Pre-Conference Tutorials

Day One: Monday, September 25, 2006

Tutorial 1. Successful Project Management Methods and Approaches to Improve Cross Multi-Disciplinary Teams and Deliver Value on Time
Project management is critical in leading the drug development phase from start to finish. Often, companies don’t have a project management department and the project is led by IT or a scientist, who aren’t certified project management specialists. Different departments need to work together efficiently and effectively in understanding the strategic goals and how the day-to-day operational aspects of the project fit in. This tutorial will explore the following:
• Structuring adequate resources and time management strategies
• Leading development timelines and criteria for satisfying specific phases
• Monitoring project fall downs and keeping the project on course
• Working with management to map project implementation with strategic goals

Tutorial 2. Opportunities and Challenges for Outsourcing Shared Services in Emerging Markets
Pharmaceutical companies around the world are faced with increasing pressures to use third party organizations to supplement services on a long-term basis. These include global infrastructure services like standard computing, document management, integration, clinical trials, economic studies, and electronic territory management systems. This tutorial will discuss the key trends for outsourcing shared services and cover the nuts and bolts of the following:
• Leveraging drug development resources to improve productivity of western companies
• Current and future trends in partnering with local companies in emerging markets
• Overcoming the logistical and cultural challenges unique to global partnerships
• Successfully building lead optimization capabilities
• Strategic planning for clinical development operations
• Best practices for navigating the regulatory landscape

Keynote Sessions

Day Two: Tuesday, September 26, 2006

Keynote Session 1:
8:45 Blurring the Boundaries: Bridging Technology with Discovery, Development and Clinical
Kathryn Gibson, Vice President, WW Research Informatics, Pfizer Inc.

Keynote Session 2:
9:30 Use of Modeling and Simulation from Preclinical to Commercial Stages: Case Study in Therapeutic Development
In order to maximize the value and information derived from preclinical experimentation, a single cynomologus monkey study was conducted encompassing pharmacokinetic, pharmacodynamic and toxicity endpoints to evaluate a candidate therapeutic monoclonal antibody. The objective of the study was to characterize the onset and duration of drug effect, as well as time to recovery of clinically validated biomarkers, then link the findings to systemic drug exposure levels. The biological processes were translated into a mathematical and statistical framework then combined with advanced Monte Carlo simulation algorithms in order to create a new sophisticated simulation program. This program was applied to validate the proposed biological mechanism of action, optimize the designs of all further experiments, and increase confidence in decision making (go/no go) during the early stages of development. In addition, it provided quantitative assessment of the probability of having a successful drug with respect to both efficacy and commercial potential. The presentation will cover the following topics:
• Partnering of pharmacokinetic/pharmacodynamic modeling mathematicians with nonclinical pharmacology and toxicology scientists to improve success in drug development
• Combination of pharmacokinetic/pharmacodynamic/toxicity data and model simulation to optimize systemic exposure of a new drug
• Understand how to utilize biological data and model simulations for making go/no go decisions
• Use of Monte Carlo Simulation algorithms to better understand the biological processes and assess commercial opportunity
Serge Guzy, PhD, Senior Scientist II, XOMA, LLC
Kathleen Meyer, MPH, PhD, DABT, Director, Toxicology, XOMA, LLC

Day Three: Wednesday, September 27, 2006

KEYNOTE SESSION 3:
2:30 In-housing the Outsource: Rapid Co-Evolution of a Discovery-Computational Team to Drive Innovation
Amylin Pharmaceuticals is a fully integrated biopharmaceutical company experiencing rapidgrowth. In such growth scenarios, staffing to meet personnel demand is a challenge. Amylin hastaken a new approach of building expertise rapidly. We have partially in-housed an entrepreneurial private company, Kelaroo, to provide an innovation module for diverse internal informatics needs.The Amylin-Kelaroo relationship started in 2000 as a typical arrangement between a professional services provider and client, with an emphasis on the integration and customization of 3rd party chemical and biological data management solutions germane to pharmaceutical research. The relationship has evolved to include multiple custom application development projects driven by teams of scientists from both companies. These projects, one of which will be presented in detail, exemplify the benefits of fostering out-of-the-box long-term
relationships between pharmaceutical companies and informatics innovators.
Michael Hanley, PhD, Vice President of Discovery Research, Amylin, Inc.
Robert D. Feinstein, PhD, VP & CSO, Kelaroo, Inc.

