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Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting

 

Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting

Reporter: Stephen J. Williams, PhD

Article ID #169: Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting. Published on 3/11/2015

WordCloud Image Produced by Adam Tubman

Achievement Beyond Regulatory Approval – Design for Commercial Success

philly2nightStephen J. Williams, Ph.D.: Reporter

The Mid-Atlantic group Life Sciences Collaborative, a select group of industry veterans and executives from the pharmaceutical, biotechnology, and medical device sectors whose mission is to increase the success of emerging life sciences businesses in the Mid-Atlantic region through networking, education, training and mentorship, met Tuesday March 3, 2015 at the University of the Sciences in Philadelphia (USP) to discuss post-approval regulatory issues and concerns such as designing strong patent protection, developing strategies for insurance reimbursement, and securing financing for any stage of a business.

The meeting was divided into three panel discussions and keynote speech:

  1. Panel 1: Design for Market Protection– Intellectual Property Strategy Planning
  2. Panel 2: Design for Market Success– Commercial Strategy Planning
  3. Panel 3: Design for Investment– Financing Each Stage
  4. Keynote Speaker: Robert Radie, President & CEO Egalet Corporation

Below are Notes from each PANEL Discussion:

For more information about the Life Sciences Collaborative SEE

Website: http://www.lifesciencescollaborative.org/

Or On Facebook

Or On Twitter @LSCollaborative

Panel 1: Design for Market Protection; Intellectual Property Strategy Planning

Take-home Message: Developing a very strong Intellectual Property (IP) portfolio and strategy for a startup is CRITICALLY IMPORTANT for its long-term success. Potential investors, partners, and acquirers will focus on the strength of a startup’s IP so important to take advantage of the legal services available. Do your DUE DIGILENCE.

Panelists:

John F. Ritter, J.D.., MBA; Director Office Tech. Licensing Princeton University

Cozette McAvoy; Senior Attorney Novartis Oncology Pharma Patents

Ryan O’Donnell; Partner Volpe & Koenig

Panel Moderator: Dipanjan “DJ” Nag, PhD, MBA, CLP, RTTP; President CEO IP Shaktl, LLC

Notes:

Dr. Nag:

  • Sometimes IP can be a double edged sword; e.g. Herbert Boyer with Paul Berg and Stanley Cohen credited with developing recombinant technology but they did not keep the IP strict and opened the door for a biotech revolution (see nice review from Chemical Heritage Foundation).
  • Naked patent licenses are most profitable when try to sell IP

John Ritter: Mr. Ritter gave Princeton University’s perspective on developing and promoting a university-based IP portfolio.

  • 30-40% of Princeton’s IP portfolio is related to life sciences
  • Universities will prefer to seek provisional patent status as a quicker process and allows for publication
  • Princeton will work closely with investigators to walk them through process – Very Important to have support system in place INCLUDING helping investigators and early startups establish a STRONG startup MANAGEMENT TEAM, and making important introductions to and DEVELOPING RELATIONSHIOPS with investors, angels
  • Good to cast a wide net when looking at early development partners like pharma
  • Good example of university which takes active role in developing startups is University of Pennsylvania’s Penn UPstart program.
  • Last 2 years many universities filing patents for startups as a micro-entity

Comment from attendee: Universities are not using enough of their endowments for purpose of startups. Princeton only using $500,00 for accelerator program.

Cozette McAvoy: Mrs. McAvoy talked about monetizing your IP from an industry perspective

  • Industry now is looking at “indirect monetization” of their and others IP portfolio. Indirect monetization refers to unlocking the “indirect value” of intellectual property; for example research tools, processes, which may or may not be related to a tangible product.
  • Good to make a contractual bundle of IP – “days of the $million check is gone”
  • Big companies like big pharma looks to PR (press relation) buzz surrounding new technology, products SO IMPORTANT FOR STARTUP TO FOCUS ON YOUR PR

Ryan O’Donnell: talked about how life science IP has changed especially due to America Invests Act

  • Need to develop a GLOBAL IP strategy so whether drug or device can market in multiple countries
  • Diagnostics and genes not patentable now – Major shift in patent strategy
  • Companies like Unified Patents can protect you against the patent trolls – if patent threatened by patent troll (patent assertion entity) will file a petition with the USPTO (US Patent Office) requesting institution of inter partes review (IPR); this may cost $40,000 BUT WELL WORTH the money – BE PROACTIVE about your patents and IP

Panel 2: Design for Market Success; Commercial Strategy Planning

Take-home Message: Commercial strategy development is defined market facing data, reimbursement strategies and commercial planning that inform labeling requirements, clinical study designs, healthcare economic outcomes and pricing targets. Clarity from payers is extremely important to develop any market strategy. Develop this strategy early and seek advice from payers.

Panelists:

David Blaszczak; Founder, Precipio Health Strategies

Terri Bernacchi, PharmD, MBA; Founder & President Cambria Health Advisory Professionals

Paul Firuta; President US Commercial Operations, NPS Pharma

 

Panel Moderator: Matt Cabrey; Executive Director, Select Greater Philadelphia

 

Notes:

David Blaszczak:

  • Commercial payers are bundling payment: most important to get clarity from these payers
  • Payers are using clinical trials to alter marketing (labeling) so IMPORTANT to BUILD LABEL in early clinical trial phases (phase I or II)
  • When in early phases of small company best now to team or partner with a Medicare or PBM (pharmacy benefit manager) and payers to help develop and spot tier1 and tier 2 companies in their area

Terri Bernacchi:

  • Building relationship with the payer is very important but firms like hers will also look to patients and advocacy groups to see how they respond to a given therapy and decrease the price risk by bundling
  • Value-based contracting with manufacturers can save patient and payer $$
  • As most PBMs formularies are 80% generics goal is how to make money off of generics
  • Patent extension would have greatest impact on price, value

Paul Firuta:

  • NPS Pharma developing a pharmacy benefit program for orphan diseases
  • How you pay depends on mix of Medicare, private payers now
  • Most important change which could affect price is change in compliance regulations

Panel 3: Design for Investment; Financing Each Stage

Take-home Message: VC is a personal relationship so spend time making those relationships. Do your preparation on your value and your market. Look to non-VC avenues: they are out there.

Panelists:

Ting Pau Oei; Managing Director, Easton Capital (NYC)

Manya Deehr; CEO & Founder, Pediva Therapeutics

Sanjoy Dutta, PhD; Assistant VP, Translational Devel. & Intl. Res., Juvenile Diabetes Research Foundation

 

Panel Moderator: Shahram Hejazi, PhD; Venture Partner, BioAdvance

  • In 2000 his experience finding 1st capital was what are your assets; now has changed to value

Notes:

Ting Pau Oei:

  • Your very 1st capital is all about VALUE– so plan where you add value
  • Venture Capital is a PERSONAL RELATIONSHIP
  • 1) you need the management team, 2) be able to communicate effectively                  (Powerpoint, elevator pitch, business plan) and #1 and #2 will get you important 2nd Venture Capital meeting; VC’s don’t decide anything in 1st meeting
  • VC’s don’t normally do a good job of premarket valuation or premarket due diligence but know post market valuation well
  • Best advice: show some phase 2 milestones and VC will knock on your door

Manya Deehr:

  • Investment is more niche oriented so find your niche investors
  • Define your product first and then match the investors
  • Biggest failure she has experienced: companies that go out too early looking for capital

Dr. Dutta: funding from a non-profit patient advocacy group perspective

  • Your First Capital: find alliances which can help you get out of “valley of death
  • Develop a targeted product and patient treatment profile
  • Non-profit groups ask three questions:

1) what is the value to patients (non-profits want to partner)

2) what is your timeline (we can wait longer than VC; for example Cystic Fibrosis Foundation waited long time but got great returns for their patients with Kalydeco™)

3) when can we see return

  • Long-term market projections are the knowledge gaps that startups have (the landscape) and startups don’t have all the competitive intelligence
  • Have a plan B every step of the way

Other posts on this site related to Philadelphia Biotech, Startup Funding, Payer Issues, and Intellectual Property Issues include:

PCCI’s 7th Annual Roundtable “Crowdfunding for Life Sciences: A Bridge Over Troubled Waters?” May 12 2014 Embassy Suites Hotel, Chesterbrook PA 6:00-9:30 PM
The Vibrant Philly Biotech Scene: Focus on KannaLife Sciences and the Discipline and Potential of Pharmacognosy
The Vibrant Philly Biotech Scene: Focus on Computer-Aided Drug Design and Gfree Bio, LLC
The Vibrant Philly Biotech Scene: Focus on Vaccines and Philimmune, LLC
The Bioscience Crowdfunding Environment: The Bigger Better VC?
Foundations as a Funding Source
Venture Capital Funding in the Life Sciences: Phase4 Ventures – A Case Study
10 heart-focused apps & devices are crowdfunding for American Heart Association’s open innovation challenge
Funding, Deals & Partnerships
Medicare Panel Punts on Best Tx for Carotid Plaque
9:15AM–2:00PM, January 27, 2015 – Regulatory & Reimbursement Frameworks for Molecular Testing, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA
FDA Commissioner, Dr. Margaret A. Hamburg on HealthCare for 310Million Americans and the Role of Personalized Medicine
Biosimilars: Intellectual Property Creation and Protection by Pioneer and by Biosimilar Manufacturers
Litigation on the Way: Broad Institute Gets Patent on Revolutionary Gene-Editing Method
The Patents for CRISPR, the DNA editing technology as the Biggest Biotech Discovery of the Century

 

 

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ANNOUNCEMENT

REAL TIME Coverage for the Press of MassBio 2015 Annual Meeting, March 26-27, 2015, Royal Sonesta Hotel, Cambridge, MA

by

Leaders in Pharmaceutical Business Intelligence

LEADERS IN PHARMACEUTICAL BUSINESS INTELLIGENCE

LPBI-Logo

will cover for the Scientific and Business Press in REAL TIME the MassBio 2015 Annual Meeting, March 26-27, 2015, Royal Sonesta Hotel, Cambridge, MA

 AGENDA

http://pharmaceuticalintelligence.com/2015/01/13/massbio-2015-annual-meeting-march-26-27-2015-royal-sonesta-hotel-cambridge-ma/

 

Dr. Lev-Ari will be in attendance on 3/26/2015 and 3/27/2015

 

Venture Overview Updated in New Company Page on LinkedIn: Leaders in Pharmaceutical Business Intelligence

http://pharmaceuticalintelligence.com/2015/03/07/venture-overview-updated-on-new-company-page-on-linkedin-leaders-in-pharmaceutical-business-intelligence/

 

ANNOUNCEMENT

at MassBio 2015 Annual Meeting, March 26-27, 2015, Royal Sonesta Hotel, Cambridge, MA

Forthcoming e-Books on Amazon-Kindle.com

by Experts, Authors, Writers of

LEADERS IN PHARMACEUTICAL BUSINESS INTELLIGENCE

Our Team

http://pharmaceuticalintelligence.com/contributors-biographies/

onepage series BCDE covers

 

onepageCVDseriesAflyervol1-4

 

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Biobanking Congress 2015, Toronto, InterContinental Toronto Centre, July 14-16, 2015

Reporter: Aviva Lev-Ari, PhD, RN

 

FINAL AGENDA

 

Cambridge Healthtech Institute’s Seventh International Leaders in Biobanking Congress: Maximizing Your Investment in Biospecimens addresses both the business and science of biobanking, bringing together biomedical and biopharmaceutical researchers, regulators, biorepository managers and practitioners to investigate the best strategies for effective use of biospecimens within today’s cutting-edge biomedical research.

KEYNOTE SESSION: IT TAKES A VILLAGE

The Complexity of Pathologist Responsibilities as Custodians of Biospecimens

Sylvia L. Asa, M.D., Ph.D., Pathologist-in-Chief, Medical Director, Laboratory Medicine Program, University Health Network; Lakeridge Health &

Womens College Hospital; Senior Scientist, Ontario Cancer Institute; Professor, Laboratory Medicine & Pathobiology, University of Toronto

Discovery and Implementation Using EHR-Linked Biobanks: The eMERGE Experience

Rex L. Chisholm, Ph.D., Vice Dean, Scientific Affairs and Graduate Education; Adam and Richard T. Lind Professor, Medical Genetics, Northwestern

University Feinberg School of Medicine

Preparing Research Samples for Future Use: Innovative Methods for Assessing Functional Quality Control and Biobanking Best Practices

Andrew Brooks, Ph.D., COO, RUCDR Infinite Biologics; Associate Professor, Genetics, Rutgers University

Generating Comprehensive Standard Operating Procedures for a Biorepository Network – The CTRNet Experience

Brent Schacter, M.D., FRCPC, Principal Investigator, CTRNet; Professor, Department of Internal Medicine, Section of Hematology/

Oncology, College of Medicine, University of Manitoba/CancerCare Manitoba

MAINTAINING A QUALITY BIOBANK

Development and Implementation of a National Biospecimen Collection Network in a Community Hospital System

Jeffrey Otto, MBA, Ph.D., National Director, Center for Translational Research, Institute for Research and Innovation, Catholic Health Initiatives

Inventory Management; Re-Organization, Consolidation, Quality Assurance and the Cost of Space in the Biorepository

Sherilyn J. Sawyer, Ph.D., Director, BWH/Harvard Cohorts Biorepository, Channing Division of Network Medicine, Brigham and Women’s Hospital

Is There a Web-Based Solution to the Challenge of Informed Consent and Re-Consent of Legacy Biobank Samples?

Daniel B. Thiel, Public Health Researcher, Health Services Organization and Policy, University of Michigan School of Public Health

Tissue Banking, Bioinformatics and EMRs: The Front-End Requirements for Personalized Medicine

K. Stephen Suh, Ph.D., Director, Genomics and Biomarkers Program, John Theurer Cancer Center, Hackensack University Medical Center

PANEL DISCUSSION: Ensuring Biobank Value through Effective Utilization

Moderators:

Marianne K. Henderson, MS, CPC, Chief, Division of Cancer Epidemiology & Genetics, Office of Division Operations and Analysis and the Center for

Global Health, National Cancer Institute; Chair, Organizing Advisory Committee, ISBER

Marianna J. Bledsoe, MA, Adjunct Assistant Professor, Department of Clinical Research and Leadership, George Washington University School of

Medicine and Health Sciences; Co-Chair, Science Policy Committee, ISBER

Panelists:

Jeffrey Otto, MBA, Ph.D., National Director, Center for Translational Research, Institute for Research and Innovation, Catholic Health Initiatives

Sherilyn J. Sawyer, Ph.D., Director, BWH/Harvard Cohorts Biorepository, Channing Division of Network Medicine, Brigham and Women’s Hospital

K. Stephen Suh, Ph.D., Director, Genomics and Biomarkers Program, John Theurer Cancer Center, Hackensack University Medical Center

Daniel B. Thiel, Public Health Researcher, Health Services Organization and Policy, University of Michigan School of Public Health

Additional Panelists to be Announced

BIOSAMPLES, BIOMARKERS AND CLINICAL TRIALS

FEATURED PRESENTATION :

TRANSLATING PRECISION MEDICINE STRATEGY INTO OUTCOME THROUGH CLINICAL TRIALS

Lillian L. Siu, M.D., FRCPC, Professor, University of Toronto; Medical Oncologist, Princess Margaret Cancer Centre

Obtaining Biospecimens for Correlative Studies in Multi-Centre Lymphoma Clinical Trials

Koren Mann, Ph.D., Assistant Professor, Oncology, Lady Davis Institute for Medical Research, McGill University

Case Study #1: Biospecimen Sciences, Clinical Trials and Precision Medicine: Examples from Our Practice

Michael H. A. Roehrl, M.D., Ph.D., Director, UHN Program in BioSpecimen Sciences, University Health Network and University of Toronto

Anthony M. Joshua, MBBS, Ph.D., Staff Oncologist/Affiliate Scientist, Princess Margaret Cancer Centre

TOOLS TO ACCESS BIOSPECIMEN QUALITY

From Research to Clinic: (Pre-)Analytical Variables and Assay Development

Veronique Neumeister, M.D., Laboratory Director, Specialized Translational Services Lab, Department of Pathology, Yale University School of Medicine

Experimental Animal Models to Inform Human Biobanking Practices

Galen Hostetter, M.D., FCAP, Associate Director, Pathology Core, Van Andel Research Institute

Freezing under Pressure: A New Method for Cryopreservation

Nickolas Greer, CSO, Rissali LLC

Microfluidic Evaluation of Red Cells Collected and Stored in Modified Processing Solutions Used in Blood Banking

Dana Spence, Ph.D., Associate Professor, Department of Chemistry, Michigan State University

FEATURED PRESENTATION:

PRE-ANALYTICAL VARIABLES IMPACTING PERIPHERAL BLOOD SAMPLES FOR IMMUNE MONITORING IN MULTICENTER STUDIES

Amit Bar-Or, M.D., FRCPC, Professor, Neurology & Neurosurgery; Director, Experimental Therapeutics Program and Scientific Director, Clinical Research

Unit, Montreal Neurological Institute, McGill University

CASE STUDIES: BIOBANKER/BIOUSER PARTNERSHIPS

Biomedical researchers and drug developers require accessible, highquality biospecimens that allow them to extract reliable and useful data.

