Genopole® France's first ever symposium on biomanufacturing:
"New Perspectives in GMP Biomanufacturing".
A satellite event at EuroBiO 2006 (the 10th European Biotech Crossroads)

Genopole® is organizing a colloquium dedicated to biomanufacturing in Evry on October 24th, 2006. For the event's first edition, France's leading biocluster has decided to link up with EuroBio 2006 (the 10th European Biotech Crossroads). The goal of this international symposium is to bring together the world's leading experts (from academy, life science companies and industrial businesses) in the field of biomanufacturing. It will provide a snapshot of the main innovations in biological drug production and regulatory issues, as well as a focus on the development and optimization of a protein's activity.
In fact, Genopole® is set to become one of France's top biomanufacturing locations - notably via the forthcoming opening (in September 2007) of an industrial GMP biomanufacturing centre at the heart of the Evry biopark, in collaboration with the MAbgène company. In view of the difficulties faced by biotech companies in producing their lead molecules in France (where supply is weak), the center will offer life science businesses, pharma companies and academic labs access to preclinical and Phase I & II clinical batches with competitive pricing and short lead-in times. Initially, the Genopole® biomanufacturing center will custom-produce biological drugs (recombinant proteins and monoclonal antibodies) in animal cells. In the mid-term, it will offer other active compounds for use in fine chemicals and the industrial, value-added exploitation of agricultural resources.

EuropaBio / INRA

Food is more than sustenance. It is part of our cultural heritage. The globalization of food trade means that more than ever consumers wish to know about the origins of what they eat. The complex structures that have arisen in order to ensure food safety and traceability have created substantial commercial opportunities. This session will ask two key questions:
1) What are the new opportunities opened up by Biotech for traceability and for controlling food safety?
2) is it always necessary to regulate just because we can?

Patients have a pressing need for effective treatments and powerful new drugs. They know that bioscience can provide them. While the life cycles of consumer products and prices have decreased dramatically and the knowledge of biology has dramatically
increased, the drug development process and the prices of drugs have hardly changed. Patients and Patient Organisations want to accelerate and increase this process. They have the vision and the tools to make this happen. This session will focus on new avenues and successful partnerships between patient organisations, science and industry.

VIB, MRC, INSERM, INSERM TRANSFERT, KAROLINSKA INSTITUTET

This session will gather senior technology transfer executives from six of the leading Life Sciences research institutions in Europe. They will address key issues and success factors of innovation in their sectors. People who have been there and done it will talk about successful industrial partnerships and the creation and development of start-ups: How do tech-transfer professionals prioritise from the huge range of intellectual property that originates in their institution? Is scientific excellence really the number one success factor in technology transfer? Should research institutes get together and bundle their patent to maximise value in the company they create?

The changing face of academic entrepreneurialism… Has industry become better at taking advantages of the applications that spring from high quality research? A panel of academic entrepreneurs compares notes on how good industry is at prospecting opportunities: does it need to be more active, or is it still the researcher who has to identify the opportunities?

Welcome Address: Marc von Montagu, Chairman, Institute Plant Technology for Developing Countries, Ghent University, Belgium - President, EFB

OPTICS VALLEY / GENOPOLE / CEA

Modern Optical Medical Imaging provides a powerful diagnostic technique that can be applied across a range of diseases. In combination with advanced data handling capabilities, called BioIT, optical images can be shared between practitioners to enable remote diagnosis and analysis. This session will explore what has already been achieved and the technological progress that is still necessary fully to exploit the potential of this area.

Welcome addresses: Maurice Klein, CEO, Opticsvalley
Pierre Tambourin, CEO, Genopole - President, Medicen Paris Région

While the European Union is creating the European Research Area, the European Members States are organizing the TRANS-NATIONAL financing of their SMEs and academic laboratories to support their strategic partnerships in R&D. How can the researchers in Biotechnology be supported starting from the finding of European partners until the financing of their collaborative projects? How are the national public bodies in Europe organized to deliver public funding in a coordinated way for supporting their trans-national collaborations? How to find the right way among the plethora of the national and European initiatives? To address these questions the session will gather national financiers, leaders of competitiveness clusters and Biotech entrepreneurs who have already benefited from various public financing for their trans-national R&D partnerships.
Main national financiers particularly involved in the financing of the trans-national R&D Projects will briefly present their instrument, then biotech CEOs will present case studies and challenge the following distinguished panel:

Stem Cell Therapies are already showing potential in limited trials. Integrating them into modern healthcare structures will necessitate further advances in delivering the therapies, paying for the therapies, and ensuring a coordinated market. Today’s scientific advances may be under threat from the absence of a US market and the fragmentation of the European market. Here, researchers will discuss both the technical and structural hurdles that challenge their route to market.

