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Tweets HIGHLIGHTS from 11th US-India BioPharma & Healthcare Summit, Thursday, May 18, 2017, Boston Marriott Cambridge

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@pharma_BI @AVIVA1950 @USAIC #USAIC17 Dr. James Bradner, Novartis, active in CRISPR, technology from outside invited in

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May 18

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@pharma_BI @AVIVA1950 @USAIC #USAIC17 Dr. William Chin, Executive Vice President and CMO, PhRMA HOW to reduce Failure in Trials??

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Aviva Lev-Ari @AVIVA1950

@pharma_BI @AVIVA1950 @USAIC #USAIC17 Dr. Michael Rosenblatt, CMO, Flagship Pioneering, Right to TRY, does that exist in India?

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@pharma_BI @AVIVA1950 @USAIC #USAIC17 Dr. Richard Moscicki, USFDA Frequensist Analysis at FDA, Precision medicine requires Bayesian approach

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Aviva Lev-Ari @AVIVA1950

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May 18

Aviva Lev-Ari @AVIVA1950

@pharma_BI @AVIVA1950 @USAIC #USAIC17 Panel on Vaccines – How do we make Vaccines more affordable for Populations, oral and stable

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several companies are chasing ONE molecule, the same one

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Vaccines Dr. Stephen Caddick, Wellcome Trust, use vaccine to mitigate bacterial resistance

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Panel on Vaccines – How do we make Vaccines more affordable for Populations, oral and stable

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We start NOW LIVE REAL TIME – 11th US-India BioPharma & Healthcare Summit, 5/18 Marriott Cambridge

Vaccines Dr. Stephen Caddick, Wellcome Trust, use vaccine to mitigate bacterial resistance

Panel on Vaccines – How do we make Vaccines more affordable for Populations, oral and stable

LIVE – 11th US-India BioPharma & Healthcare Summit, Thursday, May 18, 2017, Boston Marriott Cambridge, 50 Broadway,…

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LIVE 11th US-India BioPharma & Healthcare Summit, Thursday, May 18, 2017, Boston Marriott Cambridge, 50 Broadway, Cambridge

Aviva Lev-Ari, PhD, RN at LPBI Group will cover the event in Real Time

@pharma_BI

@AVIVA1950

@USAIC

11th US-India BioPharma & Healthcare Summit, Thursday, May 18, 2017, Boston Marriott Cambridge, 50 Broadway, Cambridge

BioPharma & Healthcare Summit 2017

Emcee – Dr. Andrew Plump, Chief Medical & Scientific Officer, Takeda

* Speakers and Timings subject to change

Time Topic
8-45 AM – 9-15 AM Registration and Networking
9-15 AM – 9-30 AM Welcome address by Karun Rishi, President, USA-India Chamber of Commerce

Opening comments by – Dr Andrew Plump, Chief Medical & Scientific Officer, Member of the Board of Directors, Takeda Pharmaceuticals

  1. Value and Access in Healthcare vs Innovations, Patients,
  2. Value in HealthCare is relative to time and location
  3. massive underserved population
  4. Access: whoever Patients are and whereever they are
  5. In India 1.3 Billion people, 70% of World population and HealthCare spending is 1% of World cost of HealthCare – need for investment ans development of infrastructure
9-30 AM – 9-55 AM India Regulatory and Clinical Research Update*
Dr. R.K. Vats , IAS, Additional Secretary, Ministry of Health and Family Welfare, Government of India
9-55 AM – 10-45 AM Panel Discussion: Oncology

  1. Immunotherapy – Tumor cells, necrosis, mutation, Response to T-Cell therapy and Tumor shrinkage
  2. What is the mechanism to enable Oncology drugs in China and India
  3. Oncology Drug are two expensive
  4. Melanoma gets best response to PD-1
  5. We might not have found the right Checkpoint molecule, new agonist therapies, new antigens
  6. Oncolytic Viruses – for tumors that do not respond to immuno therapy
  7. Combination therapy, increase in Toxicity
  8. Toxicity – Cerebral edema during clinical trials of immunotherapy
  9. Upregulation and Downregulation dependent on dosing in immuno-therapy

Panelists:

  • Dr. Edward Benz, President & CEO Emeritus, Dana Farber Cancer Institute
    1. Durable response, immuno-suppression, biological role in tumor surveillence, Checkpoint opens up the use of vaccines
    2. Block of 50 molecules
    3. How can we learn more on the Translational and Clinical level – getting smarter – HOW
    4. Screening Patients: Immuno-phynotyping, predicting markers,
  • Dr. Rakesh Jain, E.L. Steele Laboratory of Tumor Biology,  MGH Cancer Center/ Harvard Medical School
  • Dr. Timothy Clackson, President R&D and CSO, Ariad Pharmaceuticals
  • Dr. Chandru, Chairman, Strand Life Sciences
  1. Licensing HepC will be very important
  • Dr. Jeffrey Engelman, Global Head of Oncology Research, Novartis Institutes for BioMedical Research
  1. PD-1 is $50,000 a year therapy, In India affordable pricing
  2. Collaboration: PACK –  few companies and Academic – focus on immunotherapy,
  3. Foundation Medicine biomarkers Platform
  4. What is the mutation burden which will predict the response to PD-1

 

Moderator:
Dr. Vijay Kuchroo, Director- Evergrande Center for Immunologic Diseases, Brigham & Women’s Hospital/ Harvard Medical School

10-45 AM – 11-15 AM *Fireside Chat on Govnt’t Agency, Advocacy Groups, Big Phara, NIH, FDA

  • Dr. Richard Moscicki, ex-Genzyme, Deputy Director (Science Operations), Center for Drug Evaluation and Research, USFDA and
  1. Since 2004, 40 Public-Private Partnerships, relationships with NIH
  2. External relationships, where are the Scientists going,
  3. Toxicology, Biomarkers, Lexicon,
  • Dr. Chris Austin, Director, National Center for Advancing Translational Sciences, NIH
  1. Academic and Biotech companies relations: Toxicity testing, new clinical trial design, increase efficiency
  2. Knowledge of disease increased vastly
  3. HealthCare not at the same rate
  4. Rare disease tested on 5,000 patients, Genomics combinatories
  5. Clinical Trial Templets: FDA & NIH working together on
  6. FDA & DARPA – Tissue engineering
  7. mainatin Statistical Robustness yet change the process
  • Dr. R.K. Vats , IAS, Additional Secretary, Ministry of Health and Family Welfare, Government of India

 

  • Moderator:
    Dr. William Chin, Executive Vice President and Chief Medical Officer, PhRMA
  1. Efficiency of Clinical Trial needs improvement
  2. Gene therapy in US: Interaction between NIH and FDA – how is it going
11-15 AM -11-45 AM Networking & Tea Break
11-45 AM – 12-35 PM Panel Discussion: Vaccines

Panelists:

  • Dr. Stephen Caddick, Director of Innovation, Wellcome Trust
  1. management health in decline
  2. scientific complexity
  3. Science, Technology and Understanding Human Behavior neede NOT to fail society
  • Dr. Johan Van Hoof, Global Therapeutic Head- Infectious Diseases & Vaccines, Janssen Pharmaceutical Companies of Johnson & Johnson
  • Dr. Gagandeep Kang, Executive Director, Translational Health Science & Technology Institute (THISTI)
  1. Clinical Trial Design in India, integrated IRB system for evaluation
  • Michael Nally, President, Merck Vaccines, Merck & Co.
  • Dr. Niranjan Sardesai, Chief Operating Officer, Inovio Pharmaceuticals

Moderator:
Dr. William Chin, Executive Vice President and Chief Medical Officer, PhRMA

  1. Necessary expertise on emerging infectious agents
  2. Affordability of Vaccine
  3. More discussion needed on Vaccines
12-35 PM – 1-05 PM Fireside Chat with

  • Sanat Chattopadhyay, President, Merck Manufacturing Division, Merck & Co.;
  • Dr. R. K. Vats, IAS, Additional Secretary, Ministry of Health and Family Welfare, Government of India; Alok Kumar, Advisor, Niti Aayog*

Moderator:
Dr. Amrit Ray, Chief Medical Officer, Janssen Pharmaceutical Companies of Johnson & Johnson

1-05 PM – 2-40 PM Luncheon Panel Discussion: Clinical Trials & Regulatory

Panelists:

    • Dr. Richard Moscicki, Deputy Director (Science Operations), CDER, USFDA
    • Dr. Petra Kaufmann, Director, Office of Rare Diseases Research & Director, Division of Clinical Innovations – NCATS, NIH
    • Dr. G.N. Singh, Drug Controller General of India, Central Drugs Standard Control Organization, Ministry of Health
    • K.V. Subramaniam, President, Reliance Life Sciences
  • Dr. William Chin, Executive Vice President and Chief Medical Officer, PhRMA
  1. Patient’s Compliance, control investigation
  2. Value to Patient, what value do they ask for

Moderator:
Dr. Michael Rosenblatt, Chief Medical Officer, Flagship Pioneering

2-40 PM – 3-15 PM Networking & Tea Break
3-15 PM – 4-05 PM Panel Discussion: Rare & Neglected Diseases

Panelists:

  • Dr. Chris Austin, Director, National Center for Advancing Translational Sciences, National Institutes of Health
  • Dr. Jim Burns, President and CEO, Casebia Therapeutics
  • Dr David Meeker, Executive Vice President & Head, Sanofi Genzyme
  • Dr. Wim Parys, Head of R&D- Global Public Health, Janssen Pharmaceutical companies of Johnson & Johnson
  • Dr. Alfred Sandrock, Executive Vice President & Chief Medical Officer, Biogen

Moderator:
Dr. Steve Uden, Head of Research, Alexion Pharmaceuticals

4-05 PM – 4-55 PM Panel Discussion: Drug Discovery and Development

Panelists:

  • Dr. James Bradner, President, Novartis Institutes for BioMedical Research
  • Dr. William Hait, Global Head- Research & Development, Janssen Pharmaceutical Companies of Johnson & Johnson
  • Dr Andrew Plump, Chief Medical & Scientific Officer and Director, Takeda Pharmaceuticals
  1. Clinical Partnerships important, last molecule developed in house in 1999, Partnershiip in Stem Cells, development for Ciliac disease
  • Dr. David Nicholson, Chief R&D Officer, Allergan
  1. R&D is small Intell Group to identify opportunities is large, 2,500

Moderator:
Dr. Martin Mackay, Executive Vice President and Global Head of R&D, Alexion Pharmaceuticals

4-55 PM – 5-00 PM Closing Remarks
5-00 PM – 6-30 PM Cocktails & Networking Reception

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Tweets by @pharma_BI and @AVIVA1950 at World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017, BOSTON, MA

Curator: Aviva Lev-Ari, PhD, RN

 

@pharma_BI

@AVIVA1950

 

All 57 RETWEETS by  World Forum from LPBI’s Twitter.com handles

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@AVIVA1950

 

https://twitter.com/PartnersWMIF

  

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI #WMIF17 @AVIVA1950 Medical Devices – Prevention methods, Big data , AI, Heart Failure a role for Government like “CVD Moonshot”

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI @AVIVA1950 #WMIF17 a working artificial heart is more needed than another stent, personalized sensors (diagnostics) reimbursment

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@pharma_BI @AVIVA1950 #WMIF17 Monetizing Diagnostics is key no reimbursement for regenerative medicine, biological system vs physical system

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI #WMIF17 Bruce Rosengard: Crowd sourcing future mechanism for funding innovations vs ROI funding, Partnerships Academia/Industry

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@pharma_BI @AVIVA1950 #WMIF17 E. Edelman: Ideas start in Academia, Residential teaching is eroding, Industry needs assuming role of Academia

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI #WMIF17 Ronald Tompkins, MD: Regulatory FDA/Bureaucracy needs be non-adversarial relations with Hospitals or Academia or industry

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI @AVIVA1950 #WMIF17 Timothy Ring, CEO, Bard: corporate controlled fund for acquisions rely on Start up community for acquisitions

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI, #WMIF17 Michael Mussallem CEO, Edwards Lifesciences Selling services – heart-lung machine: Perfusion is a product and Service

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI #WMIF17 Lewis Sandy, MD UnitedHealth 30% of care cost is WASTE, eliminate!! Collaborations Pharma Devices: Data Analytics KEY

