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Wednesday, February 3
7:00 AM Registration and Morning Coffee
Plenary Keynote Session
8:10 When Drug Research is Personal
John F. Crowley, Founder, Novazyme Pharmaceuticals, Inc.
Mr. Crowley’s emotion-packed presentation will focus on his personal struggle to find a cure for Pompe disease, a rare and fatal illness that is caused by a defective or missing enzyme. Pompe disease affects fewer than 10,000 people world-wide, including Mr. Crowley’s two small children. Mr. Crowley, a Harvard educated businessman, created and built a pharmaceutical company devoted expressly to finding a cure for the disease. He will detail his journey through the labyrinth of scientific and business fronts, which lead up to a first-round clinical trial.
9:40 Grand Opening Refreshment Break in the Exhibit Hall
11:00 Chairperson’s Remarks
Harry Glorikian, Managing Partner, Scientia Advisors
11:05 Molecular Diagnostics as a Value Driver of Pharma/Pharma as a Value Driver for Molecular Diagnostics
Michael C. Little, Global Head, Diagnostics Development, Novartis Molecular Diagnostics
Molecular Diagnostics is a critical success factor for the future of pharmaceuticals and an essential aspect of the move toward personalized medicine. At the same time, to progress better healthcare and patient outcomes, it is imperative that the pharma industry’s understanding of both targeted drug discovery and drug commercialization is fully leveraged to enable innovative diagnostics to be put into clinical practice and influence physician decision-making. The keynote will focus on these elements and discuss 1-2 case studies of how we at Novartis are using our discovery and development approach to work toward bringing innovative companion and stand-alone diagnostic tests to market.
11:40 Building a Successful Diagnostics Business Model in the Era of Personalized Medicine
Richard Ding, CEO, bioTheranostics, a bioMerieux Company
Personalized medicine has been generally accepted as an inevitable trend in healthcare. However, much debate is still ongoing related to a sustainable business model for diagnostics companies in this new space. This presentation will identify various challenges, risks and potential returns for diagnostic companies, explore partnership models and propose some basic framework to seize the growth opportunity of personalized medicine.
12:15 PM Personalized Medicine: It Takes a Village
Mark Stevenson, President & COO, Life Technologies Corp.
New technologies, such as next generation sequencing, can be rapidly adopted in the research labs and help breakthroughs in our understanding of disease mechanisms for personalized medicine. But the journey from research technology to diagnostic systems is challenging and slow. As our understanding of disease increases the promise of personalized medicine is coming closer but what will it take to cross the bridge from research tool to routine diagnostics in personalized medicine. The Presentation will focus on the journey Life Technologies has embarked on and the partnerships and collaborations necessary to translate the tools for the research lab into solutions personalized medicine.
12:50 Luncheon Presentation
Information Trends in Biomarker Research
Colin Williams, Ph.D., Director, Product Strategy, Thomson Reuters Healthcare and Science
In recent years, the quantity of data published on biomarker research has exploded. The challenge faced by researchers is to find vital, relevant information on the best biomarker quickly and reliably. In this discussion we will introduce BIOMARKERcenter, a comprehensive, fully-indexed biomarker information resource, and through case studies show how it aids the discovery process.
1:45 Dessert in the Exhibit Hall
2:15 Chairperson’s Remarks
Linda McAllister, M.D., Ph.D.
2:20 Real-time Detection and Characterization of Influenza: The Need for Speed
Karen L. Kaul, M.D., Ph.D., Board of Directors Chair of Molecular Pathology, Director, Molecular Diagnostics Division; Director, Pathology Residency Program, NorthShore University HealthSystem; Professor of Pathology and Urology, Northwestern University Medical School
The Novel H1N1 Influenza outbreak of 2009 challenged laboratories and hospitals with the need for high volume testing and rapid resulting in order to appropriately treat and isolate infected patients. Molecular approaches offer clear advantages, though no pre-validated assays were available for this unanticipated virus. This presentation will address various assays for detection and differentiation, as well as other laboratory issues, and will review the recent outbreak from the laboratory perspective.
