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Day 1
Monday June 13, 2005
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8:00 Pre-Conference Tutorial Registration and Morning Coffee
8:30 - 11:30 Pre-Conference Tutorial
Targeted Therapeutics: Finding and Realizing the Value For Your Organization
Has targeted therapeutics lived up to its promise? Notwithstanding a few success stories in oncology and infectious diseases, personalized medicine has fallen far short of its once expected transformational impact on the pharma blockbuster business model. It seems that in many cases the science is offering applications for which the market has little appetite. It is still not clear where targeted therapeutics will find traction or what the implications will be for pharmaceutical and diagnostics
players. Key to understanding these implications is divining where biomarker information will have the highest clinical utility: i.e., where biomarker information will actually change physician treatment behaviors. Finding these pockets of value may require significant investments, and necessitates comprehension of significant scientific and market uncertainties. Realizing this potential value requires organizational alignment around a shared understanding of these opportunities.
SDG has worked with both pharmaceutical and molecular diagnostics companies to enhance their understanding and the quality of dialogue around the implications of personalized
medicine and their response to it. In this highly interactive workshop we will focus on:
• Perspectives on how targeted therapeutics will develop given the stances of
pharma, diagnostic, regulatory, payer, physician and patient stakeholders
• Success and failure modes for making targeted therapeutics add value for your organization
• Approaches for trading off the cost, risk and value of targeted therapeutics opportunities
• Integration of targeted therapeutic considerations into product development and therapeutic area strategy
These workshop topics will be informed by concrete and meaningful examples. Each topic will consist of a combination of engaging exercises and keynotes. Insights and takeaways will be supplemented by the perspectives of industry stakeholders.
The workshop leaders will be Mark Chang, William Leaf-Herrmann, and Duncan John.
All three are senior members of Strategic Decisions Group's Life Sciences Practice.
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Sponsored by: |
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The Evolving Pharmaceutical Business Model
12:00 Main Conference Registration
12:30 Chairperson's Opening Remarks
Michael Stocum, Managing Director, Personalized Medicine Partners and Former Director, Business Development & Alliance Management, GlaxoSmithKline
12:45 Pharma's Paradigm Shift and the Implications of
Personalized Medicine
Dr. Wayne Rosenkrans, Director of Business Strategy, External Scientific Affairs, AstraZeneca Pharmaceuticals & Member of the Board, Personalized Medicine Coalition
Rapid changes in the scientific and commercial environment are forcing the pharmaceutical industry to examine new business models. The classic model of using marketing throw weight to promote products with modest therapeutic benefit to an increasingly sophisticated and skeptical customer is coming under increasing fire from consumers, providers, payers, and regulators concerned about the cost of healthcare. Even the very foundation of the research-based pharma industry, that innovation in medicine is valued, has been called into question recently in the wake of large product withdrawals. The industry must reshape its value equation away from one size fits all, and move toward a sense of appropriate pharmaceutical care - the concept of "the right therapy, for the right patient, at the right dose, the first time." Personalized Medicine (PM) represents the necessary juxtaposition of science, medicine, and commercial opportunity to move in this direction. But with the promise of PM comes a need for new business models, new strategies for profitability, new challenges in development, and new policy issues.
Attend Dr. Rosenkrans presentation to discuss:
• What are the public policy issues surrounding PM?
• What should the new mental model of product success be?
• What are the challenges of understanding the new market and convincing consumers of value?
• What are the changing definitions of PM going forward?
1:20 The Impact of Biomarker Development on
Drug Discovery and Clinical Trial Design
Dr. Pamela S. Cohen, Executive Director, Oncology, Novartis
1:55 Management of Targeted Therapeutics by 3rd Party Payors
Luis T. Gutierrez, Jr., Corporate Vice President and General Manager,
Covance Health Economics & Outcomes
Both public and private payers generally have set coverage and reimbursement policies in the context of the epidemiology of their covered lives. However, targeted therapeutics change the mechanisms by which payers determine what specific patients are (and aren't) eligible for reimbursement of a given therapeutic intervention. Will targeted therapeutics enable more rational rationing?
Specific topics will include:
• Case examples of coverage and reimbursement policies for current targeted therapeutics
• Factors that payers consider when setting coverage and reimbursement policy
• Impacts on contracted payments to physicians, hospitals, and laboratories
• Mechanisms used to evaluate safety, efficacy, clinical appropriateness, and cost-benefit
2:30 Regulatory Activities in the Field of Pharmacogenomics - Translation of Pharmacogenomics into Clinical Practice
Dr. Felix Frueh, Associate Director, Genomics, Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA
Much attention is paid to FDA's new guidelines for pharmacogenomic data submissions. However, this is only one of many activities FDA is undertaking in this field. The Agency is engaging in a variety of projects targeted at translating pharmacogenomics from being a research tool in drug development into applied science and clinical practice.
