Baltimore, MD | October 5-6, 2015

The Intersection of Data Privacy, Innovative Partnerships, Genetics and Ongoing Laboratory Hurdles

2014 Agenda


DAY ONE - OCTOBER 29-30, 2014

7:45 am Registration/Continental Breakfast

8:20 am Chairperson's Opening Remarks

Mollie Roth, JD (BIO), Managing Partner, PGx Consulting, LLC

8:25 am Personalized Medicine’s Last Mile
The last mile is a phrase used in telecommunications to refer to the final leg of connectivity to the end user—it almost always represents a technical as well as practical challenge to providing the level of service consumers expect. Personalized medicine has its metaphorical last mile also: the physician’s office. Many may argue that the term should be reserved for patients, but as long as the FDA requires a physician order for lab testing, the end-user will remain the practicing physician. And just like in the telecommunications industry, genomics’ last mile is proving to be the most difficult and expensive part of the system. Solving the problem requires the same approach many of the telecommunications firms are using: "mixing networks.”  In other words, no one overarching strategy will suffice.
This presentation will explore strategies companies are using to surmount the bottlenecks of medical practice and effectively reach physician end-users: genomics education, genetic counseling consults, bioinformatics, one-on-one sales, and the use of natural “distribution networks:”  hospital medical staffs, ACOs and the myriad other networks now proliferating (under various institutional sponsorship) to meet local quality and transparency initiatives.
Lynn Dowling (BIO), Executive Director, Genomic Medicine Institute, El Camino Hospital, Principal, Dowling Associates
8:55 am An Integrated Healthcare System's Focus on Genomics
Research on the translation of genomics from the bench to the bedside is critical for effective integration into healthcare. This session will highlight the role of an integrated healthcare system in several national collaborations and local research initiatives including ClinGen, eMERGE, genome sequencing of undiagnosed patients and exome sequencing of 100,000 MyCode biobank participants including the return of clinically actionable results.
W. Andrew Faucett, MS, LGC (BIO), Director of Policy and Education, Office of the Chief Scientific Officer, Geisinger Health System
9:25 am The Next Step in Advancing Personalized Medicine: Educating Clinicians
In order for genetic-guided medicine to fulfill its promise in clinics around the world, it is vital that rigorous efforts are made to adequately educate physicians on its current capabilities, limitations and future promise. In this presentation, Dr. Johansen-Taber will discuss the challenges the AMA is facing in educating physicians on the quickly evolving state of genomic medicine and will outline the steps that are being taken by the AMA and othersto meet these challenges.
Katherine Johansen Taber, Ph.D. (BIO), Director, Personalized Medicine, Assistant Secretary, Council on Science and Public Health, American Medical Association
9:55 am Refreshment/Networking Break
10:20 am PANEL SESSION: Harnessing Big Data: What’s Working, What More is Needed?
Clinical sequencing is on the rise and use will only grow.  New biomarker discovery continues at a rapid rate. The availability of new molecular diagnostics is similarly increasing at a fast pace. New databases are being established to curate and analyze data. Demand for bioinformatics and innovative computational tools are clearly great. New companies are entering the fray on nearly a daily basis. This ecosystem is becoming larger and more complex.  
Nonetheless, innovative information technologies are starting to deliver on the value proposition for improving ‘omic’ discovery and targeted clinical care. Platforms enabling database interoperatability and automated knowledge management are, but two, examples. A panel of experts representing industry, non-profit and healthcare delivery institutions will discuss the dynamism of this evolving ecosystem. Panelists will discuss technological innovations and approaches with a focus on what is working and why, and what unmet needs exist, and how to meet them.  
MODERATOR: Carol Isaacson Barash, Ph.D. (BIO), Principal, Helix Health Advisors, Adjunct Professor, Personalized Medicine, Regis College, Editor in Chief, Journal of Applied & Translational Genomics
Dr. Gauri Naik (BIO), Chief Scientific Officer, Optra, Inc.
Alice Rathjen (BIO), Founder, Chief Executive Officer, DNA Guide
Jonathan Hirsch (BIO), Founder & President, Syapse
Grant Wood (BIO), Senior IT Strategist, Clinical Genetics Institute, Intermountain Health Care
W. Andrew Faucett, MS, LGC (BIO), Director of Policy and Education, Office of the Chief Scientific Officer, Geisinger Health System
Keith O. Elliston, Ph.D. (BIO), Chief Executive Officer, tranSMART Foundation
11:35 am Bridging the Education Gap in Precision Medicine
Uptake of genomic and precision medicine is hindered in part by an undereducated health care workforce. Last Spring, UCSF launched the first massively open online course on this topic for health care providers to an international audience of 13,000. Last Spring also marked the launch of a new magazine, Genome, aimed at educating patients on the field of genomic and precision medicine.  Dr. McCarthy will present her experience with these two educational instruments and highlight the key elements of a successful educational program in precision medicine.
Jeanette McCarthy, MPH, Ph.D. (BIO), Editor-in-Chief, Genome, Visiting Associate Professor, UCSF Division of Genomic Medicine
12:05 pm Luncheon
1:15 pm Keynote Address: Genome Diagnostics - Technology, Data, and Integrated Delivery
