As the oncology community stares down the cresting wave of promising new immunotherapies, it is clear that new biomarker strategies are needed to choose among the myriad available checkpoint modulators for a given patient-- BITEs, CAR-Ts, oncolytic viruses, and neoantigens. This session features speakers who are developing genetics-informed personalized immunotherapy approaches and will highlight the current state, the roadmap for the future, and what challenges remain in matching the patient with the optimal therapeutic combination.
Session Chair: Patrick Roche, HTG Molecular Diagnostics
(Cell free DNA, CTCs, and Exosomes)
Tumor tissue biopsies are invasive, costly, time-consuming and often inaccessible. Liquid biopsies enabled by new ultrasensitive PCR and NGS allow analysis of tumor derived nucleic acids and cells in the blood. They may be used to assess therapy selection for targeted therapeutics, initial therapy response, disease progression, and drug resistance mechanisms. Hear from those who are driving clinical development of liquid biopsies about what is possible, what has been achieved, and what challenges remain to make liquid biopsies routine in the clinic.
Session Chair: Walter Koch, Roche Molecular Systems
In perpetual awe of how 'simple' microbial organisms can perturb complex, multicellular eukaryotic organisms, our research program seeks to inspect, characterize and dissect the microbe-human interface. Infectious and environmental exposures result in drastic and sometimes fatal health consequences. In this session Dr. Bhatt will describe how her group uses modern genetic, molecular and computational techniques to better understand host-microbe interactions and decipher how perturbation of these interactions may result in human disease.
Session Chair: Ami S. Bhatt, Department of Genetics Stanford University
Genome-based biomedical research projects have yielded a spectacular number of insights from the first tens of thousands of sequenced genomes. However, at the molecular level, most disease is rare disease, and tens of thousands of genomes is not sufficient to fully understand it. Millions of genomes will be required, and these can only come from normal clinical practice. Groups such as the Global Alliance for Genomics and Health have been formed to address this problem. In this session we discuss the promise and challenge of sharing data from clinical sequencing with research projects.
Session Chair: David Haussler, University of California, Santa Cruz
Human pathologists are the bridge between the laboratory and the clinician. A laboratory test begins with the idea of performing such a test and ends after the interpretation of the final result has produced an action with an outcome. Precision (personalized) medicine is a sophisticated expression of advanced clinical laboratory testing. Best practices dictate that a physician chooses the right test on the right patient at the right time and that the result benefits the patient.
Session chair: George Lundberg, Stanford
Noninvasive prenatal testing (NIPT) or screening (NIPS) has been widely adopted and its use no longer questioned in high risk settings. However, over the past year, further research and payor models have demonstrated the utility of extending NIPT to the average risk population potentially impacting approximately 5,000,000 pregnancies per year. This session will review the data on NIPT performance in the average risk population, as well as provide clinical and reimbursement perspective.
Session chair: Kimberly A. Martin, Natera
Individual consumers can engage in science and drive new therapies forward. In fact, we can’t do it without them. Through current regulations, patients have the legal right to their test data, but what can they do with it? In this session, we will hear how individuals, when armed with the scientific information underpinning their disease, can positively impact their own care and also advance precision medicine for others.
Session Chair: Martin Naley, Cure Forward
The widespread clinical application of personalized genomic medicine has historically been hampered by several important factors, including data interpretation, the high cost of testing, and the extended turnaround times associated with in-depth genomic analysis. Expediting these technologies into clinical practice for the benefit of patients is the topic of this session. Panelists will discuss the clinical applications of genomic medicine and share insights regarding the barriers and opportunities to moving genomics into regular clinical practice.
Session Chair: Lincoln Nadauld, Intermountain Healthcare
This interactive panel discussion will feature leaders from community hospitals, integrated healthcare systems, and the payor community who will discuss how precision medicine is being systematized at their institutions and how it affects the cost and quality of patient care. They will outline their successes and challenges in using outcomes data to implement best practices and demonstrate value in their precision medicine programs.
Session chair: Jonathan Hirsch, Syapse
We are at a major inflection point in our ability to use clinical genomic information to diagnosis and manage thousands of rare diseases, yet the ability to ensure patient access to this information and innovative science remains unrealized due to an array of complex barriers. With 30 million patients in the U.S. and 300 million around the globe living with the burden of a rare disease, this unmet medical need is substantial. The panel includes a variety of stakeholders involved in finding innovative solutions to remove these barriers for patients and their healthcare providers in today’s fragmented medical care system.
Session Chair: Patrice M. Milos, Claritas Genomics
Major health factors, including diet, lifestyle, environment and genes, exert their influence on the body by subtly changing the metabolic composition. Metabolomics provides a snapshot of the current state of health and provides new information to help with immediate clinical decision-making. Advances in the field have made metabolomics a valuable first-line tool for assessing health. It can be used to identify perturbations of metabolic pathways associated with many diseases and quickly screen patients for health or disease status. In this session, we discuss the technology used in metabolomics and hear from health innovation leaders about how the routine use of this technology is guiding precision medicine today and the role of metabolomics in the future.
