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Archive for the ‘Scientific & Biotech Conferences: Press Coverage’ Category


17th Annual EmTech @ Media Lab, MIT – November 7 – 8, 2017, Cambridge, MA – This Year’s Themes, Speakers and Agenda

MIT Media Lab
Building E14
75 Amherst Street 
(Corner of Ames and Amherst)

Themes:

  • Business Impact
  • Connectivity
  • Intelligent Machines
  • Rewriting Life
  • Sustainable Energy
  • Meet the Innovators Under 35

Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston

pharma_bi-background0238

will cover in REAL TIME

The 17th annual EmTech MIT – A Place of Inspiration, November 7 – 8, 2017, Cambridge, MA

In attendance, streaming LIVE using Social Media

Aviva Lev-Ari, PhD, RN

Editor-in-Chief

http://pharmaceuticalintelligence.com

@pharma_BI

@AVIVA1950

#emtechmit

 

https://events.technologyreview.com/emtech/17/?utm_medium=email&utm_source=press_list&utm_campaign=emtech2017&utm_term=conference&utm_content=press_credentials&discount=MEDIAM172B#section-about

AGENDA FOR TUESDAY, NOVEMBER 7, 2017

  • 8:00
    Registration & Breakfast
  • 9:00
    Opening Remarks
  • 9:15
    The State of AI
  • 9:45
    Meet the Innovators Under 35
  • 10:30
    Break & Networking
  • 11:00
    AI’s Next Leap Forward
  • 12:30
    Lunch & Networking
  • 2:00
    Adapting to the reality of climate change
  • 3:30
    Break & Networking
  • 4:00
    Meet the Innovators Under 35
  • 5:30
    Lemelson-MIT Prize Honors & Reception

AGENDA FOR WEDNESDAY, NOVEMBER 8, 2017

  • 8:00
    Registration & Breakfast
  • 9:00
    What is social media doing to society?
  • 10:30
    Break & Networking
  • 11:00
    Next-generation brain interfaces
  • 12:00
    Lunch & Networking
  • 1:30
    The Future of Work
  • 2:00
    A Look Ahead: Emerging Technologies at Work
  • 3:00
    Break & Networking
  • 3:30
    Meet the Innovators Under 35
  • 5:00
    2017 Innovator Under 35 Awards & Reception

Speakers

  • Viktor
    Adalsteinsson

    Group Leader, Broad Institute of MIT and Harvard

    2017 Innovator Under 35

  • Gene
    Berdichevsky

    CEO, Sila Nano

    2017 Innovator Under 35

  • Tracy
    Chou

    Founding Advisor, Project Include

    2017 Innovator Under 35

  • Adrienne
    Felt

    Software Engineer, Google

    2017 Innovator Under 35

  • Phillipa
    Gill

    Assistant Professor, University of Massachusetts, Amherst

    2017 Innovator Under 35

  • Tallis
    Gomes

    CEO, Singu

    2017 Innovator Under 35

  • Kathy
    Gong

    CEO, WafaGames

    2017 Innovator Under 35

  • Ian
    Goodfellow

    Staff Research Scientist, Google Brain

    2017 Innovator Under 35

  • Yasmin
    Green

    Director of Research and Development, Jigsaw at Google

    Addressing Online Threats to Global Security

  • Kris
    Hammond

    Chief Scientist and Cofounder, Narrative Science

    AI’s Language Problem

  • Svenja
    Hinderer

    Scientist, Fraunhofer IGB

    2017 Innovator Under 35

  • Reid
    Hoffman

    Cofounder, LinkedIn; Partner, Greylock Partners

    The Future of Work

  • John
    Holdren

    Professor, Harvard University

    Climate Disruption: Technical Approaches to Mitigation and Adaptation

  • Joi
    Ito

    Director, MIT Media Lab

    The Future of Work

  • Mary Lou
    Jepsen

    Founder, Openwater

    Capturing Our Imagination: The Evolution of Brain-Machine Interfaces

  • David
    Keith

    Professor, Harvard University; Founder, Carbon Engineering

    The Growing Case for Geoengineering

  • Neha
    Narkhede

    Cofounder and CTO, Confluent

    2017 Innovator Under 35

  • Andrew
    Ng

    Founder, Deeplearning.ai; Adjunct Professor, Stanford University

    The State of AI

  • Tomaso
    Poggio

    Investigator, McGovern Institute; Eugene McDermott Professor, Brain and Cognitive Sciences, MIT

    Understanding Intelligence

  • Olga
    Russakovsky

    Assistant Professor, Princeton University

    2017 Innovator Under 35

  • Michael
    Saliba

    Marie Curie Fellow, EPFL

    2017 Innovator Under 35

  • Gang
    Wang

    Chief Scientist, Alibaba

    2017 Innovator Under 35

  • Jianxiong
    Xiao

    Chief Executive Officer, AutoX, Inc.

    2017 Innovator Under 35

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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

Read Full Post »


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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Highlights of LIVE Day 1: 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/

 

Monday, May 1, 2017

7:00 am – 8:00 am
Lilly Foyer
8:00 am – 11:30 am
Pfizer Ballroom
First Look: The Next Wave of Cardiology Breakthroughs

Harvard Medical School investigators describe their most promising work in rapid fire presentations highlighting commercial opportunities in cardiovascular and cardiometabolic care. Nineteen rising stars from Brigham and Women’s Hospital and Massachusetts General Hospital will present in 10-minute sessions.

For a full look at speakers and presentations, please visit the Highlight’s page.

Early career Harvard Medical School investigators kick-off the World Medical Innovation Forum with rapid fire presentations of their high potential new technologies. Nineteen rising stars from Brigham Health and Massachusetts General Hospital will highlight in ten-minute presentations their discoveries and insights that will be the disruptive cardiovascular care of the future. This session is designed for investors, leaders, donors, entrepreneurs and investigators and others who share a passion for identifying emerging high-impact technologies. The top presenter each from BWH and MGH will be awarded the Austen-Braunwald Innovation Prize on Day 2 of the Forum. The prize carries a $10,000 award.

Novel Target Discovery Pipeline for Calcific Aortic Valve Disease
Elena Aikawa, MD, PhD
Director, Heart Valve Translational Research Program, Brigham and Women’s Hospital; Associate Professor of Medicine, Harvard Medical School

  • Aortic stenosis is a progress of Calcific Aortic Valve Disease (CAVD) – 80,000 patients – sole solution is surgery
  • Imaging methods for visualization of microcalcification formation: MRI, PET/CT, CAVD Gene network, proteomics heat mapNIRF imaging, microdissection, histology, Tissue layers cells
  • Serum Sortilin associated with aortic calcification and CVD risk
  • Discovery pipeline and CAVD Mapping

A zebrafish pipeline for cardiovascular precision medicine
Manu Beerens, PhD
Postdoctoral Research Fellow, Brigham and Women’s Hospital; Harvard Medical School

  • Cardiomyopathy – group of cardiac disorders: CHF, Atherosclerosis, metabolic syndrome, AF
  • Zebrafish at the forefront of CVD Precision Medicine
  • Luciferase activity vs ttn
  • high throughput screening to identify naxos modifiers
  • Endpoints: BNP levels Cardiac contractility

Using zebrafish to understand and harness cardiac regeneration

Caroline Burns, PhD
Associate Biologist, Massachusetts General Hospital; Associate Professor of Medicine, Harvard Medical School

  • Heart regeneration
  • Regenerative hearts vs Non-Regenerative hearts
  • How cardiomyocytes proliferation induced following injury
  • Uninjured, 1 day after, 7 days after,
  • Failure to regenerate is related to failure of myoocardial proliferation
  • Genetic factors required for myocardial proliferation
  • myocardial proliferation – by Chromatin – mononuclear >4c ploidy
  • Mononuclear in Human Heart – as research target
  • How to promote myocardial proliferation
  • Small molecule as enhanced to drive proliferation

Bioactive Lipid Profiling Can Identify Potential Targets for Altering Life Course Trajectories Toward Cardiometabolic Disease
Susan Cheng, MD
Associate Physician, Brigham and Women’s Hospital, Partners HealthCare; Assistant Professor, Harvard Medical School

  • Bioactive Lipids
  • Endogenous and exhaugenous factors
  • Biochemical intermediates
  • mechanisms
  • health and disease outcomes
  • Small lipid Mediators of Upstream: Eicosanoids and Incidence of Diabetes as Targets for Present and Future
  • cardiometabolic risk in future early vs late prediabetes, and DM
  • shared pathways
  • Statins favoral response
  • Stree or Injury
  • Linoleic Acid
  • Disease and Phynotyping specific investigations
  • dosing

 

Small Molecule Predictors of Outcome After Cardiac Interventions
Sammy Elmariah, MD
Assistant in Medicine, Massachusetts General Hospital; Assistant Professor of Medicine, Harvard Medical School

  • Valvular heart disease – elderly, Aortic valve stenosis leads to failure of compensatory ventricular activity of dysfunction
  • small molecule
  • fiadnostics biomarkers
  • Acute kidney injury due to metabolite, adenohomosestine
  • validate the model – after METABOLITE data is added to the risk classification
  • Personalizing the timing of Valve Intervention
  • Biomarkers in blood predicts systolic function, EF,
  • Metabolite-Driven clinical trial of Aortic stenosis
  • TAVR

