MONDAY AUGUST 21ST, 2017
7:30 – 9:00am
Registration for Workshops – Indigo Ballroom
9:00 – 12:00noon
Cancer Evolution and Precision Oncology – Li Liu, M.D., Assistant Professor of Biomedical Informatics and Director of the Bioinformatics Core Facility, Arizona State University
Cancer, as an evolutionary process, is born with a heterogeneous and dynamic nature. Precision identification and intervention of cancer shall consider the past, present and future of each tumor. With NextGen sequencing technologies, we can now catch a glimpse of this evolutionary process. However, is it possible to use these static snapshots to help hit the moving target? How close or how far are we to apply it in clinical practice? In this interactive workshop, we will:
Introduce the basic concepts of molecular evolution and cancer subclones
Examine the relationship of host, tumor and intervention as key players in an ecological system
Decipher the evolutionary process of a drug-resistant tumor sample with NextGen sequencing data and computational modeling
Discuss the promises and challenges of cancer evolution in precision oncology
9:00 – 12:00noon
Precision Medicine 101 – Genomic Literacy – Jeanette McCarthy, Ph.D. – Founder Precision Medicine Advisors
Genomic literacy is essential for all members of the health care ecosystem, not just health care providers, but those involved in regulatory, legal, financial and technical aspects of precision medicine as well. Whether you are new to or already working in the field of precision medicine, this interactive workshop will strengthen your foundational understanding of the field. This workshop will cover
Human genomics (DNA, genes and genetic variation)
Genomics, heredity and disease (the link between genetic variation and disease)
Genomics in medical practice (current clinical applications of genetic testing)
Risks, regulation and ethics of genetic testing
12:00 – 1:00pm
1:00 – 4:00pm
Integration of Pharmacogenomics in Patient-Centered Healthcare – Adrijana Kekic, PharmD, BCACP, CTLC. – Program Director Outpatient Pharmacy Education, Mayo Clinic
This workshop is intended for clinicians, researchers, and payers interested in results of implementation of pharmacogenomics in patient-centered model of care.
The workshop is focused on sharing examples of lessons learned from the clinic. Areas of practice covered will include cardiology, psychology, transplant, anesthesia and palliative care. The intent of this workshop is to provide an interactive forum for discussion on the role and integration of PGx at bedside, with specific emphasis on chronic disease management, polypharmacy, therapy selection and pre-emptive prescribing. Goals of the Workshop
- Discuss the impact of PGx in patient centered model of care.
- Increase enthusiasm for implanting PGx testing in the clinic.
- Encourage collaborations in PGx discoveries and clinical implementations.
1:00 – 4:00pm
Establishing the Evidence Base and Quality Standards in Next Generation Sequencing – Paul Langley, Ph.D., Adjunct Professor, College of Pharmacy, University of Minnesota, Director, Maimon Research LLC
The goal of this workshop is to detail the required framework for establishing the evidence base and quality reporting standards in next generation sequencing (NGS). Accepting NGS as an integral part of patient management in physician practice will only succeed if it can be demonstrated through real time systematic observations that claims made for improved outcomes and lower costs in target patient populations can be validated and reported to the physician and NGS assay vendor in a meaningful time frame. Reporting the results of an NGS assay with suggestions for potential therapy matching to gene expression is only a first step. An assay vendor needs to work with the practice to ensure improved patient care. Participants in the workshop will:
Consider the minimum evidence standards required to support adoption of NGS interventions
Consider the information framework required to support feedback in NGS interventions
Consider options for quality incentive programs to support adoption of NGS interventions as part of physician practice under the Medicare Access and CHIP Reauthorization Act
Consider complementary data elements capturing co-morbidities and adverse events to support NGS interventions in target populations
3:00 – 6:00pm
PMLS 2017 Registration Open – Indigo West Foyer
5:30 – 8:30pm
Opening Reception – Indigo Terrace
TUESDAY AUGUST 22ND, 2017
Keynote: The Complex Strategic Landscape for Precision Medicine: Cost, Convergence, Culture, Computing and Creative Destruction
George Poste, DVM, Ph.D., FRS, Professor of Health Innovation and Chief Scientist, Complex Adaptive Systems Initiative, Arizona State University
Healthcare is entering an era of conflicting opportunities and constraints. The pace of discovery in biomedical research is accelerating with the promise of unprecedented opportunities to improve health. The demographics of an aging society will dramatically increase the prevalence of high cost diseases such as cancer and neurodegeneration and reveal the growing imbalance between infinite demand for care versus finite resources and the economic unsustainability of the current $3 trillion healthcare ecosystem. The best opportunity to balance these conflicting forces lies in the evolution of precision medicine which seeks to understand how genetics, environment, lifestyle and behavior affect individual disease risk. These insights will shift care from the current wasteful, inefficient ‘one-size-fits-all’ approach to disease treatment and prevention to more proactive approaches in which care is increasingly customized to the risk profile of an individual. Making precision medicine a reality will depend on convergence of technologies for profiling disease at the molecular level with the use of sensors, mobile devices and social media to monitor health status in real-time both in and outside of healthcare facilities. Integration of these diverse technologies will redraw the boundaries of traditional medicine and engage new participants from the telecommunications, electronics, logistics, consumer services and social media sectors. These trends will generate data of unprecedented scale and complexity. Precision medicine and data-intensive medicine are inextricably linked. The healthcare ecosystem culturally is ill-prepared for this data deluge. Implementation will impose disruptive changes in clinical practice, the design of new organizational models for health services and an increased emphasis on data analytics, machine learning and computerized decision support tools in clinical decisions. Despite the appeal of these technology-centric trajectories, demonstration of their economic value in reducing the cost of care will be the critical determinant in the speed at which precision medicine becomes routine practice.
