October 16-17, 2017  |  Orlando, Florida USA

An Official Satellite Event to the American Society of Human Genetics (ASHG) Annual Meeting

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Agenda


Day 1: October 16, 2017


7:30 am Registration/Continental Breakfast

8:00 am Chairperson's Opening Remarks

Julia Trosman, PhD, MBA, Director, Center for Business Models in Healthcare, Assistant Adjunct Professor, Northwestern University Feinberg School of Medicine, Assistant Adjunct Professor, Department of Clinical Pharmacy, University of California

8:10 am Developing Precision Medicine on the Principles of Smart Infra-structure Systems
The goal of the Precision Medicine Initiative (PMI) is improved understanding of individual variation and its effect on disease onset, progression, prevention and treatment. At least two factors are essential to reach this goal: a) precise identification of and isolation of individuals (targets) imbedded in the multi-level organization of in human ecosystems, and b) developing appropriate medical interventions to treat those specific targets. These require novel ways of data acquisition, analysis and decision making processes. We propose that the “smart infrastructure system” (SIS) concept employed in “smart grids” and “smart cities” may be implemented in precision medicine programs. Like biological systems, “smart systems” are adaptive, predictive, integrated, reactive, self-organizing and modular. In this talk, Dr. Givindaraju will present: a) concordant aspects of human diversity and salient features of smart infra-structures, b) the need for developing trans-disciplinary approaches to realize the potential of precision medicine programs spanning individuals, families and populations.
Diddahally Givindaraju, Ph.D., Visiting Professor, Glenn Center for the Biology of Human Aging, Albert Einstein College of Medicine, Affiliate Member, Dept. of Human Evolutionary Biology, Harvard University

8:40 am Open-source Platforms for Precision Medicine - i2b2, tranSMART and Arvado
Precision medicine is becoming a reality and the i2b2 tranSMART Foundation is focused on furthering development and bringing it into practice. Dr. Keith Elliston will discuss how this global non-profit organization is enabling effective collaboration for precision medicine through sharing, integration, standardization, and analysis of heterogeneous data from collaborative healthcare and research; through engagement and mobilization of a life sciences focused on an open-source, open-data community. He will talk about how it’s open-source software and databases, which represent more than 100 million patient lives to thousands of physicians and scientists worldwide, are helping organizations (academic, non-profit, healthcare, and commercial research communities) conduct collaborative research to better understand disease diagnosis, progression, treatment options, and prevention – and ultimately to realize the promise of precision medicine.
Keith Elliston, Ph.D., Chief Executive Officer, Transmart Foundation

9:10 am Enabling Precision Medicine at Scale in the Community 
The vast majority of individuals diagnosed with cancer are treated in a community health setting. Therefore, precision medicine programs anchored in the community have the greatest potential to impact and improve outcomes. Achieving scale in this setting, however, presents an array of challenges such as real-time data capture across heterogeneous networks, structuring and harmonizing molecular and clinical information, and digitization of complex clinical trial protocols. This presentation will address the innovations and technological solutions instrumental in overcoming these obstacles.
Mick Correll, President, Genospace

9:40 am Refreshment/Networking Break

10:00 am Digital technology and Pharmacogenomics – Personalizing your Future
The presentation will discuss how data sciences, artificial intelligence have enabled the stratification of complex diseases and the analyses of varied therapeutic responses, supporting a personalized medicine approach. Sensors, devices, social media, etc have helped interlink genotypic profiling to clinical responses and analytics has served as the power house to derive meaningful insights. Ethics, transparency, data security and ownership need to be prioritized, as one hurtles towards innovative models of dealing with disease.
Nimita Limaye, Ph.D., Chief Executive Officer, Nymro Clinical Consulting Services