Keynote Session 4:
3:30 Aligning Technology with Science: How Clinical Data Feeds Back into the Discovery and Development Process
Anastasia M. Khoury Christianson, PhD, Director and Global Skill Leader, Discovery Medicine Informatics, AstraZeneca R&D (Invited)

Keynote Session 5:
4:15 Democratizing the Discovery Process
The public sector has invested billions of dollars per year over the past decade to advance technologies that will fundamentally change the discovery process. Yet, realistic assessment of today’s industry shows that very little has really changed. This talk will briefly explore the evolution of enterprise software and extract lessons for information systems that will fully exploit discoveries in life sciences. A partnership model for accelerating the progress of digital biology will be presented along with a case study in collaboration toward advancing translational medicine.
• Differences between life sciences and traditional IT applications
• Prescriptive guidance for speeding development of effective applications
• User feedback from the Scripps Collaborative Molecular Environment
Don Rule, MBA, Platform Strategy Advisor for Bioinformatics, Microsoft Corporation

Track 1: Bridging Discovery and IT

Day Two: Tuesday, September 26, 2006

7:30am Registration and Morning Coffee

8:30 Chairperson’s Opening Remarks

Keynote Session 1:
8:45 Blurring the Boundaries: Bridging Technology with Discovery, Development and Clinical
Kathryn Gibson, Vice President, WW Research Informatics, Pfizer, Inc.
see page 3 for details

Keynote Session 2:
9:30 Use of Modeling and Simulation from Preclinical to Commercial Stages: Case Study in Therapeutic Development
Serge Guzy, PhD, Senior Scientist II, XOMA, LLC
Kathleen Meyer, MPH, PhD, DABT, Director, Toxicology, XOMA, LLC
see page 3 for details

10:15 Networking Coffee Break and Exhibit Viewing

11:15 Information Technology Investment Strategies in the Complex World of Discovery IT
Discovery research demands a combination of innovative IT together with globally-accessible, dependable systems to facilitate information exchange and drive effective decision-making. Layered on this dynamic environment is the need for shifting investment from non-differentiating activities to strategic areas as IT budgets remain generally flat. Adopting strategies such as shared services, capability sourcing, strong project portfolio governance and shared commitments on business outcomes can be used as a framework for successfully managing through the complex world of discovery IT today.
• Partner with drug discovery leadership in managing the portfolio of IT investments to support division objectives
• Use embedded IT resources together with chemistry informatics experts to codevelop prototype systems to support innovative chemistry initiatives leads to smoother transitions for wider deployments
• Link operational excellence and process redesign with IT redesign in approaching clinical trial sample management and archiving for biomarker initiatives
• External sourcing of non-differentiating activities through IT-Business joint funding strategies
Ingrid Akerblom, PhD, Executive Director, Research Information Services, Merck & Co., Inc.
Kevin Chapman, PhD, Senior Director, Synthetic Chemical Research, Merck & Co., Inc.

12:00pm A Research Data Warehouse and Reporting System that Caters to the Scientific Mind
We have designed a research data warehouse and reporting
system that integrates Biology, Chemistry, PKDM, and Toxicology
data. Our scientists are experts at analyzing assay results, however they often do not truly understand (nor are they interested in) data aggregation, pivoting or complex search logic. Tools that require an understanding of these concepts often go unused. Therefore we have designed a novel and powerful search and report engine that allows them to retrieve and analyze data without considering these concepts. We will emphasize the following points:
• What scientists don’t like about many ad hoc search tools
• Building an interface that allows scientists to ignore pivoting and aggregation and that Simplifies Boolean logic in searching
• A demo of the tool used in a variety of scenarios
• Our development methodology and lessons learned
• How our organization is reorganizing itself to provide flexible IT support for scientists
Robert Cain, PhD, Principal Scientist, Allergan, Inc.
Jeff Pierick, Information Technology, Allergan, Inc.

