• FBB November 2017 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

     

     
    Thank You to our  Partners
     
     

    http://www.analytics-ventures.com/
     
     
     
     
     
     
     
     
     
     
     
     

     

    Big Thank You to our Sponsors & Members
     

     
     
     
     
     
     
     
     
     
     
     
     
     

     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     

     


     
    French BioBeach November 2017 Newsletter
     
       Dear French BioBeach community,
     
    After the success of the last month beakfast at Antibody Design, we are pleased to welcome you TOMORROW (Wednesday 1st) at ABBIOTEC jointly sponsored by ODDEXO. 
     
    To start this exciting newsletter we will present our FBB events with the traditional networking opportunities –> the Breakfast and the Happy Hour rendez-vous.
     
    Because to work hard we need to play hard sometimes, our new member SOMMAILLIER will present his concept of wine imported from France in the company of the month section, with an exclusive FBB discount just for you :)
     
    We end this newsletter by some events and news we thought you might enjoy!
     
    Thanks to your support, we continue to monitor what happens in the Life Sciences community fostering new Partnering and Business Opportunities.
    The French BioBeach Team  Cool
     
    Upcoming French BioBeach Events
     
     
    Coffee & Croissants
        
    The FBB Breakfast were traditionally on the first Tuesday of the month, but we thought that hump day will work even better!
    So from now on, you are welcome to join us on the first Wednesday of the month to share the yummy croissants and the much needed morning coffee :)
        
    When? Wednesday, November 1st from 8:00 am to 9.30 am

     

    Where?  Abbiotec  | 7985 Dunbrook Road | Ste A, San Diego | CA 92126

    abbiotec.com/contact/directions


     
     
     
     
     
     
     
     
     
     
    Monthly Happy Hour @ Bella Vista
     

    End of the week, Sunset & Happy Hour After Work? Let’s get together for our Monthly Networking Happy Hours. 
     
    We look forward to seeing you there…!

      
    When? Friday, November 10th, from 5:00 to 7:00pm

     

    Where?  Bella Vista Social Club & Caffe, 2880 Torrey Pines Scenic Dr, La Jolla, CA 92037 

    Look for our French BioBeach sign!

     

     
     
     
     
     
    Free (no host bar)
    & open to all
     
     

     
     
    or just show up :)

    Whether you would like to come debrief recent events or come discuss your latest startup project, the needs of your company (funding, advisors, people, CRO, IP attorney …), your latest scientific discovery (that you have of course already covered by a provisional), or just grab a TGIF drink and a glimpse of the sunset over the ocean with a bunch of international men & women of the San Diego biotech community, come join us at Bella V. .. and don’t worry, you don’t have to be French or speak French …

    Cheers 

     
     
    Company of the Month
     
     
    SOMMAILIER : a wine club created through 5 generations of French wine making experience
     
    For this month featured “company of the month”, we’d  like to introduce a newly created company here in San Diego,  SOMMAILIER! This is not yet another new microbrewery but   instead a brand new kind of boutique wine club 100% dedicated to French wines created by San Diego local and Bordeaux-native, Laurent Yung. He comes from five generations of French winemakers and has  access to exclusive, boutique French wines through his many connections in France. That’s the reason he started Sommailier – to share exclusive handcrafted wines that you can’t find in the U.S. with people who love French wine or want to learn more about it. Best part? The wine is shipped directly to your door every three months! And you can also send it as a gift to your wine lover friends or colleagues.Members will not only receive the bottles, but they will also receive education and information. Each bottle comes with a wine card providing information about the region it was grown and sourced, and the food pairing to accompany it. 
                                           
        
     
    Learn more about Sommailier and Laurent’s authentic story at www.sommailier.com. If you are interested in joining his club, you can use the code Biobeach20 and benefit from $20 off and free shipping on your first order. Feel free to contact him directly as well at laurent@sommailier.com if you have any question about his wine club.



      
     
     
     
    Events
     
     
     
    CRO Networking Mixer
    Please join on in the McGraw Boardroom at Biocom for a hosted CRO Networking Mixer specially designed for our CRO Members. With over a hundred CRO’s in our membership, this is an opportunity to gain a better understanding of your colleagues expertise in order to foster more collaboration within the CRO Community. 

    When?   November 7th 2017 5:00 pm to 7:00 pm
     
    Where? BIOCOM – McGraw Boardroom                            
    10996 Torreyana Road Suite 200
    San Diego, California  92121

     

    JLABS San Diego

    Meet with… Dementia Discovery Fund (DDF)
      
    Dementia is arguably the greatest single global healthcare challenge, affecting more than 47 million people worldwide at an estimated annual cost to the global economy of over US $604 billion…

    When? Tuesday, November 14th |
    10:30 AM to 5:00 PM
     
    Where? CONNECT
    4790 Eastgate Mall #125
     San Diego | California 92121       
           
     
     


                                                                                           
     
     

    BioLabs San Diego 

    “Bubbly and Blowouts”

     

    Join at the new drybar in La Jolla. This is a great event to network with other women in tech and biotech. Space is limited so book your spot and get your tickets.

     

    When?  Tuesday November 14th 2017

    4:00 PM – 7:00 PM


     

    Where?  Drybar La Jolla

    8867 Villa La Jolla Drive
    La Jolla, CA 92037                                

                        


                                           
     
    In the News
     
    • Thermo Fisher Scientific Signs Oncology Companion Diagnostic Development Agreement with Blueprint Medicines 
     
     
     
     
      MabVax Therapeutics Provides Update on the MVT-5873 Phase 1 Clinical Program and Expansion of Preclinical Development Pipeline at the AACR-NCI-EORTC International Conference
     
     
      Biotech Briefing: UC San Diego, Salk Scientists Awarded NIH Grants
     
     
     
     
     
    French BioBeach
    Ph: +1 (858) 215-2462 • www.frenchbiobeach.com

            

  • FBB october 2017 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

     

     
    Thank You to our  Partners
     
     

    http://www.analytics-ventures.com/
     
     
     
     
     
     
     
     
     
     
     
     

     

    Big Thank You to our Sponsors & Members
     

     
     
     
     
     
     
     
     
     
     
     
     
     

     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     


     
    French BioBeach October 2017 Newsletter
     
    Dear French BioBeach community, 
     
    We have some great news for you… The FBB breakfast IS BACK! Thanks to our sponsor Antibody Design Labs you will have the opportunity to start this coming Tuesday with a delicious coffee and croissant :)
     
    This newsletter start with our FBB events. Our networking opportunities with our Breakfast and traditional Happy Hour rendez-vous.
     
