|
Wednesday, March 26
7:00am Registration (Open until 5:30pm)
|
8:00 Plenary Keynote Introduction
 Edward G. Heidig, General Counsel and Deputy Secretary, Business, Transportation and Housing Agency
8:10 Risk Diagnosis for Disease Prevention
 C. Thomas Caskey, M.D., F.A.C.P., Director and Chief Executive Officer, Brown Foundation Institute of Molecular Medicine, University of Texas Health Science Center
There are an increasing number of presymtomatic diagnostic options which include: genetic, imaging, and analyte technology. Examples of linking a specifi c diagnostic to a therapeutic decision and FDA approval have fueled the activity for personalized medicine. It must be appreciated that diagnos-tic capacity emerges far more rapidly than an approved safe therapeutic. Thus the personalized medicine goal has a bottle neck for broad utility. A strategy of studying approved drugs for maximal effi cacy is realistic and reasonable toward that goal since it is estimated that many approved drugs are effective in less than 50% of patients. These approaches will be discussed.
8:55 Disruption of the Pharmaceutical Industry: Moving from Products to Solutions
 Theodore J. Torphy, Ph.D., Corporate Vice President & Head, Science & Technology, Johnson & Johnson
The pharmaceutical industry is bracing itself for a period of unprecedented challenges. This new era for our industry is being brought on by the confluence of several environmental factors, both internal and external to the industry, including; 1) non-sustainable increases in healthcare expenditures, 2) spiraling costs and decreasing productivity of R&D, 3) reimbursement driven by medical and economic outcomes, and 4) the proliferation and redistribution of healthcare outcomes information. Although all of these factors threaten to disrupt our industry, it is the evolving transparency in healthcare outcomes information that represents the most unsettling threat to our current business model, as well as the largest opportunity to transform our industry. For this transformation to take place, it is imperative that we change from an industry in which the sole mission is to provide products to one that provides broader, cost-effective solutions to areas of major healthcare needs. |
9:40 Grand Opening Refreshment Break in the Exhibit Hall
11:00 Chairperson𠏋 Remarks
11:10 Valuing Discovery Platforms and Drug Candidates: Estimating NPV with Imperfect Information
Robert Freeman, Ph.D., Professor, Pharmaceutical Sciences, Texas A & M University Health Science Center
Most financial models require product candidates in a portfolio to be present before net present values can be estimated. Since emerging biotechnology companies must secure additional funding to move from discovery to development, better models are necessary to assign value to platforms and candidates. Existing models are reviewed during this presentation and modifications to existing frameworks are presented to address this issue.
11:55 Valuation Creation by Biomarkers in Product Development & Marketing
Eddie Blair, Ph.D., Corporate, Integrated Medicines Ltd
This presentation will describe the potential cash value of early decision making to a product development portfolio, with particular emphasis on the translation of biomarkers into value-adding companion diagnostic-type tests for pharmaceuticals reaching the market. Case studies will be presented.
12:40pm Q&A with Session Speakers
1:10 Walk & Talk Luncheon in the Exhibit Hall
2:15 Chairperson𠏋 Remarks
Sandor Szalma, Ph.D., Director, Discovery Informatics, Centocor R&D, Inc.
2:20 The Winding Path(ways) to Biomarker Discovery
Sandor Szalma, Ph.D., Director, Discovery Informatics, Centocor R&D, Inc.
The number of molecular platforms enabling translational research for biomarker discovery is steadily increasing. So does the plethora of algorithms and approaches aimed at interpreting the data from these different experimental modalities. We have selected a set of closely related autoimmune disorders - psoriasis, psoriatic arthritis and rheumatoid arthritis - to illustrate the challenges and possible solutions on the path towards biomarker discovery. The strengths and weaknesses of the applied informatics solutions - including statistical as well as integrative biology tools - in pharmaceutical drug discovery settings are discussed in great depth.
2:50 Predictive Response Biomarkers �ETheory and Practice
Hans Winkler, Ph.D., Senior Director, Oncology, Johnson and Johnson B.I.O.
Targeted cancer medicines have been shown to be highly effective, albeit in a limited percentage of patients in any indication. It is therefore highly desirable to be able to identify patients with high likelihood of clinical benefit from a particular treatment. Two distinct approaches will be discussed: a target expression/activity approach, as exemplified by ErbB1 and ErbB2 therapies as well as novel approaches to discovery and clinical validation of molecular profiles of tumor and blood components. The latter comprises the classification of markers based directly on patients�Ebenefit.
3:20 The Challenges of Biomarker Validation in the Clinical Setting
Stephen M. Hewitt, M.D., Ph.D., Clinical Investigator, and Chief, Tissue Array Research Program, Laboratory of Pathology, Center for Cancer Research, National Cancer Institute
There are a multitude of biomarker discovery platforms, each which produce useful but complex data. Reducing these potential clinically relevant biomarkers to clinical utility remains a bottleneck. The demands of diagnostic pathology and clinical medicine limit the utility of many potential biomarker platforms. The path toward clinical utility requires examination of analyte specification as well as assay performance to generate a useful biomarker. Routinely, assays are ported to new platforms and assays are modified to optimize performance in a clinical sample.
3:50 Expression of Genes and microRNAs as Biomarkers of Hematopoietic Stem Cell Potency
David Stroncek, M.D., Chief Blood Bank, Department of Transfusion Medicine, National Institutes of Health
CD34+ cell counts are most often used as a measure of the potency of clinical hematopoietic progenitor cell components. However, stem cells make up a small proportion of CD34+ cells and this proportion differs among various sources of hematopoietic progenitor cells. Molecular assays including gene expression profiling and microRNA expression profiling are providing more precise information that may lead to the identification of better stem cell biomarkers.
4:20 Reception in the Exhibit Hall
(Sponsorship Available)
|
5:00 �E6:00 Break-out Discussions in the Exhibit Hall
Translational Science Across the Globe: Needs, Opportunities and Challenges
Paul de Koning, Ph.D., Vice President, Exploratory Development, Astellas
This breakout session will discuss whether there are cultural differences between USA, Europe and Asia in the adoption of Translational Medicine. Practical examples will be provided of experiences of implementing Translational Medicine in a Japanese company with R&D sites in Japan, Europe and USA.
Use of Biomarkers to Make Go / No-go Decisions �EAre We Ready?
Hong Wan, Ph.D., Associate Director, Clinical Translational Medicine, Wyeth Research
This breakout session will discuss how pharmaceutical companies utilize biomarker information on internal decision making for drug development programs. Issues include the validity of the biomarker, tolerance of risk and how the biomarker data should be interpreted and used.
How Translational Medicine Can Contribute to Early R&D Productivity Using a Standards of Evidence Approach
Keith Ortiz, Partner, VantagePoint Consulting Group
Understanding how scientists develop, communicate and receive evidence is critical to our success in translational medicine. In general, the pharmaceutical industry is far behind other disciplines in this understanding (e.g., behavioral sciences no longer measure success in simple 㺸bjectives vs. outcomes�Eterms). Participants in this session will learn about Standards of Evidence (i.e., what does it take for us to believe evidence?) and how SOE can be used to improve productivity in Early R&D. We will review related initiatives (e.g., the National Academies of Sciences Standards of Evidence working group, the American Evaluation Society𠏋 educational efforts) and we will discuss how Translational Medicine staff can initiate SOE discussions across Early R&D. |
|
Japanese
Korean
English