Translational trials in microRNAs
Mark Feinberg, MD
Physician, Brigham and Women’s Hospital; Associate Professor of Medicine, Harvard Medical School

  • non-coding RNA Biologics – 98% of the genome
  • 2% are coding
  • MiRNA therapeutics for Atherosclerosis
  • MiRNA – Replacement Therapy- ApoE-?-NGL
  • Cholesterol, LDL
  • Vascular endothelium: Inflammation, HF, Diabetic wound healing – tissue thickness
  • Example: IncRNA, Example3: miR-26a – BMP-SMAD1-ID1-p21
  • 3 platforms for targeting non-coding RNAs in CVD:
  1. peptide-conjucated nc-RNA
  2. Ab-conjugasted nc-RNA

 

New approaches to controlling stem cell fate
Yick Fong, PhD
Research Scientist, Brigham and Women’s Hospital; Assistant Professor of Medicine, Harvard Medical School

  • controlling Stem cell fate by Transcription Factors
  • Pluripotent, fibroblasts – transformed into Bone, nerve, heart, pancreatic cells
  • This process is randon and inefficient
  • GOAL: Transplantation, drug/therapeutic screens
  • Cellular identity and function
  • In Vitro Reconstruction of cell-type specific Transcription
  • Identify Disease mechanism of Heart disease by mutation that cause disruptionCo-regulators disruption

 

Exercise Prescription to Improve Cardiovascular and Cancer Outcomes in Cancer Survivors
John Groarke, MD
Cardiologist, Brigham and Women’s Hospital; Instructor of Medicine, Harvard Medical

  • cancer survivers have risk for CVD
    Metabolic Equivalent ((METS)
  • METS is the highest to lower CVD in Cancer survivors
  • Onco-cardiac rehabilitation
  • Increase excercise performance vs physical de-conditioned state
  • Cardioprotection to mitigate CV Toxicities of cancer therapy

Personalizing Diabetic Management with Hemoglobin A1c
John Higgins, MD
Associate Pathologist, Massachusetts General Hospital; Associate Professor, Harvard Medical School

  • Non glucose factors that affect A1C
  1. RBC Age span – if circulate live longer accumulates more glucose
  2. AstraZeneca, Eli Lilly, Novo Nordics – ALL conduct clinical trials to lower A1C
  • Personalize DM Management
  • Using existing assays with the RBC Age adjustment — for achieving better future Outcomes
  • Device Manufacturers to adjust the device

Characterizing an Early HeartFailure pulmonary EF (HFpEF) Phenotype: Cardiometabolic Disease and Pulmonary Hypertension
Jennifer Ho, MD
Assistant Physician, Massachusetts General Hospital; Member of the Faculty of Medicine, Harvard Medical School

  • Ejection Frunction in Pulmonary Hypertension (PH)
  • Obesity >–>>> PH recapitulates human HP
  • PAECs – Molecular mechanisms – Pulmonary Artery #Endotheline Cells
  • P13K/Akt (Insulin) — AMPK  (Metformin) –>> eNOS — >> Vasodilation
  • Study ex-vivo PAEC from patients with HFpEF
  1. HFpEF subphenotypes
  2. drug therapy
  3. screening

Genetic Risk, Adherence to a Healthy Lifestyle, and Coronary Disease
Amit Khera, MD
Cardiologist, Massachusetts General Hospital; Instructor, Harvard Medical School

  • Integration of Genetic data and CVD data
  • GWAS –>> 60 variants associated with coronary risk
  • Polygenic genetic risk score
  • Risk for MI: Genetic risk Interpretation: Monogenic vs Polygenic
  • High risk comes from polygenic risk: Smoking, Obesity, Excercise, Health diet
  • Healthy lifestyle “corrects” genetic factor

Monogenic:

  • Hypercholesterolemia
  • Trycleceride
  • increased lipoproteins _ ASA Lp(a) inhibitors

Polygenic

  • life style, diet excercise
  • medicationS: Statins

A Novel Epigenetic Complex Implicated in Thoracic Aortic Aneurysm (TAA)
Mark Lindsay, MD, PhD
Physician, Massachusetts General Hospital; Assistant Professor, Harvard Medical School

  • Thoracic Aortic Aneurysm
  • Aortic dissection
  • VSCULAR SMOOOTH MUSCLE CELLS in the aorta’s leaves – neo-intima damage vs knockout MALAT1 – nepangiogenesis
  • GENETIC MUTATIONS as Biologic Probes
  • GENE: HDAC9 – BRG1, MALAT1 (RNA) – STRESS in aortic homeostasis
  • Aortic root and Ascending Aorta
  • Elastin and colagen

 

Atrial Fibrillation: Genetic Basis and Clinical Implications
Steven Lubitz, MD
Cardiac Electrophysiologist, Massachusetts General Hospital

  • 6 million in US 34 Million WOrldwide
  • Leading cause of stroke
  • AF is hard to diagnose
  • preventable with anticoagulation
  • AF is Familial and inheritable
  • Genetic Variation associated with AF – genetics stratified risk
  • AF Screening: as Stroke prevention – AliveCor
  • electronic health records are powerful repositories
  • AF genetic risk – as a Biomarker
  • Technologies for screening

Targeting Vascular Calcification to Prevent Cardiovascular Disease
Rajeev Malhotra, MD
Staff Cardiologist, Associate Medical Director of the Cardiac Intensive Care Unit, Associate Director of the Cardiopulmonary Exercise Laboratory, Massachusetts General Hospital; Instructor in Medicine, Harvard Medical School

  • Vascular Classification: Atherocalcification Vascula r disease
  • plaque destabilization
  • coronary and aortic
  • HUMAN GENETICS Studies: GWAS
  1. Genotype
  2. Aortic CT
  3. Identify Potential Genes, increase expression associated with classification
  4. Functional-Mechanical Studies: smooth muscle cell – more proliferative vs more contractile
  5. control vs inhibition
  6. Human model of Vascular classification vs Mouse Model
  7. Disease of Vascular classification: Calxiphylaxis – HEMODialysis patients – >50% mortality within 1 year of diagnosis
  8. Drug development and Clinical Trials

Stratifying Exercise Dysfunction
Bradley Maron, MD
Association Physician, Brigham and Women’s Hospital; Assistant Professor, Harvard Medical School

  • Exercise Dysfunction: Complex Pathophynotype
  • iCPET: O2, exercise capacity, Pulmonary function, Hemodynamics, Invesive cardiac performance,
  • NEW SYSTEM DESIGNED: Network-Based Clinical Risk Calculator by Four Clusters – Network determine cluster assignment
  • Point of care tool – integrate into iCPET
  • Provides insights into HTN, Valvular, Myocaritis, cardiomyopathy
  1. Pulmonary
  2. exercise capacity
  3. ventilation perf
  4. o2 transport
  5. Invasive cardiac

Novel Mouse Models of Remote Cardioprotection
Benjamin Olenchock, MD, PhD
Cardiovascular Medicine Specialist, Brigham and Women’s Hospital; Instructor in Medicine, Harvard Medical School

  • Ischemic Preconditing
  • Remote limb BP Cuff in pig prevented Ischemia in heart
  • Cell death is multi cell types and cell death
  • EGLN – succinate +CO2 – Transciptional Hypoxia responses
  • EGLN Inhibitor: Systemic Egln1 deletion vs Skeletal Muscle Egln1 Deletion – Study of Cardiac Protection
  • Cardioprotective Mediators: Tissue Hypoxia ++>> Altered hepatic Tryptophan Metabolism —>> Cardioprotection
  • Tumor xenograph

Harnessing Endogenous Mechanisms of Programmed Gene Expression for Therapeutic Benefit In Cardiometabolic Disorders
Jorge Plutzky, MD
Director, Preventive Cardiology, Cardiovascular Medicine, Brigham and Women’s Hospital

  • PPARs
  • RXR, RAR – Retinohyde –>> Retinoic Acid
  • Transcription factors: Physiology and Pathology
  • PPARalpha  <<<<—- Lipase, Lipid sustrate
  • Epigenetic Code
  • Histone Readers: Selective Inhibition of Tumor Oncogenes by DIsruption Enhancing ranked by BRD4 signal: Chemotaxis, adhesion, Migration, Thrombosis, Inflammation
  • Atherosclerosis: Knows protein, Unknown protein: Promoters, enhancers

 

Aging and the activin type II receptor pathway: a new target for heart failure therapy?
Jason Roh, MD
Assistant in Medicine, Massachusetts General Hospital; Instructor, Harvard Medical School

  • AGING and CVD – it is part of pathophysiology – CATABOLIC PROCESSES
  • Organ level

muscle waist, atropy –>> impaired function: Hand grip strength, walk speed —->> HF, systolic and diastolic Strain rate

  • Cell level: Isotype Abvs ActRII Ab

contractility, Seen in HF models and HFpEF

  • Activin-A decreases with AGE

Signaling and pulmonary vascular disease – PAH
Paul Yu, MD, PhD
Physician, Brigham and Women’s Hospital; Associate Professor of Medicine, Harvard Medical School

  • FIBROSIS: TGF
  • OSTEOGENESIS ANTI-APOPTOSIS
  • Activin/TGFBeta —>>> BMP9 (ALK1c)
  • Loss od signaling
  • Inflammation
  • high shear stress
  • PAH
  1. Idiopathic: Sporadic or heritable
  2. Associated PAH: Scleroderma or lupus
  • Dysregulated angiogenesis– Anti VEGF165 – Zr-bevacizumab – Using PET-CT
11:45 am – 1:05 pm
7th Floor
Discovery Café Breakout Sessions: Sharing Perspectives

Seven intensive workshops led by our top faculty will address cutting-edge cardiovascular topics. Seating is reserved at the point of registration. Lunch included.

