Cambridge Healthtech Institute’s Fifth Annual
Commercialization of Molecular Diagnostics
Ensuring Success of Innovative Tests
August 19-20, 2015 | Capital Hilton | Washington, DC
Moving molecular diagnostics to the market involves demonstrating the value proposition of the test while carefully managing resources and expertly navigating the constantly changing environment. With increasing pressure from rising healthcare costs, molecular testing will need to demonstrate that it can improve outcomes of patients while saving healthcare dollars. This year’s expert faculty will share best practices and case studies for handling regulatory approval, clinical adoption and market access to achieve commercial success.
In the Best Interest of the Patient: Balancing Innovation and Regulation
Moderator: Elaine Lyon, Ph.D., Medical Director, Molecular Genetics, ARUP (AMP 2014 President and Member, AMP Professional Relations Committee)
Advances in laboratory medicine hold great promise in diagnosing or predicting disease, and guiding therapy decisions. Innovative testing must provide accurate, valid and useful information. How does the field move forward in making such testing available in a timely manner, yet within a regulatory environment to ensure quality of results?
- Feasibility of FDA overseeing LDPs
- Innovative regulatory models
Jordan S. Laser, M.D., Medical Director, Pathology and Laboratory Medicine, North Shore Long Island Jewish Health System
Jamie McDonald, MS, Licensed Genetic Counselor, Co-Director, HHT Center of Excellence; Assistant Professor, Department of Pathology, University of Utah
Stephen P. Day, Ph.D., IVD Consultant
IMPACT OF PAMA REGULATIONS ON IVDS
Moderator: Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag LLP
New 2014 legislation, PAMA, is creating the biggest upheaval in laboratory pricing in 30 years, and will affect the whole industry, including clinical chemistry diagnostics, infectious disease diagnostics, point of care diagnostics, and sophisticated molecular tests.
- How has the Medicare agency proposed to implement the law?
- How will advanced molecular tests and more common tests be impacted differentially?
- How will PAMA affect the adoption and acceptance of next generation sequencing?
- When will labs have to start reporting data to CMS, and how will this likely impact IVD manufacturers?
The Impact of PAMA on Molecular Tests
Scott V. McGoohan, J.D., Vice President, Reimbursement & Scientific Affairs, American Clinical Laboratory Association
John F. Warren, Senior Director, McDermott+Consulting LLC
Donna Polizio, Associate Director, Government Accounts, Genomic Health
Paul W. Radensky, M.D., Partner, Health Products Regulation Group, McDermott Will & Emery LLP
Introduction to the Study of the Value of Molecular Tests
John W. Hanna, MBA, Vice President, Endocrinology, Veracyte, Inc.
Private Payer Evaluation of Diagnostic Tests – A Survey of 50 Medical Directors and an Insider’s Perspective on the Health Technology Assessment Process
Melissa K. Bennett, MS, CGC, Clinical Director, Laboratory Management Program, CareCore National
Elissa Passiment, Executive Vice President, American Society for Clinical Laboratory Science (ASCLS)
Roger D. Klein, M.D., J.D., Pathologist, Cleveland Clinic Foundation
Richard L. Schilsky, M.D., FACP, FASCO, CMO, American Society of Clinical Oncology
Cross-Industry Partnerships to foster Innovation and Decrease Manufacturing Time to Market in the Biomedical Business
Ali Tinazli, Vice President, Head, Business Development & Sales, Sony DADC Biosciences
Moderator: Harry Glorikian, Healthcare Consultant
- What are the value creation points for the data? How does the data make a difference in how someone is treated?
- Ensuring access to and organizing and managing data
- How are partnering deals structured? What are some key issues?
- How do you monetize the value of the data?
- Is the data more valuable than the technology that creates it?
Erynn Gordon, MS, LCGC, Medical Marketing Director, 23andme
Felix W. Frueh, Ph.D., CSO, Human Longevity, Inc.
For more details on the conference, please contact:
Executive Director, Conferences
Cambridge Healthtech Institute
T: (+1) 781-972-5464
For exhibit & sponsorship opportunities, please contact:
Associate Director, Business Development
Cambridge Healthtech Institute
T: (+1) 781-972-5431