|
|
Day One: Monday, September 25, 2006
PRE-CONFERENCE TUTORIAL
(12-4pm)
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
|
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
Dr. Gerhard Noelken, Director Research Informatics, Research Informatics, Pfizer Global R&D
|
|
|
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
|
|
|
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
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.
- Semantic Web
- Emerging Standards in Biomedical Informatics
- Auditing Software Vendors
- Interoperability of Data Integration and IT Databases
- EDC
- Knowledge Management, Learning Networks, and Collaboration Tools
- Building an In-house Dictionary to Clarify Communication Between
and End-users
- Assay Design with Data Endpoints in Mind
- To Outsource or Not to Outsource?
- Choosing the Right Project Management Model
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
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.
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 Enabling Discovery Intelligence: Improving the Performance of Drug Discovery Teams through Integrated Data Access, Analysis, and Decision Support
David Lowis, D. Phil., Senior Director, Product Management, Tripos,
Inc.
Put simply, Discovery Intelligence is a reimplementation of business intelligence concepts to allow vital discovery information to be rapidly and consistently extracted, comprehended and utilized. The key to enabling Discovery Intelligence lies in providing scientists with a single point of access to dissimilar types of research data and a platform on which to analyze such data. In this session, we will describe how drug discovery organizations are enabling Discovery Intelligence with Benchware® Discovery 360o, an application that provides scientists and research managers with a single point of entry from which they can access, analyze & share data from disparate repositories of biological and chemical data.
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.
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
has taken 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
|
|
|
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
|
|
|
5:00 Wrap-Up and Take-Aways
5:15 Close of Conference
|