Topics to be covered include:

  • Cardiac Replacement Therapy: The Next Ten Years
  • Heart Failure: Back in The Game through New Pathways
  • Payment Models: Provider’s Perspective
  • Molecular Imaging: New Biological Endpoints – Function Over Structure
  • Open Innovation in Medical Devices: What is it? What Are the Barriers?
  • Wearables for Cardiovascular Health:  How to Validate and Integrate in Care Paths?
  • Image Based Artificial Intelligence: Which Cardiac Disease Segments and Why?

For a full list of speakers, please visit the Highlight’s page.

Seven intensive workshops led by our top faculty will address cutting-edge cardiovascular topics. Seating is reserved at the point of registration. Lunch included.

Panels

Cardiac Replacement Therapy: The Next Ten Years- Great Republic | 7th Floor

  • Introducer: Seema Basu, PhD, Market Sector Leader, Partners HealthCare
  • Garrick Stewart, MD, Associate Physician, Medical Director, Mechanical Circulatory Support Unit, Brigham and Women’s Hospital; Instructor in Medicine, Harvard Medical School
  • Erin Coglianese, MD, Medical Director, Mechanical Cardiac Support Program, Massachusetts General Hospital

Heart Failure: Back in The Game through New Pathways- Essex North | 3rd Floor

  • Introducer: Dan Castro, Managing Director, Licensing, Partners HealthCare
  • Anju Nohria, MD, Director, Cardio-Oncology Program, Cardiovascular Medicine Specialist, Brigham and Women’s Hospital
  • Christopher Newton-Cheh, MD, Cardiologist, Heart Failure and Transplantation, Massachusetts General Hospital

Payment Models: Provider’s Perspective- North Star | 7th Floor

  • Introducer: Sepideh Hashemi, Market Sector Leader, Partners HealthCare
  • Thomas Gaziano, MD, Associate Physician, Cardiovascular Medicine, Brigham and Women’s Hospital; Assistant Professor, Harvard Medical School
  • Jason Wasfy, MD, Assistant Medical Director, Massachusetts General Hospital; Assistant Professor, Harvard Medical School

Molecular and Advanced Imaging: New Biological Endpoints – Function Over Structure- Baltic | 7th Floor

  • Introducer: Glenn Miller, PhD, Market Sector Leader, Partners HealthCare
  • Marcelo Di Carli, MD, Chief, Division of Nuclear Medicine and Molecular Imaging, Brigham and Women’s Hospital; Professor of Radiology and Medicine, Harvard Medical School
  • Farouc Jaffer, MD, PhD, Director, Coronary Intervention, Cardiac Catheterization Laboratory, Cardiology Division, Massachusetts General Hospital, Associate Professor of Medicine, Harvard Medical School
  • Sharmila Dorbala, MD, Director, Nuclear Cardiology, Brigham and Women’s Hospital; Associate Professor of Radiology, Harvard Medical School

Open Innovation in Medical Devices: What is it? What Are the Barriers?- Essex South | 3rd Floor

  • Introducer: Pat Fortune, PhD, Vice President for Market Sectors, Partners HealthCare
  • Elazer Edelman, MD, PhD, Senior Attending Physician, Brigham and Women’s Hospital; Professor of Medicine, Harvard Medical School; Thomas D. and Virginia W. Cabot Professor of Health Sciences and Technology, MIT
  1. Mortality of cardiovascular disease declines as a result of Medical Innovations as Devices
  2. Are innovations tappering off or New ones are coming??
  • Bruce Rosengard, MD, Chief Medical Science and Technology Officer, Johnson & Johnson Medical Devices Companies
  • Ronald Tompkins, MD, Director, Surgery, Innovation & Bioengineering, Massachusetts General Hospital; Sumner M. Redstone Professor of Surgery, Harvard Medical School

ALL

  1. Solution for Heart Failure – low hanging fruit was picked already – a workabke artificial heart more important than another Stent
  2. Large scale Programs better than multiple PI small grant applications, many are not innovating, conflict of interests, Academia and Industry relations
  3. 99% get better with a device but 1% is been harmed
  4. FDA – overworked Underfunded 52 applications reviewed per employee

 

Wearables for Cardiovascular Health:  How to Validate and Integrate in Care Paths?- Parliament/Adams | 7th Floor

  • Introducer: Thomas Aretz, MD, Vice President, Global Programs, Partners HealthCare
  • David Levine, MD, Home Hospital Director, Brigham and Women’s Hospital; Fellow in General Internal Medicine, Harvard Medical School
  • Kamal Jethwani, MD, Senior Director, Connected Health Innovation, Partners HealthCare; Assistant Professor, Dermatology, Harvard Medical School
  • Paolo Bonato, PhD, Director, Motion Analysis Laboratory, Spaulding Hospital; Associate Professor, Harvard Medical School

Image Based Artificial Intelligence: Which Cardiac Disease Segments and Why?  Empire | 7th Floor

  • Introducer: Trung Do, Vice President, Business Development, Partners HealthCare
  • George Washko, MD, Associate Physician, Brigham and Women’s Hospital; Associate Professor of Medicine, Harvard Medical School
  • Mark Michalski, MD, Director, CCDS, Brigham and Women’s Hospital, Massachusetts General Hospital
 
 
1:05 pm – 1:30 pm
1:30 pm – 1:35 pm
Boston Scientific Ballroom
Opening Remarks Christopher Coburn
Introduction by: Anne Klibanski, MD,
  • Chief Academic Officer, Partners HealthCare
  • Laurie Carrol Guthart Professor of Medicine, Academic Dean for Partners, Harvard Medical School
  • CEO, Partners HealthCare
1:35 pm – 1:55 pm
Boston Scientific Ballroom
Reinventing Cardiac Care

Two renowned clinical leaders provide an overview of the medical and economic challenges that cardiovascular and cardiometabolic disorders present.

They will highlight strategic direction in cardiac research and clinical care at Partners, and address how recent trends in investment, regulation, and policy may be dovetailed with efforts at Partners.

The experts also spotlight for attendees the various therapies, diagnostics, devices, and critical issues that will be discussed throughout the upcoming 2.5 days of the World Medical Innovation Forum.

  • Chief of Cardiovascular Medicine, Brigham and Women’s Hospital
  • Associate Professor of Medicine, Harvard Medical School
  1. New drugs: Molecular targets, Monoclonals, alternative to Statins
  2. devices implantable
  3. IT and EMR, BI
  4. Integration of Innovations, Clinical and Translational
  • Chief, Cardiology Division, Massachusetts General Hospital
  • Professor of Medicine, Harvard Medical School
  1. Aging and longevity of CVD Patients will increase the expense on CVD as disease
1:55 pm – 2:45 pm
Boston Scientific Ballroom
CEO Roundtable: Today’s Learning, Tomorrow’s Opportunities

Discussion on contribution of technology innovation to the treatment of cardiovascular disease reflecting on lessons and how they shape investment decisions.

Moderator: Benjamin Pless
  • Executive in Residence, Partners HealthCare Innovation
  1. Electrical physiology: implantable paceamker – first 1958, lead to RV, last 10years th enetire pacemaker implanted in the heart no leads. Surgical TAVR, Implantabke to Mitral valve
  • CEO, GE Healthcare
  1. Healthcare data, Analytics, data integration, machine learning, mapping efficiency,
  2. Data analytics is Present, Devices was the Past
  3. Shorten cycle of learning
  • CEO, Abiomed
  1. 20X of revenue growth since 2010
  2. HEART PUMP – only FDA approached for recover the heart, pump blood out of the heart
  3. Tracking ALL patients not samples – ALL Outcomes, all patients
  4. HF – 24×7 employees of Abiomed in labs in Hospitals, 5 years after heart attack, another attack 30% dies
  5. Protocol and standards
  • CEO, Edwards Lifesciences
  1. TAVR device no need for open heart surgery
  2. Selling services – heart-lung machine: Perfusion is a product and Service
  3. Structural heart disease – multiple innovations
  • CEO, Bard
  1. Oncology, Vascular, Urology, PDA
  2. Business model failure – clinical economic point of view
  3. Start up community and acquisitions – platforms for further investments
  • EVP, Clinical Advancement, UnitedHealth Group – Payer’s perspective
  1. Health Benefits
  2. Optum – Data to improve care,
  3. 30% of cost of care is WASTE, eliminate this cost item
  4. Heart transfer: Innvation cycle
  5. Collaboration with Pharma and with Devices: Data Analytics – fee for service vs Value Model – Total cost may be less
2:45 pm – 3:35 pm
Boston Scientific Ballroom
Tackling the AFib Epidemic

Evolving trends in diagnosis, prevention, and treatment of atrial fibrillation. Factors that will influence patient care over the next 5 years are considered, including risk stratification, procedure and technology options, and potential implications of CMS policies, such as bundling.

