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www. biotech-finances.com CONTENTS SPECIAL ISSUE n°4 - wEStErn FrAnCE Special issue on Western France Business Valneva focuses on its vaccines "A cross-border merger is always a challenge." Maïlys Ferrère p. 3 "Made in France" Lemer Pax opens to the world "A charismatic CEO’s leadership." Jérôme Fortineau p. 6 Immunobiotherapies In-Cell-Art Cytune Pharma Affilogic p. 4 Radiopharmaceuticals ISotoP4LIFE Keosys Arronax Atlab Pharma Chelatec p. 5 Regenerative medicine Biomatlante Atlanta Clean Cells reborne p. 7 Marine bioresources AlgoSource Défi microalgues Hemarina Ifremer p. 8 Biomanufacturing the Biopractis training center now open p. 9 Interview nantes envisions itself as a major center of innovation in western France p. 10 - 11 Get introduced to our BioMap France 2013 : Atlanpole Biotherapies: a strong pioneering spirit! A tlanpole has a force of 380 compa- nies, of which 77 are dedicated to life sciences and healthcare, incor- porated within the Atlanpole Biotherapies cluster. Mobilization in order to achieve critical mass is strong, and the entre- preneurial spirit and solidarity among all those involved in the area are exem- plary. Murielle Cazaubiel, Director of the Biofortis BU Clinic, a subsidiary of the Mérieux Group, presides over Atlanpole Biotherapies. Together with Jean-François Balducchi, CEO of Atlanpole and Atlanpole Biotherapies, the two revisit the strengths and challenges of their territory. Biotech finances: The Atlanpole territory is relatively new and has a very inte- resting dynamic among those involved. How would you analyze the success of your system and, in particular, that of Atlanpole Biotherapies? Jean-François Balducchi : the history of our territory is both recent and avant-garde. well, it’s recent in terms of the global academic context, with the reopening of the University of nantes as recently as 1962; and it’s avant-garde as well because the biotech/healthcare cluster, which began to emerge in the mid-1990s, was structured competitiveness cluster before the concept was launched in France. there is a true pioneering spirit here that mani- fests itself on several levels. Solidarity is a universal value, with collective efforts among the teams involved in different areas, and there is a strong culture of development and entrepreneurship. while nantes may not have the sort of industrial history in the field of Healthcare making it famous in other regions, it has nevertheless demonstrated scientific excel- lence and entrepreneurial dynamism. the cluster owes a large part of its existence and reputation to numerous entrepreneurial researchers, such as Professors Jean-Paul Soulillou and Denis Escande. originally, they were able to unite, lead, and attract the skills neces- sary to enrich our group. Gradually, we have seen the growth of a group of busi- nesses, also incubated by Atlanpole, and subsequently it was necessary to ensure the organization and promotion of this cluster, which at that time (2003) lead us to successfully organize the European Biotech Crossroads event. when the competitiveness cluster; were established in 2005 by the French government, this experience allowed for the certification of Atlanpole Biotherapies in clearly identified areas, strengthened by high-level infras- tructure and equipment. Murielle Cazaubiel: the willingness to partake in entrepreneurial endeavors resonates greatly in nantes, with a start- up mindset. we aim to be proactive at all times; this is one of the qualities of our territory. we know how to grab a hold of significant opportunities, remain diligent with regard to the businesses around us, and stay consistent with one another. For example, we are able to quickly change direction in pursuit of a particular develop- ment. we are sometimes criticized having a weak presence of major players within our territory, however, in comparison to other clusters, our system has a real dynamic for the creation and development of SMEs, some of which, like Valvena, are listed on the Stock Market, show conti- nuous growth, and could hopefully soon become European/world leaders in their respective fields. Jean-François Balducchi : the geographical context is also taken into account. nantes is located at the meeting point of several cultures - Brittany, Vendée, and Loire - and that makes for a great mix. In Vendée, the entrepreneurial spirit is very strong. this is also the case in Britain, and more gene- rally in the peripheral territory forming the Great west Atlantic. Furthermore, political leaders on both the left and the right have always supported innovation. In the mid-1990s, Jean-Marc Ayrault, the current Prime Minister was mayor of Nantes. He was always attentive to the specific needs of the biotechnology sector, just as were other officials of local and Our successes have enabled us to attract major accounts such as Sanofi or Mérieux. Jean-François Balducchi (Connued on page 2) 606-anglais.indd 1 14/10/13 13:21

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CONTENTSSPECIAL ISSUE n°4 - wEStErn FrAnCE

Special issue on Western FranceBusiness Valneva focuses on its vaccines

"A cross-border merger is always a challenge."Maïlys Ferrère

p. 3 "Made in France" Lemer Pax opens to the world

"A charismatic CEO’s leadership."Jérôme Fortineau

p. 6 Immunobiotherapies In-Cell-Art Cytune Pharma Affilogic

p. 4Radiopharmaceuticals ISotoP4LIFE Keosys Arronax Atlab Pharma Chelatec

p. 5Regenerative medicine Biomatlante Atlanta Clean Cells reborne

p. 7Marine bioresources AlgoSource Défi microalgues Hemarina Ifremer

p. 8Biomanufacturing the Biopractis training center now open

p. 9Interview nantes envisions itself as a major center of innovation in western France

p. 10 - 11

Get introduced to our BioMap France 2013 :

Atlanpole Biotherapies: a strong pioneering spirit!Atlanpole has a force of 380 compa-

nies, of which 77 are dedicated to life sciences and healthcare, incor-

porated within the Atlanpole Biotherapies cluster. Mobilization in order to achieve critical mass is strong, and the entre-preneurial spirit and solidarity among all those involved in the area are exem-plary. Murielle Cazaubiel, Director of the Biofortis BU Clinic, a subsidiary of the Mérieux Group, presides over Atlanpole Biotherapies. Together with Jean-François Balducchi, CEO of Atlanpole and Atlanpole Biotherapies, the two revisit the strengths and challenges of their territory.

Biotech finances: The Atlanpole territory is relatively new and has a very inte-resting dynamic among those involved. How would you analyze the success of your system and, in particular, that of Atlanpole Biotherapies? Jean-François Balducchi : the history of our territory is both recent and avant-garde. well, it’s recent in terms of the global academic context, with the reopening of the University of nantes as recently as 1962; and it’s avant-garde as well because the biotech/healthcare cluster, which began to emerge in the mid-1990s, was structured competitiveness cluster before the concept was launched in France. there is a true pioneering spirit here that mani-fests itself on several levels. Solidarity is a universal value, with collective efforts among the teams involved in different areas, and there is a strong culture of development and entrepreneurship. while nantes may not have the sort of industrial history in the field of Healthcare making it famous in other regions, it has nevertheless demonstrated scientific excel-lence and entrepreneurial dynamism. the cluster owes a large part of its existence and reputation to numerous entrepreneurial researchers, such as Professors Jean-Paul Soulillou and Denis Escande. originally, they were able to unite, lead, and attract the skills neces-sary to enrich our group. Gradually, we have seen the growth of a group of busi-nesses, also incubated by Atlanpole, and subsequently it was necessary to ensure the organization and promotion of this cluster, which at that time (2003) lead

us to successfully organize the European Biotech Crossroads event. when the competitiveness cluster; were established in 2005 by the French government, this experience allowed for the certification of Atlanpole Biotherapies in clearly identified areas, strengthened by high-level infras-tructure and equipment.

Murielle Cazaubiel: the willingness to partake in entrepreneurial endeavors resonates greatly in nantes, with a start-up mindset. we aim to be proactive at all times; this is one of the qualities of our territory. we know how to grab a hold of significant opportunities, remain diligent with regard to the businesses around us, and stay consistent with one another. For example, we are able to quickly change direction in pursuit of a particular develop-ment. we are sometimes criticized having a weak presence of major players within our territory, however, in comparison to other clusters, our system has a real dynamic for the creation and development of SMEs, some of which, like Valvena, are listed on the Stock Market, show conti-nuous growth, and could hopefully soon become European/world leaders in their respective fields.

