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

International Summit on Human Gene Editing: A Global Discussion, National Academy of Sciences, WashDC, December 1-3, 2015

Reporter: Aviva Lev-Ari, PhD, RN

2.1.5.25

2.1.5.25   International Summit on Human Gene Editing: A Global Discussion, National Academy of Sciences, WashDC, December 1-3, 2015, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 2: CRISPR for Gene Editing and DNA Repair

UPDATED ON 12/8/2015

Scientists on Gene-Edited Babies: It’s “Irresponsible” For Now

http://www.technologyreview.com/news/544161/scientists-on-gene-edited-babies-its-irresponsible-for-now/?utm_campaign=newsletters&utm_source=newsletter-weekly-biomedicine&utm_medium=email&utm_content=20151208

How to (Really) Engineer a Human Baby

http://www.technologyreview.com/news/543541/how-to-really-engineer-a-human-baby/?utm_campaign=newsletters&utm_source=newsletter-weekly-biomedicine&utm_medium=email&utm_content=20151201

With This Genetic Engineering Technology, There’s No Turning Back

http://www.technologyreview.com/news/543721/with-this-genetic-engineering-technology-theres-no-turning-back/?utm_campaign=newsletters&utm_source=newsletter-weekly-biomedicine&utm_medium=email&utm_content=20151124

CRISPR Leaders Argue Against Total Ban on Human Germline Editing

NEW YORK (GenomeWeb) – As scientists from around the world prepare to discuss the implications of genome editing for both science and society, two leaders in the CRISPR/Cas9 field today published essays making the case against a ban on human germline editing.

Jennifer Doudna, of the University of California, Berkeley, and George Church, of the Wyss Institute for Biologically Inspired Engineering and Harvard Medical School, both highlighted the need for regulation, but to different ends. They published their opinions today in Nature.

Doudna argued for regulation to enforce what she hopes will be widely agreed-upon boundaries on genome editing research, especially on human germline editing. “A complete ban might prevent research that could lead to future therapies, and it is also impractical given the widespread accessibility and ease of use of CRISPR/Cas9,” she wrote.
SOURCE
https://www.genomeweb.com/gene-silencinggene-editing/crispr-leaders-argue-against-total-ban-human-germline-editing?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Daily%20News:%20Human%20Longevity%20Acquires%20Cypher%20Genomics%20-%2011/30/2015%2011:30:00%20AM

AGENDA

http://nationalacademies.org/cs/groups/genesite/documents/webpage/gene_168809.pdf

International Summit on Human Gene Editing: A Global Discussion Convened by: Chinese Academy of Sciences The Royal Society U.S. National Academy of Sciences U.S. National Academy of Medicine National Academy of Sciences Building 2101 Constitution Avenue, N.W. Washington, D.C. 20418 December 1-3, 2015

Agenda

Tuesday, 1 December 2015

7:00 am Registration/Continental Breakfast

8:00 am Welcome and Introductions Summit Committee Chair David Baltimore, California Institute of Technology

8:05 am Opening Remarks Congressman Bill Foster (D-11th District, Illinois) John P. Holdren, White House Office of Science and Technology Policy Representatives of the Convening Organizations: Ralph J. Cicerone, U.S. National Academy of Sciences Victor J. Dzau, U.S. National Academy of Medicine Zhihong Xu, Chinese Academy of Sciences John Skehel, The Royal Society 2

8:35 am Context for Summit Summit Planning Committee Chair David Baltimore, California Institute of Technology

8:45 am Context Through Three Lenses: Scientific, Historical, Legal Moderator: Ismail Serageldin, The Library of Alexandria Speakers: Klaus Rajewsky, Max Delbrück Center for Molecular Medicine Daniel J. Kevles, New York University Alta Charo, University of Wisconsin, Madison

9:40 am Scientific Background on Gene Editing Technologies

Moderator: Jennifer A. Doudna, University of California, Berkeley

Speakers: Maria Jasin, Memorial Sloan Kettering Cancer Center Emmanuelle Charpentier, Max Planck Institute of Infection Biology Jin-Soo Kim, Seoul National University / Institute for Basic Science Jonathan Weissman, University of California, San Francisco Discussants: J. Keith Joung, Massachusetts General Hospital and Harvard Medical School Bill Skarnes, Wellcome Trust Sanger Institute Feng Zhang, Broad Institute of Harvard and MIT

11:05 am Comments from the Floor

11:30 am Lunch 1:00 pm Applications of Gene Editing Technology: Human Germline Modification

Moderator: Robin Lovell-Badge, The Francis Crick Institute

Speakers: Peter Braude, King’s College London Kyle Orwig, University of Pittsburgh George Q. Daley, Boston Children’s Hospital Discussants: George Church, Harvard Medical School Azim Surani, Wellcome Trust Cancer Research UK Gurdon Institute, University of Cambridge

2:30 pm Comments from the Floor 3

3:00 pm Break

3:30 pm Societal Implications of Emerging Technologies

Moderator: Annelien L. Bredenoord, University Medical Center Utrecht Speakers: John Harris, University of Manchester Hille Haker, Loyola University Chicago Marcy Darnovsky, Center for Genetics and Society Sharon F. Terry, Genetic Alliance

4:30 pm Comments from the Floor

5:15 pm Limits to Our Understanding Speaker: Eric Lander, Broad Institute of Harvard and MIT

5:45 – 7:00 pm Breakout Sessions

6:30 Reception 8:00 pm Adjourn

Wednesday, 2 December 2015

8:30 am Applications of Gene Editing Technology: Basic Research

10:15 am Applications of Gene Editing Technology: Somatic Cell Therapy

1:30 pm Governance at the Institutional and National Level

3:00 pm Governance at the International Level

4:30 pm International Perspectives

Thursday, 3 December 2015

8:40 am Interrogating Equity

10:45 am Governance, Regulation, and Control

1:30 pm Going Forward: Closing Thoughts

Summit Committee Chair David Baltimore, California Institute of Technology

SOURCE

http://nationalacademies.org/cs/groups/genesite/documents/webpage/gene_168809.pdf

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Tweets by @pharma_BI and by @AVIVA1950: Real Time Coverage and eProceedings of The 11th Annual Personalized Medicine Conference, November 18-19, 2015, Joseph B. Martin Conference Center of the Harvard New Research Building at Harvard Medical School

Curator: Aviva Lev-Ari, PhD, RN

 

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Aviva Lev-Ari ‏@AVIVA1950  Nov 19

Genomics England, Innovators in Personalized Medicine, Value of Care @AZ, 11… http://wp.me/p2kEDv-8Nc  via @Pharma_BI #PMConf @HarvardPMConf

  1. Aviva Lev-Ari‏@AVIVA1950  Nov 19

11/19/2015 noon Keynote Genomics England, Innovators in Personalized Medicine, Value of Care @AZ, 11… http://wp.me/p2kEDv-8Nc  via @Pharma_BI

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  1. Aviva Lev-Ari‏@AVIVA1950  Nov 19

11/19/2015 10:30 a.m. PMC Award: Francis S. Collins, M.D., Ph.D. ex-Director, NIH, 11th Annual Perso… http://wp.me/p2kEDv-8N8  via @Pharma_BI

  1. Aviva Lev-Ari‏@AVIVA1950  Nov 19

Personalized Medicine in Keynote: President, Worldwide R&D, Pfiz… http://wp.me/p2kEDv-8N6  via @Pharma_BI#PMConf @HarvardPMConf

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  1. Aviva Lev-Ari‏@AVIVA1950  Nov 18

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11/18/2015 10:30 a.m. – Keynote Speakers: “Precision Trials Challenge” 11th Annual Personalized Medi… http://wp.me/p2kEDv-8N0  via @Pharma_BI

  1. Aviva Lev-Ari‏@AVIVA1950  Nov 18

Keynote Address: Kathy Hudson, Ph.D. NIH – 11th Annual Personalized Medicine … http://wp.me/p2kEDv-8MY  via @Pharma_BI #PMConf @HarvardPMConf

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LIVE – 11/18/2015 8:00 a.m. -Personalized Medicine Conferenc… http://wp.me/p2kEDv-8MW  via @Pharma_BI #PMConf @HarvardPMConf

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  1. Aviva Lev-Ari‏@AVIVA1950  Nov 18

LIVE – 11/18/2015 8:00 a.m. – Welcome & Opening Remarks: 11th Annual Personalized Medicine Conferenc… http://wp.me/p2kEDv-8MW  via @Pharma_BI

 

 