Oncology experts, for instance, use patient-derived tumor collections to connect datasets, pinpoint and assess variants within cancer patients

post-diagnosis and zero in on the data that matter when tailoring therapies. Early, strategic collaborations with the biobanks that house

specimens can be mutually beneficial, maximizing the financial and technological investments of the operation managers who collect, store,

annotate and distribute the biological samples (“biobankers”) and supporting the research goals of the scientists who need those samples

(“biousers”) – all to fulfill the promise of personalized medicine.

SPECIALTY BIOBANKS

The Future of iPSCs Biobanking

Jonathan Y.H. Loh, Ph.D., Assistant Professor, Department of Biological Sciences, National University of Singapore, A*STAR Institute of

Molecular and Cell Biology

Biobanking to Improve Cardiac Transplant Outcomes

Dawn E. Bowles, Ph.D., Assistant Professor, Department of Surgery, Division of Surgical Sciences and Co-Director, Duke Human Heart Repository

Planning and Implementing an Institutional Hospital for Children and Women: Ethical and Operational Consideration

Suzanne Vercauteren, M.D., Ph.D., FRCPC, Head, Division of Hematopathology, BC Children’s Hospital and Clinical Assistant Professor,

Pathology and Laboratory Medicine, University of British Columbia

The University Health Network Genito-Urinary (GU) BioBank

Neil Fleshner, M.D., MPH, FRCSC, Chair, Urology, Department of Surgery, University of Toronto; Head, Urology, University Health Network; Director,

GU BioBank, Princess Margaret Cancer Centre

Give Life Twice – An Overview of Canada’s National Public Cord Blood Bank

Heidi Elmoazzen, Ph.D., Director, National Public Cord Blood Bank

Toronto Lung Transplant Biobanking Project, What We Are Collecting

Sassan M. Azad, Project Manager, Clinical, Translational & Biobanking Research Office, Toronto Lung Transplant Program, Toronto General Hospital,

University Health Network

MAINTAINING A QUALITY BIOBANK WITH IT

Progress Is Bringing Together Clinical and Biorepository Data in an Expandable Research Data Repository

Maureen E. Lane, Ph.D., Assistant Professor, Medicine; Director, Hem/Onc Translational Core Laboratory, The Leukemia Biorepository and Personalized

Medicine Center, Weill Cornell Medical College

Data Bank and BioRepository for Translational and Basic Research

Annmarie Nowak, Coordinator & Director, Data Bank and Biorepository, Biobanking Systems Integration Cancer Prevention and Population Science,

Roswell Park Cancer Institute

Promoting Quality Biobanks and Biobank Quality: The CRIP Toolbox and the Metabiobank p-BioSPRE

Christina Schröder, Ph.D., Head, Metabiobanks CRIP, Fraunhofer Institute for Cell Therapy and Immunology

Register by March 20th & Save!

For sponsorship and exhibit sales information, contact:

Carolyn Benton

Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-972-5412

Email: cbenton@healthtech.com

Healthtech.com/Biobanking

 

SOURCE

From: Leaders in Biobanking <kerris@healthtech.com>
Date: Fri, 06 Mar 2015 11:36:31 -0500
To: <avivalev-ari@alum.berkeley.edu>
Subject: Final Agenda Now Available

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Circulating Biomarkers World Congress, March 23-24, 2015, Boston: Exosomes, Microvesicles, Circulating DNA, Circulating RNA, Circulating Tumor Cells, Sample Preparation

Reporter: Aviva Lev-Ari, PhD, RN

 

 

VENUE

Wyndham Boston Beacon Hill
5 Blossom Street,
Boston, Massachusetts, 02114
USA

The Conference Presentations, Exhibition, as well as Lunches and Networking Reception will be held on the 15th. Floor of the Hotel featuring stunning views of the Charles River, Boston, and MIT.

The Wyndham Boston Beacon Hill is on Blossom Street which is right off Cambridge Street.  A 5-minute walk from the MBTA “T” Red Line Charles/MGH Stop.

Also, the Wyndham Boston Beacon Hill is right across from the Massachusetts General Hospital (MGH).

The 2nd. Annual SELECTBIO Circulating Biomarkers World Congress 2015 brings together academic researchers as well as industry participants to present and discuss the most up-to-date research and commercial activities in the translation of various circulating biomarker classes towards the clinic.

This Congress discusses Nucleic Acid-based Biomarkers, Protein-based Biomarkers, Extracellular Vesicle (EV)-based Biomarkers (contained within exosomes and microvesicles), and Circulating Tumor Cell (CTC)-based Biomarkers.

One of the conference tracks focuses on Sample Preparation, a key component of the workflow in circulating biomarker isolation for research, and deployment in the clinic.

A co-located exhibit hall features companies developing technologies and products for the complete workflow from sample isolation, preparation, through data analysis.

Conference delegates receive access to all three co-located conference tracks, can mix-and-match presentations from all three tracks thereby maximizing the conference experience, and can network with delegates from the various co-located tracks and exhibition.

All conference attendees receive a USB drive loaded with the most up-to-date publications and reviews focused on various classes of circulating biomarkers, these offer valuable information for R&D presentations and business plans.

Present Your Research in a Poster at this Conference. Poster Submission Deadline:  March 16, 2015

http://selectbiosciences.com/conferences/index.aspx?conf=CBWC2015

Select Biosciences is organizing a 3-track event entitled Circulating Biomarkers World Congress 2015, Boston, March 23-24, 2015 bringing together all the relevant topics and speakers from around the world addressing comprehensively the Circulating Biomarkers field.

Co-Located Parallel Congress Tracks 

1.

Exosomes and Microvesicles

2.

Circulating DNA, Circulating RNA, Circulating Tumor Cells

3.

Sample Preparation and Analysis

Topics Covered in this Congress

Biofluid Biopsy Development and Various Biomarker Classes

Circulating DNA and RNA as Potential Biomarker Classes

Circulating Tumor Cells (CTCs): Methodologies for Isolation and Interrogation

Circulating Tumor DNA (ctDNA): Potential for Monitoring Disease Progression in Oncology and for Correctly Deploying Targeted Therapeutics and Enabling Personalized Medicine

Digital PCR Applications for Circulating Biomarker Interrogation

EV Cargo and Biomarker Potential–Classes of Biomarker Cargo: DNA, RNA, Protein

EVs as Delivery Vehicles–Potential of EVs Beyond Biomarkers to Engineered Delivery Vectors

Exosomes and Microvesicles in Various Disease Classes (Cancer, Cardiovascular Disease, CNS)

Exosomes, Microvesicles, and Other Classes of Extracellular Vesicles (EVs) as Circulating Biomarkers

Head-to-Head Comparison of CTCs with ctDNA as Circulating Biomarkers

Mass Spectrometry for Protein Biomarker Analysis

Methodologies for Isolating and Characterizing Extracellular Nucleic Acids (cfDNA, Extracellular RNA)

Microfluidics/Lab-on-a-Chip Methodologies for Sample Preparation

Next Generation Sequencing (NGS) for Characterizing Circulating Biomarkers: Applications of RNA-Seq for Studying Exosomes and Microvesicles

Sample Preparation Technologies for Circulating Biomarkers in the Point-of-Care (POC) Diagnostics Environment

Tools and Technologies for Monitoring Extracellular Nucleic Acids in Biological Fluids

Confirmed Keynote Speakers

David Wong, Felix & Mildred Yip Professor, Associate Dean of Research, Director UCLA Center for Oral/Head & Neck Oncology Research. Saliva-based Exosomes for Liquid Biopsies

Dominique de Kleijn, Professor, National University of Singapore. Extracellular Vesicles as Biomarkers for Cardiovascular Disease

Doug Taylor, Chief Scientific Officer, Exosome Sciences. Exosomes: From “Dust” to Multiplexed Diagnostic Biomarker

Frank Slack, Professor of Medicine & Pathology, Director, Institute of RNA Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School. MicroRNA Biomarkers of Disease

Deaconess Medical Center/Harvard Medical School. MicroRNA Biomarkers of Disease

Jamie Platt, Vice President, Genomic Solutions, Geneuity (Molecular Pathology Laboratory Network, Inc.). Getting Back to Basics: Sample Preparation Considerations for Advanced Sequencing Technologies

Johan Skog, Chief Scientific Officer, Exosome Diagnostics Exosome Biomarkers: Current State and Future Directions

John Palma, Director, Medical & Scientific Affairs, Roche Molecular Systems. Blood-based Detection of EGFR Mutations is Predictive of Survival Outcomes in Patients Treated with First-line Erlotinib Intercalated with Chemotherapy

Lance Liotta, Professor, George Mason University. Nanotrap Nanoparticles for Discovery and Measurement of Previously Invisible Low Abundance Biomarkers