Session Chair: John Ryals, Metabolon
Rheumatoid arthritis (RA) is a phenotypically heterogeneous autoimmune disease causing chronic inflammation of synovial tissue. RA typically requires lifelong treatment with close monitoring of disease activity to prevent irreversible joint damage and physical disability. However, there is no precedent for biomarkers in inflammatory disease and there are currently no personalized treatments in RA. This panel of innovators in the field addresses the outstanding questions for understanding the pathobiology of RA, the work that has been accomplished toward identifying biomarkers and the areas that they are currently pursuing to fill the voids. Additionally, the currently available Vectra DA, multi-biomarker blood test that measures RA disease activity to help monitor patients during treatment and evaluate their risk for future joint damage, will be discussed.
Session Chair: Dr. Eric Sasso, Crescendo Bioscience
In the next 3-7 years we're on track to develop personalized cancer therapeutics that have significantly improved efficacy and safety. With the near-precipitous drop in assay and sequencing costs, the emergence of immuno-oncology, the tipping point for big data, more adaptive clinical trial design, and modernization of the FDA, these improved therapeutics will also emerge at a faster speed and be offered at more competitive prices. In this session you will hear multiple viewpoints on this phenomenon from the panel including perspectives from medical oncology, pharma, regulatory and the patient advocate.
Session Chair: George W. Sledge Jr., Stanford University Medical Center
Research continues to confirm that adoption of personalized diagnostics is limited by physicians’ lack of confidence in when and how to utilize these tests and their results. Significant challenges remain around appropriately incorporating molecular diagnostics into the clinic so they are used effectively and are reimbursable. In this session you’ll hear the perspectives of both public and private payers, healthcare providers, and patients as well as about a new resource that may be able to bring additional clarit fill an unmet need in this space.
Session Chair: Rina Wolf, XIFIN
The availability of large clinical data and other data types (e.g. toxicology, pharmacogenomics, omics, etc.) combined with the fast-paced evolution of innovative data mining tools allows us to gain new and unprecedented molecular and clinical insights. These data have the potential to impact the world of healthcare in many ways: enabling the identification of new therapeutic targets, finding new uses for existing drugs, allows the identification and characterization of new diagnostic tools, or brings us closer to the understanding of the molecular details of poorly characterized diseases. In this session, we will discuss applications and advancements that build upon large data as applied to both the therapeutics and clinical diagnostics.
Session chair: Atul Butte, UCSF and Program Chair PMWC 2016 Silicon Valley
A discussion of current thinking of how to manage the challenges of producing a report a clinician can use and a molecular lab can be proud of. The session will focus on the data integration challenges associated with genomic instruments, Electronic Health Records (EHR), Tumor Board Reviews, state of the art clinical curation processes and much more. Thought leaders that are actively providing cutting edge services in the Precision Medicine market today will participate in a lively discussion about how best to incorporate all of the new information available to researchers, clinicians and patients in a scalable and cost effective way. Don’t miss this one.
Session Chair: Sean Sigmon, Oracle
Data in isolation is of very limited value, and therefore one should be careful with drawing big conclusions from it. To be able to properly interpret complex data, large contextual data is the preferred starting point. This guidance certainly applies to genomics data. Large-scale genomics projects are defining and leading the way of transitioning genomics’ reach into the clinic. Numerous public and commercial efforts are under way that will be discussed in this session. In detail, we will hear about large-scale next-generation sequencing and omics projects, their goals, designs and specific applications, and the challenges encountered to extract knowledge for disease understanding, diagnosis, and treatment.
Session Chair: David Ledbetter, Geisinger
In oncology, biomarkers have many applications, including risk assessment, screening, differential diagnosis, determination of prognosis, response to treatment, and monitoring progression of the cancer. In this session we will highlight the current state of predictive biomarkers for oncology including recent successes, lessons learned, and challenges to come. Among the topics to be discussed are novel clinical trial designs for personalized medicine, emerging predictive biomarkers in immune-oncology trials, lessons learned from PD-L1 as an as an immunotherapy biomarker, and the path forward for next generation sequencing in cancer diagnostics.
Session Chair: Ann Kapoun, OncoMed
Liquid biopsy has captured the imagination of investors and the mainstream press alike. While the ability to assess patients non-invasively is appealing to physicians and patients, there remains much confusion regarding the capabilities and limitations of various technologies. This session will provide meaningful data and debate on the clinical utility of circulating tumor cells (CTCs), circulating tumor DNA (ctDNA) and exosomes. Companies representing each technology will present and answer audience questions regarding what some estimates forecast to be a $10BN diagnostic industry.