    Then, our partner APL (American Preclinical Services) will be presented in the “Company of the Month” section. You will also find a link to apply for a Connected Intelligence Executive Circle organized by CLC.
     
    We end this exciting newsletter by some events and news we thought you might enjoy.
     
    Thanks to your support, we continue to monitor what happens in the Life Sciences community fostering new Partnering and Business Opportunities.
     
    The French BioBeach Team  Cool
     
    Upcoming French BioBeach Events
     
     
    Coffee & Croissants
     
    The FBB breakfast is back!!! :D
       
    What’s best than a coffee and a croissant to start your tuesday properly?
        

    When? Tuesday October 3rd at 8:00am

     

    Where?  Antibody Design Labs
    Meeting in Coat-9, Conference center Union Station  –> Conference Room located next to “Come On In Cafe” @ 11120 Roselle St., Suite J San Diego, CA 92121

     

     Look for the French Flag…

     
     
     
     
     
     
     
     
     
    Monthly Happy Hour @ Bella Vista
     

    End of the week, Sunset & Happy Hour After Work? Join us for our Monthly (exeptionnaly the 3rd Friday of this month) Networking Happy Hours. 
     
    We look forward to seeing you there…!


    When? Friday, October 20th, from 5:00 to 7:00pm

     

    Where?  Bella Vista Social Club & Caffe, 2880 Torrey Pines Scenic Dr, La Jolla, CA 92037 

    Look for our French BioBeach sign!

     

     
     
     
     
     
    Free (no host bar)
    & open to all
     
     

     
     
     
    or just show up :)

    Whether you would like to come debrief recent events or come discuss your latest startup project, the needs of your company (funding, advisors, people, CRO, IP attorney …), your latest scientific discovery (that you have of course already covered by a provisional), or just grab a TGIF drink and a glimpse of the sunset over the ocean with a bunch of international men & women of the San Diego biotech community, come join us at Bella V. .. and don’t worry, you don’t have to be French or speak French …

    Cheers 

     
     
    Company of the Month
     
     
    The APS Preclinical Program: Your Path to Success

    Finding a reliable partner in the preclinical CRO space can be challenging. In the early stages of product development, having a partner you can trust and rely on is of paramount importance.
    Welcome to American Preclinical Services. APS is an AAALAC and ISO17025 accredited, USDA registered and GLP compliant preclinical center of excellence located in Minneapolis, MN.
    At APS, we have developed a comprehensive Powerful Preclinical Program to assist companies in meeting their R&D goals. The APS Preclinical Program includes regulatory, biocompatibility, interventional medical device, surgical medical device, analytical, physician training, bioskills, pathology, pharmacology, and toxicology services. 
     
    With this breadth of services under one roof, APS can advance your programs in all aspects of your product’s preclinical requirements. APS is adept at tailoring a Preclinical Program to fit your goals, with you and your team having direct collaborative control over study conduct and reporting timelines.

    Over 150 employees strong, the staff at APS have the scientific and technical expertise to guide your team in today’s fast paced and ever changing regulatory environment.  Whether you are conducting pilot evaluations, feasibility testing, or GLP studies, you will have industry experts to rely on every step of the way.
      
     
    Contact Information:
    Scott Barnhill, AS, SRS, RLATG 
    Business Development Executive 
    American Preclinical Services, LLC
    8945 Evergreen Blvd | Minneapolis, MN 55433
    Main Phone: 763-717-7990 | Direct Phone: 763-951-8990 | Mobile: 858-822-9648
    Direct Fax: 763-951-8991
    sbarnhill@apsemail.com
     
     
     
    Events
     
     
     
    CLC : 

    Connected Intelligence Executive Circle (SM)


    A virtual group coaching and networking experience like no other. By invitation or recommendation only


    All participants are sharp, supportive and interesting executives like you. Participants join each session via video conferencing from anywhere in the world, from any device, via private Zoom platform. 

    When?   Strating in October
     
    Where? video conferencing
     

    Confédération des Associations Centraliennes et Supelec
    Alumni Days Centrale(s) et Supélec 2017 à San Diego

    When? Thursday, July 20 2017 |

    4:00 pm – 7:00pm
    Where? Farmer & the Seahorse |
    10996 Torreyana Rd |
    San Diego, California 92121



     

                                                                                                             
     

    Charles River Presents : An Integrated Approach to Assess Drug-Induced Cardiovascular Liabilities

    Can we improve translation of preclinical data to clinical outcomes?


    Early in the drug development lifecycle, the process of evaluating compounds for hemodynamic and electrophysiological cardiovascular risk does not follow a regulated guideline, but more of an investigational method. Determining in-vitro assessments that translate to the whole animal and more importantly to the clinical outcome is paramount…

    When? 

    October 25, 2017 | 11:00 AM – 2:00 PM

     



    Where? 

    Green Acre | Campus Pointe 10300 Campus Point Drive | San Diego, CA 92121 Salon A


                                           
     
    In the News
     
     
    •  Drug from Sanford Burnham Prebys enters testing

     
     
     
    • International Stem Cell Corporation to Expand its Revenue Generating Biomedical Businesses to Support Ongoing and Future Clinical Trials

       

     
     
     
    LaughingThank you for reading!!         
     
