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Archive for the ‘Personalized and Precision Medicine & Genomic Research’ Category


Precision Medicine Market size worth $87.7BIL by 2023

 Article Publication Request by

Jui Kate | SEO Analyst

Global Market Insights

E-mail: jui.k@gminsights.com | Web: www.gminsights.com 

Published Date: July 25, 2016   Author: Global Market Insights, Inc.

Precision Medicine Market size is expected to reach USD 87.79 billion by 2023; as per a new research report by Global Market Insights, Inc.
Increasing demand for personalized medicine specifically in cancer treatments and advancements in new healthcare technologies will drive precision global medicine market size. Favorable government regulations and standards will help sustain revenue growth.
The individualized diagnosis approach has dramatically improved owing to large-scale biologic database development, efficient methods for patient characterization, and computational tools to analyze large data sets. Emphasizing the need for public health database, The White House dedicated USD 55 million for creation of its largest database ‘Precision Medicine Initiative’ (PMI).

 

 Request Sample Buy NowInquiry Before Buying

 

Recent research advances have helped expand benefits to various aspects of healthcare by enabling better understanding of disease mechanisms, assessment of disease risks and prediction of optimal therapy. A large number of investments in diagnostic research will further accelerate the shift from treatment to preventive medicine in healthcare.
Gene sequencing market size was over USD 8 billion in 2015. Post announcement of the PMI, FDA has recently issued draft guidelines on next generation sequencing-based tests to develop a new kind of healthcare that takes into account individual differences in people’s genes, environments and lifestyles.
Browse key industry insights spread across 94 pages with 85 market data tables & 62 figures & charts from the report, “Precision Medicine Market Size By Technology (Big Data Analytics, Gene Sequencing, Drug Discovery, Bioinformatics, Companion Diagnostics), By Application (Oncology, CNS, Immunology, Respiratory), Industry Analysis Report, Regional Outlook (U.S., Canada, Germany, UK, France, Scandinavia, Italy, Japan, China, India, Singapore, Mexico, Brazil, South Africa, UAE, Qatar, Saudi Arabia), Application Potential, Price Trends, Competitive Market Share & Forecast, 2016 – 2023” in detail along with the table of contents:

https://www.gminsights.com/industry-analysis/precision-medicine-market
Key insights from the report include:

  • Drug discovery technology contributed over USD 9 billion to the global precision medicine market size in 2015, and is estimated to expand at 8.3% CAGR from 2016 to 2023. NGS and other such technologies will open new opportunities for industry participants. Regulation of NGS based test development will help create regulatory processes for genetic test development and application.
  • The global companion diagnostics market is predicted to reach USD 17 billion by 2023. It plays a significant role in development of targeted drugs, thus speeding up the move towards more precise and individualized pharmacotherapy.
  • Oncology application was over 30% of the precision medicine market share in 2015. There have been significant developments taken place across the globe in the area of breast cancer and other related cancers. Predictive biomarkers in lung cancer therapy targets receptors such as c-ros oncogene 1 receptor tyrosine kinase (ROS1), Epidermal Growth Factor Receptor (EGFR), Immune Checkpoints, and Anaplastic Lymphoma Kinase (ALK).
  • U.S. precision medicine market share accounted for over 65% of the North American revenue in 2015, and is anticipated to continue witnessing growth due to increased government initiatives. For instance, The President’s budget in 2016 has allocated USD 130 million to the NIH for development of a national research cohort of a million voluntary U.S. participants, and the data is linked to EHR for easy access to academic scientists and physicians.
  • China contributed 25% to the Asia Pacific precision medicine market size in 2015, mainly due to considerable government initiatives supporting growth in the region. Pfizer, Novartis, Covance, Medtronics, Qiagen, Quest Diagnostics, Roche Holding, Teva Pharmaceuticals, and Biocrates Life Sciences are some notable industry participants.