The evolution of foundational genome sequencing technologies continues, and there remains promise of cheaper and more accurate diagnostic-grade data. These technologies are being employed in new and clever ways to gain insight into pathogenic states. Moving from this raw data output to actionable knowledge is a critical and nuanced step from an adoption, reimbursement and regulatory standpoint. Finally, a new and additional bottleneck is emerging related to the ability to rigorously comparatively evaluate and integrate new clinical tools and strategies into the standards of care across specialty areas.
Dietrich Stephan, Ph.D. (BIO), Chairman, Department of Human Genetics, University of Pittsburgh, Scientist-in-Chief, Silicon Valley Biosystems, Chairman, Whole Biome
1:45 pm Direct-to-Consumer Genetic Testing: the Ethics of Information and Returning Results
Direct-to-consumer (DTC) genomic services have generated controversy over who and when it is appropriate to provide genetic results to individuals. Critics have argued for restrictive regulation of such services, and even their prohibition, on the grounds of the harm they may pose to consumers. However, others argue that these services offer consumers the ability to make better informed health decisions based on increased understanding of genetic risks. In this presentation, Dr. Lee will draw upon empirical research with consumers in discussing the underlying ethical questions raised by DTC genomics and its implications for public understanding of personalized medicine.
Sandra Soo-Jin Lee, Ph.D. (BIO), Senior Research Scholar, Pediatrics, Center for Biomedical Ethics, School of Medicine, Stanford University
2:15 pm Using Drug Repositioning to Limit Resistance and Adaptations to Precision Medicines
One of the key challenges to precision medicine (PM) is the development of resistance to the PM drugs themselves. This is due to mechanisms that become more active as a response to a mutation or to a drug. Understanding these mechanisms is crucial. Targeting these mechanisms is even more important, as PM drugs are known to fail in a number of cases - especially in cancer - because of such resistance. Recent examples of targeting such adaptations  (e.g. in cystic fibrosis, in melanoma, and others) with repositioned drugs that may restore sensitivity to the PM drugs is emerging as a powerful adjuvant to PM.
Aris Persidis, Ph.D. (BIO), President & Co-Founder, Biovista Inc.
2:45 pm Refreshment/Networking Break
3:10 pm Genomic Sequencing: Who Will Pay? Who Should Pay?
Genomic sequencing is moving into clinical care, but this technological advance threatens to outpace our ability to use it effectively in clinical practice and to address the associated health policy issues. A key issue is whether payers will cover sequencing and what evidence will be needed to document its value.
This presentation will discuss UCSF’s work on current coverage policies for gene panels and the factors that determine positive or negative coverage decisions. Dr. Phillips will draw on their NIH-funded research being conducted at the UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS). Launched in 2008, TRANSPERS is dedicated to developing evidence-based information to objectively assess how personalized medicine can be most beneficial and efficient in improving health outcomes.
Kathryn Phillips, Ph.D. (BIO), Professor of Health Economics and Health Services Research, Director and Founder, UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Dept. of Clinical Pharmacy/School of Pharmacy, UCSF Institute for Health Policy Studies, and UCSF Comprehensive Cancer Center, University of California, San Francisco
3:40 pm Implementation of a Software Infrastructure for Clinical Genomics Reporting
Generating, delivering, and updating a clinical genomic sequencing report for routine clinical use has proven to be a challenge in the implementation of precision medicine. To maximize the impact of genomics-based testing at the point of care, healthcare providers and labs must be able to handle complex clinical data, high-volume genomics data, and evolving biomedical knowledge.
This talk will present a software solution, based on semantic computing principles, that enables the integration of these very different data types for the purposes of clinical reporting. Mr. Hirsch will present results of efforts to integrate these technologies into clinical practice within academic medical centers and an integrated community health care system. He will discuss the maintenance of an evolving variant interpretation knowledge base, the sharing of variant interpretation across institutions, and the coupling of knowledge base revisions to automated updates of clinical reports. He will also present the results of physician adoption of a web-based, interactive clinical genome report format that incorporates clinical care guidelines with genomic report data.
Jonathan Hirsch (BIO), Founder & President, Syapse
4:10 Clinical Trial Design in the Age of Personalized Medicine
In this presentation, Dr. O’Neill will cover the following subject matter:
► Clinical Trial Design Old and New
► Accommodating uncertainty in trials
► Regulatory aspects
Vincent J. O'Neill, MD, MRCP (BIO), Chief Medical Officer, Exosome Diagnostics
4:40 pm NGS in the Development of Companion Diagnostics for Precision Oncology
The development of next-generation sequencing (NGS) technologies has made sequencing not only rapid and cost-effective, but also highly accurate and reproducible. These advances have increased the utility of NGS in clinical settings, with applications ranging from the identification of rare diseases to the detection of chromosomal abnormalities in maternal-fetal medicine. Deep sequencing and circulating free tumor DNA in the oncology space is also trending toward clinical utility. Regulatory clearance of NGS-based platforms and approval of clinical assays utilizing NGS technologies are also central to the wide-scale implementation of NGS in personalized medicine.
Frank Ong, MD (BIO), Associate Director, Medical Affairs, Illumina, Inc.
5:10 pm Cocktail Reception

