• Pfizer (PFE) Snatches Up Hospira, Inc. for $17 Billion Cash


    New York-based Pfizer Inc. (PFE) announced today that it has inked a deal to acquire Lake Forest, Ill.-based Hospira, Inc. for about $17 billion. The deal is for $90 per share in cash.

    Pfizer plans to finance the deal with a combination of cash and new debt. It also projects annual cost savings as a result of the transaction of about $800 million by 2018. It is expected to close in the last half of 2015.

    “The proposed acquisition of Hospira demonstrates our commitment to prudently deploy capital to create shareholder value and deliver incremental revenue and EPS growth in the near-term,” said Ian Read, chair and chief executive of Pfizer in a statement. “In addition, Hospira’s business aligns well with our new commercial structure and is an excellent strategic fit for our Global Established Pharmaceutical business, which will benefit from a significantly enhanced product portfolio in growing markets. Coupled with Pfizer’s global reach, Hospira is expected to drive greater sustainability for our Global Established Pharmaceutical business over the long term.”


    In May 2014 Pfizer’s $119 billion bid for UK-based AstraZeneca PLC (AZN) collapsed and ever since, rumors have flown about who Pfizer might acquire. In October Pfizer announced a stock repurchase plan of $11 billion in conjunction with a previous $1.3 billion share repurchase program.

    Analysts of other companies rumored to be in Pfizer’s bull’s-eye were UK-based GlaxoSmithKline (GSK) , Dublin-based Actavis plc (ACT) and New York-based Bristol-Myers Squibb Company (BMY).

    “AstraZeneca’s results once again highlight the improving fundamentals and underscore why Pfizer had it in its sights,” said Mick Cooper, analyst at Edison Investment Research in a statement. “The main question remains whether management can achieve its ambitious medium-term goals and these suggest that, whilst still relatively early days, progress is being made. The acquisition of Actavis’s respiratory assets is the logical extension of the Almirall deal, and necessary to strength one of AstraZeneca’s growth pillars given the increasing competition in this market.”

    Hospira develops and markets injectable drugs and infusion technologies. In addition, it is a worldwide leader in biosimilars.

    “The Pfizer-Hospira combination is an excellent strategic fit, presenting a unique opportunity to leverage the complementary strengths of our robust portfolios and rich pipelines,” said F. Michael Ball, Hospira’s chief executive officer in a statement. “I want to recognize and thank our 19,000 employees around the world for their tireless efforts to deliver more affordable healthcare solutions, increase patient access to high-quality care and drive sustained growth for our shareholders.”

    Source: http://www.biospace.com/News/astrazeneca-plc-who-pfizer-snatches-up-hospira-inc/363533?intcid=homepage-seekercarousel-featurednews-navindex1

     

  • Sanofi to name new CEO in coming weeks as euro lifts results

    A logo is seen in front of the entrance at the headquarters of French drugmaker Sanofi in Paris

     

     

     

     

     

     

     

     

     

    (Reuters) – French drugs firm Sanofi (SASY.PA) said it would be able to name a new chief executive in the coming weeks as it delivered 1.5 percent quarterly earnings per share growth and predicted that euro weakness could boost profits this year.

    "The announcement will be before the end of the first quarter," said Chairman Serge Weinberg, who has been acting CEO since Chris Viehbacher was fired at the end of October for poor execution of strategy and lack of communication with the board.

    Analysts have said the delay in finding a new CEO after some potential candidates appeared to reject approaches has been weighing on investor sentiment.

    Sanofi shares rose almost three percent in the first few minutes of trading on Thursday.

    "We expect the shares to respond positively to the CEO search update and 2015 EPS guidance today," said Jefferies analysts in a morning research note.

    Nevertheless some traders were more skeptical after Sanofi announced a dividend for 2014 of 2.85 euros, up from 2.80 euros for 2013 but below analysts' forecasts of around 2.91 euros. They called the 2015 outlook cautious.

    A poor sales performance by its key Lantus diabetes drug in the United States was one of the reasons cited for the sacking of Viehbacher.

    Weinberg said on Thursday that he had stabilized Lantus' U.S. market share after replacing more than a third of the people running the sales side of the business.