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI #WMIF17 @AVIVA1950 Jagmeet Singh, MGH Genetic profiling for early detection, Going upstream for the Genetics and the Prevention

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI #WMIF17 Omar Ishrak, PhD CEO, Medtronic Innovations are the essence of Medical Devices development as mission in technology

 

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@Pharma_BI #WMIF17 Omar Ishrak, CEO, Medtronic Training Challenge Surgical Robotic patient comfort of minimal invasive therapy, cost lower

 

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@Pharma_BI #WMIF17 Omar Ishrak, CEO, Medtronic Mitral Valve – platform for new generation of diagnostics ETERNAL: recover fast outcome

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI #WMIF17 Marc Semigran Myokardia Preclinical trials for early insights for Younger patient with cardiomiopaty and older patient

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI #WMIF17 Makoto Suematsu initiative on Dementia, cases of +100 y-o without functional decline in Japan

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI #WMIF17 @AVIVA1950 Makoto Suematsu, collaboration with NIH, Beyond the Border Masanori Aikawa AGING disease indication is novel

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI #WMIF17 Innovations from Japan leveraged in a global corporation, Bayer, Academia and Industry Partnership investment from Bayer

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI #WMIF17 @AVIVA1950 Makoto Suematsu, Pharma’s difficulty to data access the clinical data from Academic Hospitals, gov’t IT invest

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI #WMIF17 Carsten Brunn, Bayer Osaka Innovation Center to facilitate Translational results transfer to Pharma, stem cell initiative

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI @AVIVA1950 #WMIF17 Hiroyuki Kawabata rate of CVD and HTN increased in Japan with aging population, national goal decrease BP

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI @AVIVA1950 #WMIF17 Benjamin Scirica, FDA requires PRAGMATIC TRIAL DESIGN, IDENTIFY DIFFERENT POPULATION FOR EXISTING DRUGS,

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI #WMIF17 Rowe of Edwards Mitral Valve Trans catheter is the direction PATIENT ACCESS – who will benefit devices Improve Patient

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@pharma_BI @AVIVA1950 #WMIF17 Cost of failure for AD at Eli Lilly, reduce failure rate, hedge bets to cut losses, investment may be deadend

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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#WMIF17 @Pharma_BI @AVIVA1950 Offset AD prevent vs delay age of onsett is desirable, Pharma spend $70Billion on R&D, most is D NIH is R

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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#WMIF17 @pharma_BI, @AVIVA1950, Increase Research at Eli Lilly CEO, medicine will bring value, can’t apologies for drug failure, best time

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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#WMIF17 @Pharma_BI @AVIVA1950 Stanley Shaw, MD, PhD Realization by physicians that monitoring Patients @Home is a TIME SAVER – tech adopted

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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#WMIF17 @pharma_BI Stanley Shaw Trusted Sources for Sharing genetic information with Academic Centers: Verily, AstraZeneca, AHA partnership

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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#WMIF17 @pharma_BI @AVIVA1950 Jonathan Rennert: histories of ECG before cardiac arrest: instruct do not drive, do not be alone at home

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#WMIF17 @pharma_Bi @AVIVA1950 Joe Kvedar, MD Implement technology for quality care, access and lower cost monitoring Patients while @Home

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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#WMIF17 @Pharma_BI @AVIVA1950 Robert Bradway CEO, Amgen Value of innovation at a price that allows access and lowering cost of care

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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#WMIF17 @Pharma_BI @AVIVA1950 Robert Bradway CEO, Amgen Cardiologist prescribed the medication for himself 6 month for insurance approval

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@pharma_BI @AVIVA1950 #WMIF17 Norman Stockbridge, MD, PhD Director, Division of CV and Renal Products, FDA: Preserve randomization is key

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@pharma_BI @AVIVA1950 #WMIF17 Elisabeth Björk, AstraZeneca asked Norman Stockbridge, FDA – pragmatic design avoid missing data is 12%

 

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@pharma_BI @AVIVA1950 #WMIF17 Scott Wasserman, Amgen, AI will become part of Clinical Trial Design for investigational therapies and others

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@pharma_BI @AVIVA1950 #WMIF17 Dean Li, Merck, Arrhythmia: Mutation if down played causes Arrhythmia if Overexpressed causes Arrhythmia

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@pharma_BI @AVIVA1950 #WMIF17 Sean Harper, MD, Amgen in CVD complex traits phynotype more determinative then genotyping vs Oncology,

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@pharma_BI @AVIVA1950 #WMIF17 Sean Harper, MD, Amgen Sean Harper, MD Investors:to Biotech – works on Oncology and on Orphan drugs

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@pharma_BI @AVIVA1950 #WMIF17 Jean-François Formela, MD Coolest technology: CRISPR one injection reduction of effects in a genetic disease

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@pharma_BI @AVIVA1950 #WMIF17 Highlights – LIVE Day 2: World Medical Innovation Forum – https://pharmaceuticalintelligence.com/2017/05/02/highlights-live-day-2-world-medical-innovation-forum-cardiovascular-%e2%80%a2-may-1-3-2017-boston-ma-%e2%80%a2-united-states/ … via @Pharma_BI

 

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@pharma_BI @AVIVA1950 #WMIF17 Ecosystem: Products, Patient Advocacy Groups and Regulators –alignment interaction among agencies: NIH, FDA

 

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Aviva Lev-Ari‏ @AVIVA1950  16h16 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Investment in Devices looks better vs CVD Drugs, Biologics are different, Nurtaceuticals some are harmful

 

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Aviva Lev-Ari‏ @AVIVA1950  16h16 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Robert Califf, Precision Medicine is over inflated except in Oncology, “in CVD, I wish to hear from you”

 

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Aviva Lev-Ari‏ @AVIVA1950  15h15 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Jessica Mega CMO Verily, Real Time monitoring, each Patient has own Portal, monitoring takes major resources

 

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@pharma_BI @AVIVA1950 #WMIF17 Michael Mahoney: Challenges in Emerging Markets: China more regulation India – price very low expensive stent

 

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Aviva Lev-Ari‏ @AVIVA1950  15h15 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Microelectronics new direction: Endoscopy GI Pulmonary,SPINAL CORD STIMULATION: GU GI (Crohn),Neuromodulation

 

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Aviva Lev-Ari‏ @AVIVA1950  14h14 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Aarif Khakoo, MD Amgen 1,500,000 stroke Genetics will bring the breakthrough to atherosclerosis

 

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@pharma_BI @AVIVA1950 #WMIF17 Craig Sponseller, Is triglycerides the right focus, Macrophage activation to prevent pathways resistance

 

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@pharma_BI @AVIVA1950 #WMIF17 Aarif Khakoo, MD Amgen Cost is related to FAIL less – target selection is cardinal

 

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Aviva Lev-Ari‏ @AVIVA1950  14h14 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Clive Meanwell, Phase III needs different questions and more Phase IV needed

 

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Aviva Lev-Ari‏ @AVIVA1950  14h14 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Campbell Rogers, MD Clinical burden remains: Value for Patient economic value of the outcome of the

 

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@pharma_BI @AVIVA1950 #WMIF17 Campbell Rogers, MD Imaging Efficiency free cost Plaque composition Coronary CT flow implication of stenosis

 

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@pharma_BI @AVIVA1950 #WMIF17 Craig Sponseller, MD Pragmatic Clinical Trial Design: Novel Targets, collaboration of Academia and Industry

 

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Aviva Lev-Ari‏ @AVIVA1950  13h13 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Gary Gibbons Reinvent Longitudinal Cohort Studies & Genomics sequencing – Concepts of Data Commons Analytics

 

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@pharma_BI @AVIVA1950 #WMIF17 Gary Gibbons 20% investigators take up 50% of the grants squeezing out the bandwidth need younger generation

 

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@pharma_BI @AVIVA1950 #WMIF17 Gary Gibbons, MD Pragmatic optimist in this position, scientists innovate for Patients would do it again

 

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Aviva Lev-Ari‏ @AVIVA1950  11h11 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR https://pharmaceuticalintelligence.com/2017/05/03/highlights-live-day-3-world-medical-innovation-forum-cardiovascular-%e2%80%a2-may-1-3-2017-boston-ma-%e2%80%a2-united-states/ … via @Pharma_BI

 

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@pharma_BI @AVIVA1950 #WMIF17 Disruptive Dozen 1. Quantitative Molecular Imaging for Cardiovascular Phynotypes

 

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  1. Aviva Lev-Ari‏ @AVIVA19503h3 hours ago

 

@pharma_BI @AVIVA1950 #WMIF17 Disruptive Dozen 2. Harnessing Big Data and Deep Learning for Clinical Decision Support

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@pharma_BI‏ @Pharma_BI  3h3 hours ago

 

Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

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  1. Aviva Lev-Ari‏ @AVIVA19503h3 hours ago

Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA •… https://pharmaceuticalintelligence.com/2017/05/03/highlights-live-day-3-world-medical-innovation-forum-cardiovascular-%e2%80%a2-may-1-3-2017-boston-ma-%e2%80%a2-united-states/ … via @Pharma_BI

 

Aviva Lev-Ari‏ @AVIVA1950  22h22 hours ago

 

Highlights – LIVE Day 2: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA… https://pharmaceuticalintelligence.com/2017/05/02/highlights-live-day-2-world-medical-innovation-forum-cardiovascular-%e2%80%a2-may-1-3-2017-boston-ma-%e2%80%a2-united-states/ … via @Pharma_BI

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  1. Aviva Lev-Ari‏ @AVIVA1950May 2

 

#WMIF17 @Pharma_BI @AVIVA Frans van Houten CEO, Philips eICU -measure evolution to forcast 6 hours a deterioration reduction 40% of death

 

  1. Aviva Lev-Ari‏ @AVIVA1950May 2

 

#WMIF @pharma_BI @AVIVA1950 Robert Bradway Future at Amgen: Coming drug is Pharmcogenetics for atherosclerosis

LikeAviva Lev-Ari‏ @AVIVA1950  May 2

 

Robert Bradway CEO, Amgen Pay for benefit, for outcome, no pay if med does not do what it was supposed to do – REFUND patients poor outcome

 

  1. Aviva Lev-Ari‏ @AVIVA1950May 2

 

#WMIF17 @Pharma_BI @AVIVA1950 Robert Bradway CEO, Amgen Cardiologist prescribed the medication for himself 6 month for insurance approval

 

  1. Aviva Lev-Ari‏ @AVIVA1950May 2

 

#WMIF17 @Pharma_BI @AVIVA1950 Robert Bradway CEO, Amgen Value of innovation at a price that allows access and lowering cost of care

 

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#WMIF17 @pharma_Bi @AVIVA1950 Joe Kvedar, MD Implement technology for quality care, access and lower cost monitoring Patients while @Home

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#WMIF17 @pharma_BI @AVIVA1950 Jonathan Rennert: histories of ECG before cardiac arrest: instruct do not drive, do not be alone at home

 

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#WMIF17 @pharma_BI Stanley Shaw Trusted Sources for Sharing genetic information with Academic Centers: Verily, AstraZeneca, AHA partnership

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  1. Aviva Lev-Ari‏ @AVIVA1950 May 2

 

#WMIF17 @Pharma_BI @AVIVA1950 Stanley Shaw, MD, PhD Realization by physicians that monitoring Patients @Home is a TIME SAVER – tech adopted

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  1. Aviva Lev-Ari‏ @AVIVA1950 May 2

 

#WMIF17 @pharma_BI, @AVIVA1950, Increase Research at Eli Lilly CEO, medicine will bring value, can’t apologies for drug failure, best time

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#WMIF17 @Pharma_BI @AVIVA1950 Offset AD prevent vs delay age of onsett is desirable, Pharma spend $70Billion on R&D, most is D NIH is R

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Aviva Lev-Ari‏ @AVIVA1950  May 1

Highlights of LIVE Day 1: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, M… https://pharmaceuticalintelligence.com/2017/05/01/highlights-of-live-day-1-world-medical-innovation-forum-cardiovascular-%e2%80%a2-may-1-3-2017-boston-ma-%e2%80%a2-united-states/ … via @Pharma_BI

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Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

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Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017… https://pharmaceuticalintelligence.com/2017/05/03/highlights-live-day-3-world-medical-innovation-forum-cardiovascular-%e2%80%a2-may-1-3-2017-boston-ma-%e2%80%a2-united-states/ …

 

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Merck eyes key cancer drug growth as others lose patent protection

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Empowering students today to create the world of tomorrow

 

 

 

Highlights of LIVE Day 1: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

 

 

 

Highlights – LIVE Day 2: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

 

 

Highlights – LIVE Day 2: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017… https://pharmaceuticalintelligence.com/2017/05/02/highlights-live-day-2-world-medical-innovation-forum-cardiovascular-%e2%80%a2-may-1-3-2017-boston-ma-%e2%80%a2-united-states …

 

 

Highlights of LIVE Day 1: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

 

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Highlights of LIVE Day 1: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017… https://pharmaceuticalintelligence.com/2017/05/01/highlights-of-live-day-1-world-medical-innovation-forum-cardiovascular-%e2%80%a2-may-1-3-2017-boston-ma-%e2%80%a2-united-states …

 

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@pharma_BI @AVIVA1950 #WMIF17 Disruptive Dozen 1. Quantitative Molecular Imaging for Cardiovascular Phynotypes

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@pharma_BI @AVIVA1950 #WMIF17 Disruptive Dozen 2. Harnessing Big Data and Deep Learning for Clinical Decision Support

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Sek Kathiresan MD Retweeted Aviva Lev-Ari

If competition/judging is ‘fair’ process, how is ‘20% taking up 50%’ a problem?