2:50 What Happened with SARS: Lessons Learned and Applied to Influenza
Joseph D. Miller, Ph.D., Chief, Laboratory Preparedness Officer, Influenza Division, Centers for Disease Control and Prevention
3:20 MRSA Surveillance Programs – What Impacts Success?
Lance R. Peterson, M.D., FASCP, FIDSA, Director, Microbiology & Infectious Disease, Evanston Hospital, NorthShore University HealthSystem and University of Chicago
Control of any epidemic relies on detection of those harboring the pathogen (infected and colonized). For any MRSA prevalence, the operational processes most influential are 1) sensitivity of the laboratory methods used, 2) speed at which unknown positive patients are detected, and 3) the selection of who is to undergo screening. The current understanding of these specifics will be presented.
3:50 Real-time Array PCR for Infectious Diseases (RAP-ID): Merging Multiplex PCR and Real-Time Microarray Detection in a Single Tube for Sensitive Parallel Genotyping of Pathogens and Antibiotic Resistances
Wilhelm Pluester, Ph.D., CEO, Eppendorf Array Technologies S.A.
RAP is a novel hybrid technology combining major advantages of microarrays (multiplexing, specificity) and real-time PCR (sensitivity, dynamic range). Target amplification and hybridization of amplicons proceed in a single tube (in the same buffer) resulting in a simplified, automated workflow with minimal hands-on time. First results in multiplex detection of pathogens and antibiotic resistances associated with ventilator-associated pneumonia are presented
4:05 Platform Genometrica: Novel Instrumentation for Molecular Biology and Medicine
Vera Gorfinkel, Ph.D., Associate Professor, SUNY SB, Research consultant, Genometrica Corporation
The technology platform Genometrica aims to develop methods and instruments capable of carrying out on equal footing inexpensive and highly accurate genomic studies including DNA sequencing, hybridization, and quantitative PCR assays. The session will focus on the basic principles, novel engineering solutions, data acquisition/handling methods, and unique research capabilities offered by the Genometrica platform.
4:20 Reception in the Exhibit Hall (Sponsorship Available)
5:20 BREAK-OUT DISCUSSIONS in the Exhibit Hall
Consumer Diagnostics (Not Just Genomics) – Get Used to It!
Co-Moderators: Peter S. Miller, Chief Operating Officer, and Keith F. Batchelder, Chief Executive Officer, Genomic Healthcare Strategies
Technology improvements and cost reductions will make genetic, metabolic, and proteomic analysis cheaper
Consumers will remain interested and companies will develop better ways of reaching the public
Providers of traditional care will have to come to grips with informed consumers
How will this happen?
Is Economics Going to Be the Driver of Molecular Diagnostics Adoption?
Moderator: David S. Lester, Ph.D., Vice President, Human Health Solutions, Theranos
Are molecular diagnostics going to make healthcare cheaper and/or better?
What are the barriers for adoption of molecular diagnostics?
Payers: US vs. international challenges.
How will value of the diagnostic be determined?
Patents and Diagnostics Development: Help or Hindrance?
Moderator: Frances Toneguzzo, Ph.D., Director, Office of Corporate Sponsored Research and Licensing, Massachusetts General Hospital
· Type of patents in the diagnostic space and IP fragmentation
· Other types of intellectual property protection in diagnostics development
· Differentiation in diagnostics and use of patents
· Strategies for effective use of intellectual property to stimulate diagnostic development
Making Molecular Diagnostics Work Now? The Trials and Tribulations of Labs and Money
Moderator: Ian S. Millett, Ph.D., RAC, Senior Consultant, Medical Devices, Biologics Consulting Group, Inc.
· How do you get paid for a molecular diagnostic test?
· Does implementing a molecular diagnostic test in your lab really make sense?
· Life at Ground Zero - The FDA’s changing perspective on lab-developed tests
· Pushing and Pulling- Who is your customer and just how Personal can you make that bill?
Strategies for Commercialization of Molecular Diagnostics
Moderator: Harry Glorikian, Managing Partner, Scientia Advisors
6:20 Close of Day
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