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2009 Personalized Medicine Conference Agenda
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Day One - April 23, 2009
7:20-8:05 Registration and Continental Breakfast
8:05-8:15 Chair's Opening Remarks
David Lester, Ph.D., President, ITHW Inc.
Personalized Medicine Business Models and Market Analysis
8:15-8:45 Changes in the Healthcare Industry and Markets Caused by Molecular MedicineKeith Batchelder, MD, Chief Executive Officer and Founder, Genomic Healthcare Strategies
Peter Miller, Chief Operating Officer, Genomic Healthcare Strategies
8:45-9:15 A New Integrated Model for Pharmacogenetics and Drug Development
Scott Sundseth, Ph.D., Director of Pharmacogenetics, Deane Drug Discovery Institute, Institute for Genome Sciences & Policy, Duke University
9:15-9:45 Challenges in the Implementation of the Appropriate Business Model for Personalized Medicine
This talk will cover the challenges in terms of coordinating all of the appropriate parties needed to produce Personalized Medicine products, including Pharma, Molecular Diagnostics, Regulatory and Reimbursement. The different business models for Pharma and Molecular Diagnostics are complicated and a new approach is to be proposed. The uncertain regulatory and reimbursement environments greatly affect the model(s) chosen and scenarios will be presented.
David Lester, Ph.D., President, ITHW Inc.
The Role of Biomarkers and Diagnostics in the Development of Personalized Medicine
9:45-10:15 Biomarker Discovery Technique for Identifying Molecular Signatures Free of Intellectual Property Infringement IssuesThis presentation will cover the following:
- An Introduction of new tissue and urine based molecular diagnostic tests for clinically significant prostate cancer recently licensed to Abbott, Quest Diagnostics, and Clarient.
- Description of the biomarker discovery technique using SVM and SVM-RFE technology.
- Discussion of the successful development of companion diagnostics for personalized medicine (using genomic and proteomic data as well as histologic and radiologic images).
- Discussion of the successful development of surrogate biomarkers for clinical trials.
10:15-10:45 Morning Refreshments
10:45-11:15 Measurement Challenges in Personalized Medicine: The Need for Changes in Lab Medicine to Spur on Personalized Medicine
Michael Amos, Ph.D., Scientific Advisor, Chemical Science & Technology Laboratory, National Institute of Standards & Technology, ex-officio member, Secretary's Advisory Committee on Genetics Health and Society (SACGHS), Department of Health and Human Services
11:15-11:45 Regulatory Polymorphisms in Key Candidate Genes as Potential Biomarkers for Assessing Disease Risk and Treatment Outcome
Genomic surveys of functional genetic variability support the notion that regulatory polymorphisms play an important role in mammalian evolution. The Ohio State University College of Medicine has developed methods for the systematic detection of regulatory polymorphisms in key candidate genes for disease susceptibility and drug response. Several of these newly discovered genetic variants were subsequently shown to have significant effects on clinical phenotypes (DRD2, TPH2, ACE, CYP3A4, CETP, VKORC1). This talk presents the approach taken and recent results with clinical outcomes.
Wolfgang Sadee, Dr.rer.nat., Director Program in Pharmacogenomics, Ohio State University College of Medicine
11:45-12:15 An Approach to Standardized Transcription-based Diagnostics
Colin Brenan, Ph.D., Chief Technology Officer, VP Business Development, Co-Founder, BioTrove, Inc.
12:15-1:15 Lunch
1:15-1:45 Circulating Tumor Cell Assays in the Implementation of Personalized Medicine
Professor Herbert A. Fritsche Jr., Ph.D., Professor & Chief of Clinical Chemistry, University of Texas M. D. Anderson Cancer Center
Current and Future Regulatory Hurdles to the Successful Commercialization of Personalized Medicine
1:45-2:15 Pharmacogenomic Research in Clinical Development: Regulatory and Legislative Issues From An Industry PerspectiveThis presentation will cover regulatory and legislative issues related to:
- The collection and testing of biological samples
- Challenges associated with co-development of drugs/biologics and devices
- Regulatory oversight of pharmacogenetic testing
- FDA-approved labeling and recommendations
2:15-2:45 Laboratory Testing in Personalized Medicine: Regulatory and Legislative Issues from the Laboratory Perspective
This presentation will cover the following:
- Status of current regulations of personalized medicine laboratory testing
- Update on current regulatory and legislative issues affecting the field of personalized medicine
2:45-3:15 Laboratory Tests in Personalized Medicine: An FDA Perspective
Robert L. Becker, Jr, MD, PhD, Chief Medical Officer, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, FDA
3:15-3:40 Afternoon Refreshments
3:40-4:10 Legal and Ethical Concerns in Personalized Medicine: A European Perspective
This presentation will answer the following questions:
- Can you take account of genetic differentiation during clinical trials? To what extent?