  1. @pharma_BI‏@Pharma_BI
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Real Time Coverage and eProceedings of The 11th Annual Personalized Medicine Conference, November 18-19, 2015,… http://pharmaceuticalintelligence.com/2015/11/23/real-time-coverage-and-eproceedings-of-the-11th-annual-personalized-medicine-conference-november-18-19-2015-joseph-b-martin-conference-center-of-the-harvard-new-research-building-at-harvard-medica …

    1. Aviva Lev-Ari‏@AVIVA1950  Nov 19

11/19/2015 noon Keynote Genomics England, Innovators in Personalized Medicine, Value of Care @AZ, 11… http://wp.me/p2kEDv-8Nc  via @Pharma_BI

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    1. Aviva Lev-Ari‏@AVIVA1950  Nov 19

PMC Award: Francis S. Collins, M.D., Ph.D. ex-Director, NIH, 11th Annual Perso… http://wp.me/p2kEDv-8N8  via @Pharma_BI#PMConf @HarvardPMConf

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    1. Aviva Lev-Ari‏@AVIVA1950  Nov 19

Personalized Medicine in Keynote: President, Worldwide R&D, Pfiz… http://wp.me/p2kEDv-8N6  via @Pharma_BI#PMConf @HarvardPMConf

  1. Aviva Lev-Ari‏@AVIVA1950 Nov 19

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11/18/2015 3:15 p.m. Perspectives From Professional Societies and Personalized Medicine Around the W… http://wp.me/p2kEDv-8N4  via @Pharma_BI

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    1. Aviva Lev-Ari‏@AVIVA1950  Nov 18

11/18/2015 1:00 p.m. Keynote Speaker: Deputy Commissioner, US FDA – 11th Annual Personalized Medicin… http://wp.me/p2kEDv-8N2  via @Pharma_BI

    1. Aviva Lev-Ari‏@AVIVA1950  Nov 18

“Precision Trials Challenge” 11th Annual Personalized Medi… http://wp.me/p2kEDv-8N0  via @Pharma_BI #PMConf @HarvardPMConf

 

  1. Aviva Lev-Ari‏@AVIVA1950  Nov 18

11/18/2015 10:30 a.m. – Keynote Speakers: “Precision Trials Challenge” 11th Annual Personalized Medi… http://wp.me/p2kEDv-8N0  via @Pharma_BI

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    1. Aviva Lev-Ari‏@AVIVA1950  Nov 18

Keynote Address: Kathy Hudson, Ph.D. NIH – 11th Annual Personalized Medicine … http://wp.me/p2kEDv-8MY  via @Pharma_BI #PMConf @HarvardPMConf

More

    1. Aviva Lev-Ari‏@AVIVA1950  Nov 18

LIVE – 11/18/2015 8:00 a.m. -Personalized Medicine Conferenc… http://wp.me/p2kEDv-8MW  via @Pharma_BI #PMConf @HarvardPMConf

 

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Real Time Coverage and eProceedings of The 11th Annual Personalized Medicine Conference, November 18-19, 2015, Joseph B. Martin Conference Center of the Harvard New Research Building at Harvard Medical School

Curator: Aviva Lev-Ari, PhD, RN

 

 

The 11th Annual Personalized Medicine Conference, November 18-19, 2015, Joseph B. Martin Conference Center of the Harvard New Research Building at Harvard Medical School

Live Press Coverage: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2015/07/09/the-11th-annual-personalized-medicine-conference-november-18-19-2015-joseph-b-martin-conference-center-of-the-harvard-new-research-building-at-harvard-medical-school/

Live Press Coverage in REAL TIME

Aviva Lev-Ari, PhD, RN

LIVE – 11/18/2015 8:00 a.m. – Welcome & Opening Remarks: 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

http://pharmaceuticalintelligence.com/2015/11/18/live-11182015-800-a-m-welcome-opening-remarks-11th-annual-personalized-medicine-conference-november-18-19-2015-harvard-medical-school/

 

11/18/2015 8:30 a.m. – Keynote Address: Kathy Hudson, Ph.D. NIH – 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

http://pharmaceuticalintelligence.com/2015/11/18/11182015-830-a-m-keynote-address-kathy-hudson-ph-d-nih-11th-annual-personalized-medicine-conference-november-18-19-2015-harvard-medical-school/

11/18/2015 10:30 a.m. – Keynote Speakers: “Precision Trials Challenge” 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

http://pharmaceuticalintelligence.com/2015/11/18/11182015-1030-a-m-keynote-speakers-precision-trials-challenge-11th-annual-personalized-medicine-conference-november-18-19-2015-harvard-medical-school/

11/18/2015 1:00 p.m. Keynote Speaker: Deputy Commissioner, US FDA – 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

http://pharmaceuticalintelligence.com/2015/11/18/11182015-100-p-m-keynote-speaker-deputy-commissioner-us-fda-11th-annual-personalized-medicine-conference-november-18-19-2015-harvard-medical-school/

11/18/2015 3:15 p.m. Perspectives From Professional Societies and Personalized Medicine Around the World, 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

http://pharmaceuticalintelligence.com/2015/11/18/11182015-315-p-m-perspectives-from-professional-societies-and-personalized-medicine-around-the-world-11th-annual-personalized-medicine-conference-november-18-19-2015-harvard-medical-school/

11/19/2015 8 a.m. Building a Personalized Medicine Company & Keynote: President, Worldwide R&D, Pfizer Inc. 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

http://pharmaceuticalintelligence.com/2015/11/19/11192015-8-a-m-building-a-personalized-medicine-company-keynote-president-worldwide-rd-pfizer-inc-11th-annual-personalized-medicine-conference-november-18-19-2015-harvard-medical/

11/19/2015 10:30 a.m. PMC Award: Francis S. Collins, M.D., Ph.D. ex-Director, NIH, 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

http://pharmaceuticalintelligence.com/2015/11/19/11192015-1030-a-m-pmc-award-francis-s-collins-m-d-ph-d-ex-director-nih-11th-annual-personalized-medicine-conference-november-18-19-2015-harvard-medical-school/

11/19/2015 noon Keynote Genomics England, Innovators in Personalized Medicine, Value of Care @AZ, 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

http://pharmaceuticalintelligence.com/2015/11/19/11192015-noon-keynote-genomics-england-innovators-in-personalized-medicine-value-of-care-az-11th-annual-personalized-medicine-conference-november-18-19-2015-harvard-medical-school/

 

 

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11/19/2015 noon Keynote Genomics England, Innovators in Personalized Medicine, Value of Care @AZ, 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

Reporter: Aviva Lev-Ari, PhD, RN

Live Press Coverage in REAL TIME

Aviva Lev-Ari, PhD, RN

Director & Founder, Leaders in Pharmaceutical Business Intelligence, Boston

Co-Founder, GDE

12:o0 noon – Keynote Speaker

Genomics England

Speaker

Sir John Chisholm
Executive Chair, Genomics England

  • UK is uniquely positioned
  • Medicine new movement: NHS 65th Anniversary Celebration, July 2013 by Genomics England announced by Secretary of State for Health
  • Patient Community Support, Wearables and Consumer Health Remote consulting Elective Care Out of Hospital Care
  • network support applications
  • Cyber security and consents management
  • National Repository
  • 100,000 Genomes Projects – A pioneering Step in the UK towards Routine Genomics Medicine
  • 2012 in UK: National Information Board Strategy
  1. Heterogeneous population
  2. National Health system to deliver
  3. Excellent Genomics research in the UK
  4. Cornerstone decisions
  • rare inherited disease
  • Transformation of the Medical practice: CHANGE in Clinical Data Flow:
  • Partners: Sequencing: Illumina1 was selected, Welcome Trust/Sanger
  • GMC responsibility: Concent, dna extraction, biobank, sequence, variant calling, interpretation, sharing results with client, decision on treatment, Patient in Clinic for a Protocol
  • Achieve AT rich and GC rich
  • OPTIMUM combination of choices to deliver the best Genome
  • Experimental Pathway: upstream
  • Clinical Interpretation Partnerships: 30 diseases 2500 Clinicians
  • All IP held by Genomics England is available for licensing
  • Rare diseases clinical data models for a CATALOGUE: Disease -specific element vs shared core elements
  • Commercial Partnerships: Pharma and BioTech, Bioinformatics and ANalytics
  • GENE Consorsium: Big Pharma
  • Data Architecture Schematics: Genomics Data Store VCF and BAMs
  • data interpretation: data sets Analysis Tools and Embassy done following Cleansing
  • Other aspects: Media Coverage The DNA of a Nation: Nature, August, Genomics England – Precision Medicine can be done at a National level.
  • Interpretation Partnerships: Complicated,

12:30 p.m. – Bag Lunch

Bag lunch with open seating for all conference attendees

1:30 p.m. – Panel Discussion

Innovators in Personalized Medicine

The movement in any field of medicine is dependent upon the organizations and its leaders. There are a large number of innovative ideas that are transforming the way we provide healthcare to patients and in this panel we will hear examples of how successful companies are built and how some large companies are increasing their investments in personalized medicine..

