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


Tweets by @pharma_BI and @AVIVA1950 for #PMConf  at The 13th Annual Personalized Medicine Conference, From Concept to the Clinic, November 14–16, 2017, Joseph B. Martin Conference Center, Harvard Medical School, 77 Avenue Louis Pasteur Boston, MA 02115

Curator: Aviva Lev-Ari, PhD, RN

 

@pharma_BI

@AVIVA1950

 

All TWEETS from LPBI’s Twitter.com handles at #PMConf 

@pharma_BI

@AVIVA1950

  1. Aviva Lev-Ari Retweeted Gary An

    nice comment

    Aviva Lev-Ari added,

  2. Narrative plan unsupported by facts

  3. Robert C. Green, M.D., M.P.H., Director, Genomes2People Research Program, Professor of Medicine (Genetics), Brigham and Women’s Hospital, Broad Institute and Harvard Medical School pharmacogenomics can harm if odds are so low adherence will be lower

  4. Michael Snyder, Ph.D., Stanford W. Ascherman Professor, Chair, Department of Genetics, Director, Center of GenomiPersonalized Medicine, Stanford University School of Medicine Personal sequencing for multiple etiologies rich people are sequenced

  5. Tom Miller, M.S., Founder, Managing Partner, GreyBird Ventures LLC duty to call up therapies that will not work, balance addressed by PM – diagnostics in PM clinical utility from patient selection for the therapy the patient will respond to

  6. Sandro Galea, M.D., School of Public Health, Boston University US expense on Health care the highest in the World comes on the expense of housings, mental health, education – curative vs preventive care MDs are insentiviced to keep patients sick

  7. Robert C. Green, M.D., Broad Institute and HMS Platinum vs gold standard 59 genes will identify 80,000 will get the disease and 47,000 will never get the disease, is the technology the reason for investment vs Family history?

  8. Bryce Olson, Global Marketing Director, Health and Life Sciences Group, Intel Corporation Genome sequencing found his Pi3K Pathway – PIK3CA p.E54 – Anti Inhibitor for Pi3K = Precision Medicine

  9. Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA 21st Century – metastatic solid tumors – 900 patients: accommodated plan Lab developed Tests: new approach Efficiency, transparency

  10. innovation INFORMS at NIH Center of Excellence – data collection and analysis of multiple data types Biometric sensors collecting data on cancer patients collaboration with Academia, single arm vs randomized decentralized devices are collecting data

  11. FDA considers N of One, small samples, EGFR drug was approved in 2 1/2 years since Phase 1 of NDA New trial designs: reduce bias and alternative end points narrow criteria for participation, more personalized and more patient-centered innovation

  12. Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA Advances of technology of biomarkers, disease indication Accelerated approval by FDA a collaborative of speeding the process companion diagnosis assays

  13. Unmet need, commitment is there, innovation and connectivity drive access, collaboration not competition – helps Precision medicine in emerging nations. Access to PM anywhere in the world suggested Kristin Pothier, MS, Global Head, Life Sciences EY

  14. Stephen L. Eck, M.D., Ph.D., President, CEO, Aravive Biologics; Board Chairman, PMC Laxo – A molecular target to be found by diagnostics TEST — as a basis to develop a drug Pricing and value – dimensions of Value to society How PM is done today?

  15. Marc S. Williams, MD Geisinger Clinical Genomics vs Physician specialist (i.e.,hypercholestoralemia), both in same place – paper and EMR Outcomes – tracking patients over decades – systems in place to capture the data Virtual Cycle Clinical data

  16. Timothy Cannon, M.D., Inova Molecular Tumor Board, 5 hospital in VA, Precision Genomics Cancer Therapy Poor understanding of molecular results by MDs, Refractory Patients no Forum to discuss other options 220 patients presented beyond InovaOncologi

  17. Scott A. Beck, Mayo Clinic, MN, AZ PM, Genomics sequencing, BioEthics, IT, Translational Perspective in Epi-genomics, Discovery to Translation Applicattions Pharmacy- Formulary – EMR – Champions from Disease areas to practice environment Testing

  18. payment dominates delivery of care, future PM from Genomics cost to patients Transform acceptability of PM suggested Ronald A. Paulus, M.D., M.B.A., President, CEO, Mission Health, NC, ex-Geisinger, CIO

  19. Genomics based PM to be turned into Wellness Strategy – the path not yet knows said Jeffrey R. Balser, M.D., Ph.D., Dean, Vanderbilt University School of Medicine; President, CEO, Vanderbilt University Medical Center, Nashville, TN

  20. Millianlian Diabetics NOT on Medicare, Analytics: iPhone telling patient dishes to order since SYSTEM KNOWS BLOOD SUGER 24×7 – target care by Analytics Genomics paid by NIH PM Analytics is built at Vanderbilt University MC, Jeffrey R. Balser, CEO

  21. Survival of patient with mutation and targeted drug LIVE LONGER David B. Roth, M.D., Ph.D., Simon Flexner Professor Chair, Pathology and Laboratory Medicine, Perelman School of Medicine at University of Pennsylvania

  22. Lotte Steuten, Ph.D., School of Pharmacy at University of Washington, Seattle aggregate big data , models as evidence, has value to clinical, the model under development NGS Profile of Patient vs current standard of care.

  23. David B. Roth, M.D., Ph.D., UPenn Director, Penn Center for Precision Medicine 5000 patients underwent genome sequencing Interpretation is the issue that is hard Health IT are still in silos: Pharmacy data, financial data, EMR

  24. Michael Pellini, M.D., M.B.A., Chairman, Board of Directors, Foundation Medicine; Board Member, Personalized Medicine Coalition, we know there is value in PM we need to work together on the challenges — to prove the value in PM

  25. Andrea Stern Ferris, M.B.A., President, Chairman of the Board, LUNGevity Foundation – PATIENT to be included in the conversation patient after successful treatment have hope work pay taxes pay to health plans continue family life

  26. Molecular Era, NEJM, 2017, 377, 1813-1823, BRAF in Melanoma – 80% do not need additional therapy vs 20% benefitted in the Non-Molecular Era, data by Dane J. Dickson, CureOne (formerly MED-C); Oregon Health and Science University

  27. CURES – CAR-T are they cures??? A teen-ager’s Value-based Price: $475,000 x years lived suggests  Steven D. Pearson, M.D., M.Sc., Founder, President, Institute for Clinical and Economic Review (ICER)

  28. Of 134 drugs in development – 42 have the potential to become Personalized medicine therapies, said Stephen J. Ubl, President, CEO, PhRMA

  29. Transplantation vs enhancement – resistance to senescence and pathogens to be achieved by gene editing suggests George M. Church, Ph.D., Professor of Genetics

  30. Regulatory oversight on engineering embrios is coming, metric of success in recruitment of patients said Arthur L. Caplan, Ph.D., Drs. William F. and Virginia Connolly Mitty Chair, Director, Division of Medical Ethics, New York Univ

  31. CRISPR does not handle all mutation many require a different editing tool said George M. Church, Ph.D., Professor of Genetics, Health Sciences and Technology, Harvard-MIT Division of Health Sciences and Technology

  32. understand well enough  the gentic application where CRISPR will assist medicine: Retinal degeneration, two aspects one worked in Japan said Katrine Bosley, CEO, Editas Medicine

  33. Aviva Lev-Ari Retweeted Aviva Lev-Ari

    Amazing Power in hands of informed patients

    Aviva Lev-Ari added,

  34. Patients input and sophistication increased – IRB is not aware of the engagement of Patients and their challenging feedback say Deborah Schrag, M.D., M.P.H, Dana Farber

  35. Physicians needs interfaces, dashboard information delivered to MDs, data sits unused, new tools are needed for the data display by relevance to the MDs – clinicians needs decision support in their office

  36. Standards: Toxicity criteria – library of 882 symptoms, Patient reported outcomes by Patients, Resist criteria applied to imaging data criteria for brain tumors said Deborah Schrag, M.D., M.P.H., Chief Medical Oncology, Dana-Farber

  37. drafting document on Verify data integrity in clinical trials, detect discrepancies compromise the integrity of the data – audits by FDA said Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA

  38. pre-existing autoimmune disease – not indicated for them Immunotherapy even though patients wish to try said Deborah Schrag, M.D., M.P.H., Chief, Division of Population Sciences, Medical Oncology, Dana-Farber Cancer Institute

  39. Drug approved for one indication, provide new data for supplemental indications said Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA

  40. Eric G. Klein, Pharm.D, Eli Lilly Aggregate burden of disease, existence of co-morbidities Genomics: WHY is explained – precise tools data vs intelligence – interoperability Past clinical trial, replicate studies retrospective data

  41. linkages vs computational techniques we do not have consistent data, data structured Vital sign or WBC count – we have data standardization is evolving said Deborah Schrag, M.D., M.P.H., Chief, Dana-Farber Cancer Institute

  42. use data sets prospective vs retrospective studies asked Amy Abernethy, M.D., Ph.D., Chief Medical Officer, Chief Scientific Officer, Flatiron Health; Board Member, Personalized Medicine Coalition

  43. Clinical sense vs research context, FDA is more comfortable with other than oncology products beyond drugs, namely diagnostics, diagnostics company seeking partnership with many drug areas Thermo FIscher and Novartis partnership

  44. Cost of CT Scan vs an NGS Test – Genomic testing is much cheaper yet volume is still low said Jacob S. Van Naarden, Chief Business Officer, Loxo Oncology

  45. NGS – time results come back what the mutation mean? NOW results come in few days, data analysis assist the said Joydeep Goswami, Ph.D., M.B.A., M.S., President, Clinical Next-Generation Sequencing, Oncology, Thermo Fisher Scientifi

  46. 3D BioPrinting of Drugs and the innovation storm of agents — are both benefits, value based pricing, elasticities, is that price sufficient to support R&D, dynamic environment said Joshua Ofman, SVP, Global Value, Access, Amgen

  47. Awardee of Leadership in PM, Illumina, HC system not yet ready for Precision Medicine

  48. Amgen and Harvard Pilgrims interpretation of Values related to partnerships: Novartis

  49. at Illimina – Consumer Advocacy added to Technology breakthroughs in genome sequencing said Jay T. Flatley, M.S., Executive Chairman, Illumina

  50. National Genomic Service – Sequencing becoming STANDARD of Care, phynotypes, $10 million to be spent NIH said Jay T. Flatley, M.S., Executive Chairman, Illumina

  51. 13th Annual Leadership in Personalized Medicine Award AWARDEE | Jay T. Flatley, M.S., Executive Chairman, Illumina

  52. 13th Annual Leadership in PM Award to Jay T Flatlet, Illumina

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LIVE Day Two – 13th Annual Personalized Medicine Conference, From Concept to the Clinic, November 14–16, 2017, Joseph B. Martin Conference Center, Harvard Medical School, 77 Avenue Louis Pasteur Boston, MA 02115

 

JOSEPH B. MARTIN CONFERENCE CENTER

HARVARD MEDICAL SCHOOL, BOSTON, MA 02115

http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/13th_Annual_PM_Conference37.pdf

Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston

pharma_bi-background0238

will cover in REAL TIME the 13th Annual Personalized Medicine, From Concept to the Clinic, November 14–16, 2017, Joseph B. Martin Conference Center, Harvard Medical School, 77 Avenue Louis Pasteur Boston, MA 02115

In attendance, covering LIVE using Social Media

Aviva Lev-Ari, PhD, RN

Editor-in-Chief

http://pharmaceuticalintelligence.com

@pharma_BI

@AVIVA1950

#PMConf

Agenda · Part II  NOVEMBER 16, 2017 · CONFERENCE PROGRAM | AGENDA

7:00 am Registration and Breakfast

8:00 am Opening Remarks

SPEAKER | Stephen L. Eck, M.D., Ph.D., President, CEO, Aravive Biologics; Board Chairman, Personalized Medicine Coalition

  • 2005 at Pfizer new initiative on Personalized Medicine
  • Left to go to Lilly – not to give a drug to  Patients with KRAS mutation – beginning of PM
  • Laxo – A molecular target to be found by diagnostics TEST  — as a basis to develop a drug
  • Pricing and value – dimensions of Value to society
  • How PM is done today

8:10 am Clinical Adoption of Personalized Medicine: A Two-Part Discussion Pioneering health care providers have begun to explore the business models, operational processes, IT infrastructure and educational programs that are needed to catalyze the paradigm shift toward personalized medicine. This two-part session on clinical adoption will examine the strategic and day-to-day challenges clinical organizations face as they seek to integrate personalized medicine in clinical settings — and the solutions they employ to address those challenges.

SESSION CHAIR | Marcia A. Kean, M.B.A., Chairman, Strategic Initiatives, Feinstein Kean Healthcare

Discussion Part 1

8:15 am The Case for Personalized Medicine in the Clinic: The View From the Corner Office Inspiring an organizational commitment to a new way of practicing medicine requires visionary leadership. This fireside chat will highlight the viewpoints and approaches of leaders who are spearheading efforts to adopt personalized medicine at clinical institutions, with an eye on the value proposition for changing existing norms and practices.

MODERATOR | Howard L. McLeod, Pharm.D., Medical Director, The DeBartolo Family Personalized Medicine Institute, Chair, Department of Individualized Cancer Management, Senior Member, Division of Population Sciences, Moffitt Cancer Center; Board Member, Personalized Medicine Coalition

Jeffrey R. Balser, M.D., Ph.D., Dean, Vanderbilt University School of Medicine; President, CEO, Vanderbilt University Medical Center, Nashville, TN

  • Vanderbilt University Medical Center [$500 Million in Grants] is a HealthCare System, split from Vanderbilt University School of Medicine [1200 Medical Residents], now they are like Partners
  • BioMedical Informatics very strong at Vanderbilt University School of Medicine
  • Jeffrey R. Balser, M.D., Ph.D. was first student of Dan, A pioneer in Personalized Medicine
  • PM and Non-Oncology: PLAVIX – DSS when MD order drugs DSS trigger No PLAVIX to this patient, made second decision in real time by MDs
  • Nashville – four flagship hospitals, largest HMO not for profit in the country
  • PM at Vanderbilt University Medical Center – 25 drugs – given ONLY after Genomic sequencing
  • Millianlian Diabetics NOT on Medicare, Analytics: iPhone telling patient what dishes to order since SYSTEM KNOWS BLOOD SUGER 24×7 – target care by Analytics
  • Genomics paid by NIH
  • PM Analytics is built at Vanderbilt University Medical Center said Jeffrey R. Balser, M.D., Ph.D., Dean, Vanderbilt University School of Medicine; President, CEO, Vanderbilt University Medical Center
  • what is the economics benefit of Genomic sequencing: DSS on Drugs – Peterson is documenting drug class by economic benefit – bundle to show value
  • Genomics based PM is on drugs — polimorthism – this drug will not work
  • Disease counseling is harder than drug = wellness strategy is the Fututre
  • Genomics based PM to be turned into Wellness Strategy – the path not yet knows said Jeffrey R. Balser, M.D., Ph.D., Dean, Vanderbilt University School of Medicine; President, CEO, Vanderbilt University Medical Center, Nashville, TN
  • Research Investment is R&D, decisions made to guide all research and investment in PM initiative – not generating money. Pilot studies leads to grants. One study is on Economic benefit of PM

Ronald A. Paulus, M.D., M.B.A., President, CEO, Mission Health, NC, ex-Geisinger, CIO

  • 8 most western counties in NC
  • small group of Genetists:
  1. PM and Oncology and – Cancer therapy from a Genomics stand point
  2. PM and Non-Oncology – Drug-Drug interactions
  3. Clinicians needs actionable information
  4. Primary care practices to adopt PM – HOW, where, why? what will be out of pocket expense to the individual
  5. subsidization is a must
  6. payment dominates delivery of care, future PM from Genomics cost to patients
  7. Transform acceptability of PM suggested Ronald A. Paulus, M.D., M.B.A., President, CEO, Mission Health, NC, ex-Geisinger, CIO

Discussion Part 2

9:00 am Practicing Personalized Medicine: Lessons From the Front Lines To successfully integrate personalized medicine into a health system, administrators and clinicians must also design and implement new processes related to program infrastructure and informatics; help educate physicians and patients about the field; and inspire cultural change within the institution. During this panel discussion, a group of early adopters will share lessons learned from implementing pilot programs across the United States.