Mark Sausen, Director, Research & Development, Personal Genome Diagnostics. Detection and Genotyping of Sequence and Structural Alterations in the Circulation of Cancer Patients

Nitzan Rosenfeld, Senior Group Leader, Cancer Research UK, University of Cambridge Noninvasive Cancer Genomics and Exploring Potential Clinical Applications of Circulating Tumor DNA

Phil Stephens, Chief Scientific Officer, Foundation Medicine. Assessing the Promise of Liquid Biopsy to Enable Detection of Druggable Genomic Alterations Using Targeted NGS Assays Optimized for CTCs and ctDNA

Vincent Miller, Chief Medical Officer, Foundation Medicine Comprehensive Genomic Profiling in Clinical Oncology: Overcoming the Challenges

Xandra Breakefield, Professor/Geneticist, MGH-Harvard Medical School. Extracellular RNA in Biofluids as Biomarkers of Disease

Yoshiya Oda, President, Eisai. Circulating Biomarkers for Oncology/Alzheimer’s Disease Drug Development

Confirmed Speakers Include

Abhijit Patel, Assistant Professor, Yale University School of Medicine

Anastasia Khvorova, Professor, RNA Therapeutics Institute, University of Massachusetts Medical School

Brian Dougherty, Translational Genomics Lead, AstraZeneca Oncology

Casey Maguire, Assistant Professor of Neurology, Massachusetts General Hospital/Harvard Medical School

Cesar Castro, Director – Cancer Program, Center for Systems Biology, Massachusetts General Hospital/Harvard Medical School

Cicek Gercel-Taylor, Clinical Research Director, Exosome Sciences

Daniel Irimia, Assistant Professor, Division of Surgery, Science & Bioengineering, Massachusetts General Hospital/Harvard Medical School

Daniel Jay, Professor, Tufts University

Davina Gale, Co-Founder & Head of Molecular Diagnostics, Inivata

Dolores Di Vizio, Professor, Cedars-Sinai Los Angeles

Elena Aikawa, Associate Professor of Medicine, Brigham and Women’s Hospital, Harvard Medical School

Farideh Bischoff, Executive Director, Silicon Biosystems

Hakho Lee, Assistant Professor, Massachusetts General Hospital

Héctor Peinado Selgas, Assistant Professor of Molecular Biology, Weill Medical College of Cornell University

Hugh Fan, Professor, University of Florida

Joshua Levin, Senior Scientist/Group Leader, The Broad Institute of MIT and Harvard

Katherine Richardson, Vice President, Research & Development, Transgenomic

Kelli Bramlett, Senior Manager, Research & Development, Thermo Fisher Scientific

Kendall Keuren-Jensen, Associate Professor, Translational Genomics Research Institute (TGEN)

Kenneth Kotz, Massachusetts General Hospital

Kristin Ciriello Pothier, Partner & Managing Director, Life Sciences Leader, Ernst and Young LLP

Leileata Russo, Research Professor, Massachusetts General Hospital (MGH)

Leonora Balaj, Research Fellow, Massachusetts General Hospital

Lidong Qin, Associate Professor, CPRIT Scholar, Houston Methodist Research Institute

Mark Reed, Professor of Electrical Engineering and Applied Physics, Yale University

Martin Beaulieu, Director, Regulus Therapeutics

Mike Makrigiorgos, Professor of Radiation Oncology, Dana Farber Cancer Institute/Harvard Medical School

Pavan Kumar, Senior Scientist, Eisai

Roopali Gandhi, Assistant Professor in Neurology, Head of MS Biomarkers, Brigham and Women’s Hospital/Harvard Medical School

Sandra Gaston, Director, Tufts Medical Center

Saumya Das, Assistant Professor in Medicine, Harvard Medical School

Tony Godfrey, Associate Chair – Research, Department of Surgery, Boston University Medical Center

Veronique Neumeister, Laboratory Director of Specialized Translational Services, Yale University

Weian Zhao, Assistant Professor, University of California-Irvine

Yaoyu Wang, Associate Director, Center for Cancer Computational Biology, Dana-Farber Cancer Institute

Yong Zeng, Assistant Professor, University of Kansas

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  • Oracle Industry Connect Presents Their 2015 Life Sciences and Healthcare Program

 

Reporter: Stephen J. Williams, Ph.D. and Aviva Lev-Ari, Ph.D., R.N.

oraclehealthcare

Copyright photo Oracle Inc. (TM)

 

Transforming Clinical Research and Clinical Care with Data-Driven Intelligence

March 25-26 Washington, DC

For more information click on the following LINK:

https://www.oracle.com/oracleindustryconnect/life-sciences-healthcare.html

oracle-healthcare-solutions-br-1526409

https://www.oracle.com/industries/health-sciences/index.html  

Oracle Health Sciences: Life Sciences & HealthCare — the Solutions for Big Data

Healthcare and life sciences organizations are facing unprecedented challenges to improve drug development and efficacy while driving toward more targeted and personalized drugs, devices, therapies, and care. Organizations are facing an urgent need to meet the unique demands of patients, regulators, and payers, necessitating a move toward a more patient-centric, value-driven, and personalized healthcare ecosystem.

Meeting these challenges requires redesigning clinical R&D processes, drug therapies, and care delivery through innovative software solutions, IT systems, data analysis, and bench-to-bedside knowledge. The core mission is to improve the health, well-being, and lives of people globally by:

  • Optimizing clinical research and development, speeding time to market, reducing costs, and mitigating risk
  • Accelerating efficiency by using business analytics, costing, and performance management technologies

 

  • Establishing a global infrastructure for collaborative clinical discovery and care delivery models
  • Scaling innovations with world-class, transformative technology solutions
  • Harnessing the power of big data to improve patient experience and outcomes

The Oracle Industry Connect health sciences program features 15 sessions showcasing innovation and transformation of clinical R&D, value-based healthcare, and personalized medicine.

The health sciences program is an invitation-only event for senior-level life sciences and healthcare business and IT executives.

Complete your registration and book your hotel reservation prior to February 27, 2015 in order to secure the Oracle discounted hotel rate.

Learn more about Oracle Healthcare.

General Welcome and Joint Program Agenda

Wednesday, March 25

10:30 a.m.–12:00 p.m.

Oracle Industry Connect Opening Keynote

Mark Hurd, Chief Executive Officer, Oracle

Bob Weiler, Executive Vice President, Global Business Units, Oracle

Warren Berger, Author of “A More Beautiful Question: The Power of Inquiry to Spark Breakthrough Ideas.”

12:00 p.m.–1:45 p.m.

Networking Lunch

1:45 p.m.–2:45 p.m.

Oracle Industry Connect Keynote

Bob Weiler, Executive Vice President, Global Business Units, Oracle

2:45 p.m.–3:45 p.m.

Networking Break

3:45 p.m.–5:45 p.m.

Life Sciences and Healthcare General Session

Robert Robbins, President, Chief Executive Officer, Texas Medical Center

Steve Rosenberg, Senior Vice President and General Manager Health Sciences Global Business Unit, Oracle

7:00 p.m.–10:00 p.m.

Life Sciences and Healthcare Networking Reception

National Museum of American History
14th Street and Constitution Avenue, NW
Washington DC 20001

Life Sciences Agenda

Thursday, March 26

7:00 a.m.–8:00 a.m.

Networking Breakfast

8:00 a.m.–9:15 a.m.

Digital Trials and Research Models of the Future 

Markus Christen, Senior Vice President and Head of Global Development, Proteus

Praveen Raja, Senior Director of Medical Affairs, Proteus Digital Health

Michael Stapleton, Vice President and Chief Information Officer, R&D IT, Merck

9:15 a.m.–10:30 a.m.

Driving Patient Engagement and the Internet of Things 

Howard Golub, Vice President of Clinical Research, Walgreens

Jean-Remy Behaeghel, Senior Director, Client Account Management, Product Development Solutions, Vertex Pharmaceuticals

10:30 a.m.–10:45 a.m.

Break

10:45 a.m.–12:00 p.m.

Leveraging Data and Advanced Analytics to Enable True Pharmacovigilance and Risk Management 

Leonard Reyno, Senior Vice President, Chief Medical Officer, Agensys

 

Accelerating Therapeutic Development Through New Technologies 

Andrew Rut, Chief Executive Officer, Co-Founder and Director, MyMeds&Me

12:45 a.m.–1:45 p.m.

Networking Lunch

1:45 p.m.–2:30 p.m.

Oracle Industry Connect Keynote

2:30 p.m.–2:45 p.m.

Break

2:45 p.m.–3:15 p.m.

Harnessing Big Data to Increase R&D Innovation, Efficiency, and Collaboration 

Sandy Tremps, Executive Director, Global Clinical Development IT, Merck

3:15 p.m.–3:30 p.m.

