Speaker: Sushma Selvarajan, Ph.D., Head of Business Development & Strategy, Roche Molecular Diagnostics (RMD)

The advent of high throughput gene sequencing and other genomic characterization technologies is facilitating discovery of the underlying molecular basis of many diseases at an unprecedented pace. In particular, efforts of The Cancer Genome Atlas project and others are identifying a plethora of potential drivers of aberrant cancer cell behavior that could be targeted therapeutically. As companies and academic centers race to establish Next Generation Sequencing-based characterization of tumors into routine clinical diagnostic use, there are a number of challenges for making this genomic information clinically actionable. First, newly discovered mutated or overexpressed proteins must be proven to be critical “drivers” of cancer cell growth and/or metastasis. Additionally, there is a dearth of approved drugs that target the multitude of oncoproteins and pathways that are either known or still being discovered. To increase the pace of translation from discovery to routine implementation in the clinic, novel clinical development strategies will be needed, moving from the current model of co-development of one drug with one companion diagnostic, to differential diagnosis of molecularly-defined subtypes of disease using biomarker panels, many of which will have implications for existing therapies, as well as evolving use for drugs entering into development.

Speaker: Joseph Bach, Partner, Nixon Peabody

With the onset of electronic medical records and the explosion of mobile apps, there is a fast approaching convergence of legal issues that will impact how healthcare providers interact with patients and other providers through the use of mobile technology. The session will briefly describe emerging legal issues and federal law governing the use of mobile technology for the transmission and storage of personal medical information.

Speaker: Patrick F. Terry, Chairman, Grey Group Ventures, Inc.

The near and present opportunities to help alleviate the burden of disease in cancer care, genetic conditions, infectious disease management, and the over treatment of the ill are early indicators of the tipping point taking place the practice of medicine today. The inevitable rise in the level of health literacy and consumer demands will be a significant disruptive influence on the rate of technology adoption in health care delivery. Stratified and precision medicine will become new milestones in the evolving field of clinical practice in Israel and around the world.

Speaker: Sushma Selvarajan, Ph.D., Head of Business Development & Strategy, Roche Molecular Diagnostics (RMD)

Hearing the words “You have cancer” is a stressful and difficult experience. People diagnosed with cancer have numerous questions for their physicians, including:

   · What type of cancer do I have?

   · Is this type of cancer caused by genetic factors? Are other members of my family at risk?

   · How severe is my cancer? What does this mean for my chance of recovery?

   · What are my treatment options? What is the goal of treatment?

   · Which treatment is the best option for me?

   · How often will I need to get treatment? Will this treatment have any side effects?

   · How will you monitor the effectiveness of treatment?

The improved understanding of the molecular basis of cancer has allowed us to develop new diagnostic tests that can help physicians to answer the questions raised by patients. These tests cover the spectrum of medical decision-making from diagnosis through treatment selection and treatment monitoring, and help physicians and patients to better manage cancer.

Speaker: Anthony M. Magliocco, M.D., Chair, Anatomic Pathology, Moffitt Cancer Center

Moffitt Cancer centre, the only NCI designated cancer center in Florida and one of the largest volume in the USA has launched an innovative program in personalized medicine called total cancer care, this program has enrolled almost 100,000 patients and created an exceptional annotated biorepository focused on developing novel biomarkers and initiating targeted therapy clinical trials.

Speaker: Sanjay Joshi, CTO, Life Sciences, EMC Isilon Storage Division

As the Clinical Genomics and Personalized Medicine efforts gain traction, the question of scalability is becoming the central theme: Scalability of compute-to-storage communications, patient populations, integration with medical records and imaging systems, validation methods, security infrastructures, version control of process with data and communication of results to the patient.

We will present an architectural summary for scalable personalized medicine along with a case study.

Speaker: Grainger Greene, Verinata Health

Noninvasive prenatal testing represents a major paradigm shift in maternal-fetal medicine. The verifi® test is a noninvasive prenatal test that was initially introduced to detect trisomy 21 (Down syndrome), trisomy 18, and trisomy 13 using cell-free DNA in maternal blood. The test was recently expanded with an option to test for sex chromosome aneuploidies. Verinata’s approach to advancing safe, accurate, and more comprehensive tests for physicians and pregnant women will be discussed.

Speakers: Chaim Birnboim, M.D., Founder & Chief Scientific Officer, DNA Genotek

Sometimes overlooked in the development of molecular tests for Personalized Medicine is the considerable importance of pre-analytical factors. First, ease of sample collection can be an important factor for donor compliance. Secondly, stability between collection and isolation of the analyte of interest can have major impact on the validity of a test result. In general, biospecimens begin to change immediately after they are taken. Genomic DNA is relatively stable, but other components, such as mRNA profiles and the relative proportion of microbes that colonize different body sites, begin to change rapidly in the ex vivo environment. From the time of its inception, DNA Genotek has focussed on both factors. The success of Oragene® saliva DNA kits for research and clinical uses is evidenced by citations in >700 scientific publications, from which some examples will be drawn. New applications and new directions relevant to Personalized Medicine will be presented.

Speaker: Sharon Terry, President and CEO, Genetic Alliance

Personalized medicine cannot be realized through innovative technologies and smart researchers alone. The people must move, and they must reclaim their place in the transformational ecosystem that is needed for the promise to be kept. Tools to activate ordinary citizens will be presented, with an emphasis on Registries for All (reg4all.org).

Speaker: Roman Yelensky, Ph.D., Director, Clinical Genomic Analysis, Foundation Medicine, Inc.

As the number of clinically relevant cancer genes increases, next-generation sequencing (NGS) is becoming an attractive diagnostic tool, as it can be optimized to detect most functional genomic alterations in a single assay. We have developed an NGS-based test that characterizes all classes of genomic alterations across 236 cancer-related genes from routine FFPE clinical specimens. We validated the test using reference samples reflecting key drivers of detection accuracy and verified performance in clinical specimens previously characterized by other assays. Experience with >2,000 patient cases revealed at least one clinically actionable alteration in 76% of tumors, over three times greater total actionable alterations than current diagnostic tests.

Speaker: Vicki Seyfert-Margolis, Ph.D., CSO, Precision Health & Former FDA Senior Advisor

Pharmaceutical development is an increasingly complex and expensive endeavor. On average, only 1 of every 5000 compounds discovered will reach commercialization, each requiring an investment around $1.3 billion and 10-15 years of laboratory work, clinical trials and regulatory reviews. The pharmaceutical industry increasingly recognizes that successful new product development requires not only an understanding of the drug’s benefits and risks, but also a fundamental understanding of the market into which it is launched. Consequently, targeted information concerning patient needs, behaviors, predispositions and tolerances carries significant value. Currently, pharma relies primarily upon traditional methods of gathering information – literature reviews, surveys, focus groups, and key opinion leaders. The past several years has seen a fundamental shift in the communication of health information by patients. The myriad of internet forums and social media platforms, where patients openly share experiences related to their medical conditions and treatments, represent a largely untapped storehouse of self-reported data with significant value for the drug development process. The explosion of smartphones presents another important opportunity to collect patient-reported data.

Speaker: Lars Mecklenburg, Ph.D., Vice President Clinical Operations/Biobank, Indivumed, Inc.

The development of personalized medicine in oncology is fostered by the high-throughput analysis of molecular biomarkers in human cancer biospecimens. The quality of such tissue specimens highly depends on the circumstances under which they were acquired from the patient, and the control of such pre-analytical conditions is of paramount importance for downstream analyses. Indivumed has established a unique infrastructure in order to control the quality of cancer biospecimens. In addition, we have conducted studies investigating the impact of warm and cold ischemia time on the molecular composition of cancer specimens. The talk will present quality control measures, discuss molecular changes that are induced by surgical and postsurgical processing and its implication for personalized medicine strategies.