- How can you protect discoveries arising from research in pharmacogenomics?
- To what extent is it possible to request a genetic test?
- How are testing devices regulated?
- Is it possible to use a person's "risk profile", as shown by genetic testing, against that person?
- How will a person's genetic makeup influence decision making in their medical treatment (and the way that related costs are borne by the community and/or insurance) ?
- Do family members have access to the result of a person's genetic testing?
The Role of Information Technology and Informatics in Personalized Medicine
4:10-4:40 Healthcare Information Technology as an Enabler of Personalized Medicine
This talk will examine how the adoption of electronic health records (EHRs) and the advancement of healthcare IT (HIT) will advance personalized medicine from the viewpoint of different stakeholders.
Patients and providers will have access to improved clinical decision support; the pharmaceutical industry and payers will have access to data to develop more sophisticated decisionmaking models; regulators will have to balance the opportunities of data access with privacy concerns. Overall, widespread adoption of HIT in the era of personalized medicine should help lead to better, more effective care, with better informed patients, physicians, and regulators.
Michael Cantor, MD, Director, Healthcare Informatics, Pfizer
4:40-5:10 Transinformatics for Tissue Procurement and Biomarker Discovery in Cancer Research
Developing novel therapies for “personalized” treatment on cancer requires systematic scientific approaches that will lead to identification of biomarkers for specific cancer types. First and foremost important, but often neglected, step in biomarker discovery process is the tissue procurement methods that will provide bench scientists with high quality clinical specimens. A combination of good quality samples and unique and innovative research methods can significantly shorten the time related to biomarker discoveries. A good set of biomarkers are necessary to generate effective molecular tools and diagnostic platforms that are highly applicable to translational clinical studies for achieving “personalized medicine” and chemotherapeutic interventions for anti-cancer therapies. This presentation will detail the Cancer Center’s efforts at establishing a novel approach for biomarker identification utilizing bioinformatics.
K. Stephen Suh, Ph.D., Scientific Laboratory Director, Tissue Bank and Genomics Program, The Cancer Center, Hackensack University Medical Center
5:10-6:10 Wine and Cheese Reception
Day Two - April 24, 2009
7:45-8:15 Registration and Continental Breakfast
8:15-8:25 Chair's Opening Remarks
Keith Batchelder, MD, Chief Executive Officer and Founder, Genomic Healthcare Strategies
Personalized Medicine in the Clinic
8:25-8:55 A Novel Approach to Commercializing a Pharmacogenetic Companion Diagnostic in the Clinic: Case Study-Bucindolol and GencaroThere are various emerging models for the delivery of personalized medicine in the clinic-this will cover a case study describing the process by which a companion diagnostic test was co- developed; and validated for commercial launch with the biotech partner; in a reference laboratory setting. Regulatory and commercial aspects and hurdles/solutions will be described.
Meeta Patnaik, MD, Vice President, Companion Diagnostics, LabCorp
8:55-9:25 Getting to the Point: Physicians, Personalized Care and Targeted Therapies
This session will address the need, within the medical community, for greater adoption of personalized care strategies and solutions. The provision of actionable information, clinical value, and economic value are all critical pieces in the drive to appropriate adoption.
Surya Singh, M.D., Chief Medical Officer and Vice President of Clinical Development, Proventys, Inc.
