1:50 Chairperson's Remarks
1:55 HELM: An Open Standard for the Representation of Complex Biomolecules
Sergio Rotstein, Ph.D., Director, Research Business Technology, Pfizer, Inc.
The steady increase in therapeutic research involving complex biologic entities has exposed a gap in the ability of traditional informatics tools to deal gracefully with these types of molecules. HELM is a new open standard that enables the representation of a diverse set of complex macromolecules such as oligonucleotides, proteins, antibodies, antibody-drug conjugates, etc., including those containing unnatural and chemically-modified components. This presentation will describe the HELM standard and associated toolkit, its origins and use at Pfizer, and the Pistoia Alliance HELM project that has transitioned the technology into the open source, making it available freely and openly to the biopharmaceutical industry at large.
2:15 Using Standardized Digital Identities to Develop, Protect, and Leverage Intellectual Property
James DeZazzo, Ph.D., Esq., Corporate IP Counsel, Dart NeuroScience
The chief intellectual property attorney for Dart NeuroScience will explain how the company's early adoption of standardized digital identity and signing technology is resulting in cost/time savings and other productivity improvements regarding its intellectual property. These enhancements are broadly based, encompassing not just patent-based assets, but other property such as trade secrets and proprietary databases using open source software. More generally, the implementation of digital standards is enhancing the company’s ability to develop and leverage IP assets – for example, by simplifying transactional and regulatory transactions. The intent of this presentation is to provide young and well-established biopharmas with important insights about early adoption of standardized digital identity and signature technology and its use to effectively develop, secure, and leverage IP assets.
2:35 Summary: FDA Software-Tools Reform
John A. Norris, J.D., MBA, Chairman, Norris Capital, Inc. and FDDH, Inc.; Senior US Advisor to Kanagawa, Japan, Governor Kuroiwa and GCC
This presentation discusses the efforts of the Global Collaborative Center (GCC) in helping to reform the U.S. FDA’S review methods and standards relating to data/business intelligence analytics and decision-support software tools for new medical device products. To view longer abstract, please click here.
2:55 Metabolync™: A Cloud-Based Solution for Sharing, Visualizing and Analyzing Metabolomics Data
Corey DeHaven, Vice President, Information Systems, Metabolon, Inc.
Metabolomics experiments may generate a large amount of data including both named and unnamed metabolites, group statistical analysis and biological pathway annotations. Data visualization and analytical tools are required to aid in understanding the data and relationships among detected metabolites and their effects on the underlying biology. Metabolync™ leverages cloud-based resources and web service API's to enable these functions.
3:10 Accelerate Insights – Processing Intense Simulations and Big Data Analysis
Nick Ihli, Senior Systems Engineer, Adaptive Computing
Adaptive powers the world’s largest and most robust datacenters with its scheduling and optimization software, Moab. Moab plays a huge role in accelerating insights for researchers and IT professionals. Learn about how Big Workflow accelerates insights by efficiently procession intensesimulation and big data analysis- unifyingHPC, cloud and datacenterresources, optimizing the analysis process and guaranteeing services to the business -speeding time to discovery.
3:25 Refreshment Break in the Exhibit Hall with Poster Viewing
4:00 Transforming Scientific Information into Business Intelligence through Search-Based Applications
Robert Hernandez, Informatics Scientist, AstraZeneca
The inability to harness data for scientific decision-making is a problem that negatively impacts organizations worldwide. The AstraZeneca R&D search vision is to leverage internal and external data and create insights that deliver novel search-based business applications. This presentation demonstrates the power of building search-based applications that leverage 200 million scientific documents as a solution.
4:30 In Pursuit of Knowledge Management: The Implementation of a Highly Adopted Database within a Drug Substance Process Development Department
Russell Van Buskirk, Senior Associate Scientist, Purification Process Development, Amgen
As development timelines decrease, knowledge management of drug substance development data becomes essential. Historically, the adoption of searchable databases requiring dedicated data entry by scientific staff has been low. The time savings inherent in electronic lab notebook templates with automatic report generation capabilities is perceived by the scientific staff as a benefit to their daily work flow and increases adoption with the added benefit that the template doubles as a future searchable database.
