Highlights – LIVE Day 2: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES | Leaders in Pharmaceutical Business Intelligence Group, LLC, Doing Business As LPBI Group, Newton, MA

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

May 2, 2017 by 2012pharmaceutical

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

Continental Breakfast

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.

Moderator: Masanori Aikawa, MD, PhD

Yoshiro Miwa Associate Chair and Founding Director, Center for Interdisciplinary Cardiovascular Sciences, Brigham and Women’s Hospital

Carsten Brunn, PhD

Head of Pharmaceuticals, Americas Region, Bayer

Hiroyuki Kawabata

Director, Health & Welfare Department, JETRO New York

Makoto Suematsu, MD, PhD

President, Japan Agency for Medical Research and Development

Eiji Tanaka, PhD

President, Head of Global Business Development, Mitsubishi Tanabe Pharma Holdings America, Inc.

Complications of Toxin absorption and metabolic disease
Collaboration with Academia: @ representatives are on two West Coast and 2 on the East Coast
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

Christopher Coburn

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

American Consumer of Healthcare pays more and it is not justifiable
Pay for Value, pay for Outcomes

Katrina Armstrong, MD

Physician-in-Chief, Department of Medicine, Massachusetts General Hospital
Jackson Professor of Clinical Medicine, Harvard Medical School

Challenges understand PCP services and SPacialty medicine
Adding fluids or taking it away is the majority of the decisions
In cancer treatment 40% of prescriptions are not filled due to out of pocket cost increase
In drugs Innovation are more expensive not less expensive
Economists: Physicians are irrational
Patient engagement, own health in their hands for compliance with treatment
Assist MDs with the right data for their decision on what drugs to use
Two key ways : Complications of Drugs, drive drug cost – Personalized medicine – improve outcomes on an Individual Patient basis
How important is the question, affordable drugs is more important than anything in the delivery of care

Paul Fonteyne

CEO, Boehringer Ingelheim USA

Many stakeholders are involved
Pricing of Pharmaceutical in last 10 years, “List price” and the “Net Price” collected by Pharma has widen,
high deductable plans are prevalent 40%-50% – out of pocket cost increased
backlog of generic drugs – it takes 36 month to approve vs 12 month of non-generic
Value-based pay, drug is only one enabler in MDs tool kit
Out of pocket cost: Exposure is largest on the drug-side, that is preventive to avoid hospitalization
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
FDA on Oncology drug-device, potential exists for existing drugs
Continue to do Clinical Trials in the US, claims orientations exacerbation, describe the benefit

Robert Ford

EVP, Medical Devices, Abbott

Who will pay and why?
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
Selection of areas: ORTHO – hip replacement and Pain management
Establish Global Pricing Models in USD, Premium, fair Price, desperative Prices is not good for the system

Benjamin Scirica, MD

Director of Innovation, Cardiovascular Division, Senior Investigator, TIMI Study Group, Brigham and Women’s Hospital
Associate Professor of Medicine Harvard Medical School

Cardiometabolic diseases – drugs available to avoid events down the road
new drugs at $20,000 cost per year vs Generic drugs – Economic responsibility in the Lipids area is long term
MI many types bundling cost is more difficult that in Ortho
Chronic disease, therapeutics, diagnostics, How to reduce cost? – Best utilization of drugs
Durable response to drug, not enough data in hands of MDs
Randomize Placibo and Randomize the drug, Placibo – requires better engagement
After MI – 6 MEDS, compliance
Clinical Trial very expensive, FDA requires PRAGMATIC TRIAL DESIGN, IDENTIFY DIFFERENT POPULATION FOR EXISTING DRUGS
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

What patient to target
Heterogenous population – definitive data, how it is achieved

Michael Dale

Divisional VP and General Manager, Structural Heart, Abbott

Homogenous or heterogenous
Standard of Care- restore normal function, patient outcomes more fragile as disease progresses
Paradigm, measurable reduction of regurgitation
Design of Clinical Trials: MR treatment around the World,
MitralClip reduce MR reduction is not resolution
1000 publication on MitralClip – data gather indicate improvement in life quality
TEE alone for use of MitralClip is nor enough, need to see to do the procedure