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Aviva Lev-Ari @AVIVA1950

@pharma_BI @AVIVA1950 #WMIF17 Gary Gibbons 20% investigators take up 50% of the grants squeezing out the bandwidth need younger generation

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@pharma_BI @AVIVA1950 #WMIF17 Gary Gibbons 20% investigators take up 50% of the grants squeezing out the bandwidth need younger generation

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11h11 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Campbell Rogers, MD Imaging Efficiency free cost Plaque composition Coronary CT flow implication of stenosis

Intrepid Bio Retweeted your reply

 

12h12 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Aarif Khakoo, MD Amgen 1,500,000 stroke Genetics will bring the breakthrough to atherosclerosis

Bryan Yee Retweeted your reply

 

23h23 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Scott Wasserman, Amgen, AI will become part of Clinical Trial Design for investigational therapies and others

 

Bryan Yee and Gabriel M Santibañez liked your reply

 

May 2

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@pharma_BI @AVIVA1950 #WMIF17 Scott Wasserman, Amgen, AI will become part of Clinical Trial Design for investigational therapies and others

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May 2

Eric TopolVerified account @EricTopol

A gluten-free diet may not be without hazard http://www.bmj.com/content/357/bmj.j1892 … potential of reduced grain intake & cardiovascular risk @bmj_latest #OA

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‘Creativity is highly valued in all industries’ @virgilabloh #VirgilxRISD

 

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@pharma_BI @AVIVA1950 #WMIF17 Highlights – LIVE Day 2: World Medical Innovation Forum – https://pharmaceuticalintelligence.com/2017/05/02/highlights-live-day-2-world-medical-innovation-forum-cardiovascular-%e2%80%a2-may-1-3-2017-boston-ma-%e2%80%a2-united-states/ … via @Pharma_BI

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@pharma_BI @AVIVA1950 #WMIF17 Sean Harper, MD, Amgen Sean Harper, MD Investors:to Biotech – works on Oncology and on Orphan drugs

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May 2

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@pharma_BI @AVIVA1950 #WMIF17 Sean Harper, MD, Amgen in CVD complex traits phynotype more determinative then genotyping vs Oncology,

Pearl Freier liked your reply

 

May 2

Aviva Lev-Ari @AVIVA1950

@Pharma_BI @AVIVA1950 #WMIF17 Benjamin Scirica, FDA requires PRAGMATIC TRIAL DESIGN, IDENTIFY DIFFERENT POPULATION FOR EXISTING DRUGS,

Nicole Volpe Miller liked your reply

 

May 2

Aviva Lev-Ari @AVIVA1950

@Pharma_BI #WMIF17 Omar Ishrak, PhD CEO, Medtronic Innovations are the essence of Medical Devices development as mission in technology

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May 1

Aviva Lev-Ari @AVIVA1950

@Pharma_BI #WMIF17 Marc Semigran Myokardia Preclinical trials for early insights for Younger patient with cardiomiopaty and older patient

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May 1

Aviva Lev-Ari @AVIVA1950

@Pharma_BI #WMIF17 Omar Ishrak, CEO, Medtronic Training Challenge Surgical Robotic patient comfort of minimal invasive therapy, cost lower

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May 1

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May 1

Aviva Lev-Ari @AVIVA1950

@Pharma_BI #WMIF17 @AVIVA1950 Medical Devices – Prevention methods, Big data , AI, Heart Failure a role for Government like “CVD Moonshot”

BrackenData liked your reply

 

May 1

Aviva Lev-Ari @AVIVA1950

@Pharma_BI #WMIF17 Lewis Sandy, MD UnitedHealth 30% of care cost is WASTE, eliminate!! Collaborations Pharma Devices: Data Analytics KEY

Gabriel M Santibañez liked your reply

 

May 1

Aviva Lev-Ari @AVIVA1950

@Pharma_BI #WMIF17 Ronald Tompkins, MD: Regulatory FDA/Bureaucracy needs be non-adversarial relations with Hospitals or Academia or industry

Smart Medicine Retweeted your reply

 

May 1

Aviva Lev-Ari @AVIVA1950

@Pharma_BI #WMIF17 @AVIVA1950 Medical Devices – Prevention methods, Big data , AI, Heart Failure a role for Government like “CVD Moonshot”

 

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e-Proceedings for Day 1,2,3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017, BOSTON, MA

Curator and Reporter: Aviva Lev-Ari, PhD, RN

 

https://worldmedicalinnovation.org/agenda/

 

Highlights of LIVE Day 1: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017  BOSTON, MA • UNITED STATES

https://pharmaceuticalintelligence.com/2017/05/01/highlights-of-live-day-1-world-medical-innovation-forum-cardiovascular-%E2%80%A2-may-1-3-2017-boston-ma-%E2%80%A2-united-states/

Highlights – LIVE Day 2: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

https://pharmaceuticalintelligence.com/2017/05/02/highlights-live-day-2-world-medical-innovation-forum-cardiovascular-%E2%80%A2-may-1-3-2017-boston-ma-%E2%80%A2-united-states/

Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

https://pharmaceuticalintelligence.com/2017/05/03/highlights-live-day-3-world-medical-innovation-forum-cardiovascular-%E2%80%A2-may-1-3-2017-boston-ma-%E2%80%A2-united-states/

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REAL TIME Highlights and Tweets: Day 1,2,3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017, BOSTON, MA

Deliverables Author and Curator: Aviva Lev-Ari, PhD, RN

 

https://worldmedicalinnovation.org/agenda/

eProceedings for Day 1,2,3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017, BOSTON, MA

Highlights of LIVE Day 1: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017  BOSTON, MA • UNITED STATES

https://pharmaceuticalintelligence.com/2017/05/01/highlights-of-live-day-1-world-medical-innovation-forum-cardiovascular-%E2%80%A2-may-1-3-2017-boston-ma-%E2%80%A2-united-states/

Highlights – LIVE Day 2: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

https://pharmaceuticalintelligence.com/2017/05/02/highlights-live-day-2-world-medical-innovation-forum-cardiovascular-%E2%80%A2-may-1-3-2017-boston-ma-%E2%80%A2-united-states/

Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

https://pharmaceuticalintelligence.com/2017/05/03/highlights-live-day-3-world-medical-innovation-forum-cardiovascular-%E2%80%A2-may-1-3-2017-boston-ma-%E2%80%A2-united-states/

Tweets by @pharma_BI and @AVIVA1950 at World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017, BOSTON, MA

 

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All 57 RETWEETS by  World Forum from LPBI’s Twitter.com handles

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@Pharma_BI #WMIF17 @AVIVA1950 Medical Devices – Prevention methods, Big data , AI, Heart Failure a role for Government like “CVD Moonshot”

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI @AVIVA1950 #WMIF17 a working artificial heart is more needed than another stent, personalized sensors (diagnostics) reimbursment

 

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@pharma_BI @AVIVA1950 #WMIF17 Monetizing Diagnostics is key no reimbursement for regenerative medicine, biological system vs physical system

 

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@Pharma_BI #WMIF17 Bruce Rosengard: Crowd sourcing future mechanism for funding innovations vs ROI funding, Partnerships Academia/Industry

 

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@pharma_BI @AVIVA1950 #WMIF17 E. Edelman: Ideas start in Academia, Residential teaching is eroding, Industry needs assuming role of Academia

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI #WMIF17 Ronald Tompkins, MD: Regulatory FDA/Bureaucracy needs be non-adversarial relations with Hospitals or Academia or industry

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI @AVIVA1950 #WMIF17 Timothy Ring, CEO, Bard: corporate controlled fund for acquisions rely on Start up community for acquisitions

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI, #WMIF17 Michael Mussallem CEO, Edwards Lifesciences Selling services – heart-lung machine: Perfusion is a product and Service

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI #WMIF17 Lewis Sandy, MD UnitedHealth 30% of care cost is WASTE, eliminate!! Collaborations Pharma Devices: Data Analytics KEY

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI #WMIF17 @AVIVA1950 Jagmeet Singh, MGH Genetic profiling for early detection, Going upstream for the Genetics and the Prevention

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI #WMIF17 Omar Ishrak, PhD CEO, Medtronic Innovations are the essence of Medical Devices development as mission in technology

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI #WMIF17 Omar Ishrak, CEO, Medtronic Training Challenge Surgical Robotic patient comfort of minimal invasive therapy, cost lower

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI #WMIF17 Omar Ishrak, CEO, Medtronic Mitral Valve – platform for new generation of diagnostics ETERNAL: recover fast outcome

 

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Aviva Lev-Ari‏ @AVIVA1950  May 1

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@Pharma_BI #WMIF17 Marc Semigran Myokardia Preclinical trials for early insights for Younger patient with cardiomiopaty and older patient

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI #WMIF17 Makoto Suematsu initiative on Dementia, cases of +100 y-o without functional decline in Japan

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI #WMIF17 @AVIVA1950 Makoto Suematsu, collaboration with NIH, Beyond the Border Masanori Aikawa AGING disease indication is novel

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI #WMIF17 Innovations from Japan leveraged in a global corporation, Bayer, Academia and Industry Partnership investment from Bayer

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI #WMIF17 @AVIVA1950 Makoto Suematsu, Pharma’s difficulty to data access the clinical data from Academic Hospitals, gov’t IT invest

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI #WMIF17 Carsten Brunn, Bayer Osaka Innovation Center to facilitate Translational results transfer to Pharma, stem cell initiative

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI @AVIVA1950 #WMIF17 Hiroyuki Kawabata rate of CVD and HTN increased in Japan with aging population, national goal decrease BP

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI @AVIVA1950 #WMIF17 Benjamin Scirica, FDA requires PRAGMATIC TRIAL DESIGN, IDENTIFY DIFFERENT POPULATION FOR EXISTING DRUGS,

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@Pharma_BI #WMIF17 Rowe of Edwards Mitral Valve Trans catheter is the direction PATIENT ACCESS – who will benefit devices Improve Patient

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@pharma_BI @AVIVA1950 #WMIF17 Cost of failure for AD at Eli Lilly, reduce failure rate, hedge bets to cut losses, investment may be deadend

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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#WMIF17 @Pharma_BI @AVIVA1950 Offset AD prevent vs delay age of onsett is desirable, Pharma spend $70Billion on R&D, most is D NIH is R

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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#WMIF17 @pharma_BI, @AVIVA1950, Increase Research at Eli Lilly CEO, medicine will bring value, can’t apologies for drug failure, best time

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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#WMIF17 @Pharma_BI @AVIVA1950 Stanley Shaw, MD, PhD Realization by physicians that monitoring Patients @Home is a TIME SAVER – tech adopted

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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#WMIF17 @pharma_BI Stanley Shaw Trusted Sources for Sharing genetic information with Academic Centers: Verily, AstraZeneca, AHA partnership

 

World Forum Retweeted

Aviva Lev-Ari‏ @AVIVA1950  May 2

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#WMIF17 @pharma_BI @AVIVA1950 Jonathan Rennert: histories of ECG before cardiac arrest: instruct do not drive, do not be alone at home

