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Day Two: Monday, October 1, 2007

8:30 Chairperson's Opening Remarks

8:45 Keynote Session 1: Bridging Diagnostics Technologies with Pharma and Biotech (see page 2 for details)
Tim Jaeger, Ph.D., M.B.A., Head of Medical and Scientific Affairs, Diagnostics Division, F Hoffmann La Roche AG

TRACK 1: BRIDGING DISCOVERY/DEVELOPMENT AND IT

TRACK 2: BRIDGING CLINICAL AND IT

9:30 Developing of Enabling Informatics Technology in Support of the Development of Drug Candidates
When implementing the strategy for the development of a biological candidate one needs to consider the regulatory environment and the molecular complexity of the drug candidate. To meet the changing product development requirements, various strategies were implemented for the development of analytical technology as well as informatics technology for supporting the development cycle. The various analytical technologies that have been implemented have lead to a higher throughput such that the bottle neck has switched from sample management to data management. As the throughput increased within the laboratory, there needs to be a marriage between the analytical technology and the informational technology. The lab of the future will need to develop informatics systems that integrate the information supplied from a materials management system, a laboratory information management system, an electronic laboratory notebook system, a data archival system and a data documentation system. In this presentation will discuss how higher sample throughput has lead to the integration of various analytical and informatics solutions.
Julie Hughes, Global Biologics Business IT Lead, Pfizer Global Research & Development
9:30 Developing a Knowledge Discovery Platform for Collaborative Research in Gastric Cancer
The Gastric Cancer Knowledge Management System (GCKMS) was a joint project between the Singapore General Hospital, National Cancer Centre and Nanyang Polytechnic. The objective of this project was to aggregate clinical, diagnostic and experimental data into a common data pool for Gastric Cancer. The comprehensive representation of Gastric cancer will provide for data mining and predictive modeling opportunities. The session will focus on the following:
  • Motivations for the development of this knowledge management system
  • The technical design of the database system deployed
  • Privacy and confidentiality issues and concerns of patients recruited into the research projects
  • Challenges faced in aggregating data from various clinical and experimental sources

Dr. Alvin Eng, MBBS, Registrar, Department of General Surgery, Singapore General Hospital
Adrian Png, MTech, Project Specialist, Bioinformatics Group, Nanyang Polytechnic

10:15 Networking Coffee Break & Exhibit Viewing

11:00 Making the Most of Limited Resources: Creation of a Merck-wide Biologics Database
Cell lines, cDNA clones, and antibodies are critical assets in target discovery and assay development. Scientists may spend precious resources either licensing or isolating and optimizing a critical biological reagent, only to find later that it existed elsewhere within the company. Yet despite their importance, until recently there were no tools available for scientists to quickly find what biological reagents were available within Merck. BioStore, an internally designed web application, has been built in phases to allow for management and registration of these reagents. This application has also been linked to a corporate search engine to enable one-stop shopping. This session will highlight the following areas:
  • Business drivers for a Biological Materials Database
  • Funding models for IT development
  • Application interface challenges
  • Ownership and Governance
  • Corporate Culture considerations

Lori Harmon, Manager, Drug Discovery Project Support/MRL IT, Merck & Co., Inc.
Vic Uebele, Ph.D., Research Fellow, West Point Sleep & Schizophrenia, Merck & Co., Inc.

11:45 Advancing Upload and Storage of Assay Data
The structure of data produced by experiments in Pharmaceutical R&D are typically influenced by the assay protocol definitions, where a protocol is an agreement on how a particular assay needs to be run. The diversity of biological protocols leads to a proliferation of data structures, most of which differ only in non-essential ways. At Johnson & Johnson PRD, we have been very successful in data persistence by implementing a universal framework of the experimental method. That is, an experimental method defines a complete set of parameters, their behaviors and the interrelations between them. Such an approach enables the isolation of the experimental method as a core component in data registration and persistence applications. A protocol then simply subscribes to one or more experimental methods. This approach accentuates the fact that while protocols number in the thousands, the experimental methods number in the tens. As a part of the Advanced Biological and Chemical Discovery (ABCD) platform that provides a unified and flexible set of advanced tools to the scientists at J&J PRD, we have successfully released a data registration system that implements the experimental method as a universal concept.
Simson Alex, Ph.D., Informatics Developer, Johnson & Johnson Pharmaceutical Research & Development LLC
Victor Lobanov, Ph.D., Principal Scientist, Johnson & Johnson Pharmaceutical Research and Development, LLC

11:00 Biomedical Imaging in Clinical and Discovery Medicine
Goutham Edula, Ph.D., Business Lead, Clinical Imaging Informatics, AstraZeneca

11:45 IT Support for the Clinical Use of Genetics and Genomics – Could the Infrastructure in Place Today Be Strengthened through Collaborations with Pharma IT Departments? 
Increasing use of genetic and genomic testing has the potential to dramatically improve the care of patients but will also put new stresses on the healthcare system. As a growing number of genetic variants are identified in patients, it will be increasingly difficult for physicians to track the implications of all of these variants. Healthcare IT systems can help address this issue but only if they have access to structured databases associating genetic variants with useful clinical facts. Pharmaceutical companies could be helpful in establishing the infrastructure needed to provide healthcare providers access to this knowledge. Furthermore, challenges in supporting laboratory processes and breaking data silos are common to both the pharmaceutical and healthcare/clinical research environment. This also represents a ripe area for collaboration.