10:30 am Status Update on All of Us Research Program
Imagine a future where your health care is tailored to you. We want to make that future possible through research by creating a resource that allows researchers to conduct thousands of studies on a variety of health and disease outcomes. The All of Us Research Program is a historic effort to gather data from one million or more people living in the United States to accelerate research and improve health. By taking into account individual differences in lifestyle, environment, and biology, researchers will uncover paths toward delivering precision medicine. I will be presenting an overview of the All of Us Research Program covering elements of data collection, access to the resource, the scientific framework, privacy and security principles, and more. For more information, please see: https://www.joinallofus.org/.
Joni Rutter, Ph.D., Director of Scientific Programs, All of Us Research Program, Precision Medicine Initiative, National Institutes of Health

11:00 am Precision Public Health: Microbial Genomics to Detect and Respond to Outbreaks
Next-generation sequencing has been transformational in the world of public health microbiology, with applications ranging from foodborne disease to influenza to hepatitis C to fungal diseases, to name a few. In this session, the speaker will discuss how genomics is being adopted in infectious disease public health and the role of CDC’s Advanced Molecular Detection (AMD) program in fostering this adoption in the United States.
Gregory Armstrong, MD, Incident Manager, Polio Eradication Response, Emergency Operations Center, CDC

11:30 am Pathogenicity Assessment and Clinical Interpretation of Diagnostic NGS in Neurology
María-Jesús Sobrido, MD, Ph.D., Founder, Genomic Consulting-Telegenomics 

12:00 pm Luncheon

12:55 pm Title to be Announced

Annapurna Poduri, MD, M.P.H., Associate Professor in Neurology, Boston Children's Hospital

1:25 pm Neurogenetics: an African Overview

This lecture will discuss the the advances in neuroscience, with a focus on understanding the underlying genomic underpinnings of neurodegeneration and how these relate to various neurodegenerative diseases. The translational challenges of moving from animal to human models can be particularly difficult. These challenges, clinical realities and challenges for clinicians in adopting the latest advances of preclinical as well as clinical disciplines in neurodegeneration will also be discussed. Different facets of precision medicine will be reviewed from both the angle of basic science as well as from a clinical perspective. Finally, this talk will highlight how research/clinical adoption is advancing in Africa.
Wael Mohamed Yousef Mohamed, MSc, MD, Ph.D., Assistant Professor, Menoufia University, International Islamic University Malaysia

1:55 pm Precision Medicine in Cardiovascular Disease
Key components of precision medicine as applied to cardiovascular medicine will be discussed including risk assessment, prevention, diagnosis, therapeutics, pharmacogenomics and translation of these technologies into the clinical environment. The focus will primarily be around coronary artery disease and its complications however important exemplars from other areas of cardiovascular medicine will also be discussed.
Deepak Voora, MD, Assistant Professor of Medicine, Department of Medicine, Center for Applied Genomics & Precision Medicine, Duke University

2:25 pm Refreshment/Networking Break

2:45 pm Patient Engagement and Precision Medicine: Reflections on Best Practices and Early Lessons Learned
Based on her experiences working on projects funded by the Patient-Centered Outcomes Research Institute (PCORI) and the National Human Genome Research Institute (NHGRI), Dr. Jamal will reflect on challenges and opportunities related to precision medicine research and associated ethical issues. She will discuss her early experiences with patient engagement related to genomic data-sharing and the return of results to participants in family-based genomic sequencing studies. She will also discuss lessons learned that may be relevant to health centers currently planning to implement large-scale genomic sequencing studies.
Leila Jamal, ScM, Ph.D., CGC, Hecht-Levi Postdoctoral Fellow, Johns Hopkins Berman Institute of Bioethics, Clinical Genetic Counselor, McKusick-Nathans Institute of Genetic Medicine

3:15 pm Geisinger’s Ethical Deliberations and Decision to Return Participant Results in the MyCode Community Health Initiative Biobank
Returning research results is controversial and Geisinger decided to meet this controversy head on by establishing a series of meetings and outreach to determine the best strategy for achieving the success of it’s Biobank, and hence the advancement of Personalized Medicine. This talk will discuss the ethical issues considered and the patient/public outreach it held to determine the best course of action not only for My Code but for the Geisinger community. Among its outreach efforts, Geisinger held six focus groups in 2013 to discuss return of research results and placement in the medical record. Based on findings, Geisinger modified its biobank consent form to include the return to participants of medically actionable genomic results. This session will discuss the ethical justification of the original decision to return results, additional ethical issues that have arisen during the return process, ethical support system put in place, and the potential research program benefits derived from sharing important health information with participants.
Andy Faucett, MS, LGC, Professor, Director of Policy and Education, Geisinger Health System