1 retweet

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1

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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#WMIF17 @pharma_Bi @AVIVA1950 Joe Kvedar, MD Implement technology for quality care, access and lower cost monitoring Patients while @Home

 

World Forum Retweeted

Aviva Lev-Ari‏ @AVIVA1950  May 2

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#WMIF17 @Pharma_BI @AVIVA1950 Robert Bradway CEO, Amgen Value of innovation at a price that allows access and lowering cost of care

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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#WMIF17 @Pharma_BI @AVIVA1950 Robert Bradway CEO, Amgen Cardiologist prescribed the medication for himself 6 month for insurance approval

0 replies1 retweet0 likes

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@pharma_BI @AVIVA1950 #WMIF17 Norman Stockbridge, MD, PhD Director, Division of CV and Renal Products, FDA: Preserve randomization is key

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@pharma_BI @AVIVA1950 #WMIF17 Elisabeth Björk, AstraZeneca asked Norman Stockbridge, FDA – pragmatic design avoid missing data is 12%

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@pharma_BI @AVIVA1950 #WMIF17 Scott Wasserman, Amgen, AI will become part of Clinical Trial Design for investigational therapies and others

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@pharma_BI @AVIVA1950 #WMIF17 Dean Li, Merck, Arrhythmia: Mutation if down played causes Arrhythmia if Overexpressed causes Arrhythmia

0 replies1 retweet0 likes

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@pharma_BI @AVIVA1950 #WMIF17 Sean Harper, MD, Amgen in CVD complex traits phynotype more determinative then genotyping vs Oncology,

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@pharma_BI @AVIVA1950 #WMIF17 Sean Harper, MD, Amgen Sean Harper, MD Investors:to Biotech – works on Oncology and on Orphan drugs

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@pharma_BI @AVIVA1950 #WMIF17 Jean-François Formela, MD Coolest technology: CRISPR one injection reduction of effects in a genetic disease

 

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Aviva Lev-Ari‏ @AVIVA1950  May 2

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@pharma_BI @AVIVA1950 #WMIF17 Highlights – LIVE Day 2: World Medical Innovation Forum – https://pharmaceuticalintelligence.com/2017/05/02/highlights-live-day-2-world-medical-innovation-forum-cardiovascular-%e2%80%a2-may-1-3-2017-boston-ma-%e2%80%a2-united-states/ … via @Pharma_BI

 

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Aviva Lev-Ari‏ @AVIVA1950  16h16 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Ecosystem: Products, Patient Advocacy Groups and Regulators –alignment interaction among agencies: NIH, FDA

 

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Aviva Lev-Ari‏ @AVIVA1950  16h16 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Investment in Devices looks better vs CVD Drugs, Biologics are different, Nurtaceuticals some are harmful

 

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Aviva Lev-Ari‏ @AVIVA1950  16h16 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Robert Califf, Precision Medicine is over inflated except in Oncology, “in CVD, I wish to hear from you”

 

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Aviva Lev-Ari‏ @AVIVA1950  15h15 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Jessica Mega CMO Verily, Real Time monitoring, each Patient has own Portal, monitoring takes major resources

 

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Aviva Lev-Ari‏ @AVIVA1950  15h15 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Michael Mahoney: Challenges in Emerging Markets: China more regulation India – price very low expensive stent

 

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Aviva Lev-Ari‏ @AVIVA1950  15h15 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Microelectronics new direction: Endoscopy GI Pulmonary,SPINAL CORD STIMULATION: GU GI (Crohn),Neuromodulation

 

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Aviva Lev-Ari‏ @AVIVA1950  14h14 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Aarif Khakoo, MD Amgen 1,500,000 stroke Genetics will bring the breakthrough to atherosclerosis

 

World Forum Retweeted

Aviva Lev-Ari‏ @AVIVA1950  14h14 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Craig Sponseller, Is triglycerides the right focus, Macrophage activation to prevent pathways resistance

 

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Aviva Lev-Ari‏ @AVIVA1950  14h14 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Aarif Khakoo, MD Amgen Cost is related to FAIL less – target selection is cardinal

 

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Aviva Lev-Ari‏ @AVIVA1950  14h14 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Clive Meanwell, Phase III needs different questions and more Phase IV needed

 

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Aviva Lev-Ari‏ @AVIVA1950  14h14 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Campbell Rogers, MD Clinical burden remains: Value for Patient economic value of the outcome of the

 

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Aviva Lev-Ari‏ @AVIVA1950  14h14 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Campbell Rogers, MD Imaging Efficiency free cost Plaque composition Coronary CT flow implication of stenosis

 

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Aviva Lev-Ari‏ @AVIVA1950  14h14 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Craig Sponseller, MD Pragmatic Clinical Trial Design: Novel Targets, collaboration of Academia and Industry

 

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Aviva Lev-Ari‏ @AVIVA1950  13h13 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Gary Gibbons Reinvent Longitudinal Cohort Studies & Genomics sequencing – Concepts of Data Commons Analytics

 

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Aviva Lev-Ari‏ @AVIVA1950  13h13 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Gary Gibbons 20% investigators take up 50% of the grants squeezing out the bandwidth need younger generation

 

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Aviva Lev-Ari‏ @AVIVA1950  13h13 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Gary Gibbons, MD Pragmatic optimist in this position, scientists innovate for Patients would do it again

 

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Aviva Lev-Ari‏ @AVIVA1950  11h11 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR https://pharmaceuticalintelligence.com/2017/05/03/highlights-live-day-3-world-medical-innovation-forum-cardiovascular-%e2%80%a2-may-1-3-2017-boston-ma-%e2%80%a2-united-states/ … via @Pharma_BI

 

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Aviva Lev-Ari‏ @AVIVA1950  11h11 hours ago

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@pharma_BI @AVIVA1950 #WMIF17 Disruptive Dozen 1. Quantitative Molecular Imaging for Cardiovascular Phynotypes

 

 

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@pharma_BI @AVIVA1950 #WMIF17 Disruptive Dozen 2. Harnessing Big Data and Deep Learning for Clinical Decision Support

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Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

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Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA •… https://pharmaceuticalintelligence.com/2017/05/03/highlights-live-day-3-world-medical-innovation-forum-cardiovascular-%e2%80%a2-may-1-3-2017-boston-ma-%e2%80%a2-united-states/ … via @Pharma_BI

 

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Highlights – LIVE Day 2: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA… https://pharmaceuticalintelligence.com/2017/05/02/highlights-live-day-2-world-medical-innovation-forum-cardiovascular-%e2%80%a2-may-1-3-2017-boston-ma-%e2%80%a2-united-states/ … via @Pharma_BI

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  1. Aviva Lev-Ari‏ @AVIVA1950May 2

 

#WMIF17 @Pharma_BI @AVIVA Frans van Houten CEO, Philips eICU -measure evolution to forcast 6 hours a deterioration reduction 40% of death

 

  1. Aviva Lev-Ari‏ @AVIVA1950May 2

 

#WMIF @pharma_BI @AVIVA1950 Robert Bradway Future at Amgen: Coming drug is Pharmcogenetics for atherosclerosis

LikeAviva Lev-Ari‏ @AVIVA1950  May 2

 

Robert Bradway CEO, Amgen Pay for benefit, for outcome, no pay if med does not do what it was supposed to do – REFUND patients poor outcome

 

  1. Aviva Lev-Ari‏ @AVIVA1950May 2

 

#WMIF17 @Pharma_BI @AVIVA1950 Robert Bradway CEO, Amgen Cardiologist prescribed the medication for himself 6 month for insurance approval

 

  1. Aviva Lev-Ari‏ @AVIVA1950May 2

 

#WMIF17 @Pharma_BI @AVIVA1950 Robert Bradway CEO, Amgen Value of innovation at a price that allows access and lowering cost of care

 

  1. Aviva Lev-Ari‏ @AVIVA1950May 2

 

#WMIF17 @pharma_Bi @AVIVA1950 Joe Kvedar, MD Implement technology for quality care, access and lower cost monitoring Patients while @Home

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#WMIF17 @pharma_BI @AVIVA1950 Jonathan Rennert: histories of ECG before cardiac arrest: instruct do not drive, do not be alone at home

 

  1. Aviva Lev-Ari‏ @AVIVA1950 May 2

 

#WMIF17 @pharma_BI Stanley Shaw Trusted Sources for Sharing genetic information with Academic Centers: Verily, AstraZeneca, AHA partnership

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  1. Aviva Lev-Ari‏ @AVIVA1950 May 2

 

#WMIF17 @Pharma_BI @AVIVA1950 Stanley Shaw, MD, PhD Realization by physicians that monitoring Patients @Home is a TIME SAVER – tech adopted

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  1. Aviva Lev-Ari‏ @AVIVA1950 May 2

 

#WMIF17 @pharma_BI, @AVIVA1950, Increase Research at Eli Lilly CEO, medicine will bring value, can’t apologies for drug failure, best time

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#WMIF17 @Pharma_BI @AVIVA1950 Offset AD prevent vs delay age of onsett is desirable, Pharma spend $70Billion on R&D, most is D NIH is R

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Highlights of LIVE Day 1: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, M… https://pharmaceuticalintelligence.com/2017/05/01/highlights-of-live-day-1-world-medical-innovation-forum-cardiovascular-%e2%80%a2-may-1-3-2017-boston-ma-%e2%80%a2-united-states/ … via @Pharma_BI

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Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

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Merck eyes key cancer drug growth as others lose patent protection

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Empowering students today to create the world of tomorrow

 

 

 

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Highlights – LIVE Day 2: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

 

 

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Highlights of LIVE Day 1: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

 

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@pharma_BI @AVIVA1950 #WMIF17 Disruptive Dozen 1. Quantitative Molecular Imaging for Cardiovascular Phynotypes

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8h8 hours ago

Aviva Lev-Ari @AVIVA1950

@pharma_BI @AVIVA1950 #WMIF17 Disruptive Dozen 2. Harnessing Big Data and Deep Learning for Clinical Decision Support

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Sek Kathiresan MD Retweeted Aviva Lev-Ari

If competition/judging is ‘fair’ process, how is ‘20% taking up 50%’ a problem?

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Aviva Lev-Ari @AVIVA1950

@pharma_BI @AVIVA1950 #WMIF17 Gary Gibbons 20% investigators take up 50% of the grants squeezing out the bandwidth need younger generation

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10h10 hours ago

Aviva Lev-Ari @AVIVA1950

@pharma_BI @AVIVA1950 #WMIF17 Gary Gibbons 20% investigators take up 50% of the grants squeezing out the bandwidth need younger generation

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11h11 hours ago

Aviva Lev-Ari @AVIVA1950

@pharma_BI @AVIVA1950 #WMIF17 Campbell Rogers, MD Imaging Efficiency free cost Plaque composition Coronary CT flow implication of stenosis

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12h12 hours ago

Aviva Lev-Ari @AVIVA1950

@pharma_BI @AVIVA1950 #WMIF17 Aarif Khakoo, MD Amgen 1,500,000 stroke Genetics will bring the breakthrough to atherosclerosis

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23h23 hours ago

Aviva Lev-Ari @AVIVA1950

@pharma_BI @AVIVA1950 #WMIF17 Scott Wasserman, Amgen, AI will become part of Clinical Trial Design for investigational therapies and others

 

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May 2

Aviva Lev-Ari @AVIVA1950

@pharma_BI @AVIVA1950 #WMIF17 Scott Wasserman, Amgen, AI will become part of Clinical Trial Design for investigational therapies and others

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May 2

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A gluten-free diet may not be without hazard http://www.bmj.com/content/357/bmj.j1892 … potential of reduced grain intake & cardiovascular risk @bmj_latest #OA

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@pharma_BI @AVIVA1950 #WMIF17 Highlights – LIVE Day 2: World Medical Innovation Forum – https://pharmaceuticalintelligence.com/2017/05/02/highlights-live-day-2-world-medical-innovation-forum-cardiovascular-%e2%80%a2-may-1-3-2017-boston-ma-%e2%80%a2-united-states/ … via @Pharma_BI

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May 2

Aviva Lev-Ari @AVIVA1950

@pharma_BI @AVIVA1950 #WMIF17 Sean Harper, MD, Amgen Sean Harper, MD Investors:to Biotech – works on Oncology and on Orphan drugs