 

  • Associate Chief, Cardiology Division, Massachusetts General Hospital Heart Center
  • Professor of Medicine, Harvard Medical School
  1. HF treated by five drugs
  2. 3Million Patients in 2050 20Million Patients to experience HF
  3. Heart Rate – Rythm control in normal renge
  4. ablation surgery
  5. Prevention of Strokes
  6. AF: Chronic, persistent
  7. Risk is transferred to the providers
  8. Genetic profiling for early detection
  9. Going upstream for the Genetics and the Prevention
  • Director, Cardiac Arrhythmia Service, Massachusetts General Hospital
  • Associate Professor, Harvard Medical School
  1. AF in Men with Prostate Cancer and Women with Breast Cancer
  2. Pathological issues
  3. Cardiovergent or not
  4. poor definition of the AF underpinning
  5. NEW type of anticoagulation Safer that Warfrin
  6. 2/3 of AF are not on anticoagulation: Patient preference, doctor preference related to intolerance
  7. Screening AF with Genetics
  • VP, GM, AF Solutions, Medtronic
  1. AF 26Billion spend in the Hospitals
  2. Outcome improvement
  3. Lowering AF burden is very beneficial – endpoint of freedom of 30 seconds of AF for patient with comorbidities
  4. AF – multiple CV diseases
  5. Identify AF earlier – US not labeled product for AF Patient, outcome data needed
  6. drug management – which patient will benefit: help only patients that will benefit not any patient
  7. Wholistic view of AF
  • VP, Global Health Policy, Boston Scientific
  1. Payment reduction,
  2. Chronic condition with Acute episodes, post procedure
  3. life style modification
  4. Benefits last 3 years, then they come back
  5. Payers and MDs will ask for changes in life style for chance of success [weight reduction reached to qualify for knee replacement]
  6. Frint end and backend improvement – room to be optimistic
  • President, Cardiovascular and Neuromodulation, Abbott
  1. AF – inprovement of Patient quality of life
  2. extended patient life
  3. Innovation solutions : Improve Clinical outcomens and cost care reduction final Goal: CURE
  4. Each patient need the entire Tool Box creation of multiple tools
  5. Devices – how is the value determined? value delivered along a time span not insinq with cost
  6. Innovation in patient active participation in health management – tracking by Step,
  7. Incremental innovations
  • VP US Medical Affairs, CVMD TA, AstraZeneca
  1. Drugs for AF, biology of the disease little advancement, durg approach – understand the biology of the disease and streamline approach
  2. Disease progresses, remission,
  3. Is there a Biomarker as predictor for development of AF? delay onset of AF
  4. HTN is a potential cause of AF not in all cases
  5. Sleep Apnea, life style predictors of AF
  6. Drugs do not work have high toxicity for Arrhythmia 50% reduction in AF 25% placibo reduction – wrong target – Channels is not the right target
  7. Genomics and Biology — need to understand the disease better
3:35 pm – 4:05 pm
Boston Scientific Ballroom
1:1 Fireside Chat: Omar Ishrak, PhD, CEO, Medtronic
Moderator: Paul LaViolette
  • Managing Partner & COO, SV Life Sciences Advisers
  1. Technology and Value
  2. M&A
  3. Disease pathway
  • CEO, Medtronic
  1. Innovations are the essence of Medical Devices development as mission in technology
  2. Training Challenge in Surgical Robotic – patient comfort of minimal invasive therapy, cost lower
  3. Antibacterial sleeve saves cost of hospitalization, id infection occur Medtronic reimburses Hospital
  4. Respect of NOT INVENTED HERE – internal and external
  5. M&A 0 TAVR internal development THEN acquisition, HTN – acquisition did not work
  6. DIABETIC PUMP  – investment in R&D over 15 years
  7. Care management as Services – therapy and care management
  8. Technology company paid when it is delivered: understand cohorts,
  9. Strategy: Chronic Disease: AF, ablation is needed –
  10. Strategy: episodic care – success of intervention and the recovery from acuity, HF compensation in early stageCRT – hospitalization one year after the intervention is not acceptable
  11. 9 and 10 are measuring outcome differently
  12. Mitral Valve – platform for new generation of diagnostics
  13. ETERNAL: recover fast, improve outcome
4:05 pm – 4:55 pm
Boston Scientific Ballroom
Heart Failure’s Therapeutic Mandate

One million patients are hospitalized annually for HF—80% of total US cost of HF management. After discharge from HF hospitalization, 24% are rehospitalized within 30 days, greater than 50% within 6 months. Perspective on disease management, addressing the issues of hospital readmission and optimizing therapies.

 

Moderator: Akshay Desai, MD
  • Director, Heart Failure Disease Management, Brigham and Women’s Hospital
  • Associate Professor, Harvard Medical School
  1. How to leverage Big data
  2. Need for new therapies – collaboration of Academia and Pharma and Hospital
  • VP and Medical Director, Abbott
  1. HF – number of patient will double as Population grows and ages
  2. Pharmacogenetics will explain the pathophysiology
  3. Longterm management by specialist is important vs by PCP
  4. How do we randomize trials
  5. REIMBURSEMENT is key
  6. Glory of being persistant
  • VP, Global Translational Medicine Head (CVM), Novartis Institutes for BioMedical Research
  • Senior Lecturer, Harvard Medical School
  1. HF – lags behind
  2. heterogenous disease
  3. Preserve EF
  4. Genomics data collected on large population
  5. Big data is here, genotype, phynotypes,  – high quality data sets translation od data to therapeutics is coming
  6. Biomarkers important for endpoints
  7. Impresco – HF Drug with 20% improvement in EF
  • CMO, Myokardia
  1. HF – genetic and cellular level needed – in Oncology this is basic
  2. Precision medicine requires, devices to download CMR Cardiovascular magnetic resonance imaging (CMR), – data on fibrotics
  3. diagnosis etiology of HF is complex
  4. Preclinical trials are very important for early insights
  5. Younger patient with cardiomiopaty and older patient
  • SVP, CMO, Global Health Policy, Rhythm Management, Boston Scientific
  1. CHF is s clinical Syndrome,
  2. Telemeter physiologic information
  3. Physiology of HF – is well understood vs AF
  4. Translation of pathophysiology to therapeutics NOT YET accomplished
  5. Impending HF – device better that BP by MS
  6. Combination of therapies – what strategies yield best outcome, 20,000 participants in Clinical Trials is the wrong practice
  7. Translational science fails when clinical trials fail
  8. Need to be in the long haul, there is a model to be successful
4:55 pm – 6:00 pm
Boston Scientific Ballroom
CLINICAL HIGHLIGHT: A New Chapter of PAD

PAD is the most challenging atherosclerotic syndrome, largely due to the technological challenges of managing peripheral artery disease through minimally invasive strategies. Top physician, governmental, and industry leaders in the field discuss the potential for new breakthroughs including novel implantable devices, pharmacologic approaches, and reductions in associated cardiovascular morbidity and mortality.

The panel will also discuss, Below The Knee: The Persisting Unmet Need

 

Moderator: Michael Jaff, DO
  • President, Newton-Wellesley Hospital, Partners Healthcare
  • Professor of Medicine, Harvard Medical School
  1. Reimbursement strategy for PAD
  2. Congratulate CMS for covering PAD
  3. Clinical Trial design for devices for PAD – limitations as to what to propose to FDA and CMS
  • Director, Cardiology and Interventional Cardiology Fellowship Programs, Massachusetts General Hospital
  • Assistant Professor of Medicine, Harvard Medical School
  1. Nine million patient PAD
  2. systemic therapy, early access to care, arterial insufficiancy, better vascularization
  3. Modification diet for atherosclerotic disease – Mediterranean diet – conselling patients on a regular basis
  4. training operator – baloons is a game changer
  5. durable patency – no need to go back
  6. systemic burden od atherosclerosis
  7. Public recognition of PAD as an important complex disease
  • Director, Coverage and Analysis Group, CMS
  1. coverage incentives in the payment system
  2. design trials with FDA and CMS to ensure approval and reimbursement – know early
  3. Evidence-based tool, quality measure group
  4. CMS approach for site of treatment/service so to be reimbursed
  5. “Reasonable and Necessary” definition for PAD treatment – CMS continue to be innovative
  6. CMS needs data to cover technology
  7. CMS wishes to work with MDs
  • Chief, Peripheral Interventional Devices Branch, Food and Drug Administration
  1. heterogeneity, lack of data
  2. devices approval require consistent data, collaboration with NIH, CMS – design meaningful trials
  3. Match patients and match treatment
  4. mulriple companies work with FDA – FDA is willing to accept treatment, benefit and the labeling claims
  5. Early contacting FDA
  • CMO, Cardinal Health
  1. neuronal claudication vs vascular claudication
  2. continnum of care
  • Co-Director, Endovascular Surgery, Brigham and Women’s Hospital
  • Assistant Professor, Harvard Medical School
  • Critical Limb Ischemia (CLI)
  • 3D Printing – morphologic information on density and on patency
  • PAD is a tremendous challlenge PCI was solved PAD not yet
  • SVP and President, Peripheral Interventions, Boston Scientific
  1. ANTI peripheral therapies – above the knee and below the knee – different vessels
  2. No Consistency in wound care across institutions  – complexity on top of complexity
  3. Balance of rigorous science with adjustment by FDA
  4. Strategy – Category Leadership: not a singular technology: Bare stent, Stant and baloon and drug eluting stent
  5. PAD atherectomy
  6. Stem cells harvesting for clinical Trial – early stage research to assist patient early rather at late stage
  7. PAD Options is evolving
6:00 pm – 6:45 pm
Lilly Foyer

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LIVE – Real Time – 16th Annual Cancer Research Symposium, Koch Institute, Friday, June 16, 9AM – 5PM, Kresge Auditorium, MIT

 

REAL TIME PRESS COVERAGE & Reporter: Aviva Lev-Ari, PhD, RN

 

Summer Symposium 2017

https://ki.mit.edu/news/symposium/2017

@kochinstitute #KIsymposium @Pharma_BI @AVIVA1950

A leader in Convergence, MIT’s Koch Institute for Integrative Cancer Research will, on June 16, present its 16th annual Summer Symposium: the Convergence of Science and Engineering in Cancer Research. Convergence—the merging of historically distinct disciplines such as engineering, physics, computer science, chemistry, mathematics, and the life sciences—has created extraordinary opportunities in cancer research and care. Leaders in this emerging field will discuss innovative new approaches and technologies to better detect, monitor, treat, and prevent cancer. The symposium will also feature a panel of experts to discuss the impact of Convergence on the future of medical care.