Session Chair: Murali Prahalad, Epic Sciences
In this timely session, top intellectual property attorneys Catherine Polizzi and Michael Shuster provide an update on patent law pertaining to personalized medicine issues. First, they give a brief recap of 35 U.S.C. 101 case law developments followed by a review of the 2014 Interim Guidance on Patent Subject Matter Eligibility under 35, in view of U.S. Supreme Court decisions. They survey recent patent prosecution results from diagnostics companies such as Myriad, Genomic Health, Ariosa, Sequenom and Roche and recap major litigations involving those and other diagnostics players, highlighting practical implications of developing 101 case law. Attendees will gain insight into how to adapt a patent strategy in light of these new developments.
Session Chair: Catherine Polizzi, Morrison Foerster
DNA data is a biometric and hence in theory identifiable even if made “anonymous”. As sequencing costs continue to drop, DNA banks and genomic data silos continue to build up rapidly. Would it accelerate human betterment if we were to build a collaborative genomic analysis platform that protects patient privacy, allows researchers to bring best of breed analysis methods, and provides easy-to-administer access and risk management protocols? Is this a moon shot?
Session Chair: Somalee Datta, Stanford
The adoption of Personalized Medicine is in part being driven by the omnipresence of Next-Generation Sequencing (NGS) and the fast-paced technological innovations. As a result, we can see the clinical sector responding with voicing their needs, and the industry adapting to deliver solutions that change clinical medicine and healthcare into patient-centered. This panel will focus on clinical requirements, new advancements, and the different challenges they encounter to advance genomics into the clinic.
Session Chair: Allison Ballmer, Roche Sequencing
Routine clinical sequencing and its accompanying analyses will soon extend beyond gene panels to include extensive exome and whole genome sequencing. This will result in large amounts of sequence data that needs (omit) to be stored, analyzed, and made accessible for future interrogations. To be useful, a scalable and powerful computational infrastructure, as well as technologies and tools that support the evaluation of this data in the context of human diseases must be in place, for both the research and clinical settings.
Session Chair: David Glazer, Google
As personalized medicine becomes more ubiquitous, innovative leaders must develop programs that meet the demand for personalized medicine services. With the implementation of these programs comes vast amounts of heterogeneous data from a variety of sources. Leaders in the field must transform genomic and other biomedical data into usable data-driven insight. Hear perspectives from three innovators in personalized medicine about how they are generating valuable insight at scale in a cost effective manner.
Session Chair: Mick Correll, GenoSpace
Therapeutic targets are primarily proteins. Their dysregulation and/or mutation led to the initial hypothesis of their causal involvement in specific diseases. In oncology, the majority of these drug targets are identified through genomic nucleic-acid based technologies. As a result, it is more common that the biomarker used to select patients is the genomic aberration. However, protein-based analytical technologies have continued to advance for both research and diagnostic applications.
Session Chair: Scott Patterson, Gilead
Biobanks play a crucial role in biomedicine as they maintain a wide array of biospecimens, including blood, saliva, plasma, and purified DNA, linked to phenotypic data and other trait information. Biobanksare changing the face of medical research by making available a wealth of material needed for broad research, to investigate cancerous tissues, allowing access tohealthy controls, and more. This session covers the importance of biobanks for personalized medicine, but also touches uponsome of the primary concerns associated with the management of a biobank. They include meeting standards for sample and data quality and integrity, linking biospecimens with electronic medical records in an integrated healthcare delivery system, and the protection of the individual’s rights and privacy.
Session Chair: Sir Rory Collins, UK BioBank
How is today’s patient experience different from prior to the emergence of personalized medicine and the Affordable Care Act? A “real world”patient experience will be examined through multiple lenses including that of a patient who has survived cancer following precision medicine treatment. ASCO’s Chief Medical Officer, and a renowned clinical oncologist.From diagnosis and treatment toongoing disease management and paying for advanced care, the convergence of scientific advancement and a challenging medical economy has createda new paradigm. What working and what challenges remain?
Patients who have undergone organ transplants require frequent monitoring to evaluate the organ’s graft status and to modulate a complex regimen of immunosuppressive medications. The earliest detection of immune activation and graft injury followed by therapeutic intervention leads to better outcomes. Today, noninvasive, molecular diagnostics using predictive biomarkers can detect the earliest signs of rejection, even weeks to months before functional failure, and pinpoint actionable causes, enabling precision modulation of therapy and improved outcomes in organ transplantation. In this session you’ll hear from three leaders who are at the forefront of developing commercialized molecular diagnostics for heart and kidney transplantation.
Session Chair: John Sninsky, CareDx
Omics-based biomarkers are hailed as the “holy grail” of personalized medicine and are thus considered to be of potential huge value. Their resulting wide-spread applications hold many promises, yet many hurdles still need to be overcome on the path towards a successful translation into the clinic for precise diagnosis and resulting treatment decisions in disease areas including cancer. This session will address the many aspects and learnings associated with biomarker identification, translation into clinical value, and regulatory approval for clinical use.
Session Chair: Andreas Kogelnik, Open Medicine Institute (OMI)
See entire program: http://2016sv.pmwcintl.com/all/