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May 2

Aviva Lev-Ari @AVIVA1950

@pharma_BI @AVIVA1950 #WMIF17 Sean Harper, MD, Amgen in CVD complex traits phynotype more determinative then genotyping vs Oncology,

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May 2

Aviva Lev-Ari @AVIVA1950

@Pharma_BI @AVIVA1950 #WMIF17 Benjamin Scirica, FDA requires PRAGMATIC TRIAL DESIGN, IDENTIFY DIFFERENT POPULATION FOR EXISTING DRUGS,

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May 2

Aviva Lev-Ari @AVIVA1950

@Pharma_BI #WMIF17 Omar Ishrak, PhD CEO, Medtronic Innovations are the essence of Medical Devices development as mission in technology

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May 1

Aviva Lev-Ari @AVIVA1950

@Pharma_BI #WMIF17 Marc Semigran Myokardia Preclinical trials for early insights for Younger patient with cardiomiopaty and older patient

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@Pharma_BI #WMIF17 Omar Ishrak, CEO, Medtronic Training Challenge Surgical Robotic patient comfort of minimal invasive therapy, cost lower

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@Pharma_BI #WMIF17 @AVIVA1950 Medical Devices – Prevention methods, Big data , AI, Heart Failure a role for Government like “CVD Moonshot”

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May 1

Aviva Lev-Ari @AVIVA1950

@Pharma_BI #WMIF17 Lewis Sandy, MD UnitedHealth 30% of care cost is WASTE, eliminate!! Collaborations Pharma Devices: Data Analytics KEY

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May 1

Aviva Lev-Ari @AVIVA1950

@Pharma_BI #WMIF17 Ronald Tompkins, MD: Regulatory FDA/Bureaucracy needs be non-adversarial relations with Hospitals or Academia or industry

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Aviva Lev-Ari @AVIVA1950

@Pharma_BI #WMIF17 @AVIVA1950 Medical Devices – Prevention methods, Big data , AI, Heart Failure a role for Government like “CVD Moonshot”

 

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Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017  BOSTON, MA • UNITED STATES

Leaders in Pharmaceutical Business Intelligence (LPBI) Group will cover the event in

REAL TIME

Aviva Lev-Ari, PhD, RN will be streaming live from the floor of the Westin Hotel in Boston on May 1-3, 2017

@pharma_BI

@AVIVA1950

#WMIF17

Forthcoming SEVEN e-Books in 2017 AND Eight e-Books on Amazon.com

https://pharmaceuticalintelligence.com/2016/04/24/new-e-book-titles-forthcoming-on-amazon-com-in-2016-from-lpbi-groups-biomed-e-series-forthcoming-cover-pages/

Biggest Voices in Cardiovascular Care

2017 World Medical Innovation Forum: Cardiovascular, May 1-3, 2017, Partners HealthCare, Boston, at the Westin Hotel, Boston

https://worldmedicalinnovation.org/agenda/

Wednesday, May 3, 2017

 

7:00 am – 7:30 am
Lilly Foyer
7:30 am – 7:55 am
Boston Scientific Ballroom
1:1 Fireside Chat: Robert Califf, MD, Commissioner (former), Food and Drug Administration
  • Chairman, Department of Medicine, Physician-in-Chief, Brigham and Women’s Hospital
  • Hersey Professor of the Theory and Practice of Medicine, Soma Weiss, MD Distinguished Chair in Medicine, Harvard Medical School
  1. What is the state of play and the future of CVD
  2. Why Drugs are behind vs Devices
  3. Precision Medicine in CVD
  4. Nutraceuticals – more regulations??
  5. Insights that surprised you at FDA
  6. Redesign the FDA – Areas?
  7. Patient participacition post approval
Robert Califf, MD – Now at Duck
  • Commissioner (former), Food and Drug Administration
  1. CVD – drugs vs Devices
  2. Drugs are less exciting while devices are booming
  3. Effective therapies of generic drugs is remarkable
  4. Reimbursement system is messed up
  5. DIfferent drugs have equal effects and ROI is not there, Pharma are pursuing different areas
  6. Checkpoints drugs in Oncology has no analogy in CVD
  7. Enrollment in Clinical Trials: In oncology, patients flock to Trials – that is not the case with CVD Trials
  8. Precision Medicine is over inflated, it is demonstrated in Oncology, “in CVD, I wish to hear from you”
  9. System Biology and Drugs
  10. FDA – one drug is a success for several attempts, several is large
  11. FDA is not interested in the Mechanism, they are interested in identidying the population, demonstrate safety and efficacy no adverse events
  12. Investment in Devices looks better vs CVD Drugs, Biologics are different
  13. Food supplement for Prostate, some are harmful – Law forbid regulation of Nurtaceuticals not good for public health
  14. Academic centers: Duke and Partners are far advanced in HC landscape
  15. FDA works with CMS – demonstration of Value in Drugs – Pragmatic randomized Trials
  16. Total cost, better spent
  17. FDA is a Science-based Organization – tremendous people, amazing work – learned the regulation over time
  18. Political Corporation have same status like individual for First Amendment
  19. Regulate Cosmetics and Nurtaceuticals
  20. Ecosystem: Products, Patient Advocacy Groups and Regulators — better alignment
  21. Cooperation and interaction among agencies: NIH, FDA
  22. Speeding the process if Patients are involved earlier – Pragmatic study design
  23. CVD – reassurance the patient
7:55 am – 8:45 am
Boston Scientific Ballroom
Innovation in Translational Trials

CV/metabolic disorders comprise aggregates of many niche diseases that may be targeted with therapies against specific molecular alterations, yet the final potential markets are much larger. This model creates challenges for both drug development and patient care with implications for initial indication selection and design and execution of clinical trials – from first-in-human through post marketing studies.

 

  • Director, Translational Research Center, Massachusetts General Hospital
  • Professor of Medicine Harvard Medical School
  1. CVD Success stories NOT by Cardiologists
  2. Metabolic Drugs Clinical Trials: Outcome Trials – 4% each trial is $2Billion thousand of Patients
  3. Trial design
  4. Technologies
  5. Quality control in Clinical Trial in Russia, Gorgie – no metabolites in blood
  6. Biomarkers Predictor of responses
  • SVP, Global Head of Regenerative Medicine Unit, Head of Scientific Affairs, Japan, Takeda
  1. Stem Cells Skin cells or blood cells and converted to other cells
  2. development of Cell-based therapy for Cardiac myocytes: propiatory method to purify myocytes
  3. In Japan, Cardiac transplant in very small cases – Alternative for Heart Transplant for HF – development of gene therapy and stem cell converted to myocytes
  4. Govenrment initiative to develop regenerative medicine, procedure can be improved,
  5. approval for EF improval – conditional Approval given by Government on 100 patients
  6. Severe HF — cell therapy and procedure is consider
  7. Osaka University, cell transplantatio – in Acadedmic Center
  8. If efficacy and safety — continuous improvement – inject the cell be applied to more patient beyond CVD applications
  9. Post approval registry, call patient back every few month, HF continuos Monitoring
  • CMO, Verily
  1. Tools to make the Patient the center of the Trial and engaged
  2. Information arrives in Real Time with Analytics – value derived from Dashboard design
  3. Multidimensional Data
  4. Definition of Disease – not as a point once a year but continual
  5. Real Time monitoring, deep IT design, each Patient has own Portal, monitoring takes major resources, Large Informatics companies, screen ECG of huge populations
  6. FDA interested in NEW tools, data that comes from individual
  7. Biomarkers: Biosignals broader, connection Genomics and physiology – Neurlology
  8. CVD – BP druds and QT prolongation
  9. User-centric Design – Patient-center, data infrastructure for MDs
  • SVP, Global CMO, Novo Nordisk
  1. 2016 – three drug studies CVD and DM – Insulin: (1) Post market on Safety, (2) Preapproval assessement (3) Insulin study assess data without compromising the continuation of the study (CVRT)
  2. Engaging Patients and Investigators – Global Trials varies by Regions – Global Experts, Local Experts and RN as Coordinators — worked very well
  3. CVD Outcome Trials – engaging patients
  4. Intermediate Analysis: conduct and protect the Intermediate results no disclosure till Trial is completed
  5. Identify the right site id a challenge
  6. Multiple pathway related to CVD – Biomarkers difficult to find as insightful
  7. In Israel data integrity is the highest
  8. Innovative Medical Initiative – Novo, Lilly, Sanofi — DM data comparison
  • SVP & CSO, PAREXEL International – CRO
  1. Adaptive Trials vs Traditional Cardio (no windows) – intermediate evaluation
  2. Adaptive Trials: Flexibility 50% of Phase III Fails – Adaptive design offer more values
  3. OMICS revolution – innovative revolution
  4. Umbrella Design: different treatment for single indication
  5. Platform design – infrastructure design is inefficient vs Platform: Number of Drugs Several indications
  6. Interaction with FDA: They are open to Adaptive design wiht Power, survival rate window adaptive,
  7. Tufts data and PAREXEL: Adoption 30% of new design for Phase III: maintain blindness
  8. Data Surveillence during the Trial administration – look at data cycle time, monitor margins during the study Red flags identified before end of study
  9. Biomarkers in Early Translational Research – down stream processes to identify and validate
8:45 am – 9:15 am
Boston Scientific Ballroom
1:1 Fireside Chat: Michael Mahoney, CEO, Boston Scientific

Edward Lawrence, Board of Directors, Partners

Moderator: Meg Tirrell – Biotech, Pharma
  • Reporter, CNBC
Michael Mahoney ex-GE Medical HealthCare IT and J&J Diagnostics
  • CEO, Boston Scientific

Geography – Global vs 10 years ago US focus

Pipeline strategy – Diversified: Neurology, CVD, Endoscopy – innovation cycle very strong

  • Symatec – valve company – M&A – strengthen Strategy on TAVR
  • AF product
  • Deeper Stimulation for Parkinson
  • Mitral Valve Strategy: Venture bets with VC for repair and replacement
  • TAVR – volunteer recall back in Europe – P&A – fully deployed valve synergies with Symatec
  • Digital tool
  • GHX – B to B Healthcare Exchange – automate procurement, innovate the portfolio – supply chain cost reduction
  • 30 VC investment – microelectronics, AD Neuro-modulation, Obesity, Immunology
  • Sensors – prediction of HF – two devices: diagnostics-side to reduce hospital readmission – GO HOME with Alert system to avoid ER, diagnostics
  • Cnsolidation: growing very well: Drive Category leadership – Hospitals want to deal with three suppllier.
  • Partner of Choice for Partners
  • Acquisitions: Early stage and more mature
  • Challenges in Emerging Markets:
  1. Brazil – different that China or India
  2. China – more regulation for approval
  3. India – price very low – not to offer more expensive stents
  • Cyber security – Investment in this domain to secure data – not a market reaction to this issue
  • Reimbursement: Clinical path to get Approved – Upfront effort to align approval with Reimburement
  • FDA responsive to 2nd time improvement Clinical trial designed
  • Microelectronics new direction: Endoscopy GI Pulmonary,
  • SPINAL CORD STIMULATION: GU, GI (Crohn), Neuromodulation: Depression, Pain, Parkinson

 

9:15 am – 10:05 am
Boston Scientific Ballroom
New Targets in Coronary Artery Disease

Cardiovascular trials have a proud history of providing some of the most robust data in evidence-based medicine. However the growing size and complexity of these trials imperils their future. This panel will discuss the design and implementation of clinical studies globally, considering strategies for patient access, leveraging electronic health records and mobile device data, personalized medicine, regulatory implications, cost containment and management of relationships with global service providers.

