7 dcembre 2018 Petits signaux par petits signaux Rglementation - - PowerPoint PPT Presentation

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7 d cembre 2018
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7 dcembre 2018 Petits signaux par petits signaux Rglementation - - PowerPoint PPT Presentation

Oct 08, 2023 233 likes •617 views

Diner innovation 7 dcembre 2018 Petits signaux par petits signaux Rglementation Pre-certification FDA Il y a un an, 9 socits slectionnes sur 100 pour un projet pilote de rglementation du software as medical device (SaMD)

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Diner innovation 7 décembre 2018

Petits signaux par petits signaux

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Réglementation

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Pre-certification FDA

  • Il y a un an, 9 sociétés

sélectionnées sur 100 pour un projet pilote de réglementation du software as medical device (SaMD) & du software in a medical device (SiMD) :  Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, Verily

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Jusqu’au Medical device de sous type 6, il n’y a pas de review

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Healthcare everywhere & all the time

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“Timely availability of solutions to patients”

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Passive Health monitoring & timely availabity of solutions for patients!

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L’étude de Moovcare présentée l’ ASCO en 2017: PFS médiane de 7 mois observée avec une App de suivi de patients atteints de NSCLC & SCLC

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Overall survival improvement

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Cost-effectiveness of follow-up

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Biomarqueurs – Capteurs – Data

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Vinod Khosla

  • Créateur de Sun Microsystems
  • Investisseur chez Kleiner,

Perkins

  • Il gère 1,3Mrds,
  • Le guru dit qu’il y a 3 types de

projets:

 Markers  Sensors  Data

  • Un des plus gros investisseurs

dans le domaine de la santé aux US!

  • Il a investi dans Eligo

Bioscience ! (son premier invest en France)

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Markers

  • Proxy biomarkers et markers composite

 Ex: 200 patterns pathologiques peuvent être lus sur un ECG par un Algo et peuvent-être des proxy markers ou combinés à d’autres markers

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Sensors

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Tricorder

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Data

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Flatiron

  • Créée en 2012,
  • 2013 série A 8M$,
  • 2014 série B de 130M$, invest de GV,
  • 2016 série C de 1 000M$
  • 2018 acquisition par Roche 1 900M$
  • En 18 mois ils installent gratuitement leur EMR pour oncologues dans 2500

cliniciens américains, contre consentement à céder les droits d’exploitation de la data

  • Ils constituent une base de 2 000 000 dossier patients: résultats d’analyse +

décision médicale 1 000$ le dossier patient ;)

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  • « In such a critical business situation, the

company is in dire need of utilizing real-world evidence and analytics solutions to fast track its clinical trials. Research suggests that only 3- 5% of clinical trial enrollment yields desired

  • results. The Flatiron platform is able to help

identify the right patient cohorts for almost 15 types of cancer conditions for clinical trials, which can help save developers millions of dollars”

  • “Using that information, it can create virtual

clinical studies to try to see if what happens in randomized trials matches with what happens in the real world. In one study presented earlier this year, for instance, Bristol worked with Flatiron to put together a virtual control group for a single-arm study and a small study with a placebo group testing the company’s drug Opdivo in a rare form of esophageal cancer. The conclusion? The drug may have benefit in that rare disease.”

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Les algo

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IDx : first fully autonomous AI for Dx, FDA approved

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  • Approved and reiumbursed treatment for depression
  • Deprexis = nom de marque
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  • Akili : Créée en 2011, 141M$

levés

  • Secteur: études cliniques et

Diagnostic médical

 ADHD  Autism  Multiple Sclerosis  Major Depressive disorder

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Mais aussi …

  • Opiod addiction!
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En fait, c’est pas qu’un truc de ricain

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LTSM : long term short memory

  • C’est l’agence tout-risque de l’algo, quand la data est en bordel et

impossible à nettoyer, on peut l’utiliser, il a un jeu de data pour s’entrainer et un jeu de data sur lequel il agit. Il fait du sur-mesure à chaque fois.

  • Robot control, Time series prediction, Speech recognition, Rhythm

learning, Music composition, Grammar learning, Handwriting recognition, Human action recognition, Sign Language Translation, Protein Homology Detection, Predicting subcellular localization of proteins, Time series anomaly detection, Several prediction tasks in the area of business process management, Prediction in medical care pathways, Semantic parsing, Object Co-segmentation

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Des nombres

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  • 845 oncologues !
  • 1200 anatomo-cytopathologistes
  • 700 cardiologues rythmologues – 1% de la population

C’est pas mal grand

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Google

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GV – actif depuis 10 ans dans la santé depuis moins…

  • Alector,
  • Aledade
  • Arcus Biosciences *
  • ARMO BioSciences *
  • Arsanis *
  • Aspire Health
  • Autolus *
  • BlackThorn Therapeutics
  • Cambridge Epigenetix
  • Carrick Therapeutics
  • Celsius Therapeutics
  • ClassPass
  • Clear Labs
  • Clover Health
  • Collective Health
  • Compass Therapeutics
  • Decibel Therapeutics
  • Denali Therapeutics *
  • DNAnexus
  • Doctor On Demand
  • Evelo Biosciences
  • Evox Therapeutics
  • FitStar *
  • FLX Bio
  • FogPharma
  • Forty Seven *
  • Freenome
  • Genomics Medicine Ireland
  • Grail
  • Gritstone Oncology
  • Ideaya Biosciences
  • insitro
  • LifeMine Therapeutics
  • Magenta Therapeutics *
  • Metabiota
  • Obsidian Therapeutics
  • Oration *
  • Oscar
  • OWKIN
  • PatientPing
  • Quartet
  • Rani Therapeutics
  • Relay Therapeutics
  • Rise *
  • Rodin Therapeutics
  • Science 37
  • Spero Therapeutics *
  • Spruce Health
  • SQZ Biotech
  • TinyRx
  • Transcriptic
  • Verana Health
  • Viz.ai
  • Wingu *
  • ZappRx
  • Zephyr Health

“While working on my Ph.D. at Stanford, I was exposed to some incredible developments in biotechnology. I’m amazed at how quickly these technologies are coming

  • ut of the lab and into the market. Gene editing, cell

therapy, rapid analysis of genetic data—these advances will help millions of people, and they’re quickly becoming a reality.” — Blake Byers, General Partner at GV

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Avec Duke university & Stanford

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Hal Barron, M.D.

Hal V. Barron, M.D., joined GSK as chief scientific officer and president, R&D on in January 2018. He is a member of the board and the corporate executive team. His previous role was president, R&D at Calico (an Alphabet-backed life sciences company). Prior to this, Hal was executive vice president, head of Global Product Development, and chief medical officer of Roche, responsible for all the products in the combined portfolio of Roche and Genentech. At Genentech, he was senior vice president of Development and chief medical officer. Hal was previously a non- executive director and chair of the Science & Technology Committee at Juno Therapeutics, Inc. He is associate adjunct professor, Epidemiology & Biostatistics, University of California, San Francisco. Hal holds a B.S. degree in Physics from Washington University in St. Louis and a medical degree from Yale University. He completed his training in Cardiology and Internal Medicine at the University of California, San Francisco. He has been issued several patents for his work in thrombosis and angiogenesis and has published more than 90 papers in peer- reviewed scientific journals.

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Dernière slide pour vous convaincre qu’on ne prend peut-être pas assez le digital au sérieux :P