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FRIDAY, FEBRUARY 27

8:00 Registration Open and Morning Coffee

REAL DATA ON IMPLEMENTATION OF COMPANION DIAGNOSTICS 

8:30 Chairperson’s Remarks
Moderator: Linda McAllister, M.D., Ph.D., Vice President, Diagnostics, Arbor Vita Corp.

8:35 Developing Models for Companion Diagnostics 
Peter Alperin, M.D., Medical Director, Archimedes, Inc. 
Healthcare Modeling is providing a new avenue for exploring the application and benefits of molecular diagnostics in personalized medicine. The Archimedes model, a simulation model, can be used to ask the critical “what if” questions that allow researchers, physicians, and decision makers to understand changes in health outcomes and costs generated by the application of a diagnostic test. This talk will cover the basic structure and function of the Archimedes Model and an example of its application in understanding the implementation of a molecular diagnostic.

9:05 Assessing the Efficacy of Antiplatelet Therapy via Point-of-Care Testing
Brian T. Edmonds, Ph.D., Principal Investigator, Integrative Biology/ Global External Research & Development, Lilly Corporate Center 
Antiplatelet therapy provides important benefit to those patients with acute coronary syndromes and those undergoing percutaneous coronary intervention. However, many patients experience variable response to therapy thereby creating the need for physicians to better understand the response profile of their individual patients. Various methodologies exist to assess efficacy of therapy and potential risk for recurrent thrombotic events. This talk will outline current clinical practice for testing platelet function and its use in the development of next generation therapies.

9:35 From Drug Target to Patient Selection: Opportunities and Challenges of Developing Companion Diagnostic Test in Clinical Drug Development 
Lin Wu, Ph.D., Research Leader, Pharmacogenetics, Roche Molecular Systems Inc
One key to success of targeted cancer therapy development is the appropriate integration of predictive and prognostic biomarkers into all stages of drug develop-ment. The challenges of strategic and scientific implementation of a biomarker program reside in comprehensive understanding of cancer pathways, thoughtful selection of technology platform of testing, and constant dialogue between the drug and test stakeholders during the co-development process. The use of TaqMan B-RAF V600E assay in clinical development of b-raf V600 inhibitors will be featured to illustrate Roche approach of streamlining test development to ensure efficient translation of biomarkers into future companion diagnostics. 

10:05 Sponsorship Presentation (Opportunity Available)

10:20 Coffee Break

11:00 Companion Diagnostics: Personalized Medicine in the Pharmaceutical Industry
Andrea H. Lauber, Ph.D., Strategic Transactions Group, Bristol-Myers Squibb Company
Companion diagnostic tests associated with one or more therapeutic agents of a class are increasing in demand with the recognition that personalized medicine may provide a way to improve patient care and manage healthcare costs by targeting treatments to individuals more likely to benefit from specific therapies. Bristol-Myers Squibb Company and Dako, Denmark A/S have entered into a collaboration to develop companion diagnostic tests intended to identify patients more likely to benefit from treatment with certain investigational cancer drug candidates under development by Bristol-Myers Squibb. We believe it is important for pharmaceutical and diagnostic companies to combine their expertise into a strong collaborative approach to enable development of such diagnostic tests for use with drug therapies. The Presentation will elaborate on considerations for alignment of Collaborators with different business models and how Companion Diagnostics can impact upon drug development.

11:30 Does Your Indication Have the Right DNA for a WStratified Medicine Approach?
Mark Trusheim, Visiting Scholar, Sloan School of Management, MIT
Personalized medicine has demonstrated tremendous potential with some pharmaceutical companies now requiring biomarker development for every therapeutic program. But will all therapeutic areas benefit from clinical biomarkers? This talk will explore the conditions required for a therapeutic market segment to benefit from a stratified medicine approach: criteria which go beyond molecular biology to include the practical clinical benefit to the patient and physician as well as the competitive landscape. The talk will then survey a broad range of therapeutic and rank which are already stratifying, which are clearly ready to stratify and which may never see the emergence of personalized medicine.

12:00pm Luncheon Presentation (Opportunity Available)

INCORPORATING COMPANION DIAGNOSTICS INTO DRUG DEVELOPMENT 

1:00 Chairperson’s Remarks
Jan Trøst Jørgensen, M. Sc. Pharm., Ph.D., Director, Clinical Research, CMC Contrast AB and Henrik Winther, DVM, Ph.D., Research Director, Dako Denmark A/S

1:05 From Blockbuster Medicine to Personalized Medicine
Jan Trøst Jørgensen, M. Sc. Pharm., Ph.D., Director, Clinical Research, CMC Contrast AB
In the future it may be a diagnostic test that decides which drug to choose for the individual patient and to a much lesser extent the average results from large randomized clinical trial or the marketing efforts of the pharmaceutical companies. Personalized medicine or stratified medicine should be regarded as the 21st century’s answer to the rational use of drugs. Further, the new molecular diagnostic methods will provide the pharmaceutical companies with a powerful tool that will enable them to make more objective decisions with respect to their drug development programs.

1:35 Ensuring the Safety and Utility of Companion Diagnostic Tests 
Alberto Gutierrez, Ph.D., Deputy Director of OIVD, Office of In Vitro Diagnostic Device Evaluation and Safety, Food & Drug Administration

2:05 Integrating Companion Diagnostic Development into Drug Programs - A Pharma Viewpoint
Duncan McHale, M.D., Medical Director, Personalized Healthcare, AstraZeneca 
Advances in scientific understanding and challenging regulatory and reimbursement environment make PHC an attractive approach. Integrating the diagnostic development into the drug program is crucial although to date there are limited number of examples of where this has been successfully done. This talk will discuss the crucial elements of this process when viewed from the drug development teams highlighting areas of synergy and possible conflicts with diagnostic partners.

2:35 Clinical Validation of Companion Diagnostics in Breast Cancer
Christos Hatzis, Ph.D., Founder & Vice President, Nuvera Biosciences 
Therapy-based decisions are central to management of cancer and, in particular, to breast cancer where multiple therapies exist that differ in efficacy, toxicity, and cost. Prognostic tools including clinical nomograms and more recently, genomic tests, are important in providing information about cancer aggressiveness and risk of recurrence, and therefore, helping point towards therapy in general. Predictive tests, however, are key to deciding how a physician will select from standard therapies specifically based on an individual’s tumor characteristics. Recent developments, to be presented, that compare prognostic results with therapy sensitivity show that a combination of these tests can bring the right value needed for an effective personalized medicine approach to patient management.

3:05 Close of Conference

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