Opening Speaker & Moderator:

Michael Pellini, M.D., M.B.A.
President and CEO, Foundation Medicine

  • Life Sciences Technology: NGS used of Tech incorporation into Medicine Technology is used in a meaningful way
  • Foundation Medicine – Molecular information company in 2011. In 2015 all type of information not only molecular,
  • SNP DBs, Aggregate curate, data disseminated data
  • Medical thinking: Science allowing Diagnostics to improve diagnosis
  • business relations are changing: Pharma and Diagnostics, Advocacy Groups
  • Notions of Payers partner with organization to use data
  • regulatory FDA do promote change
  • Payers could stifle innovation
  • Innovators in Healthcare, is not easy
  • If all Partners in a company all agree, destine is to fail not to succeed
  • circulating Tumor DNA — part of Patient diagnosis
  • Patient more involved FDA, more involved
  • Payers will pay
  • When and How
  • Incentives to collaborate
  • Diagnostics enable Drugs dispensing
  • Pharma and Molecular Diagnostics Companies — different interests
  • MUST UNDERSTAND WE MUST BE ABLE TO TALK BOUT EACH OTHER PARTIES PROBLEMS: PHARMA MUST UNDERSTAND DIAGNOSTICS AND THEY MUST UNDERSTAND R&D
Panelists

Christine Cournoyer
CEO, N-of-One, Inc.

  • four years ago joined N-of-One
  • target therapy for the Patient
  • molecualr profie of the Patient
  • Interpretation of results
  • molecular diagnosis test — in need for interpretation, Analysis of diagnostics Labs
  • collaboration on therapeutics models hard to foster in the commercial because of competition, Oracle will not compete on interpretation
  • End game

Michael Reitermann
CEO, Siemens Healthcare Diagnostics in 70 Countries
Member of the Executive Management, Siemens

  • collaboration
  • diagnostics area
  • adverse events
  • errors in diagnosis – malpractice
  • reimbursement
  • Diagnostics is Cost Plus
  • clinical data
  • Synergies needed as incentive

George Yancopoulos, M.D., Ph.D.
President, Regeneron Laboratories; Chief Scientific Officer, Regeneron Pharmaceuticals

  • identify a mutation to be a candidate for therapeutics
  • Ten years to secure one disease
  • one FDA approval caused stock to increse TEN folds
  • molecular, RNA, DNA, Protein targeted to therapeutics
  • genomics information, EMR for sequencing
  • DB that you can trust, Geisinger in PA sequencing the entire HealthCare System of One Institution
  • NIH needs to do more translational not only basic research
  • Champion inside the organization needed to foster new partnerships
  • CEO worries about the cost of R&D, Insurance does not care about investment in Prevention – NO profit in it
  • Elevate the discussion to cover all aspects
  • Geisinger: FULL INTEGRATION in one system vs adversary parties

AUDIENDCE

  • Genomics Diagnostics: CMS, National CMS, Roche applies Hybrid model, incentive organizations to collaborate and solve reimbursement for genomics testing
  • Quest Diagnostics works with Insurance payers worst than dealing with CMS
  • Reimbursement: Should it be by disease or all along the treatment cycle
  • AstraZeneca BUDGET OF R&D INCREASED EACH YEAR AND IS AT RECORD EVER HIGH IN COMPANY’S HISTORY

2:30 p.m. – Keynote Speaker

Opportunities in Personalized Medicine: Redefining the Value of Care

Speaker

Paul Hudson
President, AstraZenecaUS
Executive Vice President, North America

  • 979i Mutation – lung cancer
  • Improve in Precision Medicine
  • why resistance emergence – mechanism arise which one
  • why resistance show that medicine revert to normal receptor
  • 500 treatments for 800 new diseases
  • Self diagnosis by Apple watch owner and FitBit
  • T79 Mutation ct-DNA
  • blood test not biopsy for circulating tumor cells
  • lung cancer:
  • FDA has approved on 11/15/2015 the first drug based on genomic mutation in 32 month first in Human the fastest in ONCOLOGY in Us
  • Asthma: Steroid medicine developed 20 years ago no new ones
  • Asthma is a cluster of diseases each needs a different drug
  • Breakthrough Science
  • Collaboration with Abbott for Asthma and with Eli Lilly
  • datashere Project: Academia is given access to super computer facilities to use the data
  • over 15 medcine Crownfounding to rectuit patients
  • ACCESS of Patients to medicine and therapies
  • Regulated partnerships, not enough action
  • dialogue in WashDC – FDA
  • Stakeholders: WHITE HOUSE INITIATIVE FOR A HEALTHIER AMERICAN
  • Price structure of medicine: Value for Patients and Providers
  • Patient affordability
  • COst  – Partner with Payers
  • Risk sharing based on patient outcomes – NOT yet achieved
  • responsibility for failing too many
  • breakthrough of tomorrow depends on Precision Medicine
  • 2798m – resistance is the next drug for development per the model of the one approved on 11/15/2015 by FDA FOR ASTRAZENECA
  • Affordability of drugs is a concern
  • combination of drugs flex and demonstrate value
  • Collaboration with Dana Farber on blood test for circulating Tumor Cells for Lung Cancer

3:00 p.m. – Closing Remarks

Speaker

Raju Kucherlapati, Ph.D.
Paul C. Cabot Professor of Genetics, Professor of Medicine
Harvard Medical School

Ten years ago when we launched the Personalized Medicine, that wqs not the prevailing view at the HMS.
  • UK Model – On eNation and the role of Genomics
  • Foundation Medicine paradigm in Cancer diagnostics

Team recognition and PMC – team members

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.O4Znb9kq.dpuf

To Follow LIVE CONFERENCE COVERAGE PLEASE FOLLOW ON TWITTER USING

Meeting #: #PMConf

Meeting @: @HarvardPMConf

@PartnersPersMed

 

Overall good meeting #s:

#personalizedmedicine

#powerofgenomics

#genomics

#pharmanews

 

AND FOLLOW these @

@pharma_BI

@AVIVA_1950

@BiotechNews

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TALK SPECIFIC # and @

 

@2012pharmaceutical

12:00 PM Keynote Speaker

Genomics England

Speaker

Sir John Chisholm
Executive Chair, Genomics England

#personalizedmedicine

#genomics

#bigdata

#raredisease #cancer

@GenomicsEngland

@InnovateUK

@NHSEngland

 

 

 

 

1:30 -4 PM Panel Discussion: and Closing Remarks #personalizedmedicine

#health

#disease

#populationgenetics

#PopulationHealth

#innovation

#pharma

#bigdata

 

 

@PartnersNews

@BioWorld

@HarvardHealth

@harvardmed

@FoundationATCG

@regeneron

@AstraZeneca

@FiercePharma

@SiemensHealth

 

 

 

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11/19/2015 10:30 a.m. PMC Award: Francis S. Collins, M.D., Ph.D. ex-Director, NIH, 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

Live Press Coverage in REAL TIME

Aviva Lev-Ari, PhD, RN

Director & Founder, Leaders in Pharmaceutical Business Intelligence, Boston

Co-Founder, GDE

10:30 a.m. – Personalized Medicine Coalition Award

Presentation of the 11th Annual Personalized Medicine Coalition Award
for Leadership in Personalized Medicine

Award Recipient

Francis S. Collins, M.D., Ph.D. – UNDERWENT SURGERY LAST WEEK on his behalf the Award for presented to his designee, Kathy Hudson, PhD, Depute Outreach, NIH
Director, National Institutes of Health (NIH)

PERSONAL ADDRESS VIA VIDEO

WOULD HAVE LIKED OT HAVE HIS SURGERY BEEN “PERSONALIZED”

  • National commitment to understanding biological processes used for Personalized Medicine. NIH is working on a Plan in this domain, improving Medicine by Precision Medicine Initiative (PMI).
  • PMI will bring return on the NIH Investment in PM
  • synergies: Pharma working on Diagnostics
  • Advance the Frontiers of Science

 

Award Presenter
Ed Abrams, President, Personalized Medicine Coalition
Field of Opportunities and Field of Candidate for Awards – LEADERS IN PERSONALIZED MEDICINE

William S. Dalton, Ph.D., M.D.
CEO, M2Gen
Director, DeBartolo Family Personalized Medicine Institute at Moffitt Cancer Center

 

11:00 a.m. – Panel Discussion

Novel Efforts in Personalized Medicine

As the knowledge base of personalized medicine and the development of new technologies that support it are being developed, it is useful to learn about how this field is impacting many diverse fields and how novel technologies and information systems are influencing it. This panel provides a sampling of companies and how they are enhancing personalized medicine.

