Strategies and Solutions to Streamline Development
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Companion diagnostics are rapidly emerging as key components in personalized medicine. Recent FDA approvals of drugs such as Zelboraf and Xalkori have boosted both enthusiasm and investment in this burgeoning area. This conference will cover end-to-end companion diagnostic development from discovery to regulatory and reimbursement. Other key issues such as commercialization, cost-benefit analysis, and post approval will also be addressed.
Wednesday, February 13
7:00 am Registration and Morning Coffee
8:00 – 9:40 am Plenary Keynote Presentation - Personalized Oncology – Fulfilling the Promise for Today's Patients
In honor of the 20th anniversary of the Molecular Medicine Tri-Conference, CHI and Cancer Commons will present a plenary panel on Personalized Oncology. Innovations such as NGS and The Cancer Genome Atlas have revealed that cancer comprises hundreds of distinct molecular diseases. Early clinical successes with targeted therapies suggest that cancer might one day be managed as a chronic disease using an evolving cocktail of drugs.Representing all five conference channels, Diagnostics, Therapeutics, Clinical, Informatics, and Cancer, a panel of experts will lead a highly interactive exploration of what it will take to realize this vision in the near future.
9:40 Refreshment Break in the Exhibit Hall with Poster Viewing
11:00 Chairperson’s Opening RemarksPhilip D. Cotter, Ph.D., Principal, ResearchDx
11:10 Investing in Molecular Diagnostics
Sue E. Siegel, Corporate Officer and CEO, healthymagination, GE
11:40 KEYNOTE PRESENTATION IN HONOR OF DR. JEFFREY KANT, Former Chair, AMP Economic Affairs Committee“May You Live in Interesting Times:” The Evolving Landscape of CPT Coding for Molecular Testing
Roger Klein, M.D., J.D., Department of Molecular Pathology, Cleveland Clinic Foundation
2013 will herald broad implementation of more transparent CPT coding for higher volume molecular pathology tests in the oncology and genetics arenas. A number of salient issues to include fee schedule placement and valuation of new molecular pathology CPT codes should be at least partially resolved. Advancements in new technologies such as next generation sequencing of gene panels, exomes and even full genomes pose new challenges for transparent and rational coding for labs and payers. This presentation will update and review developments on these and other topics of current interest.
Dr. Jeff Kant was a dedicated College of American Pathologists member and was the Vice Chair of Scientific Affairs Council, a member of the CAP Economic Affairs Committee, the Personalized Health Committee, and the Next Generation Sequencing Work group. He was also a member of the AMA Molecular Pathology CPT WorkGroup; And the Chair of the AMP Economic Affairs Committee.
12:10 pm DxInsights: Advancing Molecular Medicine
Kristin Pothier, Founder, DxInsights; Partner, Health Advances
The American healthcare system operates on the precipice of a catastrophic economic burden. A rapidly aging population and widespread inability to eliminate trial-and-error medicine and manage costs comprise this burden’s alarming weight. High-value diagnostics can bridge the gap between the need and the solution, but we must first strengthen its foundation. This is the mission of the non-profit educational organization DxInsights. DxInsights is building operational leadership, scientific and commercial strategy, legal and regulatory grounding, and seasoned publicity and communications expertise in a world resource center that assembles the best data, unbiased guidance, and sharing of information specifically devoted to diagnostics’ expanding role in the future of healthcare. Delivered by one of its founders, this keynote will address the changing face of diagnostics in the healthcare system today, the role DxInsights is playing to take these challenges head on, and how all stakeholders can participate.
12:40 Luncheon Presentation I: Novel Multimodal cMET Panel: Simultaneous and Quantitative Analysis of Copy Number Variation and Gene Expression in a Single Reaction
Lilly Kong, CSO, PrimeraDx
1:10 Luncheon Presentation II: A Fully Automated Molecular Diagnostics Platform for Companion Diagnostics and Personalized Medicine
Richard A. Montagna, Ph.D., Senior Vice President, Corporate Business Development, RHEONIX, Inc.
1:45 20th Anniversary Cake in the Exhibit Hall with Poster Viewing
2:20 PANEL DISCUSSION: End-to-End Companion Diagnostics Development
This panel will assemble experts from each phase of the companion diagnostics value chain to examine all aspects of end-to-end development, and explore the changing landscape.
Moderator: Harry Glorikian, Founder and Managing Partner, Scientia Advisors
Panelists: Jian Wang, Ph.D., President & CEO, BioFortis, Inc.
Gregory Zdechlik, COO, Eli Lilly & Co.
Richard Watts, Senior Director, Business Development Pharma, Companion Diagnostic Partnerships, QIAGEN
Jon Minken, Director, Reimbursement North America, Regional Marketing MDx NA, QIAGEN
3:35 Commercialization of Smart Consumables for in vitro Diagnostics
Ali Tinazli, Ph.D., Director, Business Development & Sales, Sony DADC
Smart Consumables with nanoscale, microfluidic or optical features are prerequisites for emerging applications in the biomedical markets. The increasing complexity of such new products requires new manufacturing avenues. Sony DADC is applying its excellence in customized mass manufacturing to these highly sophisticated consumables in its new OEM business.
3:50 Solutions for the Outsourcing of Companion Diagnostics Development
Philip D. Cotter, Ph.D., Principal, ResearchDx
4:05 Multiplex Molecular Assays from Discovery to the Clinic on FFPE Samples:Extraction-Free
Speaker to be Announced
The session will detail HTG’s new automation for RNA and miRNA analysis from FFPE and HTG’s qNPA® technology that enables quantitative, multiplexed extraction-free RNA analysis on FFPE tissue using < a single 5µm section.
4:20 Networking Reception in the Exhibit Hall with Poster Viewing (Sponsorship Opportunities Available)
5:20 Breakout Discussions in the Exhibit Hall
6:20 Close of Day
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