     
    French BioBeach
    Ph: +1 (858) 215-2462 • www.frenchbiobeach.com

            

  • BIO Announces San Diego to Host the World’s Largest Industrial Biotechnology Conference in 2016

    Washington, DC (September 8, 2015) – The Biotechnology Industry Organization (BIO) today officially announced that logo_BIOthe 2016 World Congress on Industrial Biotechnology will be held April 17-20, 2016 in San Diego, California at the San Diego Convention Center. BIO is also announcing the call for papers for the event. Leaders from the biotechnology, bioenergy, chemical, consumer products manufacturing, and agricultural industries as well as academia and financial sectors are invited to submit proposals and individual papers beginning September 17, 2015.  

    “More than 400 biotechnology companies call San Diego their “home,” which makes it an exciting venue to host the world’s largest conference dedicated to promoting next-generation biobased products, renewable chemicals and biofuels,” stated Brent Erickson, Executive Vice President, Industrial and Environmental at BIO. “With California’s growing industrial biotech sector, BIO is excited to host the 2016 World Congress on Industrial Biotechnology in the center of it all.”

    The 2015 World Congress on Industrial Biotechnology, held in Montréal, drew 1,200 industry leaders from 725 companies, 50 countries and 37 states, as well as the District of Columbia. Further, the 2015 World Congress hosted more than 1,400 partnering meetings, a 40% increase from the 2014 BIO World Congress.

    The call for papers will open September 17 to invite submissions for breakout panels, breakout papers, posters, and Green Tech investor sessions. Leaders from the biotechnology industry, academia, and policy community are invited to offer an abstract or a proposal for a 15 minute presentation in any of the following program tracks:

    • Algae, Biomass Supply and Specialty Crops
    • Specialty Chemicals, Food & Nutritional Ingredients
    • Synthetic Biology and Genomics Research
    • Research Presentations
    • Technical Presentations
    • Renewable Chemicals and Biobased Materials
    • Advanced Biofuels and Biorefinery Platforms
    • Growing Global Biobased Markets

    Proposed papers and presentations should address any in a range of topics, including renewable chemicals, algae for fuels and bioproducts, and chemicals, biobased products, biomass utilization, cellulosic biofuels, metabolic engineering, new chemical pathways, regional economic development, synthetic biology, regulatory issues, new feedstock crops and feedstock sustainability, aviation biofuels, genetically engineered crops, project finance, biopathways to bulk chemicals, enzyme development, green plastics, work force training and specialty chemicals. 

    For more information on the conference or to submit a proposal, please visit http://www.bio.org/worldcongress

    For assistance, please contact worldcongress@bio.org.

  • Pathway Genomics Launches First Liquid Biopsy Test To Detect Cancer-Associated Mutations In High-Risk Patients

     
    pathway-logo1CancerIntercept-Detect-Monitor_header_-600x202

     

     

     

    SAN DIEGO – Sept. 10, 2015 – Pathway Genomics, a global precision medical diagnostics company, announced the launch of CancerInterceptTM, its first liquid biopsy, a non-invasive screening test designed for early cancer detection and monitoring, for as low as $299. 

     

    The test detects mutations that are commonly associated with lung, breast, ovarian, colorectal cancers and melanoma, as well as mutations that occur less frequently in other cancer types (such as pancreatic, head and neck, thyroid, gastric and prostate cancers). View an animation of howCancerIntercept works here.

    The test is offered for two general populations: CancerInterceptTM Detect is the first liquid biopsy designed to detect tumor DNA in high-risk but otherwise healthy patients; CancerInterceptTMMonitor monitors patients with active or previously diagnosed cancer. Both programs use advanced DNA analysis to identify small DNA fragments that are shed from cancer cells and released into the bloodstream. The tests analyze the presence of 96 frequently occurring DNA mutations in nine cancer genes.

    “Early detection is the single most important factor in ensuring successful treatments and improved survival rates,” said Jim Plante, CEO and founder of Pathway Genomics. “Cancer patients and those at risk for the disease can take proactive steps to safeguard their health and fight back against some of the most virulent forms of the disease.”

    In addition, with CancerIntercept Monitor, physicians are able to supplement more invasive tissue biopsies and scans with liquid biopsies to monitor cancer treatment efficacy, disease progression and recurrence. CancerIntercept Monitor can also be ordered with personalized Clinical Trial Matching for later stage cancer patients.

    “Rising levels of tumor DNA may indicate progression of the cancer before there is clinical or imaging evidence of tumor growth” said Dr. Glenn Braunstein, MD and Chief Medical Officer of Pathway Genomics. “Our liquid biopsy tests may also detect new mutations that occur over time and signal that the patient is becoming resistant to current therapy.”

    Testing can be initiated through the patient’s treating physician or through Pathway’s online physician referral network. For patients and physicians requesting repeat testing on a scheduled basis, a deeply discounted subscription service is available.

    CancerIntercept Detect and CancerIntercept Monitor are offered through Pathway’s integrated system, which streamlines the entire testing process from initial order to delivery of test reports. Key components of the system include physicians who will review online requisitions and order the tests; mobile phlebotomists to draw blood samples at the patient’s home or office; and Pathway’s medical oncology support team, who will discuss results with the patient’s treating physician upon a positive result. All positive results are released via the patient’s treating physician. Results are delivered approximately two to three weeks after testing.

    About Pathway Genomics

    Since its founding in 2008, Pathway Genomics has rapidly become a leader in the commercial healthcare industry. Pathway Genomics’ success lies in its commitment to deliver innovative healthcare solutions. The company’s program with IBM Watson is the first of its kind. The program is a smartphone app that merges artificial intelligence and deep learning with personal genetic information. The app provides users with personalized health and wellness information based on the individual’s health history.

    Based in San Diego, the company’s CLIA and CAP accredited clinical laboratory provides physicians and their patients in more than 40 different countries with actionable and accurate precision healthcare information to improve, or maintain, health and wellness. Pathway Genomics’ testing services cover a variety of conditions including cancer riskcardiac healthinherited diseasesnutrition and exercise response, as well as drug response for specific medications including those used in pain management and mental health. For more about Pathway Genomics, visit www.pathway.com or follow us on TwitterLinkedIn and Facebook.