Ian Meredith, PhD

EVP, Global CMO, Boston Scientific

State of the Art, Mitral regurgitation and degenerative Mitral valve: mechanism and elements responsible for regurgitation, repair of Annuals vs replacement of the valve.
Options at different stage of the disease
Functional Mitral Regurgitation: care pathways, compounding effects, two little too late
AF can cause Valve dilatation and regurgitation
Treatment, patient less symptomatic
HTN cause of LV systolic disfunction – treated first – improve the Mitral regurgitation
Mechanism under pinning in the decision process, CLinical Trials – Device may not work for all patients in the Study
leaflet condition dealt in repair strategy vs device selection
Having devices focus the clinical pathways for therapeutic options, TAILORING OF DEVICES TO SPECIFIC STRUCTURAL CONDITION OF THE HEART

Patrick O’Gara, MD

Watkins Family Distinguished Chair in Cardiology, Brigham and Women’s Hospital
Professor of Medicine, Harvard Medical School

Structural Heart disease: Hole in Heart,
5 1/2 years approved for TARV
TAVR will exceed Open Heart Surgery next year
Mitral valve growth is in >75 y-o more cases than Aorta
Aorta Valve – seen on Echogram stenosis seen
Mitral Valve – concert of several elements, very complicated, Coordination among: Device, FDA, CMS, MDs, Hospitals
DO doctors wait to long to intervene: Moderate to severe: Foundational approach Ventricular dysfunction, late stage not continue to progress.
MI
drivers of cords,
identify Patient – can be improved by PCPs, NPs, PAs, assess severity, Center for evaluate consensus on timing the intervention
relay on the Cardiologist in the Community – context: Not all MR needs surgery
Functional Mitral Regurgitation, poor LV function, the valve intervention will not improve longevity may improve quality of life for two years
20% survival after MI in LV dysfunction post MI then Mitral valve intervention will not improve longevity
For older pation with Functional MR and moderate LV dysfunction – trial design on utility of the intervention.
More patients will be included for treatment as recognition of the disease matures
WHO should do that procedue : Interventional Cardiologist or Cardiac SUrgeons: HARD procedure NOT fixing Coronary artery
Set up regional centers of Care links to maintain quality and PATIENT MUST DO BETTER
200 centers in the US do MitralClip procedure
Procedure expensive BEYOND THE DEVICE cost

Stanton Rowe

CVP, Advanced Technology, CSO, Edwards Lifesciences

60,000 procedures in the US vs. 2.4 million patients with the MR condition
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
Aortic stenosis: we learned which patient will benefit, clinical studies, cost effective, two companies validated the approach
Mitral Valve is in early stage Trans catheter is the direction
PATIENT ACCESS – who will benefit
devices will Improve Patient conditions

Sean Salmon

SVP and President, Coronary & Structural Heart, Medtronic

MR at medtronic: degenerative disease, repair the valve, average surgeon does 6 procedures a year,
Toolbar approach, how to do it safely no complication repeatable to know the reduction level
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

John Lechleiter, PhD

Chairman, Eli Lilly and Company

Two approaches to Beta Ameloid – fail to meet Endpoint: Mild patient Solismad 24% improvement vs placibo
Dementia not AD – mild to moderate patients, only.
Move faster is desiable, turnaround time need be faster
Would do over again, tap best minds in the World,

10:10 am – 10:25 am
Lilly Foyer

Morning Break

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

Evidence on monitoring Patients while @Home, pros and cons
2016, review evidence, recommendation for monitoring Patients while @Home
Continuing care and continuing data collection
Hospital administrator need a path to have more patients coming to the hospital
Implement technology for quality care, access and lower cost

Adam Landman, MD

CIO, VP, Brigham and Women’s Hospital
Course Co-Director, Harvard Medical School

CHF, HF, – recognize that Technology alone is not enough
People and Technology intervention targeting
Academic medical centers – monitoring Patients while @Home is a mechanism to deliver care

Michael Reitermann

COO, Siemens Healthineers

Outcome-based evidence – innovation exited 15 years ago
at Present time the market is accepting
Medical Systems do not have enough capacity – shortage of MDs
Monitoring Patients while @Home is to free time of MDs in the Office

Jonathan Rennert

CEO, Zoll Medical

Outcome-based research on a wearable cardio-devibrilator, Arrhythmic death protection
Policy: talk about reimbursement
Patient data collected, histories of ECG before cardiac arrest
what diagnostics to be used with this data: do not drive, do not be alone at home

Stanley Shaw, MD, PhD

CSO, One Brave Idea, Brigham and Women’s Hospital
Associate Dean for Executive Education, Harvard Medical School