EGAN

Hippocrates said 2,500 years ago “Let food be your medicine and medicine be your food”. Today’s buzz words are Nutrition, Functional Foods and Nutrigenomics.
Some micro-nutrients and nutraceuticals have gained acceptance in the prevention and management of certain diseases but, in order to avoid charlatanism, stringent scientific demonstration of therapeutic effects is necessary. The objective of this session is to paint a realistic landscape of the subject and present a rational view of expectations.

INRIA

Computer modelling of living systems is moving into the main stream of the Life Sciences, promising to make pharmaceutical/biotech R&D development more efficient. But harnessing the hidden information in the plethora of heterogeneous sources of biological information is not simply a question of linking data stores together. BioIT must fully encompass biology and applied mathematics and deal with the question of data quality before it can be truly useful…

AMGEN

The world of biomanufacturing has evolved. What major investments have been made or are planned around the world and particularly in Europe? Why did Amgen choose to put its European Biomanufacturing plant in Ireland? Do governments
recognize the need to encourage biomanufacturing activities, and what are individual governments doing about it? What are the potential public health issues if complex biomanufacturing processes are not followed properly? What are the implications for
biogenerics producers?
What are the implications for biogenerics producers?

VIB, MRC, INSERM, INSERM TRANSFERT, KAROLINSKA INSTITUTET

This session will gather senior technology transfer executives from six of the leading Life Sciences research institutions in Europe. They will address key issues and success factors of innovation in their sectors. People who have been there and done it will talk about successful industrial partnerships and the creation and development of start-ups: How do tech-transfer professionals prioritise from the huge range of intellectual property that originates in their institution? Is scientific excellence really the number
one success factor in technology transfer? Should research institutes get together and bundle their patent to maximise value in the company they create?

While the European Union is creating the European Research Area, the European Members States are organizing the TRANS-NATIONAL financing of their SMEs and academic laboratories to support their strategic partnerships in R&D. How can the researchers in Biotechnology be supported starting from the finding of European partners until the financing of their collaborative projects? How are the national public bodies in Europe organized to deliver public funding in a coordinated way for supporting their trans-national collaborations? How to find the right way among the plethora of the national and European initiatives? To address these questions the session will gather national financiers, leaders of competitiveness clusters and Biotech entrepreneurs who have already benefited from various public financing for their trans-national R&D partnerships.
Main national financiers particularly involved in the financing of the trans-national R&D Projects will briefly present their instrument, then biotech CEOs will present case studies and challenge the following distinguished panel:

The Millennium Development Goals represent a global partnership, responding to the world's main development challenges as well as to the calls of civil society. The Millennium Development Goals promote poverty reduction, education, maternal health, gender equality, and aim at combating child mortality, AIDS and other diseases. Since a family’s members often work on the family farm, how can bioscience and bioindustry contribute to better family health? How can the crops they grow be made more productive? By helping the poor to produce more than they eat and so generate a surplus that can be sold, can bioscience and bioindustry contribute to triggering economic development?

2006 is an exciting year for the biotech industry notwithstanding the U.S. and world economies being less than robust. The capital markets dramatically improved for the
biotech industry and IPOs have returned, driven by powerful new genomics and other enabling technologies that are changing both drug discovery and development…
and leading us toward both personalized medicine and a move to more predictability and ultimately to preventative medicine (the treatment of wellness). Regulatory development, product approvals, product success in the marketplace and mergers have changed the landscape for biotech dramatically. G. Steven Burrill’s annual analysis of the “State of the Industry” has been an important part of the
biotech industry’s view of itself over the last 20 years.
Biotech 2006, a perspective on where the industry has been and is going, will be the focus of this talk.

INRA

Europe’s oil fields are vegetable not mineral: refining and synthesis will be biological processes; the products are not food but fibres and resins for construction biomaterials, lipids and proteins for lubricants, detergents and surface-active agents.
Escalating fossil fuel prices and the cultural imperative of a clean environment are focussing attention on a new green chemical industry. More research and innovation
are needed but the future direction that Europe must take is already clear.

EFPIA / LEEM

Why is it that when we know so much more about disease processes and health, the productivity of pharmaceutical R&D appears to be decreasing?
Innovation ought to be an answer: biomarkers provide new diagnostic and prognostic monitoring; genomics enables predictive medicine while cell & molecular therapies and vaccines provide potential new approaches to diseases. But how soon will healthcare systems deliver these therapies? Do regulators need to act first? Are pharmaceutical companies rapidly adopting these new approaches?