     

    Read SD Union Tribune article:Sdut-logo

     

    New blood test helps detect cancer early

     

     

     

     

     

     

  • Celgene buys Receptos for $7.3 billion

     

    In one of the largest sales of a San Diego County biotech company to date, Receptos has agreed to a $7.32 billion cash purchase by Celgene, a New Jersey-based cancer drug maker with an office in San Diego.

    Celgene will gain a much-anticipated drug in clinical testing by Receptors for multiple sclerosis and ulcerative colitis. The drug, called ozanimod, is in a Phase 3 trial for relapsing multiple sclerosis.

    Formerly called RPC1063, the drug's potential has helped propel Receptos into becoming a multibillion-dollar company since its initial public offering in 2013. Receptos shares have surged more than fivefold over the last year as ozanimod progressed in clinical testing.

    The company agreed to pay $232 per share for Receptos, a 12 percent premium from Tuesday's closing price. The deal is expected to close this year.

    Receptos and Celgene valued the deal at $7.2 billion excluding Receptos' cash on hand. That's larger than all but a few local biotech purchases, the biggest of which was the $13.6 billion purchase of Carlsbad's Life Technologies by Thermo Fisher Scientific in 2014.

    Faheem Hasnain, Receptos' CEO, is highly regarded in the industry. Before Receptos, Hasnain led Facet Biotech, sold for $450 million cash to Abbott Laboratories in March 2010.

    Facet developed Zenapax, an injectable drug for multiple sclerosis. The Receptos drug is taken orally.

    Celgene, based in Summit, New Jersey, employs several hundred people in San Diego, said spokesman Greg Geissman. The workforce performs early stage research on identifying potential new drugs.

    "We're very excited about this," Geissman said. "This is a great opportunity for us to continue to bolster this inflammation and immunology franchise."

    Receptos has 68 employees, according to a profile on Yahoo Finance. Celgene is interested in keeping Receptos employees, but it's not clear how many will be retained, Geissman said.

    Receptos reported about $2 billion in first-quarter sales of its drugs, which include the multiple myeloma treatments Revlimid and Pomalyst and breast and lung cancer drug Abraxane.

    Revlimid, its top seller, is also used to treat severe anemia and mantle cell lymphoma.

    The purchase of Receptos is part of a push to boost its sales of treatments for inflammatory and immune diseases. In 2014 Celgene launched its first drug in that category, the psoriasis and psoriatic arthritis treatment Otezla.

    Receptos doesn't have any approved drugs on the market. The company expects results from late-stage trials of ozanimod in 2017 and 2018 and hopes to get the drug approved as a treatment for multiple sclerosis in 2018.

    In addition to ulcerative colitis, Receptos is also studying ozanimod as a treatment for inflammatory bowel disease. The companies said they think its annual sales could reach $6 billion.

    In extended trading, Receptos shares added 10 percent, or $21.17, to $228.35. The stock closed at $37.75 a year ago.

    Celgene shares rose nearly 6 percent, or $7.07, to $129.92 in late trading. Last month Celgene agreed to invest about $1 billion in drug developer June Therapeutics Inc., mostly by buying stock. The companies plan to develop cancer and autoimmune disease treatments.

    Source: UT San Diego By Bradley J. Fikes | 7:10 p.m. July 14, 2015

  • Illumina Non-Invasive verifi® Prenatal Test May Reflect Presence of Maternal Cancer

    Study of Illumina's Non-Invasive verifi® Prenatal Test Suggests that Test Results, When Discordant from Fetal Karyotyping, May Reflect Presence of Maternal Cancer

    – Results Published in Journal of the American Medical Association –

    SAN DIEGO–(BUSINESS WIRE)–

    Illumina, Inc. (ILMN) today announced that a preliminary study retrospectively correlated 10 cases of occult maternal cancer among pregnant women receiving an “aneuploidy detected” or “aneuploidy suspected” positive results on the verifi® noninvasive Prenatal Test (NIPT)1 to discordant results of fetal karyotypes for the women, suggesting that discordant NIPT test results may be indicative of maternal cancer.

    Maternal cancers sometimes leave tell-tale abnormal cell free DNA fragments in plasma. In 8 of 10 reported cancer cases, Illumina scientists and physicians reviewed all the genome-wide sequencing data and identified nonspecific copy-number changes across multiple chromosomes, suggesting that these changes, when present in a woman whose fetal karyotype tests as normal, might represent a signal to the clinician to probe for the presence of cancer.

    The results of the study, entitled “Noninvasive Prenatal Testing and Incidental Detection of Occult Malignancies,” are available online today in The Journal of the American Medical Association and the full article can be accessed at broadcast.jamanetwork.com. The paper will be included in the July 14 print edition of JAMA.

    “Abnormal tumor DNA, shed from maternal malignancies, can cause highly unusual NIPT results, including the findings of more than one chromosome abnormality detected,” commented Diana W. Bianchi, M.D., Executive Director of the Mother Infant Research Institute at Tufts Medical Center, and lead author of the publication. “All abnormal NIPT results should be confirmed with a diagnostic test, such as amniocentesis or chorionic villus sampling (CVS). If there is a difference between the fetal diagnostic test and the NIPT results, maternal cancer can be a rare but important underlying explanation. In order to provide the best maternal clinical care, this possibility should be considered, especially when multiple abnormalities of chromosome number are identified on the NIPT report.”

    In a retrospective analysis of 125,426 noninvasive verifi® Prenatal Tests, 3,757 (three percent) were positive for one or more aneuploidies involving chromosomes 13, 18, 21, X or Y. As part of Illumina’s standard procedures, the laboratory contacts the referring physician to discuss all positive test results and to recommend a diagnostic procedure to obtain a confirmatory fetal karyotype. From this group of 3757 positive cases, 10 cases of maternal cancers were subsequently (between 3 and 39 weeks after NIPT) reported to the laboratory. At the time of NIPT these women were not diagnosed with cancer. In 3 cases the abnormal NIPT findings prompted a search for an underlying malignancy. Seven of these eight women had diagnostic tests that indicated a chromosomally-normal fetus, discordant with the NIPT test result. One woman did not undergo a diagnostic procedure.