DAY TWO - OCTOBER 30, 2014

7:45 am Continental Breakfast

8:30 am The Radically Changing Market for Lab Test Pricing: PAMA 2014 and Beyond
Over the past two years, the pathology trade press has been rife with payor price reductions, increasingly strict coverage, and lab bankruptcies or consolidations. 2014 Medicare reform (PAMA) will radically change the way Medicare pays for fee for service lab tests, through drastic changes in the coding, reporting, and price setting system. Impacts will ripple through commercial contracts and Medicaid payments as well. Strategic options for labs will be discussed, as well as key decisions that CMS policymakers must resolve in order to implement the new law.
Bruce Quinn, MD, Ph.D. (BIO), Senior Health Policy Advisor, Foley Hoag LLP
9:00 am The $1,000 Genome Meets Reality
Much has been said in the media in the last few years about the remarkable transformation novel DNA sequencing technologies will bring to medicine, delivering vast amounts of genetic information speedily and with ever decreasing cost. Glib references to “the $1,000 dollar genome” have emphasized the point, but have never taken into account the realities of delivery of this product. In this talk Dr. Morrison will present an overview of the implementation of NGS into the clinical practice at one of the leading comprehensive cancer centers, Roswell Park Cancer Institute. He will discuss strategies that begin with defining the panel of genes to be tested, optimal design of infrastructure to validate and deliver such testing, to the final process of engaging payers and gaining reimbursement. In the end “the $1,000 dollar genome” will meet the reality of the overall investment across the continuum of this process.
Carl Morrison, MD, DVM (BIO), Executive Director of the Center for Personalized Medicine, Clinical Chief, Department of Pathology & Laboratory Medicine, Director, Division of Molecular Pathology, Director, Pathology Resource Network, Roswell Park Cancer Institute
9:30 am Clearing the Remaining Hurdles in the Field of Personalized and Precision Medicine
In this presentation, Dr. Jacques will discuss a number of the challenges that are impeding the progress of personalized medicine. Questions he will be answering include:
► What should the patient do when multiple tests give different answers to the same clinical question?
► Is the current RCT paradigm the best tool to close the evidence gaps in personalized medicine?
Louis B. Jacques, MD (BIO), Senior VP and Chief Clinical Officer, ADVI (Formerly Director, Coverage & Analysis Group (CAG), Centers for Medicare and Medicaid Services (CMS)
10:00 am Refreshment/Networking Break
10:30 am PANEL SESSION: Reimbursement and Precision Diagnostics - A Conversation in Three Perspectives
While personalized and precision medicine continue to promise improved care, better prediction of disease progression and reduced burden of unnecessary interventions, reimbursement issues remain a challenge. Historical opacity in the claims coding system made payers reluctant to embrace this new paradigm, and significant evidentiary questions remain to be answered. CMS' MolDX pilot, recently supported by the PAMA legislation, sought to address ongoing issues related to coverage and payment for newer diagnostic technologies.  Smaller start-ups with potentially powerful technologies need to understand what factors private payers will consider for desired coverage and payment.
This conversation brings together four formidable thinkers and doers in the area of reimbursement and reimbursement policy: 
Louis Jacques, MD (BIO), Sr. VP & Chief Clinical Officer at ADVI, was formerly the Director, Coverage & Analysis Group, CMS and is an expert on CMS' approach and reasoning on reimbursement of diagnostic technologies
Paul Billings, MD, Ph.D. (BIO), Chief Medical Officer, Omicia, Inc. was formerly the Chief Medical Officer, Life Technologies, Inc. and has a depth of expertise and content knowledge of diagnostics unsurpassed in the industry