INTRODUCTORY REMARKS

Tyler Jacks Tyler Jacks, PhD
Director, Koch Institute, MIT
David H. Koch Professor of Biology, MITLIVE – new Solutions for Cancer the mission og KI. Sponsors: Affiliates, Collaborators, Patrons, Friends, Vendors. Introduction to Prof. Sharp. 40th Anniversary of RNA related discovery leading to Nobel Prize of Prof. Sharp. 

Concluding the Symposium

  • continum
  • June 15, 2018 – NanoMedicine
  • Fall Symposium in September 2017
Phillip A. Sharp  

Phillip A. Sharp, PhD
Institute Professor, MIT
Koch Institute, MIT

LIVE – Convergence of Science and Engineering. Key note by a convergent personality – Eric Lander.

Convergence is a blueprint for innovation – NOW transformation of Life Science that follows the transformation of Physical sccience. Molecular biology – Delbruck, transmission of genetic phenotypes. Revolution of Biological Sciences in 20th Century

1st Revolution – DNA Structure, 1953

2nd Revolution – genomics Human Genome 2003

3rd Revolution – Integration of Science and the Environment in 21st Century

Such Small investment, 3.4% of NI Funding went to PI in BioEngineering 2000-2016

Introduction to Eric Lander – 1986 – to Whitehead Institute and MIT, now at Broad

KEYNOTE SPEAKER

Eric Lander

30 Years of Convergence

Eric Lander, PhD
President and Founding Director, Broad Institute of Harvard and MIT
Professor of Biology, Department of Biology, MIT
Koch Institute, MIT
Professor of Systems Biology, Harvard Medical School

LIVEPersonal Reflection on Convergence in BioMedicine

Process is important inconvergence — WHAT ARE WE CONVERGING TOWARD?

1985 — today — 2045

BioMedicine  – born from 4 Intellectual Revolutions:

  • Biochemistry – since 1890
  • Genetics – since 1900
  • Molecular Biology – since 1945, 1953, 2003
  • Recombinant DNA – since 1970

GENOMICS comes along: a View of

  • Completeness, Nature, 1986 – before the flood of data
  1. Biology is Finite – systematically perturbed
  2. Proteomics

Comprehensive views

Discovering Disease Genes – 1980s: Mendelian rare inherited, Common variation, Somatic

  • Human Genome – Finished, 2003
  • DNA, RNA, Proteins (Kinase, E3 Ligase) are finite and can be recognized from signatures

Human Genome Variations

Discovering Disease Genes – 2000s:

2017: 100 diseases are derived from Genome variation

  1. Disease Pathways discovered systematically: schesophrenia
  2. Cancer – Chromatin regulators and remodelers
  3. Regulatory elements: Conversation of species – finite and tractable
  • Evolutionary
  • signatures of cellular processes – connectivity map Dependency Map
  • 3D

Programmable Genome Targeting –

  1. CRISPR GPS
  2. Genome-wide CRISPR Screen

Human cells – unified coordinated to classify Cells and Tissues

  1. Combine single cells with CRISPR Screening to systematically discover cellularpathway

Comprehensive Tools

  1. Programmable Therapeutics –
  • DNA-directed Chemical synthesis
  • DNA-encoded Chemical Libraries
  • Programmable activation in cell type
  1. Healthcare systems –>> Learning systems

SPEAKERS

James Collins

Synthetic biology and next-generation diagnostics

James Collins, PhD
Termeer Professor of Medical Engineering and Science and Professor of Biological Engineering, MIT
Broad Institute of Harvard and MIT
Wyss Institute

LIVE

Synthetic Biology – Reprogramming life

  • Design & model network
  • Encode into DNA plasmid
  • Transfer to cell
  • monitor results

Potential for Synthetic Gene Biology

    • Paper-based synthetic Biology
    • distribution without refrigeration
    • RNA sensors with Colorimetric output
    • Rapid prototyping: Ebola sensors
    • Key features of Fieldable paper-based system
    • CRISPR-Cas9 Component for Strain Discrimination – NASBA-CRISPR Cleavage
    • Paper-based Diagnostics for the GUT microbiome
    • Paper-based Diagnostics for HPV: Rapid, Inexpensive
    • Sherlock – Nucleic Acid Detection with CRISPR-Cas13a
    • Human Genotyping Using SHERLOCK
    • Single-based gene usong Shrlock
Gad Getz

Cancer Genome and the Cloud

Gad A. Getz, PhD
Director, Cancer Genome Computational Analysis Group, Broad Institute of Harvard and MIT

LIVE –  Cancer is a disease of the Genome and epigenome – Life history of a Tumor

  • Drivers: Cancer phenotype
  • Smoking
  • Defect in DNA repair
  • Mutation type: C->T
  • Part 1: Finding Drivers Score genes by number and type of mutations: mutation tally and score of repair
  • 450 genes va 11 genes
  • 33 NEW cancer genes: 4,729 tumors, 21 tumor type, 254 significant genes
  • Gene Catalogue by Tumor type – 2,000 samples needed – to detect 90%
  1. Burden
  2. clustering
  3. Non-coding drivers: Promoter, Insulator
  4. 9 significant mutations in Breast cancer gene – promoter Hotspot in FOXA1 is activated through E2F – Estrogene receptor

Mutational Signatures

  1. Non-negative Matrix Factorization (NMF)
  2. posterior distribution of the signatures
  3. Homologuos recombination repair pathway

BRCA1/2: Signature analyzer: Breast Cancer mutation signatures

 

Mono-alleleic inactivation of BRCA

Germline mutation PALB2  PAthogenic mutations in genes

RAD51C – the third BRCA

Signature 3 is associated with BRCA

www.firecloud.org

 

Paula Hammond

Targeting Aggressive Cancers Nanolayers at a Time: A Platform Approach to Engineered Nanomedicine

Paula T. Hammond, PhD
David H. Koch Professor in Engineering, MIT
Head of the Department of Chemical Engineering, MIT
Koch Institute, MIT

LIVE

  • Layer-by-Layer (LBL) Assembly – The ultimate Nanofab Tool
  • Multilayered, multifunctional LbL Nanoparticles – chemotherapy at the core of a sphere
  • Engineering, Biology and Medicine — to understand activation
  • Incorporate siRNA – a modular design
  • pH-Dependent [6.0 – 7.4] Cell Uptake at Hypoxic Conditions
  • surface induce acid pH
  • avtive Tumor targeting (CD44) – Drug-loaded nanoparticle/PLL
  • Triple Targeting Threat: size, tumor hypoxia, cell receptor
  • A model target: MRP1 protein – Multidrug resistance
  • A tumor treatment study in TNBC subcutaneous model using synergisitc siRNA
  • Combo LbL NanoP’s work
  • KRAS inhibition: NSCLC: Kras siRNA + miRNA miR34a MicroRNA
  • cisplatin naoparticle – Orthotopic KP model: siRNA
  • Second Window NIR Imaging (NIR-II) – deep tissue of Ovarian Cancer
  • Nanoparticle Characterization
  • Ovarian Cancer imaging
  • Charged Assembly a Different way: Electrostatic Self-assembly of Oligopeptide Amphiphiles
  • Peptide Nanoparticles are suitable for Vivo – p53-Deficient Cells
  • Target: MK2 Mediates DNA Damage Repair
  • Small molecules: Not safe not specific

 

 

Robert Langer

New chemical engieering approaches to convergence

Robert S. Langer, ScD
David H. Koch Institute Professor, MIT
Koch Institute, MIT

LIVE

  • Lysozyme
  • soybean Trypsin inhibitor
  • Alkaline phosphatase
  • Catalase

Combinatorial lipid synthesis

Next generation LNPs: with novel lipids – potency improvement

Nano formulations for Entdothelium – combinatorial generation

Nano particle library

Current techniques:

Electroporation

  1. – insert inside the gene – CellSqueeze of the cytoplasm
  2. Full transcriptome microarray
  3. Applications to Personalized Medicine
  4. Injectable chip with combination drug therapy inserted into the Tumor, MIS,
  5. Confining region of tumor

Conversion : Clinicians and Engineers

Daniel Larson

Understanding transcription and splicing heterogeneity in cancer progression

Daniel Larson, PhD
NIH Stadtman Investigator, Center for Cancer Research
Head, Systems Biology of Gene Expression, National Cancer Institute

Daniel Larson, NCI – Transcription and Splicing in Heterogeneity in Cancer Progression