    Despite the stabilization at its important diabetes division, the company said in a statement it would need the euro to stay weak if it was to secure significant group earnings growth this year.

    It said it saw "stable to slightly growing" 2015 EPS at constant average exchange rates, but with a positive impact of 4 to 5 percent assuming end-2014 exchange rates.

    Business earnings per share grew a reported 1.5 percent from a year ago in the fourth quarter to 1.39 euros ($2). At constant exchange rates there would have been no growth.

    For the year as a whole, double-digit sales growth in each of its four targeted growth divisions helped Sanofi deliver EPS growth of 3.0 percent to 5.20 euros, ahead of an average analyst forecast of 5.17 euros according to Thomson Reuters I/B/E/S data.

    The French pharmaceuticals group shocked investors three months ago by predicting Lantus would deliver little growth in the years up to 2018. Viehbacher's sacking followed a day later.

    Fourth quarter sales grew 7.3 percent to 9.072 billion euros and 4.6 percent at constant average currency rates. Business net income grew 0.8 percent, but adjusted for constant average exchange rates it fell 0.3 percent.

    Source: http://www.reuters.com/article/2015/02/05/us-sanofi-results-idUSKBN0L90IP20150205

  • Myriad Genetics Ending Patent Dispute on Breast Cancer Risk Testing

    Myriad Genetics has essentially given up trying to stop other companies from offering tests for increased risk of breast cancer, ending a dispute that was the subject of a landmark Supreme Court ruling that human genes cannot be patented.

    The company has settled or is in the process of settling patent-infringement lawsuits it filed against other companies that now offer such testing, a Myriad spokesman said on Tuesday.

    Myriad’s lucrative monopoly on testing for mutations in two genes linked to an increased risk of breast and ovarian cancer ended in 2013, when the Supreme Court ruled that human genes were not eligible for patents because they were products of nature.

    Numerous laboratories began offering tests, some for much less than the roughly $4,000 Myriad charged for a complete analysis of the two genes, known as BRCA1 and BRCA2.

    Myriad sued many of those companies, saying they were infringing other patent claims that had not been invalidated by the Supreme Court.

    But last March, a federal district judge in Utah ruled against Myriad’s request for a preliminary injunction against one competitor, Ambry Genetics. Last month, the Court of Appeals for the Federal Circuit upheld the lower court’s decision and ruled that those remaining claims were also ineligible for patents.

    After that ruling, “we decided it was in the best interest of the company to settle these matters,” the Myriad spokesman, Ronald Rogers, said.

    Settlements have been reached with LabCorp Invitae and Pathway Genomics. Mr. Rogers said Myriad was in talks with Ambry, Quest Diagnostics, GeneDx and Counsyl.

    In the settlements announced so far, the companies have agreed to dismiss the claims and counterclaims against one another, and Myriad has promised not to sue the companies on any remaining patents in the litigation.

    Myriad is shifting from the BRCA gene test to a more comprehensive test of 25 genes linked to cancer risk. It is also developing new types of tests to reduce its reliance on the BRCA test.

    Source: http://www.nytimes.com/2015/01/28/business/myriad-genetics-ending-patent-dispute-on-breast-cancer-risk-testing.html?smid=li-share

     

     

  • European Medicines Agency Accepts Samsung Bioepis’ Enbrel® Biosimilar Candidate, SB4, for Regulatory Review

    European Medicines Agency Accepts Samsung Bioepis’
    Enbrel® Biosimilar Candidate, SB4, for Regulatory Review

    – First biosimilar from Samsung Bioepis to advance to EMA regulatory review –
    – First Enbrel biosimilar to be filed in the EU –
    – If authorized, SB4 will be marketed 
    in Europe by Biogen Idec

    INCHEON, Republic of Korea, Jan. 21, 2015 – Samsung Bioepis Co., Ltd., today announced that the Marketing Authorization Application (MAA) for its Enbrel (etanercept) biosimilar candidate, SB4 has been validated and accepted for review by European Medicines Agency (EMA). The acceptance of the MAA marks the first Enbrel biosimilar to advance into regulatory review in the European Union (EU). The MAA is based on results from a Phase III clinical trial in patients with moderate-to-severe rheumatoid arthritis (RA). 

