March 27, 2013
11:30 am - 12:30 PM EDT

Sponsored by:

Symposium Course Description:

This course seeks to highlight the key elements of successful transitions of companion diagnostics from clinical development to commercial planning for drug and diagnostic innovators. The challenges of companion diagnostic/drug development programs will be reviewed with an emphasis on identifying strategies and activities that will facilitate successful patient access to both the test and the drug therapy. The presenters will review the current laboratory testing and market access landscape in the US, EU, and select emerging markets. Predicate case studies will be examined to illustrate how the landscape for companion diagnostic/drug programs is changing in terms of pathways and clinical evidence requirements for reimbursement/funding of both the companion diagnostic and the drug therapy.

Learning Objective Bullet Points

• Summarize different development/distribution models for companion diagnostics and highlight key considerations for innovators considering how to transition products from development to commercial stages
• Review the current laboratory testing and market access landscape in several key markets
• Examine the evolving evidence requirements for successful market adoption of companion diagnostics
• Explore possible opportunities and hurdles associated with collaborations between clinical development and commercialization strategy teams

Who Should Attend:

• Biopharmaceutical strategy leaders with responsibility for upstream business planning during early and mid stages of clinical development
• Biopharma Clinical Development Program Leaders responsible for incorporating a companion diagnostic into a clinical development program for a biopharmaceutical product
• Diagnostics developers responsible for pharma partnering and commercial strategy
• Executives with responsibility for regulatory or reimbursement functions within the biopharmaceutical or clinical diagnostics industries

Program Agenda:

• Key Development and Commercialization Issues for CDx: Comparison of Rx and Dx models
• Dimensions of Global Laboratory Distribution and Market Access Strategy
• Evolving Evidence Requirements
• Review of Case Studies

Speaker Information:

Thomas F. Goss
Senior Vice President
Boston Healthcare
75 Federal Street
Boston, MA 02110
Direct: 617-912-5590
email: tgoss@bostonhealthcare.com

Dr. Goss has more than 20 years of health care experience, including managing and directing research on the impact of public and private payer policy on patient access, health economics, and patient-reported outcomes (including health-related quality-of-life, patient preference, and patient satisfaction). He has published extensively in these areas and has more than 40 peer-reviewed publications and over 75 peer-reviewed abstracts and invited publications.

Prior to joining Boston Healthcare, Dr. Goss was Vice President and Director of Consulting Services at Covance Market Access Services where he had a 15-year career with increasing levels of responsibility in the areas of client management and executive management.

Dr. Goss received a Pharm.D. degree from the State University of New York at Buffalo, and a B.S. degree from the Albany College of Pharmacy. He completed graduate course work in epidemiology, and a postdoctoral fellowship in pharmacoepidemiology and outcomes research at the State University of New York at Buffalo. As a member of the American College of Clinical Pharmacy Outcomes and Economics Practice Research Network, Dr. Goss has authored chapters Pharmacoeconomics and Outcomes: Applications to Patient Care and he is a member of the International Society of Pharmacoeconomics and Outcomes Research.

Charles Mathews
Vice President
Boston Healthcare
75 Federal Street
Boston, MA 02110
Direct: 617-912-5118
email: cmathews@bostonhealthcare.com

Mr. Mathews has worked on a variety of reimbursement projects identifying public and private payer coverage channels, coding options, and pricing and payment possibilities for drugs, diagnostics and medical devices. His specific area of expertise is in diagnostics with a focus on value-based pricing for laboratory tests and molecular diagnostics. His experience includes work with both test and platform developers and laboratories, drug/diagnostic combinations, and pharmaceutical product launches.

Mr. Mathews’ prior experience includes working on health policy as a legislative aide on Capitol Hill. He has also worked for the government affairs office of Genentech and has participated in a National Institutes of Health sponsored clinical trial which focused on genetic testing for Alzheimer’s disease.

Mr. Mathews has a master’s degree in public policy from Duke University and completed his undergraduate work at Colgate University.

Moderator Information:

Tom and Charles co-presenters