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| 7:00 a.m. - 8:00 a.m. | Registration and Continental Breakfast with Exhibits |
| 8:00 a.m. - 8:15 a.m. | Welcome and Opening Remarks
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| 8:15 a.m. - 9:00 a.m. | Keynote: Gaining Ground in Molecular Diagnostics: Advancing Clinical Utility, Easing Access, and Conquering the Data Deluge
Learning Objectives:
- Discuss how easing access to, and interpretation of, the genome for physicians is the key to gaining ground in molecular diagnostics
- Identify strategies for transforming complex and often massive datasets generated through molecular diagnostics into clinically relevant information
- Gain insight into novel software, databases, and bioinformatics tools that promise to democratize the practice of genetic testing so it is a pervasive part of health care
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| 9:00 a.m. - 9:45 a.m. | Providing Cost-Effective Molecular Diagnostics: How to Overcome the Challenges
Learning Objectives:
- Understand the challenges associated with providing cost-effective molecular diagnostics for personalized medicine and companion diagnostics in a manner that meets the needs of laboratories, patients, physicians, payers, and manufacturers
- Learn how to select, develop, and perform tests that make sense from a clinical and cost standpoint – not just those that are cutting-edge diagnostic tools
- Outline the numerous factors laboratories need to consider before bringing in any molecular diagnostic tests
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| 9:45 a.m. - 10:30 a.m. | Reimbursement Realities of Molecular Diagnostics: A Payer’s Perspective
Learning Objectives
- Discuss current challenges in clinical and network management for molecular diagnostics
- Share perspective on potential strategies to address challenges and impact to stakeholders
- Examine the role of clinical utility in reimbursement decisions made by managed care organizations and other
payers
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| 10:30 a.m. - 11:00 a.m. | |
| 11:00 a.m. - 12:00 p.m. | Molecular Diagnostic Payment: Policy and Practical Implications for Labs and Consumers
Learning Objectives
- Discuss Medicare and managed-care reimbursement for new molecular pathology codes
- Understand the policy and practical implications of the regional MAC pricing, which in some cases does not cover the costs of the test
- Get insight into the long-term effect of such low pricing on labs and on consumer access to genetic testing
Rina Wolf, Vice President, Commercialization Strategies, Consulting and Industry Affairs, XIFIN, Inc. Patric Hooper, Esq., Partner, Hooper Lundy & Bookman and counsel to the California Clinical Laboratory Association |
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| 12:00 p.m. - 12:30 p.m. | What’s Now and What’s Next for MDx? Panel Discussion and Q&A
Learning Objectives
- Recap and reinforce the morning’s key takeaways
- Present varying perspectives relating to molecular diagnostic testing priorities
- Discuss key themes and findings
Dietrich Stephan, Richard A. Montagna, Glenda Flemister, Rina Wolf, and Patric Hooper
Moderator: Stephanie Murg |
| 12:30 p.m. - 1:45 p.m. | |
| 1:45 p.m. - 2:30 p.m. | Case Study: Molecular Diagnostics and Genomic Medicine at the Children's Hospital of Philadelphia
Learning Objectives
- Review the history, workflow, staffing, technology, and current priorities of the Center for Applied Genomics at the Children’s Hospital of Philadelphia
- Discuss how the laboratory has shaped its menu of tests in a range of areas
- Outline strategies for growth through strategic partnerships
Nancy B. Spinner, Ph.D., FACMG , Evelyn Willing Bromley Endowed Chair in Pathology, The Children's Hospital of Philadelphia; Chief, Division of Genomic Medicine; Professor of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania |
| 2:30 p.m. - 3:15 p.m. | Growth Strategies for Molecular Diagnostics: Changing Clinician Behavior
Learning Objectives
- Get insight into drivers of molecular diagnostics market growth and key challenges
- Discuss strategies for effectively conveying the value proposition of molecular diagnostic testing to clinicians
- Assess how these issues are shaping key priorities for clinical laboratories performing molecular diagnostic testing
Theo McCormick, Director, Business Intelligence, Boston Heart Diagnostics |
| 3:15 p.m. - 3:45 p.m. | Networking Break with Exhibits |
| 3:45 p.m. - 4:30 p.m. | Emerging Technologies in Molecular Diagnostics: Here We Go Again!
Learning Objectives
- Review some of the up-and coming technologies that will impact the clinical molecular diagnostics laboratory in the very near future
- Gain insight into how these changes are rapid, robust, and respondent in today’s testing arena
- Understand the clinical applications of emerging technology, including next-generation sequencing
Gregory J. Tsongalis, Ph.D., HCLD, CC, Professor of Pathology; Director, Molecular Pathology; and Co-Director, Translational Research Program, Department of Pathology, Dartmouth Hitchcock Medical Center and The Audrey and Theodor Geisel School of Medicine at Dartmouth |
| 4:30 p.m. - 5:15 p.m. | Next-Generation Sequencing: The Challenges Ahead
Learning Objectives
- Understand how next-generation sequencing has the potential to change cancer diagnosis and management
- Discuss the challenges in adopting this transformational technology
- Gain insight into the difficulty in getting paid for next-generation sequencing
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| 5:15 p.m. - 6:15 p.m. | |
| 7:30 a.m. - 8:30 a.m. | Registration and Continental Breakfast with Exhibits |
| 8:30 a.m. - 9:15 a.m. | Keynote: The Future of Molecular Diagnostics
Learning Objectives
- Understand how current payer decisions will impact the future development of molecular testing
- Get insight into how molecular testing is likely to evolve over the next five years
- Discuss how labs can best position themselves in this growing market
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| 9:15 a.m. - 10:00 a.m. | The Evolution of Genetic Testing in Medical Practice
Learning Objectives:
- Understand the role of genetic testing as part of a medical evaluation, including the role of pre- and post-test counseling
- Outline the applications, benefits, and limitations of different types of genetic testing in use today
- Learn what whole genome/exome sequencing is, and its applications and limitations
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| 10:00 a.m. - 10:30 a.m. | Networking Break with Exhibits |
| 10:30 a.m. - 11:15 a.m. | How to Successfully Market and Sell to Physicians
Learning Objectives
- Discuss why molecular diagnostics is an area requiring physician education in addition to just “detailing the test”
- Evaluate strategies for educating clinicians about novel tests and their interpretation
- Understand how to work with diagnostic companies to offer physician symposia and workshops that will show how to incorporate tests into current practice guidelines
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| 11:15 a.m. - 12:00 p.m. | Liability: The Next Big Thing for Personalized Medicine
Learning Objectives
- Understand how the threat of liability can drive adoption of molecular testing
- Hear how labs, test manufacturers, and physicians are at risk in the molecular diagnostic testing arena
- Find out how to mitigate potential liability
Gary Marchant, Ph.D., J.D., Regents’ Professor and Lincoln Professor Emerging Technologies, Law and Ethics; Faculty Director, Center for Law, Science and Innovation, Sandra Day O’Connor College of Law, Arizona State University |
| 12:00 p.m. - 12:45 p.m. | The Challenge of Companion Diagnostics: The Hope, the Promise, and the Reality
Learning Objectives
- Get insight into the challenges faced by developers of companion diagnostics
- Discuss strategies for overcoming hurdles in gaining physician acceptance and obtaining payer coverage and reimbursement
- Learn which companion diagnostics are most-often requested by doctors and most-often covered by insurers
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| 12:45 p.m. | Adjournment
Program Subject to Change | |
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