LIVE

  • TFF1
  • Transcription in living cells: Estrogene response
  • Transcription occures in bursts: seconds to several hours – regulated over multiple timescale
  • 4oth Anniversary of Splicing
  • high throughput approach for labelling thousands of genes at their endogenous loci
  • SLC2A1
  • Splicing times andd burst size are highly similar across genes.
  • Strong conservation in Eucaryote ccells
  • Splicing factor mutations emerged in almost all tumor types
  • 3″ SS recognition factor U2AF1 has a missense mutation in the zinc finger domain
  • DNA damage after X-Ray treatment: U2AF1 S34F cells show – cell survive high dose (20 Gy) irradiation, becomes senescent and live >1 month in culture abd secrete interleukin 8
  • Interleukin 8 Upregulated even before DNA damage – expression and secretion in rare cells
  • IL-8 induces Epithelial-Mesenchymal Transition i  primary mamary epithelial cells
  • Stochastic transcription and RNA splicing – IL-8 Secretion

 

 

Franziska Michor

Computational Models of Cancer

Franziska Michor, PhD
Professor of Computational Biology, Dana-Farber Cancer Institute
Harvard T.H. Chan School of Public Health

LIVE

  • Tumor evolve by natural selection
  • Tarceva – approval 2004 – NSCLC – patients with EGRF mutant
  • Effect of dosing:Number of sensitive cells in Two drug concentrations: Sensitive vs Resistant cells
  • Combination Treatment
  • Better parameter estimation: using single cell lineage tracing data
  • microenvironment determinants of Treatment response
  • Determining Optimum radiation schedules in GBM
  • mathematical modeling of treatment response
  • understanding the intratumor heterogeneity based on mouse modeling
  • optimal radiation schedule –>>
  • dose constraints – Ultra fractionated dose vs.
  • Practicality constraints
  • slower proliferation
  • Radiation plus temozolomide: Optimized; time post treatment/percent survival
  • Treatment modalities: Immunotherapy, chemo drugs

 

 

Chad A. Mirkin

Spherical Nucleic Acids as a Powerful New Platform for Cancer Therapy

Chad A. Mirkin, PhD
Director, International Institute for Nanotechnology
George B. Rathmann Professor of Chemistry, Department of Chemistry, Northwestern University

LIVE

Next wave of Pharmaceuticals

  1. Small molecules’
  2. biologics
  3. Nucleic Acids – limitations: Address disease in the Liver

 

  • The Promise of Therapeutic Oligonucleotides
  • Antisense DNA
  • Spherical Nucleic Acids (SNA)  – New way of thinking on DNA and RNA
  1. Hybridization Thermodynamics of SNAs
  2. SNAs enter cells rapidly and efficiently – over 60 different Cell Types
  3. Cy5-labeled SNA
  4. SNAs Come in many forms: Micellar SNA, Protein SNAs, Lipoprotein SNAs
  5. Late endosome nOT lysosomeow
  6. How does cell membrane recognition of SNAs and trigger exocytosis
  7. SNAs as Therapeutics: Skin (topical for Psoriasis), Brain (GBM)
  8. Immunostimulatory SNAs – activity of IS-SNAs in Vivo
  9. Oligonucleitides strands mimicking bacterial DNA or RNA
  10. SNA – Vaccines: Antigen presenting cells
  11. 3D Architecture of SNAs leads ti enhanced TLP9 Activation – B-cell NF-KB Activation
  12. SNAs Vaccines: -In Vivo Testing: retired Tumor growth vs control – inserted inside liposome
  13. Advantages SNAs Vaccine vs Standard Formulations vs adjuvant (antigen)
  14. SNA TLR-9 Activator Treatmeent vs Linear Oligo (EMT-6 Breast Cancer Model] – it potentiates activity of Anti-PD-1 Antibodies in PD-1 Resistant  tumor confers immunity

SNA Competitive advantage

Dissecting the tumor ecosystem with single cell genomics

Aviv Regev

 

Aviv Regev, PhD

Director, Klarman Cell Observatory and Cell Circuits Program, Broad Institute of Harvard and MIT
Professor of Biology, Department of Biology, MIT
Koch Institute, MIT

LIVE – Tumors: A complex cellular Ecosystem

  1. How to use Genomic sto study tumors?
  2. Option 1: Gene Atlas – single cell genomics can help dissect thie ecosystem – bulk cell
  3. Option 2: Tumor Cell Atlas – single cell
  4. Single cell RNA-Seq in Precision Medicine pipeline
  5. 19 metastasis melanomas: “non-design” design – 4600 cells
  6. Malignant or not? DNA or RNA-inferred
  7. Micronvironment of the cell – Diverse T cells, Naive,  – Tumar infiltrating T cells: Activation-independent variation in exhaustion program across cells
  8. cytotoxicity, exhausion, naive
  9. RNA-Seq associates T cell clones with their states

Cell-types and states in the melanoma ecosystem:

  • single cell signature used to cluster bulk tumors by their microenvironment composition
  • TCGA – Tumors – melanoma vs Cell type specific signature genes
  • inferring cell-cell interactions: Cell type A and Cell type B: Correlation of gene’s expression with inferred proportion of cell type B (bulk samples)
  • CAF expression of chemokines and complement associated with CD8 T cell infiltration
  • Primary Test Stronger control
  • The ecosystem of Malignant Melanoma – 19 malignant cells

Treatment naive vs Immunotherapy resistant (ITR) – CD8 cells from ITR sample – intratumor variation

How malignant melanocyte affect T-cells?

  • Infiltrated tumor vs exclusion tumor
  • ITR has prognostic value – predicts response to anti-PD1 in Pationts
  • ITR Signatures in malignant and CD8 T cells
Xiaowei Zhuang

Illuminating biology at the nanoscale and systems scale using single-molecule and super-resolution imaging

Xiaowei Zhuang, PhD
David B. Arnold Professor of Science, Harvard University

Session I: NEW VIEW

Xiaowei Zhuang, Harvard University — Single-Cell Transcriptome and Genome Imaging,

  • Science, 2015,
  • PNAS, 2016

LIVE

  • molecular specificity
  • moleculare-scale resolution
  • genome scale throughputspatially-resolved single-cell transcriptome
  1. subcellular organization of the transcriptome
  2. Spatial organization of transcriptome in tissue
  • Transcriptome Imaging
  1. single-molecule FISH (smFISH) [Image 1,2,3,4,, Decoded Image]
  2. Error-robust encoding: Hamming code

Modified Hamming distance 4 – multiplexed, hydridization

Applications:

  1. MERFISH imaging of Tissue
  2. Spacial organization of cells in Tissues
  3. High throughput image-based screening: Barcodes, gene activation/inhibition agents
  4. Tracing the 3D conformation of Chromatin
  5. Spatial organization of A-B compartments: Transient, Polarized, radial
  6. Super resolution of chromatin imaging with Transcriptome imaging

 

EXPERT PANEL: CONVERGENCE IN HEALTH

Cori Bargmann LIVE

Cori Bargmann, PhD
President of Science, Chan Zuckerberg Initiative
Torsten N. Wiesel Professor, The Rockefeller University

LIVE – translation of the needs in computational, biology, IT, mathematician, medicine, physics and engineering. BRAIN Initiative at NIH. How to motivate? by a Problem in need for solution

 

Marc N. Casper  

Marc N. Casper, MBA
President and CEO, Thermo Fisher Scientific

LIVE – convergence from a tool perspectiveLast 20 years – integration of Biology into the physical sciences,

SCREENING AND DIAGNOSTICS

Victor Dzau  

Victor Dzau, MD
President, National Academy of Medicine

LIVE

As cardiologist: Pace maker Convergence in Research.

Funding research does not encourage convergence

innovation is killing disease, need to introduce cost effectiveness – economics into the play. Recognition of cost in Precision Medicine: economic model as a tool to consider cost effectiveness,

Convergence to include SOcial Sciences and Economics

Diagnostics;

Tyler Jacks  

Tyler Jacks, PhD
Director, Koch Institute, MIT
David H. Koch Professor of Biology, MIT

LIVE

– Convergence at Koch

NIH created few CENTERS for research in Cancer, Brain, Nanotech, focus on Cancer did help the convergence

Next step of Convergence: common language, Learning by doing, mechanisms to encourage and continue the convergence

Better efficiency:

  • Which Drug to which Patient
  • Early detection and prevention
Nancy Simonian  

Nancy Simonian, MD
CEO, Syros Pharmaceuticals, Inc.

LIVE – convergence is required to understand the biology of a disease, genomics, computational biology and chemistry is a new approach

Cost of Medicines: reibbursement per value  vs no concern to value. Innovation t carry premium allowing cost reduction while effciency is been exploled.