    In Europe, Enbrel is indicated for the treatment of a number of rheumatic diseases, including moderate to severe RA, certain forms of juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. If authorized by the EMA, SB4 could be available for use in all of the same indications as Enbrel. 

    "This MAA validation represents a significant milestone for Samsung Bioepis in our work to develop and manufacture world-class biosimilars. More significantly, it offers an opportunity to provide high-quality and effective therapies for broadening access to patients in Europe" said Christopher Hansung Ko, chief executive officer of Samsung Bioepis.  If authorized by the EMA, SB4 will be commercialized in Europe by Biogen Idec. It will also be produced at the company’s manufacturing facility in Hillerød, Denmark which is one of the largest biologic manufacturing facilities in the world.  In addition to the European filings, Samsung Bioepis intends to move forward with additional applications for regulatory approvals in other territories worldwide. 

    About the SB4 

    Samsung Bioepis previously conducted SB4 Phase 1 and Phase 3 clinical studies. The MAA for the etanercept biosimilar was based on data from a Phase 3, controlled, randomized, multicenter study in Europe where SB4 demonstrated its comparability to Enbrel®. The primary and secondary endpoints of the study were assessed and met the qualification standard for the MAA submission. Full data from the study will be available later this year. 
     

    About Samsung Bioepis

    The company was established in 2012 as part of the Samsung group, with the mission to produce affordable, high-quality biopharmaceutical products to many patients in need. The company aims to be the world leading biopharmaceutical company with its heritage of innovation and advanced technologies. Please visit www.samsungbioepis.com for more information.

  • Roche acquires France-based biotech firm, Trophos

    Roche (RHHBY) Up On Plans To Acquire Trophos To Expand Into Neuromuscular Disease Business

    Roche, a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics, has agreed to acquire Trophos, a privately held biotechnology company based in Marseille, France.

    Trophos’s proprietary screening platform generated olesoxime (TRO19622), which is being developed for SMA – a rare and debilitating genetic neuromuscular disease that is most commonly diagnosed in children.

    Results from a pivotal phase II clinical trial with olesoxime in SMA showed a beneficial effect on the maintenance of neuromuscular function in individuals with Type II and non-ambulatory Type III SMA, as well as a reduction in medical complications associated with the disease. These data were first presented in April 2014 at the annual meeting of the American Academy of Neurology (AAN).

    “This acquisition highlights Roche’s commitment to developing medicines for spinal muscular atrophy, a serious disease with no effective treatment,” said Sandra Horning, M.D., chief medical officer and head of global product development at Roche. “We will build on the work done by Trophos and the French Muscular Dystrophy Association to advance the development of olesoxime and to bring it to people who live with this devastating condition as quickly as possible.”

    Under the terms of the agreement, Trophos’s shareholders will receive an upfront cash payment of EUR 120 million, plus additional contingent payments of up to EUR 350 million based on achievement of certain predetermined milestones.

    “SMA is a grievous disease with a huge impact on the daily life of patients and their families, who are currently left only with supportive care. We are proud to see the development of this medicine evolving, with the ultimate goal of a potential first medicine for SMA,” said Christine Placet, chief executive officer of Trophos. “This is a tremendous recognition of the work done by Trophos’s teams and supporters over the past 16 years.”

    SMA is a life-limiting and highly disabling genetic disease characterised by progressive muscle weakness and loss of motor function. SMA affects the motor neurons of the voluntary muscles used for activities such as crawling, walking, head and neck control and swallowing.

    Olesoxime (TRO19622) is an investigational medicine designed to protect the health of motor nerve cells. Results of a pivotal phase II study of olesoxime in Type II and non-ambulatory Type III SMA patients from the ages of three to 25 years were first presented in April 2014 at the 66th American Academy of Neurology (AAN), Philadelphia, PA, USA. Trophos’s development program was supported by the French Muscular Dystrophy Association. Olesoxime has been granted ‘Orphan Medicinal Product’ designation for the treatment of SMA by the European Medicines Agency and orphan drug designation by the US Food and Drug Administration.

    Trophos is a clinical stage pharmaceutical company developing innovative therapeutics. The company has developed a proprietary cholesterol-oxime based chemistry platform.

    Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=86210&sid=2

     

  • Ready to discuss your Europe Expansion? Contact us today, SBA Delegation coming to San Diego Feb 9th-13th

    Our French Partners are coming back in town! French BioBeach is welcoming our South Bio Alliance Delegation in San Diego from February 9th to the13th.

    Medical Device/Diagnostics Companies with European Strategy Development/Expansion in mind, Contact us today to explore if meeting with them would be beneficial for your company. 

    Subjects would include but not restricted to:
    · Access to the European market and presentation of the various incentives
    . Co-developing opportunities
    . CE-marking
    . Possibility of implementation of European subsidiaries.

    Download (PDF, 684KB)

  • Valneva buys cholera vaccine

    580x327x2_79b7022e42.jpg.pagespeed.ic.F78YC9fRN7

     

     

     

     

     

     

     

     

    05.01.2015 – Austrian-French biotech company Valneva SE is bolstering its vaccine business and has acquired oral cholera vaccine Dukoral and its manufacturer Crucell Sweden AB.

    Lyon-based Valneva is set to pay €45m to Dutch Crucell Holland B.V. in exchange for vaccine specialist Crucell Sweden AB. The agreement entails the purchase of the manufacturing site in Solna and will affect around 115 employees. Included in the deal are all assets, licenses and privileges related to Dukoral and a Nordics vaccine distribution business. Dukoral is an oral vaccine against cholera and traveller's diarrhea caused by ETEC, the leading bacterial cause for diarrhea in the developing world.

    With the move, Valneva aims to boost its traveller's vaccines business and complement its serum for Japanese encephalitis – the only vaccine currently in the company's portfolio. "With this second traveller's vaccine in our portfolio, together with its commercial infrastructure, we are strengthening our foundations for further growth. This acquisition is in line with Valneva’s strategy to reinforce its commercial vaccines portfolio and accelerates the company’s path to financial self-sustainability,” commented Thomas Lingelbach, President and CEO of Valneva. The acquired business generated revenues of €38m in 2013 and €23m in the first nine months of 2014 from the sales of Dukoral and the distribution of several other vaccines for third parties.

    Valneva plans to finance the deal with a combination of debt and equity, and expects to finalise the acquisition in February.

    Source:http://www.european-biotechnology-news.com/news/news/2015-01/valneva-acquires-cholera-vaccine.html

     

  • FDA To Test San Diego Company’s Ebola Treatment Device

     
     
    A hemopurifier, which was created by Aethlon Medical, is shown.
     

    A blood filtration device that was developed in San Diego and can be used on Ebola patients has been cleared for further testing by the U.S. Food and Drug Administration, Aethlon Medical announced Friday.

    The company said its hemopurifier will be tested at 10 sites for up to 20 U.S. patients. The goal of the study is to standardize and evaluate the use of the device in the treatment of Ebola. An outbreak of the disease last year in three West African countries killed nearly 8,000 people and, for the first time, patients brought the virus to U.S. soil.

    More than 20,200 people have been sickened in the outbreak, mainly in Guinea, Liberia, Mali and Sierra Leone, but also some in Nigeria, Senegal, Spain and the U.S., according to the World Health Organization.

    The hemopurifier was being tested on HIV/AIDS and hepatitis C patients overseas before the recent Ebola breakout.

    The device can be hooked directly to a patient via a tube or attached to a dialysis machine in order to remove large quantities of the Ebola virus and proteins the disease creates to suppress the immune system, according to Aethlon founder and CEO Jim Joyce.

    The hemopurifier was used in Germany on a physician who became sick while treating Ebola patients in Sierra Leone.

    According to Aethlon, what's known as the "viral load" of Ebola in the critically ill doctor was 400,000 virus copies per milliliter of blood. After a 6 1/2-hour treatment, the load was reduced to 1,000 copies. The treatment was well tolerated with no adverse events reported, Aethlon reported.

    The company said that at the time of treatment, the physician was unconscious and suffering from multiple organ failure, which required mechanical ventilation, continuous dialysis and the administration of vasopressor medications.

    The patient has since made a full recovery and returned home to his family.