  • A walkthrough of the IT infrastructure that is in place within the Harvard Medical School – Partners HealthCare Center for Genetics and Genomics to support laboratory operations and the reporting of genetic variants
  • An explanation of how this infrastructure integrates with the Partners HealthCare Electronic Medicine Record and how genetic awareness and clinical decision support is being implemented in this environment
  • A discussion of how we would like to expand this infrastructure to further advance genetic and genomic based personalized medicine and how we believe Pharma may be able to help

Samuel (Sandy) Aronson, Director of IT, Harvard Partners Center for Genetics and Genomics (HPCGG)
Heidi Rehm, Ph.D., Geneticist, Harvard Partners Center for Genetics and Genomics (HPCGG)

12:30pm Luncheon Workshop (Sponsorship Available) or Lunch on Your Own 

2:00 An Integrated Desktop Computing Environment for Chemists
Increased use of in silico calculated molecular properties, pharmacophore and QSAR models, and structure-based drug design calculations to assist the drug discovery effort has resulted in heavy demand being placed on computational chemists to deliver modeling results. To address this demand, we have implemented a system to place many such tools normally accessible via ‘expert’ software packages on Unix or Linux machines directly in the hands of medicinal chemists and biologists. The system is underpinned by the Computational Chemistry Toolbox, a set of commonly used routines accessible in a central server area by many desktop applications.
  • The high-level architecture of the system will be described
  • Application uses for reagent selection, property calculations, docking and scoring, and pharmacophore modeling calculations will be shown
  • Placing easy to use tools directly on the chemist’s desktop machines via java-based front ends takes the load off the computational chemist to do database searches and computational chemistry calculations
  • Ready access to computational chemistry tools facilitates a ’design culture’ in the discovery of new medicines

Daniel Ortwine, Research Fellow, Chemistry Technologies, Pfizer, Inc.
Robert Goulet, Ph.D., Senior Principal Scientist, Pfizer, Inc.

2:45 Building a Seamless Service - Implementing an SOA-Based Global Compound Sourcing Tool for Chemists 
Mike Rippin, Ph.D., Director, Operations, Tessella, Inc. 
Customer Co-Presenter TBD

2:00 Are We Playing Dice With Informatics Projects?
All too often research management launches new Informatics initiatives without the planning and support necessary to ensure success. Projects teams are often hastily assembled with lofty but ill-conceived goals. Requirements for large projects defined in 2-3 pages of bullet points become the target for the project, but these do not begin to convey the changes in workflow that the researchers will need to undergo. When informatics projects are successful, it is because management and project teams make the right investment. Researchers and management are involved at all stages along the way to ensure that the organization is ready to integrate new informatics systems into the fabric of the research process. Examples will be presented from a clinical process assessment project and a clinical LIMS implementation project. Discussion of these projects will highlight the collaboration of business functional groups and IT to resolve the systems and process related issues, such as organizational methodology, and systems changes needed to support the business.
Haishan Jang, Ph.D., Director, Scientific Systems & Process Management, Clinical Pharmacology & Experimental Medicine, Centocor R&D, Inc.
Rob Studt, Functional Area Lead for Clinical, Centocor R&D, Inc.
Bob O’Hara, Associate, Centocor R&D, Inc.

2:45 Technology Highlights 
Better appreciate the interplay of the research and technology drivers impacting pharmaceutical and biotechnology companies, and learn to apply them productively within your own organizations. Find out more about these solutions and capabilities to help you tackle your daily challenges.

3:30 Networking Refreshment Break & Exhibit Viewing 

4:00 Keynote 2: Creating the IT Infrastructure to Enable Adaptive Clinical Development (see page 2 for details)
Jerald S. Schindler, Dr.P.H., Vice President, Late Stage Clinical Development Statistics, Merck & Co.

4:45 Interactive Roundtable Discussions & Report Outs 
Each concurrent roundtable will be limited to twelve (12) participants and a facilitator. A leader from each roundtable will be chosen to present a short summary of the group discussions. A moderator will then open a discussion amongst all attendees addressing the most critical questions facing the industry. 

5:45 Networking Reception in the Exhibit Hall

7:00 End of Day Two

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