Jean-François Balducchi : the geographical context is also taken into account. nantes is located at the meeting point of several cultures - Brittany, Vendée, and Loire - and that makes for a great mix. In Vendée, the entrepreneurial spirit is very strong. this is also the case in Britain, and more gene-

rally in the peripheral territory forming the Great west Atlantic. Furthermore, political leaders on both the left and the right have always supported innovation. In the mid-1990s, Jean-Marc Ayrault, the current Prime Minister was mayor of Nantes. He was always attentive to the specific needs of the biotechnology sector, just as were other officials of local and

Our successes have enabled us to attract major accounts such as Sanofi or Mérieux.

Jean-François Balducchi

(Continued on page 2)

606-anglais.indd 1 14/10/13 13:21

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2 BIOTECH FINANCES - Special issue n°4 - Western France

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S p e c i a l i s s u e o n W e s t e r n F r a n c e

regional authorities. Having felt the need to catch up in terms of Public research, especially in the domain of life sciences, everyone was in tune and heading in the same direction. the Pays de la Loire region is the 3rd industrial region of France, and 10th or 11th in the ranking for life sciences. the territory is there-fore perceptive to industrial messages. this led it to anticipate and manage change, with large facilities/structural projects such as the Arronax cyclotron which was dedicated to the research and production of radioisotopes for cancer treatment; Atlantic Bio GMP (ABG), which is a production site for innovative drug therapies (gene and cell therapies) for rare diseases; the IHU (University Hospital Institute); and of course support for business development, dialogue with investors, the construction of the new University Hospital Center on the Isle of nantes, etc.

Biotech finances: How would you characterize your actions for the deve-lopment of this area?Jean-François Balducchi: Atlanpole Biotherapies is focuses on three strong main themes: Immunobiotherapies, radiopharmaceu-ticals, and regenerative medicine, in which innovative technology for biothe-rapy plays a key role. these themes have been bolstered by excellent research,

as I’ve already mentioned, as well as by companies of various backgrounds, including Valneva (formerly Vivalis) or Biofortis, which promoted the results of this research. we are characterized by a well developed and professional process geared toward the detection and support of innovative projects, either in refe-rence to new businesses or new projects arising from existing companies. we organize and provide services tailored to the needs of those involved in the area, within the context of the aforementioned themes. we promote interaction among all the members of the network, including cooperation with subsidiaries. our know-how in the area of engineering innova-tion covers pre-incubation, incubation and post-incubation. one of the charac-teristics of Atlanpole is being proactive. we consistently visit laboratories to ascertain what is recoverable. we have at our disposal in-house skills necessary for setting up collaborative projects, in addi-tion to a team dedicated to the incuba-tion of projects and companies. In total, the biotech team of six people covers the entire value chain. today, including all of our areas of focus, we are proceeding at a rate of 50 consortia certified each year, primarily consisting of SMEs and 1/4 to 1/3 of these projects are funded. we have also launched highly collaborative networking events for players in the area. the Startwest facility has been around for

13 years and allows us to bring in inves-tors and project developers. Early on, we were able to identify the complexity of the financing needs of Young Innovative Companies and have acted appropria-tely to overcome difficult times. now investors come to Startwest with the assurance of getting a preview of quali-fied projects that are able to best meet their criteria. the cluster is very involved in the regional Advisory Committee for research and technological Development (CCrrDt) of the Pays de la Loire for the development of regional strategies. It has played an important role in the PIA, with EQUIPEX ArronaxPlus and LABEX Iron for the research and deve-lopment of radiopharmaceuticals in the areas of oncology and neurology, LABEX IGo for the r&D of immunotherapies in the Great west, not to mention the University Hospital Institute - CEStI. this is dedicated to the disciplines of trans-plantation and immunotherapy. It brings together the University of nantes, the University Hospital Center of nantes, oniris (national Veterinary and Agri-Food University), the EFS of the Pays de Loire, and the Atlanpole Biotherapies center of competitive excellence, which is supported by nantes Métropole, the region Pays de la Loire, and the PrES of the university nantes-Angers-Le Mans. At the international level, Atlanpole Biotherapies is a driving force in the

early development of rege-nerative medicine. the European project tErM (tissue Engineering and regenerative Medicine) which targets the develop-ment of innovative thera-pies to repair or replace damaged or defective tissues, offers new perspec-

tives in the treatment of serious diseases such as cancer, diabetes, Alzheimer’s or Parkinson’s. It is one of the seven winners of the «regions of Knowledge» program. this has allowed us to continue working with the clusters which we know well in Europe, such as those in Berlin, London, Milan, or Madrid, and this all contributes to the creation of new opportunities and an increased international visibility for us.

Biotech finances: In terms of attrac-tiveness, have you achieved the desired results?Jean-François Balducchi : our successes have enabled us to attract major accounts such as Sanofi or Mérieux, which regu-larly come to meet local players and sometimes go as far as to buy the chips made in our area. the example of Biofortis with the Mérieux group is quite telling. Personally, I think that it’s better to know the skills and strengths of our territory in order to create opportunities rather than spending a lot of energy pros-pecting, which has an uncertain outcome. with regard to international matters, we don’t necessarily have a very aggressive marketing policy. we would first like to support our businesses the best that we can, either individually or collectively. During the last BIo in Chicago, we had 12 Atlanpole Biotherapies companies, inclu-ding two from normandy, and we made sure that they were in an environment

conducive to their business activities. we also help our SMEs to expand inter-nationally thanks to the In2LifeSciences (In2LS) Program, which facilitates the access of SMEs to international develop-ments, such as assignments or travel to international fairs. In this domain as well, being a team player with our interna-tional partners such as CCI International and the regional Council is our best asset.

Biotech finances: How do you feel about the future of Atlanpole Biotherapies? Jean-François Balducchi : Since the beginning, we have created over 60 biotech companies, with only six or seven bankruptcy filings. we’ve had some great successes with companies that are progressing in a very interesting way: Atlangene, Biofortis, Vivalis became Valneva, Effimune, In-Cell-Art, Clean Cells or Affilogic are also excellent references. we hope to see all of the companies acce-lerate in their growth, and we try to do our best to help them. the gradient needs to be high for them to be the necessary critical mass and subsequent transfor-mation of the SMEs into Intermediate-Sized Enterprises (EtI). the objective is to strengthen the three strategic focal points of the cluster, and first in terms of a research base. the region has launched a call for proposals, Connect talent, to find and then assist in the development of breakthrough projects, while furthe-ring the scope thereof. the purpose is to recruit international talent in the areas in which it is important to have leaders. we also plan to intensify our efforts in the development of marine bioresources, in partnership with the Mer Bretagne cluster via the Atlanpole Blue Cluster. Finally, at the institutional level, the tentative agreement recently reached with the Brittany and Central regions paves the way for the expansion of the Atlanpole Biotherapies cluster toward the Great west, which is excellent news for all of our members, companies, and academic partners.

Murielle Cazaubiel: Atlanpole Biotherapies is truly involved in the medicine of tomorrow, with innova-tive areas of focus for the development of new therapies and the discovery of unexplored methodologies for human treatments. we are very rigorous and consistent in these three areas which are greatly enriched by cross-cutting technologies. we must now succeed in consistently organizing the different players and create a magnifying effect in the region, with two to three significant projects which will really show the excel-lence of our expertise in innovative medi-cine, personalized medicine based on cutting-edge research, and in the deve-lopment of antibodies with the targeting strategies of extremely new therapies. we have arrived at a key moment in which, finally, things are beginning to fall into place as a result of the themes which have been at the center of our focus. All that needs to be done is articulating and organizing the whole thing, and this is already underway.

Create a ma-gnifying effect in the Region, with two to three signi-ficant projects.