Global Market Insights has segmented the precision medicine industry on the basis of technology, application, and region:

  • Precision Medicine Market Technology Analysis (Revenue, USD Million; 2013 – 2023)
    • Big data analytics
    • Gene Sequencing
    • Drug discovery
    • Bio Informatics
    • Companion Diagnostics
  • Precision Medicine Market Application Analysis (Revenue, USD Million; 2013 – 2023)
    • Oncology
    • CNS
    • Immunology
    • Respiratory
  • Precision Medicine Market Regional Analysis (Revenue, USD Million; 2013 – 2023)
    • North America
      • U.S.
      • Canada
    • Europe
      • UK
      • Germany
      • France
      • Italy
      • Scandinavia
    • Asia Pacific
      • China
      • Japan
      • India
      • Singapore
    • Latin America
      • Mexico
      • Brazil
    • MEA
      • South Africa
      • Saudi Arabia
      • Qatar
      • UAE

SOURCE

From: Jui Kate <jui.k@gminsights.com>

Date: Friday, February 17, 2017 at 6:35 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Article Publication Request

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Personalized Medicine Meeting – Discussion on FDA Regulation with Outgoing FDA Commissioner, Pharma and Investors

Reporter: Aviva Lev-Ari, PhD, RN

The agency has long felt that the current oversight provided by the Centers for Medicare & Medicaid Services under CLIA has critical gaps and is putting patients at risk. However, for more than two decades, the lab industry has aggressively fought against FDA regulation by threatening legal action and lobbying Congress. Despite industry objections, the FDA two years ago pushed ahead a draft guidance outlining a risk-based oversight plan for LDTs. However, following the November elections, the agency said it would hold off on finalizing those plans in order to consider input from other groups and await further input from the new administration.

Then, a week before Donald Trump was sworn into office, the agency released a discussion paper outlining a revised regulatory framework for LDTs based on more than 300 comments to its draft guidance, a public workshop, and meetings with stakeholders. The paper allowed the agency, without issuing enforceable regulations, to publicly respond to the lab industry’s concerns about burdensome requirements, demonstrate that it had listened to critics of the draft plan, and lay out the rationale, once again, for why FDA needed to step in to look at aspects of test development that CMS doesn’t.

“I think the community better take this really seriously,” Califf said discussing LDT regulation at the PMWC. While on the one hand regulation shouldn’t stifle innovation, he noted that doctors can’t be left to figure out which test they should order. “We’ve got to come up with some middle ground, so regardless of where you are in the US you can get a reproducible laboratory result,” he said, especially when patients’ treatment decisions depend on those results. “I think that’s upcoming work for this year,” Califf added.

Some industry observers have noted that in a crowded immunotherapy market, the availability of multiple PD-L1 tests, the availabilty of FDA approved kits and unapproved LDTs that seemingly gauge the same analyte, and the companion versus complementary diagnostic categories, are actually confusing physicians. This has led to some to suggest that drugmakers work with regulators to advance one test.

Additional Sources

  • New Complementary Dx Category Provides Regulatory Flexibility, but Poses Real WorldChallenges

GenomeWeb , 2016

  • At CDx Harmonization Meeting, Drugmakers Take First Step Toward Exploring Test Differences

GenomeWeb , 2015

  • In Approving Opdivo With Dakos Complementary Test, FDA Advances Rx Personalization Option

GenomeWeb , 2015

  • In 2016, Personalized Medicine Saw More CDx Deals, Flexible FDA, No LDT Guidance

GenomeWeb , 2017

  • Agilents Dako Lands FDA Approval for Lung Cancer Complementary Dx

GenomeWeb , 2015

  • In 2015, Precision Medicine Options Grew; FDA, Labs Still at Odds; Payment Remained Mostly Elusive

GenomeWeb , 2015

Outgoing FDA Commissioner, Pharma, Investors Discuss Regulation at Personalized Medicine Meeting

Jan 24, 2017 | Turna Ray

SOURCE

https://www.genomeweb.com/molecular-diagnostics/outgoing-fda-commissioner-pharma-investors-discuss-regulation-personalized?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Daily%20News:%20NSF,%20USDA%20Award%20Microbiome%20Research%20Grants%20-%2001/24/2017%2004:15:00%20PM

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Dr. Jennifer Doudna (UC Berkeley): PMWC 2017 Luminary Award, January 22, 2017 @PMWC 2017, January 23-25, Silicon Valley

Reporter: Aviva Lev-Ari, PhD, RN

 

 

