Day One: Tuesday, January 16, 2007

10:00 am Summit Registration

Better Strategies to Manage R&D Processes

11:00 am Summit Welcome and Opening Address

Moving the Needle: An Integrative Approach to the R&D Productivity Conundrum
As we all know too well, R&D productivity has been impacted by high late stage attrition, accelerating costs, and historically low number of candidate com pounds. While, over the years, the industry has embarked on many worthwhile initiatives, the downward trend has, by and large, proven itself resistant to these efforts. However, due to a confluence of factors, we now have the opportunity to make a dent in the trend line. This presentation will suggest that the answer (to the R&D productivity conundrum) lies in a portfolio of simultaneous and closely related initiatives, which cumulatively will improve productivity. We will explore some of these initiatives and the linkages between them.

• Conducting more experimental/translational (as opposed to regulatory) trials, off-shore, to rapidly and economically generate the information required to make superior decisions

• Using predictive models (based on the value of information paradigm) to guide decisions about which experimental/translational trials to conduct and in which order (or maybe in parallel)

• Implementing an operations infrastructure that will facilitate the conduct of a greater number of smaller and faster trials

Wade Speir, PA Consulting Group

11:30 am Presentation Title TBD
Kathleen Metters, Ph.D., Senior Vice President and Head, Worldwide Basic Research, Merck &
Co, Inc.

12:15 pm Good Pre-Market Drug Development Through the Use of Critical Path Tools
The leadership of government agencies has expressed their scientific vision for the future of medicine in terms of roadmaps and critical paths. Executing the strategies in the NIH Roadmap Initiative or the FDA Critical Path Initiative is like paving the road while we’re driving on it. Each initiative has their respective themes, initiatives, and implementation challenges. By and large, the pharmaceutical industry and patient advocacy groups have embraced these initiatives enthusiastically. From a broad perspective, the FDA Critical Path Initiative emphasizes the need for much better predictive biomarkers, bioinformatics, and clinical trials during the clinical phases of drug development. Highlights of this presentation will be:

• Status report on the FDA Critical Path Initiative

• New quantitative tools for assessing efficacy and safety

• Selecting doses to fit patient profiles

• Role of collaboration in overcoming obstacles

• Why the critical path initiative can fail

Lawrence J. Lesko, Ph.D., F.C.P., Director, Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research,
Food and Drug Administration

2:15 pm Globalization of Drug Development: Leveraging Emerging Regions
Pfizer conducts clinical development globally. In doing business across the world, the company considers standard of medical practice, quality of healthcare, regulatory/compliance issues, market drivers, and the cost of doing business and speed of operations. There has been a lot of recent discussion promoting investigator/patient recruitment in emerging regions. While there may be cost and speed advantages, these need to be balanced carefully against
the other factors such as the standard of patient care, the ability to conduct clinical research within acceptable good clinical practices, and the longterm effect to the region. Clinical trial support activities such as data management, programming, or writing are not quite as complex but still need to be managed carefully if moved to emerging regions.

• Review of key issues around country selection for investigator recruitment

• Regulatory challenges

• Global distribution of studies

• Local country offices vs. Clinical Research Organizations for monitoring

• Discussion on whether to build or buy other clinical trial support activities

Adrian Otte MB.., BCh., F.F.P.M., Senior Vice President, Worldwide Development Operations, Pfizer, Inc.

Executive Roundtable Discussions

3:00 Executive Roundtables
Concurrent roundtables to discuss some of the more broad, yet poignant, questions facing the industry. Each roundtable will be limited to twelve 
(12) participants and a facilitator. Additional roundtables and facilitators will be added as needed based on registration.

 Roundtable 1:  Medical Imaging in Drug Development 
• Standardization of image acquisitions across the various diagnostics platforms - regulatory and industry perspective
• Independent evaluations of the images acquired in clinical trials to prove efficacy of the drugs - prospective development of imaging charter and optimizing partnership with imaging CROs
Facilitator: Kohkan Shamsi, M.D., Ph.D., Head, Medical Development, Diagnostic Imaging and Radiopharmaceuticals, Berlex, Inc.

 Roundtable 2:  Discovery and Development Collaboration
• Need for common objectives 
• Creating structural alignment 
• Early integration of ADMET 
• Role of new technologies for safety assessment
Facilitator: Michael O'Callaghan, Ph.D., Vice President, Preclinical Biology, Genzyme Corporation

 Roundtable 3:  Biomarkers: Intellectual Playground or Business Effective Initiative?
• Role and development of a biomarker strategy: indication/compound specific or generic?
• Biomarkers in the expansion of indications/life cycle management
• Can the role and interplay of industry, academia, and agencies be improved?
• Future directions: population specific clinical trials, personalized medicine, etc.
Facilitator: Phillips Kuhl, President, Cambridge Healthtech Institute

 Roundtable 4:  The Future of Toxicity Testing in the Pharmaceutical Industry 
• What is the purpose of toxicity testing? 
• What is histopathology telling us? 
• Are other technologies more pertinent to understanding organ function after xenobiotic exposure thereby improving risk assessment?
Facilitator: David Brewster, Ph.D., Vice President, Non-Clinical Drug Safety, Hoffman-La-Roche, Inc.

 Roundtable 5:  Enhancing R&D Productivity - Where Do the Opportunities Lie?
• External opportunities
• Internal opportunities
• Process optimization including project, resource, and portfolio management 
Facilitator: Mark Horn, Director, Finance Information Management, Project Planning and Administration, Wyeth

 Roundtable 6:  Managing Industry (& Therapeutic Area) Information Overload - Moving Toward the Ideal in the 21st Century
• High stakes, but little time…
• Self-serve vs. other; holistic view vs. narrow; human-filtered vs. not… 
• Delivering an intelligence edge in the midst of budget cutbacks…
Facilitator: Daniel Clark, Vice President, ABIS Group

4:00 Networking Refreshment Break

Roundtable Synopsis and Findings

4:30 Executive Panel: Roundtable Synopsis and Findings 
Each roundtable group will designate a leader to sit on a panel and present a short summary of their discussion. A moderator will then open a discussion amongst all attendees addressing the most critical questions facing the industry. 
Moderator: Timothy Noffke, PMP, Vice President, Life Sciences, Integrated Project Management Company

5:45 Opening Cocktail Reception	Hosted by

7:00 Close of Day One