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AI App for People with Digestive Disorders

Reporter: Irina Robu, PhD

Artificial intelligence (AI) constitutes machine learning and deep learning, which allows computers to learn without being clearly programmed every step of the way. The basic principle decrees that AI is machine intelligence leading to the best outcome when given a problem. This sets up AI well for life science applications, which states that AI can be taught to differentiate cells, be used for higher quality imaging techniques, and analysis of genomic data.

Obviously, this type of technology which serves a function and removes the need for explicit programming. It is clear that digital therapeutics will have an essential role in treatment of individuals with gastrointestinal disorders such as IBS. Deep learning is a favorite among the AI facets in biology. The structure of deep learning has its roots in the structure of the human brain which connect to one another through which the data is passed. At each layer, some data is extracted. For example, in cells, one layer may analyze cell membrane, the next some organelle, and so on until the cell can be identified.

A Berlin-based startup,Cara Care uses AI to help people manage their chronic digestive problems and intends to spend the funding raised getting the app in the hands of gastrointestinal patients in the U.S. The company declares its app has already helped up to 400,000 people in Germany and the U.S. manage widespread GI conditions such as reflux, irritable or inflammatory bowel, food intolerances, Crohn’s disease and ulcerative colitis “with a 78.8% treatment success rate.” Cara Care will also use the funding to conduct research and expand collaborations with companies in the pharmaceutical, diagnostics and food-production industries.

SOURCE
https://www.aiin.healthcare/topics/connected-care/ai-app-digestive-disorders-raises-7m?utm_source=newsletter

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The launch of SCAI – Interview with Gérard Biau, director of the Sorbonne Center for Artificial Intelligence (SCAI).

 

Reporter: Aviva Lev-Ari, PhD, RN

Why create a center dedicated to artificial intelligence at Sorbonne University?

Today, artificial intelligence (AI) is everywhere. It is already transforming society and changing our lives. In the context of increasing international competition, the French government launched an ambitious strategy, AI for Humanity, in March 2018 with the goal of propelling France among the leaders of AI. SCAI is fully committed to this program.

Thanks to Sorbonne University’s faculties of Letters, Medicine and Sciences & Engineering, with its partners of the Alliance, has brought together considerable strength in the fundamental aspects of the AI (in mathematics, in computer science, in robotics), its applications (in health, environment or artistic creation) and in digital humanities. In total, more than one hundred experts from many laboratories are directly involved in AI research.

The aim of SCAI is to unite these capabilities in a place where the disciplines can enrich each other, share their experiences and identify common issues to advance innovative projects.

Designed as an “AI house” in the heart of Paris, the center aims to motivate, organize and make visible multidisciplinary research in AI through the establishment of chairs of excellence, support and hospitality, interdisciplinary projects, concerted responses to calls for tenders, the creation of task forces, the setting up of doctoral programs and more.

Internationally recognized experts, such as Jim Kurose, professor emeritus at the University of Massachusetts and advisor to the US government on AI, will bring their expertise to define the strategic directions of the center.

What relationships does the research and training center intend to maintain with the industrial world?

The development of AI, which involves the deployment of technological objects such as the autonomous car, will not happen without the expertise and know-how from companies. It is therefore essential to involve our industrial partners today to focus on an application transformation of AI.

To achieve this goal, we wanted to establish Chairs of Excellence that will allow us to collaborate on innovative themes with the industrial world. A memorandum of understanding has been signed with Thales and Total and a partnership with Atos is being developed on the subject of precision medicine.

In addition, we have signed an agreement with the AP-HP which should enable the exchange of expertise, skills, the setting up of joint projects, the implementation of simplified access to the Health Data Warehouse, the mobility of researchers or students, and communication and awareness actions.

SCAI is also working with international transfer and industrial recovery centers and will be an integral part of Paris Parc, the future innovation park of Sorbonne University.

SCAI:

  • 4 research areas: mathematics-informatics-robotics, health-medicine, climate-environment-Universes and digital humanities
  • More than 100 scientists, 150 doctoral and post-doctoral researchers, 300 students
  • More than 20 industrial partners (from start-ups to large international groups)
  • 700 m² in the heart of Paris
  • 1 satellite center on the Abu Dhabi campus of Sorbonne University

SOURCE

http://www.sorbonne-universite.fr/en/newsroom/actualites/launch-scai


#NYVS19#NewYorkVentureSummit July 9th – 10th, Where #innovation Meets #Capital#startups connect with over 150 #AwesomeVCs& #Angels.http://bit.ly/30E9ci5 $100 off with Discount Code:LPBIVIP

 

From: “Gil Garalnick [FinTrack Venture Summit]” <Gil@youngstartup.com>

Date: Sunday, June 23, 2019 at 11:19 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>, Preston Michaels <preston@youngstartup.com>, Jukka K <jukan_koti@hotmail.com>

Subject: RE: youngStartup Ventures

Hi Aviva–

Pleased to share an updated list of over 120 VCs and Angels already confirmed to speak and judge at the New York Venture Summit (below).

Would it be feasible to share an email update before the end of June? I can send updated copy.