Evidence and publishing results, MDs and Patient’s perspective on Autonomy vs monitoring Patients while @Home
DIgital Health Comapny vs Academic Study on monitoring Patients while @Home – Wearable Patch surpass wearing a holter
External wearable now acceptable and clinical evidence will convince all stakeholders
Realization by physicians that monitoring Patients while @Home is a TIME SAVER in their practice will endore the technology at a rapid pace
Published studies: Sharing genetic information with Academic Centers: Verily, AstraZeneca and AHA partnership
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

Amgen –>>> Biotech to Pharma

Robert Bradway

CEO, Amgen

Six areas: CVD, Cancer, Inflammation,
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
Innovation in Human genetics new sequencing technologies allowed to see disease in Human populations, disease and pathways
Aging associated with risks of CVD, How we pay for innovative therapies?
Benefit from innovation – 800,000 in US have a stroke every year $60 Billion treatment for patient of CVD
Value of innovation at a price that allows access and lowering cost of care
Cardiologist prescribed the medication for himself it took 6 month for insurance to approve
Utilization management – move to innovative technologies if current therapies do not work
Pay for benefit and for outcome, no pay if med does not do what it was supposed to do – refund patients
focus on right patient get access. if LDL is so high – the therapy is there – the payers, enable access
Access challenge: Discount, Rebates, Co-pay assistance to access therapy as REPATA at $5 a day value is high,
A single payer is the Government in other countries
Future at Amgen: Potential for Innovation to improve Medicine, paying for innovation needs to be strainten
Coming drug is Pharmcogenetics for atherosclerosis

12:00 pm
GE Ballroom

Lunch

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

Why Healthcare?
How your approach to innovation enable to move fast?
Develop technologies that are more affordable
Data, Insight, How to get insight from data about a deterioration

Frans van Houten

CEO, Philips

A 125 year company, shade lighting business to focus of Healthcare, global challenge a goal in Humanity for solution, services, products
R&D diagnostics, Informatics to integrate data
Africa and India – emerging markets with infant mortality high — develop a clinic as franchise for every price point
shift from Products to Cloud-based solutions – Prevention, Diagnostics, @Home care: Neuro, Cancer, CVD
Academic Institutions: Karlinska in Sweden – Stroke solution in partnership with Philips
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
Patient monitoring 24×7 in ICUs,
eICU – measure evolution to forcast 6 hours in advance a deterioration – highest performance, reduction 40% of death by insight from data
Complex diseases created enormous data,
Measuring progression of AM – AI algorithms for a digital platform
Data integration, oncology patients: Genomics, Pathology, Clinical Data Scientist,
R&D will be co-creation with clinical validation and publication for Market adoption
Head of Radiology across several Hospitals – Better Outcomes Operations improvement due to technology
Rural Africa market connected to a Hospital in a city — working on that teleconference
UAE – crowdsource for nearest AED – locate incidence like UBER for CVD
AI in Pathology – genomics and patient targeting – Lab in Cambridge, Big Data

1:00 pm – 1:10 pm

Transition

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.

Moderator: Marc Sabatine, MD

Chairman, TIMI Study Group, Lewis Dexter, MD Distinguished Chair in Cardiovascular Medicine, Brigham and Women’s Hospital

Bar is very high, events went down, that necessitates very large studies 30,000 patients, 12 sites around the globe, acquisition of data
Outcomes, where is Pharma in development of a compound
Other indications that LIPIDS
surrogate outcomes
Diabetes: requirements mutual effect on CVD, benefit of DM drugs for CVD OutcomesGathering data on approved drugs, looking at different doses
A model for dosing compounds per each patient
Benefit or harm different in the US and in other sites
genetics, how it inform in drug development, validation to pan out
Real World evidence in 21 Affordable Act – randomize
multivariable adjustment on how many variable affect the Power of the study

Elisabeth Björk, MD, PhD

VP, Cardiovascular & Metabolic Disease Head, Global Medicines Development, AstraZeneca

Patient population,
new medicine vs existing registries
Real World evidence include observational dat after the drug is on the market
Randomization – identify population, register, randomize, collect

Daniel Bloomfield, MD

SVP, Global Clinical Research, Therapeutic Area Head, Cardiometabolic & Womens Health, MRL Lead, China R&D, Merck

data from medical record
investigational drugs more difficult

Jonathan Plehn, MD

VP Cardiovascular Medicine, Covance

Productive sites, approaches: Russia, Russia-Georgia, dishonest recruitment, combine resources to find sites
50% of blood analysis at sites that do not recruit at all
Internal vs External validity: Early on in drug development, protocol deviation, drug MOA, variability off set by study power
Patient reporting outcomes