Murielle Cazaubiel

Interview conducted by Jacques-Bernard Taste

(Continued from page 1)

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3BIOTECH FINANCES - Special issue n°4 - Western France

Business

The news came at the begin-ning of the summer. Valneva, a merger of Vivalis/Intercell (1),

will cease its bioproduction activi-ties under contract before the end of the year, in order to refocus on the development of vaccines. A risky operation, jointly led by Franck Grimaud, former CEo of Vivalis, and by the Austrian management of Valneva, which have come together to find a buyer that would main-tain the nature of the plant, as well as its employees. this mission was accomplished, with the continued presence of 22 employees at the site who are now acting on behalf of the Indian biopharmaceutical company, Biological E. For the buyer, which is the manufacturer and retailer of the

first vaccine by Valneva in Asia, the strategy is clear: open a bridgehead in Europe to prepare for the commer-cialization of vaccines and innovative medicines in the territory. the assi-gnment of this CMo activity should allow Valneva to save 3 M€ per year in operating expenses. the company will also receive financial compensa-tion for the sale, the terms of which have not been disclosed, but which exceeds the net book value of the site. "The cessation of our services involving the EB66® cell line, which

is derived from embryonic duck stem cells and used for the production of vaccines to replace manufacturing systems, does not mean the end of the exploitation of this techno-logy, as we expect to find specia-lized partners with whom we may continue such work through global licensing agreements. Several discus-sions are underway, with the aim of signing the first deals by the end of the year, explains Frank Grimaud. This additional source of recurring revenue will be added to our own funds to develop our line of vaccines and therapeutic antibodies."

Launching a new vaccine on the marketwith its first vaccine, which is used

to fight Japanese ence-phalitis, Valneva has demonstrated its ability to develop, record, produce and market an initial vaccine in a niche market with high poten-tial. with technology in hand, the leaders of the

company want to continue down this path by investing in the develop-ment of a second vaccine candidate, which could hit the market within three years. Among the poten-tial leads, the company is working on three main areas: its internally produced vaccine Pseudomonas aeruginosa, which is in Phase II/III, intended for use against the gram-negative bacteria of the same name; its Clostridium difficile program, tested in Phase Ia on a population of healthy volunteers; or a totally new

external project through in-licen-sing. "The decision to promote one molecule or another will be made at the end of the year based on the results of the current trials underway for Pseudomonas aeru-ginosa, says Franck Grimaud. It will be supported by the conclusion of a refinancing operation, which we have just secured for nearly 40 M€ from Bpifrance, the Grimaud Group and one of its financial partners, two banks, as well as our histo-rical shareholders through a capital increase with preferential subscrip-tion rights." Such strong financial backing suggests good prospects for the Franco-Austrian group which now has all of the necessary pieces to move forward and become an integrated player recognized for its fair market value.

Valneva focuses on its vaccines

A fresh perspective on Valneva

Maïlys Ferrère, director of investment - Bpifrance"the joining of Vivalis and Intercell to create Valneva was a key operation for the two companies which have several significant points of commonality. Both entities were initially independent with the plan for capital vis-à-vis industrial partners, which in turn leaves them an important and strategic field of operation. these two companies, however, have already received recognition from their peers, with key partnership deals with novartis for Intercell or Sanofi and GSK for Vivalis, among others. on the technological side, Vivalis has contri-buted with its EB66 technological platforms and the VIVAScreen, whereas Intercell had a more advanced tool with late stage products and a vaccine already on the market. this expertise in the areas of clinical know-how,

marketing and commercialization will be a tremendous asset in bolstering the business prospects of Valneva in the years to come. A cross-border merger is always a challenge, both for individual and cultural reasons. In this case, this operation was devised and directed by various teams and supported by managers who had worked together for over 18 months. this is an important point which will most likely aid in a smooth operation of the merger. once the integration is complete, the companies’ leaders should focus on strengthening their corporate structure, while continuing to advance the more cutting-edge projects in order to ensure a strategic positioning in niche markets which will ensure the future growth of the group."

V a l n e v aLyon / Saint-Herblain

Banks

Crédit Agricole, Crédit Lyonnais, Caisse d’Épargne, Crédit Mutuel, Natixis, CIC

Law firm for license agreements

Jonathan Burnham, Cabinet HBC

Law firm for IP

Cabinet Regimbeau, BPIF

Audit firm

Deloitte, Cabinet Chesneau et associés (co-commissariat)

Juliette Lemaignen

1 – Read “Viva Valneva!” in Bf No. 576 from 12/24/2012

A capital increase with preferential subscription rights.

Franck Grimaud

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R a d i o p h a r m a c e u t i c a l s I m m u n o b i o t h e r a p i e s

Affilogic is advancing its lead toward the clinical phase

Proposing alternatives to thera-peutic antibodies in order to develop internal projects

for specific proteins is the goal set by olivier Kitten, CEo of Affilogic. Founded in nantes in 2010, the company uses a patented technology platform to generate a new class of affinity ligands: nanofitines®. Linked to specific targets, these show production rates which are more than ten times

higher than those of antibodies and make it possible to act on indications which are not accessible by the competing molecules. to kick-start its activities, Affilogic established partnership agreements with manufacturers wanting to develop molecules with specific targets. this mission has allowed the company to finance its own development

and to open some indications for its in-house line. the most emblematic project in this area is backed by the European Commission under the framework of the SADEL (Scaffolds for Alternative Delivery) consortium. Its goal is to develop oral formulations of nanofitines® for the treat-ment of chronic inflammatory bowl diseases including Crohn’s disease. Currently in preclinical development, the alliance, which has brought together seven partners since the start of 2012, is implementing a strategic change with the imminent integration of a pharmaceutical partner. this marks a wide-spread industrial recognition in a much courted therapeutic sector which reveals pros-pects for Affilogic to have an interesting clinical launch of its compound. In the meantime, the start-up plans to consolidate its assets by raising a first round of financing for about €800,000. It’s likely that regional funds will be responsive to this beautiful piece of local history.

olivier Kitten

Cytune Pharma launches a new generation of cytokines

Originated from academic research in nantes, biotech company Cytune Pharma is preparing to

conduct the regulatory preclinical phase of its drug candidate CYP0150, which is an optimized version of interleukin-15. this cytokine (IL-15) plays a key role in the immune system because of its ability to stimulate the proliferation natural killer cells. However, in the 2000’s, it was shown that effectiveness of such cells was

limited, mainly because the alpha chain of their alpha recep-tors are cut by tumor escape mechanisms which prevent them from acting. In 2005, a team from Inserm decided to make a fusion protein by combining IL-15 with a portion of the alpha receptor, known as ELI or CYP0150, which optimizes immune response. CYP0150 may work against various advanced forms of cancer, including melanoma, kidney cancer or lung cancer. In 2009, Cytune Pharma acquired a license from Inserm for this compound. "This is the beginning of the development of a mole-cule that could offer an innovative therapeutic response in addi-tion to the immunomodulatory antibodies currently employed.

Regulatory industrial development will begin in late 2013 and has the primary objective of producing the protein on an indus-trial scale, as well as validating the safety profile of the candi-date in order to obtain the necessary authorization to inject the product into humans," explains Dr. David Bechard, who along with Dr. Yannick Jacques co-founded Cytune Pharma in 2007. the management team is aiming for human use by the end of 2015 and is already looking into sources of funding for the first two clinical phases. It is assessing the possibility of using invest-ment funds, business charity, or support from foreign institu-tions such as the nIH. Discussions are underway, together with several pharmaceutical companies, which could lead to the signing of a co-development agreement within 24 months. to move forward on these objectives, Cytune Pharma will need to refinance and intends to initiate fundraising before the end of the year in order to raise €5 million. It already raised €1 million in 2012 from Idée, the regional Council investment fund, and three VCs which are already shareholders - the nantes-based Sodero, the Swiss remora Capital, and Starquest Capital from Paris. If things go well, the SME could break into the market of immunotherapeutic agents, which could reach €26 billion by 2020.