Attached updated social media copy below. Feel free to share with your network. Your network is now entitled to an additional $100 off the current rates ($400 off the on the door rate) using the same discount code (LPBIVIP). They should register as soon as possible to lock in the lowest possible rates.

Twitter

 

#NYVS19#NewYorkVentureSummit July 9th – 10th, Where #innovation Meets #Capital#startups connect with over 150 #AwesomeVCs& #Angels.http://bit.ly/30E9ci5 $100 off with Discount Code:LPBIVIP

 

Where do #startups connect with over 150 #AwesomeVCs& #Angels? #NYVS19#NewYorkVentureSummit July 9-10, Where #innovation Meets #CapitalExtra 10% off early bird rates.http://bit.ly/30E9ci5 $100 off with Discount Code:LPBIVIP

 

Facebook

Leaders in Pharmaceutical Business Intelligence Group invites you to attend #NYVS19#NewYorkVentureSummitJuly 9th – 10th, Where #innovation Meets #Capital#startups connect with over 150 #AwesomeVCs& #Angels. $100 off with Discount Code:LPBIVIP

 

LinkedIn

Leaders in Pharmaceutical Business Intelligence Group invites you to attend #NYVS19#NewYorkVentureSummitJuly 9th – 10th, Where #innovation Meets #Capital#startups connect with over 150 #AwesomeVCs& #Angels. $100 off with Discount Code:LPBIVIP

 

Whether you are an investor seeking access to new early stage deals, or a CEO or Founder of a new venture looking for funding, visibility and growth, #NYVS19is one event you won’t want to miss.

 

Partial list of over 120 VCs and Angels confirmed to speak and judge includes:

Jenny Abramson, Founder & Managing Partner, Rethink Impact | Nick Adams, Managing Partner & Co-Founder, Differential Ventures | Karine Agajanian, Senior Analyst, Anzu Partners | John Albright, Managing Partner, Relay Ventures | Andrew Aldrich, Principal, American Family Ventures | Jay Amarasekera, Senior Technology Manager, SABIC Ventures | Mark Austin, Managing Director, Viridian Capital | Michael Baldwin, Senior Associate, Moderne Ventures | Natalie Bartlett, Investor, General Catalyst | Liza Benson, Partner, Moderne Ventures | Lily Bernicker, Associate, Collaborative Fund | Eric Bielke, Investment Director, GE Ventures | Laura Bock, Investor, QED Investors | Eric Breese, Investment Manager, Evonik Venture Capital | Matt Brennan, Partner, General Catalyst Partners | Joel Brightfield, Principal, SixThirty | Ciara Burnham, Partner, QED Investors | Daniel Burstein, Managing Partner, Millennium Technology Value Partners | Don Burton, Founding & Managing Partner, LearnStart | Jason Cahill, Founder & Managing Director, Carbon Ventures | Alex Carusillo, Venture Associate, OCA Ventures | Benjamin Cukier, Founder, Centana Growth Partners | Soraya Darabi, General Partner, Trail Mix Ventures | Tyler Dean, Investor, Point72 Ventures | Parth Desai, Investor, Flare Capital Partners | Alan Du, Investor, Millennium Technology Value Partners | Tyler Durham, Principal, Schlumberger Ventures | Kenny Estes, Co-Founder & Partner, West Loop Ventures | Dave Fan, Principal, Alumni Ventures Group | Michael Fanfant, Senior Associate, Runa Capital | Matt Fates, Founder & General Partner, Pulse Ventures | Sana Fathima, Investment Manager, Lockheed Martin Ventures | Mark G. Fields, Partner, Alsop Louie Partners | Linda Fingerle, President and Managing Director, Tappan Hill Ventures | Lindsay Fitzgerald, Managing Director, American Express Ventures | Haley Fradkin, Investment Associate, Plum Alley Investments | Daniel Franke, Associate, M Ventures | Ben Freeberg, Senior Associate, Alpha Venture Partners | Kyle Fugere, Head of Ventures, dunnhumby Ventures | Alexander Galitsky, Co-Founder and Managing Partner, Almaz Capital | Anna Garcia, General Partner, Runway Venture Partners | Elaine Gilde, Board Member, New York Angels | Stephen Gilfus, Founder, Blackboard Inc. | Karim Gillani, General Partner, Luge Capital | Samara Gordon, Senior Associate, Hyperplane Venture Capital | Edward Greer, Corporate Technology Scout, Dow Ventures | Amanda Groves, Partner, PLUS Capital | John Gu, Investor, Spring Mountain Capital | Whitney Haring-Smith, Managing Partner, Anzu Partners | Will Hawkins, Senior Associate, Founder Collective | Martin Heidecker, Director, Investment Manager, Boehringer Ingelheim Venture Fund | Cat Hernandez, Partner, Primary Venture Partners | Ann Hickey, Vice President, Town Hall Ventures | Kyle Howard-Johnson, Investor, Catalyst Investors | Vinay Iyengar, Investor, Bessemer Venture Partners | Deborah Jackson, Founder, Plum Alley Investments | Dhruv Jain, Investor, Bessemer Venture Partners | Christina Jenkins, Lead Investor, Portfolia | Del Johnson, Principal, Backstage Capital | Jay Karandikar, Venture Partner, New Crop Capital | Hana Khosla, Investor, Activant Capital | Avery Klemmer, Investor, FirstMark Capital | Jak Knowles, Vice President Venture Investments, Leaps by Bayer | Steve Konsek, Program Director, National Science Foundation | George Krautzel, Managing Partner, MissionOG | Ricky Lai, Senior Associate, Portag3 Ventures | Eddie Lee, Senior Associate, White Star Capital | Oivind Lorentzen, Investor, Oak HC/FT | Marissa Lowman, Head of Education Practice, Village Capital | Bion Ludwig, Partner, Savano Capital Partners | Coppelia Marincovic, Investment Manager, Solvay Ventures | Elizabeth McCluskey, Principal, Impact Engine | Shripal Meghani, Partner, Cleveland Clinic Ventures | Arpesh Mehta, Investment Director, DSM Venturing | Andrée-Lise Méthot, Founder & Managing Partner, Cycle Capital Management | Ed Michael, Co-founder and Managing Partner, LionBird Ventures | Bá Minuzzi, General Partner, BABEL Ventures | Karolina Mrozkova, Associate, White Star Capital | Sonia Nagar, Partner, Pritzker Group Venture Capital | Greg Neufeld, Partner, ValueStream Ventures | Stuart O’Keeffe, Principal, Great Oaks Venture Capital | Jason Palmer, General Partner, New Markets Venture Partners | Victor Pascucci III, Managing Partner, Lightbank | Matt Perlman, Principal, IA Capital Group | Victoria Pettibone, Managing Director, Astia Angels | Daniel Pianko, Partner, University Ventures | Adam Plotkin, Partner, ff Venture Capital | Jean-Noel Poirier, Managing Partner, Clean Energy Venture Group | Greg Pope, Principal, Anzu Partners | Bryan Rabenau, Principal, BP Ventures | Suraj Kumar Rajwani, General Partner, DoubleRock | K.P. Reddy, Founder, Shadow Ventures | Alison Andrews Reyes, General Partner, 1843 Capital | Lisa Rhoads, Managing Director, Easton Capital | Douglas Roth, Managing Director, Connecticut Innovations | Boris Ryabov, Managing Partner, Bright Capital | Ernst Sack, Partner, Blue Bear Capital | Praveen Sahay, Managing Director, WAVE Equity Partners | Zak Schwarzman, Partner, MetaProp | Thomas Seo, Vice President, Citi Ventures | Connie Sheng, Founding Managing Partner, Nautilus Venture Partners | Jaidev Shergill, Managing Partner, Capital One Growth Partners | Zacary Sherman, Associate, Pereg Ventures | Nicole Shimer, Investment Associate, Insight Partners | Bennett Siegel, Investor, Coatue Management | Raj Singh, Managing Partner, JetBlue Technology Ventures | Jean Sini, Angel Investor | Corinne Spears, Associate, University Ventures | Lutz Stoeber, Investment Director, Evonik Venture Capital | Neil Swami, Principal, Catalyst Health Ventures | Erica Van, Associate, Charles River Ventures | Maria Velissaris, Founding Partner, SteelSky Ventures | Patrick Walsh, Director, National Grid Partners | Jamie M. Weston, Managing Director, Spring Mountain Capital | Simon Wu, Principal, Cathay Innovation | Anthony Xu, Partner, New Ground Ventures | Lisa Xu, Investor, FirstMark Capital | Wesley Yiu, Senior Associate, Triphammer Ventures | Chris Young, Partner, Revel Partners | Greg Zaic, General Partner, NMT Capital | Katherine Zamsky, Managing Partner, Carbon Ventures | Stephanie Zepeda, Senior Associate, Arbor Ventures | Lu Zhang, Founder & Managing Partner, Fusion Fund | Chris Zock, Managing Director , Sandbox Insurtech Ventures and many more.

Regards

Gil

 

Gil Garalnick

Associate 

youngStartup Ventures

“Where Innovation Meets Capital”

 

p: 212.202.1002

e: gil@youngstartup.com

u: www.youngstartup.com

 


Retrospect on HistoScanning; an AI routinely used in diagnostic imaging for over a decade

Author and Curator: Dror Nir, PhD

This blog-post is a retrospect on over a decade of doing with HistoScanning; an AI medical-device for imaging-based tissue characterization.

Imaging-based tissue characterization by AI is offering a change in imaging paradigm; enhancing the visual information received when using diagnostic-imaging beyond that which the eye alone can see and at the same time simplifying and increasing the cost-effectiveness of patients clinical pathway.

In the case of HistoScanning, imaging is a combination of 3D-scanning by ultrasound with a real-time application of AI. The HistoScanning AI application comprises fast “patterns recognition” algorithms trained on ultrasound-scans and matched histopathology of cancer patients. It classifies millimetric tissue-volumes by identifying differences in the scattered ultrasound characterizing different mechanical and morphological properties of the different pathologies. A user-friendly interface displays the analysis results on the live ultrasound video image.

Users of AI in diagnostic-imaging of cancer patients expect it to improve their ability to:

  • Detect clinically significant cancer lesions with high sensitivity and specificity
  • Accurately position lesions within an organ
  • Accurately estimate the lesion volume
  • AND; help determine the pre-clinical level of lesion aggressiveness

The last being achieved through real-time guidance of needle biopsy towards the most suspicious locations.

