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Archive for June, 2018

Re-Tweets and Likes by @Pharma_BI and by @AVIVA1950 from #BIO2018 @IAmBiotech @BIOConvention – BIO 2018, Boston, June 4-7, 2018, BCEC

Curator: Aviva Lev-Ari, PhD, RN

 

  1.   Retweeted

    Aviva Lev-Ari Retweeted Jeff Galvin

    Well put I agree with you, Jeff

    Aviva Lev-Ari added,

  2.   Retweeted

    Aviva Lev-Ari Retweeted I Am Biotech

    Aviva Lev-Ari added,

  3. Aviva Lev-Ari Retweeted Christiane Truelove

    BRAVO FDA in 2018 is AGILE

    Aviva Lev-Ari added,

  4. Aviva Lev-Ari Retweeted CCAB

    ASCO weigh in on CAR-Ts versus bispecific antibodies

    Aviva Lev-Ari added,

  5. Aviva Lev-Ari Retweeted Dana-Farber News

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  6. Aviva Lev-Ari Retweeted Jim Greenwood

    BRAVO inaugural Henri A. Termeer Biotechnology Visionary Award

    Aviva Lev-Ari added,

  7. Aviva Lev-Ari Retweeted JNJ Innovation

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  8.   Retweeted

    The 2018 Bio International Convention has been amazing! This was the view from our water taxi ride to the hotel last night! 🚤🛳🛥⛵️

  9. Aviva Lev-Ari Retweeted Ozmosi

    Aviva Lev-Ari added,

  10. Aviva Lev-Ari Retweeted Sanofi US

    BRAVO Sanofi

    Aviva Lev-Ari added,

  11. Aviva Lev-Ari Retweeted Sue Desmond-Hellmann

    HEROS for cure

    Aviva Lev-Ari added,

  12. Aviva Lev-Ari Retweeted BIO Intl Convention

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  13. Aviva Lev-Ari Retweeted Noy Kaufman

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  14. Aviva Lev-Ari Retweeted Business Sweden Invest

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  15. Aviva Lev-Ari Retweeted Alaric DeArment

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  16. Aviva Lev-Ari Retweeted Mike Huckman

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  17. Aviva Lev-Ari Retweeted JNJ Innovation

    Aviva Lev-Ari added,

  18. Aviva Lev-Ari Retweeted Elizabeth Cutler

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  19. Aviva Lev-Ari Retweeted Sanofi US

    BRAVO Sanofi, so smart to have bought Genzyme

    Aviva Lev-Ari added,

  20. Aviva Lev-Ari Retweeted Biotech Institute

    BRAVO Challenge!

    Aviva Lev-Ari added,

  21. Aviva Lev-Ari Retweeted IAM Platform

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  22. Aviva Lev-Ari Retweeted Sema4

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  23. Aviva Lev-Ari Retweeted Worldwide Clinical

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  24. Aviva Lev-Ari Retweeted Lori Collins

    ‘Largest Business Partnering Event’! Proud to cover the event in

    Aviva Lev-Ari added,

  25. Aviva Lev-Ari Retweeted Mike Huckman

    Aviva Lev-Ari added,

  26. Aviva Lev-Ari Retweeted Cleveland Scott York

    45,000 Partening sessions – BRAVO !!

    Aviva Lev-Ari added,

  27. Aviva Lev-Ari Retweeted Thermo Fisher G.R.

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  28. Aviva Lev-Ari Retweeted The Global IP Center

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  29. Aviva Lev-Ari Retweeted NHS Research Scotland

    BRAVO Scotland in

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  30. Aviva Lev-Ari Retweeted Quanterix

    BRAVO landscape in in light of

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  31. Aviva Lev-Ari Retweeted Vanitha Sekar

    made by Bill & Melinda Gates Medical Research Institution most nobel cause

    Aviva Lev-Ari added,

  32. Aviva Lev-Ari Retweeted HLC

    in Medicine

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  33. Aviva Lev-Ari Retweeted BlueCloud

    BRAVO Argentine

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  34. Aviva Lev-Ari Retweeted NFIA North America

    BRAVO Holland! places Holland No. 1 in the world for medical technology patents!

    Aviva Lev-Ari added,

  35. Aviva Lev-Ari Retweeted Intract Pharma

    Amazing COnference

    Aviva Lev-Ari added,

  36. Aviva Lev-Ari Retweeted MacBioCom

    Aviva Lev-Ari added,

  37. Aviva Lev-Ari Retweeted Hassan Naqvi

    meets INDUSTRY: BIOTECH & PHARMA with success

    Aviva Lev-Ari added,

  38. Aviva Lev-Ari Retweeted IN-PART

    INDEED, the best conference I have attended since 2013 when I cover in Real Time conferences as

    Aviva Lev-Ari added,

  39. Aviva Lev-Ari Retweeted JNJ Innovation

    BRAVO J&J for your broad spectrum in

    Aviva Lev-Ari added,

  40. Aviva Lev-Ari Retweeted Penny Heaton

    MOST NOBEL cause by MRI can be a catalyst to address urgent global health

    Aviva Lev-Ari added,

  41. Aviva Lev-Ari Retweeted I Am Biotech

    bRAVO I Am Biotech

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  42. Aviva Lev-Ari Retweeted ARMI

    BRAVO Aussi

    Aviva Lev-Ari added,

  43.   Retweeted

    Fireside chat with at

  44.   Retweeted

    Jeff Galvin, CEO of Rockville-based presented his company’s innovations in therapies for HIV, phenylketonuria, and cancer at . After the presentation, he was mobbed by potential investors and partners!

  45.   Retweeted

    How do you schedule hundreds of meetings all at once? has it figured out. Meeting many great potential supporters.

  46.   Retweeted

    It doesn’t get more epic than this l! The QUEEN, DIANA ROSS!

  47.   Retweeted

    Absolutely inspiring group of advocates on the patient voice panel. I feel honored to be in the room with them, listening to their remarkable stories and insights.

  48.   Retweeted

    Board of Directors Chair on diversity in during his Fireside Chat

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    And for more on-the-ground analysis while you’re at , sign up for our daily newsletter, BIO in 30 Seconds.

  50.   Retweeted

    THURSDAY: (yes, twice!), 9:00am, 259B, on biotech’s data tsunami

  51.   Retweeted

    TUESDAY: , 4:15pm, 259A, on a new era of biotech journalism

  52.   Retweeted

    TUESDAY: , 1:45pm, 210B, on how to apply the lessons of immunotherapy from cancer to other diseases.

  53.   Retweeted

    MONDAY: , 4:00pm, 210A, talking how to cut waste between big pharma and payers in precision medicine.