3:45 pm Standardization in Next-generation Sequencing – From Standards to Clinical Adoption
Higher throughput, lower cost and better quality of data were the incentive for a range of enterprises developing new next-generation sequencing (NGS) devices in the last 12 years, whereas economic issues and competitive pressure resulted simultaneously in accelerated vanishing of several companies. Due to the fast development, NGS is currently characterized by a lack of standard operating procedures, quality management/quality assurance specifications, proficiency testing systems and even less approved standards along with high cost and uncertainty of data quality. These aspects represent major obstacles for essential implementation of NGS in important areas such as clinical diagnostics, where reliable results, traceable and reproducible data as well as fast processing are crucial. These points emphasize the importance of standardization in NGS, which is the prerequisite and foundation for sufficient quality of downstream results, i.e. clinically relevant sequence data.
Christoph Endrullat, Scientific Staff Member, Division of Molecular Biotechnology and Functional Genomics, Technical University of Applied Sciences Wildau

4:15 pm Cost-Effective Genomic Profiling for Cancer Patients: Focusing on Clinical Utility
Performing over 1.1 million molecular tests in the last 12 months, PathGroup identified and implemented numerous ways to integrate previously disparate information into a single source report for their clients and patients. This presentation will focus on the clinical impact of genomic profiling through disease specific testing that utilizes multiple methodologies based on the patient’s clinical state. Case studies will be presented spanning both focused and broad-based genomic profiling balancing both high quality genomic profiling and cost-effective patient care.
Pranil Kumar Chandra, DO, Vice President and Chief Medical Officer of Genomic and Clinical Pathology Services, Path Group

4:45 pm Patient Engagement & MyCode
Patient engagement is increasingly important though can mean different things to different organizations. This talk will explain Geisinger’s definition of patient engagement and explain its vital importance to research and the success of personalized medicine. Based on it’s approach to patient engagement, The MyCode Community Health Initiative biobank has recruited and consented over 145,000 participants and has returned clinical results to over 300 participants. MyCode participants consent to learning about medically actionable research results and placement of results in the electronic medical record. In addition, this session will discuss the return process, early lessons learned, and suggestions for groups considering a similar program.
Andy Faucett, MS, LGC, Professor, Director of Policy and Education, Geisinger Health System

5:15 pm Lessons Learned from eMERGE Relevant to the Implementation of Precision Medicine
The Electronic Medical Records and Genomics (eMERGE) network is an NHGRI-funded consortium. It was established in 2007 initially purely to study the feasibility of using EHR data for the purposes of genomic discovery. In the subsequent 10 years eMERGE has begun studying the implementation of genomic medicine in the clinic. This talk will provide an update on the current eMERGE activities and summarize enablers and barriers encountered by the eMERGE network sites that predict the success of implementation.
Marc Williams, MD, Director, Genomic Medicine Institute, Geisinger Health System

5:45 pm End of Day's Proceedings

Day 2: October 17, 2017

7:30 am Continental Breakfast

8:00 am Title to be Announced

Charis Eng, MD, Ph.D., FACP, Sondra J. & Stephen R. Hardis Endowed Chair of Cancer Genomic Medicine, Chair and Director, Genomic Medicine Institute, Director, Center for Personalized Genetic Healthcare, American Cancer Society Clinical Research Institute, Cleveland Clinic Lerner Research Institute

