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Tuesday, April 14, 2009
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12:55 pm -
1:45 pm
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- The FDA and Healthcare IT: What went wrong?
- Why massive FDA-reform and massive healthcare-IT-reform must lead the way for the rest of healthcare-reform
- What are the key evils of de facto and de jure rationing of care, and how can we avoid them as much as possible, and distribute the rationing-burden equitably for the rest
- Building on a solid foundation of massive FDA-reform and massive healthcare-IT-reform: What are the remaining key elements of a sound action-plan for healthcare-reform
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John Norris, JD, MBA
CEO and General Counsel
Norris Capital, Inc.;
Former COO, U.S. Food and Drug Administration
 View Biography
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- Amgen's commitment and strategic approach to pipeline development
- Innovation in biotechnology medicine – An industry's relentless mission to deliver breakthrough therapies
- Keeping medical innovation alive in a changing healthcare environment
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David L. Lacey, MD
Senior Vice President, Discovery Research
Amgen
View Biography
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1:50 pm -
2:40 pm
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- Understanding the many perspectives and definitions of EBM
- Developing a paradigm for the pharma industry to generate evidence and create value and comparing to health technology and comparative effectiveness
- Understanding the impact of purchasing trends on the business model including value-based purchasing and measurement systems
- New risk models for money back guarantees for pharmaceutical products
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Stephen J. Boccuzzi, PhD, MBA, FAHA
Vice President - Evidence Based Medicine
sanofi-aventis - US
View Biography
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- Identifying core requirements of value-based purchasers
- Applying a patient-centric risk/benefit model to ensure value-based clinical decisions about treatment choices
- Adding value for purchasers by creating tools to make consumers more successful in their roles as CEOs of their own health & health care
- Making the enterprise more indispensible to purchasers by expanding its role to address cross-cutting problems such as polypharmacy
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Elizabeth L. Bewley
President and Chief Executive Officer, Pario Health Institute;
former Vice President, Strategic Planning, Johnson & Johnson Health Care Systems Inc.
View Biography
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| Moderator: |
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Maria Malavenda
Partner and Life Science Practice Lead
Kalypso
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3:10 pm -
4:00 pm
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Hector S Izurieta, MD, MPH
Chief of the Analytic Epidemiology Branch (AEB)
CBER's Office of Biostatistics and Epidemiology (OBE)
View Biography
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- An evolving approach to monitoring drug and device safety within a data-rich environment in an integrated delivery system (IDS)
- Opportunities for public-private partnerships and collaboration to improve safety surveillance
- Challenges the partnerships present to "data owners" in balancing patient privacy and proprietary data ownership with the public good of researcher access to data and enhanced safety information
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Sharon Levine, MD
Associate Executive Medical Director
The Permanente Medical Group
View Biography
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- Product and medication safety from the health system perspective: An example of postmarketing efforts conducted in VA for improved safety measures
- Internal safety programs conducted by the VA and applicability to external organizations
- How the VA can interact with the FDA to evaluate product safety measures and life cycle approaches
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Francesca Cunningham, PharmD
Director of the Center for Medication Safety
Department of Veterans Affairs (VA) Pharmacy Benefits Management Services (PBM)
National Center for Patient Safety (NCPS)
View Biography
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| Moderator: |
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Noel Sobelman
Partner
Kalypso
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10:40 am -
11:30 am
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- Reframing personalized medicine: A review of the data on genomic testing to improve the quality and cost of care
- Successes in genetic testing for oncology – How the data supports genetic testing and grappling with issues of lack of physician compliance with clinical guidelines and insufficient decision support
- Addressing the business model of diagnostics including the investments necessary and existing reimbursement challenges
- How Genzyme Genetics pursued patent protected tests, pharma sales model and development of an R&D; lab
- Proposing a new market-based reimbursement system to price diagnostics similar to therapeutics and reimbursement that is technology agnostic
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Mara G. Aspinall
former President, Genzyme Genetics;
Visiting Lecturer, Dana-Farber Cancer Institute/Harvard Medical School
View Biography
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- Why payers should care about genomic testing – Recent results from 100 payer clients that have approved genetic testing for two classes of drugs
- Why doctors should know – Data on 90% of physicians believing that genetics will inform a drug decision but 89% admit they don't know enough about what tests are available
- Real adoption experience – What data is needed to influence payers and employers to approve coverage
- Future directions and the need for business model transformation to incent diagnostics development
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Robert Epstein, MD
Senior Vice President, Medical Affairs and Chief Medical Officer
Medco Health Solutions, Inc
View Biography
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- Assessing the consumer demand for genetic testing – How inexpensive but information-rich genomic testing is being pulled by consumers
- Genetically informed consumers can then target specific risks and are engaged consumers for preventive and behavior/lifestyle management
- Reaching the tipping point of genetic testing – Understanding how payers are developing cost-effectiveness methodologies to reimburse for genetic testing
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Linda Avey
Co-Founder
23andMe
View Biography
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11:35 am -
12:20 pm
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- The market forces of licensing – How Novartis approaches licensing opportunities to maximize licensing fees
- Specific examples of successful deals and the negotiation strategies that led to a profitable partnership
- Emerging trends for in-licensing, co-development, out-licensing and marketing & promotion deals
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Anthony Rosenberg
Global Head of Business Development and Licensing
Novartis Pharma AG
View Biography
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