    Source:http://www.kpbs.org/news/2015/jan/02/fda-test-san-diego-companys-ebola-treatment-device/

     

  • FBB December 2014 Newsletter

     
     
     
    Our newsletter keeps you in the loop of FBB's News & Events. If for any reason you would like to
    You are welcome to join us again at a later time
     
     
    BECOME A
    to attend our events at discounted rates

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     
    Big Thank You to our Sponsors & Members
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
    French BioBeach December 2014 Newsletter
     
    Dear French BioBeach community,
     
    Holiday Season has officially begun, let the rush to the end of the year begin…accompanied by holiday parties and friends/family gatherings. We started the month with the sad news San Diego won't be the home of the 2017 America's cup (Congrats Bermuda!), then we forgot all about it when diving into planning some 2015 FBB events & opportunities for your companies.
     
    Let's begin with a recap of our November events with our FocusOn Biosimilars, our 3rd edition of the FBB Fall Regatta, as well as the Innovation Night and the 2014 Biocom Annual Dinner we attended.
    Join us this Friday to network with the community during our monthly Happy Hour rendez-vous. Mark your calendars for our 3 upcoming 2015 events, an event on the Latest Innovations to Optimize Point-Of-Care Rapid Diagnostic Testing, a Biocom Breakfast on European Expansion Strategies and our South Bio Alliance Delegation coming in SoCal to meet with you.
    Attend one of our members webinar, and conclude by reading about the development of 3-D Organ Tissues, a Report on the Boom in California’s Biomedical Industry as well as 5 San Diego Products Named Top 10 Life Sciences Innovations of 2014.
    Thanks to your support we continue to monitor what happens in the Life Sciences community fostering new partnering and business opportunities.
    Happy December month and Thank You for reading,

    The French BioBeach Team
     
    Recap FBB Hosted & Some Attended Events
     
    FBB Focus on: "Challenges associated with biosimilars"
     
    When was it? Thursday, Nov 6th, 5:30 to 9:00 PM
    Where? 12235 El Camino Real Suite 200 San Diego, CA 92130.
    What happened? Links to PicturesProgram & Presentation
    What's next? Look for our next Focus On event beginning of next year..

    Wilson Sonsini Goodrich & Rosati LogoBioagiltytix
     
    3rd Edition of"Life Sciences on the Bay" FBB Fall Regatta
     
    When was it? Saturday Nov 15th, 12:00 to 3:00pm
    Where? San Diego Bay
    What happened? This year was a special year, as we did race for a cause & dedicated this race to Alex. Our goal was to initiate our efforts to raise awareness for the undiagnosed children. Links to Pictures:
     
    Innovation Night @ La Jolla Playhouse
     
    When Was it? Wednesday Nov 12th
    Where? La Jolla Playhouse
    What happened? Members of the life science & tech communities (including FBB!) were treated to a spectacular reception followed by the Playhouse’s smash hit musical, “The Hunchback of Notre Dame.” Pharmatek President (and Biocom Board member) Tim Scott again acted as co-chair of the event.

    A video & some pictures HERE

     
    2014 Biocom Annual Dinner, “Making Waves”
     
    When Was it? Thursday Nov 20th
    Where? Hyatt Regency La Jolla
    What happened? Read from Biocom & some pictures HERE
     
    Upcoming FBB December Events
     
    Happy Hour
     
    Don't forget our Monthly (2nd Friday) Networking
    Happy Hours!
     
    When? Friday Dec 12th, 5:00 to 7:00pm
    Where? Bella Vista Social Club & Caffe, 2880 Torrey Pines Scenic Dr, La Jolla, CA 92037, United States.
    Look for our French BioBeach sign!
     
    2015 FBB Events & Opportunities
     

    Latest Innovations to Optimize Point-Of-Care Rapid Diagnostic Testing
     
    Save the Date! French BioBeach co-organizes with Odexxo, Abbiotec and JPac Medical a workshop on the latest Innovations to Optimize Point-Of-Care Rapid Diagnostic Testing. Stay Tuned for more details to come…
    When? Thursday Feb 5th
    Where? TBD

     
     
     
     
     

    Biocom Breakfast on European Expansion Strategies
     
    Save the Date! More details to come … French BioBeach organizes a Biocom Breakfast on European Expansion Strategies, We'll talk about regulations, clinical and business development strategies. Among our speakers, our french MedTech consulting partner, MD101.
     
