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DAY 2
Tuesday, September 21, 2004
Special Business Strategy Session
| 8:00 Morning Coffee |
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| 8:30 Chairpersons Opening Remarks |
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| 8:45 Adding Business Minds to the Drug Discovery Process-Mixing Different Cultures
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Creating a process where various functions within the drug development continuum (e.g. discovery-commercial), where decision making is integrated at an early stage without stifling scientific creativity, is a significant challenge that needs to be met. Discussion points include:
Developing common mechanism platforms
Elements required for a productive discussion between the two divisions
(scientific/medical)
Feasibility, regulatory risk, unmet need, market value and other aspects that
need developing within a cross-functional team
Steve J. Offord, Ph.D., Head New Products CNS/ Thrombosis, Global Marketing & Medical, Aventis
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9:30 Cross-Functional Cooperation:
A Strategy to Improve Big Pharma's Decision Making
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How managers must integrate efforts in decision making
Creating R&D and marketing synergies to better manage risk
Understanding the differences between the marketing and scientific cultures, and blending them for high productivity and creativity
Reducing portfolio attrition by creating a mix of scientific and market opportunities
Maureen Kiley, Director, New Product Planning, Eli Lilly and Company |
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| 10:15 Networking Refreshment Break |
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| 10:45 Steps to Create a Culture that Enables Better Go/No-Go Decisions
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Evaluating why the discovery and development relationship is so complex
Gaining "buy-in" from your scientists
Encouraging risk-taking, limiting bureaucracy and rewarding good decision making
Implementing important communication mechanisms
Continuously driving change in the R&D culture
Janet White, Senior Director, Business Operations, La Jolla Development, Pfizer Global Research & Development
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Special Biomarker Strategy Session |
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| 11:30 Biomarker Strategy Session Introduction: Building a Biomarker Bridge Across the Translational Chasm
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The chasm between preclinical and human testing is littered with the wrecks of once-promising compounds, despite exhaustive preclinical testing. These failures are rapidly becoming an unsustainable burden to the pharmaceutical industry, and a major component of the sky-rocketing cost of bringing a successful drug to market. In response, the industry is increasingly looking to molecular biomarkers to achieve greater certainty and confidence in its translational decision-making.
Minimize pharmacologic surprises.
Enrich the supply of clinical candidates.
Bring increased clarity to clinical protocols.
Facilitate regulatory decision-making.
Andrew F. Branca, Senior Vice President & Group Leader, Cambridge Healthtech Advisors
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| 12:00 A Strategic Approach to Biomarkers:
Regulatory and Clinical Implications of Utilizing Biomarkers in both Discover and Development
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Distinguishing biomarkers from surrogates from endpoints
Use of biomarkers in dose selection for regulatory filings
Approval paradigms using surrogates-real life examples
Possible paths forward in the regulatory process
Implications on late stage attrition
Donald M. Black, M.D., M.B.A., Vice President, Global Regulatory Policy and Strategic Development, Merck and Co.
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| 12:45 Networking Luncheon
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Hosted by: |
The Networked R&D Organization: Using Technology to Automatically Connect Employees
David Gilmour, President and CEO, Tacit Software
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| 2:00 Provide an Early Mechanism for Aligning Biomarkers And Predictability Between Discovery And Development-Reduce
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Late-Stage Failures
Utilizing new development methodologies in the clinic
The role of systems biology in experimental design
Better business practices for biomarker development
Novel ways of collecting data
Applying early biomarker work to the clinical practice
Is stratifying patient populations during clinical trials in the near future?
David S. Lester, New York Site Head, World Wide Clinical Technology, Pfizer Global R&D
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| 2:45 Biomarker Analysis as a Decision-Making Tool in Drug Discovery and Development
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Use of biomarkers is one of the means to effect rational drug development decisions in an efficient and cost-effective manner. Biomarkers have potential utility from preclinical research through drug development, and ultimately even in clinical practice. Recent advances in genomics and proteomics may increase the pace of biomarker discovery and their value in early drug development. Highlights of this session include:
What is the basis for selection of novel biomarkers?
How are novel biomarkers qualified for use in clinical studies?
How can biomarkers be used to make decisions in drug development?
John Wagner, M.D., Ph.D., Senior Director, Department of Clinical Pharmacology, Merck Research Laboratories
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| 3:30 Clinical Models to Bridge from Discovery to Development
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For novel classes of medications, few models are predictive of ultimate efficacy. Nevertheless, they provide a chain of physiologic events, and bridge from pre-clinical to clinical efficacy evaluation. Greatest value is in confirming pharmacologic activity in early development. This presentation will discuss models to bridge these functions, and ultimately provide scientists with better ability to reduce late stage attrition.
Richard Scheyer, M.D., Senior Distinguished Scientist, Product Realization, Aventis |
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| 4:15 Close of Executive Forum
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About The Pharmaceutical Strategy Series
The Pharmaceutical Strategy Series (PSS) is a division of Cambridge Healthtech Institute. PSS programs have been designed to help the R&D leaders and corporate executives assess business opportunities, enhance corporate value and forecast the economic and regulatory landscape within the rapidly changing pharmaceutical & biotechnology industries. PSS chooses the most topical issues to cover, based largely on advice given by the PSS Advisory Board. The Advisory Board is comprised of decision-makers at most of the worlds leading pharmaceutical companies. Presentations in each Executive Forum will give you the ideas, information, and resources you need to make faster and smarter decisions. You can review an updated PSS schedule at
www.pharmaseries.com.
Call for Sponsors
CHI offers a variety of conference sponsorships designed to bring your
company face to face with key executive decision-makers, position your
solutions/services and increase revenue opportunities in a highly
competitive marketplace. You will interact with Vice Presidents, Heads of
Departments and Directors of Pharmaceutical and Biotechnology companies, who
will attend this focused executive forum.
For details, please contact:
Eric Glazer at 781-972-5442; email: eglazer@healthtech.com
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