MODERATOR | Daryl Pritchard, Ph.D., Senior Vice President, Science Policy, Personalized Medicine Coalition

Bonnie J. Addario, Founder, Chair, Bonnie J. Addario Lung Cancer Foundation; Board Member, Personalized Medicine Coalition; Lung Cancer Survivor

Scott A. Beck, M.B.A., Administrator, Center for Individualized Medicine, Mayo Clinic, MN, AZ

  • PM, Genomics sequencing, BioEthics, IT, Translational Perspective in Epi-genomics,
  • Discovery to Translation Applicattions
  • Pharmacy- Formulary – EMR – Champions from Disease areas to practice environment
  • Testing offering, approve value
  • 25 Projects: PharmacoGenomics Testing to patients, change drug before repeat endoscopy

Timothy Cannon, M.D., Clinical Director, Inova Schar Cancer Institute Molecular Tumor Board

  • 5 hospital in VA,
  • Precision Genomics Cancer Therapy
  • Poor understanding of molecular results by MDs, Refractory Patients – no Forum to discuss other options
  • Molecular Tumor Board for Inova Health System: 220 patients presented beyond Inova
  • Oncologists had concerned that patients are aware of drug that MD can’t deliver to client

Peter Hulick, M.D., M.M.Sc., Medical Director, Center for Personalized Medicine, NorthShore University HealthSystem

  • 4 hospitals – 950 MDs
  • PCP to get engaged
  • Neurology
  • Genetic Assessment tool DSS offers PCP option for electronic ordering of the Genetic Testing, Results appear in Patients’ charts
  • Proactive testing
  • 20,000 patients in the system to be tested for pharmaco-genomics testing

Marc S. Williams, M.D., F.A.A.P., F.A.C.M.G., F.A.C.M.I., Director, Genomic Medicine Institute, Geisinger – Central PA

  • 30% of providers are Geisinger the rest are not
  • Genomics: PM — Microbiome bank – broad user consent: recontact and return results
  • Genomics Medicine Institute – 2014 Partnership with Regeneron – genomics sequencing and profiling — all result to be used by Geisinger
  • 170,000 patient consented – 90% responded, 8,000 sequences available
  • 80 gene with potential actionability – interpretation by Scientists
  • Pathologic calls return results –
  • Clinical Genomics vs Physician specialist (i.e.,hypercholestoralemia), both in same place – paper and EMR
  • Outcomes – tracking patients over decades – systems in place to capture the data
  • Virtual Cycle Clinical data – dashboards were created to deliver results per week.
  • 1/2 people do not need criteria
  • Geisinger will disseminate internationally

10:15 am Networking Break (sponsored by Moffitt Cancer Center)

10:45 am Harvard Business School Case Study — Intermountain Healthcare: Pursuing Precision Medicine Intermountain has a long history of being at the forefront of health care quality improvement and the development of treatment protocols. In 2013, Intermountain Precision Genomics (IPG) was started with Dr. Lincoln Nadauld as its Executive Director. IPG focused on stage 4 cancer patients and performed three distinct functions: genomic sequencing, interpretation of sequencing results with recommendations for precision therapies, and drug acquisition and reimbursement. A paper published in February 2017 reported that in addition to having a higher quality of life, patients who received the targeted therapies had progression-free survival rates of almost twice as long as other patients. The purpose of our case discussion will be to assess these efforts, to consider their broader applicability and to review IPG’s plans for the future.

PRESENTER | Richard Hamermesh, D.B.A., Co-Faculty Chair, Harvard Business School Kraft Precision Medicine Accelerator

12:00 pm Overview of the International Landscape for Personalized Medicine

PRESENTER | Kristin Pothier, M.S., Global Head, Life Sciences, Parthenon-EY

  • Precision Medicine in the Globe – stackholder ecosystem
  • India
  • Latin America
  • USA
  • Africa
  • EU
  • APAC
  • Middle East

Regional Spotlight:

China – strength emerging 1.4 Billion people, 4.2 million annual incidence of Cancer – systemic challenges will limit access

Brazil – 440,000 cancer incidents a year, 207 Million Corporate, Hospital, Government, Academic research, collaboration vs competition, collaboration will win

Dubai – 28.5 Million population

Qatar

UAE – Initiative to sequence the entire population, 6,000 done

Saudi Arabia

Middle East – 0.4 oncologist for 100,000

Summary – Unmet need, commitment is there, innovation and connectivity drive access, collaboration not competition – helps Precision medicine in emerging nations. Access to PM anywhere in the world suggested Kristin Pothier, M.S., Global Head, Life Sciences, Parthenon-EY

12:30 pm Bag Lunch

1:30 pm Personalized Medicine at FDA: An Inside Look at the Agency’s Priorities for the Field

INTRODUCTION | Cynthia A. Bens, Vice President, Public Policy, Personalized Medicine Coalition

KEYNOTE | Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA

  • Advances of technology of biomarkers, disease indication
  • Accelerated approval by FDA a collaborative of speeding the process
  • companion diagnosis assays and drug or biologics
  • FDA considers N of One, small samples, EGFR drug was approved in 2 1/2 years since Phase 1 of NDA
  • New trial designs: reduce bias and alternative end points
  • narrow criteria for participation, more personalized and more patient-centered
  • innovation INFORMS at NIH Center of Excellence – data collection and analysis of multiple data types
  • Biometric sensors collecting data on cancer patients
  • collaboration with Academia, single arm vs randomized, decentralized
  • devices are collecting data in clinical trials
  • 21st Century – metastatic solid tumors – 900 patients: accommodated plan
  • Lab developed Tests: new approach
  • Efficiency, transparency

2:00 pm The Patient Perspective on Personalized Medicine

INTRODUCTION | Susan McClure, Founder, Publisher, Genome magazine; Board Member, Personalized Medicine Coalition

  • Precision medicine and relevant information for Patients
  • Genomic sequencing is the Opening Gate to PM

KEYNOTE | Bryce Olson, Global Marketing Director, Health and Life Sciences Group, Intel Corporation

  • genome sequencing found his Pi3K Pathway – PIK3CA p.E54 – Anti Inhibitor for Pi3K = Precision Medicine

2:30 pm Patient 2.0: Exploring the Future of Personalized Medicine Many observers speculate that the coming wave of gene editing, gene therapy, direct-to-consumer genetic tests and the personalized use of wearables will change the psychology, sociology, economy and efficacy of health care. Informed by the previous panel discussions, this conversation will examine the future of personalized medicine and the merits of these emerging trends.

MODERATOR | Robert C. Green, M.D., M.P.H., Director, Genomes2People Research Program, Professor of Medicine (Genetics), Brigham and Women’s Hospital, Broad Institute and Harvard Medical School

  • Neurologist first , Geneticist thereafter
  • Platinum vs gold standard
  • 59 genes will identify 80,000 will get the disease and 47,000 will never get the disease
  • is the technology the reason for investment vs Family history
  • pharmacogenomics can harm, if odds are so low than adherence will be lower

Sandro Galea, M.D., M.P.H., Dr.P.H., Dean, Robert A. Knox Professor, School of Public Health, Boston University

  • Skeptical of societal aspects: race, 50% of the country health getting better vs 50% getting worse but enthusiast on technology
  • US expense on Health care the highest in the World comes on the expense of housings, mental health, education – curative vs preventive care
  • MDs are insentiviced to keep patients sick
  • Folic Acid
  • Nudge behavior
  • invest in long livivng

Tom Miller, M.S., Founder, Managing Partner, GreyBird Ventures LLC

  • duty to call up therapies that will not work, balance addressed by PM – diagnostics in PM
  • clinical utility from patient selection for the therapy the patient will respond to
  • fantasy: Medical decision making to be made to avoid un neccesary care

Michael Snyder, Ph.D., Stanford W. Ascherman Professor, Chair, Department of Genetics, Director, Center of Genomics and Personalized Medicine, Stanford University School of Medicine