Speaker: Niko Drivas, Director of Business Development & Licensing, Abbott Molecular

The successful development and commercialization of a CDx requires much forethought, coordination and joint execution. Contractual provisions should be written to allow for project scope changes due to adaptive clinical outcomes and the associated regulatory requirements. Alliance Management plays a key role in maintaining a productive collaboration and ensuring that the project timeline and budget are on track. The deal structure must have business incentives for both parties to be successful from inception and throughout the life of the therapeutic/CDx.

    · Establish the collaboration based on a common vision, norms and stated objectives

    · Define and abide by a process for issue resolution

    · Maintain flexibility to accommodate contingency plans

    · Develop the CDx with user interface input

    · Commercialize the CDx with global access in mind

Speaker: Jack Young, Director, Qualcomm Life Fund

The growth of sensors and smartphones is altering the health care landscape, placing affordable clinical quality medical diagnostics and monitoring tools in everyone’s hands. Increasing amounts of venture capital is pouring into related startups, with early offerings already demonstrating a significant impact. Building on the industry momentum and the creation of Qualcomm Life Inc, Qualcomm Ventures (QVC) launched a $100M dedicated health fund called the Qualcomm Life Fund (QLF). With the portfolio grown to 8 companies, QLF/QCV was ranked as the most prolific investor in digital health in 2012. During this presentation, Director of Ventures, Jack Young will cover the history behind QVC’s investments in the healthcare industry and offer insights as to what’s on the horizon.

Speaker: Amir Handzel, Ph.D., Associate Director, Bioinformatics Astellas Pharma

Precision medicine is emerging as a central paradigm for drug development and clinical practice. Yet no general framework exists for early evaluation of drug development programs with companion diagnostics. This gap in strategic planning can lead to failure that carries high cost and loss to the pharmaceutical company, to patients and ultimately to society as a whole. We have developed a comprehensive quantitative methodology that can help close this strategic gap. Key parameters which determine the potential for success have been identified and their joint relations have been carefully mapped. They include the prevalence of response to the intended treatment, the clinical strength of response, and the potential strength of an enrichment marker. The new methodology can help leaders guide development efforts of a CDx program towards success.

Speaker: Amir Onn, M.D., Director, Center of Pulmonary Oncology, Sheba Medical Center

Clinical trial design in oncology has become complex because of rapid progress in the development of cancer therapeutics and identification of multiple biological markers of response or resistance to these agents. The WIN Consortium (Worldwide Innovative Networking in personalized cancer medicine) has developed an original academic and international clinical trial named WINTHER. This is the first clinical trial offering a choice of cancer therapeutics guided by the individual's specific tumor biology. Double biopsy will be obtained from the primary tumor (or metastasis) and normal tissue of each patient. A comprehensive biological analysis will be conducted, including studies for expression of DNA, RNA and microRNA. The therapeutic options will be discussed between study leaders and decision will be based on an estimated drug efficacy scoring bioinformatics tool. The aim of this study is to propose a personalized treatment approach for most of the patients enrolled in WINTHER. Participating centers include MD Anderson Cancer Center ( Houston, Texas, USA), Vall d'Hebron Hospital (Spain), Chaim Sheba Medical Center (Israel) and Gustave Roussy Institute (Villejuif, France).

Speaker: Noam Shomron, Ph.D., Director, RGI-Israel, Tel Aviv University

Short non-coding RNAs, termed microRNAs, extensively regulate gene expression. These molecules were shown to be dominant regulators and valuable biomarkers in various diseases. In our laboratory we combine high-throughput methods and bioinformatics to explore how microRNAs are deregulated in olfactory epithelium of schizophrenia patients and controls. We looked into changing microRNA levels and how they can potentially affect the cellular processes. Overall our team pursues research that aims to deepen our understanding on the development of diseases in order to generate a significant impact through translating ideas into clinical reality.

Speaker: Zvi Livneh, Ph.D., Professorial Chair in Biomedical Research, Weizmann Institute of Science

DNA repair plays a key role in preventing cancer, via its DNA safeguarding activities, whichprevent mutations and genomic instability. We have developed a panel of three personalized risk biomarkers based on DNA repair, and used them to calculate a personalized integrated DNA repair score. We found that low DNA score is strongly associated with lung cancer risk. The panel can be useful for , and for defining an extra-high risk group, well above smoking, for subsequent low-dose CT screening.

Speaker: Marc Samuels, Managing Partner, HillCo HEALTH

The presentation will provide insight on U.S. health policy for coding, coverage and payment of molecular diagnostic tests, with examples of specific tests and how they are treated differently in policy based on fee schedules, site of service and other variables. Recent changes in each of these policy areas will also be reviewed using specific examples to illustrate the changes and to forecast the health policy environment for new technologies such as next generation sequencing and new prognostic assays. In addition, the Affordable Care Act and sequestration will be reviewed for their impact on policies associated with molecular diagnostics.

Speaker: Lindsey Rolfe, MBChB, VP Clinical Development, Clovis Oncology

Rucaparib is a potent oral inhibitor of poly (ADP-ribose) polymerase (PARP) 1 and 2. It is currently in clinical development for the treatment of high grade serous adenocarcinoma. The evidence for activity of PARP inhibitors in tumors with mutations in the BRCA 1/2 genes is strong. However, PARP inhibitor sensitivity extends beyond BRCA and the challenge will be to identify the additional genetic aberrations associated with PARP sensitivity in a wider patient population. The talk will describe the ongoing clinical development program of rucaparib including the integrated strategy for identification of sensitive patients, and its application in the clinic.

Speaker: Alexandre Passioukov, M.D., Ph.D., Biomarker Experimental Medicine Leader, Roche (pRED)

The advent of anticancer targeted therapies in the last decades has impressively changed the landscape of lung cancer treatment options. Even if only a few markers have a demonstrated clinical utility so far, - like FDA-approved EGFR gene mutation, predictive of sensitivity to EGFR TKIs erlotinib and gefitinib, or EML4-ALK fusion gene mutation predictive for response to crizotinib, a larger number of emerging promising biomarkers (eg. EGFR, ERCC, RRM1 and TS gene expression, or KRAS mutation) is following. This list will keep growing, with a very high likelihood that additional markers would make their way into the clinics in coming years. Main challenges for the molecular diagnosis field, along as with potential new venues for lung biomarkers discover will be discussed.

Speaker: Paul Billings, M.D., Chief Medical Officer, LIFE Technologies

The utilization of innovations developed in pursuit of life science research to better measure and characterize disease, and care for the ill are goals of Personalized Medicine. In this presentation, using specific oncology examples, I will discuss new approaches enabled by Next Generation Sequencing to deliver precision care. Informatic infrastructure and data sophistication along with professional services are required to “fast track” these important clinical developments.

Speaker: Michael Snyder, Ph.D., Professor & Chair, Stanford Center of Genomics & Personalized Medicine

We used a combination of omics methods to assess health states in a single individual over the course of almost three years. Genome sequencing was used to determine disease risk. Longitudinal personal omits profiling of transcriptome, proteome and metabolome was used to monitor disease assess, including viral infections and the onset of diabetes. These approaches are elected to transform personalized medicine.