Unlike most technologies that get obsolete as time passes, AI gets better. Availability of more processing power, better storage technologies, and faster memories translate to an ever-growing capacity of machines to learn. Moreover, the human-perception of AI is transforming fast from disbelief at the time HistoScanning was first launched, into total embracement.

During the last decade, 192 systems were put to use at the hands of urologists, radiologists, and gynecologists. Over 200 peer-reviewed, scientific-posters and white-papers were written by HistoScanning users sharing experiences and thoughts. Most of these papers are about HistoScanning for Prostate (PHS) which was launched as a medical-device in 2007. The real-time guided prostate-biopsy application was added to it in late 2013. I have mentioned several  of these papers in blog-posts published in this open-access website, e.g. :

Today’s fundamental challenge in Prostate cancer screening (September 2, 2012)

The unfortunate ending of the Tower of Babel construction project and its effect on modern imaging-based cancer patients’ management (October 22, 2012)

On the road to improve prostate biopsy (February 15, 2013)

Ultrasound-based Screening for Ovarian Cancer (April 28, 2013)

Imaging-Biomarkers; from discovery to validation (September 28, 2014)

For people who are developing AI applications for health-care, retrospect on HistoScanning represents an excellent opportunity to better plan the life cycle of such products and what it would take to bring it to a level of wide adoption by global health systems.

It would require many pages to cover the lessons HistoScanning could teach each and all of us in detail. I will therefore briefly discuss the highlights:

  • Regulations: Clearance for HistoScanning by FDA required a PMA and was not achieved until today. The regulatory process in Europe was similar to that of ultrasound but getting harder in recent years.
  • Safety: During more than a decade and many thousands of procedures, no safety issue was brought up.
  • Learning curve: Many of the reports on HistoScanning conclude that in order to maximize its potential the sonographer must be experienced and well trained with using the system. Amongst else, it became clear that there is a strong correlation between the clinical added value of using HistoScanning and the quality of the ultrasound scan, which is dependant on the sonographer but also, in many cases, on the patient (e.g. his BMI)
  • Patient’s attitude: PMS reviews on HistoScanning shows that patients are generally excited about the opportunity of an AI application being involved in their diagnostic process. It seems to increase their confidence in the validity of the results and there was never a case of refusal to be exposed to the analysis. Also, some of the early adopters of PHS (HistoScanning for prostate) charged their patients privately for the service and patients were happy to accept that although there was no reimbursement of such cost by their health insurance.
  • Adoption by practitioners: To date, PHS did not achieve wide market adoption and users’ feedback on it are mixed, ranging from strong positive recommendation to very negative and dismissive. Close examination of the reasons for such a variety of experiences reveals that most of the reports are relying on small and largely varying samples. The reason for it being the relatively high complexity and cost of clinical trials aiming at measuring its performance. Moreover, without any available standards of assessing AI performance, what is good enough for one user can be totally insufficient for another. Realizing this led to recent efforts by some leading urologists to organize large patients’ registries related to routine-use of PHS.

The most recent peer-reviewed paper on PHS; Evaluation of Prostate HistoScanning as a Method for Targeted Biopsy in Routine Practice. Petr V. Glybochko, Yuriy G. Alyaev, Alexandr V. Amosov, German E. Krupinov, Dror Nir, Mathias Winkler, Timur M. Ganzha, European Urology Focus.

Studies PHS on statistically reasonable number (611) of patients and concluded that “Our study results support supplementing the standard schematic transrectal ultrasound-guided biopsy with a few guided cores harvested using the ultrasound-based prostate HistoScanning true targeting approach in cases for which multiparametric magnetic resonance imaging is not available.”


Novel delivery system in REMfresh mimics the way the body naturally releases and maintains melatonin over a 7-hour period

Real-world evidence confirms previous clinical data on improved sleep duration and sleep quality with REMfresh

Reporter: Gail S. Thornton, M.A.

Chronic disorders of sleep and wakefulness affect an estimated 50-70 million adults in the United States.[i] The cumulative long term effects of sleep loss have been associated with a wide range of damaging health consequences, including obesity, diabetes, impaired glucose tolerance, cardiovascular disease, hypertension, anxiety and depression.[ii]In terms of preventing health consequences, sleeping 6-8 hours per night consistently may provide optimal health outcomes.[iii]

This month, real-world evidence from two recently completed patient-reported outcomes (PRO) studies presented at SLEEP 2019 in San Antonio, Texas, confirms previous clinical data demonstrating statistically significant improvements in sleep onset, sleep duration, sleep maintenance and sleep quality with REMfresh®, the first and only continuous release and absorption melatonin (CRA-Melatonin™). This data supports and reinforces the benefits of REMfresh, which is designed to give patients up to 7 hours of sleep support. PRO studies of this kind, which more closely address real-world patient experience, are increasingly being recognized by regulatory authorities and academia in evaluating new therapies.