  54.   Retweeted

    MONDAY: , 1:00pm, 206AB, talking what drug hunters look for in early stage assets.

  55.   Retweeted

    MONDAY: , 12:30pm at , talking best practices for co-working in the life sciences. (From the archives)

  56.   Retweeted

    THREAD: STAT is all over . Here’s where to find us.

  57.   Retweeted

    speaking with the member delegation at We’ve come to share with the world the excellence of our life science community in Canada.

  58.   Retweeted

    Team Queensland ready to showcase our state’s fantastic capabilities in all things biotech in Boston

  59.   Retweeted

    kicks off tomorrow in Boston, MA. Dr Glenn Begley, CEO and Linda Peterson, COO will be attending. DM us if you would like to connect with them.

  60.   Retweeted

    Heading to my first BIO convention, the rain can’t stop my excitement! 😁

  61.   Retweeted

    Proud to sponsor . We at love supporting and their missions to improve our health! See you at as we keep the startup celebration going tomorrow night! BIOGA25 for $25 GA tix

  62.   Retweeted

    Our friends at have put together the ultimate guide to the (). It features a complete list of conferences, private events/receptions, plus much more, all happening throughout the week. Get it here >>

  63.   Retweeted

    Through Pfizer Ventures, we plan to invest $600M in innovative science, with approximately $150M specifically targeted toward neuroscience. Join us at to learn more:

  64.   Retweeted

    “It will take you 10-15 years to get a breakthrough, but if you don’t start, you’ll never get there,” says J&J’s CSO Paul Stoffels when asked about at – at Boston Convention & Exhibition Center

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    Great Q on driving (innovation in) “Huge opportunity in partnering with Pharma, not in replacing them, mainly due to the complexity of

  67.   Retweeted

    Penny Heaton Retweeted BIO Intl Convention

    Looking forward to next week, where we’ll have the opportunity to formally introduce the Gates MRI and share the mission, vision, and values behind the work we’re doing to accelerate product development for diseases that disproportionately affect the world’s poorest.

    Penny Heaton added,

  68.   Retweeted

    Attending ? These SECRET STAIRS, only minutes from the convention center, lead to our local Fort Point restos, breweries and more!

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    At … it’s like Epcot in here! So many countries and states courting the bio biz.

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    the best way to conclude this incredible !!!

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    Making History in Boston.

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    At biggest biopharma partnering event in the world, scale is pretty amazing…

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    I can’t believe attendees are told by conference organizers that “locals” recommend: “Let loose and explore the nightlife of Boston, grab a couple beers at the iconic “Cheers” bar.” Let me qualify that: NOBODY IN THIS CITY WOULD RECOMMEND THAT.

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    How cool is this new tool from ?! It provides info on partnering opportunities and contacts for over 60+ patient advocacy groups. Very useful!

  75.   Retweeted

    And here it is, the most famous Paul Stoffels quote we hear ALL THE TIME at “You take the risk and I take the blame” in

  76.   Retweeted

    We MADE GUINNESS HISTORY!

  77.   Retweeted

    . – tonight, Karl-Rudolf Erlemann of was all of us.

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    Which biopharmaceutical companies are making a real difference for patients? Our CSO Michael Severino explains how to spot R&D leaders.

  79.   Retweeted

    Had to get to the front row for the encore at live!

  80.   Retweeted

    There is till time to visit us at , booth 1344. If you require nucleosides and carbohydrates for your business, come to speak to our specialist – maybe we can help.

  81.   Retweeted

    Thank you and for helping me meet a real life superhero. Ashanti DeSilva the first person in the world treated with 28 years ago. A passionate , advocate and a personal inspiration

  82.   Retweeted

    Wonderful to meet Baroness Fairhead CBE, Minister of State at DIT on the UK Pavilion at

  83.   Retweeted

    The expo floor is a trip around the world of innovation!

  84.   Retweeted

    Great reception at Startup Stadium today. It’s been a great week here in Boston.

  85.   Retweeted

    No rest for attendees! It’s the last day of Convention, but the action isn’t slowing down yet. Look out for these featured events in today’s schedule:

  86.   Retweeted

    It was another history-making ! We look forward to hosting you in on 2019 to make even more history!

  87.   Retweeted

    Pitt has once again surpassed its records for startups in fiscal 2019 with 21 companies spun out of the university. Could a Pitt startup be your next entrepreneurial or investment opportunity?

  88.   Retweeted

    I will survive! ⁦ very Darwinian!

  89.   Retweeted
    Replying to 

    No “jail” means being forced to listen to speak at . I hope he’s wearing cool socks.

  90.   Retweeted

    Don Seiffert Retweeted Suzanne Fraser

    Diana Ross performing “I Will Survive” at the Convention Center for

    Don Seiffert added,

  91.   Retweeted

    Agendia Retweeted PMC

    Thanks for inviting our CMO, Dr William Audeh, to join this important and timely in Action panel at

    Agendia added,

  92.   Retweeted

    Last day for and last chance to meet 10 companies from and health cluster. Visit us on booth 527, France pavilion.

  93.   Retweeted

    Still time to visit us at booth 1753

  94.   Retweeted

    Find and meet our BD Manager Emmanuelle Astoul who is attending in Boston to talk about collaboration opportunities with

  95.   Retweeted

    Today last day! Come visit us at booth #1328 and enjoy some argentinian alfajores and coffee!

  96.   Retweeted

    Today at 10:30am, join our Senior Investment Director, Dr. Karen Hong at for “Business Development & Finance: An Investor’s Perspective on Value of New Biotherapeutics” in Room 252AB, Level 2.

  97.   Retweeted

    Fun session y’day at on drug prices, R&D cost, and innovation – many thanks to & ! Good convo abt whether (a) competition will ⬇️ prices in cancer and rare dz, & (b) NIH, prizes, etc. can sustain & focus Rx innovation in the future.

  98.   Retweeted

    Speak to our Team on the UK Pavilion (stand 1333) at the Bio International Convention

  99.   Retweeted

    Want to learn more about collaboration between and JPEO-CBRND? Stop by booth 1913 to learn more and how Industry can engage with us.

  100.   Retweeted

    Home stretch! Day 4 begins with business development first thing in the morning. .

  101.   Retweeted

    Last day of kicks off with fireside chat in one hour

  102.   Retweeted

    At Shares the Journey: being an award-winning broadcast journalist and author, and a survivor of breast cancer and myelodysplastic syndrome (MDS),

  103.   Retweeted

    Over the past 21 years, we’ve forged long-term, mutually successful partnerships, bringing innovations and solutions together to meet the worlds healthcare needs. Connect with us at the Scottish Pavillion to discover what we can do for your clinical trial journey.