Speaker: Takashi Kido, Research Manager, Riken Genesis

This talk will cover the concept of MyFinder, a new framework for realizing an intimate personal genome service with AI technologies. The speaker will talk about his own quantified self (QS) experiences in parallel with his whole genome sequencing analyses, and report what these data driven QS activities reveal. Also discussed will be the “CitizenScience” genetics projects in predictive medicine (diabetes), psychological and cognitive performance, and sleep, which provide new insights for preventive medicine.

Speaker: Ronen Tamir, Pharma Segment Leader, GE Healthcare

In order for precision Dx to have true value, it needs to have multi-modality (in-vivo and in-vitro) components that provide insight throughout the precision Rx process - patient selection, therapy selection and therapy monitoring. A good companion Dx tool needs to be comprehensive and integrated to include Hardware (machines), Software (analytics) and Wetware (from PET tracers to antibodies and reagents). This integration unlocks the value that precision Dx brings to all players in the healthcare system, from Pharma and physicians to payers and patients. Current business models between pharma and diagnostic companies rarely takes this value creation into consideration. The current model of Dx is antiquated with a pay structure that is unsustainable and limits innovation due to the development cost and the regulatory and commercialization demands from the Dx industry. The Dx company has to validate monetary recognition of value with the payers, in a pay-per-labor environment. We need new, innovative models that recognize the value it brings and the risk that the diagnostics company takes as a strategic partner to pharma.

Speaker: Lawrence Corey, M.D., President & Director, Fred Hutchinson Cancer Research Center

Chronic viral and bacterial infections are a leading cause of morbidity worldwide. Many of these pathogens, such as hepatitis B and C, HIV, EBV, HHV-8, and heliobacter pylori, are associated with cancer. Other chronic viral infections, such as HSV, cause often lifelong relapsing morbidity. The interplay by which an organism persists long term in the human for years is being unraveled. Technology to elucidate host viral interactions on a single cell level in vivo are providing insights into how one can alter this milieu to tip the host-pathogen balance toward clearance of the pathogen. Currently, shingles vaccine is the lone therapeutic vaccine. However, inroads in the development of vaccines for eradicating these organisms and hence, interrupting their role in cancer, are in development.

Speaker: Dave Kronlage, SVP Pipeline Development and Pre-commercialization, Pamlab Inc.

Errors of metabolism have been found in subgroups of patients with certain chronic conditions related to the underlying disease pathophysiology. Some of these biomarkers predict an inadequate response to standard treatment and a poorer prognosis. Bioactive nutrients that by-pass errors in metabolism or address specific metabolic processes have been shown to enhance patient outcomes. Pamlab is a biomedical company that specializes in natural personalized medicine by offering health care providers high quality prescription medical foods to safely target the distinct nutritional requirements of patients suffering from a neurologic or metabolic disorder.

Speaker: Mara Aspinall, CEO, Ventana Medical Systems, a member of the Roche Group

Diagnostics has emerged – everyone is talking about them. Pharma is paying for them, scientists are improving them, venture capitalists are funding them, and conference organizers are constantly focusing on them. Efficacy as well as sensitivity and specificity have improved dramatically with old and new technologies.

Yes medical schools are not teaching them, physicians are not using them regularly, regulators are perplexed by them and payors are constantly looking for ways to pay less for them.

Why is happening? How can innovation improve the situation? What can do about it?

Speaker: Anil Sethi, CEO, Pinch Bio

Personalized Medicine refers to diagnostic and clinical interventions. However, patient involvement from Personalized Healthcare is exploding, by way of Patient-Controlled Health Records (PCHRs). PCHRs capture health info from the white space, between clinical encounters. In 2014, ONC/CMS Meaningful Use Stage 2 mandates that patients have amazing new rights to View/Download/Transmit clinical summaries (into their PCHRs), after every encounter. Patients will curate data: clinical and self-reported, direct-to-consumer genetic testing, Quantified-Self data from Fitbit-like sensors, plus iPhone apps. Meaningful health progress happens only when advanced clinical therapeutics leverages this PCHR data, to inform PM. We'll map-out federal mandates, timelines, and opportunities.

Speaker: Robert Jesse, M.D., Ph.D., Principal Deputy Under Secretary for Health, Department of Veterans Affairs

The Veterans Health Administration is committed to transitioning its model for health care delivery to one that it Personalized, Proactive, and Patient Driven. This is instantiated across the organization at the highest level through VHA’s strategic plan. Operationalizing this broad goal requires commitment and training across all levels of the organization, including the resources to ensure success, and, it absolutely requires the engagement of the patients. This will be supported by a foundation based on both team-based care and connected-health capabilities that ensure patients can optimize their health and well-being.

Speaker: Joe W. Gray, Ph.D., Director, Spatial Systems Biomedicine Center & Chair of Biomedical Engineering, OHSU

International breast cancer analysis efforts have now completed a first draft of the breast cancer "ome". These studies suggest the existence of approximately 10 defined subtypes defined by recurrent transcriptional and genomic features plus tens to hundreds of genomic aberrations that occur rarely or may be unique to an individual tumor. This presentation will focus on (a) computational strategies to identify pathways controlling aspects of cancer pathophysiology that are deregulated by the diverse genomic aberrations, (b) development of cell model systems that mirror these deregulated pathways, (c) high throughput image analysis based analysis strategies for elucidation of the aspects of cancer pathophysiology enabled by specific deregulated pathways and (d) strategies to prioritize and target the most promising deregulated pathways.

Speaker: Mavis L. Yee, Partner, Nixon Peabody LLP

With the onset of electronic medical records and the explosion of mobile apps, there is a fast approaching convergence of legal issues that will impact how healthcare providers interact with patients and other providers through the use of mobile technology. The session will briefly describe emerging legal issues and federal law governing the use of mobile technology for the transmission and storage of personal medical information.

Speaker: Rowan Chapman, Ph.D., Head of Precision Diagnostics at GE Healthcare

With aging populations and unsustainable increases in healthcare spending, the need for personalized medicine has never been greater. As scientific innovations and technologies proliferate, how can healthcare providers manage the overwhelming amount of diagnostic data that is being generated from multiple sources and collaborate across specialties to select the right treatment for the right patient at the right time? Rowan Chapman will discuss the opportunity to digitize and integrate data – to make diagnostic information actionable – and the impact this could have on patients, providers and payers across the world.

Speaker: Evian Gordon, BSc, Ph.D., MBBCh Chairman and CEO Brain Resource

The complementary benefit of predicting treatment response using cognition, genomics and EEG is presented in 1000 patients with Depression and 336 patients with ADHD. In predicting treatment response to Escitalopram, Sertraline and Venlafaxine XR, included cognition interaction between thinking and emotion, genomics BDNF and EEG biomarkers of frontal theta. In ADHD response to stimulant medication, cognition attention and response variability, DRD4 and EEG theta (4-7Hz)-beta (SMR 12-15Hz) ratio provided different clinical insights into treatment prediction.

Speaker: Jeffrey D. Marrazzo, Chief Business Officer, MolecularHealth

The falling cost of sequencing, growing number of available cancer therapies and trials, and rapidly expanding body of biomedical knowledge together are enabling the interpretation of NGS for those patients who can afford it. However, the reality of interpreting NGS data within the context of drug data and biomedical knowledge, even for expert clinicians like molecular pathologists and geneticists, requires the implementation of new technologies. These technical capabilities, along with the growing responsibilities of clinical pharmacologists in the NGS-informed treatment decision-making process, will continue to evolve and become adopted as genetic sequence-informed Personalized Cancer Therapy moves into the community oncology setting.