Aiming High for Precision Medicine – A World Without Disease
Moderator: Brad Perkins, Chief Medical Officer, Human Longevity, MD, MBA
Panelists: Werner Verbiest, Global Head – Janssen Diagnostics, Thomas Bock, MD, MBA, Chairman & CEO HeritX, Marian Rewers, MD, PhD, Executive Director, Barbara Davis Center for Childhood Diabetes University of Colorado School of Medicine, David S. Karow, Ph.D., MD, Chief Medical Imaging Officer, Human Longevity, Inc.
Precision medicine’s greatest value may derive from shifting our unprecedented tools and technologies from the back end of diseases (treating diseases and their systems) to their front end: pre-disease interception and disease prevention. Leaders from academia, industry and philanthropy describe how this vision is already being implemented in cancer, diabetes and others fields affecting billions of people around the world. The panel will discuss opportunities, hurdles to overcome, and collaborative efforts across traditional boundaries to make reality that people can stay healthy and lead productive lives.
Tissue is Still the Issue – A Paradigm Shift in Biopsy Philosophy
Moderator: Mary E. Edgerton, M.D., Associate Professor, Department of Pathology,The University of Texas MD Anderson Cancer Center
Panelists: Mark Boguski, MD, Chief Medical Officer – Inspirata, Michael Misialek, MD Associate Chair, Pathology, Newton-Wellesley Hospital, Eric Glassy, MD, FCAP, Director of Pathology, Providence Little Company of Mary Medical Center.Wayne William Grody, MD, PhD, Director of the Diagnostic Molecular Pathology Laboratory, UCLA Medical Center
Precision diagnosis is an often underappreciated, but absolutely critical, component of precision medicine. Despite the promise of “liquid biopsy” technologies for monitoring response to therapy and detecting recurrence of cancers, primary diagnosis will still require a biopsy of tissue. The future of precision oncology will require both quantitative, computational image analysis of tissue specimens (“digital pathology”) in conjunction with various types of molecular subtyping. Indeed, digital pathology of traditional tissue specimens may prove to have a better cost/benefit ratio than some types of molecular tests and also a greatly accelerated turn-around time. Examples of companion diagnostics, both image-based and molecular, for “tissue agnostic” immune checkpoint inhibitors will be discussed.
The Information Integration Revolution – Leveraging Diversification and Big Data for Precision Medicine Initiatives
Moderator: Alan Sachs MD, Ph.D., Chief Scientific Officer – Thermo Fisher Scientific
Panelists: Thomas P. Conrads, Ph.D., Associate Director of Scientific Technologies, Inova Schar Cancer Institute, Todd Hembrough, Ph.D., President of Proteomics, NantOmics, Jerry S. H. Lee, Ph. D., Deputy Director, Center for Strategic Scientific Initiatives, National Cancer Institute, National Institutes of Health, Patrick Lilley, M. B. A., Founder and CEO, Emerald Logic, Kaylene Simpson, Ph.D., Head, Victorian Centre for Functional Genomics, Peter MacCallum Cancer Centre
Precision Medicine has the opportunity to capitalize on a unique and historic convergence of need, knowledge, technology, and support to improve the health of individuals and populations for years to come. Health care economics demand that we present patients with optimal treatment strategies first. This is a complex undertaking that requires well-timed and strategic collaborations between the clinical community, academia, biopharma, industry, and patients, an initiative that will need to leverage a robust infrastructure supported by the diversity of technology solutions.
In order to bring precision medicine to scale in a cost efficient and timely manner, we need to understand the full molecular profile of an individual, through a multidisciplinary approach, while managing the vast amount of data in a secure and collaborative environment. Standardization of workflows will accelerate efficiency & sensitivity of screening, diagnosis, treatment and monitoring of disease, and ultimately provide reproducibility of results, all of which should enable precision medicine applications to be scalable and actionable. In this session we have an exceptional breadth of experts that will debate the main challenges and opportunities driven by the multi-omic integration of information, and will focus on the principles based on which we need to build an efficient PMI infrastructure and to better converge the efforts and information generated within the PMI community.
Biomarker “Purgatory”: Why so many Biomarkers “Discovered” but So Few Successes?