8:45 am Identifying and Addressing Critical Policy Challenges to the Clinical Adoption of Next Generation Sequencing:  Results of a Policy Delphi Exercise
New policy approaches are needed to facilitate appropriate integration of next-generation sequencing (NGS) into clinical care. In particular, realizing the full potential benefit of this technology requires attention to challenges in three critical policy domains: oversight of the quality of tests and related services; intellectual property; and coverage and reimbursement. This presentation will review the results of a systematic investigation of expert multi-stakeholder views conducted through a modified policy Delphi exercise. The investigation was designed to identify and build solutions to the three highest priority policy challenges related to clinical integration of NGS. The presenter will also offer reflections on the results and insights into the evolving policy landscape for genomics, especially as it pertains to challenges of coverage and reimbursement.
Donna Messner, Ph.D., Senior Vice President, Center for Medical Technology Policy

9:25 am Advancing Precision Medicine from Novelty to Necessity
Precision medicine is advancing across many fronts as investments in the human genome find their way into clinical use as diagnostics, therapeutics, or theranostics. But in most settings, precision medicine is still considered esoteric, technology that is exciting but elusive. This session will describe the technical, educational, and intuitional resources that are necessary to implement an effective program to enhance traditional medicine with information to practice more precisely.
Don Rule, MBA, Founder and CEO, Translational Software

10:00 am Novel Approach to Pharmacogenomics: Adding Predicted Drug/Gene "Interactions" to the Current Pharmacogenomics Knowledge Base
Pharmacogenomics will never be an exact science. It is impractical and virtually impossible to study all potential drug/gene interactions, let alone incorporating drug/drug/gene interactions, drug/gene/gene interactions and additional clinical variables. An important step in addressing these deficiencies is to predict possible drug/gene, drug/drug/gene, and drug/gene/gene interactions utilizing pharmacokinetic and pharmacodynamic principles. The clinician, presented with known drug/gene interactions and an array of potential predicted interactions, can then make better informed clinical prescribing and patient monitoring decisions. The methodology will be discussed and examples given.
Mark Rosenbloom, MBA, MD, Ph.D., Founder and CEO, PEPID, Inc., Founder and CMO, LIFEFORCE Medical Institute

10:30 am The Role of Depression Pharmacogenetic Decision Support Tools in Shared Decision Making
An estimated 40 million Americans are on antidepressants to reduce suffering from depression. Patients often cease taking antidepressants due to lack of knowledge of their disorder, unrealistic expectations, personality factors and/or occurrence or perception of unwanted side effects. Shared decision making invites patients to play an active role in the treating team through psychoeducation, presentation of choices and ultimately participation in the selection of a treatment pathway. This has been shown to subsequently increase adherence and tolerance of medications. Pharmacogenetic decision support tools have the capacity to encourage shared decision making through initiating a discussion of values, expectations and side-effects.
Harris A. Eyre, MD, PhD., Entrepreneur-In-Residence in Precision Psychiatry, Texas Medical Center Innovation Institute

11:00 am Refreshment/Networking Break

11:15 am The Power of the Empowered Patient in the Era of Precision Medicine
Patient reported health information is rapidly evolving to be a critical component to accelerating research and care. To this end, understanding the patients’ perspective and empowering/partnering with them through the process becomes the bedrock to a successful patient-engagement strategy for personalized health development. In this session, Richard Tsai, VP of Marketing at Inspire, a leading condition-specific social network of more than millions of users, will share key patient engagement themes on Inspire and relevant activities around individualized medicine:
♦ How the power of community can solidify engagement for research.
♦ How patients think about personalized medicine and its perceived value.
♦ Degree and depth of data patients want to contribute and control
Richard Tsai, MS, VP of Marketing, Inspire

11:45 am How Health Policy and Technology are Enabling Patients to Access and Use their Own Data to be their Own Precision Medicine Champions
In cancer, a molecular diagnosis can identify or eliminate treatment options to get patients to the right therapy or a clinical trial more reliably. However, most patients do not receive a molecular profiling test in the course of their care, and very few patients ultimately enroll in clinical trials for the newest investigational therapies. Doctors are short on time to interpret these tests or find trials – they need help. It turns out that the patient and their family caregivers can participate in the discovery process to find therapy options and trials, through online applications and services. The result is a win for everyone – the patient, the physician, and investigators who are seeking patients for their trials. In this session, Martin Naley will describe how a multi-sided platform approach can create new connections between cancer patients and clinical trials through patient-centered service, clinical trial relationships, and technology.
Martin Naley, MBA, Founder and Chief Strategy Officer, Cure Forward

