OCTOBER 21-22, 2013  |  BOSTON, MA        Westin Boston Waterfront

This Year's Conference

The 6th Annual Personalized Medicine is Coming to SAN FRANCISCO, CA on OCTOBER 23-24, 2014. Please check back in the coming weeks and months for updated information.

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WEDNESDAY, SEPTEMBER 12th

7:30 Registration and Continental Breakfast

8:15 Chairperson's Opening Remarks

Keith Batchelder, MD, Founder and CEO, Genomic Healthcare Strategies

8:25 What Genome Information is Ready for Clinical Use?- Approaches in the Coriell Personalized Medicine Collaborative
As personal genetic information becomes more widely used clinically, one must consider the current standards for use, as well as identify dynamic mechanisms that can be put into play to continually evaluate the utility of genetic information in this rapidly changing landscape. Dr. Christman will discuss how these issues have been approached in a large cohort study, the Coriell Personalized Medicine Collaborative (CPMC), in which personal genetic results are reported to study participants. A new partnership in personalized medicine with the United States Air Force and Johns Hopkins University Applied Physics Laboratory will also be discussed.

Michael F. Christman, Ph.D., President & CEO, Coriell Institute for Medical Research

8:55 Empirical Studies in the Implementation of Genomic Medicine
As we approach the age of individual genomic medicine, whole genome sequencing (WGS) will soon be available for physicians to utilize in the clinical care of patients. However, much is unknown about how WGS may be appropriately and effectively integrated into the practice of medicine and what the impact of doing so will be. This will be particularly true for the extensive incidental risk information generated. How should genetic risk information be communicated? Will it cause anxiety, depression or distress? Will it be understood and remembered and will it change baseline risk perceptions? How will genetic information influence health behaviors, health outcomes and health care costs for both patients and physicians? How will genetic information influence non-medical domains such as insurance purchasing behavior and social relationships? And, is there a potential for falsely reassuring individuals who learn they are at a decreased genetic risk for a particular disease?  This presentation will address these questions by presenting data from several NIH-funded clinical trials and ongoing surveys that are exploring emerging themes in translational genomics.

Robert C. Green, MD, MPH, Director, G2P Research Program, Associate Director for Research, Partners Center for Personalized Genetic Medicine, Brigham and Women's Hospital and Harvard Medical School

9:25 Clinical Next Generation Sequencing: Challenges and Opportunities
In this presentation, Dr. Miller will discuss how Foundation Medicine is utilizing clinical next generation sequencing to identify genetic alterations in formalin fixed paraffin embedded solid tumor specimens and in turn empowering oncologists with critical information that may change or expand treatment options.

Vincent A. Miller, MD, Senior Vice President, Clinical Development, Foundation Medicine, Consultant, Thoracic Oncology, Memorial Sloan-Kettering Cancer Center

9:55 Refreshment and Networking Break

10:20 Panel Session: Data Deluge and Opportunity in Personalized Medicine
Personalized medicine increasingly requires sophisticated management, analysis and interpretation of large multi-national databases; some proprietary, others public or open-source, and each varying in approach to consent, data sharing, privacy and result disclosure. Next generation, exome, and whole genome sequencing are accelerating the creation of even more data whose use is critical to the growth of personalized medicine.  This panel will explore clinical, ethical, technological and business strategy issues related to data collection, sharing and use in the context of the growth needs for personalized medicine, a growing emphasis on personally controlled health information, and public acknowledgement of the need to address social justice interests in global benefit sharing.

Chair & speaker: Carol Isaacson Barash, Ph.D., Principal, Helix Health Advisors, Adjunct Professor of Personalized Medicine, Regis College
Samuel J. Aronson, A.L.M., M.A., Executive Director of IT of the Partners HealthCare Center for Personalized Genetic Medicine
Robert C. Green, MD, MPH, Director, G2P Research Program, Associate Director for Research, Partners Center for Personalized Genetic Medicine, Brigham and Women's Hospital and Harvard Medical School
Dana Hosseini, Co-Founder, CEO & President, Seqster, Inc., Co-Founder, DiThera, Inc., ex-CEO, Iceland Genomics

11:35 From Blockbuster to Nichbuster - Addressing the Challenges for Successful Co-Development of CDx Assays
The drug development process is witnessing a paradigm shift in which new therapies need to be tailored to well defined patient sub-groups via a companion diagnostic assay.  From the perspective of a global IVD developer, the speaker will address the challenges of co-development programs and discuss strategies to achieve successful development and commercialization of these IVD products.

