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7:30 am Breakfast Presentation (Opportunity Available)
Contact Jon Stroup at 781-972-5483 or jstroup@healthtech.com for information.
8:30 Chairperson’s Remarks
Ling Santora, Ph.D., Senior Scientist, Biologics, Abbott Bioresearch Center
8:35 The Biological Pharmacy
Ling Santora, Ph.D., Senior Scientist III, Biologics Pharmacy, Abbott Bioresearch Center
Abbott Laboratories conducts research and development in small molecule and Biologics drug candidates in different indications and at different locations globally. The Biologics Pharmacy, as the biologics reagent inventory center at Abbott Bioresearch Center, provides and qualifies commonly used protein reagents for biologics research and discovery across the company. The Biologics Pharmacy routinely transfers, registers, aliquots, dispenses and ships protein reagents across all research departments within Abbott globally. Biologics Pharmacy protein reagents and relevant documentation are accessed globally using Biologics Pharmacy inventory database through the Abbott intranet web page. The Biologics Pharmacy manages reagent releasing criteria to ensure protein reagent quality and maintains protein reagent quality documentation, embodied in a Certificate of Testing (CoT), receiving and dispensing records to ensure tractability of reagents through a reagent inventory database. The Biologics Pharmacy interacts closely with Abbott’s internal Informatics groups to maintain and improve Biologics Pharmacy Inventory Database and Global Biologics Registration System (GBRS).
9:05 Compounding Sample Management Challenges: Introduction of Biologics Libraries
Adrian Poffenberger, M.S., Director, Yale Center for High Throughput Cell Biology, Yale University
Management of siRNA libraries shares principles derived from small molecule compound screening, yet important differences exist in managing and screening these distinct sample types. Our experience, equipment, and established processes, originally developed for small molecule screening, were adapted and successfully applied to high throughput screening of partial- and full-genome siRNA libraries. This session will compare the reagent libraries in terms of inventorying, processing & preparation, screening, and data management.
9:35 Evolution of a cDNA, RNAi Library Management System
Karen Billeci, Scientific Manager, Assay & Automation Technology Group, Genentech
Over the last 10 years we have seen significant growth in our cDNA and shRNA collections from just a handful of clones/oligos to over 400,000 clones. Bioinformatics has provided excellent tools to identify plamids/oligos in our collection, but these databases have not been useful as a tool to manage our library inventories. The following talk will discuss our experience developing a cDNA and RNAi inventory management structure and integrating inventory management needs into the gene based database search structure.
10:05 Sponsored Presentation (Opportunity Available)
Contact Jon Stroup at 781-972-5483 or jstroup@healthtech.com for information.
10:20 Morning Coffee Break with Exhibit and Poster Viewing
11:00 EXPERT PANEL:
Recruiting and Retaining Compound Management Professionals
Moderator: Greg Wendel, Ph.D., Consultant
Panelists:
Robert Smith, Ph.D., Head, Compound Management, Novartis Institute for Biomedical Research
Moneesh Chatterjee, Ph.D., Group Leader, Compound Management, Bristol-Myers Squibb
Karen Billeci, Scientific Manager, Assay & Automation Technology, Genentech
Edward Heebner, Director, Compound Management, Ligand Pharmaceuticals
Managing staff is just as important as managing your compounds. Compound/Samples Management groups perform many
- Hear techniques and approaches to reducing employee attrition and reducing training timelines.
- Industry and academic panelists will share their experiences, methods and success stories for recruiting and retaining compound management professionals.
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12:00 pm Close of Morning Session
12:15 Sponsored Luncheon Presentation
(Opportunity Available) or Lunch on Your Own
Contact Jon Stroup at 781-972-5483 or jstroup@healthtech.com for information.
1:30 Chairperson’s Remarks
John J. Isbell, Ph.D., Director, Analytical Sciences and DMPK, Genomics Institute of Novartis Research Foundation (GNF)
1:35 Informatics for Biologics
Jeremy Packer, Ph.D., Head, Bioinformatics, Abbott Laboratories
Similarities and differences between small molecules and biologics from an informatics perspective will be presented along with a discussion of the central position of registration in compound information management. Integration of multiple systems into a unified information framework will be addressed in this presentation as well.