Moderator: Anna Barker, Ph.D., Co-Director, Complex Adaptive Systems Initiative – Arizona State University
Panelists: Razelle Kurzrock, MD, Director, Center for Personalized Cancer Therapy, San Diego Moores Cancer Center – UCSD, Hartmuth Kolb, Ph.D., Head of Neuroscience Biomarkers, Johnson and Johnson, Robert Loberg, Ph.D., Director, Head of Clinical Biomarkers & Diagnostics – Amgen, David Spetzler, MS, Ph.D., MBA, President and Chief Scientific Officer – Caris Life Sciences
Biomarkers represent what is arguably one of the largest area of scientific inquiry, and associated publication “tsunami,” in the history of biomedicine. Touted as the foundation for “precision medicine,” biomarkers represent an unparalleled “value proposition,” as they are central to transitioning from a 20th century “one size fits all” approach to healthcare to a 21st century molecularly based model. Based on individual patient molecular (and other) biomarkers, such a model would connect research to patient care in a seamless process. Motivated by this vision, and some early biomarker successes in cardiovascular disease and cancer, it seemed that the discovery and development of successful biomarkers for all complex diseases might indeed be straightforward. However, achieving that vision has proven elusive. Although literally thousands of biomarkers have been reported as “discovered,” in the case of protein biomarkers, FDA has approved less than one per year since the early nineties. Moreover, the discovery and development of molecularly based therapies and diagnostics is significantly impacted by this lack of validated biomarkers – especially the ability to project potential success of new agents in late stage clinical trials in oncology and other complex diseases.
In the last few years, advanced technologies such as whole genome sequencing (WGS), nanotechnology, and imaging are producing unprecedented (and already unmanageable) multi-dimensional molecular and clinical data sets. Although these “molecular profile”-focused, data sets offer new opportunities for biomarker discovery, overall the functional role of most of these molecular alterations remain unknown. In addition to the profound scientific questions facing the biomarker field, there are real world problems ranging from a lack of biospecimen quality standards in biomarker discovery to poor data quality and the relevance of the original clinical question to clinical care. Although the FDA is currently attempting to address some of these problems through its biomarker qualification program, the development of evidentiary standards and pathways for biomarker discovery and development will fall mainly to the affected communities. This session will focus on the state of the biomarker field: are we indeed in biomarker “purgatory,” and if so, can the purposeful convergence of scientific knowledge and multi-sector collaboration create the end-to-end solutions needed to achieve promised patient benefit?
How Do We Implement Precision Medicine in the Real World?
Moderator: Gary Siuzdak, Ph.D., Professor and Director of the Scripps Center for Metabolomics – The Scripps Research Institute
Panelists: Dr. John Rudan, Professor and Head of Department of Surgery, Britton Smith Chair in Surgery– Queen’s University, Ontario, Mary E. Maxon, Ph.D., Associate Laboratory Director for Biosciences, Lawrence Berkeley National Laboratory, Frederick J. Meyers, MD, MACP, Associate Dean for Precision Medicine & Professor of Internal Medicine / Hematology-Oncology, UC Davis School of Medicine, M. Arthur Moseley, Ph.D., Director of Proteomics and Associate Professor in Medicine at Duke University School of Medicine
The relentless increase in costs of treating diseases such as cancer, neurodegeneration, heart disease and other chronic diseases is helping to drive an urgent need for precision medicine, for new and improved diagnostics and therapies. Despite the urgency, few discoveries survive the development pipeline. In addition, new technologies are also challenged to make the transition into the clinic. The future of medicine depends on better answers that bridge the gap between scientific pursuit and practical applications to truly impact patient care.
- What is needed from a precision medicine test in terms of robustness, reliability, accuracy and speed?
- How do we manage the change from current paradigm to the new precision medicine world?
- How do we address the challenges of integrating “new” technologies that enable precision medicine into the clinics?
- How do we pay for this extra upfront cost of new precision medicine costs, technology development and patient costs?
- Is there a mechanism for interfacing between regulators and the fast moving field of precision medicine?
Is Regulatory Agility an Oxymoron?
Moderator: James Czaban, JD, Chairman of the FDA and Medical Products Regulatory Practice Group – DLA Piper
Panelists: Elizabeth Mansfield, Ph.D., Head, Regulatory Strategy – GRAIL, Katlin McKelvie Backfield, JD. Founder, Backfield PLLC, Edward Abrahams, Ph.D. President, Personalized Medicine Coalition, Paul Billings, MD, Ph.D. Co-Founder Fabric Genomics
The pace of innovation in Precision Medicine is blindingly fast, yet for many products of the PM revolution, the FDA does, or believes it can, assert regulatory jurisdiction, including requirements for pre-market approval or clearance. As a massive bureaucracy with limited resources and a longstanding institutional culture of conservatism in reviewing medical innovations, can the FDA adequately keep pace with PM innovation while fulfilling its public health obligations to ensure the safety and efficacy of the products it regulates? This panel will delve into the past, present, and future of FDA’s regulatory posture toward Precision Medicine and explore ways in which the agency can be more agile in meeting the competing goals of fostering innovation and protecting the public health.
Disruptive Precision Therapeutics – Where are we now and where are we headed?
Moderator: Yves Lussier, MD, Associate Vice-President for Data Science, Chief Knowledge Officer, Center for Biomedical Informatics and Biostatistics – University of Arizona.
Panelists: Nigam Shah, MBBS, Ph.D., Associate Professor of Medicine Biomedical Informatics – Stanford University, Marc Williams, MD, – Director Genomic Medicine Institute – Geisinger Health System, Christopher A. Longhurst, MD, MS, Chief Information Officer, UC San Diego Health, Clinical Professor of Biomedical Informatics and Pediatrics, UC San Diego School of Medicine.
