Baltimore, MD | October 5-6, 2015

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

2013 Agenda


7:45 Registration/Continental Breakfast

8:30 Chairperson's Opening Remarks

8:35 Evolving Dynamics of the Personalized Medicine Value Chain
The emergence of personalized medicine is driving changes in business models, business strategies, IP, technologies for clinical testing, clinical research paradigms, regulation, and medical practice. Optimizing value creation in personalized medicine will require an in-depth and accurate understanding of the drivers in these areas and their dynamics. Key concepts relevant to developing more robust innovation strategies for PM include: the need for a fuller understanding of economic dependences of treatment and diagnostic markets, the importance of investments in aligning test and treatment development, and the extent to which partnering strategies can strengthen or weaken investments. Several approaches have been developed for studying innovation value chains, such as the The Analysis of Life Science Innovation Systems (ALSIS) model. This presentation will provide a summary of a systematic review of types and key aspects of value chains in personalized medicine as well as their relationship with and relative impacts on value creation. Key questions answered by this review include:

  • What are the various business models currently in operation?
  • How do they integrate within a broader value chain?
  • In what ways do they enable or hinder value creation?
  • What drivers and contextual factors are important to the success or failure of particular models?

Within this context, case studies and scenarios will be provided that illustrate key dynamics of value creation, in particular related to investment, IP, ROI, and partnering. Best practices or strategies supported by these findings and needs for future research in the area will be discussed.

Katherine Bonter
Director of Promotion and Advocacy, Centre of Excellence in Personalized Medicine (Cepmed)

9:05 Addressing the Ethical, Legal, Social and Policy Issues Related to Integrating Personalized Medicine into Routine Clinical Care
Ten years after the completion of the Human Genome Project, there is now incredible opportunity to apply the knowledge and technology from this effort directly into clinical practice. Pharmacogenetics has been considered one of the most promising areas to truly translate this knowledge into clinical care, and if implemented appropriately, could clear the path for the expansion of individualized genomic medicine to optimize health care. Provision of personalized medicine, and the infrastructure necessary to support its success, requires careful consideration of relevant ethical, legal, social and policy issues (ELSIP). These issues can act as barriers or facilitators to successful integration of genomic information into clinical practice. They can also serve to drive policy to support its implementation. This presentation will discuss two inter-related ELSIP areas: Equity/Social Issues and Information Issues. Some of the questions to be addressed include:

  • Who benefits from and has access to personalized medicine?
  • Are we disseminating accurate information and educating stakeholders, including the public?
  • Do best practices exist to assess levels of evidence for different stakeholders?
  • Who should have access to genomic data and how should this be shared?

Whenever possible, these and other questions (and ways to address them), will be informed by empirical data and potential resources that stakeholders can turn to for help.

Lynn G. Dressler, Dr.P.H.
Director, Personalized Medicine and Pharmacogenomics, Mission Health, Fullerton Genetics Center

9:35 Personalized Medicine in Practice
This talk is based upon lessons learned from supplying advanced reporting to deliver genetic test results to practicing physicians. It will explore the components that are necessary to transform raw data into actionable guidance for clinicians that have limited training in genetics. Topics will include the speaker’s experience in creating a knowledgebase, technical issues with genetic test results and laboratory integration, and suggestions for developing reports that are informative and efficient to use.

Don Rule
Founder, Translational Software

10:05 Refreshment/Networking Break

10:35 Panel: Big Data - The Driving Force in Enabling Point of Care Personalized Medicine: Challenges & Potential Solution Strategies
The big data Tsunami is here, but it must expand to generate the knowledge necessary to bringing personalized medicine to the clinic. Technological, IP, operational and ethical complexities complicate efforts to identify and interpret clinically useful knowledge and integrate it into daily medical practice via provider and patient adoption. While E-data management solutions have enabled greater efficiencies for achieving the goals of personalized medicine, data from private (closed) and public (open) sources pose challenges for even the most advanced systems.

