LIVE eProceedings Day One – The 14th Annual Personalized Medicine Conference: PREPARING FOR THE NEW POSSIBLE,
November 14, 2018, HMS, Boston
Real Time Press Coverage: Aviva Lev-Ari, PhD, RN
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@pharma_BI
@AVIVA1950
PART I
The Infrastructure for Innovation

“We need to make the transition to a predict, prevent and protect health system.”
Senior Vice President, Global Value, Access and Policy, Amgen
Keynote Speakers
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Joseph B. Martin Conference Center at Harvard Medical School
77 Avenue Louis Pasteur, Boston, MA 02115
SPEAKER | Edward Abrahams, Ph.D., President, Personalized Medicine Coalition
- Evidence-based to interact with providers
- Future of Health care: Infrastructure of innovations, technologies and business aspects for efficient Health care delivery
- Strategies to stimulate Personalized Medicicne
- DIagnostics regulations for patient protection
- cost of drugs, therapy costs 7 figures
- clinical trial design
- Prevention of illness
- clinical and economic utilities of genome sequences
- moving health care to a better future
- Advisory committee contributed vastly in topic selection for the agenda for the two days conference
- Sponsores Intermountain Genomics
SPEAKER | Elizabeth Nabel, M.D., President, Brigham and Women’s Hospital
Government executives have an enormous influence over the direction of health systems and can therefore play a role in developing personalized medicine — but they need to know what works and what doesn’t if their respective efforts to promote personalized medicine are going to succeed. With that in mind, government representatives from around the globe will discuss the competitive advantages various countries have in personalized medicine and explore the common challenges and notable achievements of government initiatives to advance the field during this panel discussion.
MODERATOR | Antonio L. Andreu, M.D., Ph.D., Scientific Director, EATRIS European Infrastructure for Translational Medicine, Amsterdam
- General Medicine: Metabolomics, biological systems vs GENOMICS
- Medical care – due to genomic testing, MDs will call to tell patients bad news
Ora Dar, Ph.D., Senior Expert, Medical Sciences, consultant to the Israel Innovation Authority
- $300Miliion R&D sponsored clinical data on genomics, MDs are trained to place genomics data on EMR, epidemiology, sequencing of genetic diseases
- Genetic testing early implementation in Israel due to marriage of 3rd degree of kin,
- Private insurance vs Public Insurance for genomic testing, Healthcare Basket coverage of genomics is not complete
- 2nd largest HMO collect data from Patients arriving to their Annual Exam will be genomically sequenced = Healthy and ill Patients – data gathered
Tom Fowler, Ph.D., Deputy Chief Scientist, Genomics England
- Building infrastructure, education, future, National approach to genomic testing, built in a National lab, scaling research
- three areas: Technical Operations, samples from Urban Hospitals to rural areas, population Health and Population system, Patients need to be brought about, do they want genomic testing?
- rapid change in knowledge been flexible for genomic testing
- Fooled not to come on board for Genomics in Medicine
- Stories of patients that had success with Genomic-based therapy
Marc LePage, President, CEO, Genome Canada
- Social impact, adoption systems for focusing on rare diseases, following UK and US trends, 10 sites in Canada, aggregate the date at the National level, extract clinical data securely implementation and expertise needs transfer for having it in each hospital
- better health care at a lower cost can be achieved if genomics will become part of the equation – Open science
- Optimism and hope
Liisa-Maria Voipio-Pulkki, M.D., Ph.D., Director General, Chief Medical Officer, Ministry of Social Affairs and Health, Finland
- Public sector is the majority of Health care systems, Expertise is as high as can be, entrepreneurship is on the rise in search for opportunities
- Brought to Parliament decision on funding a Center for Genomics Research as an independent institute for experimental therapies
- Barrier in Health Care system National Screening and communication with other parts of the Health Care system
- TRUST: validation of algorithms, insurance disclosure, ethics of AI,
- Train new generation of CLinical Trial
- Evaluation of Health care systems – new methods are needed for that task
- pharmacogenomics – recommended for the Health system, ICU cost is very high will not change due to evidence from a genomic test which is preventative in nature
Light refreshments provided.