  • Personal sequencing for multiple etiologies
  • rich people come to get sequenced
  • libraries
  • Providers to be incentivized if patients are health

3:30 pm Closing Remarks

SPEAKER | Edward Abrahams, Ph.D., President, Personalized Medicine Coalition

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LIVE Day One – 13th Annual Personalized Medicine Conference, From Concept to the Clinic, November 14–16, 2017, Joseph B. Martin Conference Center, Harvard Medical School, 77 Avenue Louis Pasteur Boston, MA 02115

 

JOSEPH B. MARTIN CONFERENCE CENTER

HARVARD MEDICAL SCHOOL, BOSTON, MA 02115

http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/13th_Annual_PM_Conference37.pdf

Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston

pharma_bi-background0238

will cover in REAL TIME the 13th Annual Personalized Medicine, From Concept to the Clinic, November 14–16, 2017, Joseph B. Martin Conference Center, Harvard Medical School, 77 Avenue Louis Pasteur Boston, MA 02115

In attendance, covering LIVE using Social Media

Aviva Lev-Ari, PhD, RN

Editor-in-Chief

http://pharmaceuticalintelligence.com

@pharma_BI

@AVIVA1950

#PMConf

Agenda · Part I  NOVEMBER 15, 2017 · CONFERENCE PROGRAM | AGENDA

7:00 am Registration and Breakfast

8:00 am Opening Remarks SPEAKER | Edward Abrahams, Ph.D., President, Personalized Medicine Coalition

  • 13th Annual PM Conference at HMS
  • Paradigm shift from One medicine FITS ALL – 13 years ago was a promise in 2017 it is a REALITY
  • Liquid biopsies, read and write gene therapy
  • Value, Pricing, Access
  • Evidence for reimbursement and FDA directions
  • Introduction od PM to the Clinic
  • Case study on Value and Healthcare System
  • Future of PM Stanford, BU, Investor
  • Translation to Chinese, 50 guests from 20 countries and 21 from CA

 

8:10 am The State of Personalized Medicine

INTRODUCTION |

Steven D. Averbuch, M.D., Head, Precision Medicine Research & Development, Bristol-Myers Squibb; Board Member, Personalized Medicine Coalition

  • Known Tom for few decades, collecting tissue on lung cancer.
  • EGFR – discovered at HMS

KEYNOTE |

Thomas J. Lynch, Jr., M.D., Executive Vice President, Chief Scientific Officer, Research & Development, Bristol-Myers Squibb

  • Apply right drug to right patient
  • Gefitinig (AstraZeneca) vs Carboplatin/Paclitaxel – lung cancer – advanced NSCLC
  • Gene mutation – EGFR negative vs Positive – cost of sequencing inverse to Moore’s Law
  • Genome Sequenced at <$1,000
  • Lung Adenocarcinoma: 2016: PIK3CA, KRAS, BRAF
  • 2015NEJM – Design drugs: Resistance mutation vs. negative – no mutation EGFR
  • Immune -Biology of Cancer is Complex – Tumor, Effector Cells, Immune regulatory & APGs
  • NEXT opportunities: Novel I-O mechanisms, patient selection is key
  • Biomarkers: PDL-1, MSI – H Tumor mutation Burden (TMB) LAG-3
  • Future: Gene signature
  • Pembrolizumab Free survivsls – 50%
  • BMS – FoundationOne – calibration used by BMS: Mutational Burden: FoundationOne assey: Exploratory analysis: High TMB (Nivoluman vs Chemo, Nivo id bettervs LowTMB
  • Combination Drug Therapy: Nivo +Ipi
  • Assessment of TMB: coding regions of 21K genes: WES vs FoundationOne (F1)
  • TMB in Blood (bTMB) in 2L + NSCLC (POPLAR and OAK)
  • bTMB <16 vs bTMB >16
  • PM – molecular profiling of Hundreds of Cancers and PM of drug treatment driven by molecular profiles
  • F1 is promising

8:40 am 13th Annual Leadership in Personalized Medicine Award

AWARDEE | Jay T. Flatley, M.S., Executive Chairman, Illumina

  • Precision Medicine – still inpact is limited
  • Regulatory and Reimbursement are BARRIERS in the HealthCare system,
  • Kidney Cancer treated off-label – great
  • less 10% of tumors have been sequenced, sufficient tissue needed, physician voted not to sequence deeming it un-actionable
  • Cystic Fibrosis – only sequencing lead to FDA approval, POST marketing required significant resources
  • Translational researchers validated 200 genes
  • 400 genes at FoundationOne
  • DIagnostics companies – reimbursement process is TOO LONG
  • Regulatory – emerging diagnostics: Product in use in clinical trials
  • Risk models to be shared with Diagnostics companies – reimbursement at end of period when results are available
  • Blockchain technology is promising for handling data
  • Rare diseases in Cancer  – One milion genomes sequenced
  • National Genomic Service – Sequencing becoming STANDARD of Care, phynotypes, $10 million to be spent NIH said Jay T. Flatley, M.S., Executive Chairman, Illumina
  • at Illimina – Consumer Advocacy added to Technology breakthroughs in genome sequencing said Jay T. Flatley, M.S., Executive Chairman, Illumina

9:10 am Networking Break

9:35 am Progress in Partnerships: A Two-Part Discussion Aligning the constructs of the health system with the principles of personalized medicine will require stakeholders to scale the most promising cross-sector partnership models. This series of conversations will examine the potential of several of the most promising models that have emerged thus far.

Discussion

Part 1 9:35 am A Model for Risk-Sharing Agreements Between Payers and the Pharmaceutical Industry Many payers are reluctant to assume that covering personalized medicines will help mitigate costs associated with major medical events that require hospitalization. During this fireside chat, however, representatives from Amgen and Harvard Pilgrim Health Care will discuss the logic and implications of their groundbreaking agreement to share the financial risks of covering a targeted medicine based on that premise. Under the terms of the agreement, Amgen agreed to cover treatment costs for patients who have a heart attack or stroke while taking its personalized therapy for familial hypercholesterolemia.

MODERATOR | Meg Tirrell, M.S.J., Reporter, CNBC

Joshua Ofman, M.D., M.S.H.S., Senior Vice President, Global Value, Access and Policy, Amgen

  • Hyperlipidemia – Partnering, Amgen with Harvard Pilgrim Health Care
  • Arrangements: Patients who need the medication will get access to the medication
  • effective stuards: Co-Pay not too high, replacement of medication by generics
  • Medicare has requirements
  • Migraine medications are coming out from Amgen – novel payment
  • Combination drug therapy – Payment system not ready for it yet
  • 3D BioPrinting of Drugs and the innovation storm of agents — are both benefits, value based pricing, elasticities, is that price sufficient to support R&D, dynamic not linear environment said Joshua Ofman, M.D., M.S.H.S., Senior Vice President, Global Value, Access and Policy, Amgen

Michael Sherman, M.D., M.B.A., M.S., Chief Medical Officer, Senior Vice President, Harvard Pilgrim Health Care; Board Member, Personalized Medicine Coalition

  • complications,  cost, outcome work vs does not work
  • Gene therapies coming from Novartis and Partnership with Harvard Pilgrims
  • Value proposition for one drug and one cancer – to assure access Pharma and Payers Partnership
  • Drug and Outcome, high cost drug coming, very expensive, life saver for who needs them

Discussion

  • Pharma’s revenue stream is international, it is in the US that payers require Value

 

Part 2 10:05 am Models for the Development of Personalized Medicine Diagnostics Pharmaceutical and diagnostics companies have responded to a host of complex scientific, regulatory and reimbursement challenges partly by developing innovative partnership models around companion diagnostics. This panel discussion will feature representatives from the pharmaceutical and diagnostics industries, who will discuss the challenges partnerships have helped industry overcome as well as the obstacles that continue to inhibit the development of the diagnostic tools upon which personalized medicine depends. Agenda ·

 

MODERATOR | Alexander Vadas, Ph.D., Managing Director, L.E.K. Consulting

Joydeep Goswami, Ph.D., M.B.A., M.S., President, Clinical Next-Generation Sequencing, Oncology, Thermo Fisher Scientific