    Maternal cancers were most frequently associated with the rare NIPT finding of multiple aneuploidies that were discordant with the fetal karyotype. The cancer types were clinically diverse, including three cases of B cell lymphoma and single cases of T-cell leukemia, Hodgkin’s lymphoma, unspecified adenocarcinoma, leiomyosarcoma, and neuroendocrine, colorectal and anal carcinomas. The cancers ranged from stage II to metastatic disease (IV). In one case, after completion of treatment, the abnormal DNA signature became undetectable in follow-up testing.

    “This study shows that NIPTs that use whole genome sequencing techniques may have the ability to detect some cancer signatures under certain conditions,” said Dr. Rick Klausner, Illumina’s Chief Medical Officer. “The sensitivity and specificity of the verifi Prenatal Test to detect cancer is not currently known, and further studies will be required to develop a test for this specific purpose. We have published these results to help clinicians improve overall patient care by considering the possibility of maternal cancer if there is discordance between positive NIPT results and a normal fetal karyotype. We also want to encourage health care providers to contact the clinical sequencing laboratory with follow-up information on abnormal NIPT results that show concordance as well as discordance with fetal karyotype, including cancers diagnosed in pregnant women, so that we can better understand the nonspecific patterns of DNA changes that precede clinical symptoms.”

    About the verifi® Prenatal Test

    The Illumina verifi® Prenatal Test analyzes genetic material (cfDNA) from a pregnant woman’s blood to look for too few or too many copies of chromosomes in the mother and baby, or babies in the case of twins. Missing or extra copies of chromosomes are referred to as “aneuploidies” and may be related to conditions in pregnancy such as trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome) or sex chromosome (X and Y) associated conditions.

    Source: Results from Journal of the American Medical Association, published by BusinessWire

  • IPC & Innate Pharma collaborate on Translational Research for Novel Immune Checkpoint Inhibitors

    IPC, The comprehensive Cancer Center of Marseille, and Innate Pharma collaborate on Translational Research for Novel Immune Checkpoint Inhibitors

    The Paoli Calmettes Institute (IPC), a private not-for-profit comprehensive cancer center in Marseille, France, has initiated a collaboration with Innate Pharma SA (Euronext Paris: FR0010331421 – IPH), a biopharmaceutical company based in Marseille, to conduct translational research aimed at identifying specific populations of patients with hematological cancers who may benefit most from treatment with Innate Pharma’s novel proprietary antibodies, and to identify associated biomarkers.

    innate-logoNicolai Wagtmann, Chief Science Officer of Innate Pharma, said: “This agreement strengthens our translational research capabilities, at the core of our drug development process. IPC is a leading center in hematology-oncology with deep understanding in immunology and capabilities in immune monitoring. Early-stage testing of Innate Pharma’s promising antibodies on patient samples will greatly optimize subsequent clinical development by better identifying the most relevant indications, patient populations and biomarkers”.

    logo-ipc-bigPr. Patrice Viens, Chief Executive Officer of IPC, stated that “This new R&D collaboration with Innate Pharma further expands a long-lasting relationship which started with lirilumab, a fully human monoclonal antibody blocking the interaction between Killer-cell immunoglobulin-like receptors (KIR) on NK cells with their ligands on tumor cells. IPC conducted the “first-in-man study” of lirilumab and continues to be involved in the development of this drug. IPC and Innate Pharma are also involved in other partnerships within the frame of the Marseille SIRIC* and of Marseille Immunopole **”.

    The collaboration will operate under the direction of Pr. Daniel Olive, Head of the Immunity and Cancer research team and of the immune monitoring platform at IPC, and Pascale André, Senior Director, R&D, at Innate Pharma. It will also involve drug-discovery research teams and experts in translational research at IPC, including Pr. Norbert Vey and Pr. Anthony Gonçalvès, and other scientists with expertise in converting promising drug discoveries into clinical treatments for cancer patients.

    Under the terms of the collaboration agreement, IPC will test Innate Pharma’s new therapeutic antibodies in immuno-oncology using IPC’s extensive biological resource collection. Innate Pharma’s antibodies are designed to block immune checkpoints, one of the most promising classes of drugs in oncology. These immune checkpoints interfere with the natural defense mechanisms of our immune system against cancer and regulate immunosuppressive mechanisms. Their blockade can unleash the patient’s immune system to recognize and eliminate cancer cells. However, only a fraction of patients respond to current immune checkpoint inhibitors, and identifying the population of patients most likely to respond to various checkpoint blockers would be of great interest. This R&D collaboration will facilitate the development of novel therapeutic antibodies by identifying the best suited patient population and indications for a given drug.

    * The Marseille SIRIC is the site for integrated cancer research focused on breast cancer, leukemia and myelodystrophy, glioma and pancreatic cancer funded by the French National Cancer Institute, which brings together   IPC, the Assistance Publique – Hôpitaux de Marseille (AP-HM) and their associated research centers.

    ** Marseille Immunopole is a unique collaborative ecosystem for therapeutic innovation in immunology, integrating all the skills from academic to clinic. It aims to make Marseille the European capital of the R&D of immune-based therapy

  • AN UNEXPECTED SURPRISE: EUROPE TO MOVE AWAY FROM FDA-STYLE APPROVAL PROCESS FOR MEDICAL DEVICES

    European FlagsLast week provided breaking news in regards to a highly anticipated and much-talked about topic – the future of the medical device approval process in Europe.

    The 2011 breast implant controversy, where the French company PIP produced defective breast implants made from cheap industrial silicone, has since put the Medical Device Approval process in the EU under the microscope. As a result of this scrutiny, many had raised the question of whether a European-wide, “FDA” style approval process should be adopted for medical devices.

    With the unforeseen leak of the draft report from the Council of Europe on June 11th, it seems that the answer behind a proposal for centralisation is now a resounding ‘no.’ The proposed regulation  put forward by the Latvian presidency and corroborated by many of the Member States discussed the placing, making available and putting into service medical devices on the market. This will be seen as welcome news for American companies seeking EU commercialisation while they are undergoing the arduous FDA process.