12:45 Lunch on Your Own (Sponsorship Available)

2:00 Creation and Use of an Informatics Platform that Integrates Drug Discovery and Development Data
We have developed an Informatics platform that includes a multi-tiered architecture to manage our data assembly and viewing environment. The system consists of a combination of commercial and internally developed applications integrated through a service-oriented architecture. The User Community can access the various data stores via discrete client tools as well as a web interface that assembles all available and internally published data for centralized viewing. The data integration approach includes solutions to manage file server and database access, and includes User access to study reports created as part of our R&D data pipeline.
• Description of Millennium’s Informatics platform
• Overview of critical systems and integration points
• Discussion of User requirements and client tools
• Data assembly strategy and roadmap
• How key cheminformatics applications are used by project teams
David Sedlock, PhD, Director, Research Informatics, Millennium Pharmaceuticals, Inc.
Paul Greenspan, PhD, Associate Director of Medicinal Chemistry, Millennium Pharmaceuticals, Inc.

2:45 Building an Informatics Infrastructure for High-Throughput,High-Content Compound Screening
Odyssey has established an efficient, cost-effective platform to perform compound profiling and drug discovery. The platform is based on high content (automated microscopy) screening and the system has been designed to execute these assays in a massively parallel, high throughput format. The central challenge, therefore, is dealing with multiple data acquisition and processing steps with little intervention. Session highlights will be presented on the challenges in building the infrastructure, and in bridging the management, scientists and the informatics staffs.
• Brief introduction of Odyssey Thera’s PCA technology and assay development efforts
• Building a large scale information management system which consists of data driven automation, image analysis and statistical calculation pipeline, data querying, reporting and visualization tools
• Establishing a hardware infrastructure based on automated confocal microscopes, database and other types of servers, Linux blade center, SAN storage and liquid handling robots
• A tight blend of IT/informatics with biology processes and efforts
• Carefully crafted QC measures and reporting, and intensive communication among biology and informatics scientists
Zhengping Huang, PhD, Group Leader Bioinformatics, Odyssey Thera, Inc.

3:30 Networking Refreshment Break and Exhibit Viewing

4:15 Managing and Integrating Discovery Data with Semantic Technologies
Decision-making within the life sciences industry requires the integration of data from many disparate sources. However, such
integration has proven to be challenging to achieve due to the complexity of the data. The Semantic Web is a promising new technology for data integration that seems well suited to the challenges of the life sciences industry as it takes advantage of explicit semantics and well-defined ontologies.
• Describes Oracle’s interest in being an early adopter of Semantic Web technologies
• Provides an overview of the Oracle RDF Data Model
• Highlights of experiences gained from implementing Semantic Web technologies within pharmaceutical companies
Susie Stephens, Principal Product Manager, Life Sciences, Oracle