Speaker: Mathias Ehrich, M.D., VP, Research and Development, Sequenom

Noninvasive prenatal testing (NIPT) has recently been introduced for testing of women at high risk for carrying a baby with trisomy 21. Saldivar, et al have presented their overall experience in >30,000 patients undergoing NIPT for fetal aneuploidy. Of these high-risk patients the indications for testing included age-related risk (73.3%), ultrasound abnormalities (26.4%), positive serum screening results (12.6%), and history of aneuploidy (4.3%). We will present data from our experience in a high-throughput testing environment.

Speaker: Walter Koch, Ph.D., Vice President & Head of Global Research, Roche Molecular Systems, Inc.

The advent of high throughput gene sequencing and other genomic characterization technologies is facilitating discovery of the underlying molecular basis of many diseases at an unprecedented pace. In particular, efforts of The Cancer Genome Atlas project and others are identifying a plethora of potential drivers of aberrant cancer cell behavior that could be targeted therapeutically. As companies and academic centers race to establish Next Generation Sequencing-based characterization of tumors into routine clinical diagnostic use, there are a number of challenges for making this genomic information clinically actionable. First, newly discovered mutated or overexpressed proteins must be proven to be critical “drivers” of cancer cell growth and/or metastasis. Additionally, there is a dearth of approved drugs that target the multitude of oncoproteins and pathways that are either known or still being discovered. To increase the pace of translation from discovery to routine implementation in the clinic, novel clinical development strategies will be needed, moving from the current model of co-development of one drug with one companion diagnostic, to differential diagnosis of molecularly-defined subtypes of disease using biomarker panels, many of which will have implications for existing therapies, as well as evolving use for drugs entering into development.

Speaker: John Hornberger, M.D., CEO and President, CEDAR Associates LLC

Much of the future of personalized medicine is based on development of sophisticated algorithms predicting diagnosis, outcome, or response to therapy. Medicare recently stated an unwillingness to reimburse for such algorithms. The sophistication of these algorithms – developed based on solid principles of biostatistical and artificial intellegence - are such that even the most mathematically capable human cannot replicate the computations. Establishing policies not to reimburse for such algorithms lacks face validity, akin to assigning all the value of a computer to the hardware and assigning no value to the software, and creates disincentive to invest in this nascent field. This talk will discuss theoretically credible and proven methods for assigning a value, and thereby a price, to such innovations in health care.

Speaker: Ralph Snyderman, M.D., Chancellor Emeritus, Duke University

The concept of personalized medicine, spurred by the genomic revolution, was proposed a decade ago as the next transformation of medicine. Despite the development of exciting technical innovations, the practice of medicine has largely remained unchanged. However, the adoption of personalized health care is now rapidly gaining ground through continued advances in technology and the understanding of the power of personalized health care (PHC) as a new practice model. PHC uses personalized medicine applications, along with personalized health planning, to improve how care is delivered by making it more predictable, proactive, and strategic, thereby providing the best care for each patient. The transformation of medicine by PHC has indeed begun.

Speaker: Randy Scott, Ph.D., Chairman and CEO, InVitae Corporation

The power, speed and low cost of next generation DNA sequencing is rapidly changing the paradigm of genetic testing by making it economically feasible to aggregate all genetic testing into a single assay at very low cost. How we manage and incorporate that information into routine medical practice and empower that data for the research community may be the largest informatics business opportunity of the 21st century -- with the power to dramatically alter how we define, research, treat, and prevent human disease.

Speaker: John Mattison, M.D., CMIO & Assistant Medical Director, Kaiser-Permanente, SCAL

Much of the current healthcare crisis derives from diseases of lifestyle that result in obesity, diabetes and their numerous comorbities. "Information Therapy" has been remarkably ineffective in addressing these epidemics. I will focus on how personalizing the behavioral approaches for each consumer is required to support healthier lifestyles.

Speaker: Colin Hill, CEO, President, Chairman & Co-Founder, GNS Healthcare

Despite numerous breakthroughs in biotechnology, the quality of healthcare has improved only incrementally, while costs have soared. This is due in part to our one-size-fits-all approach to medicine. Thus, there is a huge opportunity to reduce costs while improving care for patients by harnessing Big Data to discover what works and for whom. We are doing this today using Real World Outcomes data: medical claims, pharmacy claims, and electronic medical records. Using high performance supercomputing and sophisticated machine learning algorithms, we are building causal models of disease at the individual patient level. We are using these models to predict individual patient risk and disease trajectories in IBD, and to match interventions to individual patients at risk of developing diabetes and serious heart conditions. Our partners in the health insurance industry are using these models to optimize benefit design and disease modification programs to reduce costs and improve patient outcomes. Using similar models, we are helping our partners in the pharmaceutical industry match treatments to patients by identifying predictive biomarkers for diseases such as cancer and rheumatoid arthritis using genomic and proteomic data. As these types of molecular data become combined with Real World Outcomes data and Electronic Health Records, even more opportunities will open up, allowing Big Data analytics to help usher in a new era of personalized medicine.

Speaker: Stephen M. Stahl, M.D., Ph.D., UCSD

Major depression is a debilitating illness that affects over 121 million people worldwide and is considered by the WHO to be the leading cause of disability worldwide. The current paradigm of antidepressant "trial and error" results in a poorer prognosis and greater cost for patients. There is a high unmet medical need for therapies linked to biomarkers that predict a greater chance of treatment success in mental illness. Emerging therapies that that target specific biomarkers in major depression hold promise for personalized medicine in mental illness.

Speaker: Ann Kapoun, Ph.D., Vice President of Translational Medicine, OncoMed Pharmaceuticals

Dr. Kapoun will discuss OncoMed’s approach and implementation of predictive biomarkers into their clinical trials for patient selection. OncoMed Pharmaceuticals is a clinical-stage company that discovers and develops novel therapeutics targeting cancer stem cells, the cells shown to be capable of driving tumor growth, recurrence and metastasis. OncoMed has advanced five anti-cancer therapeutics into the clinic, including demcizumab (OMP-21M18, Anti-DLL4), OMP-59R5 (Anti-Notch2/3), OMP-52M51 (Anti-Notch1), OMP-18R5 (Anti-Fzd7), and OMP-54F28 (Fzd8-Fc), which target key cancer stem cell signaling pathways including Notch and Wnt.

Speaker: Gil Omenn, M.D., Ph.D., Director, University of Michigan Center for Computational Medicine & Bioinformatics

Molecularly-targeted therapies require companion diagnostic tests to identify and stratify patients for most appropriate choices of therapy. Few biomarker candidates have been developed to clinical utility. The Institute of Medicine created a Committee on Omics-Based Predictive Tests; its 2012 report is “Evolution of Translational Omics: Lessons Learned and Path Forward”. Its framework for test development has three phases: discovery, validation, and demonstration of clinical utility. Numerous lessons are drawn from case studies, notably including now-retracted publications from Nevins, Potti, and collaborators at Duke and premature launch of companies and clinical trials. Guidance is provided for the responsible parties: all co-authors, host institution, funders, regulators, and journals. Hopefully these recommendations will help accelerate progress toward personalized medicine.

Speaker: Yael Mosse, M.D., Perelman School of Medicine, University of Pennsylvania

Advances in the treatment of children with high-risk neuroblastoma have, until recently, involved the addition of cytotoxic therapy to already dose-intensive regimens. The discovery of hereditary and germline mutations in the oncogene ALK places neuroblastoma among other cancers such as melanoma and non-small cell lung cancer which benefit from targeted therapies with small molecule tyrosine kinase inhibitors. However, inhibition of mutated ALK has proven to be complex and remains a therapeutic challenge. This presentation will focus on (a) biology of ALK in neuroblastoma compared to ALK-translocated human malignancies, (b) preclinical progress with ALK inhibition, (c) integration of functional and computational modeling to stratify patients to ALKi therapy, (d) Combining therapeutic interventions with molecular diagnostics for patient selection and clinical trial design.