This panel will discuss challenges and potential solution strategies from the perspective of 1) IT architecture, 2) data harnessing, interpretation and integration, 3) IP, closed versus open systems and 4) privacy, personal ownership and consent. Panelist presentations will explore the scope of challenges and present innovative approaches to overcoming barriers.

Carol Isaacson Barash, Ph.D.
Principal, Helix Health Advisors, MDx Content Developer, McKesson Health Solutions, Adjunct Professor, School for Nursing, Science and Health Professions, Graduate Program in Regulatory and Clinical Research Management, Regis College

Nikhil Kumar
President/CEO, ApTSi (Applied Technology Solutions, Inc.)

Leslie Francis, Ph.D., JD
Associate Dean for Faculty R&D and Alfred C. Emery Professor of Law, Professor of Philosophy, S.J. Quinney College of Law, University of Utah

Don Rule
Founder, Translational Software

Priscilla Short, MD 
Genetics Consultant, American Medical Association, Division of Science & Public Health

11:45 Next Generation Sequencing: Product vs Service Business Models
In this presentation, Mr. Daum will highlight for the audience the difference in service vs product business models within next generation sequencing and how the likely successes and pressures of the models are different. He will also provide his thoughts on how low cost sequencing will impact drug discovery and patient treatment in the coming years.

Wolfgang Daum
President & Chief Executive Officer, Knome, Inc.

12:15 Luncheon

1:25 Clinical Utility, Comparative Effectiveness and Value: View from the Technology Evaluation Center (TEC)
Clinical tests can provide more information, but does that information improve patient health outcomes? Demonstrating the clinical utility of diagnostic and predictive tests is challenging, whether the nature of a test is genomic, imaging, or a predictive algorithm. Dr. Aronson will give an overview of the Technology Evaluation Center and approaches to assessing the clinical utility of a test or combination of tests. More broadly, she will address molecular diagnostics in the context of comparative effectiveness and a sustainable care health care system.

Naomi Aronson, Ph.D.
Executive Director, Clinical Effectiveness and Policy, Technology Evaluation Center, Blue Cross Blue Shield Association

1:55 Public Policy Issues in Molecular Diagnostics
As the leader of the team responsible for creating and maintaining new CPT codes for molecular diagnostic tests, Ms. Madsen will lend her expertise in this area to a discussion which will lay out the keys to obtaining coverage and payment in today’s healthcare landscape. Her talk will discuss the current environment for reimbursement of molecular diagnostic tests, focusing on the intersection of business strategy and public policy.

Jennifer Madsen, MPH
Sr. Director, Economic and Regulatory Affairs,
College of American Pathologists

2:25 Personalized Medicine at the Bedside, Achieved with Systematic Drug Repositioning
As the ability to derive a patient's genome, including that of disease tissue, becomes more and more commoditized, there is an increasing and pressing need to translate that information to an effective therapy at the bedside. This is especially true in cases where the patient is failing current or standard therapies, as occurs in many cancers. By applying large scale drug repositioning, filtered by a patient's genomic context, at the bedside, it is now possible to use existing drugs in novel ways, that are also appropriate as personalized medicines. Case studies in pancreatic cancer and other indications will be described.

Aris Persidis, Ph.D.
President & Founder, Biovista, Inc.

2:55 Refreshment/Networking Break

3:25 Practical Perspectives on Whole Genome/Exome Studies: A Genetic Counselor’s Point of View
In this presentation, Ms. Mester will discuss the following:

Benefits and limitations of whole genome/exome sequencing in the clinic

  • Implications for the patient/family
  • Resultant changes to genetic counseling practice

Anticipatory guidance for researchers

  • Points of consideration for study protocols involving genetics research
  • How to enact new guidelines for returning results to patients

Jessica Mester, MS, CGC
Certified Genetic Counselor, Cleveland Clinic

3:55 How will Next Gen Sequencing Tests be Evaluated by Payers?
In this presentation, Dr. Deverka will discuss CMTP's recently released Effectiveness Guidance Document (EGD) on molecular diagnostics. The purpose of this EGD is to close the gap between the presumed benefits of tests undergoing technology assessments and the information needs of payers, clinicians and patients. The EGD recommendations were created through an iterative process that incorporated the perspectives of major stakeholder groups, including researchers, clinicians, payers, industry, guideline developers and patient advocates.