2:15 Compound Management Informatics: A Unifying System for Small Molecules and Proteins
 John J. Isbell, Ph.D., Director, Analytical Sciences and DMPK, Genomics Institute of Novartis Research Foundation (GNF)
Cheminformatics plays a key role in integrating compound management within a drug discovery organization. The successful expansion of compound management from compound storing, caretaking and delivery to tracking compound solution integrity and concentration and associating these important data with assay results requires implementation of innovative solutions and buy-in from key stakeholders.
Our success with small molecule compound management led to added responsibilities in handling proteins, which in turn led to adaptation of compound registration to support protein registration. Similar to the solution used for small molecules, our sequence-based protein registration system integrates with several corporate and public databases, linking a protein record to protein analytical database, the functional genomics database and various public bioinformatics databases. As will be shown, the extension of the commonly-used tools of medicinal chemists, such as analog search, availability search and mechanism of action annotations, have enhanced the value of the data generated.
Sponsored by
 2:45 Is There a Home for Automated NMR Verification in Compound Management?
Ryan Sasaki, NMR Product Marketing Manager, Advanced Chemistry Development, Inc., (ACD/Labs)
The compound libraries of pharmaceutical companies have often been referred to as the “crown jewels” or the “core of their intellectual property”. However, despite the incredible value that has been attached to these libraries, the analytical efforts to verify the compound’s identity, have been under-emphasized. With the shift in many drug discovery laboratories from analytical service environments to open-access and walk-up environments, fewer compounds are going through expert analytical analysis before compound registration. Add to this compounds that can go through degradation or precipitation in-house, or compounds from libraries that are obtained from outside the organization prior to screening efforts, and the possibility for discrepancies is real.
This talk will investigate the advances in high-throughput analytical data collection, but most notably the performance of automated structure verification routines using both LC-MS-UV and NMR data in an unattended validation environment. In addition, liabilities and risks of current approaches will be discussed.
3:00 Chairperson’s Remarks
Sue Holland-Crimmin, Ph.D., Site Head & Director of Sample Management and Technologies, Philadelphia, GlaxoSmithKline
3:05 Quality Approaches in Sample Management: Best Practice, Current Status and Future Challenges
Sue Holland-Crimmin, Ph.D., Site Head & Director of Sample Management and Technologies, Philadelphia, GlaxoSmithKline
Quality initiatives in sample management are now well established as best practice in the industry. This presentation will describe these approaches to sample stability, quality monitoring and control of processes, material and data together with the cost benefit of these approaches. Furthermore, some of the challenges and potential opportunities will be described as new technology is implemented in mainstream processes.
3:35 Refreshment Break – Last Chance for Poster and Exhibit Viewing
4:00 Explaining the Unexplained: Quality Questions Answered
Moneesh Chatterjee, Ph.D., Group Leader, Compound Management, Bristol-Myers Squibb
- Do solvent-extractable contaminants from plastic labware possess biological activity and impact biological assay results?
- Bio-characterisation of contaminants: Applying analytical chemistry to prepare samples for testing
- Using chromatography/mass spectroscopy analysis of the DMSO-extracted material to study various contaminants
- Solutions to preventing contamination
4:30 Integrating LCMS Automation for HTS Compound Management
Louis Scampavia, Ph.D., Senior Engineer, Associate Professor, Lead ID, The Scripps Research Institute
From compound synthesis through HTS hit confirmation, automation of LCMS analysis is critical in providing timely informatics in the Drug Discovery process. Scripps has implemented a flexible LC-MS platform for quality control of small-molecule samples at several stages in the drug discovery process. In addition to analytical flexibility, the platform is capable of automation of analysis, summarization of standardized results and is also compatible with our corporate database. Presented are case studies focusing on how the platform balances analytical sensitivity with automation, and its implementation with respects to QC/QA in our HTS operations
5:00 Talk Title to be Announced
Theodore Mifflin, Ph.D., Technical Director, TCL Laboratory, University of Pennsylvania School of Medicine
5:30 Close of Conference
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