This new millennium is bursting with biotechnological and data analytics advancements such as ‘omics-scales measures of molecules of life and big data science. Together with legion-size data warehouses (health data, GEO, dbGaP) and comprehensive machine-executable knowledge bases of molecular mechanisms and pathophysiology (e.g. GO, SNOMED), these technologies enable paradigm-shifting precision in determining optimal therapy in microstratified patient cohorts. This session will discuss the state of the art and future directions in precision therapeutics. Four facets of this progress will be discussed:
(i) insights on the GenomeFIRST approach for identifying and treating patients with highly penetrant Mendelian disorders, based on data from the first 300 return of results.
(ii) the pharmaceutical industry’s vision on microstratification of patients’ responses to therapy embracing large-scale molecular profiling beyond Mendelian or mutational genetics,
(iii) the systematic analysis of large clinical data warehouses with machine learning methods for optimizing care in clinical situations lacking evidence-based guidelines. “Case-based reasoning” at point-of-care empowers clinicians to learn an effective, individualized treatment plan, grounded in practice-based evidence,
(iv) a decision-making framework for precision therapeutics inclusive of these emerging sources of evidence: big data analytics of multi-omics and practice-based data.
Access and Affordability of Advances in Precision Medicine and Disparities of Care
Moderator: Ralph Riley, MBA, Co Dx Market Access Leader, Janssen Global Services
Panelists: Lynn Dressler, Dr.P.H., Director, Personalized Medicine and Pharmacogenomics – Mission Health, Lee Schwartzberg, M.D., F.A.C.P., Executive Director and Chief Medical Officer of the West Cancer Center, Professor of Medicine and Chief, Division of Hematology/Oncology – The University of Tennessee Health Science Center, Kathryn Phillips, Ph.D., Professor & Founder UCSF Center for Translational & Policy Research on Personalized Medicine – UCSF, Nicholas Keeling, PhD Candidate, University of Mississippi School of Pharmacy, Graduate Research Assistant, St. Jude Children’s Research Hospital
While technology is driving a medical revolution through precision medicine the costs of accessing tests may limit the ability of this revolution to reach a large proportion of those patients who can benefit. Value in healthcare is defined by the outcomes received for each dollar spent. With a variety of means by which precision medicine can improve outcomes there is misalignment between patients, clinicians, industry and payers in how to account for the value of precision medicine and the evidence required to support it. We will explore this misalignment and its consequences for those unable to access the technology and identify potential means to mitigate those consequences including value frameworks, evidence generation, education and regulation.
Free Evening – Enjoy the sights and sounds of San Diego’s broad array of restaurants and nightlife
WEDNESDAY AUGUST 23RD, 2017
Looking Through San Diego’s Genomic Lens – A Model for Precision Medicine.
A Conversation with Joe Panetta, CEO, Biocom and David Wellis, Ph.D., CEO San Diego Blood Bank
Hosted by Beth Anne Baber, Ph.D., M.B.A. Co-Founder and CEO, The Nicholas Conor Institute
Genomics has shaped the future of medicine and San Diego has contributed significantly to the genomics industry’s growth and progress. Although young in comparison to the other biotechnology hubs around the world, San Diego has become a world-class destination for biotechnology, scientific research, and innovation. What are the key factors that led to the rapid expansion of San Diego’s genomics industry, allowing the city to become a leader in the field of precision medicine? Is it San Diego’s genomics ecosystem is complete, spanning sequencing to analysis and interpretation to clinical implementation? Is it the ecosystem is being continually fed by San Diego’s research institutions and medical centers? Is it the influx of venture capital and federal funding allowing young companies to thrive? Is it the homegrown genomics and computer science talent supply? Is it the collaborative mindset within San Diego’s genomics industry? We will explore the contribution of each of these factors to San Diego’s success and the challenges and opportunities that lie ahead in this new era of healthcare.
Paying for Personalized Value: New Models for New Science
Moderator: Gretta Stone, Deputy VP, Policy – PhRMA
Panelists: James C. Robinson, Ph.D., MPH, Dir. Berkeley Center for Health Technology, University of California – Berkeley, Andrea Ferris, MBA, President & Chairman of the Board, LUNGevity Foundation, Jerry Conway, VP of Reimbursement & Payer Strategy, Foundation Medicine
In the last decade, there have been remarkable advances in the science of personalized medicine such that today there are more than 140 personalized medicines that provide patients with treatment options that treat disease in a more targeted and individualized way. While these innovative treatments can lead to improved care and outcomes for patients and create value for the health care system, they can only do so if patients have access to them. We convene a distinguished panel of thought leaders from the diagnostic, payer, biopharmaceutical, and patient communities to discuss how we can appropriately assess and pay for value in the era of personalized medicine.
“Reawakening a Broken Brain” -Precision Medicine Approaches in Psychiatry Research
Moderator: Gregory Light, Ph.D. Professor and Deputy Vice Chair of Education and Training, Department of Psychiatry, UCSD
Panelists: Fred “Rusty” Gage, M.S., Ph.D., Professor in the Laboratory of Genetics, Salk Institute for Biological Studies; Daniel Mathalon, M.D., Ph.D., Psychiatry, University of California, San Francisco; William Potter, B.A., M.S., M.D., and Ph.D., Senior Advisor, National Institute of Mental Health; and, Gerard Marek, M.D., Ph.D, Executive Medical Director, Astellas
The field of psychiatry is evolving, and the research community (including industry, academia, and government) must also evolve in order to be successful. It is imperative to consider how new advances or ideas can help when analyzing the brain. This session will consider the biomarkers and new technologies available and those that are being utilized in the field of psychiatry – including genomics and patient stratification – as well as potential approaches and challenges for implementing precision medicine approaches in this area of drug discovery and development.