5:00 Sponsored Presentations (Opportunities Available)
5:30 - 6:30 Best of Show Awards Reception in the Exhibit Hall
THURSDAY, MAY 1
7:00 am Registration Open
7:00 Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:00 Chairperson’s Opening Remarks
Kevin Davies, Ph.D., Vice President Business Development & Publisher C&EN, American Chemical Society; Founding Editor, Bio-IT World
8:05 PLENARY KEYNOTE SESSION
Click here for detailed information.
10:00 Coffee Break in the Exhibit Hall and Poster Competition Winners Announced
10:30 Chairperson's Opening Remarks
10:35 From Animal to Image - Integrating a Research Pathology Lab Environment at Roche pRED
Angelika Fuchs, Ph.D., Senior Scientist, pRED Informatics, Roche pRED
We present an exemplary case study where several components (in house implemented tools as well as customized commercial platforms) have been successfully integrated into a departmental system landscape for the pathology department in Roche pRED leading to a strong increase in transparency as well as efficiency. One major component is the first installation of a system for sample tracking used in routine pathology labs within a pharma research environment exemplifying how innovation originating from the clinical and diagnostic space can be used with great benefit within a pharma exploratory research environment.
10:55 Navigator Workbench - An Integrated Analysis Platform for Modeling & Simulation
Alexandra Grebe de Barron, Ph.D., Consultant, R&D IT Early Development, Bayer Pharma AG
We will present an integrated platform for modeling and simulation (population PK/PD analysis) in a regulated environment. The first results of the proof-of-concept at Bayer Pharma AG will be shown. The solution includes an internal high-performance cluster for routine analysis and a private external cloud for peak computing demands. Data security and validation approach will also be presented.
11:15 Enterprise Level SharePoint Administration for Program Management
Brian Bissett, IT Specialist, Office of Systems, Social Security Administration
SharePoint is rapidly becoming ubiquitous as the tool of choice for online collaboration, document management, portals, workflows, approval chains, and intranet sites. Using InfoPath, SharePoint’s capabilities can be expanded to design, distribute, file, and submit electronic forms containing structured XML data. Numerous third party tools can expand both SharePoint and InfoPath’s capabilities far beyond their original scope to include functions such as Project Management, Dashboarding, and Asset Management. Limitations, pros and cons, and cost effective solutions will be discussed.
11:35 Sponsored Presentations (Opportunities Available)
12:05 pm Luncheon Presentation I
Speaker to be Announced
12:35 Luncheon Presentation II (Sponsorship Opportunity Available)
1:15 Dessert Refreshment Break in the Exhibit Hall with Poster Viewing
1:55 Chairperson's Remarks
2:00 Data Security – Keep It Simple, But Make It Sexy!
Jon Reich, IT Program Quality Manager, AIT, Novartis/HGP Asia
Keeping pace with the evolving threats to information security posed by the ever-changing global information space is an organizational challenge. Across Southeast Asia, companies are struggling to interpret and apply appropriate data security controls. The application of an integrated framework simplifies the management of these controls and their ongoing development and refinement.
2:30 Information Classification: The Key to a Sane Security Strategy
William Telford, Director, R&D IS Security, Sanofi R&D
Understanding your information is key to your security success and enables collaboration. This talk will address the key topics to consider and challenges that must be overcome.
3:00 PANEL DISCUSSION: The Big Data Storage and Security Maze: Balancing Collaboration and Privacy
Moderator: Toby Bloom, Ph.D., Deputy Scientific Director, Informatics, New York Genome Center
Philip Groth, Ph.D., IT Business Partner, CoE Research, Bayer HealthCare Pharmaceuticals
John Sabey, President, Sabey Data Center Properties
William Telford, Director, R&D IS Security, Sanofi R&D
Additional Panelists to be Announced
Big data has led to organizations turning to virtual networks for information storage and processing. Thus, unauthorized access to data and implementation of effective governance structures are growing concerns. To balance knowledge sharing and respect for confidentiality, researchers must consider how and where to store and secure data – plus what data and why. This panel gathers representatives from academia, pharma and IT to discuss these issues. Topics include:
- How secure is your data?
- When should you favor data sharing and when should you restrict data flow?
- What data actually needs to be protected in the first place?
- What security systems and practices are most appropriate for specific research needs?
4:00 Conference Adjourns
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