PMWC will be honoring Dr. Jennifer Doudna (UC Berkeley) with the Luminary Award for spearheading the development of the groundbreaking Crispr-Cas9 genome editing technology

 

PMWC Interview with Dr. Jennifer Doudna (UC Berkeley)

http://www.pmwcintl.com/jennifer-doudna-qa/ 

Session Themes

http://www.pmwcintl.com/2017sv/program/sessions/

Event Registration

http://www.pmwcintl.com/2017sv/registration/

pmwc2017sv-logo

Luminary & Pioneer Awards

The PMWC Luminary Award recognizes recent contributions of preeminent figures who have accelerated personalized medicine into the clinical marketplace. The PMWC Pioneer Award is given to rare individuals who presaged the advent of personalized medicine when less evolved technology and encouragement from peers existed, but still made major advances in the field.

This year, PMWC will be honoring Dr. Jennifer Doudna (UC Berkeley) with the Luminary Award for spearheading the development of the groundbreaking Crispr-Cas9 genome editing technology and Edward F. Chang for developing advanced neurophysiologic brain mapping methods. For the Pioneer Award, Dr. James Allison (MD Anderson Cancer Center) will be recognized for pioneering cancer immunotherapy through his discovery of the immune checkpoint blockade. Dr. Stephen Quake (Stanford) will receive a Pioneer Award for his prolific inventions of technologies in microfluidics and genetics that have enabled personalized medicine, drug discovery and non-invasive diagnostics.

When: January 22, 2017 at 6:30-8:30pm

http://www.pmwcintl.com/2017sv/awards/ 

 

SOURCE

From: Tal Behar PMWC <talb=pmwcintl.com@mail29.atl161.mcsv.net> on behalf of Tal Behar PMWC <talb@pmwcintl.com>

Reply-To: Tal Behar PMWC <talb@pmwcintl.com>

Date: Tuesday, December 20, 2016 at 1:50 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Largest Biotech Patent Case in History Will Determine Who Owns CRISPR

 

Other related articles published on CRISPR on this Open Access Online Scientific Journal include the following:

 

UPDATED – Status “Interference — Initial memorandum” – CRISPR/Cas9 – The Biotech Patent Fight of the Century: UC, Berkeley and Broad Institute @MIT

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/01/06/status-interference-initial-memorandum-crisprcas9-the-biotech-patent-fight-of-the-century/

 

First CRISPR clinical trial gets green light from US panel – The technique’s first test in people could begin as early as the end of the year, 22 June 2016

Sara Reardon

http://www.nature.com/news/first-crispr-clinical-trial-gets-green-light-from-us-panel-1.20137

 

We Celebrate 5,000 Scientific Articles @pharmaceuticalintelligence.com – 2016 was a GREAT Year !!!!!

https://pharmaceuticalintelligence.com/2016/12/19/we-celebrate-5000-scientific-articles-pharmaceuticalintelligence-com-2016-was-a-great-year/

CRISPR – 124 articles on 12/20/2016

https://pharmaceuticalintelligence.com/category/crisprcas9-gene-editing/

Personalized Medicine and Precision Medicine and Genomics Research – 618 articles on 12/20/2016

https://pharmaceuticalintelligence.com/category/personalized-and-precision-medicine-genomic-research/

Contributions to Personalized and Precision Medicine & Genomic Research: Larry H. Bernstein, MD, FCAP 

https://pharmaceuticalintelligence.com/2016/02/19/contributions-to-personalized-and-precision-medicine-genomic-research-larry-h-bernstein-md-fcap/

 

Genomics Orientations for Personalized Medicine

on Amazon since 11/23/2015

http://www.amazon.com/dp/B018DHBUO6

Chapter 21 in this e-Book:

Advances in Gene Editing Technology: New Gene Therapy Options in Personalized Medicine – Medical Interpretation of the Genomics Frontier – CRISPR – Cas9

Chapter Curators: Larry H Bernstein, MD, FCAP, Stephen J Williams, PhD and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/biomed-e-books/genomics-orientations-for-personalized-medicine/volume-one-genomics-orientations-for-personalized-medicine/
genomicsinpersonalizedmedicinecovervolumeone

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LIVE Tweets via @pharma_BI and @AVIVA1950 for Presentations on 11/16 – 11/17, 2016, The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