  • monitor disease , biopsy changes in 6 month and repeat is needed
  • NGS – results come back in a month what the mutation mean? NOW results come in few days, data analysis  assist the MDs for action in treatment said Joydeep Goswami, Ph.D., M.B.A., M.S., President, Clinical Next-Generation Sequencing, Oncology, Thermo Fisher Scientific
  • How to accelerate the need for safety and the avalangue of innovations
  • Clinical sense vs research context, FDA is more comfortable with other than oncology products beyond drugs, namely diagnostics

Jacob S. Van Naarden, Chief Business Officer, Loxo Oncology

  • Increase in need of drugs in NGS World, Tissue agnostics, ALL the drugs and all the tumors
  • reduction in cost with technology, can’t be too expensive,
  • LOXO drug development  – each testing addresses a focused medical issue  – cancer alterations  for ALL extremely aggressive cancer
  • DNA and RNA based events detected by tools
  • cost of test need to be low, Reference Labs need to collaborate to standarize technology and explain to the Payers
  • Cost of CT Scan vs an NGS Test – Genomic testing is much cheaper said Jacob S. Van Naarden, Chief Business Officer, Loxo Oncology
  • Educational

10:35 am Real-World Personalized Medicine: Examining the Role of Real-World Evidence in Personalizing Health Care FDA has offered a definition of real-world evidence, but the community continues to debate what is needed to fully integrate it into decision-making. This panel will explore what real-world evidence is, how it is being used and what regulatory requirements are needed to realize its potential.

MODERATOR | Amy Abernethy, M.D., Ph.D., Chief Medical Officer, Chief Scientific Officer, Flatiron Health; Board Member, Personalized Medicine Coalition

  • Collection of evidence to accelerate from lab to the Clinic
  • use data sets prospective vs retrospective studies asked Amy Abernethy, M.D., Ph.D., Chief Medical Officer, Chief Scientific Officer, Flatiron Health; Board Member, Personalized Medicine Coalition

Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA

  • 3/2017 established to have an integrative approach by FDA – real world dat ais important to FDA
  • Drug approved for one indication, provide new data for supplemental indications said Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA
  • co-morbidities cause EXCLUSION from clinical trials, i.e., HIV patients, experience of patients excluded to learn how differently they can be treated
  • drafting a document on Verify data integrity in clinical trials, detect discrepancies compromise the integrity of the data – audits by FDA said Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA
  • Validation of devices- FDA Innovation Initiative,

Eric G. Klein, Pharm.D., Senior Director, Oncology, Global Patient Outcomes and Real-World Evidence, Eli Lilly and Company

  • Aggregate burden of disease, existence of co-morbidities
  • Why it was occurring – Genomics: WHY is explained – precise tools
  • data vs intelligence – interoperability
  • Past clinical trial – replicate studies with retrospective data
  • finding the responding patients – pragmatic trial, not randomized, collect end point – very expensive and requires statisticians
  • end pint definition changed

Eleanor M. Perfetto, Ph.D., M.S., Senior Vice President, Strategic Initiatives, National Health Council

  • How patients  wish to see usage of their experience – how side effect information can be used.
  • New indication
  • reimbursement
  • improved used of existing drug higher rating vs new indications
  • clinical trial design gets input from patients, Patient can announce, dropping participation if a change is not made

Deborah Schrag, M.D., M.P.H., Chief, Division of Population Sciences, Medical Oncology, Dana-Farber Cancer Institute

  • Major gene mutation and Drugs
  • Drug exposure correlate with evidence, Worldwide,
  • linkages vs computational techniques we do not have consistent data, data structured or not, respond to medication: symptoms, prospects vs Vital sign or WBC count – we have data standardization is evolving said Deborah Schrag, M.D., M.P.H., Chief, Division of Population Sciences, Medical Oncology, Dana-Farber Cancer Institute
  • clinical decision support what is structured is data upon admission, monitoring the drugs given in this period, turning to patients willing to offer feedback and cooperate
  • pre-existing autoimmune disease – not indicated for them Immunotherapy even though patients wish to try said Deborah Schrag, M.D., M.P.H., Chief, Division of Population Sciences, Medical Oncology, Dana-Farber Cancer Institute
  • Standards: Toxicity criteria – library of 882 symptoms, Patient reported outcomes by Patients, Resist  criteria applied to imaging data criteria for brain tumors said Deborah Schrag, M.D., M.P.H., Chief, Division of Population Sciences, Medical Oncology, Dana-Farber Cancer Institute
  • Physicians needs interfaces, dashboard information delivered to MDs, data sits unused, new tools are needed for the data display by relevance to the MDs
  • Patients input and sophistication increased – IRB is not aware of the engagement of Patients and their challenging feedback say Deborah Schrag, M.D., M.P.H, Dana Farber

11:50 am Luncheon

1:00 pm The Designer Genome: Exploring the Implications of Gene Editing and Gene Therapy for the Future of Medicine and Humanity Many scientists believe the clustered regularly interspaced short palindromic repeats (CRISPR) genetic engineering tool and recent developments in gene therapy will dramatically alter the trajectory of medicine, but the specific implications of these developments for health systems around the world remain unclear. During this session, a panel of experts will discuss the status of these new technologies and how the medical community and regulatory agencies may have to adapt to keep up with forthcoming developments.

MODERATOR | Kevin Davies, Ph.D., Co-Author, DNA: The Story of the Genetic Revolution (with Jim Watson and Andrew Berry); Executive Editor, The CRISPR Journal

Katrine Bosley, CEO, Editas Medicine

  • spectrum of ease to correct a mutation, some mutation are easier than others for editing,
  • understand well enough  the gentic application where CRISPR will assist medicine: Retinal degeneration, two aspects one worked in Japan said Katrine Bosley, CEO, Editas Medicine

Arthur L. Caplan, Ph.D., Drs. William F. and Virginia Connolly Mitty Chair, Director, Division of Medical Ethics, New York University Langone Medical Center

  • Bioethics, super babies, engineering embrios,
  • Regulatory oversight on engineering embrios is coming, metric of success in recruitment of patients said Arthur L. Caplan, Ph.D., Drs. William F. and Virginia Connolly Mitty Chair, Director, Division of Medical Ethics, New York University Langone Medical Center
  • cell repair is cheaper that transplantation,
  • clone of super person next door
  • Bioterrorism accomplished by gene engineering !!

George M. Church, Ph.D., Professor of Genetics, Health Sciences and Technology, Harvard-MIT Division of Health Sciences and Technology; Director, Harvard Medical School NHGRI-Center of Excellence in Genomic Science; Director, Harvard Medical School Personal Genome Project; Founding Member, Wyss Institute for Biologically Inspired Engineering at Harvard University

  • Delivery, more precise,
  • Longevity and aging – one blockbuster is needed
  • Engineered mutation, machine learning
  • CRISPR does not handle all mutation many require a different editing tool said George M. Church, Ph.D., Professor of Genetics, Health Sciences and Technology, Harvard-MIT Division of Health Sciences and Technology; Director, Harvard Medical School NHGRI-Center of Excellence in Genomic Science; Director, Harvard Medical School Personal Genome Project; Founding Member, Wyss Institute for Biologically Inspired Engineering at Harvard University
  • over regulation – Do not touch germ line – is not desired
  • Transplantation vs enhancement – resistance to senescence and pathogens to be achieved by gene editing suggests George M. Church, Ph.D., Professor of Genetics
  • Bringing back genes – elephants with fur

Jeffrey D. Marrazzo, M.B.A., M.P.A., CEO, Spark Therapeutics

  • Retina degeneration causes blindness, deliver drug to back of the retine, inject genetic material and achieved remarkable results, drug approval of genetic therapy in the US for a genetic disorder in Retina causing blindness
  • 21st Century schema of Payment and benefits

 

2:15 pm Pricing Personalized Medicines The increasing pressure on industry stakeholders to alter their drug pricing practices has particular significance for personalized medicines, which must recoup research and development costs from smaller patient populations. This conversation will explore the pharmaceutical industry’s strategies for facilitating sustainable access to these innovative therapies.