  • Director, Center for Genomic Medicine, Massachusetts General Hospital
  • Associate Professor of Medicine, Harvard Medical School
  1. expose new pathways: Biology is most important, BP, High polygenic risk identification of patients for early treatment
  • VP Research, Cardiometabolic Disorders Therapeutic Area Head, Site Head Amgen San Francisco, Amgen
  1. 1,500,000 stroke
  2. CVD and atherosclerosis – is a complex disease
  3. at Amgen – Genetics will bring the breakthrough to atherosclerosis
  4. Cost is related to FAIL less – target selection is cardinal
  5. Phynotyping and genotyping for targeting the Patient that will benefit the most
Clive Meanwell, MD, PhD – Oncologist
  • CEO, The Medicines Company
  1. Orphan drugs for Genetic targets vs Opportunities of the prevalent diseases of the Heart
  2. Big Pharma are in CVD, do not discourage, CVD major cause of death
  3. Phase III needs different questions and more Phase IV needed
  4. Biomarkers:
  • Director, Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital
  • Eugene Braunwald Professor of Medicine, Harvard Medical School
  1. Residual Real Risk: Inflammatory response, triglycerides innovations in LDLc reduction – Class of PSCK9
  2. Know biology, follow biology
  3. Science is endangered in WashDC
  • EVP, CMO, HeartFlow
  1. Clinical burden remains: Which patient will benefit?
  2. Value for Patient
  3. No investment in Coronary disease – Devices investment in this space, setbacks in bioabsorbable stents
  4. goal is holistic for economic value of the outcome of the trials
  5. Imaging Efficiency: Plaque composition, Coronary CT, flow implication of stenosis
  • CMO, Kowa Pharmaceuticals
  1. Is triglycerides the right focus
  2. Macrophage activation to prevent pathways and prevent resistance
  3. chronic HIV- pathophysiology – immune activation
  4. Pragmatic Clinical Trial Design: Novel Targets, preclinical must be faster, collaboration of Academia and Industry
10:05 am – 10:25 am
Lilly Foyer
10:25 am – 10:55 am
Boston Scientific Ballroom
1:1 Fireside Chat: Gary Gibbons, MD, NHLBI
  • President, Brigham Health
  • Professor of Medicine, Harvard Medical School
  1. What innovative projects at NHLBI
  2. Young Investigators
  3. Large Cohort studies: Framingham Study, 1958 – CVD Risk for: Policy: Lowering BP and Cholesterol
  4. CVD hot areas
  5. Value-based Care
Gary Gibbons, MD – Public Service, appointed by NIH Director, not by the President
  • Director, NHLBI
  1. Enabling other the pursuit of Science for Public Good
  2. Ecosystem – the Government arm –
  3. ROI – funds Projects
  4. KI – New Program – funding PIs – investigators initiatives – Next generation of Scholars
  5. 50% of KI converts to ROI
  6. Reduction in CVD is an ROI in research in CVD Biology and Drug development and Devices
  7. 2018 NIH Funding – last two years increase in budget, cuts may or may not occur
  8. Opportunity to reinvent Longitudinal Cohort Studies with insertion of Genomics sequencing – 7,000 Whole Genome – target 100,000
  9. Concepts of Data Commons – Sharing ONE resource for distributed Analytics: Reusability, interoperability, API
  10. CVD – portfolio to include Minority Population disease prevalent
  11. Translation of Science, concept mechanism
  12. Epigenomics and Patho-biology DB and changes over time -a rare resource
  13. Science is to be done for the Public Good, commonwealth of the entire nation – Accessibility of Genome Data after the National goal of sequencing the Genome
  14. 20% investigators take up 50% of the grants and squeeze out the younger generation
  15. Pragmatic optimist in this position, scientists innovate for Patients

 

10:55 am – 11:45 am
Boston Scientific Ballroom
The Skinny on Fat: Therapeutic Opportunities

Explore the evolving role of adipose tissue as an active endocrine organ and discuss the possibilities to discover novel signaling pathways relevant to cardiovascular health and viable druggable targets.

  • SVP and US Medical Leader, Eli Lilly and Company
  1. Obesity and DM2 – direct (Heart Disease Arthritis) and indirect cost (quality of life and productivity)
  2. What is most exciting
  3. What is the challenges
  4. Best ideas
  5. NASH
  6. Microbiome
  7. Food Science
  • SVP and CSO, CVMET, Pfizer, Cambridge
  1. Cardiometabolic in same department with Neurodegenerative Disease – affected by metabolic state
  2. Behavior modification does not work – 1:1 care is too expensive
  3. therapeutics needed for obesity
  4. Which drugs will be translatable
  5. NASH – most die with Heart disease – if NASH treated no death??
  • Global VP, Cardiovascular, Renal and Metabolism AstraZeneca
  1. Renal condition CKD
  2. CVD
  3. comorbidity
  4. Drug perspective: White fat in not inert, signalling
  5. combination of drug
  6. compounds that have impact on CV system
  7. Three Barriers: (1) Science, (2) access to medicines (3) holistic approach: Nephrology needs to use DM drugs, Cardiologist other drugs than cardiac drugs
  8. NASH – it is a REAL disease, impact on Patient
Thomas Hughes, PhD – ex-Novartis
  • CEO, Zafgen
  1. Inhibiting enzyme in obisity for weight reduction
  2. Inflammation burden, lipid, thrombotic events
  3. NASH
  4. Fat and glucose metabolism – integrated physiologic view
  5. Cardiovascular Outcomes: lack of harm vs showing benefit caused by emerging therapies
  6. Food and obesity
  • Director, Obesity, Metabolism & Nutrition Institute, Massachusetts General Hospital
  • Associate Professor, Harvard Medical School
  1. MGH-GI, Bariatric Surgery, effect on comorbidity Vascular Pressure –>> Hypertrophy, conduction and Arryhythmia
  2. Obesity in 6 Countries not only in US, Urban and Rural
  3. CVD occurs in Asia in absence of Obesity
  4. Bariatric surgery is not a public solution – it affects the gut different that drugs do
  5. what get a person to obesity and waht maintain the obesity
  6. complications of obisity – abnormal target of stores
  7. move from the ideas of calories consumption vs Brain function
  8. Develop drug against the complications vs against the obesity itself: Science of Obesity not understood,
  9. Voluntary obesity vs life style – stigma against obesity, heterogenous disease
  10. Microbiome – effect size is small master regulator are interactive Pro-biotics needs to be invented

Bruce Spiegelman, PhD

  • Stanley J. Korsmeyer Professor of Cell Biology and Medicine, Dana Farber Cancer Institute, Harvard Medical School
  1. Molecular development of fat molecule and in exercise impart on energy expansion,
  2. Capture the molecules that participate in exercise to be given to bedridden patients
  3. Obesity is a disease of energy imbalance – Food Intake and Energy expenditure – BEIGE FAT cells that expend energy
  4. Molecular involvement: Exercise causes neurogenesis: ALS, Parkinson, AD
  5. Exercise affect, Heart, Brain and cognition
  6. Science had budget challenge, Biotech, Pharma: CVD Outcomes studies
  7. R&D has challenges to get traction
  8. Microbiome – natural context  provide modest benefit, some effects
11:45 am – 12:45 pm
Boston Scientific Ballroom
Disruptive Dozen: 12 Technologies that will reinvent Cardiovascular Care
  • Chief of Cardiovascular Medicine, Brigham and Women’s Hospital
  • Associate Professor of Medicine, Harvard Medical School
  • Chief, Cardiology Division, Massachusetts General Hospital
  • Professor of Medicine, Harvard Medical School

12. Aging and Heart Disease: Can we reverse the process?

11.Nanotechnologies for Cardiac Diagnosis and Treatment

10. Breaking the Code: Diagnosis and Therapeutic Potential of RNA

9. Expanding the Pool of Organs for Transplant

8. Finding Cancer therapies without Cardiotoxicity

7. Less is more: Minimalist Mitral Valve Repair

6. Understanding Why exercise works for Just about every thing

5. Power Play: The Future of Implantable Cardiac Devices

4. Adopting the Orphan of Heart Disease

3. Targeting Inflammation in cardiovascular Disease

2. Harnessing Big Data and Deep Learning for Clinical Decision Support

  1. Quantitative Molecular Imaging for Cardiovascular Phynotypes

 

1:00 pm
Lilly Foyer

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Highlights – LIVE Day 2: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017  BOSTON, MA • UNITED STATES

 

Leaders in Pharmaceutical Business Intelligence (LPBI) Group will cover the event in

REAL TIME

Aviva Lev-Ari, PhD, RN will be streaming live from the floor of the Westin Hotel in Boston on May 1-3, 2017

@pharma_BI

@AVIVA1950

#WMIF17

Forthcoming SEVEN e-Books in 2017 AND Eight e-Books on Amazon.com

https://pharmaceuticalintelligence.com/2016/04/24/new-e-book-titles-forthcoming-on-amazon-com-in-2016-from-lpbi-groups-biomed-e-series-forthcoming-cover-pages/

Biggest Voices in Cardiovascular Care

2017 World Medical Innovation Forum: Cardiovascular, May 1-3, 2017, Partners HealthCare, Boston, at the Westin Hotel, Boston

https://worldmedicalinnovation.org/agenda/

Tuesday, May 2, 2017

7:00 am – 8:00 am
Lilly Foyer
7:00 am – 7:45 am
Pfizer Ballroom
FOCUS SESSION: Japan Today: Advancing Cardiometabolic Therapies

Discussion on unique aspects of cardiometabolic market in Japan, its projected trend over the next 5 years and explore transformative models of open innovation to accelerate development of new therapeutic options.

  • Yoshiro Miwa Associate Chair and Founding Director, Center for Interdisciplinary Cardiovascular Sciences, Brigham and Women’s Hospital
  • Head of Pharmaceuticals, Americas Region, Bayer
  • Director, Health & Welfare Department, JETRO New York
  • President, Japan Agency for Medical Research and Development
  • President, Head of Global Business Development, Mitsubishi Tanabe Pharma Holdings America, Inc.
  1. Complications of Toxin absorption and metabolic disease
  2. Collaboration with Academia: @ representatives are on two West Coast and 2 on the East Coast
  3. CVD and HTN related to aging is on the rise National Initiative to encourage change in Life Style
7:50 am – 8:00 am
Boston Scientific Ballroom
Opening Remarks
  • Chief Innovation Officer, Partners HealthCare
8:00 am – 8:50 am
Boston Scientific Ballroom
Pricing to Enable Affordability and Innovation

Balancing acceptable answers to high and escalating drug prices in the United States while making strides in medical innovation. Leaders in innovation, policy, care delivery, academia, and insurance discuss potential collaborative solutions.

 

Moderator: Peter Slavin, MD
  • President, Massachusetts General Hospital
  1. American Consumer of Healthcare pays more and it is not justifiable
  2. Pay for Value, pay for Outcomes
  • Physician-in-Chief, Department of Medicine, Massachusetts General Hospital
  • Jackson Professor of Clinical Medicine, Harvard Medical School
  1. Challenges understand PCP services and SPacialty medicine
  2. Adding fluids or taking it away is the majority of the decisions
  3. In cancer treatment 40% of prescriptions are not filled due to out of pocket cost increase
  4. In drugs Innovation are more expensive not less expensive
  5. Economists: Physicians are irrational
  6. Patient engagement, own health in their hands for compliance with treatment
  7. Assist MDs with the right data for their decision on what drugs to use
  8. Two key ways : Complications of Drugs, drive drug cost – Personalized medicine – improve outcomes on an Individual Patient basis
  9. How important is the question, affordable drugs is more important than anything in the delivery of care
  • CEO, Boehringer Ingelheim USA
  1. Many stakeholders are involved
  2. Pricing of Pharmaceutical in last 10 years, “List price” and the “Net Price” collected by Pharma has widen,
  3. high deductable plans are prevalent 40%-50% – out of pocket cost increased
  4. backlog of generic drugs – it takes 36 month to approve vs 12 month of non-generic
  5. Value-based pay, drug is only one enabler in MDs tool kit
  6. Out of pocket cost: Exposure is largest on the drug-side, that is preventive to avoid hospitalization
  7. Unfair pricing leading to not be active in certain markets, Price control outside the US, take position on Importation, not disrable to import drugs into the US, we do not wish drug shortage around the world, Canada is a Small market US is a huge market
  8. FDA on Oncology drug-device, potential exists for existing drugs
  9. Continue to do Clinical Trials in the US, claims orientations exacerbation, describe the benefit
  • EVP, Medical Devices, Abbott
  1. Who will pay and why?
  2. How we challenge development team to bring down cost of technology and plans showing cost savings in 12 month not few years down the road
  3. Selection of areas: ORTHO – hip replacement and Pain management
  4. Establish Global Pricing Models in USD, Premium, fair Price, desperative Prices is not good for the system
  • Director of Innovation, Cardiovascular Division, Senior Investigator, TIMI Study Group, Brigham and Women’s Hospital
  • Associate Professor of Medicine Harvard Medical School
  1. Cardiometabolic diseases  – drugs available to avoid events down the road
  2. new drugs at $20,000 cost per year vs Generic drugs – Economic responsibility in the Lipids area is long term
  3. MI many types bundling cost is more difficult that in Ortho
  4. Chronic disease, therapeutics, diagnostics, How to reduce cost? – Best utilization of drugs
  5. Durable response to drug, not enough data in hands of MDs
  6. Randomize Placibo and Randomize the drug, Placibo – requires better engagement
  7. After MI – 6 MEDS, compliance
  8. Clinical Trial very expensive, FDA requires PRAGMATIC TRIAL DESIGN, IDENTIFY DIFFERENT POPULATION FOR EXISTING DRUGS
  9. develop platform to test simple questions, in Cardiology
8:50 am – 9:40 am
Boston Scientific Ballroom
CLINICAL HIGHLIGHT: Emerging Devices for Complex Structural Heart Disease

Evolution of mitral disease management, current practice and impact of new technologies on both repair and replacement, implications of a heterogeneous patient population, triage, timing of intervention.