Intellectual Property Challenges in Personalized Medicine Development
9:25-9:55 IP Fragmentation in Diagnostic GeneticsThe intellectual property rights involving diagnostic tests that rely on mutliple mutations or polymorphisms in multiple genes become fragmented when multiple owners have patents for the test, where each patent may block a different mutation, polymorphism or gene. As a consequence, intractable thickets have already appeared and are increasingly likely to appear in the future. This presentation will outline possible solutions such as, for example, the use of patent pools relying on medically driven best practices as guiding standards.
Jorge Goldstein, JD, Ph.D., Director, Sterne, Kessler, Goldstein & Fox
9:55-10:25 Patentability Requirements in the U.S. Relating to Personalized Medicine: Considerations and Pitfalls for the Unwary
Obtaining and defending patents in the field of personalized medicine has its own special considerations. A number of U.S. court decisions are likely to impact patentability of subject matter relevant personalized medicine, particularly in the area of diagnostic tests. This presentation will discuss a few of these cases and their impact on patenting considerations. For example, careful claim drafting can help avoid many pitfalls seen in previous cases.
Jacqueline D. (Jackie) Wright Bonilla, JD, Ph.D., Partner, Foley and Lardner LLP
10:25-10:45 Morning Refreshments
Funding and Financing the Development of Personalized Medicine
10:45-11:15 Fostering Translation of Genetic Research on Common Disease: An NIDDK PerspectiveThis presentation will explore ways by which the research community can transition from their discovery efforts into translational research, through meetings and funding initiatives. Dr. Rasooly will focus on the NHI’s efforts specifically as head of the Translation component of the NIH Genes, Environment, and Health Initiative which has emphasized using genetics to help understand, diagnose and treat common diseases. Dr. Rasooly will discuss the challenges that NIDDK is facing in trying to develop a research program that translates exciting genetic findings from major studies into practical use and the approaches we are taking.
Dr. Rebekah Rasooly, Program Director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
Achieving a Successful Model for Reimbursement of Personalized Medicine Diagnostics and Therapies
11:15-11:45 Pharmacogenomics: Perspectives from the Payers, Physicians, and PatientsTeresa DeLuca, MD, Vice President Dept of Personalized Medicine, Medco
11:45-12:15 Achieving Value-Based Payment for Personalized Medicine Diagnostics
How are innovative diagnostic companies securing value-based rather than cost-based payment? Mr. Terry will discuss how these innovators are building compelling clinical and economic evidence to support coverage and value-based payment from payers.
Objectives of this presentation:
- Review a number of development models and approaches
- Discuss the generalizability of these different models
- Identify opportunities and challenges associated with the value approach
12:15-1:15 Lunch
1:15-1:45 Coverage, Coding, Payment: Three Chasms Facing the Personalized Medicine Industry
Many payors have trouble grasping different evidence issues for therapeutics versus diagnostics. Dr. Quinn will discuss how Medicare's payment system and other regulations are particularly dysfunctional for innovative laboratory tests and what innovative new systems for coding and laboratory benefit management are currently being proposed.
This presentation will cover the following:
- Legacy coding and payment rules uniquely impact the laboratory industry
- Why insurers find coverage decisions for diagnostics more problematic than for therapeutics
- How to deal with the system as it is, and prospects for change
1:45-2:15 Personalized Medicine Meets Payer Policies: Barriers and Strategies to Overcome Them
Wayne Roe, Director, Celera Diagnostics, Director, In-Cube Ventures
Returning the Investment: What will Drive ROI in Personalized Medicine?
2:15-2:45 The Need for Financial Transparency in Driving Forward Personalized MedicineMollie Roth, Esq., Corporate Counsel, VP Business Development, Diaceutics
2:45-3:00 Afternoon Refreshments
3:00-3:30 Value Creation and Value Capture in Personalized Healthcare: A View from the Industry
Thomas Metcalfe, Ph.D., Head, Personalized Healthcare Portfolio, F. Hoffmann-La Roche Ltd
3:30-4:00 Where is the ROI for Targeted Therapies? Understanding the Barriers to and Benefits of Adopting Personalized Medicine
Asif Dhar, MD, MBA, Senior Fellow, Deloitte Center for Health Solutions; Senior Manager, Deloitte Consulting LLP
4:00 End of Conference