MODERATOR | Meg Tirrell, M.S.J., Reporter, CNBC

Stephen J. Ubl, President, CEO, PhRMA

  • minimum 10% invested in R&D at each Pharma
  • Of 134 drugs in development – 42 have the potential to become Personalized medicine therapies, said Stephen J. Ubl, President, CEO, PhRMA
  • Icer methodology – average patient aggregate data, value pricing is a better model: RA targeted to subset of patients
  • Price gauging is a problem – bring solutions to the table, Patients asks for incentives
  • amortizing costs like mortgage
  • Outcome-based arrangements: If money-based guaranteed it negate Medicaid negotiation power. If transportation is covered – it leads to locking product in use

2:45 pm Networking Break (sponsored by GreyBird Ventures)

3:15 pm Precision Valuation: A Discussion of How Value Assessment Frameworks Can Account for Personalized Medicine Payers control access to personalized medicine, and some have begun to take an interest in findings from value assessment frameworks that are challenged to account for developments in the field. In addition to exploring their potential impact on individualized care, this session will examine how value assessment frameworks can and should consider personalized medicine as part of their processes for evaluating therapeutic options.

MODERATOR | Jennifer Snow, M.P.H., Director, Health Policy, Xcenda, AmerisourceBergen

  • Quality Era moved to Value Era

 

Dane J. Dickson, M.D., CEO, Founder, CureOne (formerly MED-C); Director, Precision Medicine Policy and Registries, Knight Cancer Institute at Oregon Health and Science University

Molecular Era

  • NEJM, 2017, 377, 1813-1823
  • BRAF in Melanoma – 80% do not need additional therapy vs 20% benefitted in the Non-Molecular Era

data by Dane J. Dickson, M.D., CEO, Founder, CureOne (formerly MED-C); Director, Precision Medicine Policy and Registries, Knight Cancer Institute at Oregon Health and Science University

 

Robert Dubois, M.D., Ph.D., Executive Vice President, Chief Science Officer, National Pharmaceutical Council

  • Value Assessment and PM: ACC, ASCO, ICER< Memorial Sloan,
  • The patient: survival, QOL, Adverse events, Out of pocket cost, extra survival by disease, treatment burden,
  • PAYERS: One size does not fit all – AVERAGE is meaningless
  • MDs vs Patients – are different in preference

Andrea Stern Ferris, M.B.A., President, Chairman of the Board, LUNGevity Foundation

  • PATIENT to be included in the conversation

Steven D. Pearson, M.D., M.Sc., Founder, President, Institute for Clinical and Economic Review (ICER)

  • Precision Medicine vs Value Assessment
  • Novartis CAR-T Kymriah:  relapsed B-cell precursor ALL under 25 – 5 yr survival – 10%
  • Changes associated with Gene therapies: single arm trials, surrogate outcomes, less certainty safety and benefits
  • Gene therapy – >> innovations Kymriah – $475,000 price
  • Long term value for money vs Short term affordability

PRICE-based on Value – discount from prices after rebate to meet ICER value-based Price range

  • More targeted = higher value more favorable cost-effectiveness
  • Rare/ultra-rare populations: broader value range:
  1. Use EARLIER
  2. will it work for patients without genetic marker?
  • Years of Life weighted by an INDEX of quality of life (1=perfect health;  0=dead)
  • willingness to pay: WHO and ACC: 1-3x
  • individual x2 salary
  • Opportunity cost x1 per capita GDP in UK
  • Future of value assessment and precision medicine
  • CURES – CAR-T are they cures???
  • A teen-ager’s Value-based Price: $475,000 x years lived suggestsSteven D. Pearson, M.D., M.Sc., Founder, President, Institute for Clinical and Economic Review (ICER)

4:30 pm The Utility Proposition: An Analysis of Case Studies in the Economic Value of Personalized Medicine Although personalized medicine’s proponents contend that the field can deliver economic value by helping doctors avoid prescribing costly but ineffective therapies, the field lacks literature testing that hypothesis. This session will highlight recent studies on the clinical and economic value of personalized medicine, shedding light on what we know about personalized medicine’s clinical and economic utility — and what we don’t.

MODERATOR | Michael Pellini, M.D., M.B.A., Chairman, Board of Directors, Foundation Medicine; Board Member, Personalized Medicine Coalition

  • we know there is value in Personalized Medicine
  • we need to work together to acknowledge the challenges — to prove the value in PM

Lincoln Nadauld, M.D., Ph.D., Executive Director, Precision Medicine, Precision Genomics, Intermountain Healthcare

  • Interpretation by Medical Oncologists beyond: KRAS, BRAF
  • Measuring the value and presenting that to the payers and inside the organizations
  • 2013 –

David B. Roth, M.D., Ph.D., Simon Flexner Professor Chair, Pathology and Laboratory Medicine, Perelman School of Medicine at University of Pennsylvania; Director, Penn Center for Precision Medicine

  • 5000 patients underwent genome sequencing
  • Interpretation is the issue that is hard
  • Health IT are still in silos: Pharmacy data, financial data, EMR are not integrated yet
  • Survival of patient with mutation and targeted drug LIVE LONGER

Lotte Steuten, Ph.D., M.Sc., Associate Faculty Member, Hutchinson Institute for Cancer Outcomes Research (HICOR), Fred Hutchinson Cancer Research Center; Affiliate Associate Professor, Pharmaceutical Outcomes Research and Policy Program, School of Pharmacy at University of Washington, Seattle

  • aggregate big data , models as evidence, has value to clinical, the model under development NGS Profile of Patient vs current standard of care. Model Payer advisor committee, Oncologist Advisory Committee great benefit to PM on the cost side data is for targeting treatment using the promise of PM

5:45 pm Elements Café Cocktail Reception

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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

MIT Technology Review’s EmTech conference

In attendance, covering LIVE using Social Media

Aviva Lev-Ari, PhD, RN

Editor-in-Chief

http://pharmaceuticalintelligence.com

@pharma_BI

@AVIVA1950

#emtechmit

@techreview

 

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 – Elizabeth Bramson-Boudreau, MIT TR
  • In Media Lab – MIT and MIT Technology Review was established in 1899
  • EmTech 1999 – 100 years to MIT Technology Review
  • Innovations and pushing the boundaries
  • AI – potential and limitations
  • Climate change requires new technologies
  • Brain Technologies: Biology Vision
  • Tomorrow: emerging technologies: Cybercrime, role of technology
  • Automation and future of work
  • Partners: GE, Lamburghini
  • Lemelson-MIT
  • MITTR – Whova on AppleStore
9:15
The State of AI – Andrew Ng, CS.AI, Stanford University – was 2008 Young Innovator,
Founder, Deeplearning.ai; Adjunct Professor, Stanford University
  • Trends in AI – AI is the new Electricity
  • Deep Learning & Neural Networks (NN):
  1. Input a picture –>> output: Is it You?
  2. loan application outcome: will you repay (%)
  3. picture from car – Output GPS address –>> Supervised Learning
  4.  doing act in <1 sec of thinking
  5. training SMALL, Medium size very large NN
  6. Algorithm innovations:

Supervised Learning algorithm types:

  • Transfer Learning
  • Unsupervised learning
  • Reinforcement learning – hunger for data: i.e., robotic applications

Importance of Data accumulation for launch a Product –  Users — data growth

  • Shopping Mall + website is not equal an Internet company
  • Internet company:
  1. push data to CEOs
  2. A–B Testing
  3. Short cycle time
  4. Decisions made by PM and ERP

AI era

traditional company + NN not equal AI company

  • Strategic data acquisition
  • Unified data warehouse
  • NEW JOB DESCRIPTIONS
  • Precision automation
  • ORGANIZATION CHART to interface in a matrix with AI Teams – hire Ai in the Business Units
  • Scarce talent of AI

Discussion

  • Children MUST learn to code
  • Human-Computer communication will be by writing code
9:45
Meet the Innovators Under 35
  • Future of work
  • warranted reliant digital connectivity
10:30
Break & Networking
11:00
AI’s Next Leap Forward