Break

3:30 p.m.–4:45 p.m.

Transforming Clinical Research from Planning to Postmarketing 

Kenneth Getz, Director of Sponsored Research Programs and Research Associate Professor, Tufts University

Jason Raines, Head, Global Data Operations, Alcon Laboratories

4:45 p.m.–6:00 p.m.

Increasing Efficiency and Pipeline Performance Through Sponsor/CRO Data Transparency and Cloud Collaboration 

Thomas Grundstrom, Vice President, ICONIK, Cross Functional IT Strategies and Innovation, ICON

Margaret Keegan, Senior Vice President, Global Head Data Sciences and Strategy, Quintiles

6:00 p.m.–9:00 p.m.

Oracle Customer Networking Event

Healthcare Agenda

Thursday, March 26

7:00 a.m.–8:15 a.m.

Networking Breakfast

8:30 a.m.–9:15 a.m.

Population Health: A Core Competency for Providers in a Post Fee-for-Service Model 

Margaret Anderson, Executive Director, FasterCures

Balaji Apparsamy, Director, Business Intellegence, Baycare

Leslie Kelly Hall, Senior Vice President, Policy, Healthwise

Peter Pronovost, Senior Vice President, Patient Safety & Quality, Johns Hopkins

Sanjay Udoshi, Healthcare Product Strategy, Oracle

9:15 a.m.–9:30 a.m.

Break

9:30 a.m.–10:15 a.m.

Population Health: A Core Competency for Providers in a Post Fee-for-Service Model (Continued)

10:15 a.m.–10:45 a.m.

Networking Break

10:45 a.m.–11:30 a.m.

Managing Cost of Care in the Era of Healthcare Reform 

Chris Bruerton, Director, Budgeting, Intermountain Healthcare

Tony Byram, Vice President Business Integration, Ascension

Kerri-Lynn Morris, Executive Director, Finance Operations and Strategic Projects, Kaiser Permanente

Kavita Patel, Managing Director, Clinical Transformation, Brookings Institute

Christine Santos, Chief of Strategic Business Analytics, Providence Health & Services

Prashanth Kini, Senior Director, Healthcare Product Strategy, Oracle

11:30 a.m.–11:45 a.m.

Break

11:45 a.m.–12:45 p.m.

Managing Cost of Care in the Era of Healthcare Reform (Continued)

12:45 p.m.–1:45 p.m.

Networking Lunch

1:45 p.m.–2:30 p.m.

Oracle Industry Connect Keynote

2:30 p.m.–2:45 p.m.

Break

2:45 p.m.–3:30 p.m.

Precision Medicine 

Annerose Berndt, Vice President, Analytics and Information, UPMC

James Buntrock, Vice Chair, Information Management and Analytics, Mayo Clinic

Dan Ford, Vice Dean for Clinical Investigation, Johns Hopkins Medicine

Jan Hazelzet, Chief Medical Information Officer, Erasmus MC

Stan Huff, Chief Medical Information Officer, Intermountain Healthcare

Vineesh Khanna, Director, Biomedical Informatics, SIDRA

Brian Wells, Vice President, Health Technology, Penn Medicine

Wanmei Ou, Senior Product Strategist, Healthcare, Oracle

3:30 p.m.–3:45 p.m.

Networking Break

3:45 p.m.–4:30 p.m.

Precision Medicine (Continued)

4:30 p.m.–4:45 p.m.

Break

6:00 p.m.–9:00 p.m.

Oracle Customer Networking Event

Additional Links to Oracle Pharma, Life Sciences and HealthCare

 
Life Sciences | Industry | Oracle <http://www.oracle.com/us/industries/life-sciences/overview/>

http://www.oracle.com/us/industries/life-sciences/overview/

 
Oracle Corporation

 
Oracle Applications for Life Sciences deliver a powerful combination of technology and preintegrated applications.

  • Clinical

<http://www.oracle.com/us/industries/life-sciences/clinical/overview/index.html>

  • Medical Devices

<http://www.oracle.com/us/industries/life-sciences/medical/overview/index.html>

  • Pharmaceuticals

<http://www.oracle.com/us/industries/life-sciences/pharmaceuticals/overview/index.html>

 
Life Sciences Solutions | Pharmaceuticals and … – Oracle <http://www.oracle.com/us/industries/life-sciences/solutions/index.html>

http://www.oracle.com  Industries  Life Sciences

 
Oracle Corporation

 
Life Sciences Pharmaceuticals and Biotechnology.

 
Oracle Life Sciences Data Hub – Overview | Oracle <http://www.oracle.com/us/products/applications/health-sciences/e-clinical/data-hub/index.html>

http://www.oracle.com  …  E-Clinical Solutions

 
Oracle Corporation

 
Oracle Life Sciences Data Hub. Better Insights, More Informed Decision-Making. Provides an integrated environment for clinical data, improving regulatory …

 
Pharmaceuticals and Biotechnology | Oracle Life Sciences <http://www.oracle.com/us/industries/life-sciences/pharmaceuticals/overview/index.html>

http://www.oracle.com/us/…/life-sciences/…/index.html

 
Oracle Corporation

 
Oracle Applications for Pharmaceuticals and Biotechnology deliver a powerful combination of technology and preintegrated applications.

 
Oracle Health Sciences – Healthcare and Life Sciences … <https://www.oracle.com/industries/health-sciences/>

https://www.oracle.com/industries/health-sciences/

 
Oracle Corporation

 
Oracle Health Sciences leverages industry-shaping technologies that optimize clinical R&D, mitigate risk, advance healthcare, and improve patient outcomes.

 
Clinical | Oracle Life Sciences | Oracle <http://www.oracle.com/us/industries/life-sciences/clinical/overview/index.html>

http://www.oracle.com  Industries  Life Sciences  Clinical

 
Oracle Corporation

 
Oracle for Clinical Applications provides an integrated remote data collection facility for site-based entry.

 
Oracle Life Sciences | Knowledge Zone | Oracle … <http://www.oracle.com/partners/en/products/industries/life-sciences/get-started/index.html>

http://www.oracle.com/partners/…/life-sciences/…/index.ht&#8230;

 
Oracle Corporation

 
This Knowledge Zone was specifically developed for partners interested in reselling or specializing in Oracle Life Sciences solutions. To become a specialized …

 
[PDF]Brochure: Oracle Health Sciences Suite of Life Sciences … <http://www.oracle.com/us/industries/life-sciences/oracle-life-sciences-solutions-br-414127.pdf>

http://www.oracle.com/…/life-sciences/oracle-life-sciences-s&#8230;

 
Oracle Corporation

 
Oracle Health Sciences Suite of. Life Sciences Solutions. Integrated Solutions for Global Clinical Trials. Oracle Health Sciences provides the world’s broadest set …

 

 

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Tweets by @pharma_BI and by @AVIVA1950 for @PMWCIntl, #PMWC15, #PMWC2015 LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA, January 26, 2015, 8:00AM to January 28, 2015, noon PST

Curators: Aviva Lev-Ari, PhD, RN and Stephen J Williams, PhD

Top / All

Regulatory & Reimbursement Frameworks for Molecular Testing, LIVE… via

2:15PM – 3:00PM, 1/26, 2015 – Impact Genomics on Cancer Care 2015 Personal… via

8:30AM–12:00PM, January 28, 2015 – Morality, Ethics & Public Law in PM, LIVE Valley…

8:30AM–12:00PM, January 28, 2015 – Morality, Ethics & Public Law in PM, LIVE Valley 2015 Personalized…

2:00PM–5:00PM, January 27, 2015 – Personalizing Evidence in the Learning Healthcare System &…

2:00PM–5:00PM, January 27, 2015 – Personalizing Evidence in the Learning Healthcare System &…

2:00PM–5:00PM, January 27, 2015 – Personalizing Evidence in the Learning Healthcare System & Biomarker Discovery…

9:15AM–2:00PM, January 27, 2015 – Regulatory & Reimbursement Frameworks for Molecular Testing,…

9:15AM–2:00PM, January 27, 2015 – Regulatory & Reimbursement Frameworks for Molecular Testing, LIVE Valley…

7:45AM–9:15AM, January 27, 2015 – Risk, Reward & Innovation, LIVE Valley 2015…

7:45AM–9:15AM, January 27, 2015 – Risk, Reward & Innovation, LIVE Valley 2015 Personalized Medicine World…

3:30PM –5:15PM, January 26, 2015 – NGS Applications: Impact of Genomics on Cancer Care…

3:30PM –5:15PM, January 26, 2015 – NGS Applications: Impact of Genomics on Cancer Care Valley 2015…

2:15PM – 3:00PM, January 26, 2015 – Impact of Genomics on Cancer Care Valley 2015…