 

  1. Aviva Lev-Ari‏@AVIVA1950 Nov 17

#PMConf The 12th Annual Personalized Medicine Conference, GENOMICS data sharing initiatives https://pharmaceuticalintelligence.com/2016/11/17/live-1117-145pm-5pm-the-12th-annual-personalized-medicine-conference-harvard-medical-school-joseph-b-martin-conference-center-77-avenue-louis-pasteur-boston/ … via @Pharma_BI

 

  1. Aviva Lev-Ari‏@AVIVA1950 Nov 17

LIVE 11/17 1:45PM – 5PM – The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, … https://pharmaceuticalintelligence.com/2016/11/17/live-1117-145pm-5pm-the-12th-annual-personalized-medicine-conference-harvard-medical-school-joseph-b-martin-conference-center-77-avenue-louis-pasteur-boston/ … via @Pharma_BI

 

  1. Aviva Lev-Ari‏@AVIVA1950 Nov 17

#PMConf @pharma_BI Announcing: BROAD + Intel Center for Advanced Genomic Data Engineering, Anthony Philippakis, M.D., Ph.D.,Broad Institute

 

  1. Aviva Lev-Ari‏@AVIVA1950 Nov 17

#PMConf @pharma_BI My Research Legacy: Broad & AHA – Launched November 13, 2016 Anthony Philippakis, M.D., Ph.D., AMAZING mind among us

 

  1. Aviva Lev-Ari‏@AVIVA1950 Nov 17

3PMConf @pharma_BI Genetic component to become part of Patient care Recepient Leadership in Personalized Medicine Award, Raju Kucherlapati

 

  1. Aviva Lev-Ari‏@AVIVA1950 Nov 17

#PMConf @pharma_BI Kristine Bordenave, M.D., Lead Medical Director, Humana complex Clinical perspective, cost to patient, clinician, Pharma

  1. Aviva Lev-Ari‏@AVIVA1950 Nov 17

#PMConf @pharma_BI 25 of 50 States are participants in MOlDx — NOT New England State Elaine Jeter, M.D., MolDx Medical Director, Palmetto

 

  1. Aviva Lev-Ari‏@AVIVA1950 Nov 17

#PMConf @pharma_BI Richard Hamermesh, Harvard Bus School led GREAT Case Study Presentation on IP disputed DNA-editing technologies, CRISPR

 

9.  Aviva Lev-Ari ‏@AVIVA1950  Nov 17

#PMConf @pharma_BI 65,000 molecular tests in the market in the Registry only 10,000 Elaine Jeter, M.D., MolDx Medical Director, PalmettoGBA

10. Aviva Lev-Ari‏@AVIVA1950 Nov 17

@pharma_BI #PMConf Daniel O’Day, CEO, Roche Pharmaceuticals is Optimistic on Personalized Med – new US Gov’t – no change in Roche Mission

11. Aviva Lev-Ari‏@AVIVA1950  Nov 16

#PMConf Pricing Drugs and THerapeutic Outcomes, The 12th Annual Personalized Medicine Conference, HMS https://pharmaceuticalintelligence.com/2016/11/16/live-1116-315pm-530pm-the-12th-annual-personalized-medicine-conference-harvard-medical-school-joseph-b-martin-conference-center-77-avenue-louis-pasteur-boston/ … via @Pharma_BI

 

 

  1. Aviva Lev-Ari‏@AVIVA1950  Nov 16

#PMConf Molecular DIagnostics LIVE 11/16 1:15PM – 2:45PM – The 12th Annual PM Conference, https://pharmaceuticalintelligence.com/2016/11/16/live-1116-115pm-245pm-the-12th-annual-personalized-medicine-conference-harvard-medical-school-joseph-b-martin-conference-center-77-avenue-louis-pasteur-boston/ … via @Pharma_BI

 

  1. Aviva Lev-Ari‏@AVIVA1950  Nov 16

STAR @ #PMConf Eric Dishman, Director, All of Us Research Program, National Institutes of Health https://pharmaceuticalintelligence.com/2016/11/16/live-1116-8am-noon-the-12th-annual-personalized-medicine-conference-harvard-medical-school-joseph-b-martin-conference-center-77-avenue-louis-pasteur-boston/ … via @Pharma_BI