Stem cell research, pharmacogenetics, and organ transplantation continue to present us with many ethical, legal, and societal challenges. But often these advances outpace our ability to anticipate the consequences. The result is reactive, poorly conceived policy. It would be better to begin a dialogue about the future to better anticipate the new challenges and to address them. Some challenges will come from the technologies themselves, others from public policy and law, some from the role of the private and government sectors, and still others from ethical and religious considerations. This groundbreaking panel brings together a distinguished international group to discuss the future of bioscience and the role of bioethics—to develop a “bioethics for the future”.

- An innovative code of protein surface comparison is adressing several needs in the pharmaceutical industry
Fabrice Moriaud

- Simulations and Optimizations of Microfluidic and MEMS Devices
Mustapha Megahed

- Visual and Image Mining in Bioinformatics for Complex Biological Systems
Rachid Gherbi

- ImmunoGrid: the European Virtual Human Immune System Project
Vladimir Brusic
Marie-Paule Lefranc

- Molecular modeling: toolset for creation of new drugs
Tobas A. Knoch

- Application of Advanced flui dynamics Analysis for the design of an innovating extra corporal blood pump
Alan Frydman

- Integrated Biomedical Informatics for the Management of Cerebral Aneurysms
Rodney Hose

- Drug targeting by dynamic system biology
Jean-Baptise Dumas

- Computational modeling of knowledge, the key to the integration of biological data
Patrice Garnier

OFFICIAL OPENING under the high patronage of Jacques Chirac, President of France

Research and Innovation is too important to be left to those who research and innovate: it must have impetus from national and international political leaders. What kind of society would we have if Europe manages to achieve the 3% target envisioned by Europe national leaders in Lisbon? What would happen if advanced nations spent 15% of their GDP on R&D like pharmaceutical and other innovative companies do? Is it yet politically acceptable to invest in an industrial future rather than struggling to maintain our industrial past? This Grand Plenary Session will feature leaders from the highest echelons of National Politics and Innovation.

Enjoy a working breakfast and learn how Ontario and France are leading the fight against Cancer through research and translation. Dr. Peter Dirks of Ontario’s
Hospital for Sick Children will explain his latest research to identify cancer stem cells in tumours eventually leading to new therapies that specifically target these stem cells.
Listen as Drs. Tom Hudson of the Ontario Institute for Cancer Research and Francois Amalric of National Cancer Institute of France explain their complementary strategies that will help research scientists like Dr. Dirks and industry partners discover, test and market research discoveries. Finally learn how several innovative, commercially,
oriented companies in both Ontario and France are translating comparative genomic ybridization (CGH) and Gene Expression Profiling (GEP) research into products
set to revolutionize cancer diagnostics.

Bionest Partners will host its annual Healthcare meeting during EuroBiO 2006. Bionest Healthcare Club is an opportunity offered to selected top executives from the
pharma, biotech, diagnostic and finance sectors to discuss cross-border strategic issues. This year, we have decided to tackle the pharma/biotech link from a financial
perspective. Pharma companies tend to pay an increasingly high price compared to private equity valuation and market capitalization to acquire Biotech companies and
assets. Trade sale ranks as number one exit strategy for a growing number of private and public investors.

Is this situation going to last? Is the pharma/Biotech system inflationist? Are pharma players always wise in their choices? Are the “non-bought/non-partnered” assets worthless?

Attendance is by invitation only.

EMEA / AFSSAPS

The regulation of drugs is an ever changing field, especially in Europe. Because of the coexistence of national and pan-European regulations, there is really no such thing as a single European market for pharmaceuticals. Not only, however, are there ways
through the centralized and fast track procedures, orphan drug legislation and the clinical trial directive, but if you are a small company the authorities will advise you at no cost.

RETIS

The incubator concept is well established as a way of translating research projects into commercial activity. This session will look in detail at various economic models for running incubators, for incubation exits, for post-incubation funding, and for rewarding the investment made by the incubator centres. It will also deal with new and proposed structures for innovative incubation initiatives.

Global competition is encouraging Member States in the European Union to support investment in R&D, in particular among small and medium size companies.
Several countries have developed a range of direct and indirect incentives supporting biotechnology and other innovative sectors.
This round-table session will discuss the benchmark study made by Sweden Bio and partners within the “YIC status” project: the study compares tax incentives for R&D in Canada, France, UK and Norway.