David Bechard

In-Cell-Art begins collaboration with Stallergenes

This isn’t the first time that the biotech In-Cell-Art has worked with a major player in the industry. Specializing in

the development of nanocarriers for the formulation of vaccines and antibodies, this company, which was founded in 2005, works together with Sanofi Pasteur under the framework of a research consortium funded by the American Department of Defense, and has just granted a licensing option for the use of its technology by the

French leader in the area of vaccines. Furthermore, In-Cell-Art has experienced quite a reputation since its inception, as one of its founders was the nobel Prize winner in the area of chemistry in 1987, Jean-Marie Lehn. It is therefore hardly surprising that it has captured the interest of the specialist in allergy immunothe-rapy, Stallergenes. the partnership between the two is intended for the production of new antibodies for the research programs of Stallergenes. In-Cell-Art will employ its ICAntibodies™ technique which will allow for the customized discovery of

antibodies. there will be no need for antigens, the DnA sequence alone will suffice. once the DnA strand has been synthesized, it is formulated in a nanotaxi®, the type of carriers developed by In-Cell-Art, before being injected into the animal that final produces the desired antibody. "The technological superiority of our ICANtibodies™ technology, in comparison with other genetic immunization methods, is based on the use of Nanotaxis® which induce a strong antigen expression and a significant stimula-tion of the immune system, including against extremely diffi-cult targets," explains Bruno Pitard, one of the founders of the company which now has 10 employees. this agreement, the financial terms of which have not been disclosed, will provide new revenue for In-Cell-Art. Primarily owned by its founders, the SME, which operates on a mixed model with a turnover greater than 1 M€, relies on its own resources to finance its projects. In addition to the works performed for third-parties, In-Cell-Art is developing its own drug candidate: a therapeutic and preventa-tive vaccine against liver cancer, which should enter the regula-tory preclinical studies before the end of the year. this start-up from nantes isn’t finished yet!

Bruno Pitard

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R a d i o p h a r m a c e u t i c a l s

ISOTOP4LIFE, the small network that wants to go bigCreated around eight manufacturers

and four academic teams involved in the field of nuclear energy and

its effects on health, the scientific and economic alliance ISotoP4LIFE now has new growth ambitions. "researchers in the sector are very well structured but they are still not officially connected with the indus-trial world represented in this case by our

group, explains Jean-François Gestin, founder of ISotoP4LIFE. Getting all of these people to work together, under the same

banner and with common economic and territorial interests, would be a very good way to consolidate the forces present in the region in order to be better equipped to face international competition." Among the areas of development envisaged to achieve this goal are the strengthening of the sector through the creation of a multimodal imaging center in nantes and the launch of a radiopharmaceutical production center fulfilling the GMP norms. the submission of an application to the Connect talent call for proposals is expected to boost this development. Certification results expected for the fall.

Arronax operates the Nantes cyclotron at full speed Operational for over two and a half

years and already almost at full capacity, the nantes cyclotron,

which was built within the walls of the PIrG Arronax, has remained busy. "research projects such as those involving production proceed according to well defined sche-dules and protocols," comments Jacques Barbet, director of the PIrG Arronax, highli-ghting the importance given to on-site safety. "Given its specific characteristics, our device finds all of its power in r&D

applications, which is an area that must remain a priority and

in line with industrial applications." Since its launch in 2011, and in order to ensure its financial sustainability, Arronax has established a production routine for strontium-82, a radioactive tracer used for PEt imaging in the field of cardiology. Sold exclu-sively in the U.S., this product could soon be adapted for the European market based on the project being carried out by the nantes-based company Lemer Pax, which is working with the Arronax team to develop a generator and automatic injector. At the national level, support for this initiative, which is known as the QuantiCardi, has an FUI endowment of €4 million which will serve as leverage for this new market which could be covered in three years time. As of now, projects are launched on-site.Jacques Barbet

The American dream of KeosysSpecializing in management solutions

for medical imaging data, Keosys acce-lerates its international development.

After opening an office in Singapore, this 30-person company based in Saint-Herblain has just opened a new office in the United States, in Philadelphia. "This first establish-ment across the Atlantic allows us to attract large American accounts, to which we will offer our unique IT platform for managing clinical trials," says Jérôme Fortineau, presi-

dent of Keosys, which has a turnover of €2.5 million. Discussions

are already underway with several U.S. pharmaceutical compa-nies, including 4 or 5 concrete leads which could result in contracts by the end of the year. the FDA, which requires the use of an independent expert for the management of clinical trials, pushes American businesses to make use of external service providers. Keosys is backed by strong credibility, after registering €10 million in orders in 2012 to conduct clinical trials over five years for well-known companies such as GSK and Servier. Its cloud platform for managing medical imaging files makes it possible to centralize and share patient records between geographically remote locations. the company’s leader aims to reach €10 million in turnover by 2015.

Jérôme Fortineau

On to Phase III for Atlab Pharma Scientific results have been successful

for Atlab Pharma, which has made a flawless progression to Phase II with

its flagship molecule AtL101. this new drug candidate for vectorized radiotherapy is active against metastatic prostate cancer with a very specific targeted mechanism. AtL101 combines the humanized mono-clonal antibody J591, which is located in the tumor cells, with a radioactive atom of Lutetium-177, which irradiates the tumor by the electrons it emits. these electrons

have a very short range in matter, which is particularly suitable for metastatic prostate cancer which is small in size. A Phase IIb international trial with AtL101 will start within six months in order to optimize its mode of administration for Phase III. Meanwhile, Atlab Pharma is working on a new generation of targeted radiotherapy which this time will utilize Astatine-211 which emits alpha particles that travel even shorter distances than Lutetium-177. this new formulation will make it possible to target individual cells, especially in cases of patients who have had operations done on their primary tumor and who could still have some undetectable metastases.

Jean-Marc Le Doussal

Chelatec picks up the paceSpecialized in radioactive labeling and

preclinical evaluation of molecules, Chelatec finished the year in line

with its forecasts. "We should exceed one million Euros in turnover in 2013 thanks to the work executed by all of our employees and through additional efforts in terms of international communication," states Jean-François Gestin, who founded the company in 2000 alongside Anthony Loussouarn. Chelatec’s success has been forged step by step since its creation in 2000, basing its

development strategy on innovation, flexibility, and customer satisfaction. Starting in 2010, this company of 13 people was impacted, just as were many other players in the field, by lower r&D expenditures from big pharmaceutical companies in the wake of the economic crisis. Since then, the company has managed to overcome the situation and has been able to give itself a new boost: the development of a production area in parallel to its service activities in the field of radiolabeling, new tools for validating molecules in pre-clinical phases and the expansion of its portfolio of international clients. However, Chelatec is looking ahead and aims to embark upon the radioac-tive marking of products in clinical phases. Jean-François Gestin

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R e g e n e r a t i v e m e d i c i n e

Going from 40% of exports to 80% in three years, the objective set by Pierre-Marie

Lemer, Chairman and CEo of the nantes-based company Lemer Pax specializing in radiation protection, is ambitious but realistic, just like the rest of the strategy of this family business which has been operating in Carquefou since 1970. to reach this threshold, the CEo has focused on strengthening the company’s

network of international distribu-tors, with several key areas in mind, including russia, Brazil, Germany, China, Japan, and India. "Finding good partners who understand what we have to offer and who harmo-nize this with the portfolio of exis-ting products requires many months of prospecting, discussions, and, finally, adaptations", explains Pierre-Marie Lemer who adds, "After nearly two years of this long and tedious procedure, we have gained access to the Indian territory thanks to our participation last spring in a presi-dential tour organized in Mumbai. The impact of this experience was top-notch, better than I even could have imagined. Being part of a presi-dential or ministerial delegation is a fantastic business accelerator which I wish for all SMEs seeking to boost their growth." the InPI trophy for

Innovation, presented last February by the Minister for SMEs, Fleur Pellerin, was the real trigger for the meeting. Granted to the most inno-vative French industrial SME of the year, this award is a wonderful reco-gnition of over 40 years of innova-tions and the result of the 66 patents filed over the past four years.