2:15PM – 3:00PM, January 26, 2015 – Impact of Genomics on Cancer Care Valley 2015 Personalized Medicine…

1:00PM – 1:15PM, January 26, 2015 – Clinical Methodologies of NGS – LIVE Valley 2015…

1:00PM – 1:15PM, January 26, 2015 – Clinical Methodologies of NGS – LIVE Valley 2015 Personalized Medicine…

10:30AM-12PM, January 26, 2015 – NGS Applications: Impact of Genomics on Cancer Care – LIVE…

10:30AM-12PM, January 26, 2015 – NGS Applications: Impact of Genomics on Cancer Care – LIVE Valley 2015…

9AM-10AM, January 26, 2015 – Newborn & Prenatal Diagnosis – LIVE Valley 2015…

9AM-10AM, January 26, 2015 – Newborn & Prenatal Diagnosis – LIVE Valley 2015 Personalized Medicine World…

7:55AM – 9AM, January 26, 2015 – Introduction and Overview – LIVE Valley 2015…

7:55AM – 9AM, January 26, 2015 – Introduction and Overview – LIVE Valley 2015 Personalized Medicine World…

  1. @PMWC2015 Morality, Ethics & Public Law in PM, Valley 2015 P… via

  2. Personalizing Evidence in the Learning Healthcare System & Biomar… via

  3. NGS Applications: Impact of Genomics on Cancer Care – LIVE via

  4. 9:15AM–2:00PM, 1/27, 2015 – Reimbursement Molecular Testing, LIVE… via@Pharma_BI

  5. The Healthcare Buzz Continues After JP Morgan at PMWC 2015 Silicon Valley via

 

 

  1. Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA, January 26, 2015, 8:… via

    Buzz After JP Morgan at PMWC 2015 Silicon Valley via @Pharma_BI@AVIVA1950

  1. Hamburg, Snyderman to Address Timely Issues in Personalized Medicine at 2015 Personalized Medicine … via

  2. The Personalized Medicine Coalition welcomes the Administration’s focus on Personalized Medicine via


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Presentations Content for Track One @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA, January 26 to January 28, 2015

Reporter: Aviva Lev-Ari, PhD, RN

 

Event Coverage in Real Time: Aviva Lev-Ari, PhD, RN

The Event

Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA, January 26, 2015, 8:00AM to January 28, 2015, 3:30PM PST

http://pharmaceuticalintelligence.com/2015/01/08/silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca-january-26-2015-800am-to-january-28-2015-330pm-pst/

 

Prior to the Event — In the Media

The Healthcare Buzz Continues After JP Morgan at PMWC 2015 Silicon Valley

http://pharmaceuticalintelligence.com/2015/01/19/the-healthcare-buzz-continues-after-jp-morgan-at-pmwc-2015-silicon-valley/

 

Hamburg, Snyderman to Address Timely Issues in Personalized Medicine at 2015 Personalized Medicine World Conference in Silicon Valley

http://pharmaceuticalintelligence.com/2015/01/22/hamburg-snyderman-to-address-timely-issues-in-personalized-medicine-at-2015-personalized-medicine-world-conference-in-silicon-valley/

 

The Personalized Medicine Coalition welcomes the Administration’s focus on Personalized Medicine

http://pharmaceuticalintelligence.com/2015/01/21/the-personalized-medicine-coalition-welcomes-the-administrations-focus-on-personalized-medicine/

 

LIVE in REAL TIME from the Computer History Museum in Mountain View, CA

 

7:55AM – 9AM, January 26, 2015 – Introduction and Overview – LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA

http://pharmaceuticalintelligence.com/2015/01/26/755am-9am-january-26-2015-introduction-and-overview-live-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/

 

9AM-10AM, January 26, 2015 – Newborn & Prenatal Diagnosis – LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA

http://pharmaceuticalintelligence.com/2015/01/26/9am-10am-january-26-2015-newborn-prenatal-diagnosis-live-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/

 

10:30AM-12PM, January 26, 2015 – NGS Applications: Impact of Genomics on Cancer Care – LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA

http://pharmaceuticalintelligence.com/2015/01/26/1030am-12pm-january-26-2015-ngs-applications-impact-of-genomics-on-cancer-care-live-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/

 

1:00PM – 1:15PM, January 26, 2015 – Clinical Methodologies of NGS – LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View,CA

http://pharmaceuticalintelligence.com/2015/01/26/100pm-115pm-january-26-2015-clinical-methodologies-of-ngs-live-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/

 

2:15PM – 3:00PM, January 26, 2015 – Impact of Genomics on Cancer Care @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA

http://pharmaceuticalintelligence.com/2015/01/26/215pm-300pm-january-26-2015-impact-of-genomics-on-cancer-care-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/

 

3:30PM –5:15PM, January 26, 2015 – NGS Applications: Impact of Genomics on Cancer Care @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA

http://pharmaceuticalintelligence.com/2015/01/26/330pm-515pm-january-26-2015-ngs-applications-impact-of-genomics-on-cancer-care-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/

 

7:45AM–9:15AM, January 27, 2015 – Risk, Reward & Innovation, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA

http://pharmaceuticalintelligence.com/2015/01/27/745am-915am-january-27-2015-risk-reward-innovation-live-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/

 

9:15AM–2:00PM, January 27, 2015 – Regulatory & Reimbursement Frameworks for Molecular Testing, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA

http://pharmaceuticalintelligence.com/2015/01/27/915am-200pm-january-27-2015-regulatory-reimbursement-frameworks-for-molecular-testing-live-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/

 

2:00PM–5:00PM, January 27, 2015 – Personalizing Evidence in the Learning Healthcare System & Biomarker Discovery Technologies, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA

http://pharmaceuticalintelligence.com/2015/01/27/200pm-500pm-january-27-2015-personalizing-evidence-in-the-learning-healthcare-system-biomarker-discovery-technologies-live-silicon-valley-2015-personalized-medicine-world-confere/

 

8:30AM–12:00PM, January 28, 2015 – Morality, Ethics & Public Law in PM, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA

http://pharmaceuticalintelligence.com/2015/01/28/830am-1200pm-january-28-2015-morality-ethics-public-law-in-pm-live-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/

 

 

 

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Views of Content Presentations – Track One @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA, January 26 to January 28, 2015

Reporter: Aviva Lev-Ari, PhD, RN

 

Event Coverage in Real Time and Data Compilation: Aviva Lev-Ari, PhD, RN

 

#Views on 2/11/2015 Title URL
218 (1/8)023 (1/16) Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA, January 26, 2015, 8:00AM to January 28, 2015, 3:30PM PST http://pharmaceuticalintelligence.com/2015/01/08/silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca-january-26-2015-800am-to-january-28-2015-330pm-pst/
154 The Healthcare Buzz Continues After JP Morgan atPMWC 2015 Silicon Valley http://pharmaceuticalintelligence.com/2015/01/19/the-healthcare-buzz-continues-after-jp-morgan-at-pmwc-2015-silicon-valley/
034 Hamburg,Snyderman to Address Timely Issues in Personalized Medicine at 2015 Personalized Medicine World Conference in Silicon Valley http://pharmaceuticalintelligence.com/2015/01/22/hamburg-snyderman-to-address-timely-issues-in-personalized-medicine-at-2015-personalized-medicine-world-conference-in-silicon-valley/
015 7:55AM – 9AM, January 26, 2015 – Introduction and Overview – LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA http://pharmaceuticalintelligence.com/2015/01/26/755am-9am-january-26-2015-introduction-and-overview-live-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/
019 9AM-10AM, January 26, 2015 – Newborn & Prenatal Diagnosis – LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA http://pharmaceuticalintelligence.com/2015/01/26/9am-10am-january-26-2015-newborn-prenatal-diagnosis-live-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/
020 10:30AM-12PM, January 26, 2015 – NGS Applications: Impact of Genomics on Cancer Care – LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA http://pharmaceuticalintelligence.com/2015/01/26/1030am-12pm-january-26-2015-ngs-applications-impact-of-genomics-on-cancer-care-live-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/
026 1:00PM – 1:15PM, January 26, 2015 – Clinical Methodologies of NGS – LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA http://pharmaceuticalintelligence.com/2015/01/26/100pm-115pm-january-26-2015-clinical-methodologies-of-ngs-live-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/
025 2:15PM – 3:00PM, January 26, 2015 – Impact of Genomics on Cancer Care @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA http://pharmaceuticalintelligence.com/2015/01/26/215pm-300pm-january-26-2015-impact-of-genomics-on-cancer-care-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/
023 3:30PM –5:15PM, January 26, 2015 – NGS Applications: Impact of Genomics on Cancer Care @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA http://pharmaceuticalintelligence.com/2015/01/26/330pm-515pm-january-26-2015-ngs-applications-impact-of-genomics-on-cancer-care-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/
010 7:45AM–9:15AM, January 27, 2015 – Risk, Reward & Innovation, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA http://pharmaceuticalintelligence.com/2015/01/27/745am-915am-january-27-2015-risk-reward-innovation-live-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/
009 9:15AM–2:00PM, January 27, 2015 – Regulatory & Reimbursement Frameworks for Molecular Testing, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA http://pharmaceuticalintelligence.com/2015/01/27/915am-200pm-january-27-2015-regulatory-reimbursement-frameworks-for-molecular-testing-live-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/
015 2:00PM–5:00PM, January 27, 2015 – Personalizing Evidence in the Learning Healthcare System & Biomarker Discovery Technologies, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA http://pharmaceuticalintelligence.com/2015/01/27/200pm-500pm-january-27-2015-personalizing-evidence-in-the-learning-healthcare-system-biomarker-discovery-technologies-live-silicon-valley-2015-personalized-medicine-world-confere/
011 8:30AM–12:00PM, January 28, 2015 – Morality, Ethics & Public Law in PM, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA http://pharmaceuticalintelligence.com/2015/01/28/830am-1200pm-january-28-2015-morality-ethics-public-law-in-pm-live-silicon-valley-2015-personalized-medicine-world-conference-mountain-view-ca/
062 The Personalized Medicine Coalition welcomes the Administration’s focus on Personalized Medicine http://pharmaceuticalintelligence.com/2015/01/21/the-personalized-medicine-coalition-welcomes-the-administrations-focus-on-personalized-medicine/
Total Views: 664