Norman Stockbridge, MD, PhD

Director, Division of Cardiovascular and Renal Products, Food and Drug Administration

Surrogates: likely outcome endpoint for decision,
CVD is difficult, graveyard of program that failed, inotropic drugs were stopped
Global trial, most expensive to do in the US – in the US the care given need be comparable to the care in the US
Requirement that the results will be relevant to type of care in the US
Preserve randomization is key

Scott Wasserman, MD

VP, Cardiovascular Medicine, Global Development, Amgen

What is the hypothesis for testing, population match, understand the molecule for the modality
Decode, benefits and risks – phynotype
aggregation of data with investigational therapies,
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.

Sean Harper, MD

EVP, R&D, Amgen

Outcomes for RAPATA – a pharmacogenomic drug
Precision medicine in CVD – optimistic
CVD – phynotype more determinative then genotyping vs Oncology, complex traits
Bippharma moves away from big public health diseases, trials are expensive, FDA harch requirements
Investors:to Biotech – works on Oncology and on Orphan drugs
Methodology for targeting by using genetics are more precise
In Phase III a drug where biology is very well understood

Dean Li, MD, PhD

VP, Head Translational Medicine Merck

CVD in Merck – rearrange resources in South SF on
Arrhythmia: Mutation if down played causes Arrhythmia if Overexpressed causes Arrhythmia – caution in terapeutics tatgets – gene indication not to develop therapy
Diastolic HF – make a drug, pick up one signaling cascade and show efficacy not in all pathways
Populations that are resilient in diseases as HF

David Milan, MD

Assistant in Medicine, Massachusetts General Hospital
Assistant Professor, Harvard Medical School

AF model in Translational medicine, metabolites
moderately optimistic
molecular phynotyping

Christine Seidman, MD

Director, Cardiovascular Genetics Center, Brigham and Women’s Hospital
Thomas W. Smith Professor of Medicine and Genetics, Harvard Medical School

Genetic in CVD – Cardiomyopathy and genetics
target molecule for therapy of genetic
gene mutation variants are different the genes are the same
LDL receptor led to development of Statins
PCSK9 was developed from genetic observation on familial
protein profiles very important
Genotype more informative than phynotypes
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

M&A landscape

Leslie Bottorff

Managing Director, Healthcare, GE Ventures

Advanced diagnostics
value-based care
no investment in drugs
Insurance are into the Game of Data Analytics – fast adoption to become standard of care
Reimbursement: Tech investors and Healthcare investors with having in mind FDA approval process
Mobile health cool: eye disease, DM, skin care ECG, few specialists in China, mobile tools
Interoperability in Digital Health

Jean-François Formela, MD

Partner, Atlas Venture

Only investment in drug discovery
Segment genotypes – pure innovations as differentiators
Patient Analytics, Physician-Patient SW development applications – scale broad audience – value add
Focus on Medical Professions tool development for this sector
Learning curve for novel productivity tools Cardiac MR – Imaging Analytics – Precision medicine not in drugs but in imaging
M&A – activity 4 years time horizon, new biology new modality – risk is higher
First in Class
Translational Research and Drug discovery are two different beasts, doing drug development inside a basic research organization
Coolest technology: CRISPR – one injection reduction in a genetic disease

Bob Hopkins

Managing Director, US Medical Technology, Equity Research, Bank of America Merrill Lynch

Medtech, CVD is exciting , i.e., Valve area, ICD, Stents, Stroke, AF,
Medical devices – exciting
No clear leader in Mitral Valve repair and Replacement by 2019 – approved products in Europe: Abbott, Medtronic (12), Edwards
Value in the market exists for investors
coolest technology: Stroke – stents in the barin

Roger Kitterman

VP, Venture, Partners HealthCare

165million fund: Drugs, devices, diagnostics – ONLY from Partner COMMUNITY developed IP
Orphan CVD driven by genomics
Stratify the patients to show effects
Exit for medical devices is longer than drugs with innovative business models
Wearables are medical devices
Data will be huge and valuable
Skill set needed for Drug discovery and Academic science — DOES work well in one place
Editas – Academic Center: Innovations everywhere