Academia is still the place where innovation starts. But the translation from a research concept to a market product is a lengthy and risky process. Biotechnology spin-outs, like all innovation based start-ups, need different funding options. In today’s financial environment, pre-seed and seed funding appear more and more essential in order to fill the primary equity gap and to prepare start-ups for the next round of funding.

The objective of this session is to provide an overview of the numerous seed capital fund models that have merged, and to discuss issues like fund strategy, anagement
skills, risk profiling, exits, and the bargaining power of seed capital funds.

Scientist and entrepreneur? Ever considered founding your own Biotech start–up? This session will consider the practical issues you need to consider to establish your own company. Our panel of entrepreneurial researchers will give you the chance to pick their brains on how to commercialise your research and provide a valuable insight into their path to success. In this interactive session our panellists will also proffer their expert advice on business models and securing finance for your venture.

Biomaterials are moving far beyond applications as mere structural components in replacement procedures. The most spectacular applications have been bone graft substitutes, tissue-inducing biopolymers and artificial organs. In drug delivery, biomaterials can help target drugs with precision to specific organs or wound sites. Artificial organs have been produced for more than three decades but modern materials are more similar to living tissue and respond to the body’s needs.

BioPoles

BioClusters have to be more than geographical clubs: they are self mentoring, outward facing organisations that can take positive group action and present a substantial business development front on behalf of their members. Meet managers from the most successful European BioClusters to understand the value of being linked and connected, and discover why the European Commission has so much interest in these initiatives.

IBM / EGAN

Human tissue and biological samples are valuable resources, especially those from people with rare diseases. The way in which patients and their representatives have organised specialised bio banks provides a model for others to follow. Involving patients more intimately in the process provides a structure in which privacy and confidentiality are more overtly respected.

From the perspective of entrepreneur, what are the key strategic elements that a company should take into consideration to achieve growth? IPOs versus consolidation, pros and cons? Which stock market to choose for an IPO? What are the criteria from the company’s point of view and from the investor’s point of view? What are the implications of a business plan for the company? What factors will be determined by the overall economic situation? How biotech-biotech consolidation be fostered and what can be done to make European biotech companies predators instead of prey?

European Patent Office

The Life Sciences throw out particular challenges to intellectual property practice. In cell therapy, are autologous treatments patentable or not? From a technical perspective, the use of biomarkers is expected to dramatically improve the efficiency of drug development; but it is unclear whether the patent system is going to encourage development in this direction. What is the best way to protect heragnostics?
What specific treatments are used in specific populations? Treatment methods are not patentable in Europe but what about patterns?

EuropaBio

Europe has made industrial biotechnology one of the pillars of its environmental policy. But the economic and practical development of biofuels, biomaterials, bioplastics, biochemicals and industrial enzymes will require a substantial amount of industrial and research effort. The first challenge addressed in this session is how high technology solutions can be provided at sufficiently low cost to be widely adopted. The second question is how rapidly these solutions can be developed - and that will depend on the level of capital investment from private, public and industrial sources.

Human resources management in Biotech start-ups runs up against the problems of all small companies. Specifically, however, these companies have to develop and adapt very quickly. They need particularly well-trained international personnel, with state-of-the art knowledge, often experienced and having the potential to evolve with the company. Although there are many people searching for professional opportunities and new challenges, the recruitment process is often a headache for Management. What ways and means does management have at its disposal to conclude this vital task for the company? What are the principal difficulties encountered? Companies at different stages of development will relate their experiences.

The working luncheon will be an opportunity for an open interaction between leaders of world main bioclusters, on their experience and the issues they face for tomorrow’s continued success. The audience will be invited to intervene in the discussion, so that participants can learn from others’ experience and perspectives. The debate will be facilitated by Leslie Alexandre, President and CEO of the North Carolina Biotechnology Center, and Bernard Brigonnet, CEO of Medicen Paris Region

As the European Union creates the European Research area, and RTD goes beyond the laboratory, the strength of the EC as a force mobilizing bioscience is increasing greatly. Centralised funding stimulates national funding to build a European entreprise that starts with the Life Sciences.
Find out about building collaborations, building businesses, and expanding the horizon of the research process…

European Venture Capitalist Association

The evolution of the biopharmaceutical market has lead to significant evolution in investment strategies. Even for early rounds, up to ten times more money is required now for initial investments than ten years ago. Hybrid business models, multiplayer financial schemes and innovative exit strategies are the latest trends of modern venture capitalism. Last but not least, new markets, noticeably Italy, are emerging in Europe for biotech start-ups and VC investment.