5:00 Executive Roundtables
see page 2 for list of topics

6:00 Networking Reception and Exhibit Viewing

7:00 Close of Day Two

Day Three: Wednesday, September 27, 2006

8:00am Registration and Morning Coffee

8:30 Chairperson’s Opening Remarks

8:45 Plenary Session - Roundtable Findings
see page 2 for details

9:45 Networking Coffee Break and Exhibit Viewing

10:45 Leveraging Partnerships to Ensure Successful Integration of Complex HTS Operations and Processes Within a Corporate IT/IS Infrastructure
Wyeth has made a significant investment to plan, design and implement an HTS facility with the capacity to meet the goals and metrics of the Discovery organization. Since the key deliverable from the HTS process is data that enables project teams to decide to support medicinal chemistry efforts, the important role of informatics for data capture, analysis, storage and retrieval was recognized early during the planning phase. What was not so obvious was the required IT/IS infrastructure to enable the day-to-day operations and processes within the facility. This presentation will highlight the key issues, potential solutions and successful strategies implemented based on critical relationships developed between the scientific staff and the IT/IS organization.
• Wyeth’s goals and metrics mandating an investment in HTS
• Designing an IT/IS infrastructure to provide maximal operational
segmentation while maintaining necessary connectivity to the corporate enterprise systems
• Providing third party access for optimum maintenance and service with minimal security risk
• Identification, implementation and training on software tools for data acquisition, analysis, storage and tracking plus management of process logistics
• Building relationships through communication, transparency and shared goals
Jeff Paslay, Vice President, Screening Sciences, Wyeth Research
Victoria Emerick, HTS Operations Manager, Screening Sciences, Wyeth Research
Sue Tomczyk, Associate Director, Discovery Research Applications, Wyeth Research

11:30 Technology Spotlights

12:15pm Networking Luncheon

1:45 Plenary Session – Solutions Provider Panel

Keynote Session 3:
2:30 In-housing the Outsource: Rapid Co-Evolution of a Discovery-Computational Team to Drive Innovation
Michael Hanley, PhD, Vice President of Discovery Research, Amylin, Inc.
Robert D. Feinstein, PhD, VP & CSO, Kelaroo, Inc.
see page 3 for details

Keynote Session 5:
4:15 Democratizing the Discovery Process
Don Rule, MBA, Platform Strategy Advisor for Bioinformatics, Microsoft Corporation
see page 3 for details

5:00 Wrap-Up and Take-Aways

5:15 Close of Conference

Track 2: Bridging Development and IT

Day Two Tuesday, September 26, 2006

7:30am Registration and Morning Coffee

8:30 Chairperson’s Opening Remarks

10:15 Networking Coffee Break and Exhibit Viewing

11:15 Facilitating Drug Discovery and Development Interactions
Drug discovery and drug development traditionally have
been two distinct fields of study. Recently many organizations have begun to realize the potential application of drug discovery technologies in drug development. For example, high-throughput (HT) technologies which were pioneered in discovery a decade ago are now becoming commonplace in development settings. These automation technologies share common strategies for carrying out assays, including pipetting, dispensing of solids, incubation, sampling, analysis, and reporting. As such, similar supporting informatics technologies and strategies can be applied across discovery and development, thereby facilitating a closer interaction between these departments.
• New approach to information management for discovery and how it can be applied in a development organization
• Advantages and challenges involved
Dimitris K. Agrafiotis, PhD, Senior Research Fellow and Team Leader of Molecular Design & Informatics, Johnson & Johnson Pharmaceutical Research & Development, LLC
Adam M. Fermier, PhD, Principal Scientist, Johnson & Johnson Pharmaceutical Research & Development, LLC

12:00pm Applying in silico PK Modeling for Predicting Preclinical Drug Efficacyin Oncology
Pharmacological studies in Oncology, central to making critical go/no go decisions, routinely entail significant time and resources. In order to streamline the process and analysis outputs, XOMA employs innovative in silico modeling and simulation tools based on population statistics to aid both preclinical and clinical studies. In this exemplary study we characterized the dose response relationship with minimum in vivo experimentation. A single dose escalation in vivo study was performed. The biological processes (tumor growth, binding of drug to target and Pharmacokinetics of the drug) were translated into a mathematical framework using the data from the study. This led to the identification of the model parameters which were utilized for further optimal experimental design, i.e. maximum efficacy and minimal toxicity. This study exemplifies the use of IT resources (hardware, software and modeling) to support, interpret and streamline pharmacological experiment.
• Use embedded IT resources together with population statistics experts to co develop prototype systems to support biology initiatives leads to better management of limited resources
• The use of IT tools to optimize in vivo biological experimentation for
critical decision-making
• Effective utilization and adaptation of in silico modeling to support Pharmacology
Seema Kantak, PhD, Director, Pharmacology, Preclinical Research & Development, XOMA, LLC
Serge Guzy, PhD, Senior Scientist II, XOMA, LLC