Speaker: Bruce R.Conklin, M.D., Departments of Medicine & Pharmacology, Gladstone Institute of Cardiovascular Disease.

Dr. Conklin is using induced pluripotent stem (iPS) cells to model human disease. His major focus is on genes that cause “sudden death” due to abnormal heart rhythm, as well as genes involved in heart failure from cardiomyopathy. He uses iPS cells from patients who have genetic diseases, and is also engineering iPS cells to have specific mutations. Engineering iPS cells allowing direct comparison of many gene variants with the exact same (isogenic) background. Recent genetic studies such as GWAS, provide gene variant associations that largely remain untested. The use of iPS cells with discrete mutations in an isogenic background provides an experimental system to directly test gene variants that have been implicated in genetic studies. Personalized medicine can benefit from experimental testing of gene variants to prove (or disprove) hypothetical associations that GWAS and other genetic studies.

Speaker: Stephan Brock, Ph.D., Chief Technology Officer, President, Molecular Health

The practice of medicine has historically emphasized the role of guidelines – standards set by oversight bodies reviewing clinical studies, published literature and anecdotal evidence. With the advent of gene sequencing, powerful technologies to analyze immense volumes of data, and diminishing barriers to accessing patient data, novel clinico-molecular analyses are enabling increasingly precise treatment decision-making. Considered together in a real-world case study, Genomic, Pharmacological safety, and “Population” level integrated data analysis provides health practitioners with a compelling toolkit to optimize medical decision-making.

Speaker: Nigam H. Shah, MBBS, Ph.D., Assistant Professor of Medicine (Biomedical Informatics), Stanford University

We present data mining methods that transform unstructured patient notes taken by doctors, nurses and other clinicians into a de-identified, temporally ordered, patient-feature matrix using standardized medical terminologies. We demonstrate how to use the resulting high-throughput data to monitor for adverse drug events and profile the safety of specific drugs based on the clinical notes in the EHR. We will discuss a proof of principle study which shows the potential of text-analytics to uncover ‘natural experiments’, which profile the safety of Cilostazol in patients with Congestive Heart Failure. Such data-mining methods have applications in post-marketing drug safety surveillance and in obtaining personalized insight into difficult-to-test clinical hypotheses.

Speaker: Janet Woodcock, M.D., Director, Center for Drug Evaluation & Research, FDA

By fast-tracking individualized treatments through the FDA approval process and encouraging collaboration between the regulatory and industry arenas, Dr. Woodcock has shown dedication to personalized medicine. In 2011 during her tenure, Xalkori and Zelboraf, individualized treatments both paired with companion diagnostics, received FDA approval.

Speaker: Laura Esserman, M.D., Director, Carol Franc Buck Breast Care Center, Professor of Surgery and Radiology, UCSF

Dr. Esserman will review the need for new approaches to clinical trials. Give an example of an approach to clinical trials that will allow us to screen Phase II agents and identify the tumor subtypes for which the agents are most effective. Also she will discuss the eventual need to develop therapeutic switching if we want to harness emerging targeted therapies.

Speaker: Steffan Ho, M.D., Ph.D., Director, Translational Oncology, Pfizer Inc.

Lung cancer has undergone a remarkable transformation from a histology-defined malignancy treated with chemotherapy to a disease in which molecular characterization directs treatment with an increasingly diverse spectrum of highly effective targeted therapeutic agents. The evolution of diagnostic testing in lung cancer provides a broadly relevant view of the real world application of Personalized Medicine in the clinic, and offers important insights into future challenges.

Speaker: Susan Garfield, Lou Hochheiser, Naomi Aronson, Rina Wolf, Jeanne De Sa, Ira Klein

During this panel discussion, payers, health technology assessment leaders and leaders from medical groups will discuss how personalized medicine technologies will be evaluated and paid for. Each will describe the key factors in assessing value from their constituent perspectives. The session will provide audience members with insights into payer perspectives on personalized medicine, evidence requirements to achieve coverage and payment, how health technology assessments are evolving to assess personalized medicine technologies, and how healthcare provider groups are considering the economics of practice change related to adopting personalized medicine.

Speaker: James Kobielus, Big Data Evangelist, IBM

Healthcare providers and payers require analytics-driven decision support tools to personalize treatment delivery, improve patient outcomes, and lower operational costs. A key new technology to support these objectives is similarity analytics, which identifies patients who are similar to a given patient for decision support and comparative effectiveness research analysis. In this presentation, Jianying Hu and James Kobielus from IBM will discuss the treatment personalization applications of patient similarity analytics and complementary big-data analytics technologies.

Speaker: Cliff Reid, Ph.D., CEO, Complete Genomic

Whole human genome sequencing is becoming so accurate and inexpensive that it will soon be less expensive to sequence the entire genome than to run even a few genetic tests. Once a person’s genome is sequenced and securely stored, it acts as the ultimate genetic test: all subsequent genetic tests are nothing more than database lookups, which cost approximately nothing. This offers a promising path to reducing healthcare costs, with national health care systems well positioned to benefit, and private insurance systems struggling to adapt. But the biggest winners from this disruptive technology may be an entirely new category of diagnostics companies.

Speaker: Brett Davis & Deven Atnoor, Oracle

The volume, variety and velocity of new genomic data, along with dramatic declining cost of obtaining it are having a profound impact on the prospects for personalized healthcare. However, gains in genomic data are only part of the journey toward personalized healthcare and new data management platforms will be required to bring a variety of currently siloed data types together to truly achieve value based, personalized healthcare. This presentation will discuss the opportunities and challenges in the quest for personalized healthcare as well as the new informatics platforms that will be required to support not just translational research but the personalization of care. Specifically, Oracle will demonstrate its Translational Research Center (TRC) platform that is being implemented by many of the world’s leading academic medical centers, integrated delivery networks and cancer centers to answer the “hard questions” in healthcare – what works, for whom, why, in what context and at what cost?

Speaker: Mark Trusheim, Visiting Scientist & Executive-In-Residence, MIT Sloan School of Management

Science leading to ever smaller patient sub-populations, regulatory and payer evidence standards increasing, patents weakening, reimbursement under pressure globally - is personalized medicine facing an economic crossroads? Through the challenges, there exists a path to sustainable, viable economics for all. It will require some change by all to realize the potential for patients and unlock incentives for all. Pulling together recent quantitative research, we’ll move beyond talking points to evidence based rationale for that change.

Speaker: Hasso Plattner, Prof. Dr. h.c. mult. Co-founder, SAP

SAP and the Hasso Plattner Institute Potsdam have pioneered the use of SAP HANA, an in-memory database, to provide an integrated platform for processing and real-time analysis of large volumes of genomic data. The platform supports a wide variety of alignment and variant calling algorithms. Variants are stored in a large in-memory database and seamlessly aggregated with numerous international scientific databases (including NCBI, PubMed, 1000 genomes project and dbSNP). This novel storage mechanism gives the researcher an unprecedented ability to perform sophisticated real-time analyses of variants across large cohorts.

Speaker: Joyce Peng, Marketing Director, BGI Americas

BGI, the largest genomics organization in the world, is legendary for its extensively published research. This talk will cover recent medical research by BGI, including the application of metagenomics in diabetes and single-cell sequencing in cancer research. With the goal of translating medical research breakthroughs into global healthcare solutions, BGI is bringing state-of-the-art multi-omic technologies to the clinical setting. Building on extensive clinical testing experience in China, BGI today is enabling medical providers and patients worldwide realize the promise of genomics-based medical diagnostics and personalized healthcare.