Attend Dr. Frueh's presentation to hear about the latest FDA developments and activities, including how FDA is:
• Engaging in collaborations and alliances
• Looking at labeling (and re-labeling) strategies
• Supporting new approaches to clinical trials
• Developing new guidelines in pharmacogenomics
• Coordinating efforts with other international agencies to get a worldwide perspective of pharmacogenomics
3:05 Networking Coffee Break
3:35 Chairperson's Remarks
Dr. Edward Abrahams, Executive Director, Personalized Medicine Coalition
Patient and
Clinical Perspective
3:40 From Personalized to Predictive Medicine - Using Patient Data to be Proactive
Dr. Michael Caldwell, Principal Investigator, Personalized Medicine Research Project, Surgery, Marshfield Clinic
The revolution in healthcare, which began with the concept of Personalized Medicine, will culminate in predicting the outcome, not only of medications and procedures, but also the potential for complications or hospitalization where most healthcare dollars are spent. Using available patient data and family medical history, augmented by selective biomarkers, we should be able to alert physicians in advance of impending complications or hospitalizations. Join Dr. Caldwell as he discusses how with that alert, and available clinical guidelines, we should be able reduce these adverse events and healthcare costs to better provide healthcare for all citizens.
4:10 The Patient & Advocate Perspective: An Evolution of Influence
Sharon Terry, President & CEO, Genetic Alliance, and Founding Executive Director, PXE International
As scienentific knowledge grows in sophistication, and biological pathogenesis of disease is elucidated, the development of personalized medicine products becomes a foreseeable reality for industry, regulatory agencies, policy makers, and the public. Within this changing ecosystem, blockbuster marketing strategies become unsustainable as a business enterprise in certain disease categories and the changing environment results in the customer-patient emerging as a key dynamic and increasingly influential partner in the drug development process. Individuals, disease organizations, research advocates, and communities of interest emerge as new power-brokers and critical participants in the process from clinical trials to post-market surveillance. Advocacy groups and research organizations that implement new strategies and managerial tactics that leverage the community of patients and their advocates can be essential partners in reducing and navigating the barriers to successful personalized medicine products. As the consumer advocacy community matures and embraces a more fervent sense of responsibility to change the status quo; of drug development, approval processes, regulatory oversight, and delivery of quality medicines, a new social movement that could be disruptive or productively enhance the commercialization of new nitchbuster products. The opportunity to impact companies and regulatory agencies in the development and analysis of clinical validity, clinical utility, drug response, surrogate endpoints,
biomarks, value-based pricing, and quality measures for individualized medicine products will ignite a new passion and information based advocacy in the future.
Participants will:
• Develop awareness of the value of patient advocacy participation
• Understand the structures and emerging trends within the patient community
• Think critically about the role the patient community can have in personalized medicine
4:40 Real-World Experiences Translating the Vision of Personalized Medicine into Practice
Dr. Peter Verlander, Associate Director for Strategic Development, Laboratory for Molecular Medicine, Harvard Medical School/Partners Healthcare Center for Genetics and Genomics
The Laboratory for Molecular Medicine (LMM) has launched a series of molecular diagnostic tests to identify mutations in protein kinase genes. Designed to guide oncologists in their decisions for selection of therapy, these tests have been rapidly adopted by oncologists practicing at Massachusetts General Hospital and the Dana-Farber Cancer Center. The discussion of and our experience with these tests, will provide some of the best available practical insight into the current state of this field, as well as likely near term developments.
Diagnostic tests that drive therapeutic decisions represent the holy grail of personalized medicine. Oncology will be the area where genomic markers will make the biggest impact on therapeutic decisions for the foreseeable future. Real-world experiences developing and delivering these novel molecular diagnostics will highlight the issues confronted when translating the vision of personalized medicine to practice.
5:10 Cost-Effectiveness Analysis at the Individual Level
Dr. Mohan Bala, Director of Outcome Research, Centocor, Inc.
The efficacy and toxicity of any given drug can vary substantially from one individual to another. The heterogeneity in individual genetics contributes in part to this variability. Pharmacogenomics attempts to use each patient's individual genetic information to identify the drug with the best efficacy-safety profile for that patient. However, heterogeneity is also present in individuals' preferences for alternate efficacy-safety profiles. In this talk we discuss whether, as health care evolves towards individualized drug therapy, preference elicitation and cost-effectiveness analysis should also be performed at the individual level. Key issues that will be addressed include:
• Case examples of coverage and reimbursement policies for current targeted therapeutics
• The rationale for performing economic analysis at the individual level
• Theoretical basis for individual analysis
• Practical challenges
• Ideas on implementation
5:40 Closing Remarks
5:45 Networking Reception and Roundtable Discussions
7:00 Close of Day One
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