Short Courses | Day 1 | Day 2 | Day 3 | Download Brochure
Friday, February 5
U.S. UNIVERSAL HEALTH - BREAKING NEWS
8:30 AM Chairperson’s Opening Remarks
Brian T. Edmonds, Ph.D., Research Advisor, Global External Research & Development, Lilly Corporate Center
8:35 Regulatory Considerations for Companion Diagnostics and Personalized Medicine
Elizabeth Mansfield, Ph.D., Senior Genomics Advisor, Office of the Chief Scientist; Director, Personalized Medicine, Office of in Vitro Diagnostic Device Evaluation and Safety, Food & Drug Administration
Advances in genomics-based discovery and therapeutic agent targeting have led to greatly increased interest in development of diagnostic/therapeutic combinations that promise to deliver “personalized” therapy to patients. With this vision comes the realization of the importance of the diagnostic test performance upon which the therapeutic safety and efficacy will rest. This presentation of regulatory issues for companion diagnostic devices and codevelopment will address proposed regulatory pathways for the diagnostic device, and emphasize the need for adequate analytical and clinical validation.
9:05 Value Based Laboratory Tests -- What Went Wrong on the Way to the Fair?
Ian S. Millett, Ph.D., RAC, Senior Consultant, Medical Devices, Biologics Consulting Group, Inc.
In spite of tremendous interest, expenditures, and pro-active work by industry, academia, and government, the personalized health care revolution seems to have stalled in the area of new test development and use. This talk will focus on potential reasons for slow uptake of new diagnostic technology, will survey the upcoming landscape, and will remind participants that in the end, it was the tortoise that won the race.
9:35 Medco Personalized Medicine: Advancing Healthcare
Lon Castle, M.D., Senior Director, Personalized Medicine, Medco Health Solutions, Inc.
Pharmacogenomic tests bring a new level of precision to pharmaceutical care, enabling treatment that is targeted to the unique genetic characteristics of individual patients. These tests are becoming the standard of care in many therapeutic areas, as physicians and payers become more conversant with the value of testing. Medco’s Personalized Medicine healthcare can improve outcomes and reduce the overall costs of care.
10:05 Innovations in Molecular Diagnostics and Sample Preparation Methods: Accelerating Sample-to-Result Diagnostics
Kevin Banks, Ph.D., Head of Marketing and Sales, Akonni Biosystems
Akonni Biosystems (Frederick, MD) was founded in 2003 and has over 20 patents with 13 others pending. The company's core platform utilizes a gel-drop array technology optimized for developing medical applications, with an emphasis on greatly accelerating the time from sample to result. This session will provide an introduction and overview of the technology and platform. Preliminary results with a number of clinical applications will be discussed.
|
Sponsored by:
|
10:20 Coffee Break
11:00 Economics of Having Diagnostics Reimbursed and the Practical Challenges in Getting Reimbursement
Philip C.M. Ma, Ph.D., Director, McKinsey & Company, Inc.
The impact of diagnostics in influencing care continues to grow with technology advancements in clinical genomics and other molecular markers. In spite of this, the current reimbursement system in the U.S. does not appropriate incentives for effective use - both over and under-use of diagnostics can result. This talk will review how mis-aligned incentives can result from the under-lying micro-economics of different stakeholders (physicians, patients, payors, and diagnostic manufacturers), and will suggest a few ways to improve the micro-economic situation.
11:30 Panel Discussion: Personalized Medicine and Challenges for Implementation
- How will universal healthcare impact your business?
- How will it impact molecular diagnostics adoption?
12:00 PM Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:00 Chairperson’s Remarks
VALUE OF CONSUMER BASED GENOMICS:
What is the Consumer Going to do with it?
- How good is the information delivered by these tests?
- How well can people understand the results?
- How effectively can they help people manage their health?
1:05 Consumers and Their Genomes
Brian Naughton, Ph.D., Founding Scientist, 23andMe
Over 30,000 individuals now have access to their personal genetic information through 23andMe’s web-based services. Consumers sign up for these services to learn about their disease risk or carrier status, to discover their ancestral roots, to find new relatives, or to participate in research on a particular disease such as Parkinson’s. This presentation will discuss the ongoing studies that are beginning to reveal how people respond to their personal genetic information.
1:35 The Patient Directed Research Enterprise
Patrick F. Terry, CEO, Technic Solutions, LLC; Acting CEO, Grand Therapeutics, Inc.
2:05 Drinking from the Firehouse: Are Consumers Ready?
Sharon Terry, MA, President and CEO, Genetic Alliance
2:35 Panel Discussion and Q&A with Audience
3:05 Close of Conference
Short Courses | Day 1 | Day 2 | Day 3 | Download Brochure