12:15 pm Luncheon

1:00 pm On Call GC Consult: A Novel Alternative Mode of Increasing Access to Genetic Counselors
The backbone of the much-awaited era of Personalized Medicine is genetic testing. However, the clinicians traditionally involved in clinical genetic services – the genetic counselors (GCs)– do not have an adequate workforce to provide care to all patients in need of genetic testing. In efforts to meet the demand for counseling, Alternative models to 1 on 1 GC –patient counseling have emerged- such as group counseling and telemedicine. While these models help extend the reach of GCs, they do not address the gap of providing care at time of cancer diagnosis – an important piece of the care plan for those newly diagnosed with cancer. Here Ms. Kurz will present a study exploring collaboration between GCs and surgeons, designed to provide immediate, on-demand GC consultation for physicians who wish to order genetic testing prior to surgical decision-making to risk-appropriate patients. In this presentation, she will:
♦ Describe the various alternative modes of delivery of genetic services, including group genetic counseling, telemedicine, etc.
♦ Review publications describing outcomes of alternative genetic services delivery.
♦ Present data about efficacy of, and satisfaction with, a hybrid GC-surgeon model of genetic counseling
Raluca Kurz MS, CGC, Doctoral Student, UCLA Fielding School of Public Health, Senior Genetic Counselor, Torrance Memorial Medical Center

1:30 pm Increasing Access to High Quality Genetic Testing
Color is a health technology service focused on decreasing barriers to accessing important health information. Color increases access to genetic testing by offering a high quality, physician-ordered genetic test at an affordable cost that is drastically lower than historical prices for similar tests, and includes genetic counseling at no additional charge. By combining advanced software with expertise in medical genetics, bioinformatics, variant science, computer science, and design, availability of genetic testing for common hereditary disorders can expand to a wider population. This improves the chances of prevention and drives crucial advances in research on the link between genetics and disease.
Jill Hagenkord, CMO, Color Genomics

1:50 pm Solving a Critical Access Barrier in the Realization of Personalized Medicine
The genetic testing market is growing at a rapid rate leading to challenges in infrastructure, access and service delivery. The expansion of genetic counseling into many fields of medicine has increased patient comprehension of this new molecular landscape while improving clinical care and efficiency. However, barriers remain to accessing genetic counselors, impacting patient decision-making and potentially outcomes. GeneMatters was created to ensure that everyone has access to expert genetic counseling when they need it. GeneMatters’ solution combines expert genetic counseling with a proprietary technology platform to seamlessly connect patients to genetic counselors on-demand. Through this HIPAA-compliant web- and telephone-based technology, the platform matches the patient inquiry/order with the right genetic counselor by specialty area, state license, preferred language and schedule. This solution also allows labs, hospitals, researchers and health systems a rapidly scalable solution to providing specialty expertise with a positive user experience for staff and patients.
Jill Davies, MS, CGC, Chief Operating Officer, GeneMatters

2:10 pm PANEL SESSION: Beyond Buzzwords: Ethics and Patient-Centerednness in Genomic Medicine
Moderator:
Leila Jamal, ScM, Ph.D., CGC, Hecht-Levi Postdoctoral Fellow, Johns Hopkins Bernan Institute of Bioethics, Clinical Genetic Counselor, McKusick-Nathans Institute of Genetic Medicine
Panelists:
Alicia Staley, Patient Advocate, Cure Forward
Raluca Kurz MS, CGC, Doctoral Student, UCLA Fielding School of Public Health, Senior Genetic Counselor, Torrance Memorial Medical Center
Jill Davies MS, CGC, Chief Operating Officer, GeneMatters
Jill Hagenkord, CMO, Color Genomics

3:00 pm End of Conference

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