|
|
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 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
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 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
|
Keynote Session 3:
11:30 EDC: Implementation through Partnership
To be successful, an electronic data capture
(EDC) implementation requires new processes, new technology, and people working in new and varied roles. With EDC there is a learning curve. New processes have to be developed. Established methods need to change, and processes have to be reassessed and adjusted. An
EDC-enabled study requires more upfront planning than a traditional paper-based study. EDC also introduces new cross-functional dependencies and new tasks into an organization. Initially, these can stress an organization’s clinical study planning and development processes -- creating conflict or confusion. This session will focus on the partnership between business and informatics teams at Bristol-Myers Squibb that led study teams to adopt new practices and work differently in the course of a successful EDC rollout.
|
|
Lisa Garrison, Business Process Manager, Bristol-Myers Squibb ,Global Biometric Sciences, Exploratory Development |
|
Ed Kellar, EDC Implementation Lead (Consultant), Bristol-Myers Squibb, Pharmaceutical Research Institute Information |
|
|
12:15pm Networking Luncheon
1:45 Plenary Session – Solutions Provider Panel
Keynote Session 4:
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.
 |
Lisa Garrison, Business Process Manager, Bristol-Myers Squibb ,Global Biometric Sciences, Exploratory Development |
|
Robert D. Feinstein, PhD, VP &
CSO, Kelaroo, Inc. |
|
|
|
Keynote Session 5:
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 6:
|
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
|