Chris Hall (BIO), Chief Commercial Officer at Veracyte, was formerly the Chief Business Officer of Berkeley HeartLab and Senior VP at Celera, brings a wealth of experience with industry and their approach to obtaining reimbursement from private insurers. 
The conversation will be moderated by Bruce Quinn, MD, Ph.D. (BIO), Senior Policy Advisor, Foley Hoag, a national expert on successful business strategies within the U.S. healthcare reimbursement system.
11:30 am NGS, PGX, OIG and Beyond: An update Regarding What to Expect Now and Through 2015
This session will explore the new initiatives and trends we are seeing on the parts of both CMS and commercial payers that will have the most potential for impacting the way you do business. This session will explore the following:
► How are commercial payers paying for mopath codes and other trends?
► What are the latest PAMA and 2015 draft rule updates?
► Compliance and OIG concerns and watch outs
Rina Wolf (BIO), VP Commercialization Strategies, Consulting & Industry Affairs, XIFIN, Inc.
12:00 pm Luncheon
1:15 pm Translating the Approach of Precision Medicine to the Oncology Clinic
We are in an era of rapid information dissemination and improved understanding of complex biological processes. Treating advanced cancer with agents that target a single cell surface receptor, up-regulated or amplified gene product, or mutated gene, has met with some success; however, eventually the cancer progresses. Technologic advances and gene sequencing cost reductions have propelled the field of oncology to quickly integrate "-omics"-based precision medicine into clinical research and clinical practice. This lecture will provide an overview of some of the technical and logistical considerations one should be aware of related to "-omics"-based medicine in oncology and how these tools are being applied now in clinical research that will inform clinical practice.
Glen J. Weiss, MD, MBA (BIO), Director of Clinical Research & Phase I and II Clinical Trials, Cancer Treatment Centers of America, Co-Head, Lung Cancer Unit, Cancer & Cell Biology, Clinical Associate Professor & Translational Physician Scientist, TGen-The Translational Genomics Research Institute, Clinical Associate Professor of Medicine, University of Arizona School of Medicine-Phoenix
1:45 pm Innovation, Evidence, and Coverage: The Case for Personalized Medicine in Oncology
The pace of innovation in cancer care is staggering. So is the associated cost. The rate of rise in the cost of cancer care is widely felt to be unsustainable. Most Americans have employer or government supported health care, and health plans are charged with being stewards of the health care spend. How can payers be good stewards in the area of personalized medicine in oncology? How can we promote innovation while optimizing value? This talk will review current payer process, the evidence supporting personalized medicine, and propose a path forward.
Michael Kolodziej, MD, FACP (BIO), National Medical Director, Oncology Solutions, Aetna
2:15 pm Delivering Personalized Medicine with Next-Generation Sequencing
Truly individualized diagnostic and treatment programs require many clinical modalities. The potential to assess all the genomic contributions to this end is rapidly becoming available, timely and affordable. Full knowledge of the genome and its modifiers will be necessary to completely understand primary and background modifiers of clinically important parameters. While developing this data, certain select conditions (rare disorders, unknown presentations, relapsed cancer patients, etc) will be relatively personalized first. Data analytics and clinical reporting with support will be crucial to making the avalanche of new information relevant and valuable.
Paul Billings, MD, Ph.D. (BIO), Chief Medical Officer, Omicia, Inc. (Formerly Chief Medical Officer, Life Technologies, Inc.)
2:45 pm End of Conference

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