A presidential trip to India Among the latest innovations, the

r&D team of a dozen people has just deve-loped the industrial prototyping of a next generation radioprotec-tive membrane known as novashield®. this ecological composite sheet, which is light

and flexible like tissue and easily injectable, offers an alternative to the lead plates currently used for protection against radiation. this is a huge new market for the company, which has already received much

encouragement from manufac-tures interested in this biomate-rial with high added value. EDF has already shown interest in this medium for the modernization of its nuclear facilities. this is just one of many products for this leading company that doesn’t seem to have any intentions of slowing down. "I always like to give requests serious consideration before saying no. This is a principle of mine. And, in the end, we find a solution for the customer’s demands in most cases by combining the technological building blocks which we have already developed for other applications," adds Pierre-Marie Lemer who has his sights on a turnover of €15 million this year, in line with the double-digit growth the company has had for several years. this is a great success which radiates throughout the region of Pays de la Loire, with already fifty full-time equivalent positions created in the region via out-sourcing.

B u s i n e s s

Juliette Lemaignen

"Made in France" Lemer Pax opens to the world

We want to achieve 80% of export sales in 2017.

Pierre-Marie Lemer

A fresh perspective on Lemer Pax

Jérôme Fortineau, Chairman – Keosys"we have worked with Lemer Pax for many years on numerous projects, including the most recent, Quanticardi, which is headed by Lemer Pax and has a total budget of almost €3.2 million. Quanticardi has the objective of developing the use of PEt imaging in the field of cardiology in Europe, which represents huge potential both medically and economically. one of the program’s areas of focus will be the development of an image analysis software dedicated to the monitoring of strontium 82, which will be created at the nantes cyclotron Arronax and then injected into the patient according to the innovative mechanism developed by Lemer Pax. After the consortium, we will be working more directly with our partners under the framework of a co-marketing agreement. the strong expertise of Lemer Pax in the radiopharmaceutical sector, supported

by the leadership of its charismatic CEo, Pierre-Marie Lemer, will be a tremendous asset in convincing opinion leaders to adhere to the new concept which we are developing. the stakes are high since heart imaging, which today focuses primarily on myocar-dial perfusion, is a very common procedure, with 400,000 cases each year in France, 3 to 4 million cases in Europe and 6 to 7 million cases in the U.S."

Key figures• Headquarters in nantes - France• workforce: 53 employees with large part in r&D department• Patents: over 66 in France and overseas during the last four years

History 1970 - Creation of Lemer Pax 1983 - Standardisation of the first shielded hot cells1995 - Development of radiation laminated lead glass window and new protective lead free materials (novashield®)2001 - Development of the world first cardiology cabin (Cathpax®)2004 - First radioisotope injector (Posijet®)2011 - Siemens Innovation: Grand Prix for the Posijet®2012 - Creation of Lemer Pax USA (Indiana - Scottsburg)

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R e g e n e r a t i v e m e d i c i n e

Biomatlante wages on synthetic bone substitutes

The coming months will be decisive for the biotech Biomatlante, which deve-lops and markets biomaterials to stimu-

late bone regeneration. the company seeks to impose its technology on a highly competi-tive market where innovative SMEs and major orthopedic companies compete against one another. "It is by attracting opinion leading surgeons that we will move forward," says Chantal Gobin, president of the company which was co-founded with researchers from the University of nantes in 1995. "We are going to intensify our business develop-

ment efforts, enhance our visibility at congresses, and expand our industrial partnerships and R&D." Still, confidential discussions are underway with several large groups and in october, the company shall promote its particular solutions at the Eurospine Congress in Liverpool. Biomatlante operates in two distinct sectors: dental surgery, which represents a market of €300-400 million, and the orthopedic market (including applications for the spine), which is more significant at €2-3 billion. Its latest fundraising, resulting in

€3.5 million in 2009, has allowed it to complete certain develop-ments and to strengthen its executive committee with the addition of a financial manager and a sales manager. Its product lines are sold in over fifty countries and are based on MBCPtM technology, which today has become the global benchmark of synthetic matrices for tissue engineering and on which more than a dozen patents and exclusive licenses have been established. this microporous and macroporous ceramic is resorbable and promotes the differentiation of bone cells for its gradual replacement by natural bone structures. "Our substitutes are less expensive and have advantages over the combined solutions." the medical community is very interested in synthetic alternatives, autografts, allografts, and xenografts, which have serious drawbacks including the use of a long and invasive surgery, the risk of contamination, and the lack of osteointegration in some patients. Biomatlante seeks not only to meet these needs, but also looks for tomorrow’s solutions. It is also involved in several research programs, including GeltoP for the encapsulation of active ingredients for controlled release in situ, rEBornE whose goal is to create biomaterials combined with adult stem cells, and the even more cutting-edge GAMBA for gene therapy to repair tissue damage associated with osteoarthritis.

Chantal Gobin

A new site and new projects for AtlantaIt’s in a brand new 1,200 m² building

structured around research laborato-ries, administrative and commercial

offices, and a state of the art animal faci-lity that ronan Le Bot, CEo of the holding company Atlanta, is designing his new development strategy. totally at ease advancing his projects and recruiting the necessary personnel, the young entre-preneur is promoting his business plan in three areas in the field of bone therapy: the provision of contract services for the precli-

nical evaluation of substandard products (Atlantic Bone Screen), the production of tailor-made organic syntheses for third-party

molecules (Atlanchim Pharma), and the development of thera-peutic molecules (Atlanthéra). this last unit, which represents the company’s most ambitious mission, has made it possible to identify an initial drug candidate active against osteosarcoma. the principle behind it is combining an anticancer compound with an anti-osteoporosis molecule in order to obtain a targeted dual molecule. In order to pursue further development in this area and to achieve the desired Phase IIa clinical proof of concept, ronan Le Bot’s team is working to open sources of capital. In addition to the first round of financing which has already been secured and public aid received, €3-4 million will be needed by the end of the year. to this end, initial contacts have already been made.

ronan Le Bot

Reborne: bone repair 2.0The excitement is palpable in the voice

of Pierre Layrolle, Inserm research Director and supporter of the European

project reborne, which is preparing to take part in the first injection of its innovating compound in humans. "At age 35, the patient whom we’re going to operate on is a traffic accident victim with a tibial fracture that wasn’t able to recover naturally. The thera-peutic alternative for him was clear: an auto-graph, with the usual risks and side effects which surgery entails, or the testing of our

technology, which has the advantage of combining high added value biomaterial with adult stem cells taken from the patient’s own bone marrow," explains Pierre Layrolle, who has strong experience

in clinical development due to his participation in the adventure of one of the first Dutch biochips for bone regeneration about ten years ago. Professor Layrolle, who is very careful when it comes to his capital and partnership strategy, hopes this time to internally validate all proofs of concept in order to have a commercially avai-lable product within two years. this will also be a way for him to ensure that his innovation, irrespective of patient resources, will reach the 1 out of a 1000 patients who are not able to recover from their fractures. But, this virtuous process comes at a price: many hours of work and the "absorption" of dozens of regulatory files to get approval of the transfer of the technology to clinical applica-tions. And all this without special support from regulatory agencies which still remain cautious regarding the use of adult stem cells, as they are still considered risky due to a lack of documentation.