Hospitals are central to the delivery of healthcare but they are not often thought of as engines of innovation.
Physicians not only do everything they can for patients, they also know what they would like to do but can not. The hospital networks therefore are the interface between innovative companies and their market. How do hospital administrations encourage and manage this innovative process so that they can incorporate the best of experimental medicine into current practice for patients?

he careers snapshot section in Nature Reviews Drug Discovery, to be launched in October this year, profiles personalities from the biopharma world. Participants highlight what has attracted them to the careers they have chosen and what they feel have been the most important lessons they have learned on the way.
Peter Kirkpatrick, Chief Editor of Nature Reviews Drug Discovery, will be moderating this round table event, which will involve personalities who are featuring in the
inaugural Career snapshot section. Attendees will gain insights on a wide range of positions and career paths that are often only obtained by talking to people in person, and inspiration for those seeking to develop their careers.

Created to foster collaborative R&D projects in Life Sciences between Paris Region and North America, the Paris Bio Prize 2006 rewards two outstanding partnership projects in Oncology both private and academic between Paris Region and North
American structures.

The Paris Bio Prize was launched in 2005 by the Paris Region Economic Development Agency to promote exchanges between international bioclusters to build up a strong image of Paris Region in Life Sciences and to develop and nourish a strong
network community.

The biotechnology companies and academic laboratories rewarded will receive a Û50,000 grant (about US$67,000) to finance the work of a post-doctorate R&D scientist in a partnership project with a North American company or academic structure for one year.

As a platinum sponsor, Laboratoires Servier is financing one of the grants of the 2006 Paris Bio Prize. The laureates of the R&D collaborative projects of this “Paris Bio Prize SERVIER” will be announced October 26, at 4.00 pm before the Grand Plenary
Session on Finance at EuroBiO, by Servier’s Head of Research.

How does the supply of capital at ALL stages of development influence strategic planning?

In the past, the majority of European Life Sciences companies have turned to the United States to raise late stage capital. Does the renewed enthusiasm for BioIndustry mean that companies can now raise the large amounts of capital they need in Europe?

Last and certainly not least, WHICH of the leading Stock Exchanges DARES to back this strategic sector?

Pharma-Biotech Speed Meeting is a free initiative led by InterBiotech¹ in which all participants meet each other for a short period² of time and exchange their business cards.
It provides a highly efficient opportunity to make new contacts and stimulates the development of business relationships - in just an hour; you can meet more than 40 people.

1: InterBiotech is a non-profit organization that facilitates networking for people in life sciences business. Its goal is to promote entrepreneurial and business relationships with an international perspective. www.interbiotech.com

2: Five minutes for meeting a small group of 5 people

>> REGISTRATION

At Yole, we are convinced that Micro & Nanotechnologies (MNT) are a very powerful way for the Life Sciences industry to strengthen its innovation strategy.
Therefore we have decided to launch a business convention during EuroBio in Paris to help you to:
· Discover the technological and economics potential of MNT and see what is a scientific dream, a mid term prospective or a concrete business reality
· Learn how MNT can increase your product performance in terms of accuracy, sensitivity, biological and physical functions integration, cost reduction
· Assess innovative solutions and their technological feasibility
· Detail the way your competitors already address MNT
· Meet with managers to better understand each other requirements and initiate contacts with your future development partners in a multicompetency converging approach
By daily surveying this market at Yole, we identify a wide range of applications or process where MNT bring concrete answers and accelerate technology innovation:
· Boehringer Ingelheim’s inhaler based on a microstructured nozzle
· Agilent HPLC-Chip integrating sample preparation and electrospray tip on a single microfluidics chip
· Genefluidics 45 mn rapid pathogens detection from sample collection to read-out.
We don’t question the effectiveness of MNT for Life Sciences, we still see translation and timing issues, the need to work together and learn from each other in a common language. Therefore we want to be cross borders and assist you to adopt a multicompetency converging approach to bridge between your field and the MNT world.

Agenda
Morning session: Special case study
· From design to manufacturing and integration, what are the microfluidic challenges?
· How to get the key ingredients to successfully integrate MNT in Life Science systems?
Afternoon session: Business meetings and one to one Q&A session with Yole Experts and speakers
Conclusion & General Session
For qualified business meetings, please register before October 6th, and address your own priorities and question to Sandrine Leroy (leroy@yole.fr).

Take a day with Yole, to know more about Micro & Nanotechnologies. You will get the opportunity to discuss with future partners combining expertise to successfully collaborate in your innovative project.

We ALL want the response to new health threats to be global and effective, but are we really prepared to act in an integrated manner? Decisions makers from International Health or Research Organisations interfacing with major Pharmaceutical Corporations will discuss the strategic and operational actions to be taken.