The REMfresh Duration Validation (REMVAL) study provides further evidence of a correlative relationship between the 7-hour pharmacokinetic profile observed in the earlier clinical study, REM Absorption Kinetics Trial (REMAKT), and the hypnotic effects of REMfresh, observed in subsequent studies, as demonstrated by improvements in sleep onset, sleep duration, sleep maintenance, sleep quality and patient satisfaction. This latest study further validates the findings of past studies that have been presented and undergone peer review at major sleep conferences:  

  • REMfresh Patient Reported Outcomes DURation (REMDUR), the first, 500-patient, PRO study of this sleep brand, presented at the annual meeting for sleep specialists, SLEEP 2018, which demonstrated that more than 77 percent of patients achieved 6 or more hours of sleep compared to 23.6 percent who slept that duration prior to taking REMfresh (p<.0001)[iv], and
  • REM Absorption Kinetics Trial (REMAKT), a pharmacokinetic study presented at SLEEP 2017 and 2018, which demonstrated that REMfresh mimics the body’s own seven-hour Mesa-Wave® release profile, a natural pattern of melatonin blood levels during a normal night’s sleep cycle.[v] 

An additional PRO subset study, part of REMVAL, called the REMfresh Short Sleep Cohort Assessment (REMSS), assessed improvements in sleep duration and sleep maintenance among 311 patients with morbid or extreme short sleep duration of 4 hours or less.

These two PRO studies (REMVAL and REMSS) were presented at SLEEP 2019, the 33rd Annual Meeting of the Associated Professional Sleep Societies (APSS), which is a joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society, held in San Antonio, Texas, from June 8-12.

“These latest findings provide further confirmation of the potential for nonprescription REMfresh to help address the public health issue of  the cumulative effects of sleep loss,” said David C. Brodner, M.D., a leading sleep specialist who is Double Board-Certified in Otolaryngology — Head and Neck Surgery as well as 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. “Based on a novel Ion Powered Pump® (IPP®) delivery system that provides a pharmacokinetic (PK) profile that more closely aligns with the body’s own natural sleep pattern, REMfresh has demonstrated once again promising results and high levels of satisfaction in a real-world population of patients who have had chronic difficulties sleeping, providing up to seven hours of sleep support,” said Dr. Brodner.

Topline findings of these studies are as follows:

  • The 1,116 patient-reported outcomes (PRO) study, REMfresh Duration Validation (REMVAL), found that after taking 99 percent ultra-pure, continuous release and absorption melatonin (REMfresh®, CRA-melatonin™), the majority (78.8 percent) of patients involved achieved a sleep duration of greater than or equal to 6 hours (p<.0001), while more than 91 percent of patients reported a major/moderate improvement in sleep onset, sleep maintenance and sleep quality (p<.0001).  Of the 30.7 percent of patients (342 in total), who reported never having taken other brands of melatonin, 99.4 percent indicated they were likely or very likely to continue taking CRA-melatonin for their sleep issues (p<.0001).
  • REMVAL provides further real-world evidence of a correlative relationship between the originally observed 7-hour pharmacokinetic profile in the REM Absorption Kinetics Trial (REMAKT) and the strong observed hypnotic effects of CRA-melatonin, as demonstrated by improvements in sleep onset, sleep duration, sleep maintenance and sleep quality.
  • A second PRO subset study, REMfresh Short Sleep Cohort Assessment (REMSS), involving 311 patients who reported sleeping four hours or less nightly from the REMVAL study, found that 95.8 percent of patients who previously experienced daily, morbid short sleep duration of less than or equal to 4 hours reported an improvement in sleep duration (p<.0001), including more than 46 percent who achieved a sleep duration of greater than or equal to 6 hours (p<.0001). More than 93 percent of patients reported a major/moderate improvement in sleep onset, sleep maintenance and sleep quality (p<.0001).
  • REMVAL and REMSS also provides validation of the results from the previously peer-reviewed and presented clinical study, REMAKT, which demonstrated that REMfresh mimics the body’s own 7-hour Mesa Wave®, a natural pattern of melatonin blood levels during a normal night’s sleep cycle and the 500-patient, peer-reviewed and presented  REMfresh® Patient Reported Outcomes DURation (REMDUR) study, that demonstrated statistically significant improvements in sleep onset, sleep maintenance and sleep quality.

REMVAL Study Describes Improvements in Sleep Duration and Sleep Quality

The poster entitled, “Observed Hypnotic Effects with a Continuous-Release Ion Powered Pump Melatonin Delivery System: Self-Reported Patient Outcomes Study Results Demonstrating Improvement in Sleep Duration and Quality,” reported findings provides further real-world evidence of a correlative relationship between the originally observed 7-hour pharmacokinetic profile in the REM Absorption Kinetics Trial (REMAKT) and the strong hypnotic effects of CRA-melatonin observed in subsequent studies and may offer a new low-dose, drug-free alternative to prescription hypnotics to treat chronic sleep disturbances.

The 1,116-patient REMVAL study was designed to obtain clinically relevant information about patients’ past usage of melatonin and non-melatonin sleep aids, sleep patterns prior to taking CRA-melatonin, sleep duration before and after taking CRA-melatonin, frequency of CRA-melatonin usage, improvement in sleep onset, sleep maintenance and sleep quality after taking CRA-melatonin, and overall satisfaction with CRA-melatonin.