Dr. Deverka will summarize the lessons learned from this 3-year multi-stakeholder project on molecular diagnostics. She will describe the unique features of NGS tests (primarily from a reimbursement perspective); outline the methods challenges, and discuss how they plan on approaching a follow-on project to develop methods guidance to demonstrate the clinical utility of NGS tests, using a multi-stakeholder approach.

Patricia Deverka, MD, MS, MBE
Senior Research Director, Center for Medical Technology Policy (CMTP)

4:25 Clinical Advantages of Bioinformatics: Next Generation Non-Invasive Prenatal Testing using SNPs
This talk will focus on how advances in computing have enabled better clinical tests in the prenatal field.

Zachary Demko, Ph.D.
Director of Research & Development, Natera, Inc.

4:55 End of Day's Sessions 



7:45 Continental Breakfast

8:15 Chairperson's Opening Remarks

8:20 Understanding the Value of Advanced Diagnostics: Aligning Labs, Clinicians and Payers to Make Better Decisions
Today, over 3000 molecular diagnostic (MDx) tests are marketed for clinical use and new diagnostics are regularly emerging at a rate of several per month. No standardized system for uniquely identifying these tests or capturing and analyzing the clinical and financial impact of individual tests currently exists. This discussion will show how the coordinated effort between the AMA and McKesson will bring specificity to the use, identification, reporting and tracking of MDx tests through a mapping of AMA CPT® codes to McKesson Z-Code™ Identifiers. This coordinated process will help to improve communication and collaboration between clinicians, hospitals, labs and payers.

Matthew Zubiller
VP of Decision Management, McKesson Health Solutions

8:50 Realizing the Future Today: Development and Implementation of Noninvasive Prenatal Testing
 This presentation will describe key steps and milestones leading to successful commercialization of the verifi prenatal test, a noninvasive prenatal test that detects multiple fetal chromosomal aneuploidies using a single maternal blood sample from 10 weeks gestation. Evidence from clinical studies as well as clinical laboratory experience that has lead to practice opinions and statements by professional medical bodies and coverage decisions by insurers will be discussed.

Amy Sehnert, MD
Director, Clinical Affairs, Verinata Health, an Illumina Company

9:20 Development of a Personalized Genomic Medicine Program at a Large Community Teaching Hospital System: Trials and Tribulations
Hired as a champion of medical genetics and genomics, the speaker will outline the many steps taken to establish a world class program for patients, for the primary care community,  and  for specialists alike at a tertiary care community based teaching hospital in northern New Jersey.

Arnold Pallay, MD
Co-Director, Personalized Genomic Medicine, Atlantic Health System, Clinical Assistant Professor, Robert Wood Johnson Medical School, Department of Family Medicine

9:50 Refreshment/Networking Break

10:10 Panel: The Reality and Practice of Personalized Medicine: Stakeholders Views on Challenges and Opportunities
In this session, panelists will discuss issues key to implementation of personalized medicine. The list of stakeholders in personalized medicine has grown significantly in the past few years. Not only do providers and patients have voices, but the educational establishment, information technology professionals and payers now have an important role to play in the field. Our panelists, who come from diverse backgrounds will discuss how to solve the challenges that still exist to successful implementation of personalized medicine.

