants attended this two-day conference which was held in Berlin.

· 30 May in Brussels – Join All EBE Members for the Annual EBE Meeting
· OMP – Commission Guideline Provides Legal Certainty on Market Exclusivity
· Advanced Therapies Regulation – European Parliament Vote in April or May
· Biosimilars – Developments in Relation to Naming, Substitution and Labelling
· 20/21 June - Conference on Biopharmaceutical Development & Manufacturing
· EC Study on Biotechnology for Europe – Detailed Analysis Report Available
· Take advantage of the EBE Extranet, a Central Resource Centre for Members
· EBE Welcomes 2 New Member Companies
· Calendar – Next EBE Meetings and Conferences We Recommend Attending

EBE Press Release

Brussels, 16 February 2007

European biopharmaceutical industry welcomes new French medicinal law, which addresses biosimilars and puts patient safety first

On 6 February 2007, the French Parliament adopted a new law on medicines, transposing the European Directive 2004/27/EC - the Community code on human medicinal products - into French law. Amongst others, the law recognises the unique nature of biosimilars and does not allow automatic substitution of one biological medicine for another.  The European biopharmaceutical industry welcomes the French Parliament’s move to make patient safety paramount.

On 13 November, the World Health Organisation (WHO) hosted an open meeting in Geneva to collect the innovative industry and generic industry views on the INN naming conventions for biotechnology-derived medicinal products, including biosimilars.

But better patient access to approved orphan medicines and additional economic incentives in most Member States needed.

Brussels, 28 April 2006:  The European Biopharmaceutical Enterprises group (EBE) announced today at its General Assembly that it will implement an operational plan to reinforce its role as the representative voice of the biopharmaceutical companies in Europe and to better respond to the needs of its members’ and stakeholders.

EFPIA AND EBE WELCOME EUROPEAN COMMISSION’S INITIATIVE
ON ADVANCED THERAPIES

Brussels, 16 November 2005 - The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Emerging Biopharmaceutical Enterprises (EBE) broadly welcome the European Commission’s proposal for a new integrated EU legal framework in support of gene, cell and tissue-based therapies  as an important step for patients in the key area of biotechnology.