In the study, patients with sleep disturbances in the general population received a sample of REMfresh from their physicians and were invited to complete a 13-question online survey. After taking REMfresh, the majority (78.8 percent) of patients achieved a sleep duration of greater than or equal to 6 hours (p<.0001). More than 91 percent of patients reported a major/moderate improvement in sleep onset, sleep maintenance and sleep quality (p<.0001). Of the 30.7 percent of patients (342 in total), who reported never having taken other brands of melatonin, 99.4 percent indicated they were likely or very likely to continue taking REMfresh for their sleep issues (p<.0001).

REMSS Study Shows Improvement in Patients with Chronic, Extreme Short Sleep

The poster entitled, “Improvement in Sleep Duration and Maintenance with Ion Powered Continuous Release and Absorption Melatonin in a Cohort of Patients with Chronic Short Sleep Duration: Results from a Patient-Reported Outcomes Study,” highlighted findings from the REMfresh Short Sleep Cohort Assessment (REMSS), involving a cohort of 311 patients from the REMVAL study who reported sleeping four hours or less nightly. This cohort analysis was designed to obtain clinically relevant information from these patients experiencing morbid short sleep disturbances, including sleep patterns and melatonin usage before taking REMfresh, sleep duration before and after taking REMfresh, improvement in sleep onset, sleep maintenance and sleep quality after taking REMfresh, and overall product satisfaction.

Data from this cohort show that 95.8 percent of patients who previously experienced daily, morbid short sleep duration of less than or equal to 4 hours reported an improvement in sleep duration (p<.0001), including more than 46 percent who achieved a sleep duration of greater than or equal to 6 hours (p<.0001). This increase from less than or equal to 4 hours to greater than or equal to 6 hours represents a major sleep duration upgrade in this group facing morbid sleep disturbances. More than 93 percent of patients reported a major/moderate improvement in sleep onset, sleep maintenance and sleep quality (p<.0001). Ninety-nine percent of the patients suffering with morbid short sleep (27.2 percent of whom had never previously tried a melatonin brand) reported that they were very likely or likely to continue using CRA-melatonin. These results provide real-world evidence that CRA-melatonin with its extended 7-hour pharmacokinetic  plateau time and benign safety-profile may be a practical baseline therapy to improve sleep duration and other key sleep parameters, including, sleep maintenance and sleep quality in this group of patients who have a higher risk of all-cause mortality.[vi]˒[vii]˒[viii]˒[ix]

Statistics & Data Corporation (SDC), a top-tier clinical data services provider, has independently determined that the number of participants in the study provides adequate power (>90%) to detect even small improvements in sleep outcomes. This high power, or probability of seeing statistically significant results if CRA-melatonin is truly working to improve sleep outcomes, applies to the overall study population (REMVAL) as well as the cohort of short sleepers (REMSS). SDC has subsequently independently validated the statistical results achieved, (e.g., p-values and statistical language).

The Increasing Appreciation of PRO Studies to Include Patient Experience 
Increasingly, there is an appreciation by the U.S. Congress, regulatory authorities and academia, of the substantive value that real-world patient experience brings to assessing new therapies. In addition to the traditional randomized, placebo-controlled trial studies, regulatory authorities are now incorporating the patient perspective in their decision making, including PRO studies. A PRO study is a measurement based on a report that comes directly from the patient about the status or change in their health condition and without amendment or interpretation of the patient’s response by health-care intermediaries. PRO measures can be used to capture a patient’s everyday experience outside of the clinician’s office, and the effects of a treatment on the patient’s activities of daily living.[x]˒[xi]Together, clinical measures and PRO measures can provide a fuller picture of patient benefit.

REMAKT Clinical Study Presented at Past Medical Meetings 
Pharmacokinetic data on REMfresh® was peer-reviewed and then presented in 2017 and 2018 at SLEEP, the Annual Meeting of the Associated Professional Sleep Societies LLC (APSS), and a joint meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS). 

The study, REM Absorption Kinetics Trial (REMAKT), was 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). The study found that melatonin levels with REMfresh 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 then had a rapid decline in serum levels that did not allow melatonin levels to be maintained beyond 4 hours. 

Analysis presented at SLEEP 2017 and 2018 showed that REMfresh builds upon the body of evidence from prolonged-release melatonin (PR-M), approved by the European Medicines Agency (EMA) in 2007 as a prescription drug for insomnia, which demonstrated in well-conducted, placebo-controlled studies, statistically significant improvement in sleep quality, morning alertness, sleep onset and quality of life in patients aged 55 years and older compared with placebo.[xv] REMfresh was designed to overcome the challenges of continuous release and 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).[xvi] There was the desirable fast time to reach the sleep threshold level, 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. 

Over 5,000 healthcare practitioners are estimated to have used REMfresh for their patients and about 320,000 patients are estimated to have purchased and used REMfresh. The continuing, rapid acceptance of REMfresh by patients is observable by several markers, including rapid sales growth and availability among major drug retailers.