  104.   Retweeted

    ⁩ hosted a great alumni networking event around

  105.   Retweeted

    Rob Reiner and I will be joining you on stage shortly!

  106.   Retweeted

    Are you at ? Be sure to stop by Booth #2101 to learn more about the 10 remarkable Israeli companies, spanning the spectrum of ’s vigorous Life Sciences community- from innovative start-ups to established companies!

  107.   Retweeted

    Great discussion at today’s “Best Practices for Working with Patient Advocacy Organizations,” with our own Jessica Riviere, Senior Director, Biogen

  108.   Retweeted

    We are excited to have , CEO of with us live at the Massachusetts pavilion speaking live

  109.   Retweeted

    Our President of R&D Akshay Vaishnaw took the stage earlier today at the pavilion to tell our innovation and Massachusetts story. therapeutics

  110.   Retweeted

    Standing ovation for Ashanthi De Silva at ! “Have hope, be your own advocate, and never give up.” – at Boston Convention Center Grand Ballroom

  111.   Retweeted

    Diversity and inclusion is an BoD priority, an priority and my priority. During my fireside chat w/ Halozyme CEO Helen Torley today at , I committed to not participate in any future panel that is not diverse.

  112.   Retweeted

    Here in Massachusetts, innovation is a way of life. It truly is the . If you want it to happen, you need to be here – Massachusetts is the place where life sciences companies can find the people, the ideas and the resources they need to innovate and grow. – at Boston Convention & Exhibition Center

  113.   Retweeted

    We OFFICIALLY made history this week! BIO’s Joanne Duncan accepting our Guinness World Record for ‘Largest Business Parneting Event’

  114.   Retweeted

    Excited to hear member and Reg Affairs Committee member Kelli Tanzella of give her perspective on the regulatory paradigm for NGS panels.

  115.   Retweeted

    Trailblazing discoveries in health sciences are what we do here.

  116.   Retweeted

    Did you know that every 3.5 minutes someone will die from lung cancer? Boston University and investing in changing this

  117.   Retweeted

    We did it! We set a world record for the Largest Business Partnering Event. Thank you to everyone!

  118.   Retweeted

    I’ve been around the world twice. is the Epcot of Bio, Science & Pharma companies. Proud to see companies recognizing the Making great connections to support our students.

  119.   Retweeted

    Eager to elevate the & voice at this morning’s panel discussion on Communicating Value Through the Eye of the Beholder

  120.   Retweeted

    Need for evidence of PM’s value has emerged as & Dx Track” theme. Now, , , reps show / parallel review pathway, joint studies by commercial insurers/Dx companies will be key.

  121.   Retweeted

    The winner of Dr. Paul Janssen Award Jim Allison discusses the importance of elevating science to a household conversation if we want to improve our collective health.

  122.   Retweeted

    Congrats to for setting the Guinness World Record for largest business partnering event!

  123.   Retweeted

    Diversity and inclusion in science goes beyond who’s at the bench and all the way to who the science serves – 80% of NIH’s genomic data that’s used to push forward precision medicine is from people of European descent. (That’s not okay)

  124.   Retweeted

    speed networking is happening now! Booth #2001

  125.   Retweeted

    Honored to have had the opportunity to address this morning and talk about how real, palpable ultimately means real, palpable patient impact!

  126.   Retweeted

    We don’t do germline editing; society is not at a place to be ready for this, also it’s against recs, says Sandy Macrae . Carrie Wolinetz agrees, says term distinction is crucial, confusing these can feed back into regulatory framework detrimentally.

  127.   Retweeted

    What question would you ask at a discussion about the regulatory framework in human genome editing?

  128.   Retweeted

    “One patient at a time, positive responses are demonstrating that RNAi technology indeed has the potential to bring about a paradigm shift in medicine,” writes Mano Manoharan, SVP, Innovation Chemistry, in a blog post discussing our journey to advance therapeutics.

  129.   Retweeted

    The opportunities to advance the clinical trial model with personalized and targeted approaches are endless, from in the

  130.   Retweeted

    Fantastic dialogue going on in 204AB at . Completely candid remarks from tremendous group

  131.   Retweeted

    It was great to meet Jim Greenwood, CEO of at . – Robert Naismith, Chairman

  132.   Retweeted

    Wow knows how to put a stellar diverse panel together 🙌

  133.   Retweeted

    Front and center, Maryland is in a prime position to move business and innovation forward!

  134.   Retweeted

    This is a loaded panel & plenty of seats avail. Turbo charge R&D activities in 252AB

  135.   Retweeted

    Q to panel as public co CEOs – how do you investor risk? Dahiyat says people will invest if they think co. will make money either way. Hastings says will push some away, draw others in, so do what’s right.

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    Our Biocom team has been taking full advantage of making ALL the connections at ! Check us out at the California Pavilion or stop by Startup Stadium tomorrow where we’ll be supporting our member !

  137.   Retweeted

    For those interested in learning more about gene-based therapies, make sure to attend the “Making Genetic Therapies a Reality for Patients” panel featuring our Chief Commercial Officer, Emmanuel Dulac.

  138.   Retweeted

    & Dx Track” has showed progress on several policy fronts. But , , reps say providers are still not incentivized to deliver holistic, value-based medicine. Reimbursement paradigms must evolve, they say.

  139.   Retweeted

    Travis McCready from closes out the Possible Talks at in the – “The only way that this industry will evolve, the only way we’ll find cures, is to develop the next generation of diverse talent and to break the mold.” That’s a wrap!

  140.   Retweeted

    “Breakthrough cience occurs when you cross disciplines” Mikael Dolsten

  141.   Retweeted

    🛑! Working on a slide deck to communicate your awesome 🔬? Here are some presentation basic design tips 🎨 for this week’s !

  142.   Retweeted

    Representatives from European biotech, regulatory and venture capital describe the state of investments in Europe and how global participants can get involved

  143.   Retweeted

    Great to meet Australia’s top medical entrepreneurs, discussing how they can take their successful ideas global, creating more jobs and improving patient outcomes

  144.   Retweeted

    Biologos is having a great time at this week in Boston!

  145.   Retweeted

    Great panel at on Digiral Medicines with leaders of of of Marisa Cruz of and Mostafa Kamal of Magellan

  146.   Retweeted

    Great points from re patient consent, consent for life, by Sandy Macrae, and need to ensure patients truly understand what it is they are committing to

  147.   Retweeted

    Q based on diversity training: anybody willing to do training similar to Starbucks? Dahiyat says his company already diverse, but reaches out to area to encourage diversity in science. Johnson says similar program at Dare – get more diversity in science with local youth.