Pierre Layrolle

Clean Cells, an up-and-coming pharmaceutical companyThe holy grail of GMP certification is

now within reach for the team of olivier Boisteau, President of the

Cro Clean Cells, which specializes in medi-cine safety. this is a crucial step for the company, which has invested a lot over the last two years in order to bring its facility up to par with the most advanced stan-dards, to develop its cleanrooms, and to recruit the appropriate staff. "This is a high added value which will enable us to reach new markets and to differentiate ourselves

against potential competitors," says olivier Boisteau. "We will

thus be able to provide our customers with one-stop lab solu-tions involving the production of their preclinical and clinical batches, and one day even industrial batches, along with our own safety services." Clean Cells has developed internal know-how regarding custom-made safety testing for therapeutic products, particularly in the field of gene and cell therapy, as well as for all biopharmaceutical products for human and vete-rinary healthcare. this advanced expertise has allowed the company to achieve a turnover of €3.1 million in 2012, with a growth of nearly 22% compared to the previous year. obtaining the prized status of a pharmaceutical establishment will allow Clean Cells to make a great leap forward in terms of revenue. their verdict will come before the end of the year.

olivier Boisteau

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M a r i n e b i o r e s o u r c e s

AlgoSource seeks to develop a culture of microalgae

Cultivating microalgae in order to gain additional revenue? the idea may appeal to farmers or those wishing to

invest in a biogas station. For the directors of the company AlgoSource, which specializes in the development of microalgae, this concept addresses the dual challenge of long-term diversification of agricultural activities and the rationalization of their energy consump-tion. "Integrating a microalgae harvesting pool at a biogas station makes it possible to use the heat put off by the latter in order to produce low cost biomass," explains olivier

Lépine, Director and Co-Founder of AlgoSource, whose subsidiary, Alpha Biotech, has been producing microalgae for over 20 years. "Microalgae can then be used in various industrial fields, such as dietary supplements, and to provide farmers with additional income." the company, which supports the entire project, from conducting engineering studies to operations to producing turnkey microalgae

through its entity AlgoSource technologies, which is working on coupling a dozen biogas units into a territory which currently has 90 in total. It hopes to pick up the pace in 2014. Additionally, it seeks to establish 40 new units per year. the context is favorable for this, as the government plans to support the construction of a thousand biogas stations on farms between now and 2020 as a part of its Methane Energy and nitrogen Autonomy (EMAA) plan. with an annual turnover of €1.2 million through its two entities, Alpha Biotech (which is involved in the sale of dietary supplements and microalgae extracts) and AlgoSource technologies (r&D and consul-ting), AlgoSource is focusing on the development of its third branch, AlgoSource Projects. "Once the microalgae sector is structured, more integrated systems will emerge in different configurations in which it will be possible to cultivate microalgae," concludes the compa-ny’s leader. the company also works with Séché Environnement and the firm X-tU, the GEPEA (Process Engineering for Environment and Food) under the project Symbio2, which is supported by the region of Pays de Loire to install a façade of microalgae at a house-hold waste recycling center.

olivier Lépine

The microalgae challenge: from a dream to a realityThe goal is to create

a global microalgae production platform

with a score of industrial lines and a biorefinery system open to both resear-chers and the industry. what some wouldn’t dare

to dream of just a few months ago will become a reality next fall. At the core of the project, the GEPEA, a CnrS laboratory with a team of 200 people which, since 2000, has brought together Process Engineering teams from the University of nantes, the Écoles des Mines in nantes, and onIrIS (nantes).

Driven by the objective to develop the microalgae sector in the territory of the Great west (Loire-Bretagne area), the structure was retained by a system of "regional future invest-ments from the Pays de la Loire" to finance the project with a budget of €3.56 million. with a total surface area of 2,600 m², the building will be established in Saint-nazaire, between the University of Gavy, which includes the Polytechnic Engineering School, and the GEPEA research Centre. In anticipation of its launch, the teams of Pascal Jaouen, Adjunct Director of GEPEA, are working on a smaller scale temporary production platform. Installed on the roof-top terraces of the Gavy University, latest generation photo-bioreactors work exclusively in sunlight, and by their design aim for a very interesting energy balance.

Hemarina sets out on a quest for laboratoriesDeveloping a new generation of oxygen

carriers of marine origin, the Breton biotech Hemarina is launching its first

innovation on the market: HEMoXCell®. this is a laboratory product designed to accele-rate cell cultivation. Composed of hemo-globin from marine invertebrates which has the ability to optimize the transportation of oxygen to the cells, HEMoXCell® makes it possible to "increase the culture yields from 50% to 70% over standard conditions,"

explains Frank Zal, founder and CEo of the company which was created in 2007 and is based in Morlaix. the company has just settled a marketing agreement with the distributor Eurobio in order to supply the French market in 2013 and the rest of Europe, the Middle East, and north Africa in 2014 and 2015. HEMoXCell® could

contribute between 3 and 5 million Euros in revenue each year for the SME, which has been supported by several investors since its inception, including Inserm transfer Initiative, and business angel networks. this launch is just one part of Hemarina’s larger ambitions in the area of human healthcare. Its flagship product, HEMo2Life®, a graft preservation solution, is taking shape. A test should be launched in the second half of 2014 for sales planned in 2015. HEMo2Life® will make it possible to better preserve organs awaiting transplantation thanks to improved oxygenation of the graft in comparison with current solutions based on salt and colloids - a niche market with an estimated value of €50 million. In order to secure its value chain, Hemarina has also just acquired the France turbot site in Vendée, a strategic investment which will allow it to obtain permission to pump and discharge sea water for its marine worm farms.

Franck Zal

Microalgae Institute in preparation for IfremerWithin the scientific community,

there are few subjects without institutes dedicated to them, so

what could be more natural than proposing a Microalgae Institute? the project, which is lead by Jean-Paul Cadoret, Director of the Algae Physiology and Biotechnology Laboratory in Ifremer, is awaiting approval from public authorities. the researcher returns to his roots. "After years of delay regarding the industrial potential of

microalgae, in the mid-2000s there was a rise in popularity of these microorganisms in leading industrial areas, such as energy or healthcare," says Jean-Paul Cadoret. "Exxon, ENI and other energy companies have invested hundreds of millions of dollars in research on biofuels produced from microalgae. In Europe, in recent months there have been countless collaborative projects involving microalgae. Given the emergence of these initiatives,

we felt the need in France to have an organization covering all of these areas, from studies to the use of microalgae, which would be a global reference on the matter and with regards to which advice would be provided or sought." this institute, as it was initially envisioned, would be the result of public and private investment, and would include a team of some 40 individuals from Ifremer and elsewhere. Dedicated to r&D and designed as a "patent machine", the structure would also have the task of developing results of its work by the creation of a spin-off in order to be involved in local economic development. "Besides the fact that it would be a great tool for structuring the microalgae sector, it would also help to better manage resources in order to protect the environment," explains Jean-Pascal Bergé, Director of the Laboratory of Marine Biomass Science and technology in Ifremer. the project, which has a budget of about €10 million, still needs to find industrial partners and to receive the green light from its supervisory authorities.

Jean-Paul Cadoret

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B i o m a n u f a c t u r i n g

Everything is ready for the arrival of new trainees: brand new bioreac-tors, equipped with single-use

bags, wait alongside pristine white lab benches for the empty corridors to come alive again once business resumes as usual. the 400 m2 of cleanrooms in accordance with BPF/GMP standards that make up the bioproduction trai-ning center of Biopractis were inau-gurated one year ago at the Bioouest

site. this factory school, which is one of a kind in France, is already showing positive signs. "Trainees last year gave very enthusiastic feedback about our training programs," says Pierric Chalois, Director of Biopractis. "We even had a visit from a team from Qatar putting together a project merging gene and tissue therapy and who wanted to train under GMP conditions. This sort of international visibility is unexpected for a structure this young, which serves as further proof that the relevance of what we have to offer has attracted atten-tion beyond our borders. This promi-sing start makes us think that this year we could achieve an attendance rate of almost 100%." Biopractis provides short training of 1 to 4 days for technicians, engineers, managers, and executives of production units. the training programs have been developed with the help of

entrepreneurs in the sector in order to meet the specific needs of the biophar-maceutical industry. For example, they offer modules over biological cleaning and disinfection of cleanrooms, the use of a single-use bioreactor, the harvesting of cells in a GMP context, and each costs between €1,500 and €2,500. During the sessions, everything is done in order to place students in actual conditions of industrial production, and all the

equipment and supplies used are identical to those used in the bioproduc-tion industry. Biopractis also accommodates initial training for engineering students in the biotech-nology of healthcare sector coming from oniris (nantes Atlantic College of

Veterinary Medicine, Food Science, and Engineering) and for CPS (development and control of healthcare products) 2nd Master’s Students from the University of Nantes.