John Beeler, Ph.D., Director, Theranostics & Business Development, bioMerieux, Inc.

12:05 Luncheon

1:15 Personalized Medicine: Clinical Perspective and Experience
The goal of the presentation is to highlight how personalized medicine is being implemented in a community based hospital system both within a busy adult genetics clinic and system wide.   We will explore utilization, expectations, and potential barriers for clinical integration of genomics based technology within a community based health system.

Peter Hulick, MD, Division Head, Medical Geneticist, NorthShore University Health System Center for Medical Genetics, Clinician Educator, University of Chicago Pritzker School of Medicine

1:45 Practicing Genomic Medicine in 2012
This presentation will answer the following questions:

  • What will happen to patients, doctors and healthcare in this era?
  • What are the early risk:benefits to clinical applications?
  • How long will it take to make genomic medicine equal preventive care?

Michael Murray, MD, Director of Personalized Medicine Genomic Consultation Service and Clinical Chief, Division of Genetics, Brigham & Women's Hospital

2:15 Empirical Evidence in the Implementation of Genomic Medicine

Patrick Terry, Principal, Scientia Advisors

2:45 Clinical Implementation of Large-scale Tumor Genotyping to Guide Personalized Cancer Care
Dr. Dias-Santagata will describe herr institution's experience in developing and implementing a clinical platform for broad-base tumor genotyping. She will outline the challenges they faced and she will summarize the data of 3+ years of clinical testing. She will also include some interesting patient cases with clinical follow up.

Dora Dias-Santagata, Ph.D., Instructor of Pathology, Harvard Medical School, Co-Director, Translational Research Laboratory, Massachusetts General Hospital

3:15 Refreshment Break

3:40 Panel Session: Investing in Personalized Medicine – The Angel Investor and Venture Capital Perspective on Personalized Medicine
The investor panel will be answering the following questions:

  • Do you think Personalized Medicine is a field that’s ready for investment?
  • What kinds of Personalized Medicine companies are you seeing as part of your deal flow?
  • Which Personalized Medicine markets do you see happening soon?
  • Are there early stage investment opportunities?

Chair: Keith Batchelder, MD, Founder and CEO, Genomic Healthcare Strategies
Philip Reilly, MD, JD, Venture Partner, Third Rock Ventures
Dr. Andrew Jay, Investment Partner Venture Capital, Siemens Venture Capital
Richard Anders, Founder, Executive Director, Mass Medical Angels

4:55 Genetic Testing for Patients/Families with Hereditary Disease: Personalized Medicine in Practice
In this presentation, Dr. Bale will discuss how personalized medicine is being practiced and genetic testing is being utilized by physicians and for patients today. She will provide her insights into how diagnostic services, including mutation identification, prenatal testing, carrier testing in relatives, gene panels, and whole genome/exome approaches to genetic testing are being carried out today.

Sherri Bale, Ph.D., FACMG, Managing Director, GeneDx

5:25 Cocktail Reception



THURSDAY, SEPTEMBER 13th

7:30 Continental Breakfast

8:20 Chair's Opening Remarks

Keith Batchelder, MD, Founder and CEO, Genomic Healthcare Strategies

8:30 Asking the Right Question: What is the Role of Clinical Adoption? What other Benchmarks are Needed to Cover your Test?
This session will encompass physician adoption of molecular diagnostics and what payors need to cover your test.  The discussion will explore dynamic growth in molecular diagnostic technologies, physician awareness around unproven technology and payors tightening up their requirements for what criteria must be met for a test to receive coverage policies.  Insights into key benchmarks throughout the commercialization process that are leading to increased physician adoption will be shared. The session will also give a breakdown of the future coverage policies requirements with commercial and government payor groups. By discovering the newest developments in payors' criteria for reimbursement and validation requirements that payors are looking for, you will gain critical insight into what it takes to make your new molecular diagnostic technology the standard of care.   

Kyle Fetter, Associate VP of Molecular Diagnostic Services, XIFIN, Inc.