Opening Speaker & Moderator

Deborah Dunsire, M.D.
President and CEO, FORUM Pharmaceuticals

  • Frontaltemporal Dementia
  • Progranulin levels in FTD-GRN – FRM0334 Increased PRGN Expression
  • Reverse GRN mRNA deficit
Panelists

S. Roopom Banerjee
President and CEO, RainDance Technologies

  • Single molecule
  • Single cell sequencing
  • Power of Biological Information: mission Genomics and Big Data for detection discoveries for long term
  • ACCESS is still difficult: Mutations very many to be looked in a Big Data context and technologies
  • Early detection and Accurate Monitoring Remain Elusive
  • Colorectal Cancer: Liquid Biopsy (Plasma)
  • Remission COlon A vs Relapse Colon B
  • mCRC patients with mutated sub-clones <1 benefit anti ECFR therapies
  • proporsion of KRAS mutated
  • patient interaction
  • Genetics linkage to markers – is Hypothesis driven
  • illumina – repertoire of disease and immune system is a specific area that Illumina’s solution is too generic to solve
  • Shareholder value
  • Referendum of Sloane Kettering and MD Anderson in dealing with FDA on oncology testing

L. Patrick James, M.D.
Chief Clinical Officer, Health Plans and Policy, Quest Diagnostics

  • Pathologist
  • Persolalized Experience: Interactive Insights
  • Provider
  1. Result reports within Insights
  2. Interactive Reporting: Physician View and Patient View
  3. Tailor Report Formts
  • Quest Diagnostics: MDs struggle with Diagnostics: Personalized Information for MDs and PAtients
  • Dementia Pathway: Data Integration and Decision Support and Concierge Services
  • Population Health Management
  • Provision and Integrator company
  • Algorithms at the Quest Diagnosis Office serves 200,000 MDs in the Communities
  • Underwriters  make decisions on coverage – high risk patients coverage
  • Partnership with novolog: data diagnostics in Clinical Medicine
  • Monitising data by Sharing with insurers for them to set policies
  • proficiency testing
  • Testing can be meaningless rather thn meaningful

Jonathan Sheldon, Ph.D.
Global Vice President Healthcare, Oracle

  • Sw and HW integration
  • Life Sciences Sector – 5 years ago investment from HealthCare to Life Sciences
  • Extremely large Data sets, quality of data is critical
  •  Scale Population Health with Precision Medicine
  • Mayo  Clinics collaboration
  • mapping data is hard

Plan:

  • start with integration of EMR Clinical Data plus Genomics by using data architecture
 AUDIENCE DISCUSSION
  • Integration sources of data
  • genothype and phynotype: EMR data quality is doughtful
  • EMR – does not have a place to record HER
  • Efficacy of Testing, collection of tests  – standardize testing as a base line
  • what is the potential of IBM’s WATSON in the analysis of Big Data

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.O4Znb9kq.dpuf

To Follow LIVE CONFERENCE COVERAGE PLEASE FOLLOW ON TWITTER USING

Meeting #: #PMConf

Meeting @: @HarvardPMConf

@PartnersPersMed

 

Overall good meeting #s:

#personalizedmedicine

#powerofgenomics

#genomics

#pharmanews

 

AND FOLLOW these @

@pharma_BI

@AVIVA_1950

@BiotechNews

TALK SPECIFIC # and @

10:30 AM Presentation of the 11th Annual Personalized Medicine Coalition Award
for Leadership in Personalized Medicine –
#personalizedmedicine

#NIH

 

@nihdirector

@PartnersNews

 

 

 

 

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11/19/2015 8 a.m. Building a Personalized Medicine Company & Keynote: President, Worldwide R&D, Pfizer Inc. 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

Reporter: Aviva Lev-Ari, PhD, RN

 

Live Press Coverage in REAL TIME

Aviva Lev-Ari, PhD, RN

Director & Founder, Leaders in Pharmaceutical Business Intelligence, Boston

Co-Founder, GDE

 

 

8:00 a.m. – Opening

8:15 a.m. Welcome and Introduction

Scott T. Weiss, M.D., M.S.
Scientific Director, Partners HealthCare Personalized Medicine
Associate Director, Channing Laboratory
Professor of Medicine, Harvard Medical School

Challenge was yesterday
I will focus on my own research on genetics
ASTHMA
Chronic disease, diagnosed before the age of 6. chronic airway obstruction unrelated to smoking
  • Chromosome of 12q
  • Genetics association study – Vitamin D Receptor Genetic Variants related to Asthma
  • Respiratory infections
  • Airway smooth muscle efffects
  • Effects on developing lungs
  • Vitamin D Intake by Pregnant Mothers — reduction of Asthma and wheezing in newborn
  • Surfactant production and Vitamin D deficiency
  • Studies of Prenatal Vitamin D on early life asthma and allergy
  • Supplemental Mothers during Pregnancy with Vitamin D (75nmol/L vs control at ): 4400IU vs 400IU
  • Pragnancy and Infant Characteristics of Mothers whose Children are at Risk for Asthma
  • REDUCTION in Respiratory infections
  • Effect the strongest at newborns at age 1
  • Genomic Origins of Asthma
  • Vitamin D – supplementation good effects on Cancer
  • Ten years of studies — Genomics used for Public Health Policy formulation
  • If Pregnant Mothers are smoking, the effect is reduced with supplementation of Vitamin C and D
  • Folate pathway – Vitamin B6

8:30 a.m. Harvard Business School Case Study

Building a Personalized Medicine Company: What does it take?

Robert Higgins
Senior Lecturer of Business Administration, Harvard Business School;
Founder and GP, Causeway Media Partners

  • Genetics Diagnostic Lab (GDL) for Profit
  • In 2013 Boston Children’s Hospital (BCH) spun off GDL
  • BCH invested in- bud a Genetics Testing company in Pediatrics
  • Sell Lab services to other Children’s Hospitals
  • Speed of innovations increased
  • Involve other companies and hospitals as Strategic Partners
  • It was High Price and Low Volume – Now it is High Volume and Price is getting lower
  • Spin off examples: Eye surgery, Radiology, Basic Research vs Clinical Research

DISCUSSION on Pros and Cons for Hospital to  Spin off

  • Diagnostics Companies: can assist Academic Hospital Labs to get to the Clinics fasters with Tests that are perfected to scale
  • High Volume Test, understanding the disease better
  • Diagnostics companies focus on Solutions to providers

ISSUES

  1. InvestorsWho should be:
  • Only non-Dilutive, i.e., Grants,
  • Other Hospitals,
  • VC: Phase 1 & 2, scale fast via acquisition
  • Research collaborators
  1. Who will be on the Board: Other Genomics Companies
  2. Value of Spin off is significant to BCH that owns a piece
  3. Objective, is the Primary Service to the Community of a Source of Value Creation for BCH

What actually Happened?

  • Cerner Cincinnati Children’s Hospital and NextCODE became investors
  • Illumina dominated the research sequencing marker
  • Company developed own tests
  • Recently released Claritas Clinical Exome platform
  • Claritas executed a contract with the VA to sequence exomes and genomes of >20,00 veterans (1 Million Veteran Program)
  • Platform: Used tests, data analysis, results interpratation and delivery to EMR
  • sequence the exomes TWICE for validity, integrated with EMR, results are passed on for Research,
  • Quality driven accuracy data collection and Analysis
  • Volume drive Profits
  • TESTING and CARE — Diagnostics became more accurate affecting Outcomes
  • Research Exome, different than Clinicla Exome – ACM Criteria for interpretations
  • Clinical Exome, subsequent access for research – assays
  • CULTURAL changes:

Strategic relations:

  1. WuXi – NextCODE: Genomic SW platform for all exome data
  2. Cerner: Claritas interfaces with EMR, EPIC and Lab Information Management System (LIMS)
  3. Illiumina and Life Technology: Product obtains speed and accuracy through dual platform approach
  4. constituencies: Ordering the right TEST? How that is accomplished
  5. Expression of the phynotype for the diagnosis and the treatment

 

 

9:30 a.m. Keynote Speaker

Looking at Personalized Medicine from a Pharmaceutical Perspective

Speaker Mikael Dolsten, M.D., Ph.D. 
President, Worldwide Research and Development, Pfizer Inc.
  • Right Target

Targeting the Tumor Cancer Genome, ALK 1st & 2nd Gen

  • Right Drug(s)