    CE-markFor quite some time, it had been suggested that EU institutions should look into ways that would help tighten safety of medical devices. Some lawmakers had therefore felt that in order to solve the problem of a lax EU system, Europe needed a model which resembles the FDA; a US-centralized approval model rather than the current decentralized one, where each country sets its own legal and safety requirements, would be the only answer.

    It seems that leaving the decision and approval process in the hands of Notified Authorities is still plausible. As stated in Article 28 of the proposed regulation “a member state that intends to designate a conformity assessment body as a notified body […] to carry out conformity assessment activities […] shall nominate an authority […] for the assessment, designation and notification” of medical devices.

    This is further reiterated in Annex VIII allowing the nominated authority to still oversee and work with notified bodies, who will in turn work with manufacturers on the approval process.

    The outlined proposals in Chapter VI in regards to clinical evaluations and investigations also stress a more thorough process with the addition that “the Commission, in collaboration with the Member States, shall […] set up, manage and maintain an electronic system”.

    The discussions that took place on June 19th were set to begin the formal review of the proposal into the Trilogue between the Commission, EU Parliament and Member States.

    Although it may seem at first glance an approach to allow the ‘old ways’, it actually paves a way into making a leap from the current directive into differentiating itself from the pharmaceutical industry so that it is, in its own right, specific for medical devices.

    The proposal does not ‘shy away’ from a centralized system because of bureaucracy or financial implications, but merely that a bulky process like that of the FDA is not necessarily the correct model for the EU. It instead provides a means for tighter regulations without necessarily adding delays to its nimble approval process.

    Going forward, the Trilogue will most likely begin in September for proposed adoption by mid-2016 and full implementation in all Member States by 2019.

    SOURCE: http://www.medeuronet.com/medeuronet/an-unexpected-surprise-europe-to-move-away-from-fda-style-approval-process-for-medical-devices/

    June 22, 2015  by Dr. Sunni Patel, medeuronet clinical scientist 

  • 2015 BIO International Convention Closes in Philadelphia – New Record for Partnering Meetings & Back to San Diego in 2017

     

    logo-BIOBIO 2015 Sets Record – 29,279 Partnering Meetings in Philadelphia. Biotechnology Industry Organization to Become Biotechnology Innovation Organization in Early 2016. 15,858 Industry Leaders Attended World's Largest Biotech Gathering

    Philadelphia, PA (June 18, 2015) – The 2015 BIO International Convention, where the global biotech community meets, connecting the people, companies and innovations that help to fulfill the promise of biotechnology through healing, fueling, and feeding the world, concluded  today at the Pennsylvania Convention Center. This year’s Convention hosted 29,279 partnering meetings, a new record for the event. Organized by the Biotechnology Industry Organization (BIO), the event drew 15,858 industry leaders from 69 countries and 47 states, as well as the District of Columbia and Puerto Rico.

    “This year’s BIO International Convention was a tremendous success, bringing to Philadelphia leaders in industry, government and academia from across the globe to pursue biotechnology’s potential to solve some of society’s most pressing problems,” said BIO President & CEO Jim Greenwood.  “From our outstanding keynote speakers, to the record number of partnering meetings, the 2015 Convention was a resounding success.  This event continues to provide biotech leaders with the opportunity to showcase the best of our industry and form connections and partnerships that will drive growth in the sector for years to come.”

    BIO’s new Board Chair, Ron Cohen, CEO of Acorda Therapeutics, announced during Wednesday afternoon’s Keynote Luncheon that the Biotechnology Industry Organization would soon become the Biotechnology Innovation Organization, effective in early 2016.

    The Convention featured dynamic keynotes from legendary journalist Tom Brokaw, leading digital health expert Eric Topol and internationally acclaimed jazz musician Wynton Marsalis. Educational programming included over 750 speakers and 125 sessions in 16 educational tracks which addressed the latest business opportunities, breakthroughs in medicine, diagnostics, the environment, energy production, food and agriculture and more. For session highlights and editorial, visit www.biotech-now.org/.

    The top 15 largest international delegations included (in alphabetical order): Australia, Belgium, Brazil, Canada, China, France, Germany, India, Japan, Netherlands, South Korea, Spain, Switzerland, Taiwan, and the United Kingdom.

    Several U.S. Governors attended this year’s event including Pennsylvania Governor Tom Wolf, Delaware Governor Jack Markell, and South Dakota Governor Dennis Daugaard. New Jersey Lieutenant Governor Kim Guadagno was also in attendance as well as numerous legislators from around the country.

    The BIO Business Forum hosted a record-breaking 29,279 scheduled one-on-one partnering meetingsbetween more than 3,100 companies, and featured 207 company presentations. View highlights here.

    The BIO Exhibition featured more than 1,800 exhibitors and covered over 150,000 square feet with 47 state, regional and international pavilions. The Innovation Zone, featuring SBIR grantees from the National Institutes of Health (NIH) and the National Science Foundation (NSF), as well as the Digital Health Zone, both doubled in size this year.

    BIO would like to thank Philadelphia Mayor Michael Nutter and Pennsylvania Governor Tom Wolf for their hospitality and support leading up to and during the 2015 BIO International Convention. BIO also thanks our regional partners: BioNJ, the Delaware BioScience Association and Pennsylvania Bio.

    “With the support of BioNJ, the Delaware BioScience Association and Pennsylvania Bio, our tri-state region was able to make this year's BIO 2015 convention in Philadelphia a tremendous success,” said Jack Ferguson, Philadelphia Convention & Visitors Bureau President & CEO. “We were grateful for the opportunity to showcase our wonderful Pennsylvania Convention Center, the hotels and hospitality offerings of our city and our region's life sciences assets, and we hope BIO comes back again in the near future.”

    For BIO 2015 video, photos, and more, visit convention.bio.org.

    The 2016 BIO International Convention will take place June 6-9, 2016 in San Francisco, California at the Moscone Center. The 2017 BIO International Convention will take place June 19-22, 2017 in San Diego, California at the San Diego Convention Center. The 2018 BIO International Convention will take place June 4-7, 2018 in Boston, Massachusetts at the Boston Convention & Exhibition Center.