###

Data Presented at SLEEP 2019 Poster Sessions:

Monday, June 10, 2019, 5:15-7:15pm

  • (Abstract 0398, Poster Board #135) Improvement in Sleep Duration and Maintenance with Ion Powered Continuous Release and Absorption Melatonin in a Cohort of Patients with Chronic Short Sleep Duration: Results from a Patient-Reported Outcomes Study
    • David J. Seiden, M.D., FAASM,  David Brodner, M.D., Syed M. Shah, Ph.D.
  • (Abstract 0399, Poster Board #136) Observed Hypnotic Effects with a Continuous-Release Ion Powered Pump Melatonin Delivery System: Self-Reported Patient Outcomes Study Results Demonstrating Improvement in Sleep Duration and Quality
    • David J. Brodner, M.D., David J. Seiden, M.D. FAASM, Syed M. Shah, Ph.D.

The abstracts are published in an online supplement of the journal, Sleep, which is available at https://sleepmeeting.org/wp-content/uploads/2019/04/SLEEP_42_S1-Website-Final.pdf.

REFERENCES:


[i] 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

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

[iii] Watson, N.F., Badr, M.S., Belenky, G., et al. (2015). Joint Consensus Statement of the American Academy of Sleep  Medicine and Sleep Research Society on the Recommended Amount of Sleep for the Healthy Adult, Methodology and Discussion. Journal of Clinical Sleep Medicine, 11(6); 591-592.

[iv] Seiden,D.J., Brodner, D.C., & Shah, S.M. (2018, June 2-6). Improvement in Sleep Maintenance and Sleep Quality with Ion-Powered Pump Continuous Release and Absorption Melatonin: Results from a Self-Reported Patient Outcomes Study (Abstract #0419). Poster presented at SLEEP 2018, Baltimore, Maryland.

[v] Brodner, D.C., Shah, S.M. (2017, June 3-7). REM Absorption Kinetics Trial: A Randomized, Crossover, Pharmacokinetics Evaluation of a Novel Continuous Release and Absorption Melatonin Formulation versus a Same Strength Immediate-Release Formulation in Healthy Adults (Abstract #0396). Poster presented at: SLEEP 2017, Boston, Massachusetts.

[vi] Knutsen, K.L., Turek,, F.W., Patel, S.R., et al (2006). The u-shaped association between sleep and health: the 2 peaks do not mean the same thing.  Comment on Patel, SR, et al. Sleep, 29(7): 878-879.

[vii] Lubetkin,, E.I., & Haomiao, J. (2018). Burden of disease due to sleep duration and sleep problems in the elderly. Sleep Health, 4; 182-187.

[viii] Hafner M, et al. (2017). Why sleep matters-the economic costs of insufficient sleep: A cross-country comparative analysis, Rand Quarterly.

[ix] Ikehara, S, et al. (2009). Association of Sleep Duration with Mortality  from Cardiovascular Disease and other Causes for Japanese Men and Women: the JACC Study. Sleep, 32(3); 295-301.

[x] U.S. Food and Drug Administration. Real World Evidence. Retrieved from https://www.fda.gov/scienceresearch/specialtopics/realworldevidence/default.htm

[xi] U.S. Food and Drug Administration. 21st Century Cures Act. Retrieved from https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/21stcenturycuresact/default.htm.

[xii] 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

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

[xiv] Watson, N.F., Badr, M.S., Belenky, G., et al. (2015). Joint Consensus Statement of the American Academy of Sleep  Medicine and Sleep Research Society on the Recommended Amount of Sleep for the Healthy Adult, Methodology and Discussion. Journal of Clinical Sleep Medicine, 11(6); 591-592.

[xv] European Medicines Agency.(2007). Assessment Report for CIRCADIN.

[xvi] Brodner, D.C. & Shah, S.M. (2017, June 3-7). A Continuous Release Ion Powered Pump Melatonin Delivery System that Overcomes Challenges of Release and Absorption in the Intestines (Abstract #0385). Poster presented at: SLEEP 2017,  Boston, Massachusetts.

SOURCES:

https://finance.yahoo.com/news/significant-real-world-evidence-confirms-123000247.html

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:

2018

https://pharmaceuticalintelligence.com/2018/06/10/patient-reported-outcomes-study-presented-at-sleep-2018-provides-confirmatory-real-world-evidence-of-the-previously-presented-7-hour-action-of-remfresh-the-first-continuous-release-and-absorp/

2017

https://pharmaceuticalintelligence.com/2017/10/02/2017-nobel-prize-in-physiology-or-medicine-jointly-to-jeffrey-c-hall-michael-rosbash-and-michael-w-young-for-their-discoveries-of-molecular-mechanisms-controlling-the-circadian-rhythm/

https://pharmaceuticalintelligence.com/2017/06/11/ultra-pure-melatonin-product-helps-maintain-sleep-for-up-to-7-hours/

2016

https://pharmaceuticalintelligence.com/2016/03/16/sleep-science/

2013

https://pharmaceuticalintelligence.com/2013/03/09/melatonin-and-its-effect-on-acetylcholinesterase-activity-in-erythrocytes/


Pfizer buys out Array BioPharma for $11.4 Billion to beef up its oncology offerings

Reporter: Stephen J. Williams, PhD

As reported in FiercePharma.com:

by Angus Liu |

Three years after purchasing Medivation for $14.3 billion, Pfizer is back with another hefty M&A deal. And once again, it’s betting on oncology.

