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
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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.
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
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
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:
- predictive biomarkers – toxicity
- diagnostics
- predictive – responsive to specific treatment
- 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
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1:00 PM | 1:00 p.m. Keynote Speaker
Robert Califf, M.D.
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#personalizedmedicine
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1:30 PM | Panel Discussion: Precision Medicine in Community Healthcare Settings
Barbara McAneny, M.D. Lynn Dressler, Dr. P.H. David Ledbetter, Ph.D. John Niederhuber, M.D. |
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#health #disease #populationgenetics #PopulationHealth
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2:30 PM | Mini-Keynote: Role of Biomarker Qualification in Personalized Medicine
Anna Barker, Ph.D.
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#health #disease #biomarker #PopulationHealth
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@ASU (for Anna Barker)
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