Speaker: Michael Kamerick, DC Specialist Leader, Recombinant By Deloitte

This session will explore multiple real world deployments where organizations leverage data as an asset to support a personalized medicine mission. The technology and expertise for these projects is provided by Recombinant, a software/analytics unit of Deloitte that is 100% focused on enabling the secondary use of healthcare data.

Speaker: Jeanne De Sa, Senior VP, UnitedHealth Center for Health Reform & Modernization, UnitedHealth Group

The presentation will review recent claims data from UnitedHealthcare for genetic testing and molecular diagnostic services as well as estimates of national spending. The speaker will discuss implications of their findings for the future of personalized medicine and its role in an improved delivery system. The presentation will cover trends in Medicare, Medicaid and the commercial sector and discuss issues relevant to the use of diagnostics in those populations.

Speaker: Corey S. Goodman, Ph.D., Managing Partner & Co-founder, venBio LLC

Discoveries from biomedical research have reached heights but despite that tools, technologies and targets for drug discovery are greater than ever, Big Pharma is having problems with their internal pipelines. Additionally, many biotech companies are having problems getting funded while Life science venture capital firms are closing. To fix this ecosystem, we need all three legs of the stool – biotech, venture capital, and pharma – working together in new collaborative models to deliver on the promise of bringing important new medicines forward for human health.

Speaker: Yusra Hussain, M.D., Clinical Assistant Professor & Medical Director, Aging Adult Services, Stanford Hospital & Clinics

Much of what we know today is based on studies in centenarians and super-centenarians. Through research we are finding that aging itself is a risk factor for many diseases such as heart disease, cancer, and neurodegenerative diseases. The percentage of people with these illnesses is projected to increase considerably in the coming decades. Findings from animal studies have demonstrated that aging is a plastic process that can be manipulated by both genetic and environmental factors. I will discuss some of the genetic variants that protect centenarians from increased risk of age associated diseases. I will also touch base on the concept of compression of morbidity presented first by Dr. Fries in the mid nineties. I will also go over some of the known environmental mechanisms that promote longevity.

Speaker: Mehrdad Ayati, M.D., Faculty Stanford University School of Medicine

The geriatric population is prescribed the highest proportion of medications in relation to their percentage of the U.S population-13% of current geriatric population purchase 33% of all prescription drugs and this number will increase to 50% by 2040. Prevalence of both adverse drug reactions and treatment failures increase in the older patients. Adverse Drug Events (ADEs) are responsible for 5-28% of acute geriatric medical admissions. It has been estimated that for every one dollar we spend on medications at nursing home facilities, we spend $1.33 in health care resources for the treatment of drug related morbidity and mortality.

The genetics of drug metabolizing enzymes (DMEs), P450 or CYP, and drug transporters (DTs) play a major role in their clinical response. Our knowledge of pharmacogenomics started back in the 6th century BC by Pythagoras who found that eating fava beans caused illness in few but not all individuals. This knowledge has been built upon until our current understanding of the relationship between xenobiotic metabolism with the CYP system (examples are Clopidogrel metabolism related to CYP2C19; the impact of CYP2C9 polymorphic variants and functional genetic variants in the VKORC1 gene on the pharmacokinetics and pharmacodynamics of warfarin; and similar effects on Statin, Beta Blocker, SSRIs, Antiepileptic, etc.). Bringing the knowledge of pharmacogenomics into clinical practice will have a substantial impact in minimizing the adverse drug events and improving the quality of care in the elderly population.

Speaker: Don Morris, Ph.D., VP, Scientific Product & Technology Development, Archimedes Inc

Use of complex personal genomic information to inform routine clinical decisions requires a new approach to treatment guidelines and new tools to evaluate and then communicate the options. Archimedes IndiGO, a decision support tool already in use at Kaiser Permanente and other organizations, generates personalized guidelines that can take complex data into account. Its new risk-based decision paradigm can easily be extended allowing for a seamless integration of a variety of complex information in the clinic.

Speaker: Yaniv Erlich, Ph.D., Whitehead Fellow, Whitehead Institute for Biomedical Research

Sharing sequencing datasets without identifiers has become a common practice in genomics. We developed a novel technique that uses entirely free, publicly accessible Internet resources to fully identify individuals in these studies. I will present quantitative analysis about the probability of identifying US individuals by this technique. In addition, I will demonstrate the power of our approach by tracing back the identities of multiple whole genome datasets in public sequencing repositories.

Speaker: Kim Popovits, Chairman, CEO & President, Genomic Health

Often we hear personalized medicine as getting the right drug to the right patient in the right dose at the right time. In cancer it is really about patients understanding their individual disease since one tumor is not like any other tumor. Therefore, it is critical for physicians and patients to understand the genomic makeup, or molecular signature, of a particular tumor in order to better direct treatment. All cancer patients deserve to have access to personalized medicine regardless of where they are treated; however, several barriers stand in the way of this goal including physician education and the ability to translate an unprecedented amount of data into clinically relevant information. The knowledge and tools are here; however, industry, academia, community physicians and payors must work together to deliver high-value, precise, personalized medicine to all CANCER patients.

Speaker: Marty Tenenbaum, Sarah Green, Tony Blau, Frank McCormick

Cancer Commons is an open science initiative founded to fast-track research on personalized oncology by matching patients to the best available therapies for their tumors, and learning as much as possible from the results. The rapid learning process continually updates a consensus knowledge base of biomarkers and targeted therapies through data analysis and discussion of the latest laboratory and clinical findings. By fostering the free flow of data and knowledge among physicians, researchers and patients, and across cancers and institutions, we aim to propel fresh lines of research, suggest novel treatment approaches, and ultimately offer new hope to millions of cancer patients. Join a conversation with four of the principals and invited industry discussants to learn how you and your organization can participate.

Speaker: Steven C Quay, M.D., Ph.D., FCAP, Founder, Atossa Genetics, Inc.

How to obtain routine, repeated, painless breast biopsy samples non-invasively for cytopathology, NGS, proteome, and transcriptome analysis of precursors to breast cancer; Identifying the earliest “-omic” changes in reversible precursor lesions of the breast, such as atypical ductal hyperplasia; The use of breast specimens obtained non-invasively for biomarker discovery, clinical trial support, and patient selection, and to inform personalized medical therapy; Cancer prevention using intraductal treatment of reversible hyperplastic lesions

Speaker: Iris Grossman, Ph.D., Global Head of Personalized Medicine & Pharmacogenomics, Teva

Genomic discoveries, alongside improved precision of analytical tools for measuring biomarkers and high throughput automated technology, have now made the incorporation of personalized medicine markers into clinical development programs a reality. Teva takes a holistic approach to improving patient care and Personalized Medicine plays a key role in this, from discovery though to post-marketing pharmacovigilance. Teva designs a "tailor-made" PMP approach for each specific discovery and development program and for each specific stage of that program. One important application of PMP relates to the utilization of genetic discoveries in rare disorders to develop treatments for these acute unmet medical needs, and, at the same time, facilitate the development of drugs for broader relevant indications. One such example will be presented at PMWC 2013. TV-45070 is an exciting breakthrough compound for the treatment of a rare pain syndrome, erythromelalgia. It was discovered via a Personalized Medicine approach and the investigation of response signatures will play an active role in the design of clinical trials examining its potential in more common syndromes.