Learning basic rules in one day"This year, we added one-day courses to the program to meet the needs of manufacturers of basic modules which are shorter and focused on a specific topic, such as the correct coverings for entering cleanrooms," continued Pierric Chalois. "Additionally, we’ve also improved workshops which are days of exchanges involving three to five experts and production unit managers addres-sing a specific topic. This is an oppor-tunity for participants to ask questions about particular topics." Skills training could also be a reality within two to three years. the idea of setting up such

a center arose in 2007 from the concen-trated efforts of several entrepreneurs from nantes, such as Frank Grimaud, Chairman and CEo of Vivalis, or olivier Boisteau, President of Clean Cells, who noted the lack of skills in the area of bioproduction in the region. Companies had to recruit agri-food technicians, which is the closest sector in terms of regulatory requirements. At that time, nantes wasn’t the only city to consider the urgency of establishing a workforce trained on GMP standards, as elsewhere in Europe, and particularly in Ireland, biomanufacturing training centers were being quite successful with big pharmas. In 2008, a study by the LEEM had already pointed out the challenges which would increasingly be raised in terms of human resources by the growing investment of major companies in the area of biopharmaceuticals. Based on these facts, nantes, the region of Pays de la Loire, and the Government identified the benefits of having such a training center in terms of employment and territo-rial attractiveness. the region and the Government each financed its establish-ment with investments of €400,000, the European regional Development Fund (ErDF) should contribute €250,000, and nantes is going to host Biopractis at the Bioouest for three years, by which time the center is expected to have reached equilibrium. Biopractis is backed by oniris, in partnership with the University of nantes and with the support of the Atlanpole Biotherapies cluster. the concept has already attracted other cities in France where similar structures should emerge in the coming years.

The Biopractis training center now open

Thibault Lasgouzes, 22 years old, student at Oniris, biotechnologies field" As part of my training as an engineer, I participated in a module on controlled environment where I learned all aspects of mani-pulation under hood, and in two tutorials on the upstream cell culture. we may have the opportunity to return next year to learn

the downstream stages. this is the first time I discovered the GMP conditions and regulatory requirements, and I was pleasantly surprised by the cleanliness of Biopractis center. I immediately made the comparison with the laboratory of a public research organization in which I did an internship and where the material conditions were very different. I am convinced that this experience at Biopractis will add something special to my training. I already have mentioned it on my resume. Managing GMP conditions is a capability that is particularly recognized and valued by the industry. I will not fail to highlight the knowledge acquired while at Biopractis in my future research of internship in 2014, in France or abroad. "

Ange Filippi, training and procedures manager at Sanofi’s biomanufacturing center in Vitry-sur-Seine"Due to changes of ZAC in our biotechnological production workshop, an urgent need for training in dressing sterile class (A/B) had emerged. As we did not have in-house skills and little experience of sterile ZAC, we looked for a place outside of Sanofi. Biopractis quickly emerged as the best choice to fill our need for initial training on this subject. this young structure has first class facilities to ensure a quality education closer to our practical needs: a laboratory equipped with growing trim and real equipment that put students in real work situation. In addition, the Biopractis team has been very responsive because it took them only 15 days to implement the two training sessions, which met our immediate needs. these modules have been prepared exclusively for the needs of our employees: their content has been adapted to our request and «standard» program modified to stick to our expectations. Finally, I wish to emphasize the quality of the skills and availability of the teachers."

Anne-Laure Languille

The training pro-grams meet the specific needs of the industry.

Pierric Chalois

Training agenda 201310 october 2013 Bases of cell culture5 and 6 november 2013 GMP and handling in clean rooms7 november 2013 Biomanufacturing cell culture within a GMP context8 november 2013 Using a wave bioreactor13 and 14 november 2013 Disinfection and biocleaning of clean rooms19 and 20 november 2013 Small scale cell culture within a GMP context21 and 22 novembre 2013 Implementing a protein purification strategy26 november 2013 Bases of cell culture27 november 2013 Biocleaning of clean rooms

TRAINEES FEEDBACKS

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The city of Nantes is proud to have built a network of medium-sized companies over the last two

decades, achieving an international repu-tation thanks to a clear policy in terms of attractiveness. The implementation of projects or SMEs and the on-site main-tenance of existing businesses are key elements for supporting any regional industry. "The medium-term objective is to build a large biotech cluster around Nantes by uniting various strengths of the West," explain Christophe Clergeau, Vice-President of the Regional Council of the Pays de la Loire, and Patrick Rimbert, Mayor of Nantes, Senior Vice-President of Nantes Métropole, and President of Atlanpole.

Biotech finances: What are the strengths of the city of Nantes which distinguish it at the national level and make what it has to offer unique? Patrick Rimbert: nantes has a diversi-fied economic framework, situated on a true industrial base, a configuration which allows it to ride out the financial crisis better than other cities. During this difficult economic period, we are conti-nuing to also invest heavily in research and innovation in order to anticipate the needs of tomorrow. this ability to maintain a dynamic industrial system is dependent upon the ability of the area to offer companies an innovative and efficient environment. this consists of a quality university, several large schools (Audencia, Centrale, Mines, Véto), and an academic network of 50,000 students. therefore, a company wanting to esta-blish itself in nantes is sure to be able to recruit quality employees and to be at the heart of innovation. Another marker of our dynamism is the undeniable creative energy that drives us. the structure of the nantes biotech cluster is the result of a consensus between all the local players involved, research potential, and fast growing young companies, all forming a dynamic network. the commitment of all the players (research institutes, commu-nities, clinicians, business management schools, entrepreneurs, and support structures) and an interdisciplinary culture enable different types of organizations to contribute their expertise and collaborate in order to advance research. we have therefore implemented major equipment and biotech projects (Arronax cyclotron, the promising University Hospital Institute of CEStI, Atlantic BioGMP, University Hospital Center platforms, including UtCG) around which the start-ups and SMEs operate in close connection to the academic and clinical world. this system of innovation (incubation, individual

coaching, group training) promotes colla-boration and advances all those involved in the same direction.

Christophe Clergeau: our primary strength, and that which can boost the confidence of entrepreneurs arriving from outside the area, is our ability to grow companies in our area. one of our greatest successes is that of the company Valneva, which is the result of a merger between the Austrian biotech Intercell and the nantes-based biotech Vivalis, created in 1999 and just out of the start-up phase! we defend the maintenance of our city and expertise, and do not wish for industrial property to leave the region or the country. the takeover of Biofortis and Atlangene Applications by BioMérieux is a good example of the operations which make it possible for nantes to hold on to expertise and the jobs of the two compa-nies, from the University Hospital Center and the University, respectively, which we have helped to grow. It is this endoge-nous growth which will allow us to shine internationally.

Biotech finances: What legitimacy does Nantes have in the area of biotechnology? Patrick Rimbert: For several years, biotechnology has been one of the prio-rity areas of the economic development of nantes Métropole. Spin-offs from research done in the area of healthcare by teams from the University Hospital Center, InSErM, and the University have fostered the development of a solid network of innovative companies over the years. the particularity of this system resides in the diversity of its research organizations and in its ability to focus on its areas of excel-lence. A fertile academic setting combined with a strong thematic positioning makes nantes a place that matters in the world of biotechnology at the European level and which position it as one of the future

world leaders in terms of biotherapy. the Arronax cyclotron, inaugurated in 2008 and intended to accelerate the fight against cancer, is a major asset of this strategy. A sign of the vitality of its r&D in the area of healthcare, nantes Métropole has seen its center of compe-titive excellence, Atlanpole Biotherapies, approved by the Government in 2005.

this avant-garde cluster with a strong scientific base is marked by a strong entre-preneurial spirit and numerous start-ups, and is currently working on medicine for the future. Managed by Atlanpole, this multidisciplinary and multi-polar tech-nopolis in the nantes area is driven by long-term players and brings together 180 members, including 77 businesses, research units, technological platforms, universities, and research institutes. Atlanpole Biotherapies focuses on three major areas: immunotherapy, radiophar-maceuticals, and regenerative medicine (cell therapy, gene therapy, and bioma-terials). the cluster allows us to promote research and the competitiveness of our businesses through collaborative r&D projects in order to promote exchanges and to help establish complex projects.