Tomasso Poggio, MIT, CSAIL, BCS

  • Deep learning  – next step
  • Bet on Center Brain Mind Machines (CBMM)
  • Josh Tennenbaum at MIT
  • Autonomous Driving – Amnon Shaashua, MobilEye
  • 20 years @ MI AI: Dailmer and MIT — detection of pedestrans
  • Powerful computers and algorithms – Reinforcement Learning Networks (Brain Science), models of Vision and Deep Learning Networks – WHEN they work?
  • Building Jarvis – a buttler application in AI built by Marc Zukenberg
  • NeuroScience – MobilEye, AlphaGo
  • CBMM – NSF $50 Million in AI funding  – Science of Intelligence and Engineering of Intelligence
  • MIT & Harvard plus several organization
  • Business Partners: MS Soft, Google bought MobilEye,
  • Center for Visual Gaze – 200 msec of visual processing
  • ERGO SUM: toward symbols, Cognitive core, visual system, Brain OS – running routines
  • Breakthroughs: Theory: under which conditions,
  1. Learning theory
  2. optimization Approximation Theory: Deep vs Shallow networks
  3. Intelligence is greatest problem to solve it is like LIFE, Tomasso Poggio, MIT, CSAIL, BCS
  4. machine can help human to think better, long time horizon is needed,

Kris Hammond, Prof. Northtwestern University

  • Data analytics and Ideas
  • words vs language – past, present, future – uniquely HUMAN, now machine language is Human Partner
  • language vs Ideas
  • machines knows a lot
  • facts, dat move to narrative
  • Language is understanding
  • FIN information: Decisions about allocations,
  • Turbidity data on the beach in Chicago: Which Beach is the cleanest vs the dirtiest
  • NARRATIVE ANALYTICS: data that machine can tell us what it has as a story and presented as intelligent language,

    Cognitive Science application to autonomous driving – Yibio Zhau, Tennenbaum Lab @MIT, ISEE.AI, Computer vision, Cognitive Science

  •  interpulate and extrapulate data needed for autonomous driving
  • reasoning beyond the system: Human intelligence , intentional reasoning, pattern recognition,
  • Ali baba – funding building of a Robot for autonomous driving – understanding by imagining – causes for behavior by others
  • ISEE – Next generation of AI — driving drivessless ly for thousands of miles
  • Car to car communication is a sensoring issue, negotiation need to be taught to machines

Young Scientists 35 years old or less

Austin Olson, Luminar – object detection 99% accuracy,

Angella Schoellig — Roborts, Prof. University of Toronto, robots in predictable environments

Lorenz Meier — Vertical Technologies – Drones and safety – DB of flights

12:30
Lunch & Networking
2:00
Adapting to the reality of climate change

Lee Krevat, Sempra –

owns Wind Farms- managing a Grid with renewable energy. Variable – Wind technology wind is variable – if wind blows too much switch to diesel. 100% renewable for one hour on Islands

Growth area:
  1. 20 cents diesel, wind is 10 cents help the enviroment

mainland, not yet used, price diesel vs wind

Solar wind generation – next biggest Technology in Energy

and

Alex Tepper,Avetars

Robotics, Drones, AI and the Future of Energy – A start up incubator sponsored and funded by GE
  • RAIL – Predict derailments
  • OIL & GAS – corrosion is the enemy — knowledge of corosion progression – using AI algorithms

Growth area: Aviation

John Holdren – Harvard University – Government  Role in ENERGY and Climate Change – Obama’s advisor Presidential CSO on Climate and energy

  • mitigation
  • adaptation
  • suffering – shortcomings of mitigation and adaptation
  • harm of business as usual
  • Efficiency standards during Obama Administration, assistance to other countries led to the Agreement in Paris 195 countirs — agreement to reduce emission. China and US declare cooperation on emission of gases into the environment.
  • PRESIDENT TRUMPS CALLED CLIMATE CHANGE A HOAX  – proposed to cut energy R&D
  • All executive orders by Obama – were reverted by Trump
  • Innovations: Electricity from Solar increase and wind as well and batteries
  • Carbon capture and storage – technological challenge
  • Biofuel processing, liquid bio fuel
  • Nuclear innovations to nuclear waste
  • 2100 – 5% on defense and 2% on the environment – model under estimate the contribution of innovations for the long run.
  • 1000 businesses in deployment of technologies

Evelyn wang, MIT – Material Science – Sustainable energy – nano

  • material properties: superior properties of LOW DENSITIES
  • Light manipulation
  • membrane
  • CO2 capture
  • Technologies: Nnao, Thermoelectronics, energy and water
  • Solar 6% and wind 21%, biomass 5%voltaic
  • SOlar eneconversion
  • PHOVOLTAIC: SCALBALE, SOLID STATE, INTERMITTENT, PARTIAL SOLAR SPECTRUMrgy
  • Nanophotonics: Solar energy conversion: photo
  • Nano absorber – area ratio; Emitter: silicon and silicon  – spectral approach
  • potential STPVs
  • Transportation using energy with emission
  • Power consumed by HVAC
  • Thermal Battery for Electric Vehicle: Adsorption Heating and Cooling
  • Desorption vs Adsoption: cooling vs Heating mode
  • High capacity adsobents – Zeolite  MOF enhancing capacity heat and mass transport
  • Tmal Battery Prototype: Hybrid, electric, stationary domestic HVAC.
  • Water harvesting from Air – metal organic Frameworks: Adsorption – harvest water without need of additional electricity
  • Opportunities for Advanced Materials

Prof. David Keith, Harvard University

  • technologies to stop global changing
  • research program
  • stratospheric aerosol cool planet – pollution masking global warming
  • solar geo-engineering, vs emission cut 3x BAU vs business as usual
  • Annual maximal Temperatures, extreme precipitation,
  • carbon emission worm up vs climate risk in Time
  •  use of technology for climate change mitigation: carbon removal
  • Solar engineering is the solution
3:30
Break & Networking
4:00
Meet the Innovators Under 35

Next Generation Brain Interfaces

Andrew Schwartz, University of Pittsburg

  • Causality is obscure
5:30
Lemelson-MIT Prize Honors & Reception
Lemelson-MIT Prize Honors Feng Zhang, MIT with the Prize for contributions to CRISPR Applications as a therapeutics method in genomics

AGENDA FOR WEDNESDAY, NOVEMBER 8, 2017

  • 8:00
    Registration & Breakfast
9:00 Elizabeth Branson
9AM – 9:30AM Robots and AI in Everyday Life

Daniela Rus, CSAIL, MIT – Robots: drones, 3D Printing

hosted by David Rotman, MIT TR

  • supply chain and transportation – city will benefit from a different business model
  • autonomous driving deployed in Singapore
  • all vehicles on wheels can be made autonomous
  • blind – camera on a belt assists in navigation
  • ML: Patterns and predictions
  • AI – reasoning
  • robots: motion
  • Machine read entire libraries
  • Radiology: Read by machines vs by Radiology: AI  + Human — 0.5% error
  • Rural area medicine
  • Machines – Better Lawyers: NLP – read precedents to cases, machines can’t write a briefing or defend a plaintif
  • Factory and Automation: Robots roles – enable mass OPTIMIZATION  not only mass production
  • Machines do not have common sense and do not have ability to reason
  • crunching data vs analysis
  • JOB Categories:Tasks vs Professions: Routine data processing and labor task — are ready for automation
  • NEW jobs: User experience designer, GPS enable taxi drivers to drive and drove pay scale down
  • GDP – decreased 1966 – 2016
  • KY school to train coal miners to do data processing to become CODERS
  • JFK – new machines brings man back to jos – new jobs
  • AI supports NEW jobs: CS/AI part of literacy
  • people and machines – in collaboration

discussion

  • Who to make the transition?
  • CODING is key – people must be active in keeping up and continue to train
  • make it easy to make machines, interactions Man-Machine easier,
  • YOU ARE WRONG SIGNAL IS recognized by EEG
  • AI and Future of Work Conference at MIT – anxiety related to job changing due to technology
  • Technology can’t solve all problems, Technology helps, Technology implications on Policy – technology as a unifier societal force not a dividers
  • Transportation as Utility