12:45 Lunch on Your Own (Sponsorship Available)

2:00 Human as a “Bridge” between Drug Discovery and IT: In silico Screens and Tools for ADME/Tox
In today’s information age, IT functions are essential in pharmaceutical
industry, which is under extreme pressures to enhance productivity and cut costs associated with discovery and development of drugs. In order to judiciously and effectively employ limited IT resources we utilized a “human bridge” conversant with IT and ADME in getting only those tools developed that, on one hand, conform to the IT infrastructure of the organization and, on the other, enhance productivity of bench scientists. The session will focus on one such tool, visdom – visual in silico design of molecules.
• Application of visdom in reducing the number of compounds that are
synthesized and the number of ADME assays that are conducted
• Implementation of visdom as an integral part of the discovery process spanning acquisition of compounds through lead optimization
Vijay Gombar, PhD, Research Advisor, Eli Lilly and Co.
Jeffrey W. Cramer, Research Scientist, Lilly Research Laboratories, Eli Lilly and Co.

2:45 Incorporating in situ/in silico Approaches for Developing Supreme and Desirable Drug Products
Application of computation/simulation technology during drug discovery and development has the potential to decrease the length of time and accelerate the product development prior to NDA submission, and most importantly to reduce the number of experimental trials required for pharmaceutical screening and selection. Session highlights will be presented on exploiting modern new information technologies and molecular pharmaceutics approaches for optimizing the processes of drug development in bridging the management, scientists, clinical researchers, and the informatics staffs.
• Brief introduction of strategies and logistics of modeling and simulation
• Blend of a novel approach of using in situ gastrointestinal absorption/metabolism model with in silico methods
• Enlightenment of developing tailor-made evaluation simulation models for optimum pharmaceutical and clinical designs and practices
• Highlights of a few examples
Dongzhou Liu, MSc, PhD, PDF, Principal Investigator, Forest Research Inst.

3:30 Networking Refreshment Break and Exhibit Viewing

4:15 Drug Metabolism in silico: Using SNPs and Software to Understand Metabolites
Roche Pharmaceuticals has developed a large database cataloging genetic differences in inbred mouse strains. This database is used to predict genetic factors involved in disease susceptibility, response to treatment, toxicogenomics, and drug metabolism. In this session, methods for examining a genetic database are introduced, with the specific application of how a drug is metabolized in vivo. It is then shown how the computational use of genetic information leads to a greater understanding of an experimental result. The ultimate aim of the work is to apply personalized medicine in the clinic using genetic and computational approaches.
• How to build a genetic database
• What predictions can be made using SNP data
• How variations in drug response is a critical aspect of future phama
• What is the current state of pharmacogenomics
Jonathan Usuka, PhD, Department Head, Genome Informatics, Roche Palo Alto

5:00 Executive Roundtables
see page 2 for list of topics

6:00 Networking Reception and Exhibit Viewing

7:00 Close of Day Two

Day Three: Wednesday, September 27, 2006

8:00am Registration and Morning Coffee

8:30 Chairperson’s Opening Remarks

8:45 Plenary Session - Roundtable Findings
see page 2 for details

9:45 Networking Coffee Break and Exhibit Viewing

10:45 Integrating ADME Data into ABCD Informatics Platform
In 2005 J&J had unveiled a new unified informatics platform for drug discovery known as ABCD. ABCD combines advanced database components with the state of the art desktop tools that allow user to perform all informatics operations within the same integrated environment. Over the past year this platform has been substantially expanded to handle even more informatics needs in drug discovery operations. A case study will describe several ADME assays where ABCD platform provides means for request submission and management, tools for experimental data analysis and upload, as well as integrating query and reporting capabilities.
• Overview of the J&J PRD’s ABCD informatics platform
• Introduction to ADME operations at the Spinrg House site
• Integration of request submission, request management, data analysis and upload
• Accessing ADME results via ABCD
Norman D. Huebert, PhD, ADME Team Leader, Johnson & Johnson Pharmaceutical Research and Development, LLC
Victor Lobanov, PhD, Principal Scientist, Johnson & Johnson Pharmaceutical Research and Development, LLC