Connecting Genotype and Phenotype: Using Proteomics to Bring Together the Personal and the Precise
Moderator: Larry Gold Ph.D., Chairman & Co-Founder, Somalogic,
Panelists: Jun Wang Ph.D., CEO & Founder – iCarbonX, Simon Lovestone, Professor of Translational Neuroscience – University of Oxford, Iya Khalil, PhD, Chief Commercial Officer and Co-Founder, GNS Healthcare, Emanuel Petricoin III, Ph.D., University Professor, Co-Director Center for Applied Proteomics and Molecular Medicine, George Mason University
Medicine has always been “personalized” around phenotypic measures: The challenge has been the lack of ability to measure phenotype deeply enough to consistently provide meaningful and even actionable insights. To date, the genome has provided a limited prediction of phenotype, but it is increasingly clear that genomic analyses alone will never be more than an imprecise and partial approach to understanding real-time health and wellness. ”Molecular phenotype” measurements, in particular the constantly changing proteins that make up each individual, are absolutely needed if we will ever deliver precise – and personalized – medicine. This session will examine the connections between genotype and phenotype, and their respective roles in the emerging deep insights into human health and disease.
The Healing Power of the Narrative
Moderator: Hudson Freeze, Ph.D., Director, Human Genetics Program, Sanford-Burnham-Prebys Medical Discovery Institute
Panelists: Bryce Olson, Global Marketing Director, Health and Life Sciences Group – Intel Corporation, Peter Kapitien – Inspire2Live, Amylynne Santiago Volker – Nicholas Volker – One in a Billion Foundation
Research scientists are told “your best story beats your best data”. Without data, you’re not a scientist. Without a story, you have a tiny audience. Where does a scientist find the best stories? They come from people who used science, data and relentless determination to battle and overcome diseases, sometimes their own, sometimes in their family. Each story is deeply personal. Telling those stories enriches all the members of the personalized medicine ecosystem and expands its outreach.
- How do we improve our storytelling as patient advocates?
- How do relay these stories to a broader group beyond immediate stakeholders?
- What is the role fundamental (undirected) scientific research in the stories?
- How do we improve alliances between patients, clinicians and researchers?
Invasion of the Body Trackers – Do Wearables, Sensors, and Remote Health Monitoring Enhance Care and Outcomes?
Moderator: Wainwright Fishburn Jr, Founding Partner, Cooley, LLP
Panelists: Donald Jones, JD, MBA, Chief Digital Officer, Scripps Translational Science Institute, Cardiff Ocean Group Chairman, Michael Hodgkins, MD, MPH, Chief Medical Information Officer, AMA, Dr. Zakiuddin Ahmed, Project Director, RAH@H, King Saud University, David Ewing Duncan, Author
Going Deep in the Fast Lane – the rise of AI in Precision Medicine
Moderator: Thomas Wilckens, MD, CEO & Founder – InnVentis Ltd.
Panelists: Atul Butte, MD, Ph.D., Director, Institute for Computational Health Sciences and Professor of Pediatrics – UCSF, Simon Kos, MBBS, MBA, Chief Medical Officer – Microsoft, Andy Bartley, MBA, Senior Solutions Architect, Health & Life Sciences, Intel Corp, Nick van Terheyden, MD, Founder & CEO, Incremental Healthcare
AI will undoubtedly impact on, change and improve many aspects of R&D and will in time will play a key role in ameliorating our everyday lives; the hope is that AI will eventually enable #PrecisionMedicine. There are many challenges we face in attempting to achieve this goal. These range from a general lack of robust i.e. reliable, valid, reproducible and comparable data (in particular longitudinally in the healthy or chronically ill population), Interoperability of data sources is also an unresolved problem. Furthermore IoT/AI infrastructures are by no means scalable to deliver PM in real-time. In addition, deep learning, one of the emerging AI methods, is a “black box”, which is difficult to accept not only for regulatory purposes; i.e. we cannot explain how some results are being generated. Additional challenges reside in cybersecurity in terms of design and privacy rights. The panel’s goal should be to identify concise ad hoc action points and a roadmap to raise AI beyond academic research projects in order to deliver solutions for problems in biomedical R&D and healthcare in a timely manner. One way to generate these solutions seems to be vertically integrated flagship projects.
Digital Genomics – The Last Mile Between Sequencing and the Clinic
Moderator: Bruce Quinn, MD, Ph.D., MBA, Principal, Bruce Quinn Associates, LLC
Panelists: Sean Scott, SVP, CBO & VP Clinical Market Development, Qiagen, Enrico Capobianco, Ph.D., Lead Scientist, Center for Computational Science – University of Miami, Martin Reese, Ph.D., Founder, President, CEO, Fabric Genomics, Reece Hart, Ph.D., Chief Technology Officer at Genome Medical.