MODERATOR | Susan McClure, Founder, Publisher, Genome magazine; Board Member, Personalized Medicine Coalition
Emily Kramer-Golinkoff, Co-Founder, Emily’s Entourage, cystic fibrosis patient
- Better advocate for a Patient is the Patient him/herself
Bryce Olson, Global Marketing Director, Health and Life Sciences Group, Intel Corporation; stage IV prostate cancer patient
- Patient engage in their care, involvement in interpretation og ONES OWN Genome sequence is ate most engaging
Artificial intelligence may help inform personalized medicine in the future by perceiving which genes, proteins and other biological characteristics contribute to human disease. During this session, a diverse panel will discuss how artificial intelligence may accelerate drug development, improve clinical decision support and drive patient outcomes — and what that might mean for the future of health care.
MODERATOR | Colin Hill, Chairman, CEO, Co-Founder, GNS Healthcare
- Data, right data
- Investment is it in data acquisition or in AI
- AI is not taking over, data is critical
- Predictionds for 2025
Tom Miller, Managing Partner, GreyBird Ventures LLC
- algorithms are behind the firewall of the Hospital, for privacy. the patient’s identity is not of central point, privacy is the key
- Meta ontologies – not ready yet
- Validation of AI algorithms
- India shortage of Radiologists
- China is a huge market – AI will do functions of MDs
- Oncology will lead the way in innovations
Gregg Talbert, Ph.D., Global Head of Digital and Personalized Health Care Partnering, Roche
- AI applied to capture unusual movement allowing to detect a forthcoming neurological event.
- Data is enough to get started on mutations
- Data falls short on Patient follow up (longitudinal data on Patients) curation of EMR IS NOT AN EASY OR AUTOMATED PROCESS, IMAGING SPACE: CURATION OF IMAGES is quite a problem,
- lack of productivity in the Healthcare system: records on transfer of patient to hospitals
- Clinical Trial data for drug approval, also for future use of the analyzed data
- In developing markets – solutions needs to be not a replication of the Western World medicine
- Prediction: Data problem will be resolved in some areas, drugs developed by synthethic biologytaget to diseases drugs developed by AI
- Patients will drive processes in Healthcare
- Roche participates in data sharing and transfer protocols
Darrell M. West, Ph.D., Vice President of Governance Studies and Director of Center for Technology Innovation, Douglas Dillon Chair in Governance Studies, The Brookings Institution
- Interest in AI and in particular: Health care large part of the economy Technologies:
- Radiology: SW used in detection of disease
- Personalized Medicine and AI
- Data mining of Text using AI
- Vital signs monitoring – providers can spot Arrhythmias earlier
- Data centers have rich data , data analysis is important in Financial institutions for upselling instruments. In healthcare there is room as well
- Future of Work book authored by Dr. West – augmentation of skills not replacement of
- NY, Cold Spring: Local vs National, local progressive regulation is worrisome, pattern will migrate from NY to MA, to CA, OR, WA.
- Mobile technology in Africa is advance: Global money, smart phones
- 2015: AI will transform other technologies: Communications, smart phones,
SPEAKER | David King, J.D., Chairman, CEO, LabCorp
- Clinical outcomes at reduced cost
- PM – field with success
- challenges faced by PM
- BRCA gene at Breast Cancer patient – drug approved by FDA for this cases only
- Genetic conseling assist physicians
- What is diagnostics: NOT ONLY a test,
- NGS is part of diagnostics strategy – enormous potential vs biopsy
- Genetic testing improve outcomes
- Insurance covers BRCA I AND BRCAII – ONLY
- COVERAGE OF GENETIC TESTING : RANDOMIZED, CONTROLLED TRIALS, published in peer reviewed literature and the test will prolong life – Test do not prolong life, therefore, the test does not improve outcomes – drugs do !!!
- PM individualized treatment for a specific disease
- drug improve outcomes
- Validity od data is fundamental, credibility of testing
- Right drug to right patient
- Migraine drug to be used
- Non respondent – further researched
- MDs understanding, confidence of results
- PM Promise: close education GAP,
- convene on VALUE for individual cases not populations
- assess value among initiatives
- PM – beyond Oncology
- Regulation of diagnostics
The U.S. Food and Drug Administration and the U.S. Centers for Medicare and Medicaid Services have been working for over a decade to develop regulatory and reimbursement pathways that promote the development of innovative diagnostic tests. Many observers, however, believe the current regulatory and reimbursement landscape still limits the field. This panel of business leaders will discuss the extent to which the existing frameworks and proposed policies may help or hinder personalized medicine.