11:30 Technology Spotlights

12:15pm Networking Luncheon

1:45 Plenary Session – Solutions Provider Panel

Keynote Session 5:
4:15 Democratizing the Discovery Process
Don Rule, MBA, Platform Strategy Advisor for Bioinformatics, Microsoft Corporation
see page 3 for details

5:00 Wrap-Up and Take-Aways

5:15 Close of Conference

Track 3: Bridging Clinical and IT

Day Two: Tuesday, September 26, 2006

7:30am Registration and Morning Coffee

8:30 Chairperson’s Opening Remark

10:15 Networking Coffee Break and Exhibit Viewing

11:15 Clinical Biomarker Discovery: Developing Effective IT Systems and Business Processes in an Uncertain, Quickly Evolving Environment
Clinical trials for biomarker discovery operate at the juncture of basic research and traditional clinical trials. It is essential that data management not become an impediment to the study: legal and regulatory requirements for the use of the data must be met but can not impede efficient flow of information essential to the research enterprise. There is also an unparalleled need for effective communication between study sponsors, external collaborators and regulatory agencies. Uncertainty about the regulatory requirements regarding biomarker data also must be considered. The session will discuss strategies for building and maintaining processes, within and between the IT and scientific teams, which ensure agility and responsiveness in deploying IT solutions, while avoiding costly missteps.
• Create processes that ensure tight integration of scientific and IT teams from the beginning of a project
• Leverage IT experience with other projects to help inform decisions – even those that fall outside traditional IT boundaries
• Involve IT in initial discussions with external collaborators to significantly reduce the likelihood of expensive data communication failures later
• Manage interactions of the scientific and IT teams with other organizations in the enterprise that will have significant input into the creation and completion of a successful study
James McGurk, PhD, Manager, Research Information Systems, Merck & Co., Inc.
Peter M. Shaw, Ph.D., Senior Director, Oncology/Clinical Research, Merck & Co., Inc

12:00pm Implementing a Clinical Trial Management System (CTMS): Benefits and Lessons Learned
Many companies and CROs are choosing to use Clinical Trial Management Systems (CTMS) to better manage the components of their studies. When choosing to implement and utilize one of these dynamic systems, many benefits and challenges can arise. It provides an innovative and globally-accessible way to view current study status. This information can then be used to track study milestones and better plan for the future. Session highlights will include the following:
• Partnerships between clinical users and representatives with the IT department
• Vendor systems vs “home grown” applications
• Patient visit design and study set up
Melissa Newcomer, Section Manager, Global Clinical Quality and Training, Allergan, Inc.
Wollansa Habtu, Sr. Systems Analyst, Research and Development Scientific Information Services, Allergan, Inc.

12:45 Lunch on Your Own (Sponsorship Available)

2:00 Building a Clinical Data Warehouse A successful story of establishing Clinical Data Warehouse
(CDW). Due to rising drug research cost, a more portable and scalable technical solution is getting critical. Finding
economic ways of managing clinical data and optimizing the usages are required in pharmaceutical industry. This session will cover the joint team creation process, joint strategy planning, the selection of the best breed common technology, and the process of building strong knowledge sharing between IT and business area for long term success.
• Understand the current challenges of drug research operation
• The importance of utilizing new common technology
• The challenges of building Knowledge Bridge from IT to drug research area
Albert D. Kuo, Associate Director, Clinical System, Millennium Pharmaceuticals, Inc.
Richard Ferrante, Associate Principal Software Engineer, Informatics Management, Millennium Pharmaceuticals, Inc.