9:00 Assessing the Shifting Landscape in Molecular Diagnostic Coding and Medicare Coverage
This presentation will discuss the current changes occurring in coding, coverage and reimbursement for molecular diagnostics. Ms. Pambianco will focus on Medicare coverage at the national and local levels, including Palmetto's MolDx Program, the interplay of these changes, and the impact on other payers.

Danielle Pambianco, Director, HillCo Health


9:30 Reference-based Pricing: the Good, the Bad and the Ugly
In this presentation, Dr. Hornberger will discuss value-based pricing, as it relates to molecular diagnostics and the future of personalized medicine. He will also cover in his talk validation of assays and economic implications of risk stratifiers to predict outcomes for early-stage breast cancer, which is being published by the Journal of the National Cancer Institute.

John Hornberger, MD, CEO and President,
Cedar Associates, LLC

10:00 Refreshment Break

10:30 Panel Session: Validating and Paying for Personalized Medicine: Coding, Coverage & Reimbursement for Molecular Diagnostics

Chair: Keith Batchelder, MD, Founder and CEO, Genomic Healthcare Strategies
Kyle Fetter, Associate VP of Molecular Diagnostic Services, XIFIN, Inc.
Danielle Pambianco, Director, HillCo Health
John Hornberger, MD, CEO and President, Cedar Associates, LLC


11:30 Navigating the Market Access Challenges of PM and CDx in Europe
Market access in Europe for Molecular Diagnostics and Personalized Medicine remains a challenge for the industry. It is a mix of regulatory, pricing and reimbursement, clinicians adoption and distribution issues in a variety of European countries that have either centralized or decentralized Health Technology Assessment systems while facing economic constraints. The speaker will describe the current market access challenges, and the various initiatives currently being implemented that should make Europe a dynamic region for Molecular Diagnostics in a not too distant future.

Werner Kroll, Ph.D., Board Member, EPEMED (European Personalized Medicine Association)


12:00 Luncheon

1:15 Personalized Medicine- A Payer’s Perspective
Payers are charged with maintaining quality and managing costs while responsibly integrating the value that personalized medicine provides. In this presentation, the participant will hear a payer’s perspectives on integrating personalized medicine with the interests of the health plan, the consumer, and the provider in mind.

Bryan Loy, MD, Market Medical Officer, Humana


1:45 Mapping the Future of Molecular Diagnostics: The Role of Personalized Medicine in an Improved Delivery System
This presentation will explore the actual practice of personalized medicine and how best to bring this about. Dr. Vojta will also discuss the UnitedHealth Center for Health Reform and Modernization's recent working paper on personalized medicine and a framework for moving forward.

Deneen Vojta, MD, Senior Vice President, UnitedHealth Center for Health Reform and Modernization

2:15 Revolutionizing and Personalizing Global Health – The Solutions Perspective
This presentation will provide the solutions perspective on enabling a revolution in global health through personalized medicine-based technologies. This discussion will focus on research trends that are catalyzing a new generation of disruptive, innovative tools for finding, understanding and preventing - or at least mitigating -  the biological and environmental causes of disease, in an individualized context. The presentation will offer examples of disease-specific innovation in diagnostics, therapeutics, and prevention, including a molecular understanding of environmental factors impacting health. Through a broad, synergistic array of technologies, including next generation sequencing, multiplexed biomarker imaging and epigenetic analysis, it is envisaged that this new generation of tools will not only enable personalized medicine for patients, but personal health for all.

Kevin Hrusovsky, Sr. Vice President and President, Life Sciences and Technology, PerkinElmer Inc.

2:45 Future Commercial Applications of Next Generation Sequencing in Personalized Medicine
The perfect storm of lower costs, a wealth of data leading to clinically actionable insights, and the acceptance of personalized medicine will make the NGS platform the key driver of better patient outcomes in five plus years. Already, we’re seeing a host of companies leveraging NGS techniques but it will take the marriage of these tools with asking and answering medically relevant questions to drive adoption and in turn, healthier patients. The challenge will be great: all healthcare stakeholders will need to play a significant role. Hopefully you will walk away from this presentation feeling optimistic about the future of NGS as a clinically relevant commercial platform and get a sense for what you, as a healthcare stakeholder must be thinking about to enable this future.

Premal S. Shah, Ph.D., Director, Business Development,
Genomic Health, Inc.

3:15 End of Conference

 

 
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