More entrants provide clinical sequencing results, both for germline conditions and for cancers. Each lab must struggle to handle large amounts of clinical and genomic information, interpret results, integrate with clinical customer workflows, and differentiate from competitors. Because of the complexity and the shortage of bioinformatics staff, new entrants are emerging to outsource key bioinformatics functions. Some of these companies connect institutions, some are supporting a new era in applied clinical research, and others are trying to create a level of insight through in silico cell biology. Some efforts go as far as providing virtual tumor boards for patients in remote locations, or integrating point of care tests with personal health records and apps. This session will consider “digital genomics” as a type of healthcare industry and forecast major trends in the next two years.
Mission Possible – Moving Diagnostics to the Forefront of Precision Medicine
Moderator: Mara Aspinall, MBA, CEO & President – Health Catalysts
Panelists: Tricia Carrigan, Ph.D., Global Head of Translational Assay Technology – Bayer AG, Hannah Mamuszka, CEO & Founder – Alva10, Don Hardison, President & CEO, Biotheranostics, Inc., Mary Stevens, MBA, Director, Network Contracts, Compliance, Audit, Provider Relations, BCBS of Minnesota
Diagnostics are the critical and central foundation of Precision Medicine yet, somehow, diagnostics are not broadly recognized as having this essential role. The public story about Precision Medicine seems always to be about the miraculous drugs and not about the tests that enable access to the right patients. However, there have been recent signs that Diagnostics’ role in Medicine (both Precision and “Traditional”) is beginning to change for the better. The panel will discuss what changes we see from Regulatory Agency changes to Pharma’s investment patterns and why we are optimistic about the future.
Accurate and Fast Genomic Interpretation for Clinical Labs – Led by Martin Reese & Paul Billings Fabric Genomics
• Discuss how NGS labs can be more efficient with interpretation & clinical reporting, especially for pediatric and oncology patients
• Review how genomic interpretation tools easily integrate with EMR & LIMs
• Analyze the regulatory environment of genomic software in NGS labs
• Share thoughts on artificial intelligence (AI), and the need for advanced algorithms to maximize diagnostic yields for genome and exome data
Considering Precision Medicine Approaches in Psychiatric Research – Mitsuyuki “Mickey” Matsumoto – Astellas Pharma
- Analyze what role genomics play in patients with psychiatry
- Discuss if biotypes could be useful in clinical trials
- Brainstorm approaches and challenges for use of biomarkers or precision medicine approaches in early phase studies
The Right Prescription for AI in Healthcare – discussion leader Bryce Olson, Intel
In this discussion, experts will frame why 2017 is the year of AI exploration in Healthcare, will discuss success stories and usage models being adopted most frequently, will talk about the top challenges to overcome that get in the way of successful adoption, and conclude with the key areas that the technology industry must overcome to achieve greater adoption within the healthcare industry.
Combination Therapy in Precision Oncology – discussion leader Amelie Boichard, Pharm.D., PhD., CureMatch
- Success of combination therapy in other diseases
- Challenges of combination therapy in oncology
- Success stories of combination therapy in oncology
- The future of combination therapy in precision oncology
Exploring Strategic Trends in Precision Medicine – discussion leader Edward Tsai, Founder / CEO, Base Four
- Discuss high-level themes on the impact of precision medicine in healthcare
- Determine medium to long range effects on primary and secondary sectors
- Identify potential key insights to translate research and clinical efforts into commercial opportunities
- Share experiences and perspectives on the business of precision medicine
Challenges and Opportunities for Molecular Tumor Boards – discussion leader Kimberley Ferguson – Roche Diagnostics Information Systems
- Precision Medicine
- Utilization of all data – not just Molecular Diagnostics
- Discovery to intervention
- Conventional tumor boards vs. Virtual Panels
- Complex cases only vs. conventional cases
- Coalescence of data to facilitate MTB discussions
- Patient eligibility
Diagnostics were from Mars, Payers were from Venus: Data-Driven Alliances in New Age of Precision Medicine – discussion leader Lena Chaihorsky, VP of Payer Innovation, Alva10
- Explore the financial incentives driving and inhibiting diagnostic utilization in PM today
- Discuss high-impact pilots and the data capabilities showing payers the increased need for diagnostics
- Share unique perspectives on how payment drives healthcare delivery in Dx, and implications for PM
A Diagnostic Solution for Precision Oncology: Changing the Paradigm with NGS-based Companion Diagnostics – discussion leader Jane Li, Ph.D., Thermo Fisher Scientific
- Successful development of the Oncomine™ Dx Target Test* – the first NGS-based companion diagnostic for multiple NSCLC drug indication
- Challenges and lessons learned
- Insights toward future directions
*For In Vitro Diagnostic Use.
©2017 Thermo Fisher Scientific Inc. All rights reserved. Oncomine is the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.
Genomes, Exomes, and Panels – finding the sweet spot for clinical utility – discussion leader Andrew Barry, New England BioLabs
- Explore the factors influencing the choice of content for sequencing-based assays
- Discuss the impact of regulatory and reimbursement aspects on technology choices
- Share unique perspectives across research and clinical applications
Enabling clinical-grade NGS-based “dry lab” capabilities in Oncology and Hereditary disease testing – discussion leader Sean Scott, Chief Business Officer, Qiagen
“Interpretation” remains the rate limiting factor for Genetic Testing, Molecular Diagnostics and Molecular Pathology laboratories offering and developing accurate, cost-effective and scalable NGS test services. During Sean’s roundtable discussion he’ll discuss some of the best practices and lessons learned that he has observed working with researchers, lab directors and clinicians over the past decade in the adoption, deployment and operational scaling of genomics in precision medicine programs. During this discussion should will provide practical examples of how select labs are automating their analysis, interpretation and reporting workflows to overcome the “interpretation” challenge to enable more insightful and actionable reporting to physicians.