    “I would like to thank the Philadelphia Convention & Visitor's Bureau and the Pennsylvania Convention Center for their leadership and assistance in making the 2015 BIO International Convention such a resounding success,” said Scott Whitaker, President of the BIO International Convention. “The 2015 BIO International Convention may be wrapping-up, but I know the entire biotech community is excited to be back in San Francisco in 2016, where we expect another great BIO Convention.”  

    The BIO International Convention helps support BIO programs and initiatives. BIO works throughout the year to create a policy environment that enables the industry to continue to fulfill its vision of bettering the world through biotechnology innovation.

    Source: https://www.bio.org/media/press-release/2015-bio-international-convention-closes-philadelphia-event-sets-new-record-part

  • Top 10 European Biopharma Clusters

    Source: GEN

    Top 10 European Biopharma ClustersGenetic Engineering & Biotechnology News Logo

    Europe Is Home to Numerous Regional Communities.

    Find Out How They Rank on This GEN List

    Top 10 European Biopharma Clusters

    European countries compete vigorously not just in soccer but also in their efforts for attract and build up life science clusters. [© aberenyi/Fotolia]

    • The FDA’s approval March 6 of the first biosimilar drug for U.S. use helped shine a spotlight on European biotechnology, and not just because the biosimilar in question—Zarxio™, a variation of Amgen’s Neupogen (filgrastem)—will be marketed by the Sandoz unit of Swiss-based Novartis. As of March 10, Europe has 19 biosimilars authorized for patient use since 2006 (including Zarxio, which was approved as Zarzio in 2009).

      Yet there’s much more to biotechnology in Europe than biosimilars. The continent, like the U.S., is home to numerous regional communities or “clusters” of biotechs, pharmaceutical employers, universities, and independent research institutions. As GEN remarked last year, Europe’s biotech leaders enjoy more than one strong region, while smaller nations market their entire country as a hub for life sciences activities. Thus, unlike the U.S., European clusters cannot practically be ranked solely by region.

      And as in the U.S., there’s no central clearinghouse for statistical information using a single standard. So a list of European clusters is likely to include numerous larger bioclusters, though a few smaller clusters are notable enough to deserve mention: Norway’s Oslo Cancer Cluster, for example, is home to 66 biotech, pharma, and life sciences employers. That number is expected to increase once the cluster’s Innovation Park opens on August 24. The park will integrate the Oslo Cancer Cluster Incubator, Ullern High School, The Norwegian Cancer Registry, the Pathology unit, and bioinformatics unit at Oslo University Hospital and several biopharma businesses, from startups to bigger companies.

    • #10—Ireland

      What Ireland appears to lack in patents (14th with six) and EU research funding (13th with 86 grants), the country more than makes up for in venture capital (seventh at $103.232 million in 2013) and number of companies (seventh with 120). “Close to 50,000” are employed in biopharma (IDA Ireland). Yet when it comes to biotech in Ireland, perhaps the best known number is 12.5%—one of the lowest corporate tax rates in the Western world, and no small reason why the Emerald Isle has proven attractive to biopharmas from the U.S. and continental Europe. Under criticism from the U.S. and other nations, Ireland agreed to phase out by 2020 the “Double Irish” practice that has long allowed multinational companies to cut their tax bills legally. Yet Ireland continues to attract jobs from biopharmas based in and outside the country; last month Horizon Pharma opened its new Dublin HQ, with plans to add 60 jobs over three years, while Bristol-Myers Squibb in November said it would build a new biologics manufacturing facility in Cruiserath, County Dublin, designed to support up to 400 manufacturing jobs.

    • #9 – Sweden

      Sweden’s strengths include its number of pure biotechs (136 of some 1,500 companies) and EU research funding (211 grants). More than 30,000 employees work in the industry (SwedenBIO). But the country dips to ninth in 2014 patents (30) and places only 13th in venture capital ($16.230 million in 2013). That’s not to say Swedish companies aren’t finding money; Göteborg-based Cortendo last month completed a $26 million private placement, growing to $37 million the amount of financing raised by the developer of treatments for orphan endocrine disorders since October. And Stockholm-based NeuroVive raised its presence in Asia by establishing a subsidiary that collected $3.255 million from Taiwanese investors, ahead of a planned initial public offering in Taiwan. Sweden’s life-sci strengths remain its heritage of pharmas such as Astra (now AstraZeneca) and Pharmacia (acquired by Pfizer)—and a present-day research base that includes the Karolinska Institute as well as Lund, Uppsala, and Göteborg Universities. Karolinska and Lund joined a home-grown company, Newron Sweden, last month in reporting that a growth factor applied to the brains of a 12 patients resulted in increased signaling of dopamine—a discovery that researchers hope can someday aid in the development of a treatment for Parkinson's disease.

    • #8—Denmark

      Denmark places fifth in venture capital ($135.492 million in 2013), sixth in patents (67), and 10th in both EU research funding (151 grants) and number of core biotechs (88). The industry employs 40,000, according to the Ministry of Foreign Affairs. Yet the country’s drug developers have been generating no small share of attention; Kvistgaard-based Bavarian Nordic earlier this month licensed its Phase III Prostvac® prostate cancer vaccine to Bristol-Myers Squibb for up to $975 million. Prostvac is indicated for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).  And on March 7, Novo Nordisk presented positive Phase IIIa data at The Endocrine Society's 97th Annual Meeting for its Saxenda® (liraglutide [rDNA origin] injection) treatment, which won FDA approval in December. A rich history in agriculture spawned a research industry that has grown into a full-fledged biopharma cluster, anchored in part by the more than 100 companies within the Medicon Valley consisting of Greater Copenhagen and Sweden’s Scania region.