9:30 – 10:00 AI and the Future of Work

Iyad Rahwan, MIT Media Lab, Introduction by Elizabeth Woyke, TR

  • Physical Therapist — will not be replaced by computerisation
  • Probability of computerisation: Skilled cities are better at economics shocks
  • Adam Smith – simple operations
  • Differential Impact from Automation on Cities – the larger the city more resilient to automation
  • City size vs clusters of occupations — cluster grow with city size
  • Impact on Middle Class vs Lower and Upper: low paying jobs, middle and high
  • Skills in Occupations: mapping SkillScape correlations with Education
  • Skills in demand

discussion

  • Urbanization took place – 80% live in cities around the World
  • Outliers in CIties by size and Skills: Boulder, CO – small size very skilled labor, politics support start ups and high tech

 

10AM – 10:30AM

Meet the Innovators Under 35

  • Tracy Chou – ProjectInclude – diversity
  1. All about data

 

  • Olga Russakovsky – Princeton University – Computer vision
  • AI for education of under privileged high school
  1. IM-GENET – Data sets encode human biases
  2. AI is powered by Data
  3. AI learns societal  biases
  4. Researchers shape AI
  • 10:30

    Break & Networking

  • 11:00 – 11:30 What is Social Media Doing to Society?
 Yasmin Green, Jigsaw, Google
  • 300 million reach of Ads posted by Google in the Internet
  • Fake news
  • Network shape
  • Veracity and popularity personalized
Hosted by Martin Giles, TR
  • e 11:30 – 11:45 Meet the Innovators under 35
  • Phillipa Gill  – UMass CS – Project of Network measurement on censorship measurement platforms
  • Joshua Browder – DoNotPay

11:45 – 12:00 The Emerging Threat of Cybercriminal AI

Shuman Ghosemajumder, Shape Security

Hosted by Martin Gile

  • CyberCrime is evolving using AI – Imitation Game – Turing Test restricted Turing Tests
  • Computer vision, Solving CAPUTRE – Copletely Automated Turing  Tests
  • CAPTCHA by Google
  • Credential Stuffing Accounts Attacks – SONY was hacked and 93,000 Passwords stolen
  • Clip Farms at Google
  • BLACKFISH – identify Credential Stuffing Accounts Attacks, all invalid password are not valid to be used by cyber attackers again – that authentication is no longer valid
  • Multi Factors Authentications vs ease of use to Log In
  • Knowledge Basis – Probabilistic  SYmbols – BlackFISH – technological advantage – iPhone stores a math formulation of characteristics of the finger print not the image of the fingure
  •  12:00
    Lunch & Networking – Lamborghini -super sport car
1:30 – 2PM
Technology Spotlight: Mind-Controlled VR
Ramses Alcaide, Neurable
Hosted by Rachel Metz, TR
  • Killer Platforme ==>Killer Interaction ==>Killer application
  • Reactive ==> Proactive
  • Brain Computer Interaction (BCI) – maximum Privacy no voice involved like in SPeech
  • Voice, Motion Tracking, eye tracking
  • Human intentionality – a World without limitations
  • NASA is a client
  • consol technology for navigation, typing,
  • Problems: Add to glasses or as an Ear piece
  • the signal is ACTION POTENTIAL
  • latency differences between individuals
  • Non-invasive to invasive to capture signals

 

 
2:00 – 2:30 Capturing Our Imagination:: Evolution of Brain-Machine Interfaces
Mary Lou Jepsen, Openwater
Hosted by Antonio Ragalado, TR
  • Using functional MRI technology for a NEW device to scan emotions rather than medical diseases
  • HOLOGRAPHY of the Brain – liquid crystal display is like transistors on a chip
  • OPTICS – DISCONTINUITY of Moore’s law – high resolution like functional MRI
  • Holographic LCD – scattering material VOXEL detector – measure intensity of light, no resolution, consumer camera speed OK Inexpensive
  • Human body scattering
  • HAT and Bandage
2:30 – 3PM Future of Work – REWARD DISOBEDIENCE –
New Prize of $250,000  – Ethics and governance in AI at MIT Media lab
Reid Hoffman, Greylock Partners Founder LinkedIn
conversation with Joi Ito, MIT Media Lab
  • Tell the Truth
  • Media Lab — a Non-disciplinary place
  • Universities play a role in Social Justice
  • FEAR of AI:
  1. For profit will own it all
  2. stupid AI will govern
  3. displace work
  4. espionage
  5. catalytic institute that will make a contribution to OPENNESS vs technological dominance

Joi Ito, MIT Media Lab: AI problems –

  • MUST be democratized – Now it is in the hands of very FEW
  • RISK SCORES can’t be contested in court because they are IP of for profit companies
  • Joi Ito, MIT Media Lab at MIT do good to Society vs make the most of money which the majority are doing
  • AUTONOMICH vs autonomous agents, said Joi Ito, MIT Media Lab – Hoffman: Design goals more symbiotic: Scaling, more productive, Season 2 launched today
  • Design principle – LEARNING vs EDUCATION, Joi Ito, MIT Media Lab

Hoffman on AI Technologies

  • shaping it to avoid catastrophic negatives
  • provide a public good via participation
3:00
Break & Networking
3:30 – 4 Big Problems, Big Data Solutions
Deb Roy, MIT media Lab
  • Tweets and News, Washington Post – Tracking tweets from US on Politics related to the Elections
  • National memory on Guns, Immigrations
  • Debate brief from tweets and News rooms
  • topic classifier,  Campaign finance, SHARE OF COVERAGE IN NEWS, SHARED OF VOICE ON TWITTER
  • deep neural network training algorithms
  • Passion Gap: cut data on Twitter – Trump supporters exhibited x2 fold energy vs the Democratic candidate
  • How does Media flow: Sanders, Clinton, Trump – each is a Media Source
  • Truth, Trust, Attention  – Fact checking
  • If Trust the source then I believe it is True
  • Public Opinion: The Politics of Resentment in Rural WI – Katherine Cramer
  • Listening Networks: Human- Human Interaction: Media sharing network – change week by week – the MOST innovative methodology developed to date for Public Opinion – presentation by
    Deb Roy, MIT media Lab  – using deep Neural network training
  1. main stream
  2. conservative
  3. liberal activist
  • Health Indicators:
  • Shared attention
  • Shared Reality
  • Varied Perspective – surface under-heard voices
3:30 – 4
Meet the Innovators Under 35
1. Svenja Hinderer, Germany
  • Valve – development of Tissues, biochemical properties
  • signaling molecules
  • mechanical strength – physiological
  • Attrach stem cells – proper matrix formation
  • Functional implants
2. Viktor Adalsteinsson
  • Cancer Precision medicine – Liquid biopsy – tumor mutations
  • entire Cancer Genome – from blood biopsy
  • Scaling: Broad Institute 100 collaborators – 3,000 blood sample genomical analysis
2.Tallis Gomes, CEO Entrepreneur, Brazil
  • Easy Taxi
  • Fighting inequality
  • 15Billion – Beauty Market
3. Abidigani Diriye
  • IBM Research Africa – 300 million adults – lack of access to financial services
  • Univesities, Government  – start ups to scale ideas
Eyad Janneh
  • 5:00
    2017 Innovator Under 35 Awards & Reception
  1. Speakers
    • Viktor
      Adalsteinsson

      Group Leader, Broad Institute of MIT and Harvard

      2017 Innovator Under 35

    Gene
    Berdichevsky

    CEO, Sila Nano

    2017 Innovator Under 35

    • rechargeable battery
    • new class of materials charge and discharge in battery
    • store more energy
    • more better designed electronics: electrified flight, solar, car: Hybrid and electric
    • 21st Century belongs to electrification vs combustion in the 20th century,

      Gene
      Berdichevsky

      CEO, Sila Nano

    • 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

    • GAMING SWARD OF GLORY – EPIC NEW RTS EXPERIENCE – WAFA GAMES IN CHINA
    • Ian
      Goodfellow

      Staff Research Scientist, Google Brain, development occurred at OpenAI

      GAN’s – Generative Adversarial Network – from AI Optimization to Game Theory

      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

    • disruptive technology in the energy space
    • Gang
      Wang

      Chief Scientist, Alibaba

      2017 Innovator Under 35

    • Jianxiong
      Xiao

      Chief Executive Officer, AutoX, Inc.

      2017 Innovator Under 35

      CAMERA-first solution affordable self-driving

Read Full Post »


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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