2:45 Improving Business Processes Related to Drug Development through Secure, Standardized Electronic Information Exchange
On average, a new drug progressing through development to a Phase III study generates more than 6 million pages of paper and nearly $900 million in costs. Technology has created a fundamental shift in the way drugs are developed, manufactured, and marketed. Cross-industry collaboration in the use of electronic information has become vital. The SAFE (Signatures and Authentication for Everyone) digital identity was developed specifically for the pharmaceutical and healthcare industries to provide a secure, enforceable, convenient, and cost-efficient way to identify the parties involved in electronic transactions. This digital identity can be used to enable a regulatory compliant, legal electronic signature, provide for strong authentication of identity and encryption of information. The technology at the heart of the SAFE digital identity is public key infrastructure (PKI), a system of hardware, software, people and processes that provide a secure digital environment to issue, revoke, archive and recover digital certificates.
• Learn about the SAFE global standards
• Hear a case study of how this technology is providing value to the Johnson & Johnson family of companies by looking at how digital signatures are have enabled the elimination of paper in regulated processes
Gary Secrest, Director of Worldwide Information Security, Johnson & Johnson; Chairman, SAFE-BioPharma Association

3:30 Networking Refreshment Break and Exhibit Viewing

4:15 Biomedical Informatics Support for Proteomics in an Academic Health Center
The Penn State University College of Medicine, an organization which encompasses basic research, preclinical research, clinical research and clinical practice is building a system to support the information technology needs of its basic and clinical researchers. Basic researchers, staff scientists, computer scientists and information technology professionals are working closely together to facilitate the creation of an extensible data model to support translational research. An early outcome of this effort resulted in a system to improve the identification of ubiquitinated peptides through mass spectrometry. This talk will discuss the highlights the activities at Penn State, such as:
• Emerging standards to establish interoperability between information system that reside in different parts of the translational research cycle
• Process of establishing institutional “buy-in”
• Selection of various technologies and the Service Oriented Architecture
Richard Rauscher, MS, Director of IT, Penn State Cancer Institute, Penn State University
Bruce A. Stanley, PhD, Director of Mass Spectrometry/Proteomics, Penn State University

5:00 Executive Roundtables
see page 2 for list of topics

6:00 Networking Reception and Exhibit Viewing

7:00 Close of Day Two

Day Three: Wednesday, September 27, 2006

8:00am Registration and Morning Coffee

8:30 Chairperson’s Opening Remarks

8:45 Plenary Session - Roundtable Findings
see page 2 for details

9:45 Networking Coffee Break and Exhibit Viewing

10:45 Capacity Utilization Modeling for Process Development Scheduling
Development groups frequently must advance multiple products on limited resources and tight timelines. To address these challenges, we have adapted a capacity utilization modeling platform to schedule and de-bottleneck drug development from cell line development to GMP production. This presentation will describe the selection of a model, implementation and results of our modeling efforts.
• Choosing the model, and the model structure
• Overcoming technical/training hurdles, testing and implementation
• Examples of scheduling scenarios
• Debottlenecking solutions
Nicolina Hull-Campbell, Scientist, Pharmaceutical Development, XOMA (US) LLC

11:30 Technology Spotlights

12:15pm Networking Luncheon

1:45 Plenary Session – Solutions Provider Panel

Keynote Session 4:
3:15 Aligning Technology with Science: How Clinical Data Feeds Back into the Discovery and Development Process
Anastasia M. Khoury Christianson, PhD, Director and Global Skill Leader, Discovery Medicine Informatics, AstraZeneca R&D (Invited)
see page 3 for details

Keynote Session 5:
4:15 Democratizing the Discovery Process
Don Rule, MBA, Platform Strategy Advisor for Bioinformatics, Microsoft Corporation
see page 3 for details

5:00 Wrap-Up and Take-Aways

5:15 Close of Conference