James Topper, MD, PhD

Managing General Partner, Frazier Healthcare Partners

Drug development investment in early stage and in late stage
Focus opportunities
3 to 5 years time horizon
$50 – $60million investment range
FDA – is central to HC investment
FDA – changed regulation to enable antibiotics development
FDA in Oncology – risk reward equation – FDA played great role in drug development
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

Biology or bias

Christine Albert, MD

Director, Center for Arrhythmia Prevention, Brigham and Women’s Hospital
Professor of Medicine, Harvard Medical School

Focus on Women
Diagnostics requires women – large trials and power studies by gender
CRT,
Optimizing care for Women
EF, CHF, MI are prevalent in Women
Migraine in Women – related to CVD

Adele Gulfo

EVP & Head, Global Commercial Development, Mylan

Information on differences between women and men – Cholesterol
Woman present with different symptoms – more progress because care is delayed
Stable angina and zero plaque cardiac rehab
Female specific guidelines
wholistic approach, girl scouts as a start

Allison Kean, MD

CV Therapeutic Area Lead, Global Business Development, Pfizer

Number of women in trials? 25% – how to extrapulate from this data?
How to design trials, powering, endpoints, clinical trials, FDA – mandates reporting of Women representation in studies
Data Gap – retrospective study – 30% women, guidelines based on 70% Men data
Awareness – who is the PCP to close the Gap
OBGYN is often the PCP, the only Annual a Women goes to
Precision medicine in Women, what is actionable what is not
Harness Phynotypic leverage repository

Paul Underwood, MD

Medical Director, Boston Scientific

Women vs Minority Women – Improvement will occur if tools and strategies will represent all demographic
Accurate measurements, Women participation in trials, Latinos, Minority Women – not as % in the population
best practices and guidelines
Awareness, nosea and fatigue as symptoms,

Malissa Wood, MD

Co-Director, MGH Heart Center Corrigan Women’s Heart Health Program, Massachusetts General Hospital
Associate Professor, Harvard Medical School

Heart attacks in Women and prevention, awareness among women
Impact of Pregnancy: Preeclemxia, HTN, DM, hematologic disease, small gestation newborn, Minority Pregnant women – diet
30% less referred for Aortic stenosis or transplantation
Care for Patient vs Episodic Care
Stress in Women – metric to measure in PCP
AI to be used in referral based on Medical data
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

one of three death in the World
Limb Ischemia

Stéphane Bancel

CEO, Moderna

mRNA, clinical stage, published Human data Immuno oncology, VGEF therapeutics after MI
Recombinant VGEF, PK goes to the heart mascle if goes to serum is degraded by nucleatase
Post MI in pigs, Phase I, Phase II
Chronic response formulation short half life (6 days)
Step by step, get the right protein
Cardiology – mRNA drug for one patient

Katrine Bosley

CEO, Editas Medicine

CRISPR technology – translational medicine changes in DNA
viral vector therapy delivery: Eye liver, blood — easier for delivery
Immune response from delivery of CRISPR molecule: control over the time response of the molecule: Immunogenicity
Using biology knowledge

Mark Cobbold, MD, PhD

Center for Cancer Immunology, Massachusetts General Hospital
Member of the Faculty of Medicine, Harvard Medical School

Cancer Immune response plays a role
CVD and the Immune System: Transfer from Oncology to CVD: Mutations on genes mutations are not silent to the immune systems — development of Vaccine
Oncologists in lung cancer saw immune response against their own tumors
macrophage in the heart

John Maraganore, PhD

CEO, Alnylam

CVD Program – Phase III
PCSK9 – as a target genetically defined mutation, Hyper-cholesteronemia – subcutaneous delivery – Lowering LDL by bi-annual injection or quarterly – non-complaint with Statin
ADVANCED medicine for CVD

Ryuichi Morishita, MD, PhD

Founder, AnGes

Gene therapy – pipeline of 8 –
DNA Vaccine for HTN
Muscular therapy – Ischemia
CVD – Reduction comorbidity and mortality

5:20 pm – 6:00 pm
Novartis Foyer

Attendee Networking Reception

Posted in Cardiac and Cardiovascular Surgical Procedures, Conference Coverage with Social Media, Frontiers in Cardiology and Cardiovascular Disorders, Lipid metabolism, PCSK9 Inhibitor Therapy, Scientific & Biotech Conferences: Press Coverage | Leave a Comment

Comments RSS

Leaders in Pharmaceutical Business Intelligence Group, LLC, Doing Business As LPBI Group, Newton, MA

Follow Blog via Email

Recent Posts

Archives

Categories

Meta