Keith Batchelder, MD
Founder, CEO, Genomic Healthcare Strategies

Charis Eng, MD, Ph.D., FACP
American Cancer Society Clinical Research Professor, Hardis Endowed Chair of Cancer Genomic Medicine, and Founding Chairwoman, Genomic Medicine Institute, Founding Director, Center for Personalized Genetic Healthcare, Cleveland Clinic

Jessica Mester, MS, CGC
Certified Genetic Counselor, Cleveland Clinic

James P. Evans, MD, Ph.D.
Bryson Distinguished Professor of Genetics & Medicine, Department of Genetics, University of North Carolina at Chapel Hill

11:20 Genetic and Genomic Medicine: At the Heart of Value-Based Clinical Care
In the patient-oriented research and individual clinic implementation settings, we can now ably utilize genetics and genomics to subset by disease risk, enable personalizing clinical management and offer predictive testing of family members. However, the widespread implementation from genetic and genomic research to clinical implementation is less than stellar or assumed to be successful but in reality, not evaluated.  Value-based healthcare delivery is now here to stay. The prevailing model for the practice of genetics has never been volume-driven nor fee-driven, thus, promising to lead the way in delivery of value-based healthcare.

This session will examine the elements of successful clinical implementation of a family health history tool and of universal screening for Lynch syndrome, the most common adult onset heritable colorectal cancer syndrome, across a large academic medical center and health system. One important element for successful implementation is preparing the human resource infrastructure necessary for genomics-based clinical care.

Charis Eng, MD, Ph.D., FACP
American Cancer Society Clinical Research Professor, Hardis Endowed Chair of Cancer Genomic Medicine, and Founding Chairwoman, Genomic Medicine Institute, Founding Director, Center for Personalized Genetic Healthcare, Cleveland Clinic

11:50 Genomics in Oncology: Past, Present and Future
In his role as Chief Medical Officer of one of the largest developers of life science tools and systems for the analysis of genetic variation and function, Dr. Grosu is playing a key role in building Illumina's diagnostic capabilities through collaborations with regulatory agencies, internal product development teams, and Illumina's CLIA-certified clinical laboratory. From his vantage point, Dr. Grosu is uniquely qualified to offer his perspective on the following issues surrounding personalized medicine and next generation sequencing:

  • The roots of molecular classification in Oncology
  • The current state of genomics applications in Oncology
  • The future promise of sequencing (e.g., full genomic characterization of all tumors; circulating tumor DNA)
  • Clinical applications & utility of current and future applications of sequencing in Oncology

Daniel Grosu, MD, MBA
Vice President, Clinical Development and Medical Affairs, Illumina, Inc.

12:20 Luncheon

1:20 Realizing the True Promise of Genomic Medicine
Genomic technology is providing clinicians with powerful new tools that can be used to evaluate patient’s genomes in unprecedented detail. But like any powerful and broad new tool in medicine, defining the precise contexts in which it will provide benefit to patients is challenging. While genomics has great potential to contribute to the health of patients and the population in general, inappropriate or premature translation of any new technology into clinical care can result in harm, both literally and in an economic sense. Genomics is no exception. In this presentation, Dr. Evans will explore the clinical applications of massively parallel sequencing that appear most promising. He will also explore the use of this new tool in the public health setting.

James P. Evans, MD, Ph.D.
Bryson Distinguished Professor of Genetics & Medicine, Department of Genetics, University of North Carolina at Chapel Hill

1:50 Panel: Financing Personalized Medicine in a Challenging Economic Environment
With as many challenges as successes to point to in recent months, is it getting harder to make a case for investor returns in personalized medicine and diagnostics? The panel will explore what successful companies have done to grow in this environment, what they as key participants in the space are doing to manage deal flow, and how they see the sector moving forward.

Emily Levy, MBA
Principal, Synergy Partners

Frank Stokes
Managing Director, Healthcare Investment Banking, Leerink Swann LLC

Jason Sibley
Director, GE-Ventures, Healthyimagination Fund 

Caleb Winder 
Director, Excel Medical Ventures

3:00 End of Conference

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