 

  1. Aviva Lev-Ari‏@AVIVA1950  Nov 16

@pharma_BI @AVIVA1950 #PMConf LIVE Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Jose… https://pharmaceuticalintelligence.com/2016/11/16/live-1116-8am-noon-the-12th-annual-personalized-medicine-conference-harvard-medical-school-joseph-b-martin-conference-center-77-avenue-louis-pasteur-boston/ … via @Pharma_BI

 

  1. Aviva Lev-Ari‏@AVIVA1950  Nov 16

#PMConf @pharma_BI @AVIVA1950 covering in REAL TIME 12th Annual @PartnersPersMed at Harvard Medical School @harvardmed today + tomorrow

 

 

 

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Real Time Coverage and eProceedings of Presentations on 11/16 – 11/17, 2016, The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

 

LIVE 11/16 8AM – noon The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

https://pharmaceuticalintelligence.com/2016/11/16/live-1116-8am-noon-the-12th-annual-personalized-medicine-conference-harvard-medical-school-joseph-b-martin-conference-center-77-avenue-louis-pasteur-boston/

 

LIVE 11/16 1:15PM – 2:45PM – The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

https://pharmaceuticalintelligence.com/2016/11/16/live-1116-115pm-245pm-the-12th-annual-personalized-medicine-conference-harvard-medical-school-joseph-b-martin-conference-center-77-avenue-louis-pasteur-boston/

 

LIVE 11/16 3:15PM – 5:30PM – The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

https://pharmaceuticalintelligence.com/2016/11/16/live-1116-315pm-530pm-the-12th-annual-personalized-medicine-conference-harvard-medical-school-joseph-b-martin-conference-center-77-avenue-louis-pasteur-boston/

 

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

https://pharmaceuticalintelligence.com/2016/11/17/live-1117-8am-145pm-the-12th-annual-personalized-medicine-conference-harvard-medical-school-joseph-b-martin-conference-center-77-avenue-louis-pasteur-boston/

 

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

https://pharmaceuticalintelligence.com/2016/11/17/live-1117-145pm-5pm-the-12th-annual-personalized-medicine-conference-harvard-medical-school-joseph-b-martin-conference-center-77-avenue-louis-pasteur-boston/

 

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

 

Leaders in Pharmaceutical Business intelligence (LPBI) Group

Covering in Real Time using Social Media this Event on

Personalized Medicine

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

http://pharmaceuticalintelligence.com

Streaming LIVE @ HARVARD MEDICAL SCHOOL,

Joseph B. Martin Conference Center

@pharma_BI

@AVIVA1950

November 17

#PMConf

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

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

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

co-Chair Cancer Consorcium

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

Challenge: Reimbursement for Genomics diagnosis

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

2:15 p.m. — Networking Break

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

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

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

 

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

 

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

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

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

 

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

Learning from Users

Five causes for cardiac death:

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

PreventionGenomic Sequencingvalue in Cardiology:

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

 

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

Innovation in Genomic data sharing – bring data to researchers

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

 

DATA Research CoreVanderbuilt, Verily Broad

  1. pharmacogenomics

Launch start ups cost

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

PLATFORM

 

GATK – workhorse of genomic data – Launched 4/2016

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

 

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

Reference Architecture: Design: Single node, small cluster,

 

4:30 p.m. — Closing Remarks

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

 

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

 

#PMConf

SOURCE

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

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

Leaders in Pharmaceutical Business intelligence (LPBI) Group

Covering in Real Time using Social Media this Event on

Personalized Medicine

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

http://pharmaceuticalintelligence.com

Streaming LIVE @ HARVARD MEDICAL SCHOOL,

Joseph B. Martin Conference Center

@pharma_BI

@AVIVA1950

November 17

#PMConf

 

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

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

8:00 a.m. — Opening Remarks

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

8:15 a.m. — Fireside Chat

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

Questions from the audience

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

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

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

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

Questions from the Audience

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

9:45 a.m. — Networking Break

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

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

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

11:15 a.m. — Keynote Speaker

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

11:45 a.m. — Bag Lunch

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

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

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

 

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

 

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

 

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

#PMConf

SOURCE

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

 

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