Targeting the Immune Cancer Genome – PD-L1, 4-1BB

  • Right Patient

Targeting Inherited Genome Variability – F9 Gene Therapy

LUNG CANCER Subtypes

Diversity of Oncogene Drivers:

  • EGFR: Tarceva, ALK, ROS1 translocation

Resistance

  • ALK mut/ampl
  • RTK (EGFR, KIT)
  • RTK+ALK
  • ? Cycadia

Right Target
Lorlatinib: potential Next Gen ALK Inhibitor to address Resistance

Phase 1 Study with Xalkori-Resistant Brain Mets

Patient Treatment Timeline

  1. Xalkori, 2011
  2. mainteanime
  3. Xalkori rechallenge
  4. Carboplatin
  5. Radiation + Cisplatin 1st dose of Lorlatinib (Phase 1 trial)

Right Drug(s)

Immuno-profiling

  • Tumor: Genome Transcriptome Neoantigens Proteome (PD-L1 – Tumor Tissue
  • Immune Infiltrate:

Ovarian Cancer: Immuno-oncology Targeting the Immune Cancer Genome

  • Monotherapy: avelumab (PD-L1) Durable response in Ovarian Cancer
  • Combo-therapy: 4-1BB + rituxumab Derable CR in Rituxan Refractory FL Screening ans wmonth CT
  • immune-profiling

Exiting time for Combination Therapy and Precision Medicine based on Genomics

Gene Therapy: Targeting Inherited Genome Variability in Himpophilia

 

Glybera Gen Therapy approval in lipoprotein lipase deficiency marks

  • Which Patients to Treat
  • Community impact
  • Collaborations
  • Constituencies

Tomorrow Integrated Rx/Dx: Biomarkers for disease 

AUDIENCE QUESTIONS:

  • Pfizer Inc. – Drugs to eleviate disease burden
  • Reimbursement in UK: Advanced drugs denied to patients
  • approach in Pharma to advance Medicine, get Patients back to work
  • effective medicine and funding science
  • molecular databases: development of scientific findings for clinical
  • Drugs have approved diagnosis
  • Experimental drug for ROS dramatic results vs ALK – regulatory
  • ONE one drug One Diagnostics
  • Combination of Drugs for multiple gene expressed conditions
  • Drugs with benefit using molecular diagnostics are now at Academic Centers — HOW that could diffuse to larger populations
  • Test to be cost effective for multiple indication

 

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.O4Znb9kq.dpuf

To Follow LIVE CONFERENCE COVERAGE PLEASE FOLLOW ON TWITTER USING

Meeting #: #PMConf

Meeting @: @HarvardPMConf

@PartnersPersMed

 

Overall good meeting #s:

#personalizedmedicine

#powerofgenomics

#genomics

#pharmanews

 

AND FOLLOW these @

@pharma_BI

@AVIVA_1950

@BiotechNews

TALK SPECIFIC # and @

Day Time Talk Title # @
Thurs. Nov 19, 2015 8:00 AM Welcome & Opening Remarks #personalizedmedicine

#genomics

#Boston

#Harvard

#MGH

#biotech

#harvardhealth

@PartnersNews

@MassGeneral

 

@HarvardHealth

@harvardmed

Greetings #personalizedmedicine @newsfrompmc

(Personalized Medicine Coalition)

 

8:30 AM Building a Personalized Medicine Company: What does it take? #NIH

#AER15

#personalizedmedicine

#pharma

#startup

 

@HarvardHBS

@BV

 

9:00 AM Looking at Personalized Medicine from a Pharmaceutical Perspective

 

 

 

#personalizedmedicine

#pharma

#biotech

#biopharma

 

@Pfizer

@FiercePharma

@FierceBiotech

 

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11/18/2015 3:15 p.m. Perspectives From Professional Societies and Personalized Medicine Around the World, 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

Reporter: Aviva Lev-Ari, PhD, RN

 

Live Press Coverage in REAL TIME

Aviva Lev-Ari, PhD, RN

Director & Founder, Leaders in Pharmaceutical Business Intelligence, Boston

Co-Founder, GDE

 

 

3:15 p.m. – Conversation

Perspectives From Professional Societies

Our Conference is organized in association with the Personalized Medicine Coalition, American Association for Cancer Research, American Medical Association and the American Society for Human Genetics. All of these and many other scientific and medical organizations have established programs to educate their membership about the principles of personalized medicine and how it is influencing scientific and medical discovery as well implementation to improve human health. Representatives from these different organizations will discuss ways to improve the literacy on personalized medicine.

Opening Speaker & Moderator:

Cynthia Morton, Ph.D.
William Lambert Richardson Professor of OB/Gyn and
Reproductive Biology and Professor of Pathology, Harvard Medical School;
Director of Cytogenetics, Brigham and Women’s Hospital

  • Educate clinicians – Virtual meetings around the Globe: Genetics in your Clinics what you should know and now
  • Genetics testing – top ten in Pediatrics: English and Spanish
  • What is the message to the society of Precision Medicine
Panelists

José Baselga, M.D., Ph.D. SUBSTITUTED BY ACR – Dana Farber 
Physician in Chief and Chief Medical Officer, Memorial Sloan Kettering Cancer Center

American Cancer Research (ACR) is interested in Precision Medicine because:

  • Initiative from Memorial Sloan Kettering Cancer Center – 7 Cancer Centers to pull together all Genomics Data on Cancer
  • getting the right diagnosis, became very difficult
  • 70,000 profiles, nucleotide , communicate with surgeons, physicians in the community
  • Cohort study will help us learn
  • What we need for Research: WHAT question, may be we do not need so many samples
  • MRI shown early detection improves survival, instead of clinical trial, we can use High QUALITY REGISTRIES INSTEAD

Richard Friedberg, M.D., Ph.D.
Chair, Department of Pathology, Diagnostic Medicine Services
Bay State Health

  • 30 years ago 7 types of leukhmias were known today 58 types are known
  •  Pathology: What works in Academic Centers must work in Non-Academic Centers, not always the case
  • Mutations differs from different labs
  • NGS in 2015 – we have 150 Labs subscribers – What is the Gold Standard?
  • Free analytics for biomarkers analysis
  • PCP and Nurse Practitioners both do not know enough about Genomics and precision medicine, they are the closest to the patients, understanding what is going on is in need for additional education and training as genomics and Medicine are becoming in intertwined

James Madara, M.D.
Executive Vice President and CEO, American Medical Association

  • Procedures, methods, similar diseases
  • Physician’s practices on Precision medicine
  • Advocacy in Wash DC
  • Innovations – in chronic disease to intervention
  1. Some Cancers are chronic and need be treated in the Community
  2. CDC other organization to Scale to State level
  3. DM – 1 in 3 are preDiabetics
  4. 130 start ups: Good Ideas in HealthCare
  5. Innovation Center in South of Market in SF
  6. Personalize Medicine: Story and the Facts, a genomics sequences in absence of the social context as part of the story
  7. Cardiovascular: Blood Pressure measure
  8. MDs Students are not trained to learn to listen, communications, big data, genomics
  9. 2% R&D Budget — we need higher – robust innovation
  10. Operations: Medical Operation revenues vs Cost
  11. Payers are less interested in quality
  12. Value to Patients

COMMENTS from Audience

  • Pathologists need to be reimbursed to do the diagnosis on specimen and genomics
  • Education and training of Young MD students
  • Colon Cancer Centers of Centers of Excellence: Genetics data vs data surgeon needs for complete exceesion during tumor removal by the Surgeon
  • Standardize the collection of tissue sample
  • DECISION SUPPORT for Genomics research, public domain, continue updates
  • Insurance need to pay for one test at a time
  • conserve tissue for Genomics analysis
  • Professional Guidelines like AHA are very important

 

4:15 p.m. – Panel Discussion

Personalized Medicine Around the World

Personalized Medicine cuts across all disciplines of biology and medicine and does not have any national boundaries. However the healthcare systems in each country around the world are different and each country is taking its own unique path toward providing personalized medicine to its people. We will hear different examples from the two largest countries, China and India as well as perspectives from international business organizations.

Opening Speaker & Moderator:

Gary Palmer, M.D., J.D., MBA, MPH
Chief Medical Officer, NantHealth

  • Regulatory point of view of Personalized Medicine
  • Gap between Oncologist in Academic Centers vs the Communities
Panelists

Vijay Chandru, Ph.D.
Co-Founder, Chairman and CEO, Strand Life Sciences

  • India – self paid Medical Systems no Universal HealthCare or National HealthCare system
  • somatic profile
  • In India, the role of the Regulatory Agency: NDL National Labs, NGS  – less regulatory influence therefore less of the benefits in comparison t the US. In Medical Devices: CE
  • 6 Programs a month
  • C0sts different than US

 

Xishan Hao, M.D., FACS
Professor, Academician of Chinese Academy of Engineering;
President, Chinese Anti-Cancer Association;
Director, Tianjin Cancer Research Institute, Tianjin, China

  • Potential personalized Medicine in China
  • National Cancer Research in the US – we are here to learn from the US
  • control, no specimen can move out of  China
  • Conferences – big in China

Jack Wang
CEO, Biomobie Regenerative Medicine Co., Ltd.