Elias Zerhouni  

Elias Zerhouni, MD
President for Global Research and Development, Sanofi
Former Director, NIH

LIVE

Convergence of multidisciplines is a must for scientific solutions to emerge, horizontal integration

Patient Bill of Right

Defficiet every year in the US,

Susan Hockfield

Moderated by:

Susan Hockfield, PhD
President Emerita, MIT
Professor of Neuroscience, MIT
Koch Institute, MIT

 

 

 

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LIVE 11/17 1:45PM – 5PM – The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

 

Leaders in Pharmaceutical Business intelligence (LPBI) Group

Covering in Real Time using Social Media this Event on

Personalized Medicine

Aviva Lev-Ari, PhD, RN, Founder LPBI Group & Editor-in-Chief

http://pharmaceuticalintelligence.com

Streaming LIVE @ HARVARD MEDICAL SCHOOL,

Joseph B. Martin Conference Center

@pharma_BI

@AVIVA1950

November 17

#PMConf

1:45 p.m. — Leadership in Personalized Medicine Award

  • Presenter: William S. Dalton, Ph.D., M.D., CEO, M2Gen, Chairman, Personalized Medicine Coalition

Science, Business and Patents: Millenium, Celgenics, and Medicine/Desease – Member of AAAS

co-Chair Cancer Consorcium

PM – 1990’s on. How Human Genome at Harvard will start a new center – reach out to the Global community, conference was born. PM as subject of a Global Conference, effirt started with Genzyme, Eric Launder, Broad, Collins at NIH – effort led to Obama Initiative in PM, Duke Medical System.

Challenge: Reimbursement for Genomics diagnosis

  • PM – P care – by sequencing of Genome – become available commercially inexpensivelly
  • Genetic component to become part and parcial of Medicine and Patient care

2:15 p.m. — Networking Break

2:45 p.m. — The Data Dilemma: Fulfilling Expectations of Big Data in the Future of Personalized Medicine

There is consensus that the massive amounts of genomic, clinical, claims and other types of data could yield important insights for research and clinical care. But for years, obstacles around technical standards, interoperability, privacy and confidentiality, data security, and consent have been held up as daunting challenges that inevitably slowed progress.  During this discussion, a panel of academic and industry experts will discuss their respective organizations’ strategies to obtain and analyze the data, including what has worked and what has not; the programs and processes that have led to the most productive data usage; examples of important knowledge that has been derived from data analysis; and the infrastructure they believe is needed to achieve fulfillment of the potential of big data in personalized medicine nationwide.

  • Moderator: Marcia A. Kean, M.B.A., Chairman, Strategic Initiatives, Feinstein Kean Healthcare
  1. How one works with 20 Partners at once?

 

  • Paul Bleicher, M.D., Ph.D., CEO, OptumLabs
  1. Data collaboration of 35 Partners – bring value to Medicine, Like Bell Labs
  2. Academics, Hospitals, Physician offices – Constellations – groups of projects
  3. DATA is KEY — Public and Private Partnerships
  • Christophe G. Lambert, Ph.D., Associate Professor, Center for Global Health, Division of Translational Informatics, Department of Internal Medicine, University of New Mexico
  1. VA Data, Co-Chair of Informatics, clinical , pharmaceutical stackholders
  2. Focus Groups Patient research Partners – How to automate data
  3. Centralization above nad decentralization, below COntrol mechanism govern all variables: Increase fitness of system vs Personal Control
  4. 1984-1998 Bi-Partisan support for Data in HealthCare
  5. Big Data for early detection, prevention, `
  6. AGING, Infectious and Pediatric disease – Investment in these areas
  • Adam Margolin, Ph.D., Director, Computational Biology, Oregon Health & Science University School of Medicine
  1. Project with Intel – across institutions
  2. consorsium – success ration
  3. data sharing #1 Priority at the National Level
  4. Add value by data sharing, strategic investment in the healh system
  • Edward J. Stepanski, Ph.D., Chief Operating Officer, Vector Oncology
  1. Propriatory real time reporting to Physicians – systematic – core asset, originally,
  2. Research Group use Warehouse doing Analytics, Tools development linked with clinical data with PRO and studies based on data integretion
  3. Success is more data – PRO data informing clinical data
  4. Defragmenting the care vs drive across town for care several units disaggregated geography vs all deaprtments in one location

 

3:45 p.m. — Keynote Speaker
“Medicine and the Targeted Marketing Problem”

We live in the golden age of cloud computing and machine learning.  The organizing conundrum for the “big data era,” however, is a surprising one — the “targeted marketing problem” (i.e., the ability to better match the right customers to targeted messages). This talk will explore overlaps and similarities between the targeted marketing problem and precision medicine, and how advances in data sciences can be leveraged to create a learning medical system that in turn points to the health care system of the future.

  • Introduction: Amy Abernethy, M.D., Ph.D., Chief Scientific Officer, Senior Vice President, Oncology, Flatiron Health

 

  • Anthony Philippakis, M.D., Ph.D., Cardiologist, BWH, Chief Data Officer, Broad Institute and Partner, GV (Venture Capital)

Learning from Users

Five causes for cardiac death:

  • MI,
  • a-Fib
  • Structural
  • PE
  • Aorta dissection

PreventionGenomic Sequencingvalue in Cardiology:

  • Estonia BioBank – mutation carrier
  • Familial Hypercholesterolemia – 4 genes involved,
  • Prediction sudden cardiac death – larger data sets
  • New Model for Human Subjects Research; DIrect-to-Participant: Potentia Advantages:
  • cost, scalability, facilitate re-contact, frequent collection,
  • My Research Legacy: Broad & AHA – Launched November 13, 2016 
  • Quantified Self –>> Quantigied Physical Exam: Face dysformia, Dysarthia, Ataxia,
  • Identify every patient in the World  with this disease

 

Data sharing: Inverting the Model ; ALL OF US  – 1 Million – Precision Medicine with IBM – Mandate to innovate – Diversity: People, Geography, Health Status

Innovation in Genomic data sharing – bring data to researchers

SIX types od data wil be collected: Participant-provided Info, mHealth Data, Consent EMR

 

DATA Research CoreVanderbuilt, Verily Broad

  1. pharmacogenomics

Launch start ups cost

  1. Open source
  2. Cloud
  3. developers start ups

PLATFORM

 

GATK – workhorse of genomic data – Launched 4/2016

Partnerships: Amazon, google genomics, microsoft, IBM, Watson, 

 

Announcing: BROAD + Intel Center for Advanced Genomic Data Engineering, Anthony Philippakis, M.D., Ph.D., Chief Data Officer, Broad Institute

Reference Architecture: Design: Single node, small cluster,

 

4:30 p.m. — Closing Remarks

  • Edward Abrahams, Ph.D., President, Personalized Medicine Coalition

 

– See more at: http://www.personalizedmedicinecoalition.org/Conference/November_17_Program#sthash.zpTNQYKd.dpuf

 

#PMConf

SOURCE

http://www.personalizedmedicinecoalition.org/Conference/November_17_Program

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LIVE 11/17 8AM – 1:45PM – The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

Leaders in Pharmaceutical Business intelligence (LPBI) Group

Covering in Real Time using Social Media this Event on

Personalized Medicine

Aviva Lev-Ari, PhD, RN, Founder LPBI Group & Editor-in-Chief

http://pharmaceuticalintelligence.com

Streaming LIVE @ HARVARD MEDICAL SCHOOL,

Joseph B. Martin Conference Center

@pharma_BI

@AVIVA1950

November 17

#PMConf

 

Joseph B. Martin Conference Center
77 Avenue Louis Pasteur
Boston, MA 02115

7:00 a.m. — Registration and Continental Breakfast

8:00 a.m. — Opening Remarks

  • Edward Abrahams, Ph.D., President, Personalized Medicine Coalition

8:15 a.m. — Fireside Chat

  • Moderator: Meg Tirrell, Reporter, CNBC
  1. How did the the Economics changed
  • Daniel O’Day, CEO, Roche Pharmaceuticals – Joined Roche at 1989
  1. Roche  – 60% of investments goes to Cancer with embedded diagnostics, 20-30% of the market
  2. Hypothesis in the Lab starts an innovation – Phase I, Phase II is extension of Phase I – continue understanding of the Biology of the Disease
  3. Treat only patient that will benefit – PM – transformational benefit
  4. Early stage of discovery – protection of IP – work inside ONE company — less of an issur the protection of IP
  5. Diagnostics area – Roche collaborates with other Pharma
  6. Setting infrastructure for testing
  7. Diagnostics and Pharma are coming together – availability of big data – discover and develop with Foundation Medicine – Deep analysis of Molecular Medicine, decide o better hypothesis, do it in shorter time – 2015 – Commercialize the platform around the Globe, One standard for Clinical Trials – in China hard to move Clinical Trials Data out of China –
  8. Harnessing Global Data in Oncology – Clinical Trials
  9. Data accuracy
  10. Genentech, Foundation Medicine and Roche capabilities – FDA
  11. Comprehensive Genomics side – has needs yet to be developed for Payers to participate
  12. Foundation One – 30% more positive Lung Cancers found vs standard of testing
  13. Over simplification is dangerous, technology/diagnostocs/histology/genomics – sequencing ENHANCES not replaces
  14. Data of Phase III – robust genomics profiling: no diagnostics and wrong diagnostics
  15. In the next five years, Cancer immunotherapy, when and how resistance occur.
  16. Blood based assay – Patient journey  – fine tuning the Science tissue based sample
  17. Biomarkers: Tumor microenvironment
  18. Diagnostics is not rewarded appropriately, genetics, CMS,
  19. Outcome value for TX and Dx
  20. Mission of Roche will not Change with change of Gov’t, public Sector in the US, FDA – requires being faster a respondent,
  21. ” I am optimistic”

Questions from the audience

  • Democratizing access to sequencing data
  • accuracy of test results, Oncologist and PCP ordering genomics tests, value added
  • PM after medicine SOC (biopsy, tissue histology)
  • Reimbursement: Diagnostics vs drugs