  148.   Retweeted

    Over a 7-year period biotech job growth outpaced national growth by 14% Visit to find out why call home

  149.   Retweeted

    Life sciences companies aren’t innovating processes with and other technologies, but whoever tackles this first will win. from leads a discussion at with leaders from , , , and .

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    Independent test results confirm the new VIP ECO upright ultra-low temperature freezer has the lowest total daily energy usage in its class in the industry. Visit us at this week Booth 1927 to learn more. Download your white paper here:

  152.   Retweeted

    DrugDeliveryExperts Retweeted BIO Intl Convention

    And DDE was there… Congrats to !

    DrugDeliveryExperts added,

  153.   Retweeted

    Save the date… reminding everyone at to come visit us next year in !

  154.   Retweeted

    Some impressions representing trends on : , driving the funnel and from all over the world – at Boston Convention & Exhibition Center

  155.   Retweeted

    “Europe is a uniquely attractive place for biotech”; lively discussion at our session on Europe’s value proposition for + investment

  156.   Retweeted

    Dahiyat continues: If you are running your business in a way that is profitable, investors won’t care. If not, it doesn’t matter if you’re silent anyway.

  157.   Retweeted

    Thank you for joining today’s panel with and the and for working with us to bring the patient viewpoint forward in value assessment.

  158.   Retweeted

    Now on stage at former MA governor ; extremely inspiring and a good example that a strong political vision is a key to Life Sciences Cluster development

  159.   Retweeted

    Hats off to — Been coming for most of the last 15 years, and I’ve never seen this level of buzz about business, doing things, in . Congrats on a job well done.

  160.   Retweeted

    Today Paul Stoffels, CSO of will be discussing new strategies for the development of & for the developing world. If you’re at head to Room 251, Level 2 at 3:00pm.

  161.   Retweeted

    Fireside Chat speaker and BIO Board of Directors chair on diversity and business

  162.   Retweeted

    THE is performing LIVE at TONIGHT at the BCEC! You must have a Convention Access badge to enter, and warning: space is extremely limited. Admittance is first-come, first-served, so make sure to arrive early! Thanks to our sponsors

  163.   Retweeted

    WIB Pittsburgh Retweeted Women In Bio

    For those of you at , check this out!

    WIB Pittsburgh added,

  164.   Retweeted

    Mark your calendars! Chief Scientific Officer Paul Stoffels will sit down with founder on Monday at 4pm at to discuss how we can speed innovation in science and medicine.

  165.   Retweeted

    I believe in dreaming big and focusing small ~ great words to live by. BIOConvention

  166.   Retweeted

    So much going on today at ! Keynotes from industry leaders, panels on cutting edge research, and 1×1 partnering now happening in the Business Forum!

  167.   Retweeted

    To all who will be attending this week, a very warm welcome to my adopted hometown…AKA “The City of Champions” (in case you’ve forgotten!).

  168.   Retweeted

    As an industry, we will continue to champion the evolution of “patients as subjects” to “patients as partners.” They’re the real experts in their conditions. They’re following the research. They’re clinical pioneers. And they’re our real-life inspirations.

  169.   Retweeted

    Enjoyed dinner w/ cool and fun power women Cat Oyler, Suzy Lebold Sue Dillon, Reema Driscoll

Read Full Post »

  • More than 77 percent of patients in the REMfresh® Patient Reported Outcomes DURation (REMDUR) study reported achieving 6 or more hours of sleep after taking REMfresh®, the first continuous release and absorption melatonin (CRA-melatonin)
  • More than 91 percent experienced improvements in sleep onset, sleep maintenance and total sleep quality, after taking REMfresh® (CRA-melatonin)
  • Post-marketing, patient-reported outcomes data reinforces clinical trial evidence demonstrating the potential of non-prescription REMfresh®, as a new, non-prescription, drug-free hypnotic (sleep) product designed to achieve 7-hour sleep
  • New data confirms previously presented SLEEP 2017 study showing the patented Ion Powered Pump (IPP) technology in REMfresh® helps extend melatonin-targeted sleep maintenance levels in the body from 3.7 hours (with marketed immediate-release melatonin) to 6.7 hours, while mimicking the pattern of the body’s natural melatonin blood levels during the nightly sleep cycle

Real Time Coverage at SLEEP 2018 meeting, Baltimore.

Reporters: Aviva Lev-Ari, PhD, RN, and Gail S. Thornton, MA

BALTIMORE – (June 6, 2018) – A patient-reported outcomes study presented at SLEEP 2018 provides confirmatory real-world evidence of the previously peer-reviewed and presented data showing the 7-hour action of REMfresh®, a new product for sleep. REMfresh® Ion-Powered Melatoninis the first and only, continuous release and absorption melatonin (CRA-melatonin) to mimic the body’s own 7-hour Mesa Wave, the natural pattern of melatonin blood levels during a normal night’s sleep cycle. This induces sleep onset and provides lasting and restorative sleep for up to 7 hours.

This new data shows a correlative relationship between a 7-hour Mesa Wave pharmacokinetic (PK) profile and real-world evidence of improvements in sleep duration, onset, maintenance and sleep quality after taking REMfresh® (CRA-melatonin).

The post-marketing REMfresh® Patient Reported Outcomes DURation (REMDUR) study was presented at SLEEP 2018, the 32nd Annual Meeting of the Associated Professional Sleep Societies (APSS), LLC, a joint partnership of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS).

 

Brodner and Seiden

Pictured here is David C. Brodner, M.D., and David J. Seiden, M.D., FAASM, after presenting the latest study data which found REMfresh is the first and only continuous release and absorption melatonin™ to mimic the body’s own 7-hour Mesa Wave™.

 

In a sample of 500 patients on REMfresh® (CRA-melatonin) responding to an online survey, 77.6 percent achieved 6 or more hours of sleep compared to 23.6 percent who slept that duration prior to taking REMfresh® (p<.0001). A vast majority of respondents also reported a major or moderate improvement in sleep onset (91.6 percent, p<.0001), sleep maintenance (94.8 percent, p<.0001) and total sleep quality (97.2 percent, p<.0001). More than three-quarters (76.6 percent) of patients indicated they take REMfresh® (CRA-melatonin) nightly. The proportion of patients reporting nightly CRA-melatonin use was significantly greater than the proportion of patients with less than nightly use (p<.0001). Most importantly, over 98 percent of patients reported they were very likely or likely to continue taking REMfresh® (CRA-melatonin) to treat their sleep complaints.

“The real-world evidence reported today in REMDUR provides further confirmation that REMfresh® represents a significant advance in the use of melatonin as a baseline therapy for treating sleep complaints,” said David C. Brodner, M.D., a leading sleep specialist who is Double Board-Certified in Otolaryngology — Head and Neck Surgery and Sleep Medicine, founder and principle Physician at the Center for Sinus, Allergy, and Sleep Wellness, in Palm Beach County, Florida, and Senior Medical Advisor for Physician’s Seal, LLC®.