    When? Tuesday Feb 10th, 8am-10am
    Where? Biocom

    South Bio Alliance in SoCal
     
    Mark your Calendar!!
    Between February 9th-13th, 2015, FBB is welcoming our South Bio Alliance French Delegation here in San Diego. It is a great opportunity for you to learn more about France Key advantages for your European Expansion. Contact us today to learn more & reserve a time to speak with delegation members.
     
    When? Feb 9th-13th, 2015
    Where? Southern California, meetings can take place from San Diego to Los Angeles.

    More about the
    South Bio Alliance
     
     
    More detail about the upcoming delegation,
    Send us an email HERE
     
     
    Company of the Month
     
    APS
    Founded in 2005, American Preclinical Services (APS) is a State of the Art, ISO 17025 accredited, AAALAC accredited, USDA registered, and GLP compliant Contract Research Organization (CRO) located in Minneapolis, MN.
    APS performs SO10993, USP <87>, USP <88>, JMHLW, and custom biocompatibility testing. Our large and small animal research services include interventional, surgical, toxicology, pharmacology, pain, cadaver and bioskills labs and model development.
    We have one of the largest preclinical capacities in the world including three Siemens catheterization labs. In addition to our in-vivo and in-vitro
    Scott Barnhill, AS, SRS, RLATG
    Scientist/Business Development Executive
     
    research services we also offer comprehensive pathology services for the medical device, biotech, and pharmaceutical industries. We’ve tailored our processes, capacity, and customer service to keep up with today’s fast paced business cycles. APS will go from a quote to a ready to implement study design with your time lines in full focus.

     
    Technology of the Month
     

    SATT Sud-Est is a French BioBeach partner specialized in Intellectual Property. Each month we will present a technology from their portfolio. This month, we would like to highlight a technology that allows a new safe Molecule to Prevent, alleviate and treat acute, subacute and chronic pains

     
    PAIN (IP)
    Background
    Current pain treatments: bad sides effects, in particular gastrointestinal and renal deleterious side effects, but also tolerance, interfere with inflammation.
    Nav 1.9 channel : more and more studied pathway on pain understanding.
     
    Applications
    Pain treatment for acute, subacute or chronic pain. The technology includes also in vitro, in vivo or ex vivo screening methods for identifying agents that modulates the targeted Nav channel.

     
    Key Benefits Vs State of the Art
    -No side effect, no toxicity
    -New local treatment for pain at least as efficient as Ibuprofen
    -Molecule which treats specifically the pain’s origin (no systemic action)
    -Original and cheap molecule, easy to obtain
    Development Status
     
     
     
     
    Interested in Learning More about that IP? Teaser is available HERE, then contact French BioBeach Info@FrenchBioBeach.com
     
    Member Event | In The News
     
    Member Event
    Webinar: Your Clinical Trial Master File with Ennov
    and DIA eTMF data standards.
     
    Ennov's webinar will explain the importance of using data standards (DIA reference model) in an Electronic Document Management System, to improve the interoperability between your Clinical operation team and to enhance your Clinical electronic Trial Master File (eTMF) efficiency and quality.
     
    When? Tuesday Dec 16th, 11:00am-12noon PST
    Where? Register Here
    ennov
     
     
    In The News
     
  • Corporate Members Directory

    Abbioteclogo (3) As researchers are focusing their efforts on determining the biological functions, interactions and regulation of the human proteome, Abbiotec is dedicated to developing cell biology-based research tools that assist scientific discoveries. Besides custom services, Abbiotec offers over 12,000 antibodies, proteins, peptides, lysates and kits to assist researchers in understanding human biology and diseases at the cellular and molecular levels. www.abbiotec.com


    American Preclinical Servicesaps Founded in 2005, American Preclinical Services (APS) is a State of the Art, ISO 17025 accredited, AAALAC accredited, USDA registered, and GLP compliant Contract Research Organization (CRO) located in Minneapolis, MN. We are a full service CRO performing ISO10993, USP <87>, USP <88>, JMHLW, and custom biocompatibility testing. Our large and small animal research services include interventional, surgical, toxicology, pharmacology, pain, cadaver and bioskills labs and model development. We have one of the largest preclinical capacities in the world including three Siemens catheterization labs. In addition to our in-vivo and in-vitro research services we also offer comprehensive pathology services for the medical device, biotech, and pharmaceutical industries. We’ve tailored our processes, capacity, and customer service to keep up with today’s fast paced business cycles. APS will go from a quote to a ready to implement study design with your time lines in full focus. www.americanpreclinical.com