Moderator: Jason Mills
  • Managing Director, Head of US Healthcare Research, Canaccord Genuity
  1. What patient to target
  2. Heterogenous population – definitive data, how it is achieved
  • Divisional VP and General Manager, Structural Heart, Abbott
  1. Homogenous or heterogenous
  2. Standard of Care- restore normal function, patient outcomes more fragile as disease progresses
  3. Paradigm, measurable reduction of regurgitation
  4. Design of Clinical Trials: MR treatment around the World,
  5. MitralClip reduce MR reduction is not resolution
  6. 1000 publication on MitralClip – data gather indicate improvement in life quality
  7. TEE alone for use of MitralClip is nor enough, need to see to do the procedure
  • EVP, Global CMO, Boston Scientific
  1. State of the Art, Mitral regurgitation and degenerative Mitral valve: mechanism and elements responsible for regurgitation, repair of Annuals vs replacement of the valve.
  2. Options at different stage of the disease
  3. Functional Mitral Regurgitation: care pathways, compounding effects, two little too late
  4. AF can cause Valve dilatation and regurgitation
  5. Treatment, patient less symptomatic
  6. HTN cause of LV systolic disfunction – treated first – improve the Mitral regurgitation
  7. Mechanism under pinning in the decision process, CLinical Trials – Device may not work for all patients in the Study
  8. leaflet condition dealt in repair strategy vs device selection
  9. Having devices focus the clinical pathways for therapeutic options, TAILORING OF DEVICES TO SPECIFIC STRUCTURAL CONDITION OF THE HEART
  • Watkins Family Distinguished Chair in Cardiology, Brigham and Women’s Hospital
  • Professor of Medicine, Harvard Medical School
  1. Structural Heart disease: Hole in Heart,
  2. 5 1/2 years approved for TARV
  3. TAVR will exceed Open Heart Surgery next year
  4. Mitral valve growth is in  >75 y-o more cases than Aorta
  5. Aorta Valve – seen on Echogram stenosis seen
  6. Mitral Valve – concert of several elements, very complicated, Coordination among: Device, FDA, CMS, MDs, Hospitals
  7. DO  doctors wait to long to intervene: Moderate to severe: Foundational approach Ventricular dysfunction, late stage not continue to progress.
  8. MI
  9. drivers of cords,
  10. identify Patient – can be improved by PCPs, NPs, PAs, assess severity, Center for evaluate consensus on timing the intervention
  11. relay on the Cardiologist in the Community – context: Not all MR needs surgery
  12. Functional Mitral Regurgitation, poor LV function, the valve intervention will not improve longevity may improve quality of life for two years
  13. 20% survival after MI in LV dysfunction post MI then Mitral valve intervention will not improve longevity
  14. For older pation with Functional MR and moderate LV dysfunction – trial design on utility of the intervention.
  15. More patients will be included for treatment as recognition of the disease matures
  16. WHO should do that procedue : Interventional Cardiologist or Cardiac SUrgeons: HARD procedure NOT fixing Coronary artery
  17. Set up regional centers of Care links to maintain quality and PATIENT MUST DO BETTER
  18. 200 centers in the US do MitralClip procedure
  19. Procedure expensive BEYOND THE DEVICE cost

 

  • CVP, Advanced Technology, CSO, Edwards Lifesciences
  1. 60,000 procedures in the US vs. 2.4 million patients with the MR condition
  2. Percutanious is an opportunity not to damage the heart, challenge, how to attach  to the heart and how much regorgitation to get clinical benefit, optimal benefit to patient: Multiple products are in development
  3. Aortic stenosis: we learned which patient will benefit, clinical studies, cost effective, two companies validated the approach
  4. Mitral Valve is in early stage Trans catheter is the direction
  5. PATIENT ACCESS – who will benefit
  6. devices will Improve Patient conditions
  • SVP and President, Coronary & Structural Heart, Medtronic
  1. MR at medtronic: degenerative disease, repair the valve, average surgeon does 6 procedures a year,
  2. Toolbar approach, how to do it safely no complication repeatable to know the reduction level
  3. population exists to do the development early in the stage of MR
9:40 am – 10:10 am
Boston Scientific Ballroom
1:1 Fireside Chat: John Lechleiter, PhD, Chairman, Eli Lilly
Moderator: Susan Dentzer
  • CEO, Network for Excellence in Health Innovation
  • Chairman, Eli Lilly and Company
  1. Two approaches to Beta Ameloid – fail to meet Endpoint: Mild patient Solismad 24% improvement vs placibo
  2. Dementia not AD – mild to moderate patients, only.
  3. Move faster is desiable, turnaround time need be faster
  4. Would do over again, tap best minds in the World,
10:10 am – 10:25 am
Lilly Foyer
10:25 am – 11:15 am
Boston Scientific Ballroom
Personal Monitoring for Disease Management

Considering the evolving trends in viability and utilization and the opportunities wearables may present for real-world clinical decision making.

 

Moderator: Joe Kvedar, MD
  • VP, Connected Health, Partners HealthCare
  • Associate Professor of Dermatology, Harvard Medical School
  1. Evidence on monitoring Patients while @Home, pros and cons
  2. 2016, review evidence, recommendation for monitoring Patients while @Home
  3. Continuing care and continuing data collection
  4. Hospital administrator need a path to have more patients coming to the hospital
  5. Implement technology for quality care, access and lower cost
  • CIO, VP, Brigham and Women’s Hospital
  • Course Co-Director, Harvard Medical School
  1. CHF, HF, – recognize that Technology alone is not enough
  2. People and Technology intervention targeting
  3. Academic medical centers – monitoring Patients while @Home is a mechanism to deliver care
  • COO, Siemens Healthineers
  1. Outcome-based evidence – innovation exited 15 years ago
  2. at Present time the market is accepting
  3. Medical Systems do not have enough capacity – shortage of MDs
  4. Monitoring Patients while @Home is to free time of MDs in the Office
  • CEO, Zoll Medical
  1. Outcome-based research on a wearable cardio-devibrilator, Arrhythmic death protection
  2. Policy: talk about reimbursement
  3. Patient data collected, histories of ECG before cardiac arrest
  4. what diagnostics to be used with this data: do not drive, do not be alone at home
  • CSO, One Brave Idea, Brigham and Women’s Hospital
  • Associate Dean for Executive Education, Harvard Medical School
  1. Evidence and publishing results, MDs and Patient’s perspective on Autonomy vs monitoring Patients while @Home
  2. DIgital Health Comapny vs Academic Study on monitoring Patients while @Home – Wearable Patch surpass wearing a holter
  3. External wearable now acceptable and clinical evidence will convince all stakeholders
  4. Realization by physicians that monitoring Patients while @Home is a TIME SAVER in their practice will endore the technology at a rapid pace
  5. Published studies: Sharing genetic information with Academic Centers: Verily, AstraZeneca and AHA partnership
  6. Information in the Periphery but adopted in the center of Unifies healthcare eco system not in Silos anymore
11:15 am – 11:45 am
Boston Scientific Ballroom
1:1 Fireside Chat: Robert Bradway, CEO, Amgen
Moderator: Scott Sperling
  • Co-President, Thomas H. Lee Partners
  1. Amgen –>>> Biotech to Pharma
  • CEO, Amgen
  1. Six areas: CVD, Cancer, Inflammation,
  2. CVD opportunities: Science and commercial – Heart disease, tools of Human genetics for drug development in CVD: REPATA a molecule targeting PCSK9 – variant on gene associated with LDL Pathways – genetic clue
  3. Innovation in Human genetics new sequencing technologies allowed to see disease in Human populations, disease and pathways
  4. Aging associated with risks of CVD, How we pay for innovative therapies?
  5. Benefit from innovation – 800,000 in US have a stroke every year $60 Billion treatment for patient of CVD
  6. Value of innovation at a price that allows access and lowering cost of care
  7. Cardiologist prescribed the medication for himself it took 6 month for insurance to approve
  8. Utilization management – move to innovative technologies if current therapies do not work
  9. Pay for benefit and for outcome, no pay if med does not do what it was supposed to do – refund patients
  10. focus on right patient get access. if LDL is so high – the therapy is there – the payers, enable access
  11. Access challenge: Discount, Rebates, Co-pay assistance to access therapy as REPATA at $5 a day value is high,
  12. A single payer is the Government in other countries
  13. Future at Amgen: Potential for Innovation to improve Medicine, paying for innovation needs to be strainten
  14. Coming drug is Pharmcogenetics for atherosclerosis
12:00 pm
GE Ballroom
12:15 pm – 12:30 pm
GE Ballroom
Austen-Braunwald Award

Awarded to one BWH and one MGH First Look participant who embodies the innovative, entrepreneurial, and visionary spirit of cardiovascular legends W. Gerald Austen, MD and Eugene Braunwald, MD. Granted based on select criteria, including overall presentation quality, innovativeness, commercial potential, caliber of disruption, and market need.

  • Ben Olenchock, BWH
  • Steven Lubitz, MGH
12:30 pm – 1:00 pm
GE Ballroom
1:1 Fireside Chat: Frans van Houten, CEO, Philips
Moderator: Gregg Meyer, MD
  • CCO, Partners HealthCare
  1. Why Healthcare?
  2. How your approach to innovation enable to move fast?
  3. Develop technologies that are more affordable
  4. Data, Insight, How to get insight from data about a deterioration
  • CEO, Philips
  1. A 125 year company, shade lighting business to focus of Healthcare, global challenge a goal in Humanity for solution, services, products
  2. R&D diagnostics, Informatics to integrate data
  3. Africa and India – emerging markets with infant mortality high — develop a clinic as franchise for every price point
  4. shift from Products to Cloud-based solutions – Prevention, Diagnostics, @Home care: Neuro, Cancer, CVD
  5. Academic Institutions: Karlinska in Sweden – Stroke solution in partnership with Philips
  6. Affordability, maximum of the technology, partnership with Industry consultants, does not work everywhere, took in house the Services part and developed algorithms to assist MDs in interpretation of radiological data
  7. Patient monitoring 24×7 in ICUs,
  8. eICU – measure evolution to forcast 6 hours in advance a deterioration – highest performance, reduction 40% of death by insight from data
  9. Complex diseases created enormous data,
  10. Measuring progression of AM – AI algorithms for a digital platform
  11. Data integration, oncology patients: Genomics, Pathology, Clinical Data Scientist,
  12. R&D will be co-creation with clinical validation and publication for Market adoption
  13. Head of Radiology across several Hospitals – Better Outcomes Operations improvement due to technology
  14. Rural Africa market connected to a Hospital in a city — working on that teleconference
  15. UAE – crowdsource for nearest AED – locate incidence like UBER for CVD
  16. AI in Pathology – genomics and patient targeting – Lab in Cambridge, Big Data
1:00 pm – 1:10 pm
1:10 pm – 2:00 pm
Boston Scientific Ballroom
Global Clinical Trials: Next Generation Design and Scalability

Cardiovascular trials currently account for 10 percent of all clinical trial participants. Discussion on design and implementation of clinical studies globally, considering strategies for patient access, regulatory implications, cost containment and management of relationships with global service providers.