Christophe Clergeau: I would just like to add that one of the specific attributes of the nantes site is that we are not trying to position ourselves as a global health center. we want to be identified as being important and active players in the three areas of biotherapy just mentioned by Patrick rimbert and in the fourth area to which we also devote our attention: marine bioresources.

Biotech finances: Is the fact that your territory doesn’t have any big pharmas an impediment to its attractiveness? Christophe Clergeau: the historical manu-facturers of the pharmaceutical industry are not a part of our history, but are very active in our region today. they interact regularly with our SMEs on collaborative projects and are increasingly interested in our activities since we are focusing on sectors which are expected to grow over the next decade. this, in turn, offers several advantages. In this cutting-edge field in which we have to work on a global scale, our visibility is ensured thanks to several of our SMEs which are sometimes

better known abroad than in France. Additionally, the nantes region represents an affordable entry point for foreign companies wishing to sell their products on the French market, unlike other cities. we’ve also noted that in the absence of big

pharmas, we’ve seen the growth of manu-facturers starting from humble origins. this is the case with Eurofins Scientific, founded in nantes in 1987 and reco-gnized today as one of the global leaders in the area of bio-analytical services, with more than 14,000 employees in over 30 countries. the influence of our SMEs and the strength of a few long-established

Nantes envisions itself as a major center of innovation in Western France

I n t e r v i e w

The structure of the Nantes biotech clus-ter is the result of a consensus between all local players.

Patrick rimbert

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manufacturers in the region demons-trate the vitality of our area. we haven’t inherited an industrial base, and as such have built everything ourselves. we’re careful to keep our assets within our terri-tory, and we do not insist that our SMEs be absorbed, nor that innovation, which we have worked so hard to support and develop, migrates to other countries. A promising example of this is Biomérieux, which arrived in our territory two years ago.

Biotech finances: What do your efforts to attract businesses represent today? Patrick Rimbert: Expanding the nantes biotech network is one of our priorities, and nantes Métropole has proven to be an ambitious player for this purpose. this involves the development of dedicated tools such as financial support for the creation, support, and accommodation of biotech companies; it also entails urban and real estate projects devoted to the establishment of laboratories, businesses, and infrastructure involved in the field of life sciences. these solutions are struc-tured around three major Atlanpole sites: Bio ouest – Laennec, where a business hotel is located for biotechnology and bio-industry; La Géraudière, which is specifi-cally dedicated to agro-biosciences; and finally, the Isle of nantes for the area of healthcare. All of these places are located in close proximity to research centers and industrial platforms, and we believe that developing companies will find these business incubators to be a positive envi-ronment for their growth. For example, the Isle of Nantes Bio Ouest building 2 will house young companies and research laboratories for the biotech industry in 2,120 m2 and research space for the Irt Institute Campus in 1,741 m2 around 2015. this project has received some 23 million Euros of investment. this buil-ding is a part of the grouping planned for the hospital activities on the Isle of nantes, and is a pillar of the "center of excellence" in the area of healthcare. our competitiveness should also rely on conti-nuous professional training for SMEs and small businesses, both for entrepreneurs as well as employees, with the aim of increasing their skills. Hence the creation of Biopractis, a training center dedicated to good laboratory practices and biothe-rapy. Its program has been developed by researchers in the cluster. It is now supported by the oniris Veterinary and Agri-Food School, and by the University of nantes. thanks to these actions, the objective of nantes is to reach a European critical mass in all sectors.

Christophe Clergeau: we also make sure to find funding solutions tailored to the different entrepreneurial profiles, and to ensure that these benefit from our clout. Installations such as Start west are very effective in supporting businesses,

and then there are active regional funds, such as Idée which is the co-investment fund in the region of Pays de la Loire for business services, but also Go Capital, Sodero, or business angel funds which are increasingly numerous and active in the region. we are very responsive with regards to these cases and don’t hesitate to invest. If a project is well structured, we can unlock funds of between €30-50 million over a period of 3 to 5 years, which was precisely what we did in the case of the Arronax cyclotron. In addi-tion to regional funding, we make sure to be able to mobilize the EU’s European regional Development Fund (ErDF) in order to support projects and their respective infrastructures from the period of 2014 to 2020. the Prime Minister has also announced a future Governmental-regional agreement which will include a higher education and research component. However, though we want to advance and promote ourselves as a truly international cluster, we also have the priority of expanding our pool of businesses, which is the showcase of our strengths in the area of business creation and attractiveness.

Biotech finances: What sort of compa-nies and bioentrepreneurs do you hope to attract?Christophe Clergeau: our priority is to attract creative players who will develop their innovations within our territory and share them within our culture of partnership and innovation. this is the hallmark of research in nantes. therefore, before even considering the project in detail, we are very attentive to the wishes of start-up or SME candidates to contri-bute to the economic development of nantes and of the region. we have not determined a specific profile for the project holder. of course, we encourage the establishment of projects or compa-nies relating to one of the sub-sectors which we strive to develop (radiopharma-ceuticals, immunotherapy, regenerative medicine, and marine biotechnology). this is the mission of our "Connect talent" call for proposals, organized by the region Pays de la Loire and open until February 2014, which selects national and inter-national candidates to support entre-preneurs in the development of their breakthrough projects.

Biotech finances: How do you position yourself vis-à-vis Rennes and Brittany, which, just a few kilometers to the North, accommodate a cluster dedicated to life sciences? Patrick Rimbert: there is no competition between sites which specialize in different fields of healthcare. For example, nantes is recognized for its expertise in biological

sectors, and Angers has a specialty in the area of synthetic vectors, activities for which we research synergies. nantes has a local structure, with the interplay of inves-tors, researchers, and entrepreneurs; on the inter-regional level, with ouest Genopole, Canceropole, the Agronomique ouest cluster, and the bio-cluster France Atlantique (Brittany, Pays de la Loire, and Poitou-Charentes) at the national level, with the presence of Atlanpole within the national Innovation network (rEtIS), and finally, on the international level, here again due to the presence of Atlanpole within the EBn European network and the

IASP international network, having facili-tated the establishment of partnerships within Europe. Additionally, many themed events are organized both regionally and internationally. Several international networks are active (r&D and marke-ting) in the biotech/healthcare segments, such as tErM for regenerative medi-cine, BIoMAt’In for biomaterials, and InLifeSciences for international collabora-tions within northern Europe.

Christophe Clergeau: regional bounda-ries disappear in the economic world. nantes must perform its role as a capital of the west. In Phase III of the clusters, we want to bring together the strengths of the west in a single package inclu-ding Brittany, the Pays de la Loire, and the Centre region. the idea is to move forward together under the Atlanpole Biotherapies brand. three major projects will shape this ambition in the years to come. the moving of the nantes University Hospital Center on the Isle of nantes around 2020 will mark an impor-tant step in the objective of nantes to unite around its center. the works will include the construction of large areas for care and research activities, with pavilions connecting the clinical environment with basic research. our second objective is to place the University of nantes among the top ten French Universities and for it to be recognized as a key university within Europe. Finally, the notre-Dame-des-Landes airport project should make nantes a center of European exchanges and a gateway to the Great west. In the west, there are strong prospects and dynamics, and the role of the two regions is to maintain the consistency of the area.

Nantes must perform its role as capital of the West.

Christophe Clergeau

Interview conducted by Anne-Laure Languille

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Special issue on Western France

Land of innovation

LOOKING FOR PARTNERS?Patient

IMMUNOBIOTHERAPIESRADIOPHARMACEUTICALSREGENERATIVE MEDICINE

Biomarkers

Clinical studies

Drug discovery

Drug targeting

Preclinical studies

Biomanufacturing

[email protected] – www.atlanpolebiotherapies.com

77 companies

51 laboratories

42 core facilities

1 high-energy cyclotron (Arronax)

5 institutes combining

fundamental & clinical research

ICO: Cancer Research Center

Nantes & Angers

1 business school (Audencia)

5 universities

2 university medical centers

1 veterinary school (Oniris)

WELCOMEto the Western France biocluster

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