      Antibody Design Labslogo (1) Founded in 2011, Antibody Design Labs™ is committed to become a leader in the field of recombinant antibody technologies. Over the last 30 years, techniques have rapidly evolved to make antibodies a primary component of modern research, modern diagnostic, and emerging therapeutics. Following the initial discovery of monoclonal hybridomas, technologies such as phage display have become routine in many laboratories. Still, getting the right antibody for the right application can be a long journey where high-throughput approaches can be very effective but at prohibitive costs. Antibody Design Labs™ will be a centralized place to access tools, information, techniques in the field of recombinant antibody generation, engineering and design. www.abdesignlabs.com


      Elcelyxdownload Elcelyx Therapeutics is developing novel therapeutics based on Gut Sensory Modulation (GSM) science to address unmet needs in the pharmaceutical market. The company's lead proprietary product, metformin delayed-release (Metformin DR; also referred to as “NewMet”) has demonstrated clinical proof-of-concept for the treatment of type 2 diabetes and plans are to initiate a Phase 3 clinical trial later this year in the currently under-served moderate to severe renally‑impaired type 2 diabetes patient population. Metformin DR is being developed to potentially address the needs of the metformin intolerant and renally contraindicated type 2 sub-populations. ADA and EASD guidelines suggest that metformin is the preferred first agent for all patients with type 2 diabetes if not contraindicated and if tolerated. Metformin DR, by virtue of its unique delivery may have clinical utility in both populations. www.elcelyx.com


    Ennovdownload (3) Based in San Jose, CA, Ennov Solutions Inc. is a software publisher specializing in Electronic Document Management (EDMS) and Business Process Management (BPM) with a single focus: delivering cost effective, best-of-breed, off the shelf, highly configurable, user friendly solutions to our clients. Ennov solutions assist companies and organizations align their daily activities in conformity with their external and internal regulations and legal environment to gain the true value of their business content. Highly scalable yet easily implemented, the Ennov product line requires minimal use of IT infrastructure and resources. At Ennov, we recognize the limitations of traditional solutions and continually innovate to satisfy business and technical users equally. Ennov caters to the needs of some of the largest companies in the world as well as start-ups in just about every industry. While our customers include hospitals, food and beverage manufacturers, governmental organizations, etc. we specialize in the needs of life-science companies. The wide array of offerings from Ennov allows these clients to build a complete solution that best meets their requirements and eliminates the need for multiple vendors. Ennov is backed and recognized as a strong and sustainable business by Windcrest Partners, NY. www.ennov.com


      Explora Biolabslogo (2) Explora BioLabs is a San Diego-based preclinical CRO that provides discovery pharmacology and contract vivarium services to the biotech, pharmaceutical and academic communities. In 2004, Dr. Richard Lin realized that many researchers who require high-quality in vivo data simply lack the resources and expertise to develop their own pharmacology infrastructure. Based on this realization, Dr. Lin founded Explora BioLabs to allow researchers to achieve their goals by virtualizing their preclinical programs. www.explorabiolabs.com


      Integrium Clinical Researchlogo Integrium is a full-service Clinical Proof of Concept (PoC) Firm focused within the therapeutic areas of Cardiovascular, Metabolic, Renal, Inflammatory, Dermatology, Wound Healing, Regenerative, and Orphan Disease. Although they have the scientific, medical, operational, and regulatory expertise to cover all stages of clinical development (Phase I-IV), Integrium is Expert in the Strategy, Design and Execution of Clinical PoC Trials. www.integrium.com


    OdexxoODEXXO-logo_90 ODEXXO’s proprietary technology is developed to address the challenges of biological specimen collection and rapid testing. With the support of life science professionals and engineers, ODEXXO, Inc. designs and markets disposable devices for the medical and veterinary in-vitro diagnostic community. Our patented products are self-contained systems used with multiplex lateral-flow assays, ensuring the optimal convenience and safety for end users in a point-of-care and field setting. Our customers include global in-vitro diagnostic manufacturers and pharmaceutical companies. www.odexxo.com