 

  • Chairman, TIMI Study Group, Lewis Dexter, MD Distinguished Chair in Cardiovascular Medicine, Brigham and Women’s Hospital
  1. Bar is very high, events went down, that necessitates very large studies 30,000 patients, 12 sites around the globe, acquisition of data
  2. Outcomes, where is Pharma in development of a compound
  3. Other indications that LIPIDS
  4. surrogate outcomes
  5. Diabetes: requirements mutual effect on CVD, benefit of DM drugs for CVD OutcomesGathering data on approved drugs, looking at different doses
  6. A model for dosing compounds per each patient
  7. Benefit or harm different in the US and in other sites
  8. genetics, how it inform in drug development, validation to pan out
  9. Real World evidence in 21 Affordable Act – randomize
  10. multivariable adjustment on how many variable affect the Power of the study
  • VP, Cardiovascular & Metabolic Disease Head, Global Medicines Development, AstraZeneca
  1. Patient population,
  2. new medicine vs existing registries
  3. Real World evidence include observational dat after the drug is on the market
  4. Randomization – identify population, register, randomize, collect
  • SVP, Global Clinical Research, Therapeutic Area Head, Cardiometabolic & Womens Health, MRL Lead, China R&D, Merck
  1. data from medical record
  2. investigational drugs more difficult
  • VP Cardiovascular Medicine, Covance
  1. Productive sites, approaches: Russia, Russia-Georgia, dishonest recruitment, combine resources to find sites
  2. 50% of blood analysis at sites that do not recruit at all
  3. Internal vs External validity: Early on in drug development, protocol deviation, drug MOA, variability off set by study power
  4. Patient reporting outcomes
  • Director, Division of Cardiovascular and Renal Products, Food and Drug Administration
  1. Surrogates: likely outcome endpoint for decision,
  2. CVD is difficult, graveyard of program that failed, inotropic drugs were stopped
  3. Global trial, most expensive to do in the US – in the US the care given need be comparable to the care in the US
  4. Requirement that the results will be relevant to type of care in the US
  5. Preserve randomization is key
  • VP, Cardiovascular Medicine,  Global Development, Amgen
  1. What is the hypothesis for testing, population match, understand the molecule for the modality
  2. Decode, benefits and risks – phynotype
  3. aggregation of data with investigational therapies,
  4. AI will become part of Clinical Trial
2:00 pm – 2:50 pm
Boston Scientific Ballroom
Precision Cardiovascular Medicine: What is Different This Time

Explore how precision medicine is changing the face of cardiovascular medicine specifically. The session will examine the impact of combined phenotypic and genotypic characterization on optimizing response to therapeutics, trial design, improving outcomes, and redefining reimbursement.

  • EVP, R&D, Amgen
  1. Outcomes for RAPATA – a pharmacogenomic drug
  2. Precision medicine in CVD – optimistic
  3. CVD – phynotype more determinative then genotyping vs Oncology, complex traits
  4. Bippharma moves away from big public health diseases, trials are expensive, FDA harch requirements
  5. Investors:to Biotech – works on Oncology and on Orphan drugs
  6. Methodology for targeting by using genetics are more precise
  7. In Phase III a drug where biology is very well understood
  • VP, Head Translational Medicine Merck
  1. CVD in Merck – rearrange resources in South SF on
  2. Arrhythmia: Mutation if down played causes Arrhythmia if Overexpressed causes Arrhythmia – caution in terapeutics tatgets – gene indication not to develop therapy
  3. Diastolic HF – make a drug, pick up one signaling cascade and show efficacy not in all pathways
  4. Populations that are resilient in diseases as HF
  • Assistant in Medicine, Massachusetts General Hospital
  • Assistant Professor, Harvard Medical School
  1. AF model in Translational medicine, metabolites
  2. moderately optimistic
  3. molecular phynotyping
  • Director, Cardiovascular Genetics Center, Brigham and Women’s Hospital
  • Thomas W. Smith Professor of Medicine and Genetics, Harvard Medical School
  1. Genetic in CVD – Cardiomyopathy and genetics
  2. target molecule for therapy of genetic
  3. gene mutation variants are different the genes are the same
  4. LDL receptor led to development of Statins
  5. PCSK9 was developed from genetic observation on familial
  6. protein profiles very important
  7. Genotype more informative than phynotypes
  8. Genetic tools to direct drug discovery

Kevin Hrusovsky, Quanterix

  • Biomarkers at the bedside
  • Protein of inflammation in DM – phynotype, genotype – stratify population of patients for targeting therapeutics
  • 6 inhibitions, role of protein, multiple cytokines involved
  • Head injury – diagnostics must be very quick
  • Insurance will require prevention emphasis
  • Early diagnosis is facilitated by genokmics

 

2:50 pm – 3:40 pm
Boston Scientific Ballroom
CV Investing in the Next Decade

View on investing landscape, opportunities in the CV/metabolic marketplace, the drugs, devices and diagnostics currently in pipelines and notable positive trends.

Moderator: Meg Tirrell
  • Reporter, CNBC
  1. M&A landscape
  • Managing Director, Healthcare, GE Ventures
  1. Advanced diagnostics
  2. value-based care
  3. no investment in drugs
  4. Insurance are into the Game of Data Analytics – fast adoption to become standard of care
  5. Reimbursement:  Tech investors and Healthcare investors with having in mind FDA approval process
  6. Mobile health cool: eye disease, DM, skin care ECG, few specialists in China, mobile tools
  7. Interoperability in Digital Health
  • Partner, Atlas Venture
  1. Only investment in drug discovery
  2. Segment genotypes – pure innovations as differentiators
  3. Patient Analytics, Physician-Patient SW development applications – scale broad audience – value add
  4. Focus on Medical Professions tool development for this sector
  5. Learning curve for novel productivity tools Cardiac MR – Imaging Analytics – Precision medicine not in drugs but in imaging
  6. M&A – activity 4 years time horizon, new biology new modality – risk is higher
  7. First in Class
  8. Translational Research and Drug discovery are two different beasts, doing drug development inside a basic research organization
  9. Coolest technology: CRISPR – one injection reduction in a genetic disease
  • Managing Director, US Medical Technology, Equity Research, Bank of America Merrill Lynch
  1. Medtech, CVD is exciting , i.e., Valve area, ICD, Stents, Stroke, AF,
  2. Medical devices – exciting
  3. No clear leader in Mitral Valve repair and Replacement by 2019 – approved products in Europe: Abbott, Medtronic (12), Edwards
  4. Value in the market exists for investors
  5. coolest technology: Stroke – stents in the barin
  • VP, Venture, Partners HealthCare
  1. 165million fund: Drugs, devices, diagnostics – ONLY from Partner COMMUNITY developed IP
  2. Orphan CVD driven by genomics
  3. Stratify the patients to show effects
  4. Exit for medical devices is longer than drugs with innovative business models
  5. Wearables are medical devices
  6. Data will be huge and valuable
  7. Skill set needed for Drug discovery and Academic science — DOES work well in one place
  8. Editas – Academic Center: Innovations everywhere
  • Managing General Partner, Frazier Healthcare Partners
  1. Drug development investment in early stage and in late stage
  2. Focus opportunities
  3. 3 to 5 years time horizon
  4. $50 – $60million investment range
  5. FDA – is central to HC investment
  6. FDA – changed regulation to enable antibiotics development
  7. FDA in Oncology – risk reward equation – FDA played great role in drug development
  8. Leukemia, non-Hodkin Limphoma
3:40 pm – 4:30 pm
Boston Scientific Ballroom
CLINICAL HIGHLIGHT: Optimizing Care for the 51%: New Market Opportunities

Introduction: Cathy Minehan, Chair, MGH Corporation

Address implications of gender as a key biological factor for personalized medicine. Stroke is likely to be the first cardiovascular event, tied to AF and secondarily to hypertension. Opportunities for medication utilization and optimization in context of, manifestation of disease and understanding the biology, complications, strategies to collect relevant clinical evidence, and treatment response.

 Nancy Brown,
  • CEO, AHA
  1. Biology or bias
  • Director, Center for Arrhythmia Prevention, Brigham and Women’s Hospital
  • Professor of Medicine, Harvard Medical School
  1. Focus on Women
  2. Diagnostics requires women – large trials and power studies by gender
  3. CRT,
  4. Optimizing care for Women
  5. EF, CHF, MI are prevalent in Women
  6. Migraine in Women – related to CVD
  • EVP & Head, Global Commercial Development, Mylan
  1. Information on differences between women and men – Cholesterol
  2. Woman present with different symptoms – more progress because care is delayed
  3. Stable angina and zero plaque cardiac rehab
  4. Female specific guidelines
  5. wholistic approach, girl scouts as a start
  • CV Therapeutic Area Lead, Global Business Development, Pfizer
  1. Number of women in trials? 25% – how to extrapulate from this data?
  2. How to design trials, powering, endpoints, clinical trials, FDA – mandates reporting of Women representation in studies
  3. Data Gap – retrospective study – 30% women, guidelines based on 70% Men data
  4. Awareness – who is the PCP to close the Gap
  5. OBGYN is often the PCP, the only Annual a Women goes to
  6. Precision medicine in Women, what is actionable what is not
  7. Harness Phynotypic leverage repository
  • Medical Director, Boston Scientific
  1. Women vs Minority Women – Improvement will occur if tools and strategies will represent all demographic
  2. Accurate measurements, Women participation in trials, Latinos, Minority Women – not as % in the population
  3. best practices and guidelines
  4. Awareness, nosea and fatigue as symptoms,
  • Co-Director, MGH Heart Center Corrigan Women’s Heart Health Program, Massachusetts General Hospital
  • Associate Professor, Harvard Medical School
  1. Heart attacks in Women and prevention, awareness among women
  2. Impact of Pregnancy: Preeclemxia, HTN, DM, hematologic disease, small gestation newborn, Minority Pregnant women – diet
  3. 30% less referred for Aortic stenosis or transplantation
  4. Care for Patient vs Episodic Care
  5. Stress in Women – metric to measure in PCP
  6. AI to be used in referral based on Medical data
  7. Migrane – several medications need to be studied on Women with the disease
4:30 pm – 5:20 pm
Boston Scientific Ballroom
Disruptive Therapeutic Platforms: New Tools, New Outcomes

Recent advances of biological drugs have broadened the scope of therapeutic targets for a variety of human diseases. This holds true for dozens of RNA-based therapeutics currently under clinical investigation for diseases including heart failure. These emerging drugs could be considered in context of genomic/germ line screening, family history and epigenetics.

Moderator: Tony Coles, MD
  • CEO, Yumanity Therapeutics
  1. one of three death in the World
  2. Limb Ischemia
  • CEO, Moderna
  1. mRNA, clinical stage, published Human data Immuno oncology, VGEF therapeutics after MI
  2. Recombinant VGEF, PK goes to the heart mascle if goes to serum is degraded by nucleatase
  3. Post MI in pigs, Phase I, Phase II
  4. Chronic response formulation short half life (6 days)
  5. Step by step, get the right protein
  6. Cardiology – mRNA drug for one patient
  • CEO, Editas Medicine
  1. CRISPR technology – translational medicine changes in DNA
  2. viral vector therapy delivery: Eye liver, blood — easier for delivery
  3. Immune response from delivery of CRISPR molecule: control over the time response of the molecule: Immunogenicity
  4. Using biology knowledge
  • Center for Cancer Immunology, Massachusetts General Hospital
  • Member of the Faculty of Medicine, Harvard Medical School
  1. Cancer Immune response plays a role
  2. CVD and the Immune System: Transfer from Oncology to CVD: Mutations on genes mutations are not silent to the immune systems — development of Vaccine
  3. Oncologists  in lung cancer saw immune response against their own tumors
  4. macrophage in the heart
  • CEO, Alnylam
  1. CVD Program – Phase III
  2. PCSK9 – as a target genetically defined mutation, Hyper-cholesteronemia – subcutaneous delivery – Lowering LDL by bi-annual injection or quarterly – non-complaint with Statin
  3. ADVANCED medicine for CVD
  • Founder, AnGes
  1. Gene therapy – pipeline of 8  –
  2. DNA Vaccine for HTN
  3. Muscular therapy – Ischemia
  4. CVD – Reduction comorbidity and mortality
5:20 pm – 6:00 pm
Novartis Foyer

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