  • chronic vascular disease: Ischemia, stroke, ER, Hyperpression, Migraine,
  • Personalized Medicine will reach the goal in efficacy, over 10,000 patients served a year
  • 45 Chapters since 1984, priority in China and US prevention
  • NGS initiative in China in the last two years
  • B-to-B vs C-to-Businessne

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.O4Znb9kq.dpuf

To Follow LIVE CONFERENCE COVERAGE PLEASE FOLLOW ON TWITTER USING

Meeting #: #PMConf

Meeting @: @HarvardPMConf

@PartnersPersMed

 

Overall good meeting #s:

#personalizedmedicine

#powerofgenomics

#genomics

#pharmanews

 

AND FOLLOW these @

@pharma_BI

@AVIVA_1950

@BiotechNews

TALK SPECIFIC # and @

3:15 PM Perspectives From Professional Societies

Opening Speaker & Moderator:

Cynthia Morton, Ph.D.
William Lambert Richardson Professor of OB/Gyn and
Reproductive Biology and Professor of Pathology, Harvard Medical School;
Director of Cytogenetics, Brigham and Women’s Hospital

Panelists

José Baselga, M.D., Ph.D.
Physician in Chief and Chief Medical Officer, Memorial Sloan Kettering Cancer Center

Richard Friedberg, M.D., Ph.D.
Chair, Department of Pathology, Diagnostic Medicine Services
Bay State Health

James Madara, M.D.
Executive Vice President and CEO, American Medical Association

 

#disease

#populationgenetics

#health

#fibroids

#womenshealth

#geneticfactors

#PopulationHealth

 

@PartnersNews

@BWHResearch @Brigham

@AmerMedicalAssn

@HarvardHealth

@harvardmed

@sloan_kettering

 

@Baystate_Health

 

4:15 pm Panel Discussion Personalized Medicine Around the World

Opening Speaker & Moderator: Gary Palmer, M.D., J.D., MBA, MPH
Chief Medical Officer, NantHealth

 

Panelists:

Vijay Chandru, Ph.D.
Co-Founder, Chairman and CEO, Strand Life Sciences

Xishan Hao, M.D., FACS
Professor, Academician of Chinese Academy of Engineering;
President, Chinese Anti-Cancer Association;
Director, Tianjin Cancer Research Institute

Jack Wang
CEO, Biomobie Regenerative Medicine Co., Ltd.

 

#personalizedmedicine

#personalmed

#disease

#populationgenetics

#health

#globalhealth

#PopulationHealth

#NGS

#HealthAsia

#China

#cancer

#biotech

#Biomobie

 

@nanthealth

@StrandLife

@CDCGlobal

 

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11/18/2015 1:00 p.m. Keynote Speaker: Deputy Commissioner, US FDA – 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

Reporter: Aviva Lev-Ari, PhD, RN

Live Press Coverage in REAL TIME

Aviva Lev-Ari, PhD, RN

Director & Founder, Leaders in Pharmaceutical Business Intelligence, Boston

Co-Founder, GDE

1:00 p.m. Keynote Speaker

Robert Califf, M.D.
Deputy Commissioner, US FDA Office of Medical Products and Tobacco
Food and Drug Administration

  • New ecosystem: drugs, diagnostics, devices and Tabacco
  • Old ecosystem: Patients were passive and mDs know their job and training – Consorsium meetings
  • New Ecosystem: Patients are actives, devices are in design, patients have options in Precision Medicine
  • life span of medical products needs regulation even after deployment
  • Science and regulation and Innovation in the very competitive Space – verification of the environment
  • Tools at FDA for the Outside World: Open platforms for NGS FDA jobs is harder with Big Data
  • Biomarkers critical to PM and to Drug Discovery
  • very complex: Biomarker for inscreased risk vs genetic derived
  • BioMarker EVALUATION, Validted, Predictions, Assumptions, go up and down
  • Biomarker QUALIFICATION Process, Lab Text – What are the rules to ahve validity
  • BioMedicine: continuous data collection
  • System Biology: Cardiology – Markers for Prediction
  • Interaction of Genomics with the Environment Sociology of disease why different outcomes
  • Public shared with FDA submit data
  • Evidence to inform Policy: Companion Diagnosrtics
  • Performance measures
  • Medical Practice: FDA feel improvements are coming
  • Current System : Slow, Expensive, efficiency vs Revenues
  • estimation of diffusion of EMR to be faster than it happened
  • Learning Health Care System: Bar Code System – Outcomes to Patients
  • Big data system and randomized trials
  • NIH and FDA: Characterized Biology and sociology: Sequensing, physiology and medical devices
  • Bete understanding physiological
  • Patient engagement in Research: Myeloma Foundation: donated the Data
  • research wil move faster
  • Devices: Patient
  • Ethics: Autonomy, Privacy
  • Global: Asia’s population dominates the World
  • Safety systems must be Global: Working with other Agencies President and both Parties involved in Precision Medicine

 

1:30 p.m. – Panel Discussion

Precision Medicine in Community Healthcare Settings

Much of the U.S. population relies on their local physicians and hospitals for their healthcare needs. Many of these community based physician practices have decided that implementation of the principles of personalized medicine is critical to the well being of the patients they serve. This panel will provide examples of the implementation of personalized medicine in different settings.

Opening Speaker & Moderator

Barbara McAneny, M.D.
CEO, New Mexico Oncology Hematology Consultants, Ltd.; Immediate Past Chair, Board of Trustees, American Medical Association

  • Information coming to MDs in the Clinic
  • real time decision support
  • genetic test takes 2 weeks
  • eight companies run tests, if they relapsed
  • tissue to lab: Stroma vs tumor type
  • Insurance denied
  • Explain Patients that not all mutations are the same
  • test not paid for: Bancrupsy
  • data for patient for 50 years by HIPPA
  • second mutation found: Join
  • Mutations vs referred by MDs
  • HOW CAN WE RESTRUCTURE CLINICAL TRIALS to avoid patient refusal to participate
Panelists

Lynn Dressler, Dr. P.H.
Director of Personalized Medicine, Fullerton Genetics Center, Mission Health

  • env. 75% Medicare, MedicAid population of retirees, Cancer and other diseases
  • Cancer markers
  • Genomics evaluation
  • Variation actionable
  • Education driven program
  • Cancer side – newly formed program – What is the Value – Personalized Medicine
  • automatic genetic results sent to the PM Program
  • EMR – not connected to Cancer mutation data
  • working with medical Director, Vision, Strategy and NCO
  • CardiologY: 1500 PCI done a year they want to see their data
  • Social history Tool very effective
  • Cost effectiveness, small success along the way,
  • time to progression and survival in the context of Genomic Profiling
  • quality and parameters for Providers, systems issues
  • Paradignm shift less than 6 month, try to identify Progression
  • Dana Farber – Open Trial of Volunteers with Cancer to shorthen the duration of the Trial

David Ledbetter, Ph.D.
Executive Vice President & Chief Scientific Officer, Geisinger Health System

  • BioBank started in 1996, consent 85%-90% rate – High evidence Gene Studies
  • Regeneron – Science driven Pharma, sequensing  100,000 patients increased to 250,000
  • educational identify BRCA 1 Mutation, what that meant — not understood to patient
  • Familial Hypercholesterolemia
  • Focus Groups on protocol design
  • How Providers will use the information
  • Genomics Research Planning Sessions: Design Studies for Patient Outcomes
  • Redesign definitions of the outcomes, total cost of care, partner to do Outcome research

John Niederhuber, M.D.
Executive Vice President, Inova Health System;
CEO, Inova Translational Medical Institute;
Adjunct Professor of Oncology and Surgery, Johns Hopkins University School of Medicine;
Deputy Director, Johns Hopkins Clinical Research Network