“REMfresh® Ion-Powered Melatoninhas been shown to be an effective drug-free solution that is now available to the millions of Americans in need of a good night’s sleep, many of whom seek new therapies that will induce sleep and keep them asleep until the morning, without causing residual effects they’ll feel the next day. With its unique delivery system that imitates the body’s own natural sleep pattern, REMfresh® has revolutionized the role of melatonin, when delivered in the CRA form. It is no longer just a treatment for jet lag, but the CRA-melatonin found in REMfresh® has been shown to provide substantial relief to individuals having nightly sleep challenges,” said Dr. Brodner.

The scientifically advanced, patented delivery system in REMfresh® (CRA-melatonin), called Ion Powered Pump (IPP™) technology, replicates the way in which the body naturally releases and absorbs melatonin, unlike conventional melatonin sleep products. Since REMfresh® is not a drug, there is no drug hangover.

Nearly one-third of U.S. adults sleep less than the recommended seven hours daily.[1],[2] Increasing evidence suggests an association between sub-optimal sleep duration and adverse health outcomes including a higher risk of diabetes, hypertension, heart attack, stroke, obesity and depression.[3] A pooled analysis of 16 studies and over one million patients found short sleep duration corresponded with greater risk of morbidity and mortality.[4]

 REMDUR Study Design

The post-marketing REMfresh® Patient Reported Outcomes DURation (REMDUR) study was designed to obtain real-world evidence about patients’ sleep patterns, duration of sleep before and after REMfresh® (CRA-melatonin), daily REMfresh® (CRA-melatonin) use, onset of action, sleep maintenance, quality of sleep, and overall satisfaction with REMfresh® (CRA-melatonin).

Patients with sleep disturbances in the general population who received a sample of CRA-melatonin (REMfresh®) from their physicians were invited to complete a 12-question survey. Survey responses were received from 500 patients.

Confirmation of the REMAKT Clinical Study

REMDUR confirmed clinical trial findings from REMAKT (REM Absorption Kinetics Trial), a U.S.-based randomized, crossover pharmacokinetic (PK) evaluation study in healthy, non-smoking adults that compared REMfresh® (CRA-melatonin) with a market-leading, immediate-release melatonin (IR-melatonin).[5]

The study results, peer-reviewed and presented last year at SLEEP 2017, showed that melatonin levels with REMfresh® (CRA-melatonin) exceeded the targeted sleep maintenance threshold for a median of 6.7 hours, compared with 3.7 hours with the leading IR-melatonin. Conversely, the levels of the market-leading IR-melatonin formulation dramatically increased 23 times greater than the targeted levels of exogenous melatonin for sleep maintenance and had a rapid decline in serum levels that did not allow melatonin levels to be maintained beyond 4 hours.

The REMfresh® (CRA-melatonin) studies build upon the body of evidence from prolonged-release melatonin (PR-M), marketed in Europe, which demonstrated in well-conducted, placebo-controlled studies, statistically significant improvement in sleep quality, morning alertness, sleep latency and quality of life in patients aged 55 years and older compared with placebo. REMfresh® (CRA-melatonin) was designed to overcome the challenges of absorption in the intestines, thereby extending the continual and gradual release pattern of melatonin through the night (known as the Mesa Wave, a flat-topped hill with steep sides). There was a fast time to Cmax, which is anticipated to result in improved sleep onset, while the extended median plateau time to 6.7 hours and rapid fall-off in plasma levels at the end of the Mesa Wave, may help to improve sleep maintenance and morning alertness.

Conventional melatonin products have had challenges at mimicking the profile of a Mesa Wave™. The scientific work behind REMfresh® (CRA-melatonin) sought to overcome these challenges by having the melatonin formulation in a matrix that maintains a patented, solubility-enhancing pH environment to help with the transport to the brush border of the gut and its subsequent absorption.

Designed as a hydrogel matrix tablet, REMfresh® (CRA-melatonin) provides rapid release of the melatonin from the surface of the tablet, as the hydrogel release-controlling matrix is setting up in the acidic environment (pH of 1 to 3.5) in the stomach. As the tablet moves into the higher pH (5.5 to 6.5) environment of the small-intestine, which is above the pKa of melatonin (~4.0), the acidic moiety in the tablet is designed to maintain the pH within the tablet below 4.0 for 7+ hours. The hydrogel matrix, after proper hydration, allows continuous release of the active melatonin and acidic moiety into the lumen of the intestines.

Melatonin: The Body’s Natural Sleep Ingredient

Melatonin is produced by the pineal gland in the brain and is the body’s natural sleep ingredient. Melatonin levels normally begin to rise in the mid-to late evening and remain high for the majority of the night. Levels begin to decline towards early morning, as the body’s wake cycle is triggered. As people age, melatonin levels can drop by as much as 70 percent[6] and their bodies may no longer produce enough melatonin to ensure adequate sleep.

Other available products, such as immediate-release melatonin, help initiate the onset of sleep but are usually unable to sustain prolonged sleep maintenance due to an immediate burst of melatonin, which is quickly degraded due to its relatively short half-life (60 minutes). Absorption in the lower digestive tract is limited by melatonin’s limited ability to be absorbed in a low acidity or neutral pH environment.

Importance of Sleep

Sleep is an essential part of every person’s life. The body requires a certain amount of sleep in order to properly rest, repair and renew itself. Sleep is customarily divided in four different stages, with each stage having a different effect. These four stages are:

N1, N2, deep sleep and REM sleep. The body moves among these four stages several times while asleep. If sleep is disrupted for any reason, a person’s body may not have a chance to properly restore itself, especially if it is struggling to get to the later stages, called deep sleep and REM sleep. Studies have shown that sound and sufficient sleep is important for learning, memory and a healthy immune system. A regular pattern of deep sleep and REM sleep will help a person begin the next day feeling refreshed and ready to go.

About Non-Prescription REMfresh®

REMfresh® (CRA-melatonin) is the first and only, continuous release and absorption formulation of UltraMel® melatonin (available as 2 mg and 5 mg and with a 0.5 mg anticipated in the second half of 2018). UltraMel® melatonin is a high-quality, 99 percent ultra-pure melatonin sourced from Western Europe exclusively for Physician’s Seal®.

REMfresh® (CRA-melatonin) is a dietary supplement and is regulated under the Federal Dietary Supplement Health and Education Act, which does not require pre-approval. Melatonin has been in common use for over two decades and has a well-established profile of safe use by millions of people around the world. As with all supplements, individual results may vary.