MODERATOR | Joseph V. Ferrara, CEO, Boston Healthcare Associates
- Regulatory action for reimbursement of test
- new categories of tests: new payment if Innovation, PLA codes, 45 months approval, CPT codes
3. Michael Doherty, Senior Vice President, Head of Product Development, Head of Research & Development, Foundation Medicine – ex Genentech/Roche
- Operate in regulated environment, how to establish a company for long term
- companion diagnostics
- payment collection is the burden of the company
- challenge for future products, investment process changes
Julie Khani, President, American Clinical Laboratory Association
- FDA will establish a center for Diagnostics, proposal for pre-certification like in Medical devices
- congress is involved in the decision making
- Labs are prohibited from providing the data
2. Kimberly Popovits, Chairman of the Board, CEO, President, Genomic Health – Oncology, Breast cancer molecular diagnostics
- Genomic testing saved the Health care System billions of dollars
- Genomic testing will not be placebo, 12 years study controlled arms
- proprietary test vs. test offered by all labs — different markets
- Utility agreed upon like “MedicalDevicesInnovation.org”
- demonstrate a pathway of product development that was already followed
4. Mark P. Stevenson, Executive Vice President, Chief Operating Officer, Thermo Fisher Scientific
Light refreshments provided.
Sponsored By
The U.S. Food and Drug Administration (FDA) remains firmly committed to regulatory strategies designed to advance personalized medicine. During this wide-ranging fireside chat, two senior leaders from government and industry will discuss the agency’s latest actions impacting the oversight of personalized medicine products and services. The discussion will cover topics including but not limited to next-generation sequencing, diagnostic test regulation, digital health, and real-world evidence.
MODERATOR | Cynthia A. Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition
Jess Berlin, Sc.D., Vice President and Global Head of epidemiology, J&J
- Proposal for protocol, comments from FDA several cycles – makes science better
- data source caused variability in results – challenge, primarily if one data source
- City patient involvement – Patient preference study
- Patient advocacy teach approach – ProjectLead teaching advocacy methods
- Devices: ecosystem test feasibility NIST,
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- breath and depth of data vs completeness (change in employer, data disappears)
- consent patient to access EMR – Patient access to own data
Lauren Silvis, J.D., Chief of Staff, Immediate Office of the Commissioner, FDA
- FDA listen to stack holders in the diagnostics from the medical community for regulation development
- Pre-market review for test review
- Pre-certification
- Product reviews in 2019
- Digital Health – FDA develops
- Diagnostics – development with the industry participants
Advancing a medical paradigm that focuses on the unique characteristics of each patient will require, by definition, that patients from diverse backgrounds participate in the medical studies that advance our understanding of disease. Also critical is the need to ensure that those patients have access to personalized care informed by those studies. During this session, four panelists will discuss the effort to ensure that all patient populations benefit equally from personalized medicine.
MODERATOR | Donna R. Cryer, J.D., President, CEO, Global Liver Institute
- diversity of the Genome initiative for inclusion and generalizability
Vence L. Bonham, Jr., J.D., Senior Advisor, Director on Genomics and Health Disparities, U.S. National Human Genome Research Institute
- Genomics data is of European dissents no diversity
- minority populations not represented
- sland populations not represented
- hispanics not represented proportionally to their share in the population
Alex J. Carlisle, Ph.D., Chairman, CEO, National Alliance Against Disparities in Patient Health
- PM with focus on disparities, racial biologic, socio ecological
- Patient centered – raise health education
- Translation for interpretation Physicians and Patients
- Cancer as a disorde,
Adolph P. Falcón, Executive Vice President, National Alliance for Hispanic Health
- community based organization 50 million
- improving healthcare access
- improve inclusion in science, no advancement in 45 years
- Hard to reach through – academic language of research protocols is not understood by patients
- common language, inclusion, diffusion to the field of the models that were developed to work
- PROTOCOL TO BE IN ENGLISH AND IN SPANISH
- OPERATES IN 24 CITIES
- Funding needed to find which clinical trials support inclusion “data not available”
- Community work must be married with Health initiatives
Edward Tepporn, Executive Vice President, Asian & Pacific Islander American Health Forum
- since 1985 minorities education
- all surveys conducted in English, Asian American
- access to affordable health care
- services to accommodate services for communities of Asian American
- encourage NIH to conduct studies on Asian American
SPEAKER | Amy Abernethy, M.D., Ph.D., Chief Medical Officer, Chief Scientific Officer, Senior Vice President, Oncology, Flatiron Health
- Science is better than ever
- Technologies: AI, Countries with platforms
- Regulatory framework, reproducibility of results
- Taking care of people, standardization of data analysis
- Inclusion, populations that historically were excluded
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