  • Started at NCI, sequence genomics, left NCI 2010,
  • integrate genomics with clinical — usable for a PCP very busy
  • Interpretation, fast and accurate — HOW to do that?
  • Epigenetic Data from Mothers, 3000 families 8000 sequencing
  • 100 Countries of Origin rich Library: Screening, Mendelian Mutations, enough to learn on the Patient and Physician side
  • Medical Genomics trained Physicians
  • Lab for testing and validation of abnormality
  • Group effort, information sent back to Patients
  • Standards for Lab Results — not standardize: Doing it inside — control of Standards vs different results from different labs
  • Standardization is an issue
  • Variance on the Exon
  • Shorten Clinical Trial: New designs, How to do it better, 5-10 years from now using imaging
  • Breast Cancer: Patient requested to fix Clinical Trials – not done yet

2:30 p.m. – Mini-Keynote

Role of Biomarker Qualification in Personalized Medicine

Speaker

Anna Barker, Ph.D.
Co-Director, Complex Adaptive Systems Initiative
Director, National Biomarker Development Alliance (NBDA);
Professor, School of Life Sciences,
Arizona State University

  • In Oncology – very few Biomarkers make it to Clinical Trials
  • Other pathway is Diagnostics to Clinical Trials
  • Biomarkers: Old Definition, 2000
  • Biomarkers: New Definition, 2015 – it is not an Surrogate Endpoint, almost none in oncology
  • QUALIFICATION of Biomarker (BQ):
  • Types of Biomarkers:
  1. predictive biomarkers – toxicity
  2. diagnostics
  3. predictive – responsive to specific treatment
  4. pharmacodynamic biomarker – biological response; BP, cholesterol

Problem Statement:

FDA – Biomarkers rules change: Guidance for Industry on Biomarkers in Drug Development Tools

Companion Diagnostics – Biomarkers in the Drug development as a tool

  • Context of use
  • use statement
  • conditions for qualified use

Why we care about BQ:

  • Molecualr biomarkers reflect the molecular mechanism of the disease
  • priority biomarkers to be used
  • expent context of use – plan for that phase
  • partner with other Consorsia
  • develop data for sharing
  • future expansion beyond Context of use

DDT – Drug Development Tools Qualifications

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.O4Znb9kq.dpuf

To Follow LIVE CONFERENCE COVERAGE PLEASE FOLLOW ON TWITTER USING

Meeting #: #PMConf

Meeting @: @HarvardPMConf

@PartnersPersMed

 

Overall good meeting #s:

#personalizedmedicine

#powerofgenomics

#genomics

#pharmanews

 

AND FOLLOW these @

@pharma_BI

@AVIVA_1950

@BiotechNews

TALK SPECIFIC # and @

1:00 PM 1:00 p.m. Keynote Speaker

Robert Califf, M.D.
Deputy Commissioner, US FDA Office of Medical Products and Tobacco
Food and Drug Administration

 

#personalizedmedicine

#FDA

#regulation

@FDA

 

1:30 PM Panel Discussion: Precision Medicine in Community Healthcare Settings

Barbara McAneny, M.D.
CEO, New Mexico Oncology Hematology Consultants, Ltd.; Immediate Past Chair, Board of Trustees, American Medical Association

Lynn Dressler, Dr. P.H.
Director of Personalized Medicine, Fullerton Genetics Center, Mission Health

David Ledbetter, Ph.D.
Executive Vice President & Chief Scientific Officer, Geisinger Health System

John Niederhuber, M.D.
Executive Vice President, Inova Health System;
CEO, Inova Translational Medical Institute;
Adjunct Professor of Oncology and Surgery, Johns Hopkins University School of Medicine;
Deputy Director, Johns Hopkins Clinical Research Network

#personalizedmedicine

#health

#disease

#populationgenetics

#PopulationHealth

#FixMedicareNow

#InovaCPH

 

@BarbaraMcAneny

@AmerMedicalAssn

@FoundationAVL

@PartnersNews

@GeisingerHealth

@InovaHealth

@HopkinsMedicine

 

2:30 PM Mini-Keynote: Role of Biomarker Qualification in Personalized Medicine

 

Anna Barker, Ph.D.
Co-Director, Complex Adaptive Systems Initiative
Director, National Biomarker Development Alliance (NBDA);
Professor, School of Life Sciences,
Arizona State University

 

 

#personalizedmedicine

#health

#disease

#biomarker

#PopulationHealth

 

@ASU (for Anna Barker)

 

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11/18/2015 10:30 a.m. – Keynote Speakers: “Precision Trials Challenge” 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

Reporter: Aviva Lev-Ari, PhD, RN

Live Press Coverage in REAL TIME

Aviva Lev-Ari, PhD, RN

Director & Founder, Leaders in Pharmaceutical Business Intelligence, Boston

Co-Founder, GDE

 

10:30 a.m. – Keynote Speaker

“Precision Trials Challenge”

Speaker

Richard Hamermesh, D.B.A.
Senior Fellow and Former MBA Class of 1961 Professor of Management Practice
Harvard Business School

with
Robert Kraft
Chairman and Chief Executive Officer
Kraft Group

will introduce Harvard Business School’s “Precision Trials Challenge” – Kraft Family Foundation donate $20Million for Precision Medicine harnessed to understand disease 

HBS and the Broad Institute – collaboration Catalyst – computational bottlenecks

  • precision Medicine Ecosystem
  • incubation of ideas
  • commercialize collaborative initiative
  • Initiate a Challenge in January 2016 – Faster, smaller, cheaper and more efficient Clinical Trial by using Precision Medicine and bringing FASTER to market new drugs.
  • Prize of $2000 for NEW ideas on improving Clinical Trials
Interview with Robert Kraft  
  • lost wife to ovarian cancer
  • Team first and competition
  • Broad Institute is here and HBS coming up reunion of Robert and son, Jon from HBS, to celebrate the reunion by the gift to HBS and Broad Institute
  • Vision on MIT and Harvard collaborate: Dana Farber and Broad Institute
  • Vision on execution
  • NIH can not be alone on Precision Medicine – Private funding is important

Interview with Head of Broad Institute

  • Cancer research
  • Sense of urgency
  • Catalyse the process of drug Discovery
  • Research community around the Country to use competition for advancement of research
  • Breaking down silos – collaboration between Institution to For Teams across institutions
  • Routinely in Oncology biological and clinical implications on Clinical Trials pre clinical to trials, Alzheimer’s and Demetia not only Cancer

KATHY: Myeloma was tuckled by Broad and HMS and the outcome need be replicated for other diseases

11:00 a.m. – Panel Discussion

Precision Medicine Initiative in US and Abroad

President Obama has announced a Precision Medicine Initiative in the US earlier this year. A part of that effort is to collect information from a very large cohort of patients. Such efforts have been initiated at many Institutions in the US and around the world. This panel will discuss the successes of these efforts and the challenges they face.

 

Opening Speaker and Moderator

Elizabeth Karlson, M.D.
Co-Investigator, Partners Biobank, Partners HealthCare Personalized Medicine; Associate Professor of Medicine, Harvard Medical School

  • Biobanks links to clinical data and EMR
  • Pharmco-genetics focus on Cancer
  • Beside Cancer, what other diseases BioBank could help?
  • Q – biggest challenge to implement Precision Medicine in your Country
  • Patients consent to be in BioBank and they do not get the results back
  • Reactions of MDs and Patients: False positive requires more tests
  • How can we handle getting back wiht results to 1Million Volunteers
  • lessons from BioBank that can inform the President Cohort PMI

PARTNERS Experience

  • Risk prediction model
  • calling back patients with results
  • bIoBank is linked for query Portal integrates all data for all participants
  • Genotyping 25,000 Patients
  • Honing Phenotypes and curated Phenotypes connected with gentic sequence data more evidence needed to call Data Acitonable
  • Cost impact LDL receptor, genetic component in the context of Trial
  • consent to PMI, may be some Patients will
  • Sharing Consent FORMS – a possibility for Standardization, All online
  • Partners HealthCare was approved by IRB in 18 month and the FORM will stand for ever.
  • Patient Portal: Patient identity Verified
  • Patient Portal used only by Educate White Populations
  • A Team to do Face to Face
  • Online recruitment targeted to White Educated
Panelists

Hadi Abderrahim, M.D., Ph.D., M.B.A.
Managing Director, Qatar Biobank

  • Hospital system develop the use of Biobanking, model for data collection using questionnaire Measurement of relations of the Database, volunteer patients, 1000 participant to 5000 participants
  • Biobank can be instrumental for Diabetes
  • education occur at the Clinic level not online

Taro Inada, Ph.D.
General Manager, Denka Co., Ltd. Japan

  • Chemical Company
  • Colon Cancer in Japan is increasing
  • Precision Medicine: Protocol for Diagnosis
  •  infectious disease in Japan
  •  Sharing information keeping the motivation and the relationship with Academia

Nahid Turan, Ph.D.