REMfresh® (CRA-melatonin) is non-habit forming and does not contain narcotics, hypnotics, barbiturates, sedatives, antihistamines, alcohol or other harsh or additive chemicals. The usual adult recommended dose is 1-2 tablets 30-60 minutes before bedtime. Follow specific dosing instructions found on the back of the box for proper use of supplements.

REMfresh® (CRA-melatonin) is available at Walmart, Rite Aid and CVS/pharmacy. In 2017 REMfresh® was ranked as  the #1 recommended brand for sleep management by sleep doctors[7].

About Physician’s Seal®

Physician’s Seal® is the innovator of REMfresh®, the first and only continuous release and absorption, 99 percent ultra-pure melatonin (CRA-melatonin) that mimics the way the body naturally releases and maintains melatonin over a 7-hour period. Physician’s Seal®, founded in 2015, is a privately held company based in Boca Raton, Florida. It is committed to bringing cutting-edge life science applications to doctors and their patients. For more information, visit www.remfresh.com and connect with us on Facebook and You Tube.

Its sister subsidiary, IM HealthScience® (IMH) is the innovator of IBgard® and FDgard® for the dietary management of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), respectively. In 2017, IMH added Fiber Choice®, a line of prebiotic fibers, to its product line via an acquisition. IMH® is a privately held company based in Boca Raton, Florida. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. The company is dedicated to developing products to address overall health and wellness, including conditions with a high unmet medical need, such as digestive health. The IM HealthScience® advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting® (SST®). For more information, visit www.imhealthscience.com to learn about the company, or www.IBgard.com,  www.FDgard.com,and www.FiberChoice.com.

This information is for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care professional. You should not use this information for diagnosing a health problem or disease. The company will strive to keep information current and consistent but may not be able to do so at any specific time. Generally, the most current information can be found on www.remfresh.com. Individual results may vary.

Data Presented at SLEEP 2018 Poster Session on Sleep Maintenance/Sleep Quality

Tuesday, June 5, 2018, 5-7pm

  • (Abstract 0419, Poster Board #104) Improvement in Sleep Maintenance and Sleep Quality with Ion Powered Pump Continuous Release and Absorption Melatonin: Results from a Self-Reported Patient Outcomes Study
    • David J. Seiden, M.D., FAASM, David C. Brodner, M.D., Syed M. Shah, Ph.D.

Visit Physician’s Seal® at booth 220 to learn more about REMfresh®.

The abstract is published in an online supplement of the journal, Sleep, which is available at http://www.sleepmeeting.org/docs/default-source/default-document-library/abstractbook2018.pdf?sfvrsn=2

[1] Ford, E.S., Cunningham, T.J., & Croft, J.B. (2015, May 1). Trends in Self-Reported Sleep Duration among US Adults from 1985 to 2012. Sleep, 38(5):829-832. doi: 10.5665/sleep.4684.

[2] Watson, N.F., Badr, M.S., Belenky, G., Bliwise, D.L., Buxton, G.M., Buysse, D.,…Tasali, E. (2015). Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society on the Recommended Amount of Sleep for a Healthy Adult: Methodology and Discussion. Journal of Clinical Sleep Medicine, 11(8):931-952. doi:10.1176/appi.ajp.158.11.1856.

[3] Colten, H.R., & Altevogt, B.M. (Eds). (2006). Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem.  Institute of Medicine (US) Committee on Sleep Medicine and Research. Washington, DC: National Academies Press (US). doi: https://doi.org/10.17226/11617.

[4] Cappuccio, F.P., D’Elia, L., Strazzullo, P.,&  Miller, M.A. (2010). Sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. Sleep, 33(5):585-592

[5] For this clinical trial, the head-to-head comparison was with the 5 mg form; a 2 mg form of the comparator was not available.

[6] Zisapel, N. (2010). Melatonin and sleep. The Open Neuroendocrinology Journal, 3: 85-95.

[7] Among primary care physicians with a certification in sleep disorders who recommended a brand of modified-release melatonin. Quintiles IMS ProVoice July-September 2017 survey.

REFERENCE/SOURCE

Physician’s Seal® and REMfresh® (www.remfresh.com)

Dr. David C. Brodner, Center for Sinus, Allergy, and Sleep Wellness (http://www.brodnermd.com/sleep-hygiene.html)

Other related articles published in this Open Access Online Scientific Journal include the following:

2017

Ultra-Pure Melatonin Product Helps Maintain Sleep for Up to 7 Hours

Ultra-Pure Melatonin Product Helps Maintain Sleep for Up to 7 Hours

2016

Sleep Science

Genetic link to sleep and mood disorders

https://pharmaceuticalintelligence.com/2016/02/27/genetic-link-to-sleep-and-mood-disorders/

2015

Sleep quality, amyloid and cognitive decline

https://pharmaceuticalintelligence.com/2015/10/31/sleep-quality-amyloid-and-cognitive-decline/

2013

Day and Night Variation in Melatonin Level affects Plasma Membrane Redox System in Red Blood Cells

https://pharmaceuticalintelligence.com/2013/02/23/httpwww-ncbi-nlm-nih-govpubmed22561555/

 

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News Release BIO 2018 Makes History in Boston – Attendees, Sessions and Videos highlights

Reporter: Aviva Lev-Ari, PhD, RN

News Release

 

 

 

1201 Maryland Avenue, SW l Ste. 900 l Washington, D.C. l 20024 l 202-962-9200

 

Web:www.bio.org           Blog:www.biotech-now.org           Twitter: @IAmBiotech

 

 

 

For Immediate Release

Contact:

Theresa Brady

202.997.9034

BIO 2018 Makes History in Boston 

 

In celebration of its 25th anniversary, BIO recognizes progress made

and the transformative innovations yet to come

 

Boston, MA – (June 7, 2018) – The 2018 BIO International Convention (BIO 2018) today wrapped up four days of programming under the theme of “Make History.” Hosted by the Biotechnology Innovation Organization (BIO), BIO 2018 attracted thousands of U.S. and international attendees, celebrated innovations that have shaped the past 25 years and recognized the companies, patient groups, academic centers and investors that continue to advance novel solutions to the world’s toughest challenges.

The Convention drew 18,289 biotechnology industry leaders – the most attendees in the last 10 years – from 49 states, the District of Columbia, Puerto Rico and 67 countries.

 

“This year’s 2018 BIO Convention demonstrated, more than ever, that partnering and collaboration will drive cutting-edge advancements and propel the industry forward,” said Joanne Duncan, President, Membership and Business Operations at BIO. “With 46,916 one-on-one meetings held during the last four days, we know that the knowledge exchange and partnerships forged this week have the potential to transform our world for the better.”