    • #7— Belgium

      Belgium is perhaps Europe’s most consistent biotech sector, placing seventh in EU research funding (228 grants), 2014 patents (45), and number of companies (more than 140), but faring worse in venture capital (ninth at $61.294 million). More than 30,000 people worked in the industry as of 2013 (Embassy and Consulates of Belgium in the U.S.). Biopharmas are concentrated in a few regions—from Leuven, Mechelen, and Walloon Brabant (South East of Brussels), to Ghent, where home-grown ActoGeniX agreed last month to be acquired by Intrexon for $60 million, in a deal that will combine the companies’ technologies to create new oral biologic drugs. Expansion works both ways with Belgian biotechs. Earlier this month, Cardio3 BioSciences based in Mont-Saint-Guibert, Walloon Brabant, selected as the site of its first U.S. facility Rochester, MN—home to the Mayo Clinic, which holds a 3% stake in the Cardio3 BioSciences, and licenses its intellectual property to the company.

    • #6—Italy

      Italy fared best in core biotechs (fourth with 264 of a total 422 biotechs) and EU research funding (fifth with 322 grants), but lagged somewhat on 2014 patents (eighth with 31) and lagged especially on venture capital (a mere 12th with $25.808 million in 2013). The industry had 6,626 R&D employees in 2013, trade group Assobiotec Federchimica and the Italian Trade Agency with Farmindustria reported last year. The country has built a new generation of biotechs by leveraging its heritage chemical and pharmaceutical businesses, especially near Milan. But least one U.S. biotech has taken notice of Italy’s research: Biogen Idec agreed in January to develop gene therapies for hemophilia A and B with the San Raffaele-Telethon Institute for Gene Therapy (TIGET), a joint venture of Italy’s Fondazione Telethon and Ospedale San Raffaele.

    • #5—Switzerland

      Switzerland’s combination of corporate R&D, university research, and a strong financial sector helps explain its numbers: The country finished third in 2014 patents (94) and venture capital ($172.591 million in 2013), but placed sixth in core biotechs (146) and ninth in EU research funding (165 grants). Swiss Biotech counted 14,131 employees in 2013. The numbers also reflect the presence of a new generation of biotechs emerging from the lengthy shadows of heritage pharma giants Novartis and Roche, both of which are still headquartered within the Swiss Confederation. For example, the €30 million ($33 million) biotech startup support program launched by Merck Serono when it closed its Geneva R&D hub has its first success, with Prexton Therapeutics last month closing on an €8.7 million ($9.4 million) Series A financing round toward developing new small molecules targeting the metabotropic Glutamate Receptor 4 (mGluR4) through Phase I trials. Sunstone Capital and Ysios Capital co-led the round, with MS Ventures participating.

    • #4—The Netherlands

      The Netherlands ranked highest in EU research funding (fourth with 328 grants), and was middle-of-the-list in both 2014 patents (76) and number of core biotechs (114), dipping only slightly in venture capital (sixth with $148.396 million in 2013). The country’s biotech sector employed nearly 35,000 in 2013 (Commission on Genetic Modification or COGEM), and remains among the more diverse in Europe, with tools giant Qiagen, contract research organization Quintiles, and Royal DSM, a drug developer that expanded into contract manufacturing and development (through its DPx joint venture with JLL Partners). Yet a Dutch biotech, Lead Pharma, garnered attention last month by launching a partnership with Sanofi to develop and commercialize small molecule therapies for a broad range of autoimmune disorders by targeting the nuclear receptors known as retinoic acid receptor-related orphan receptor gamma (RORγt).

    • #3—France

      France has made some impressive strides in biotech the past few years, climbing to second in both 2014 patents (124) and venture capital ($188.721 million in 2013), and to third in both EU research funding (438) and core biotechs (224 according to EY; 255 according to France Biotech). Industry employment last year stood at 110,006 (European Federation of Pharmaceutical Industries and Associations or EFPIA) Yet in December, France Biotech cited several obstacles to investment in the smallest startups—from “excessive paperwork and administrative tasks when dealing with multiples layers of academic institutions” to delays in review of applications for the CIR or Research Tax Credit, to the need for more understanding of industry needs by regulators. The most closely watched drug developer is heritage pharma Sanofi, whose new CEO Olivier Brandicourt, M.D., comes from France—unlike predecessor Christopher Viehbacher, whose move from Paris to Boston and pursuit of job cuts in the Republic contributed to his ouster by the board. Dr. Brandicourt will begin work on April 2. The Ile de France region that includes Paris remains the center of France’s life sciences activity, followed by Rhône-Alpes.

    • #2—United Kingdom

      The U.K.’s world-renowned universities and their biotech spinouts keep the kingdom first in EU research funding (516 grants) and in venture capital ($446.801 million in 2013), while finishing second in number of core biotechs (309 by EY, among 4,980 companies identified by the government in 2013) and fourth in 2014 patents (87). A total 175,761 people worked in the industry as of 2013 (UK government), though the figure includes 76,723 “medical technology” staffers in a category broad enough to include in vitro diagnostics and wound care. Like Germany, the U.K. benefits from two powerhouse clusters—the triangle formed by London, Cambridge, and Oxford and sometimes known as “East of England;” and Edinburgh, Scotland, institutions and companies focused on stem cell research (capitalizing on since-lifted restrictions in the U.S.) and industrial biotech. The U.K. also benefits from ambitious public-private efforts; in July 2014, the government joined Illumina and The Wellcome Trust in committing £311 million ($470 million) to map 100,000 human genomes by 2017–and thus catapult the kingdom to global leadership in genetic research into cancer and rare diseases.

    • #1—Germany

      Germany leads Europe in biopharma activity by 2014 patents (267) and number of “core” biotechs dedicated exclusively to the industry (428), while placing second to the U.K. in public funding, thanks to the presence of two dynamic regional clusters, North-Rhine Westphalia (NRW) and Bavaria. VC activity lags behind other Euro-giants (fourth at $169.365 million in 2013), in large part because of Germany’s unfavorable tax environment for investments. Industry employment was reported last year at 110,006 (EFPIA). About half of Germany’s companies are in the country’s two strongest clusters: North-Rhine Westphalia (more than 400, including 87 core biotechs and another 15 “additionally biotech active” companies, mostly global giants such as Bayer) and Bavaria (333 companies, including 160 to 170 core biotechs).