Speaker: Patrice Hugo, Ph.D., Senior Global Director, Scientific Affairs, LabCorp Clinical Trials

Collaborations between drug developers, diagnostics companies and testing laboratories is key to bring companion diagnostic to market. Recent advances in targeted therapies and diagnostics facilitate the practice of personalized medicine, identifying which patients are most likely to respond favorably to particular therapies. Over the last decades, few companion diagnostics have been approved by the regulators and made a real impact in care management despite major investments. In the recent years, many companion diagnostics have been successfully developed in parallel with targeted therapies and are currently offered to patients to enhance treatment benefit. This presentation will focus on key factors to considerer when developing and deploying companion diagnostics in clinical trials leading to successful approbation and post approval launch.

Speaker: Ruth L. Katz, M.D., Professor of Pathology, Director of Image Analysis Lab, M.D. Anderson Cancer Center

Potential of circulating tumor cells in lung and breast cancer for molecular characterization and monitoring therapy."Neoplastic cells that shed into the blood stream, also known as “Circulating Tumour Cells “ have generated excitement as a minimally invasive source of tumor cell procurement or “liquid biopsy”. Many platforms are being developed to procure CTCs, but there is only one FDA approved system which uses an EpCAM based immunomagnetic purification method to enumerate CTCs. This method however, is not sensitive for early stage lung cancer as it cannot detect neoplastic cells shed early on, that have undergone epithelial-mesenchymal transition (EMT). We developed antigen independent FISH based methods for use in lung cancer patients in which many cytogenetically abnormal cells “CACs “are detected that correlate in number with stage of disease. We also used a lineage-labeling system to demonstrate phenotypic switching and lineage plasticity in CACs over different time points. Finally as a paradigm for personalized therapy, we will demonstrate an example of how CTCs in breast cancer can act as a surrogate marker for choice of therapy and disease response.

Speaker: Peter R. Carroll, M.D., Co-director of Urologic Cancer, UCSF

Screening with serum PSA in men reduces the risk of dying from prostate cancer. However, it does so at the risk of overdetection, detecting prostate cancer of such low grade and volume that they would not progress if left untreated. Such patients are good candidates for active surveillance, a strategy that has been shown to be safe in selected centers However, for newly diagnosed prostate cancer patients and their physicians, limited confidence in the accuracy of existing pretreatment risk assessment tools has led to underutilization of active surveillance and overtreatment of nonlethal cancers with attendant morbidity and cost. A biopsy-based gene expression profile predictive of clinically aggressive prostate cancer was developed and validated in the context of tumor heterogeneity, multifocality, and biopsy undersampling, thereby enabling more accurate, individualized risk assessment at the time of diagnosis. This profile allows more patients and their physicians to consider active surveillance in lieu of immediate treatment.

Speaker: Ketan Patel, Ph.D., Solutions Consultant, Oracle Health Sciences

This presentation will focus on our work to provide a scalable secure platform for personalized medicine that accelerates biomarker discovery, validation and delivery to the point of care. This session will discuss in detail our methodology to integrate in a manner that is agnostic to scientific approach and technology cross platform 'omics' data with high quality clinical data to provide an integrated view across genotype and phenotype whilst still ensuring scalability at hundreds of thousands of whole genome sequences. We will also discuss how the current flat file paradigm is no longer fit for purpose as translational medicine moves into 'production' and the false dichotomy that exists between enterprise and open source software and how both need to coexist somewhat uniquely in this area

Speaker: Nicky Lieberman, M.D., Head, Community Medicine Division, Clalit Health Services

Personalized technologies in medicine are supposed to target the treatment, to minimize mistreatments and side effects, and improve life expectancy and quality.

Today most of the payers consider the high price of "targeting technologies but do not consider the total cost of disease for the medical system, for the patient and his family, and for the whole country, and so they are not keen to fund these tests.

Clalit embraced personalized medicine in 2006, being the 1st public organization to introduce PM tests in its basket. I'll try to use the oncotype dx example to show how payers should decide upon PM funding.

Speaker: Steven C Quay, M.D., Ph.D., FCAP, Founder, Atossa Genetics, Inc.

As medical practice moves toward more ‘protocol’ driven treatment paradigms, the ability of genomics-based diagnostic companies to launch innovative tests becomes ever more difficult. Using the CarePath business model and the understanding of practice patterns to design products and services to address the entire CarePath of a disease or condition provides an innovative way to distinguish a start-up company from the crowd, establish synergies across all parts of the business, and build stakeholder value for the organization. The Breast Health CarePath established by Atossa Genetics, comprising five FDA-cleared medical devices, four CLIA-validated Laboratory Developed Tests, and a pharmaceutical/ biotech treatment program, will be provided as an example.

Speaker: David Sidransky, M.D., Chairman Champions Biotechnology

Preclinical oncology drug development typically originates from high passage number immortalized cell lines. While information from these models is useful in discovery and initial proof-of-concept studies, their clinical relevance is often limited due to alterations and adaptations from successive passages in tissue culture and animals. Preclinical personalized models established from donor patient tumor fragments passaged only a few times in vivo may better represent clinical disease. Following establishment, models can be characterized at the molecular level and then correlated with in vivo sensitivities of various agents and clinical information from patient donors as well as current standards of care. Molecular characterization studies identified known mutations in several signaling molecules important in cancer progression as well as novel markers of sensitivity and resistance to standard agents. These low passage models offer an alternative to standard xenografts and are much more representative of clinical disease. Clinical studies have shown a very high predictive power for drugs tested in vivo with true responses in patients with solid tumors. Data collected from molecular characterization and in vivo evaluation of these models will aid greatly in development of novel agents and predictive biomarkers for personalized treatment approaches.

Speaker: Peter J. van der Spek, Ph.D., Head of the Department of Bioinformatics, Erasmus Medical Center, Netherlands

Medicine is more and more becoming evidence based; our work at the Erasmus Medical Center focuses on the development of the skull and the brain in relation to transcriptional programs and epigenetic regulation during development and cancer. We will present mutations in various genes expressed in stem cells, during proliferation, differentiation and apoptosis and address the IT strategy used for storing whole genome sequencing data. Also illustrated will be our molecular imaging genomics approach, used for validation of our candidate mutations.

Speaker: Stefan Roever, CEO, Genia Technologies

DNA Sequencing is used in the clinic today, but what does it take to make sequencing part of routine clinical care? Genia’s mission is to make genetic information universally available. Its integrated circuits and proprietary NanoTag chemistry enable massively parallel single-molecule DNA sequencing. This versatile nanopore-based platform allows for single molecule, electrical, real-time analysis without the need for complicated optics, labels, amplification, or fluidics. By developing a true integrated circuit on standard semiconductor process technology, Genia's sequencing platform enables the use of molecular diagnostics in everyday clinical care.

Speaker: Jeff Wisotzkey, Ph.D., HCLD, CC, Director, Molecular Pathology and Technical Director of Laboratory Operations, Central Pennsylvania Alliance Laboratory

Dr. Wisotzkey's presentation will focus on the day to day issues inherent to the ever changing landscape of companion diagnostics in the clinical molecular pathology laboratory with specific emphasis on providing a synopsis of the FDA approval and subsequent implementation of the QIAGEN therascreenR KRAS molecular assay from the perspective of the clinical laboratory. Dr. Wisotzkey also will touch briefly on several other companion diagnostic applications in his laboratory.

Speaker: David A Pearce, Ph.D., VP Research, Sioux Falls Region, Sanford Health

Sanford Health is the largest rural health provider in the USA having a 220,00-square mile service area over 5 states. Through development of our clinical research programs we are learning to apply personalized medicine across our footprint. Through use of a global consenting process patients have the option to participate in research. Through integration of an electronic medical record with biobanking we are prepared for the advent of genomic medicine through having a patients DNA sequence available for targeted therapies and interventions.