PI, National Institute of General Medical Science Human Genetic Cell Repository, Coriell Institute

  • gene discovery to prolong life
  • mutation on a gene protected from EBOLA
  • Drug Safety of upmost importance
  • follow up all patients that has samples in the BioBank
  • challenge is big with Data Collection and reporting back to patients
  • Privacy
  • Risk for melanoma – Education needed for Patients

QUESTIONS FROM THE AUDIENCE

  • Q – Channels for Patient Education
  • A – Online is very participatory

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.O4Znb9kq.dpuf

To Follow LIVE CONFERENCE COVERAGE PLEASE FOLLOW ON TWITTER USING

Meeting #: #PMConf

Meeting @: @HarvardPMConf

@PartnersPersMed

 

Overall good meeting #s:

#personalizedmedicine

#powerofgenomics

#genomics

#pharmanews

 

AND FOLLOW these @

@pharma_BI

@AVIVA_1950

@BiotechNews

TALK SPECIFIC # and @

10:30 AM Keynote Speaker

“Precision Trials Challenge”

Richard Hamermesh, D.B.A.
Senior Fellow and Former MBA Class of 1961 Professor of Management Practice
Harvard Business School

with
Robert Kraft
Chairman and Chief Executive Officer
Kraft Group

 

#personalizedmedicine

 

@HarvardHBS

@PartnersNews

@Harvard

 

 

 

11:00 AM Panel Discussion: Precision Medicine Initiative in US and Abroad

Elizabeth Karlson, M.D.
Co-Investigator, Partners Biobank, Partners HealthCare Personalized Medicine; Associate Professor of Medicine, Harvard Medical School

Hadi Abderrahim, M.D., Ph.D., M.B.A.
Managing Director, Qatar Biobank

Taro Inada, Ph.D.
General Manager, Denka Co., Ltd.

Nahid Turan, Ph.D.
PI, National Institute of General Medical Sciences Human Genetic Cell Repository, Coriell Institute

#personalizedmedicine

#health

#healthcare

#globalhealth

#biobank

#PopulationHealth

 

 

@PartnersNews

@HarvardHealth

@harvardmed

@Qatar_Biobank

@QF

@Coriell_Science

 

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11/18/2015 8:30 a.m. – Keynote Address: Kathy Hudson, Ph.D. NIH – 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

Reporter: Aviva Lev-Ari, PhD, RN

 

Live Press Coverage in REAL TIME

Aviva Lev-Ari, PhD, RN

Director & Founder, Leaders in Pharmaceutical Business Intelligence, Boston

Co-Founder, GDE

 

8:30 a.m. – Keynote Address

The Impact of Precision Medicine on the Future of Healthcare

Speaker

Kathy Hudson, Ph.D.
Deputy Director for Science, Outreach and Policy
National Insitutes of Health

EMPOWER patients, providers, researchers
PMI – PrecisionMedicine Initiative (PMI)
– cohort
– Cancer
– FDA
– ONC
A million volunteers DIRECT Recruitment
  • DIFFERENCES among individuals: GENES, LIFESTYLE, ENVIRONMENT
  • MUST look beyond the Genome: diet, environment, behavior

FNIH Survey of Public Opinion on large US Cohort – 79% agree cohort probably need be done

54% participate in the Cohort

Participants as “Partners” not as “Subjects”

2015: President Obama launched $215 Million in the PMI for the NIH

  • PMI Cohort $130
  • PMI for Oncology $70
  • FDA $10
  • Health IT $5

PMI Working Group – 20 members

  • Partners
  • Harvard Pilgrims
  • GE
  • Intel

Assembling the PMI Cohort

  • Recruitment denovo
  • Lonngitudinal Cohort
  • One Million Volumteers
  1. Direct volunteer – any one can sign up
  2. Healthcare provider Organizations
  • Initial Core Data Set
  • Policy for PMI Cohort Program
  1. IRB – Single Institutional Review Boards
  2. Privacy and Security
  3. Share results Clarify CLIA and HIPPA
  • Information Flow In
  • Participants will receive: Individual Data, individual Health Information, Ongoing study updates Aggregate results
Proposed Revisions to the Common Rule
  • Required single institutional
  • PMI Cohort Program Governance
  1. Program director
  2. executive committee
  3. steering v=committiee with 5 sub committiees
  • data
  • biobank
  • resource access

IMPLEMENTATION

  • underserved communities
  • start with Volunteer ONLINE enrollement not with HC Provider Organizations

ANNOUNCMENT Four Funding Announcement for Cooperative Agreement

  • Transaction Award Announcements
  • National Search Outstanding Scientist to LEAD the PMI Cohort Program
  • Appointment committee members
  • Synch-4-Science Pilot

QUESTIONS from the AUDIENCE

  • Q – Direct Volunteer Program – 1 Million  Volunteer
  • A – Pilot launched
  • Q – Consumers of Health Care
  • A –

9:00 a.m. – Panel Discussion

Investments in Personalized Medicine

During the past several years there have been increased levels of financial investments in fields related to Personalized Medicine. The new initiative on Precision Medicine by President Obama is also fueling discussions about new types of investments. This panel will explore the reasons for interest in investing in Personalized Medicine products and how both large and small companies are developing programs to expand their interest in this area.

Opening Speaker and Moderator

Sue Siegel
CEO, GE Ventures & healthymagination, GE

  • 2014 – 83 IPO Healthcare related
  • 2015 – 64 IPO Healthcare related
  • Regulatory and reimbursement
  • Value based Pricing – hard to define, thus, hard to invest in some patient related innovations
  • consumer driving value in the Financial Industry and Energy is creating Value why Healthcare is less taboo then Financial data
  • 40% voted that a newborn will be sequenced at birth, what about in 10 years
  • Hard time with Biomarkers and reimbursement
  • PMI is an effort to COLLECT DATA paid by the Government so research will follow to edify the community on Public Health
Panelists

Sean George, Ph.D. exCEO Navgenics
President, COO, and Co-Founder, Invitae

  • what are the barriers related to Patient Value-based Pricing
  • 10% of populations primary health issues are related to Genetics
  • Uber example vs Genomics driver unknown in Uber, Results of genomic sequencing are not desired to become known

Mark Levin
Partner, Third Rock Ventures

  • Drugs: Biologics
  • Diagnostics and Prevention Medicine
  • Big Data – MyoCardiac: data, Foundation Medicine: data
  • Innovation that PMI will help to develop: The Molecular Statoscope: genome and other factors
  • Chinese do not have Data on reimbursement and No legacy systems
  • Investment in ALS, Parkinson, Regulation all diseases less on Cancers as investment focus
  • CMS and Payer will benefit form PMI

Kimberly Popovits, ex-Genentech
Chairman of the Board, CEO and President, Genomic Health

  • Precision Medicine progress depends on development of diagnostics
  • Barriers by Technology, less and less so
  • Payer do look at Diagnostics more favorable then in the Past
  • Big Data more and more important
  • cancer is a front runner in improvement of disease state
  • Delivery of Value: Cancer Targeted Therapeutics workes only in 25% of the Cases – Shall we invest unless we achieve 60% working vs 25%
  • Actionalbe Value from haveing the genome Sequence  — >> change in Outcomes
  • Roles fro CMS, Payers, FDA

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.O4Znb9kq.dpuf

To Follow LIVE CONFERENCE COVERAGE PLEASE FOLLOW ON TWITTER USING

Meeting #: #PMConf

Meeting @: @HarvardPMConf

@PartnersPersMed

 

Overall good meeting #s:

#personalizedmedicine

#powerofgenomics

#genomics

#pharmanews

 

AND FOLLOW these @

@pharma_BI

@AVIVA_1950

@BiotechNews

TALK SPECIFIC # and @

8:30 AM Special Guest Keynote Speaker Kathy Hudson, Ph.D.
Deputy Director for Science, Outreach and Policy
National Institutes of Health
#NIH

#AER15

#personalizedmedicine

#pharma

#healthcare

#PublicHealth

#HealthPolicy

#clinicaltrial

 

@KathyHudsonNIH

@nihdirector

 

9:00 AM 9:00 a.m. – Panel Discussion Investments in Personalized Medicine

Sue Siegel
CEO, GEVentures & healthymagination

Sean George, Ph.D.
President, COO, and Co-Founder, Invitae Mark Levin
Partner, Third Rock Venture

Kimberly Popovits
Chairman of the Board, CEO and President, Genomic Health

 

 

 

#personalizedmedicine

#GeneticTesting

#venturecapital

#startups

#startup

 

#biotech

#biopharma

 

@_SueSiegel

@GE_Ventures

@Invitae

@GenomicHealth

@VCapitalGuide

@MassBio

@MALifeSciences

@FierceBiotech

 

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