In the first big M&A deal under new CEO Albert Bourla, Pfizer has agreed to buy oncology specialist Array BioPharma for a total value of about $11.4 billion, the two companies unveiled Monday. The $48-per-share offer represents a premium of about 62% to Array stock’s closing price on Friday.

With the acquisition, Pfizer will beef up its oncology offerings with two marketed drugs, MEK inhibitor Mektovi and BRAF inhibitor Braftovi, which are approved as a combo treatment for melanoma and recently turned up positive results in colon cancer.

The buy will enhance the Pfizer innovative drug business’ “long-term growth trajectory,” Bourla said in a Monday statement, dubbing Mektovi-Braftovi “a potentially industry-leading franchise for colorectal cancer.”

RELATED: Array’s ‘extremely compelling’ new colon cancer data spark blockbuster talk

In a recent interim analysis of a trial in BRAF-mutant metastatic colorectal cancer, the pair, used in tandem with Eli Lilly and Merck KGaA’s Erbitux, produced a benefit in 26% of patients, versus the 2% that chemotherapy helped. The combo also showed it could reduce the risk of death by 48%. SVB Leerink analysts at that time called the data “extremely compelling.”

Right now, one in every three new patients with mutated metastatic melanoma is getting the combo, despite its third-to-market behind combos from Roche and Novartis, Andy Schmeltz, Pfizer’s oncology global president, said during an investor briefing on Monday.

It is being studied in more than 30 clinical studies across several solid tumor indications. Moving forward, Pfizer believes the combo could potentially be used in the adjuvant setting to prevent tumor recurrence after surgery, Pfizer’s chief scientific officer, Mikael Dolsten, said on the call. The company is also keen to know how it could be paired up with Pfizer’s own investigational PD-1, he said, as the combo is already in studies with other PD-1/L1s.

But as Pfizer execs have previously said, the company’s current business development strategy no longer centers on adding revenues “now or soon,” but rather on strengthening Pfizer’s pipeline with earlier-stage assets. And Array can help there, too.

“We are very excited by Array’s impressive track record of successfully discovering and developing innovative small-molecules and targeted cancer therapies,” Dolsten said in a statement.

On top of Mektovi and Braftovi, Array has a long list of out-licensed drugs that could generate big royalties over time. For example, Vitrakvi, the first drug to get an initial FDA approval in tumors with a particular molecular feature regardless of their location, was initially licensed to Loxo Oncology—which was itself snapped up by Eli Lilly for $8 billion—but was taken over by pipeline-hungry Bayer. There are other drugs licensed to the likes of AstraZeneca, Roche, Celgene, Ono Pharmaceutical and Seattle Genetics, among others.

Those drugs are also a manifestation of Array’s strong research capabilities. To keep those Array scientists doing what they do best, Pfizer is keeping a 100-person team in Colorado as a standalone research unit alongside Pfizer’s existing hubs, Schmeltz said.

Pfizer is counting on Array to augment its leadership in breast cancer, an area championed by Ibrance, and prostate cancer, the pharma giant markets Astellas-partnered Xtandi. For 2018, revenues from the Pfizer oncology portfolio jumped to $7.20 billion—up from $6.06 billion in 2017—mainly thanks to those two drugs.

Source: https://www.fiercepharma.com/pharma/pfizer-never-say-never-m-a-buys-oncology-innovator-array-for-11-4b

 

About Array BioPharma

Array markets BRAFTOVI® (encorafenib) capsules in combination with MEKTOVI® (binimetinib)  tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K  mutation in the United States and with partners in other major worldwide markets.* Array’s lead clinical programs, encorafenib and binimetinib, are being investigated in over 30 clinical trials across a number of solid tumor indications, including a Phase 3 trial in BRAF-mutant metastatic colorectal cancer. Array’s pipeline includes several additional programs being advanced by Array or current license-holders, including the following programs currently in registration trials: selumetinib (partnered with AstraZeneca), LOXO-292 (partnered with Eli Lilly), ipatasertib (partnered with Genentech), tucatinib (partnered with Seattle Genetics) and ARRY-797. Vitrakvi® (larotrectinib, partnered with Bayer AG) is approved in the United States and Ganovo® (danoprevir, partnered with Roche) is approved in China.

 

Other Articles of Note of Pfizer Merger and Acquisition deals on this Open Access Journal Include:

From Thalidomide to Revlimid: Celgene to Bristol Myers to possibly Pfizer; A Curation of Deals, Discovery and the State of Pharma

Pfizer Near Allergan Buyout Deal But Will Fed Allow It?

Pfizer offers legal guarantees over AstraZeneca bid

Re-Creation of the Big Pharma Model via Transformational Deals for Accelerating Innovations: Licensing vs In-house inventions


Tweets, Pictures and Retweets at 18th Annual Cancer Research Symposium – Machine Learning and Cancer, June 14, 2019, MIT by @pharma_BI and @AVIVA1950 for #KIsymposium PharmaceuticalIntelligence.com and Social Media

 

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eProceedings 18th Symposium 2019 covered in Amazing event, Keynote best talks @avivregev ’er @reginabarzelay

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