To encourage students to attend BIO and learn more about careers in the biotechnology industry, BIO 2018 included the first Free Student Day. Eligible participants got a one-day Exhibition Access registration and the opportunity to meet with representatives from the biotechnology community. The breadth and depth of offerings and the networking opportunities afforded to thousands of industry stakeholders and students continues to make the Convention the premiere event for the biotechnology industry.

 

BIO 2018 drew companies, academic centers, patient groups, researchers and investors working to advance innovation in key areas such as drug development, brain health, digital health, oncology, opioids, renewable fuels and agriculture. Celebrities also made a presence at BIO, with stories of triumphs over illnesses such as cancer and addiction. Robin Roberts, a cancer survivor and an award-winning journalist, and Rob Reiner, an actor, director and advocate, delivered keynote addresses that emphasized the challenges faced by patients, the importance of patient advocacy and the need for continued innovation to address unmet needs.

 

This year’s International Convention was held with the support of BIO’s state affiliate organization MassBio.

 

“MassBio and our members were thrilled to welcome the world to Massachusetts this week, so they can see firsthand why we’re the state of possible,” said Robert K. Coughlin, President and CEO of MassBio. “From Cambridge to Worcester to Springfield, our state is the hub of biotechnology innovation, and BIO 2018 allowed us to show what’s possible when industry, academia, and government work together as partners to advance patient health worldwide.”

Setting a Guinness World Record for “The Largest Business Partnering Event,” BIO 2018 hosted 46,916 partnering meetings, facilitated by BIO’s One-on-One Partnering™ system— a 13% increase over 2017. These invaluable connections form the foundation of innovative industry collaborations and scientific breakthroughs.

BIO 2018 also included over 1,800 exhibitors, more than a thousand speakers, 180 sessions, 17 plus super sessions and fireside chats and 19 education tracks. Special programming, such as the Start-Up Stadium, also provided a forum for up and coming companies to receive invaluable advice to accelerate their growth and potential.

 

Videos highlights of BIO 2018 can be found here.

The 2019 BIO International Convention will take place in Philadelphia from June 3-6. In 2020, the Convention returns to San Diego for the fourth time from June 8-11.

 

About BIO

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO’s blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

 

###

 

Contacts

Biotechnology Innovation Organization (BIO)

Theresa Brady

202-997.9034

Web: www.bio.org

Blog: www.biotech-now.org

Twitter: @IAmBiotech

SOURCE

From: Colleen Connolly <cconnolly@we-worldwide.com>

Date: Thursday, June 7, 2018 at 5:22 PM

To: Colleen Connolly <cconnolly@we-worldwide.com>

Subject: Press Release: BIO 2018 Makes History in Boston

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Digital Health Breakthrough Business Models, June 5, 2018 @BIOConvention, Boston, BCEC

Reporter: Aviva Lev-Ari, PhD, RN

 

4:30 PM–5:30 PM Jun 5, 2018 Location: 210C

digitalhealth_icon

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Biotechnology Financing, Deal-Making and State of the Industry: Findings from EY Industry Analysis, June 5, 1:45-2:45PM, BIO 2018!, Boston, BCEC

Reporter: Aviva Lev-Ari, PhD, RN

 

1:45 PM–2:45 PMJun 5, 2018

business_icon

Business Development & Finance

Biotechnology Financing, Deal-Making and State of the Industry: Findings from EY Industry Analysis
Speakers
  • Valuation for 23andme?
  • Each pool of capital has different investors been attracted
  • Science is extraordinary
  • A lot of capital and very many tech ventures
  • over supply of capital accelerates the business
  • More capital is better, understanding in what to invest is critical
  • 2015 greatest year of capital availability
  • Venture (private) capital (US and Europe)
  • Life Sciences M&A – New players and abundant Capital
  • Partnering with investors is critical rounds be bigger and faster
  • In 16 years rained $4Billion and expenses $2.5Billion
  • Orphan Drug for rare disease: Genzyme sold for $18Billion – MS drug
  • Immuno-Oncology: Juno and Kite ~$13Billion
  • New Theory  – came at late stage private company, invest again after iPO then gone
  • Investor’s decision if to invest in early stage or come late??

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Personalized Medicine & Diagnostics, June 5, 11-12, BIO 2018! Boston, BCEC

Reporter: Aviva Lev-Ari, PhD, RN

 

11:00 AM–12:00 PM Jun 5, 2018

personalmedicine

Personalized Medicine & Diagnostics

Precision Medicine Coming of Age with Dr. Raju Kucherlapati, Paul C. Cabot Professor of Genetics and Professor of Medicine, Harvard Medical School
  • Ed Abrams, President PMC – 13% of American are adequately informed on Personalized Medicine. Supporting infrastructure, Scientific and public
Speakers
  • Precision Medicine & Personalized Medicine (PM-PM)
  • cloning gene for CF took 10 years
  • 1990 – Human Genome Program – NIH – sequence the entire Human Genome – for improving disease
  • completed in 2000 at $2.5 Billion cost  – NIH
  • Illumina  – second company to sequence CHinese company will be able to sequence Human Genome for $600
  • Physicians were excited about the Human genome sequencing for PM-PM
  • Millenium , Celera,
  • Genetech –  1998 – Receptin – subset of women Breast Cancer over expression of a gene BR
  • Cancer drug 2001 – Reva – Novartis, CML – only patients with good outocme increased from 30% to 98%
  • Gleevac – is a Blockbuster drug – encouraged development of drugs for rare disease
  • Prevention of Disease  – detect at-risk patients, i.e., CF
  • Meryad Genetics acquired a company that developed technology to detect at-risk in multiple genes not one at a time
  • Amniotic fluid carry fetal DNA — Testing developed to detect fetal disorders
  • Detection at pre-natal stages of multiple fetal disorders, abnormality, diagnosis drive treatment – genetic testing critical in cost containment
  • Cardiomayopaty: in Young athlete genetic disorder, other are related to increased age, 100 genes are involved in right side heart enlargement
  • 10% of Lung Cancer Patients responded to treatment in 2004 – genetic based drug is prescribed only to Patient with EGFR – all positively respond
  • Immune therapies initially in melanoma, improvement in progression pre-survival – if free of Cancer over 5 yeras, patient considered ot be cured
  • Mutation burden measures – drug approved based on probability of positive response
  • Reimbursement – CMS – determineat the National level appproved test in Cancers for reimbursement – it was a challenge
  • Database with million of people with genetic and medical information — searches of profile too group patients for optimal drug matching, integration of EMR with DB of genetics – IBM technologies, Google, Amazon, Microsoft – integrate information

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Press Conference: Exosome-based Drug Delivery Systems, June 5, BIO 2018!, Boston, BCEC