The Next Frontier in Diagnostics for Precision Medicine: Neurodegenerative and Developmental Disorders discussion leader Matthew MacManus, MD, Ph.D. CEO, President, Asuragen
- The role of genomics in Neuro disorder prevention and management
- Understanding the challenges that exist in In Vitro Dx to providing meaningful and actionable results for Neurodevelopmental and Neurodegenerative disorders?
- Do neurodevelopmental and degenerative genetic predisposition testing offer the opportunity for the reversal of the conventional CDx model to a CRx model?
Investment Sources for Precision Medicine – discussion leader Jay Goth, Managing Partner, Forentis Fund
In this roundtable, we will discuss various options including traditional angel and VC funding, non-dilutive grant funding, the growing area of impact investing by family offices, and other non-traditional funding sources.
Drug and Gene: Pharmacogenomics for the Modern Healthcare Team – discussion leaders Adijana Kekic, PharmD, Christopher Grilli, PharmD, Mayo Clinic
- Discuss the impact of pharmacogenomics on team based care.
- Outline how roles and responsibilities, as they relate to pharmacogenomics are forming within a modern healthcare team.
- Explore clinical pearls and lessons learnd from implementation of a pharmacists lead pharmacogenomic consult service
Pharmacogenomics in Clinical Practice: Conduits and Barriers to Implementation and Utilization – discussion leader Ross Higgins, MBA, MLS (ASCP), OneOme
- Single gene vs. Targeted Panels vs. Comprehensive Panels
- Providers and Clinical Teams: The Landscape of Enablers and Resistance Fighters
- Pharmacists as Champions
- Payors: Insurance, Institutional, and Patient
Precision Medicine: Advancing Patient Care through Genomic Data – discussion leader Philip Beales MD FRCP FMedSci, Great Ormond Street Hospital, London
- What are the current limitations in the infrastructure of healthcare institutions to enable clinical genomics?
- How can deep phenotyping make a difference in clinical diganosis?
- What needs to change in the field of precision medicine to enable its implementation at a faster pace?
- How can biopharma make strides in rare disease treatment and diagnosis?
Medical Imaging and Artificial Intelligence – What does the Future Hold for Clinical Research? discussion leader Daniel Braga, Medidata, Principal, Medical Imaging
THURSDAY AUGUST 24TH, 2017
Keynote Next Generation Clinical Trials are Here – Are We Ready?
Laura J. Esserman, MD, MBA, Director Carol Franc Buck Breast Cancer Center, Professor of Surgery and Radiology, USCF
Precision Medicine: A Boon or Bust for Pharma?
Bernard Munos, MBA, Standish Fleming, Founding Manager, Forward Ventures, David Shaywitz, MD, Ph.D., Chief Medical Officer, DNA Nexus
The future of pharma depends on its ability to develop new products. Ironically, the industry has evolved to the point at which it is better at making money than products. Limited productivity that has forced a number of the largest companies to depend on disruptive and ultimately destructive M&A is not sustainable for them or the industry. Pharma must change the way it discovers and develops new molecules at a time when precision medicine is transforming the entire health-care landscape, and society is clamoring for more affordable therapies. Change within change: chaos or opportunity? Three distinguished panelist will discuss the future of innovation in the pharmaceutical industry in the era of precision medicine.
Minority Report – Ethnic Diversity and the Real Promise for Precision Medicine
Robert Sebra, Ph.D., Director of Technology Development & Associate Professor – Icahn School of Medicine at Mount Sinai, Valerie Schneider, Ph.D., Staff Scientist, NCBI. Benedict Paten, Ph.D., Assistant Professor, UCSC, Justin Zook, Ph.D., Co-Leader, Genome in a Bottle Consortium (GIAB), National Institute of Standards and Technology (NIST)
Precision medicine promises to deliver improved genetic testing and reporting for all patients, enabling individually tailored treatment plans. However, providing access to these benefits for global populations will require deeper thinking about ethnic diversity and genetic background in study designs. The current Human Reference Genome assembly (GRCh38), was derived from sequencing the DNA of more than 50 ethnically diverse individuals. As such, the reference sequence represents an admixed background of contributing populations and switches from one ethnic haplotype to another at multiple places. This reference-bias can impact genetic study results if it is not properly accounted for. Effective study design requires representation of ethnic diversity both in patient populations, and in the way genetic background is represented in testing methods. This session will explore topics covering ethnic diversity in genetic testing including: expanding diversity in the Human Reference Genome, representing diversity during the design of genetic tests, and improving carrier testing with population-specific reference sequence.
Inside the NICU: Evidence for the Clinical and Economic Advantages of Neonatal Precision Medicine
Conversation with Stephen Kingsmore, MD, MSc., President & CEO The Rady Children’s Institute for Genomic Medicine and Rick Kronick, Ph.D., Professor, Department of Family Medicine & Public Health, UCSD School of Medicine – Moderated by Pieter van Rooyen Ph.D.
President and CEO, Edico Genome.
