2014 Archived Content

Cambridge Healthtech Institute’s Second Annual

Companion Diagnostics

Implementing the New Standard

February 10-12, 2014 | Moscone North Convention Center | San Francisco, CA  

Day 1 | Day 2 | Day 3 | Download Brochure 

Wednesday, February 12 

7:00 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee 

8:00 Plenary Keynote Session (Click Here For More Details) 

9:45 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall 


10:35 Chairperson's Remarks 

Alan B. Carter, President, MDx Consulting

10:40 ConfirmMDx for Prostate Cancer: Navigating a Dynamic and Challenging Reimbursement Landscape 

Jan Groen, Ph.D., CEO, MDx Health

Molecular diagnostics have lead to a significant improvement in diagnosing, treating and managing patient care. Despite significant advancements, labs and MDx innovators are faced with challenges encompassing coding, billing, and attempting to obtain coverage and fair reimbursement. The evidence bar is rising, with the burden on the MDx laboratory to prove clinical utility. In this case study we discuss the challenging reimbursement path for a new epigenetic test for prostate cancer.

11:10 Found in Translation: Taking the Cardiac Biomarker ST2 from Discovery to Clinical Adoption 

James V. Snider, Ph.D., President, Critical Diagnostics

This presentation will touch on the discovery research and original identification ST2 as a potential cardiac biomarker. The emphasis though will be on the effort to develop a validated assay and the clinical evidence to justify routine clinical use of ST2 as a cardiac disease patient management tool, and will conclude with a discussion of the regulatory and reimbursement landscape.

11:40 Better Clinical Outcomes through Cardiovascular Genomics 

Lon Castle, M.D., Medical Science Liaison, Medical Affairs, CardioDx

As the upcoming tidal wave of genomic tests floods the market, the molecular diagnostic industry will be faced with convincing payers that a new test provides enough value to warrant reimbursement. This presentation will focus on how a company can navigate the evidence development process in order to sail through a payer's technology assessment committee. The importance of testing the waters with an internal economic forecast modeling the impact of coverage will also be discussed.

12:10 pm Optimize for Variant Calling Confidence: Impact of Sample Type and Analytical Methods on NGS Data Quality
Milos Popovic, Technical Product Manager, Seven Bridges GenomicsSeven Bridges Genomics, in collaboration with DNA Genotek, will present data and best practises for variant calling based on whole genome sequencing of DNA from matched pairs of saliva collected and stabilized with Oragene vs blood. When introducing personalized medicine offerings it is imperative to consider all parts of the patient value chain from sample collection to processing and validated results. Optimizing the patient experience, ensuring quality samples and future-proofing lab analysis through high quality specimen inputs is key to enabling successful, scalable health solutions.     

12:25 Luncheon Presentation: Meeting the Clinical Utility Needs of Payers and Regulators for Molecular Diagnostics

David Parker, Ph.D., Vice President, Market Access Strategy, Precision for Medicine
Judi Smith, Vice President, in vitro Diagnostics and Quality, Precision for Medicine

Increasingly, the FDA and payers are requesting clinical utility evidence as part of their approval and acceptance processes for molecular diagnostics. Precision will explore how the type of diagnostic test, its regulatory status, and its clinical application affect clinical utility evidence development. We will take a deeper dive into how various designs could meet stakeholders’ needs and, in turn, affect the ROI on evidence development.

1:00 Refreshment Break in the Exhibit Hall and Last Chance for Poster Viewing 


1:40 Chairperson's Remarks 

Harry Glorikian, Managing Director, Strategy, Precision for Medicine


New Frontiers in Medical Diagnostics 

Carlos Cordon-Cardo, M.D., Ph.D., Professor & Chair Pathology; Professor Genetics and Genomic Sciences; Professor Oncological Sciences, Mount Sinai Hospital


With the dramatic increase in data being generated by molecular diagnostic devices (NGS in particular), very few clinical decisions are "binary" in nature today. Further, new technologies and clinical findings (mutations, pathways, drug resistance profiles) are being introduced regularly. To help compensate for the complexity and data overload, clinicians are hopeful that clinical decision support systems will meet the challenge. The panel will discuss their aspirations for these systems and whether existing solutions are solving their needs.

Additional Panelist:

Carlos Cordon-Cardo, M.D., Ph.D., Professor & Chair Pathology; Professor Genetics and Genomic Sciences; Professor Oncological Sciences, Mount Sinai Hospital

Kathryn A. Teng, M.D., FACP, Director, Center for Personalized Healthcare, Staff Physician, Internal Medicine, Cleveland Clinic; Assistant Professor, CWRU Lerner College of Medicine

Christopher D. Gocke, M.D., Pathology; Hematology Molecular Diagnostics and Program Director, Molecular Genetic Pathology Fellowship, Johns Hopkins University


EU Regulatory Keynote 

3:15 Chairperson’s Remarks

Richard A. Montagna, Ph.D., Senior Vice President, Scientific Affairs, Rheonix, Inc.

3:20 Diagnostics Regulation and Policy in the EU

Hans-Georg Eichler, M.D., Senior Medical Officer, European Medicines Agency (EMA)

3:50 Refreshment Break



4:00 Chairperson's Remarks 

Dalia Cohen, Ph.D., Founder & President, ALN Associates

4:05 Big Data's Big Role in Understanding Complex Diseases 

Andreas Kogelnik, M.D., Ph.D., Founder and Director, Open Medicine Institute

The Open Medicine Institute (OMI) is effectively applying a collaborative, "big data"approach to understand and address complex diseases including: Autism, Lyme, Chronic Fatigue Syndrome, Parkinson's, and various cancers. This presentation will discuss the creation of a patient-centric infrastructure that handles and analyzes genomic sequencing information, bio-sampling data, physiology tests, basic research, patient experiences and physician evaluations to deliver needed information about a range of diseases.

4:35 Progress on Aggregating all the World's Genetic Tests into a Single Assay 

Randy Scott, Ph.D., CEO and Co-Founder, InVitae

Technology is moving rapidly to enable massively parallel genetic testing. The ability to sequence DNA, however, is only the first step in building the infrastructure to analyze, store, manage, and interpret medical genetic information for patients. InVitae is focused on building the infrastructure to bring more comprehensive genetic testing into routine medical practice throughout the world.

5:05 Big Data Analytics and the Future of Healthcare and Drug Development 

Iya Khalil, Ph.D., Executive Vice President and Co-Founder, GNS Healthcare

5:35 Close of Conference Program 

Day 1 | Day 2 | Day 3 | Download Brochure 

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