    OZ Biosciences logo (2) OZ Biosciences is a product development company that creates, develops and commercializes delivery systems of bioactive materials (DNA, siRNA, proteins, antibodies…), intended for the worldwide scientific community and pharmaceutical industries. Our mission is to assist scientists to accelerate the rhythm of discoveries by offering them technologically advanced tools such as transfection reagents and other life science research products. Principal innovations are based on propietary technologies such as Magnetofection (magnetic-assisted transfection or infection), Magneto-Biolistic and lipids-based delivery systems. Specialized and expert in drug delivery systems, we also provide custom transfection service and are involved in many international research projects. www.ozbiosciences.com


    Phyco-Biotechdownload (4) Our experts are in the field of extraction and purification of fluorescent labels for fifteen years and their skills are internationally recognized by many companies. In addition, we obtained the Young Innovative Company status in 2011, and we are eligible for research tax credit since October 2013. Today, Phyco Biotech is able to offer a wide range of highly purified natural fluorescent labels for medical diagnosis. Thus, building on the development of its human and technical assets, Phyco-Biotech has expanded its activity to two other sectors, both food supplements and cosmetics. www.phyco-biotech.com


    Prestwick Chemicaldownload (5) Prestwich Chemical, a premium provider of medicinal chemistry services and smart screening libraries was founded in 1999 by Prof. C.G. Wermuth, a world-known expert in medicinal chemistry, along with top scientists from Strasbourg University. The company consists of 30 people and is located in its own purpose built facility in the ’Parc d’Innovation d’Illkirch’ near Strasbourg, at the crossroads between France, Germany, and Switzerland. We provide comprehensive R&D services in early drug discovery, including hit identification and validation, hit to lead, and lead optimization, using our long term expertise supported by state of the art computational technology. www.prestwickchemical.com


    Roowindownload (6) Roowin is a privately owned Contract Research Organisation (CRO) headquartered at Paris, France. Its core business being in high value added fine chemistry, Roowin offers services in the following areas: – GMP synthesis – Clean room synthesis. Laminar flux. Positive pressure and negative pressure (cytotoxic substances) – Lead optimization – Process development & scale up. We have a pilot plant with reactors up to 400l – Custom synthesis – Stability studies – Analytical chemistry services – Cheminformatic services (virtual screening, lead hopping) We are proud to be able to accompany our customers from early drug discovery over process development to medium-scale GMP production, supporting our operations by strong analytical chemistry capabilities. www.roowin.com


      Rx TranslationsRx_Translations_Final_314x138 Rx Translations is a woman-owned, boutique translation company specializing in French < > English medical translation. Jenae Spry started Rx Translations to provide quality translations to industries such as healthcare, biotechnology, medicine, pharmaceuticals, medical devices and clinical trials, and she has done so for over 7 years now. www.rxtranslations.com


    Sanofidownload (1) Sanofi US is part of a leading global healthcare company that discovers, develops, produces and markets innovative therapies to help protect health and enhance people's lives. Along with the other U.S. affiliates, Genzyme, Sanofi Pasteur, Merial and Chattem, we work to prevent and treat the diseases we know about today, as well as those we may face tomorrow. Sanofi US, with headquarters in Bridgewater, New Jersey, employs more than 16,900 professionals throughout the country. At Sanofi, we work for what really matters: health www.sanofi.us


      San Diego Center for Systems Biology (SDCSB)sdcsb_logo SDCSB began in 2005 as the San Diego Consortium for Systems Biology to bring together scientists across disciplines and institutions, promote collaborative research and training, and to support the exchange of ideas and resources. In 2010, we became one of the National Centers for Systems Biology funded by the National Institute of General Medical Sciences (NIGMS) (Grant #GM085764). SDCSB comprises activities in (i) scientific research, (ii) scientific outreach, and (iii) educational outreach. www.sdcsb.ucsd.edu


    Searen Searen is behing the Vacuum AirLift (VAL) technology,download a new, sustainable and efficient water treatment system. It is an innovative and versatile, yet simple, technology platform with three basic functions: particle extraction, circulation, and gas exchange. The VAL provides superior water treatment solutions for many industries, including Oil & Gas, Aquaculture, and Microalgae production. www.searen.com