Speaker: Michael Thaler, Professor, UCSC

‘Personalized’ or ‘Precision’ medicine is informed by associations between genomic variation, clinical phenotypes, and disease. The utilization of genetic data in clinical decision-making generates novel challenges that require reinterpretations of bioethics principles as occurred with the social and scientific transformations of the 1970’s, yet the ethical and legal questions raised by the new paradigm remain largely unaddressed. This presentation will focus on informed consent issues in the era of personalized medicine.

Speaker: Mark Monane, M.D., Chief Medical Officer, CardioDx, Inc.

Every day, approximately 10,000 patients present to primary care clinicians with signs and symptoms suggestive of coronary artery disease. Despite this large number, the diagnostic work-up of these patients remains highly variable and poses an enormous burden on the healthcare system, including $5 billion in testing costs, as well as patient risks associated with the ionizing radiation and contrast dye used in diagnostic tests. Corus® CAD is the first cardiovascular genomic test designed to help clinicians safely, accurately, and conveniently determine, from a blood sample, whether their patients’ symptoms are due to blockages in the heart arteries, also known as obstructive coronary artery disease.

Speaker: Ian Walker, Ph.D., MBA, Head of Stratified Medicine and Combinations Alliance, Cancer Research, UK

In December 2012, Prime Minister David Cameron announced plans to undertake whole-genome sequencing for cancer and rare disease patients in the UK and be the first country to introduce the technology within a mainstream health system.

Dr. Ian Walker will discuss lessons learned from another personalized medicine initiative that combines clinical practice and research objectives. Cancer Research UK, government, and two leading pharmaceutical companies have been working in partnership to standardize genetic testing of tumors across the UK and build a national database linking tumor profiles, treatments and outcomes.

Speaker: Carol Berry, Senior VP and GM, Pharmacogenomic Services Division & CLIA Laboratory, Asuragen

Thyroid cancer is on the rise. Statistics show there are many unnecessary surgeries being performed based on cytology results alone. The case study will present a real world study incorporating molecular testing to aid in resolving indeterminant cytology and how it changed the surgical approach in many cases.

Speaker: Janet Woodcock, M.D., Director, Center for Drug Evaluation & Research, FDA

Genetically-targeted drugs and individualized diagnostics are now being incorporated into mainstream medicine: personalized medicine has reached a “tipping point”-- it is no longer a prediction, but a reality that has arrived much sooner than expected and represents a major scientific accomplishment. Nevertheless, given the current financial problems in healthcare, additional challenges can be foreseen. Can use of these technologies make medicine more cost-effective? Will personalized medicine reach this next milestone, and if so, when?

Speaker: David Levison, President and CEO, CardioDx, Inc.

There’s been a historical disconnect between payers and diagnostic test manufacturers regarding data required for positive-coverage decisions. New test makers claim they are held to higher standards than existing competitive modalities. The launch of CMS’ MolDx Program is a step towards clarifying the process and requirements for coverage of tests. However, challenges remain in navigating the complex paths to coverage. Industry must sustain momentum for solutions with a dialogue more focused on risk-sharing and common objectives, enabling providers, payers and test manufacturers to succeed.

Speaker: Matthieu-P. Schapranow, Ph.D., Principal Investigator of In-Memory Technology for Life Sciences, Hasso Plattner Institute

This presentation will outline how SAP and the Hasso Plattner Institute Potsdam have applied in-memory technology to combine high-performance alignment, annotation and analysis of full genome data. We will provide you with detailed background information about the technology foundation SAP HANA presented in the keynote of Prof. Hasso Plattner. In addition, we will outline how to integrate existing genome data processing pipelines into and how to design and implement specific scientific applications on top of SAP HANA. Furthermore, the technical background of optimized alignment algorithms for SAP HANA will be outlined.

Speaker: Edward Abrahams, Sheila Walcoff, Alberto Gutierrez, Jeffrey Marrazzo, Risa Stack, Paul Billings

The regulatory pathways that govern personalized medicine products have evolved over time. Multiple agencies, centers within agencies, and different stakeholders, many of which employ different business models, all play a role in determining how our emerging understanding of individual variation will transform health care. This panel will review the current regulatory environment for diagnostic and other personalized medicine products as well as outline current proposals to reform the process.

Speaker: Masato Mitsuhashi, M.D., Ph.D., Chief Scientific Officer, Hitachi Chemical Research Center

In order to simulate pathological or pharmacological events in test tube, whole blood is immediately exposed to specific agents, and the induction of early responder mRNAs is quantified by Hem(A)+ system we developed. This ex vivo assay is a powerful biomarker discovery platform by using numerous combinations of stimulations and target mRNA species. The resultant biomarkers are used to predict individual variations in drug responses/toxicities. Moreover, Hem(A)+ system is now capable of quantifying poly(A)+ RNA in exosome/microvesicles in plasma, urine, culture supernatants, etc. without ultracentrifugation. By measuring cell/tissue specific- or disease-specific mRNAs in plasma and urine exosome, post-treatment clinical course can be monitored quantitatively. Two platforms (ex vivo and exosome) will revolutionize current personalized medicine diagnostics into next dimension.

Speaker: Karthikeshwar Kasirajan, M.D., Chief Medical Officer, Natural Molecular

For decades many have often debated and written about the great promise of pharmacogenomics. However, the concept has not become the standard of care for drug delivery for a variety of reasons. The greatest impediment to routine use is that it remains a complex clinical pathway to implement, with a lack of physician education that allows seamless integration into clinical practice. In order for pharmacogenomic tests to be actionable and user friendly the final product should consist of drug recommendations based on individual genotype and not a delivery of genetic test results. This presentation will discuss the delivery of a user friendly report that for the first time holds the promise of taking pharmacogenomics from bench to bedside in a large scale.

Speaker: Mickey Kertesz, Ph.D., Co-founder & CEO, Moleculo

Moleculo was founded in late 2011 and started operating out of its San Francisco lab in early 2012, developing a novel DNA sequencing method that provides extremely long and accurate reads. Through fast prototyping, the use of consultants rather than inflating the team and maintaining focus on an important unmet need, Moleculo was able to quickly secure deals with over a dozen large academic, industry and government customers while maintaining low burn-rate. Moleculo then went on to develop a second product, and as it was ready to close a financing round in December 2012, it was acquired by Illumina. Moleculo demonstrates that off-the-shelf DNA sequencing technologies are now powerful and stable enough to be used as the underlying workhorse in the development of valuable higher-level applications. This type of lower capital requirement solutions should fit the innovative, fact-paced Israeli entrepreneurial arena and could drive a wave of successful biotech startups based in Israel.

Speaker: Neil de Crescenzo, Senior Vice President and General Manager, Oracle Health Sciences

With the explosion of next generation sequencing technology at rapidly declining price points, the most significant bottleneck is the interpretation of the resulting information to drive critical decision-making that impacts patient care. Leaders in the field are integrating data from heterogenous sources, including Electronic Medical Records and multiple high throughput omics platforms, into scalable, cloud-based platforms that can provide these interpretations while leveraging the ever evolving reference data sets from sources worldwide. This presentation will describe the challenges leading institutions are experiencing in addressing this opportunity. It will provide specific examples of how they are successfully implementing platforms to harness novel insights that lead to the discovery and application of biomarkers for enhanced drug efficacy and safety as well as more targeted diagnoses and treatments for patients.