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8:30AM–12:00PM, January 28, 2015 – LIVE – Morality, Ethics & Public Law in PM, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA

Reporter: Aviva Lev-Ari, PhD, RN

 

Real Time Conference Coverage with Social Media

@Computer History Museum by Dr. Aviva Lev-Ari, PhD, RN

8:30AM – 9:00AM         David H. Persing, Cepheid

The Digital Miasma: Detection and Monitoring of Emerging Infections in the 21st Century

LIVE FROM THE PODIUM 

  • It started with TB Test, now used in Infectious diseases based on Germ Theory
  • Cholera Epidemic – The Ghost map – Cholera was named Miasma = dehydrations – source of Cholera in SOho near sewage septic tank, household situated near the pump had the first Miasma affected victims
  • Digital Miasma – The machine that help end TB, 11/2011
  • Sputum viscose specimen – in a sealed cup for DNA analysis: requirement to de-activate the life bacteria befor open cap for DNA analysis
  • NEJM – Epert MYB/RIF – Rapid Molecular Detection of TB and Rifamin
  • GeneXpert – diagnostics kit: Sputum, stool, blood, BAL, CSF, urine swabs
  • GeneXpert System: module GX-1, GX-2, GX-4, GX-16, GeneXpert Infinity – data goes directly to Medical Record
  • Impact of Rapid Testing: Demonstration Studies: Decentralized testing: more results reported same day
  • Dedecntralized testing:- Fewer MDR TB
  • Policy Impact – WHO endorse Expert system in 2010 –
  • Today 7500 systems deploed at global locations
  • South African Miner Testing for TB
  • RemoteXpert cloud-based Dx monitoring
  • Precision medicine and infectious disease dat placed into the Cloud – actionable Policy on Human Health
  • Decentralized data architecture: HBDC Release
  • 2011 17,000 patients 2014 1Million
  • Data mining Capability by location, time, % scaling, Over time
  • Device GeoLocation
  • Impact of Testing and Technology
  • TB Prevalence and drug resistence
  • Site and staff monitoring tool
  • “Google Flu” and “Flu near you”
  • Xpert Edola – Sierra Leone
  • Ebola testing, Challenges
  • Xpert Ebola
  • Sexual health Clinic in London: Patient Notificcation
  • Next-gen technology max medical impact: closer to Patients

Personalized Medicine Patent Law Update

9:00AM –  9:30AM  – Catherine Polizzi, Morrison & Foerster (Chair)

  • Thoughts on Strategy
  • Summary: USPTO has loosened its guidelines for examination of subject matter eligibility
  • only SUBSET OF MOLECULE not monopolizing the law of correlation
  • 2014 Interim Eligibility Guidance Quick Reference Sheet
  • Does the claim recite additional elements that amount to significantly more than the judicial exception: well understood routine
  • Is natural product “markedly different” rom the naturally occuring products – structure, function, other properties
  • Sequences of molecule
  • December 2014 – Guidance post Alice, supersedes March 2014 Guidance
  • March 2014 – Guidance post Myriad and Prometheus  – direction to Laws of Nature and products of nature
  • 2010 – Interim guidance post Bilski – machine transformation is helpful…
  • USPTO Struggle to keep up
  1. Simple correlation better,
  2. Companion Diagnostics: Identify then treat – will do well
  3. Biomarkers are Methods will have hard time
  4. US vs ex-US strategy
  5. Trading eligibility for divided infringement

LIVE FROM THE PODIUM

Michael Shuster, Fenwick & West

  • Patent office and in Court on behalf of companies to recover damages of patent infringement
  • Patent eligibility Subject matter Recap: Who ever invents or discovers any new and useful process, machine, manufacture, composition of matter
  • Exceptions:
  1. abstract ideas
  2. tie up usage of subject matter
  3. Matter of Nature; Laws of Nature and products of nature
  • Unprecedented level of Supreme Court Focus on Patent Eligibility Law
  • LabCorp v. Metabolite (2006)
  • Bilski v. Kappos (2010) (unanimous)
  • Mayo v. Prometheus (2012) (unanimous)
  • Assc for Mol. Pathology v. Myriad (2013)
  • Alice Corp. v. CLS Bank (2014) (unanimous)

Jose J. Haresco, JMP Securities

  • Myriad Stock Price profile as a result of Circuit Court decision
  1.  If company plans to go Public
  2. short interest — public bet on more competition and price drops
  3. diversification a rapid pace of product introductions, and channel strength have become an important aspect of the story
  • Foundation Medicine
  1. Roche acquisition price increase
  2. NEW business model for value creation – How many test are added to the DB
  3. drive value from the data component
  4. Planning the IPO
  • BREATH AND RAPID PRODUCT LINE
  • BULL CALLS
  • BEAR CALLS
  • Platform vs. Proprietary Diagnostics
  • Short Interest vs Days to cover
  • Competition: Proprietary Diagnostics will do better than Platform
  • Public Diagnostics Compensations: Diversified, better valuations

Conclusions

  • Myriad scaleable technology
  • test volume and leverage data – bioinformatics
  • pipeline of innovation
  • Key drivers: Regulatory, scalability innovations,
  • small caps product new issued – Investors like that
  • greed to fear – Big growing markets – listen to opportunities
  • price/performance
  • Fear: No one wants to miss the opportunity to make money

9:30AM – 10AM Panel, Q&A

Jose: assumes FDA will come down  –  did not happened

Schuster:

  • origin of disease , if better understood – business convergence

Polizzi:

  • SW companies vs Life Sciences – Focus in IP will have a longer life time is an IT Component in Proprietory DIagnostics

 

 

Morality, Ethics & Public Law in PM

 

10:30AM – 10:45AM George Lundberg, CollabRx (chair)

Personal Morality, Societal Ethics, and Public Law in Personalized Medicine

LIVE FROM THE PODIUM 

  • PERSONAL MORALITY
  • SOCIETAL ETHICS
  • PUBLIC LAW

AMA – CEJA – Principles

SPJ

HI Ethics

eHealth Code of Ethics – May 2000: Candor quality

  • N of One = Me
  • Shift from Paternalism: Dr. Know it alll Dr. Information Dr. Interpretation Collaboration
  • Need for new codes of ethics: PM, telemedicine, Medical Mobile Apps, Social Media, Lab tests, Right to Try
  • Self governance – Essence of Professionalism

10:45AM – 11:00AM Jodi Halpern, UC Berkeley

Innovative Ethical Approaches to Personalized Medicine

LIVE FROM THE PODIUM 

  • Distributive Justice in Personalized Medicine
  • Efficiency: Prevention, Care and Cure
  • Increasing Health Disparities
  • Health Innovators have societal responsibilities
  • Oragon: Rationing of healthcare to MedicAID Patients – Negative implications to society
  • Fair chance of dissent life
  • Impartiality,
  • Highest Priority is for Children, Chronomically ill — they have a less than — Fair chance of dissent life
  • Condition if RARE, does not means not to offer fair share
  • Promotion of Personalized medicine
  • Empathy Expert

11:00AM – 11:15AM Patrick McCormick, AMA

Patients, Physicians & Personalized Medicine: Ethical Implications of New Clinical Possibilities