8:45 a.m. — Coverage is King: Identifying the Evidence That Leads to Reimbursement

Many innovators in personalized medicine are unclear on the kinds of evidence that inform the coverage and payment decisions of payers. That lack of clarity can have negative financial consequences for personalized medicine companies with products and services that are on the market but not paid for. During this panel, payer representatives will help define the reimbursement landscape for the field by providing examples of the evidence they consider appropriate for coverage and payment. Confirmed panelists include:

  • Moderator:Amy M. Miller, Ph.D., Executive Vice President, Personalized Medicine Coalition
  1. What each of the companies does in PM
  2. Targeted therapeutics: 25% are targeted,
  3. Value of Diagnostics
  • Kristine Bordenave, M.D., Lead Medical Director, Humana
  1. Clinical perspective, how much it cost to patient, clinician, Pharma – both need to be paid,
  2. Population Health, 100% of GDP to go to HealthCare — can’t be
  3. Humana Perspective: How to cover – organized criming: Charges for Testin – several month doen in one day, sharing drugs, expired drugs, repackaged and sold, drugs resold
  4. Independent Research Department: MS, Pharmacists, Statisticians — Looking at the Value of Test in Population context
  5. Large Medicare, Small managed care company, Value-based contracts: working with Pharma – early on at Phase II stage
  6. Testing: genetics, radiographic — 60 gene panel – done by two labs,
  7. Duplication in ordering genetic testing: optometrists, Physical therapist, ordering genetic profiling
  • Matthew Fontana, M.D., Vice President and Chief Medical Officer, Pharmacy, Health Care Service Corporation
  1. WHY REFERE TO US AS PAYERS – BUSINESS MODEL: MULTIPLE CUSTOMERS MEDICAID, BIG PROVIDERS, MANAGED CARE INDUSTRY
  2. Cost and Revenue
  3. FDA is been pushed to ignore the science (DMD), lack of coordination in HealthCare
  4. Pay for diagnostics if not linked to Therapeutics – morbidity
  5. elaboration of Diagnostics
  6. Accuracy of testing – expensive  – misinterpretation
  • Elaine Jeter, M.D., MolDx Medical Director, Palmetto GBA
  1. Access of Patients – 25 of 50 States are participants in MOlDx — NOT New England States
  2. All molecular assays to register for code specificity – to be able to control appropriate coding – Panel matched to unit of service issue between Genome Profiling and assay
  3. Reimbursement – Lung Cancer – Clinical utility  – genomic profiling ONLY IF THE DATA IS IN A REGISTRY — IF PROVED UTILITY AND THE REGISTRY SHOULD BE IN PUBLIC DOMAIN
  4. Analytical minimal standard accepted
  5. Developed Assessment meetings – Labs come to receive guidance  – clinical utility information, as a contractor – Central Office allowed PM vs Lab developing tests – assist Lab – pay for service obtain end points
  6. Assays for Prostate Cancer – innovative – high disease demand, define endpoints
  7. Paying premium for FDA approved genetic testing – onlu 2% of molecular assays — 98% are not FDA approved
  8. 65,000 molecular tests in the market in the Registry only 10,000, every day 2-3 new molecular assay tests are introduced
  9. By statue, no screening covered by Medicare for Genetic testing – congress need to act upon that – change coverage of Medicare. Memogram and colonoscopy, lung X-ray – are by statue – covered by Medicare

Questions from the Audience

  • Why premium paid if FDA approved a test?
  • Screening and early detection

9:45 a.m. — Networking Break

10:15 a.m. — Harvard Business School Case Study Presentation

DNA-editing technologies have been hailed as revolutionary with the possibility to edit out mutations that cause disease.  Yet the CRISPR-Cas system is currently locked in a legal dispute between two great research institutions involving, as one journalist put it, “who owns molecular biology.”  The CRISPR technology in short raises the broader issue of whether these new techniques should be privately owned or placed in the public domain. The technology also raises serious ethical issues. The case study will serve as the point of departure for our discussion of these issues.

  • Leader:Richard Hamermesh, D.B.A., Senior Fellow and Former MBA Class of 1961, Professor of Management Practice, Harvard Business School
  1. Ethical issues in the case
  2. Stacks are very high

11:15 a.m. — Keynote Speaker

  • Introduction:William Chin, M.D., Chief Medical Officer, Executive Vice President, PhRMA
  • Keynote:Victor Dzau, M.D., President, National Academy of Medicine (ex-IOM) – part of NIH
  1. Global Landscape of PM: Integration into HealthCare — Cost effectiveness
  2. Evidence for PM
  3. better health and well being
  4. high value health care
  5. strong science & technology – 150 papers in JAMA ans NAS
  6. Precision Medicine: patient/public engagement, NGS: omics, biomarkers, collection of clinical & research data, integration of omics, EHR
  7. Challenges: Tests & Therapies
  8. efficacy of PM AFTER actually being used in clinical practice
  9. Evidence of PM efficacy for implementation in Practice
  10. Regulatory and Reimbursement for utility
  11. Reward Value vs cost
  12. Aligning Results: 10% incidence reduction vs 50% incidence reduction
  13. Evidence generation:
  14. Modeling could be used to assess the potential economic impact of PM approaches
  15. Final regulatory & Payment Pathwaysand payer approval
  16. Analytic Validity — clinical validity — economic impact analysis– Assess Clinical Utility
  17. Strength of evidence Low to High
  18. investigational experiment
  19. Assess cost effectiveness: initial experimentation — Economic analysis — provisional approval — validation — final approval
  20. Integration with clinical Practice: Clinician Educatuin, integration pathways
  21. Genomic Medicine:guideline and care pathways — Clinical DSS —
  22. Data infrastructure and sharing: EHR (DIGITize) – genomics – GA4GH
  23. PATIENT/PUBLIC ENGAGEMENT – concern of Privacy and Data Ownership – Fear of discrimination  — consent — education of Patients
  24. Future needs: data, National scale learning system, Global collaboration G2GH
  25. Support Data infrastructure
  26. PM – quality, access, cost, improve clinical outcomes, inequality mitigate
  27. PRECISION PUBLIC HEALTH – ZIKA, EBOLA,
  28. GENOMICS and Population Health Action Collaborative
  29. working Groups: Evidence generation

11:45 a.m. — Bag Lunch

12:45 p.m. — Personalizing Care: Strategies for Integrating Personalized Medicine into Health Care

Personalized medicine lacks sufficient literature on how health care providers can integrate personalized medicine into clinical care, which makes it difficult for providers to take advantage of the growing number of personalized medicine products and services now available to them. During this session, panelists who have spearheaded integration efforts will share the strategies they found most useful for speeding the pace of personalized medicine’s adoption in clinical settings. Confirmed panelists include:

  • Moderator:Howard McLeod, Pharm.D., Medical Director, DeBartolo Family Personalized Medicine Institute, Moffitt Cancer Center
  1. Awareness & education
  2. Patient empowerment
  3. value recognition
  4. IT and Information Management
  5. ensuring Access to Care: Case if Neuropathy than 15 more visits causing 8 other Patients to be pushed in the queue

 

  • Amy Abernethy, M.D., Ph.D., Chief Medical Officer, Chief Scientific Officer, Senior Vice President, Oncology, Flatiron Health
  1. Family and Care givers need to understand as well
  2. More Advocacy in Washington

 

  • Dax Kurbegov, M.D., Physician Vice President, National Oncology Service Line, Catholic Health Initiatives – CHI (103 Hospitals) and DIgnity ospitals – Community system
  1. Provide speed of service
  2. Permeate piece by piece by each institution, economics – problematic IT infrastructure for Genomics is expensive, centralized system needed
  3. broader beyond Oncology
  4. complex Patients with polypharmacy
  5. If physician needs to write a special note for service , patients are lost in the way for testing
  6. as NGS become accessible in labs — CHI provide infrastructure to LINK Patients with Experts and Labs outside the system
  • Lincoln Nadauld, M.D., Ph.D., Executive Director of Precision Genomics, Intermountain Healthcare, UT (22 Hospital 107 physicians – Molecular Tumor Board)
  1. Pilot Project approach implemented in 3 hospitals, built lab, implement by Molecular Tumor Board placed on the report
  2. Barriers: getting drug is difficult – mutation exists, drug exists — How to get the drug ordered, approved and shipped
  3. Patients want to know that their oncology is up to date the care is best, Patient advocate for themselves, Patient empowerment
  4. Barriers to PM – Physician compensated better for next line IV chemo vs Targeted Genomic-based therapy
  5. Tumor Board
  6. Get Genomics EARLY not late – it will max the course of treatment
  7. MOST PATIENT CAN’T TRAVEL FOR CARE because it is expensive
  8. Utility and Value asked by Payors, cost saving need be demonstrated not only efficacy vs SOC – reduce cost must be demonstrated

 

  • Peter H. O’Donnell, M.D., Assistant Professor of Medicine and Associate Director for Clinical Implementation, Center for Personalized Therapeutics, The University of Chicago
  1. Lab Testing, way to long, system for Physician to look at Genomic data,
  2. If Physician is buying in shared decisions with Patient easier
  3. all tests are bundled and results are presented to PCPs – they love that
  4. Drugs fail because Patients do not take them vs Pharmacogenomics – more likely to help Patients

#PMConf

SOURCE

http://www.personalizedmedicinecoalition.org/Conference/November_17_Program

 

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