Reporter: Aviva Lev-Ari, PhD, RN

10:00 AM–11:00 AM Jun 5, 2018 Room 153B

bio2018-mybio-sessionicon-session

Press Conference: Exosome-based Drug Delivery Systems

ALXERION

2007 IDE for Exosome-based drug delivery system in 2018 in Phase III clinical system

In Argentina – Biobank of Exosomes 35,000  sequensed for new drugs in Partnership with MIT

Speakers
  • PI working with Prof. Edelman
NOT Attended
  • DNA samples can be collected for RNA sequences best conditions in lab are needed
  • EXOKIT Cartilege – personalized exosome-based medicines – drug delivery device & system technology for PM
  • High throughput for screening exosomes for genetic drugs,
  • Conflict among species: Fungus and Bacteria – cross communication
  • incubate samples in invitro conditiond as in nature and the Medium has the entire ecosystem – a sample of – basal conditions technologies
  • intra extra viscicles
  • strong discovery and strong delivery
  • In a month – launch of Cancer new drug, lung, use isolated exosome

 

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Tales from the Translational Frontier – Four Unique Approaches to Turning Novel Biology into Investable Innovations @BIOConvention #BIO2018

Reporter: Aviva Lev-Ari, PhD, RN

translationalresearch
Description

The translational pipeline of medical innovation that flows from academic research centers is at the heart of modern society’s ability to turn the explosion of biological discovery into transformative new medicines. A variety of different models have emerged to overcome the inherent challenges in identifying and advancing biological discoveries to a point where they become investable and can attract private sector partners capable of completing their development, regulatory approval and commercialization. However, most of these models involve academic medical centers, pharma companies and venture investors in the established biotech hubs.
This panel will explore how four distinctive programs that lie outside the flourishing ecosystems of the major biotech centers have been navigating the translational landscape and turning inventions into investable innovations.

Ability Level: All

Session ID: 21200

Tags

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Fireside Chat with James (Jay) Bradner, MD, President, Novartis Institutes for Biomedical Research (NIBR)

Reporter: Aviva Lev-Ari, PhD, RN

 

  • Novartis Publications show vast collaborations with Academia, #1 collaborator of Biotech/Pharma and Academia
  • Publish early and Patent late
  • Social experience, Serial entrepreneur doing research through teams
  • Legendary Disease areas build the larges #chemicalbiology team in the World Killer projects need focus resourced 25 big bets therapeutics lightness RNA splice molecule form rig=dges separating active binders from therapeutic binders small molecule biophysics What drugable means?
  • Computational look up table created with UC Berkeley reactive cyctine mapped
  • #ML finding Drugs? relevant to drug discovery
  • measure phynotype screen relations to molecule – quantify benefits
  • @MIT fatiguability measured
  • #ML – another tool – data screening optimization,

 

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June 4, 2018 – Department of Defense Medical Innovation and Biodefense Forum, BIO 2018! at Boston Convention & Exhibition Center

Announcement

Aviva Lev-Ari, PhD, RN,

https://mybio.org/profile/member/2029564?profile_tabs=profile

Founder and Director of LPBI Group will be in attendance covering the event in REAL TIME

https://pharmaceuticalintelligence.com/2018/05/26/bio-2018-june-4-7-2018-at-boston-convention-exhibition-center/

@pharma_BI

@AVIVA1950

for

#BIO2018

@BIOConvention

  • How DoD can assist Industry to commercialize technologies
  • How the coordination in the Infectious disease takes place
  • Manufacturing for DoD
  • Infrastructure to manage across Government RFP Process
  • Devices requires detailed engineering for use in Field hospitals
  • Regulatory, Scheduling and Engineering problems
  • Development is for all the Forces of the US and for all the Forces of US Allies — design for CIvilian first respnders as well
  • Some partners are commercial Partners, they need to approach DoD with novel product concept
  • FDA approved vs Right to Try – DoD uses both
  • Small business Program, success in bringing product to market
  • 20 years ago: Communities of interest – 20 orgs community common goals in Health Care, rehabilitation after coming home,
  • MROC – Conference in Florida DoD to explain the Public the process of engagement with Do
  • Interagency partnership
  • DoD starts with good ideas, concept studies – innovators
  • Collaborations with Academia, we are available to be approached
  • DoD will partner with small businesses to avoid the Regulatory process  – to save time and resources in the commercialization process
  • How a civilian concept FITS the needs of DoD
  • Sustaining an innovation along the years
  • Need for small business to approach DoD to make the contact
  • Where is a small business in the Development cycle? DoD can help calibrate
  • A System of Systems: Diagnostics drive decisions
  • develop partnerships in consortia
  • Six month to vaccinate 17,000 with a Vaccine for EBOLA
  • DoD of respective countries are collaborating with US DoD
  • Threat environment changes over time vs modify known threats
  • Monoclonal antibody – the Industry developed the manufacturing technology and DoD is user of Industry products
  • All research for the Joint Force, Chemical, Biological,
  • Short time to market solutions are of interest for DoD to identify
  • Military relevance: Key for funding
  • Announcements of DoD on WHAT PROBLEMS DoD tries to solve
  • DoD and HHS — aligned for common solution to avoid redundancy
  • Development of profilaxix is very expensive, DoD budget has competing goals: Next soldier suit,
  • FDA and DoD need to collaborate for DoDs needs
  • Order transaction authority,
  • Congress set aside a budget for small businesses to use accounting systems for Small business to interact with DoD
  • How to get a digital signal to the brain: Expertise in many disciplines: EE, Ethomology
  • Delivery, test , evaluation, develop sensors, IS to manage threats, Diagnostics,
  • How to do Business with Industry?
  • Congress asked for a Consorsium to engage with Industry in a different form than we engaged before
  • Partnerships for out of the box thinking and going quickly – the appetite for is greater then evr before
  • Successful area: Diagnostics – adoptation of existing diagnostics for military applications
  • Platform technologies: Metabolic, Vaccines,
  • Leverage existing technologies to solve DoD concerns
  • involved with MCS help Government to learn how to build their Office
  • Genomic, Proteomics, therapeutics candidates, Prophylaxis as Vaccines
  • In the event of an outbreak: clinicians, 1st responders
Panel 2: Clay Holloway, Director of Strategic Initiatives, Joint Project Manager, Medical Countermeasure Systems (JPM-MCS)
  • Partnering is key
  • capability requirements: broad spectrum capabilities
  • Decision tools to be used at studies for data analysis for decision making
  • Risks in partnership: DoD needs to evaluate ideas for next generation to SKIP one generation
  • How to used different agreement strategically? Streamline DoD Methods
  • Have continuous access to assets

 

LOCATION

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