LIVE FROM THE PODIUM

  • CEJA & Code of Ethics
  • AMA: Health care informed by clinical, genetic and environmental
  • new context:
  1. Consent: Informed and Voluntary,
  2. Confidentiality – Privacy
  3. Access to care – minimize health care disparities – Genomics has benefits – all need to have access to
  4. Stewardship: MD equilibrium – regulatory, stackholders
  5. DTC Genetic Testing: Interaction outside the MD -Patient relations – Data is externally proceed
  6. Patenting: Genetic research – better medical treatment and technologies
  7. Granting patent protection should not hinder this goal
  • Vaccination: an example: HPV adolescence vaccination, or of RNs and Allied Health Care Professionals
  • Accountability, Medical Codes, Licensing,

11:15AM – 11:30AM Hank Greely, Stanford University

The Biggest Problem with Personalized Medicine

LIVE FROM THE PODIUM

  • PM will lead to relief of human suffering

The Problem in PM

  • More said than done, the bliss is minimal,
  • disconnection between the hype and the results
  • Genetically, Genomically, Omically
  • Genomic Level: Payoff five years away in the last 20 years
  • Pharmacogenomics for Anticaugulation –  No difference if Genomics is involved
  • FoundationMedicine – we do not know the payoff
  • Making difference in People life: Inersia,
  • Payors need to be conveinced that it is for real
  • Communication with Patients – through Videos
  • Healthcare outcomes, better research is needed – not to compromise Privacy

 

Leveraging Cloud Technology to Optimize PM

 

11:30AM – 11:45AM Pravene Nath, Stanford Health Care

Cloud Technologies for the Delivery System: Opportunities and Challenges

LIVE FROM THE PODIUM

  • Personalized experience of the Patient leads to satisfaction, loyalty, lifelong relations
  • Customers: MDs, RNs, employees of the Hospital
  • Internal Customer loyalty
  • External Customers: PORTAL for the entire continuum: Patients, families,
  • Online engagement with using the Portal: Favorable results – system integrators: Amazon Web Services, box, Epic, Abode, LIVEPERSON
  • SW Design of the Portal: Mobile apps Integration of Patient life wiht Stanford HealthCare
  • ClickWell Care – Complete Primary Care Online: Personalized care
  • Test bed: +1Million Patients a year
  • Partnering success
  • Vision of the Future

 

11:45AM – 12:00PM Kathryn Lee Blair, Seven Bridge Genomics

The Cancer Pan-Genome in the Cloud

LIVE FROM THE FLOOR

  • SW to improve the sequencing process
  • cancer Genomics Cloud – @genomicscloud, sbgenomics.com/cancer-genomics-cloud
  • # patients # Significant genes with tumor types – Frequency of genes: In Nature, Broad Institute
  • Sequencers vs Data in TB: 2017: 6,000 Sequencers
  • Graph Genomes – 97% of variance in DB
  • Reference Sequence, Variant Sequence – divergence Kurai (Submitted)
  • Current Model: TCGA – stored in one location, copy to your local and sequence in your private environment
  • Three cancer genomics cloud pilots at Broad, System Biology Institute and at Seven Bridge Genomics
  • TCGA: interoperability
  • # of insertions total Known: Linear, Graph
  • Cancer at the cellular level: Personal Reference – Tumor A, Primary, Tumor A and B
  • SUnding MCI, Genomics Institute

 

 

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2:00PM–5:00PM, January 27, 2015 – Personalizing Evidence in the Learning Healthcare System & Biomarker Discovery Technologies, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA

Reporter: Aviva Lev-Ari, PhD, RN

 

Real Time Conference Coverage with Social Media

@Computer History Museum by Dr. Aviva Lev-Ari, PhD, RN

 

Personalizing Evidence in the Learning Healthcare System

 

2:00PM – 3:00PM  Panel: Personalizing Evidence Nigam Shah, Stanford (Chair)

 

Malay Gandhi, Rock Health

  • Training data aggregation
  • relationship search
  • case data collection
  • individual case characterization
  • Recommendation contextualization
  • performance capture

Predictive Analytics in Healthcare

$1.7 Billion investment inAnalytics in HealthCare

  • Providers is the focus of the Analytics not the Patients
  • Clinical 71% type of data included in Predictive Analytics

Chris Longhurst, Stanford

  • Can Big Data tell
  • Practice based Medicine vs Evidence based Medicine – Learn from patients not unde one’s care.
  • Achieving a NationwideLearning Health System
  • every child with Cancer was placed on a trial — only 50% of adult, though

Lawrence “Rusty” Hofmann, Grand Rounds

  • Two-Tier Health System for Patients – Medical insiders
  • Patient Portal – Delightful experience for MDs and Patients
  • Dig data in use of Patients
  • 65% of the time – Diagnosis change after consultation with GroundRounds DB of Experts

 

Applying Complementary Technologies Towards Biomarker Discovery

3:30PM – 3:45PM Bonnie Anderson, Veracyte (Chair)

LIVE FROM THE PODIUM

Giulia C. Kennedy, Veracyte

Using Multiple Sources Of High-Dimensional Genomic Data to Build Diagnostic Algorithms

  •  Thyroid Nodule Before Afirma – 60%-75%  are benign: Surgery, aspiration for cytology, Molecular testing
  • Afirma Test: 50% of surgeries were unnecessary surgery – cost is minimized
  • BRAF testing misses 60% of the Cancers
  • Add NGS Panel: Coin toss — 50% specificity and 50% sensitivity
  • Biology and data need be matched

3:45PM – 4:00PM

Murali Prahalad, Epic Sciences –  Series C Funding

CTCs Come of Age as Biomarkers

  • Profile rare cells in cancer
  • Cancer metastasized via tumor cells in the blood
  • separation of normal from cancer cells
  • CTC identification: Small CTC and Apoototic cells, CK -CTC, speckled, macro nucleoli CTC
  • Comperative of: cfDNA/ctDNA;
  • Genomics enabled clonal drift traceablility
  • Range of analyses
  • CTC give information on cancer’s current state: Biopsy; bone metastatic; blood sample
  • Cell types; ctc numbers
  • CTC Heterogeniety
  • epic confirms MOA & PD, predicts drug response
  • epic technology identified
  • Sample insights we’re generating to guide clinical decisions
  • Heterogeneity of android
  • Predicting de vono resistence to AR Tx utilizing phenotypical
  • Biomarker predicts AR Tx failures but not taxane failure
  • CTC Phynotype
  • Adding Genomics datafor Drug Targeting via pathways
  • Epic’s cision od combo therapy from diagnostics to extended life

 

4:00Pm – 4:15PM John Sninsky, CareDx

New Era In Post-Transplant Surveillance: Insights From Gene Expression & Cell Free DNA

  • Clinical diagnostics for immuno-suppresive life long therapy
  • Patient care Post-Transplantation is challenging
  • Transplantation Outcomes Vary Over Time – no improvement over decades
  • Unmet clinical needs – Transplantation of Lung, Heart, Liver, Kidney
  • AlloMap Surveillance Solutions
  • indicated for heart transplant reciepients: 55 days after transplant age 12 and higher
  • Validation of studies in place – minimally acceptable performance criteria to be met
  • AlloMAp Regulatory Pathways: CLIA and FDA
  • Predictors of Outcomevevents: age transplant
  • Utility of cf-DNA in Transplantation – Prospective study about rejection
  • Statistical metrics for Risk prediction
  • NGS of cfDNA represents a Universal Assay

 

 

4:15PM – 4:30PM Shawn M. Marcell, Metamark Genetics

A New Age of Proteomic Biomarker Discovery

  • Agenda
  • Clinical Proteomics
  • Clinical Applications
  • Beyond Prognosis
  •  Actionable Disease outocmes: BRCA1/2
  • Accelerated drug approval: Zelboraf ~50% melanoma
  • Tissue architecture and cellular resolution is utilizing by analyzing protein biomarkers in situ
  • Platform for research and clinical applications
  • Prostate Cancer is over treated
  • ProMark integrates molecular and morphological information and classifiers – Five Clinical Trials
  • De Novo Performance-based Biomarker Selection Approach
  • Biomarker Selection too overcome Biopsy
  • Biomarket predictors both aggressiveness and bioinformatics analysis
  • Optimal Clinical Nomogram
  • ProMark is actionable on 80% of the population
  • 7-10 days from specimen reciept to result to patient
  • Course of action; Patient responder selection (Co
  • Disrupt Disease-causing pathway by Companion Diagnostics)

4:30PM –5:00PM Panel Q&A

Last comment by Dr. Kennedy: Cost effectiveness to improve the test used in disease detection

 

 

 

 

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#PMWC15

#PMWC2015

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#Cancer Therapy

#science  #innovation @BloombergTV

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