Rapid Precision Medicine is being advanced through research at the Rady Children’s Institute for Genomic Medicine. Using Rapid Whole Genome Sequencing (rWGS), the Institute is enabling the prevention, diagnosis and treatment of rare genetic diseases. The work is also providing evidence for the economic utility of rWGS in critically-ill infants with undiagnosed diseases. Dr. Stephen Kingsmore will discuss the case of a newborn who was the youngest patient ever to be diagnosed with Otahara Syndrome caused by a novel KCNQ2 mutation as a result of rWGS. The diagnosis was obtained in just four days, allowing doctors to immediately and successfully adjust treatment. Thus far, the infant is stable, at home and has avoided further seizures and neurological damage. In other cases, this syndrome almost inevitably leads to severe neurological damage with a 50 percent mortality rate by age two.
Precision Planet – A Global View of Population Health
Moderator: Kristin Pothier, Ph.D., Parthenon-EY Life Sciences
Panelists: Hans Erik Henriksen, CEO – Healthcare DENMARK, Maurice Treacy, PhD MBA, Co-Founder, Genomics Medicine Ireland, Vijay Chandru, Ph.D., Executive Chairman & Co-Founder Strand Life Sciences, Mark Punyanitya, MS, President & CEO PhenoMX, Inc.
In precision medicine, the pace of innovation and emphasis on value are driving the convergence of historically distinct stakeholders. Biopharma, diagnostics, consumer health, and tech companies are collaborating in sophisticated new ways, leading to both novel technologies and a flood of potentially valuable data. However, in many markets around the world, mere access to healthcare is inadequate – never mind the innovation that other countries enjoy. In this panel, we will illuminate the various challenges that governments, industry, and the nonprofit sector face when implementing the evolving technologies of precision medicine. A geographically and experientially diverse group of leaders will discuss the obstacles they face, those they’ve surmounted, and those that remain for us all to overcome.
The Invisible Ecosystem – Illuminating the Microbiome with Precision Medicine
Moderator: Karen Nelson, Ph.D., President – JCVI
Panelists: Bernard Parker, MBA, Managing Director, Caligen Bio, Rohit Loomba, MD., Vice Chief, Gastroenterology Director, Hepatology, UCSD, Pamila Brar, MD, Medical Director, Human Longevity, Dana Hosseini, MBA, CEO ProdermIQ, Inc.
The human microbiome refers to the trillions of microbes that live in and on us. This community of our natural flora has emerged as a promising modality to enable personalized patient care. Current research suggests that sequencing via 16S gene surveys as well as whole genome shotgun (WGS) of the microbiota may provide actionable clinical insights to aid in disease prediction. In addition, recent clinical data have demonstrated that management of microbial dysbioses positively influences disease outcomes. Illumination and translation of the microbiome has the potential to provide models and create new opportunities for the development of diagnostics and medicines that precisely predict, prevent, and treat disease across a range of therapeutic areas. This panel brings together thought leaders in academic research, big pharma, biotech, diagnostics, and the life sciences to discuss the opportunities and challenges in discovering and developing drugs and diagnostic tools associated with the microbiome.
High Resolution in the Clinic – Building a Scaleable, Diverse and Contextualized Precision Medicine Design Framework.
Moderator: Elizabeth Baca, MD
Panelists: Panelists: Riley Bove, MD, Assistant Professor – UCSF, Jennifer Pearce, MPA, Founder – Plain Language Health, Frank Velasco, Technical Project Manager – Sutter Health, Walter “Buzz” Stewart, Ph.D., Chief Research Officer – Sutter Health
A shift is happening to apply precision medicine approaches to a broad spectrum of diseases from cancer to cardiac disease to multiple sclerosis. Yet, to truly take precision medicine to scale will take moving it from the bench to the bedside and require new partnerships to do so. Learn how the California Initiative to Advance Precision Medicine is supporting programs, such as Sutter health system, to bring novel cross-sector teams to take precision medicine directly to the patient.
Primum Non Nocere – A Clarion Call for Ubiquitous PGx Testing in the Clinic
Moderator: Deepak Asudani, MBBS, MPH, Associate Clinical Professor of Medicine – UCSD
Panelists: Jeanette McCarthy, Ph.D., Founder – Precision Medicine Advisors, Chris Grilli, PharmD, MBA, Manager of Outpatient Pharmacy – Mayo Clinic, Ross Higgins, MBA, MLS, Director of Laboratory Operations, OneOme, Douglas J. Conrad, MD, Professor of Medicine, Director for Adult Cystic Fibrosis Program, UCSD
Contemporary prescription patterns tend to be empiric with a standardized ‘one cap fits all’ approach and little regard to the genomic configuration of an individual. As we embrace newer technology and as the gene sequencing technology has matured, we have more actionable data and robust evidence at hand that guides individualized drug selection. Applied genomics increasingly should be part of decision making in prescribing safe individualized treatment. Minimizing patient harm is an inherent aspect of practicing medicine. Besides getting the best outcomes, there needs to be increased sensitivity towards the statute of ‘first do no harm’. With abundant evidence available, we are more than ever in a position to apply the principles of pharmacogenomics. This session will examine why it will no longer be optional to advise prescription patterns and drug choices without widespread PGx testing. The session will also seek expert discussants’ views on the pitfalls from ubiquitous testing.